Allegato A
NOME COMPOSTO
ANASTROZOLO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
-Carcinoma della mammella
donne in post-menopausa
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
in -Trattamento del tumore della mammella
maschile
-Trattamento adiuvante negli stadi -Trattamento neoadiuvante delle forme
precoci, estrogeno-positivi
localmente avanzate del carcinoma della
mammella
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Trattamento neoadiuvante nelle forme localmente
avanzate del carcinoma della mammella
Viola G et al. Neoadjuvant endocrine therapy for locally
advanced breast cancer. Clin Ter 2007;158:441-452
Freedman OC et al. Using aromatase inhibitors in the
neoadjuvant setting: evolution or revolution? Cancer Treat Rev
2005;31:1-17
Dixon JM et al. Neoadjuvant endocrine therapy of breast cancer:
a surgical perspective. Eur J Cancer 2002;38:2214-2221
ARSENICO
TRIOSSIDO
-Leucemia promielocitica acuta
-Mieloma multiplo refrattario o recidivante
Mieloma multiplo refrattario o recidivante
-Sindromi mielodisplastiche
Berenson JR et al. Efficacy and safety of melphalan, arsenic
trioxide and ascorbic acid combination therapy in patients with
relapsed or refractory multiple myeloma: a prospective,
multicentre, phase II, single-arm study . Br J Haematol
2006;135:174-183
-Leucemia/Linfomi a cellule T
Berenson JR et al. A phase I/II study of arsenic
trioxide/bortezomib/ascorbic acid combination therapy for the
treatment of relapsed or refractory multiple myeloma. Clin
Cancer Res 2007;13:1762-1768
Wu KL et al. Phase II multicenter study of arsenic trioxide,
ascorbic acid and dexamethasone in patients with relapsed or
refractory multiple myeloma. Haematologica 2006;91:17221723
Sindromi mielodisplastiche
Schiller GJ et al. Phase II multicenter study of arsenic trioxide in
patients with myelodysplastic syndromes. J Clin Oncol
2006;24:2456-2464
Vey N et al. Arsenic trioxide in patients with myelodysplastic
syndromes: a phase II multicenter study. J Clin Oncol
2006;24:2465-2471
Leucemia/Linfomi a cellule T
Ishitsuka K et al. Therapeutic potential of arsenic trioxide with
or without interferon-alpha for relapsed/refractory adult T-cell
leukemia/lymphoma. Haematologica 2007;92:719-720
Hermine O et al. Phase II trial of arsenic trioxide and alpha
interferon in patients with relapsed/refractory adult T-cell
1
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
leukemia/lymphoma. Hematol J 2004;5:130-134
BLEOMICINA
Attività metaplastiche di alcuni -In regimi di associazione nel linfoma di
tessuti (epiteli malpighiani ad alta Hodgkin
cheratinizzazione)
-Da solo o in associazione, nei tumori solidi
Cicli di combinazione per linfomi non-Hodgkin
Gobbi PG et al. The role of dose size in a chemotherapy regimen
(ProMECE-CytaBOM) for the first-line treatment of large B-cell
lymphomas: a randomized trial by the Gruppo Italiano Studio
Linfomi (GISL). Ann Oncol 2006;17:676-682
Tumore dell’ovaio a cellule germinali
-Cicli di combinazione per linfomi non
Hodgkin
Pectasides D et al. Granulosa cell tumor of the ovary. Cancer
-Tumore dell’ovaio a cellule germinali
Lu KH et al. Update on the management of ovarian germ cell
tumors. J Reprod Med 2005;50:417-425
-Carcinoma
uterina
Carcinoma squamoso della cervice uterina
squamoso
della
cervice
-Neoplasie non melanomatose della cute
Treat Rev 2007 [Epub ahead of print]
Vermorken JB et al. Randomized phase III trial of bleomycin,
vindesine, mitomycin-C, and cisplatin (BEMP) versus cisplatin
(P) in disseminated squamous-cell carcinoma of the uterine
cervix: an EORTC Gynecological Cancer Cooperative Group
study. Ann Oncol 2001;12:967-974
Smith HO et al. Treatment of advanced or recurrent squamous
cell carcinoma of the uterine cervix with mitomycin-C,
bleomycin, and cisplatin chemotherapy. Gynecol Oncol
1993;48:11-15
Neoplasie della cute non melanomatose
Mishima Y et al. Effect of bleomycin on benign and malignant
cutaneous tumours. Acta Derm Venereol 1972;52:211-215
BORTEZOMIB
-Mieloma multiplo
-Linfoma non-Hodgkin indolente
Linfoma non-Hodgkin indolente e mantellare
-Linfoma non-Hodgkin mantellare
O'Connor OA et al. Phase II clinical experience with the novel
proteasome inhibitor bortezomib in patients with indolent nonHodgkin's lymphoma and mantle cell lymphoma. J Clin Oncol
2005;23:676-684
-Sindromi mielodisplastiche
Fisher RI et al. Multicenter phase II study of bortezomib in
patients with relapsed or refractory mantle cell lymphoma. J
Clin Oncol 2006;24:4867-4874
Kane RC et al. Bortezomib for the treatment of mantle cell
lymphoma. Clin Cancer Res 2007;13:5291-5294
2
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Chen CI et al. Bortezomib is active in patients with untreated or
relapsed Waldenstrom's macroglobulinemia: a phase II study of
the National Cancer Institute of Canada Clinical Trials Group. J
Clin Oncol 2007;25:1570-1575
Treon SP et al. Multicenter clinical trial of bortezomib in
relapsed/refractory Waldenstrom's macroglobulinemia: results of
WMCTG Trial 03-248.Clin Cancer Res 2007;13:3320-3325
Goy A et al. Phase II study of proteasome inhibitor bortezomib
in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin
Oncol 2005;23:667-675
Sindromi mielodisplastiche
Terpos E et al. Bortezomib is an effective agent for MDS/MPD
syndrome with 5q- anomaly and thrombocytosis. Leuk Res
2007;31:559-562
CAPECITABINA
-Carcinoma del colon e del retto:
adiuvante nello stadio III o in
monoterapia
nelle
forme
metastatiche
-Carcinomi del colon-retto in fase avanzata
o metastatica da sola o in associazione ad
altri farmaci antitumorali registrati per
questa patologia
-Tumore della mammella localmente -Alternativa al fluorouracile dove non si
avanzato o metastatico
ritenga opportuno o indicato un trattamento
infusionale
-Tumore dello stomaco avanzato
-Carcinoma della mammella localmente
avanzato o metastatico in associazione ad
altri farmaci antineoplastici registrati in tale
patologia
Carcinoma del pancreas localmente avanzato o
metastatico
Boeck S et al. Capecitabine plus oxaliplatin (CapOx) versus
capecitabine plus gemcitabine (CapGem) versus gemcitabine
plus oxaliplatin (mGemOx): final results of a multicenter
randomized phase II trial in advanced pancreatic cancer. Ann
Oncol 2007 [Epub ahead of print]
Park BB et al. A phase II trial of gemcitabine plus capecitabine
for patients with advanced pancreatic adenocarcinoma. Cancer
Chemother Pharmacol 2007;60:489-494
Herrmann R et al. Gemcitabine plus capecitabine compared with
gemcitabine alone in advanced pancreatic cancer: a randomized,
multicenter, phase III trial of the Swiss Group for Clinical
Cancer Research and the Central European Cooperative
Oncology Group. J Clin Oncol 2007;25:2212-2217
Carcinoma a cellule renali metastatico in monoterapia
-Carcinoma del pancreas
avanzato o metastatico
localmente
Oevermann K et al. Capecitabine in the treatment of metastatic
renal cell carcinoma. Br J Cancer 2000;83:583-587
-Carcinoma a cellule renali metastatico in
monoterapia
Pagliaro LC et al. Phase II study of capecitabine single-agent
therapy in patients with metastatic renal cell carcinoma. Urol
Oncol 2006;24:487-491
-Carcinoma dello stomaco
Carcinoma dello stomaco
3
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
-Carcinoma del colon e del retto (Dukes
B/stadio II) per i quali non si ritenga
opportuno un trattamento infusionale con
fluorouracile o fluorouracile in bolo in
associazione con leucovorin
-Colangiocarcinoma
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Ajani J. Review of capecitabine as oral treatment of gastric,
gastroesophageal,
and
esophageal
cancers.
Cancer
2006;107:221-231
Carcinoma del colon e del retto (Dukes B/stadio II)
Figueredo A et al. Adjuvant therapy for stage II colon cancer
after complete resection. Provincial Gastrointestinal Disease Site
Group. Cancer Prev Control 1997;1:379-392
Feliu J et al. XELOX (capecitabine plus oxaliplatin) as first-line
treatment for elderly patients over 70 years of age with advanced
colorectal cancer. Br J Cancer 2006;94:969-975
Colangiocarcinoma
Iyer RV et al. A phase II study of gemcitabine and capecitabine
in advanced cholangiocarcinoma and carcinoma of the
gallbladder: a single-institution prospective study. Ann Surg
Oncol 2007;14:3202-3309
CARBOPLATINO
avanzato -Alternativa al cisplatino quando questo è
controindicato oppure quando, a parità di
efficacia, carboplatino risulti essere meno
-Carcinoma
epidermoide
del tossico
distretto cervico-facciale
-Tumori ovarici e polmonari (associato a
tassani)
-Carcinoma del polmone a piccole
-Seminoma
cellule
-Carcinoma
dell’ovaio
-Teratoma
epiteliale
-Mesotelioma pleurico
-Carcinoma della mammella (da solo o in
associazione)
Carcinoma della cervice uterina
Tangjitgamol S et al. Paclitaxel and carboplatin for large cell
neuroendocrine carcinoma of the uterine cervix. J Obstet
Gynaecol Res 2007;33:218-224
Lee
MY
et
al.
Concurrent
radiotherapy
with
paclitaxel/carboplatin chemotherapy as a definitive treatment for
squamous cell carcinoma of the uterine cervix. Gynecol Oncol
2007;104:95-99
Kim K et al. Efficacy of paclitaxel and carboplatin as a regimen
for postoperative concurrent chemoradiotherapy of high risk
uterine cervix cancer. Gynecol Oncol 2006;101:398-402
Glioblastoma multiforme
-Ad alte dosi nei regimi di condizionamento
nel trapianto di cellule staminali
emopoietiche
Aoki T et al. Phase II study of nimustine, carboplatin,
vincristine, and interferon-beta with radiotherapy for
glioblastoma multiforme: experience of the Kyoto NeuroOncology Group. J Neurosurg 2006;105:385-391
-In sostituzione al cisplatino ed in
associazione nel salvataggio di linfomi
Nakagawa T et al. The combined effects of multiple
chemotherapeutic agents for malignant glioma cells. J
Neurooncol 2007;84:31-37
4
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
Hodgkin e non-Hodgkin
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Kim JW et al. Current management strategies for intraocular
retino-blastoma. Drugs 2007;67:2173-2185
Rabdomiosarcoma
-Carcinoma della cervice uterina
-Glioblastoma multiforme
-Rabdomiosarcoma
-Neoplasie a sede primitiva ignota
Chisholm JC et al. Children's Cancer and Leukaemia Group
(CCLG; formerly United Kingdom Children's Cancer Study
Group). Efficacy of carboplatin given in a phase II window
study to children and adolescents with newly diagnosed
metastatic soft tissue sarcoma. Eur J Cancer 2007;43:2537-2544
Van Winkle P et al. Ifosfamide, carboplatin, and etoposide (ICE)
reinduction chemotherapy in a large cohort of children and
adolescents with recurrent/refractory sarcoma: the Children's
Cancer Group (CCG) experience. Pediatr Blood Cancer
2005;44:338-347
Neoplasie a sede primitiva ignota
Schneider BJ et al. Phase II trial of carboplatin, gemcitabine, and
capecitabine in patients with carcinoma of unknown primary site.
Cancer 2007;110:770-775
Pittman KB et al. Gemcitabine and carboplatin in carcinoma of
unknown primary site: a phase 2 Adelaide Cancer Trials and
Education Collaborative study. Br J Cancer 2006;95:1309-1313
CARMUSTINA
-Mieloma multiplo
-Condizionamento pre-trapianto
Condizionamento pre-trapianto
Buser AS et al. High-dose chemotherapy using BEAM without
autologous rescue followed by reduced-intensity conditioning
allogeneic stem-cell transplantation for refractory or relapsing
lymphomas: a comparison of delayed versus immediate
transplantation. Bone Marrow Transplant 2007;39:335-340
-Linfomi non Hodgkin
-Tumori cerebrali
-Glioma maligno di grado elevato
Josting A et al. Dexamethasone, carmustine, etoposide,
cytarabine, and melphalan (dexa-BEAM) followed by high-dose
chemotherapy and stem cell rescue-a highly effective regimen
for patients with refractory or relapsed indolent lymphoma. Leuk
Lymphoma 2000;37:115-123
Faulkner RD et al. BEAM-alemtuzumab reduced-intensity
allogeneic stem cell transplantation for lymphoproliferative
diseases: GVHD, toxicity, and survival in 65 patients. Blood
2004;103:428-434
CISPLATINO
-Tumore del testicolo
-Carcinoma della mammella
Carcinoma squamoso dell’ano
Hung A et al. Cisplatin-based combined modality therapy for
5
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
-Carcinoma dell’ovaio
-Mesotelioma pleurico
-Carcinoma del distretto cervicofacciale
-Carcinoma dello stomaco
-Carcinoma della vescica
-Carcinoma della prostata
-Tumore dell’endometrio
-Linfomi
-Alcune neoplasie dell'infanzia
-Sarcomi
-Linfomi
-Tumore del polmone
-Tumore dell’esofago
-Tumore della tiroide
CITARABINA
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
-Carcinoma spinocellulare della cute
-Carcinoma del pancreas
-Neoplasie cerebrali
-Carcinoma della cervice uterina
-Neoplasie a sede primitiva ignota
-Colangiocarcinoma e carcinomi delle vie
biliari
-Regimi di associazione nel trattamento di
salvataggio dei linfomi Hodgkin e nonHodgkin
-Carcinoma squamoso dell’ano
-Neuroblastoma
-Regimi terapeutici per mobilizzazione di
cellule staminali periferiche
-Melanoma maligno
-Mieloma multiplo
-Leucemia acuta mieloide dell’
adulto e del bambino
-Ad alte dosi nelle leucemie acute, nei
linfomi non-Hodgkin, e in regime di
condizionamento nel trapianto di cellule
staminali emopoietiche
-Altre forme proliferative della serie
bianca
-Linfoma di Hodgkin
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
anal carcinoma: a
2003;97:1195-1202
wider
therapeutic
index.
Cancer
Regimi terapeutici per mobilizzazione di cellule
staminali periferiche
Watts MJ et al. ESHAP and G-CSF is a superior blood stem cell
mobilizing regimen compared to cyclophosphamide 1.5 g m(-2)
and G-CSF for pre-treated lymphoma patients: a matched pairs
analysis of 78 patients. Br J Cancer 2000;82:278-282
Lee JL et al. ESHAP plus G-CSF as an effective peripheral
blood progenitor cell mobilization regimen in pretreated nonHodgkin's
lymphoma:
comparison
with
high-dose
cyclophosphamide plus G-CSF. Bone Marrow Transplant
2005;35:449-454
De Latour RP et al. Mobilization of peripheral blood progenitor
cells after DHAP regimen with or without rituximab: a large
multicenter comparative study in patients with malignant
lymphoma. Leuk Lymphoma 2007;48:897-904
Mieloma multiplo
Corso A et al. The VAD-DCEP sequence is an effective pretransplant therapy in untreated multiple myeloma. Haematologica
2004;89:1124-1127
D'Sa S et al. Etoposide, methylprednisolone, cytarabine and
cisplatin successfully cytoreduces resistant myeloma patients and
mobilizes them for transplant without adverse effects. Br J
Haematol 2004;125:756-765
Linfoma di Hodgkin
Schütt P et al. Ifosfamide, etoposide, cytarabine, and
dexamethasone as salvage treatment followed by high-dose
cyclophosphamide, melphalan, and etoposide with autologous
peripheral blood stem cell transplantation for relapsed or
refractory lymphomas. Eur J Haematol 2007;78:93-101
Olivieri A et al. Salvage therapy with an outpatient DHAP
schedule followed by PBSC transplantation in 79 lymphoma
patients: an intention to mobilize and transplant analysis. Eur J
Haematol 2004;72:10-17
CLADRIBINA
-Leucemia a cellule capellute
-Linfoma non-Hodgkin indolente
Linfoma non-Hodgkin indolente
6
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
-Leucemia linfatica cronica B
resistente a terapia alchilante
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
-Macroglobulinemia di Waldenström
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Blum KA et al. Prolonged follow-up after initial therapy with 2chlorodeoxyadenosine in patients with indolent non-Hodgkin
lymphoma: results of Cancer and Leukemia Group B Study
9153. Cancer 2006;107:2817-2825
Robak T et al. Rituximab combined with cladribine or with
cladribine and cyclophosphamide in heavily pretreated patients
with indolent lymphoproliferative disorders and mantle cell
lymphoma. Cancer 2006;107:1542-1550
Robak T et al. Cladribine combined with cyclophosphamide and
mitoxantrone is an active salvage therapy in advanced nonHodgkin's lymphoma. Leuk Lymphoma 2007;48:1092-1101
Macroglobulinemia di Waldenström
Weber DM et al. 2-Chlorodeoxyadenosine alone and in
combination for previously untreated Waldenstrom's
macroglobulinemia. Semin Oncol 2003;30:243-247
Gertz MA et al. Treatment recommendations in Waldenstrom's
macroglobulinemia: consensus panel recommendations from the
Second
International
Workshop
on
Waldenstrom's
Macroglobulinemia. Semin Oncol 2003;30:121-126
Treon SP et al. Update on treatment recommendations from the
Third
International
Workshop
on
Waldenstrom's
macroglobulinemia. Blood 2006;107:3442-3446
DACARBAZINA
-Melanoma metastatico
-Carcinomi neuroendocrini
Carcinomi neuroendocrini
-Sarcomi dei tessuti molli
-Tumori desmoidi
Bajetta E et al. 5-Fluorouracil, dacarbazine, and epirubicin in the
treatment of patients with neuroendocrine tumors. Cancer
1998;83:372-378
-Linfoma di Hodgkin
Nocera M et al. Treatment of advanced medullary thyroid cancer
with an alternating combination of doxorubicin-streptozocin and
5 FU-dacarbazine. Groupe d'Etude des Tumeurs à Calcitonine
(GETC). Br J Cancer 2000;83:715-718
Orlandi F et al. Chemotherapy with dacarbazine and 5fluorouracil in advanced medullary thyroid cancer. Ann Oncol
1994;5:763-765
Tumori desmoidi
Gega M et al. Successful chemotherapeutic modality of
doxorubicin plus dacarbazine for the treatment of desmoid
tumors in association with familial adenomatous polyposis. J
7
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Clin Oncol 2006;24:102-105
DOCETAXEL
-Tumore della mammella
-Tumore del polmone non a piccole
cellule
-Carcinoma della mammella, in trattamento
neoadiuvante
Trattamento
mammella
neoadiuvante
del
carcinoma
della
-Carcinoma della prostata
-Carcinoma avanzato dell’ovaio
precedentemente trattato
Estévez LG et al. Evidence-based use of neoadjuvant taxane in
operable and inoperable breast cancer. Clin Cancer Res
2004;10:3249-3261
-Adenocarcinoma dello stomaco
-Carcinoma del pancreas
Jørgensen J et al. Primary inoperable breast cancer. Ugeskr
Laeger 2007;169:3091-3093
-Tumori del distretto cervicofacciale
-Carcinoma del polmone a piccole cellule
Carcinoma avanzato dell’ovaio
-Sarcomi
Ferrandina G et al. Docetaxel and oxaliplatin in the second-line
treatment of platinum-sensitive recurrent ovarian cancer: a phase
II study. Ann Oncol 2007;18:1348-1353
-Carcinoma della vescica
-Carcinoma dell’esofago
Strauss HG et al. Phase II trial of docetaxel and carboplatin in
recurrent platinum-sensitive ovarian, peritoneal and tubal cancer.
Gynecol Oncol 2007;104:612-616
Vasey PA et al. Phase III randomized trial of docetaxelcarboplatin versus paclitaxel-carboplatin as first-line
chemotherapy for ovarian carcinoma. J Natl Cancer Inst
2004;96:1682-1691
Carcinoma del pancreas
Burtness B et al. Phase II trial of weekly docetaxel/irinotecan
combination in advanced pancreatic cancer. Cancer J
2007;13:257-262
Fine RL et al. The gemcitabine, docetaxel and capecitabine
(GTX) regimen for metastatic pancreatic cancer: a retrospective
analysis. Cancer Chemother Pharmacol 2008;61:167-175
Carcinoma del polmone a piccole cellule
Pallis AG et al. A multicenter phase II study of the combination
of gemcitabine and docetaxel in previously treated patients with
small cell lung cancer. Lung Cancer 2004;43:329-333
Skarlos DV et al. Docetaxel and gemcitabine combination, as
first-line treatment, in patients with extensive disease small-cell
lung cancer. A phase II study of the Hellenic Cooperative
Oncology Group. Lung Cancer 2003;41:107-111
8
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Sarcomi
Bay JO et al. Docetaxel and gemcitabine combination in softtissue sarcomas treatment. Bull Cancer 2007;94:S122-S126
Maki RG. Gemcitabine and docetaxel in metastatic sarcoma:
past, present and future. Oncologist 2007;12:999-1006
Carcinoma della vescica
Galsky MD. The role of taxanes in the management of bladder
cancer. Oncologist 2005;10:792-798
Carcinoma dell’esofago
Tanaka T et al. Second-line combination chemotherapy with
docetaxel for cisplatin-pretreated refractory metastatic
esophageal cancer: a preliminary report of initial experience.
Chemotherapy 2007;53:449-453
Albertsson M et al. Phase II studies on docetaxel alone every
third week, or weekly in combination with gemcitabine in
patients with primary locally advanced, metastatic, or recurrent
esophageal cancer. Med Oncol 2007;24:407-412
Ajani JA. Chemotherapy for advanced gastric or
gastroesophageal cancer: defining the contributions of docetaxel.
Expert Opin Pharmacother 2006;7:1627-1631
DOXORUBICINA
-Sarcoma dei tessuti molli e
osteosarcoma
-Mieloma multiplo, in regimi di associazione
Carcinoma dell’endometrio
- Sarcomi (tutti gli istotipi)
Kodama J et al. Chemotherapy for high-risk early-stage
endometrial cancer. Curr Opin Obstet Gynecol 2007;19:42-47
-Linfoma di Hodgkin e non Hodgkin
-Lucemia linfoblastica acuta
-Leucemia mieloblastica acuta
-Carcinoma della tiroide
-Carcinoma della mammella
-Carcinoma dell'ovaio
Carcinoma della cervice uterina
-Carcinoma dell’endometrio
-Carcinoma della cervice uterina
-Tumori maligni del timo
Papadimitriou CA et al. A phase II trial of methotrexate,
vinblastine, doxorubicin, and cisplatin in the treatment of
metastatic carcinoma of the uterine cervix. Cancer
1997;79:2391-2395
Tumori maligni del timo
Yokoi K et al. Multidisciplinary treatment for advanced invasive
thymoma with cisplatin, doxorubicin, and methylprednisolone. J
Thorac Oncol 2007;2:73-78
9
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
-Carcinoma della vescica
-Carcinoma polmonare
-Neuroblastoma
-Tumore di Wilms
-Tumori superficiali della vescica
-Carcinoma dello stomaco
-Carcinoma del fegato
-Carcinoma del pancreas
-Carcinoma del sigma retto
-Carcinoma del distretto cervicofacciale
-Carcinoma della prostata ormonorefrattario
DOXORUBICINA
LIPOSOMIALE
-Tumore della mammella
metastatico
-Carcinoma della mammella localmente
avanzato
-Tumore dell’ovaio
-Rabdomiosarcoma
-Sarcoma di Kaposi AIDS- correlato -Sarcoma di Ewing
-Mieloma multiplo
-Linfomi Hodgkin e non-Hodgkin
-Tumori maligni della tiroide
Carcinoma della mammella localmente avanzato
Ulrich-Pur H et al. Phase II trial of pegylated liposomal
doxorubicin (Caelyx) plus gemcitabine in chemotherapeutically
pretreated patients with advanced breast cancer. Acta Oncol
2007;46:208-213
Ardavanis A et al. Pegylated liposomal doxorubicin in
combination with vinorelbine as salvage treatment in pretreated
patients with advanced breast cancer: a multicentre phase II
study. Cancer Chemother Pharmacol 2006;5 8:742-748
Alexopoulos A et al. Phase II study of pegylated liposomal
doxorubicin (Caelyx) and docetaxel as first-line treatment in
metastatic breast cancer. Ann Oncol 2004;15:891-895
Rabdomiosarcoma e Sarcoma di Ewing
Nielsen OS et al. Phase 1 European Organisation for Research
and Treatment of Cancer study determining safety of pegylated
liposomal doxorubicin (Caelyx) in combination with ifosfamide
10
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
in previously untreated adult patients with advanced or
metastatic soft tissue sarcomas. Eur J Cancer 2006;42:2303-2309
Skubitz KM. Phase II trial of pegylated-liposomal doxorubicin
(Doxil) in sarcoma. Cancer Invest 2003;21:167-176
Mieloma multiplo
Rifkin RM et al. Pegylated liposomal doxorubicin, vincristine,
and dexamethasone provide significant reduction in toxicity
compared with doxorubicin, vincristine, and dexamethasone in
patients with newly diagnosed multiple myeloma: a Phase III
multicenter randomized trial. Cancer 2006;106:848-858
Orlowski RZ et al. Randomized phase III study of pegylated
liposomal doxorubicin plus bortezomib compared with
bortezomib alone in relapsed or refractory multiple myeloma:
combination therapy improves time to progression. J Clin Oncol
2007;25:3892-3901
Zervas K et al. Greek Myeloma Study Group. Primary treatment
of multiple myeloma with thalidomide, vincristine, liposomal
doxorubicin and dexamethasone (T-VAD doxil): a phase II
multicenter study. Ann Oncol 2004;15:134-138
Linfomi Hodgkin e non-Hodgkin
Macpherson N et al. Liposomal encapsulated doxorubicin
(Caelyx) in the treatment of relapsed aggressive non-Hodgkin's
lymphoma: a phase II study. Leuk Lymphoma 2006;47:13271332
Di Bella NJ et al. Pegylated liposomal doxorubicin as singleagent treatment of low-grade non-Hodgkin's lymphoma: a phase
II multicenter study. Clin Lymphoma 2003;3:235-240
Orlowski RZ et al. Phase 1 trial of the proteasome inhibitor
bortezomib and pegylated liposomal doxorubicin in patients with
advanced hematologic malignancies. Blood 2005;105:3058-3065
Tumori maligni della tiroide
Moscetti L et al. A partial response in anaplastic carcinoma of
the thyroid with liposomal doxorubicin. J Exp Clin Cancer Res
2005;24:151-154
Tennvall J et al. Anaplastic thyroid carcinoma: three protocols
11
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
combining doxorubicin, hyperfractionated radiotherapy and
surgery. Br J Cancer 2002;86:1848-1853
EPIRUBICINA
-Carcinoma della mammella
-Sarcomi delle parti molli
-Carcinoma dello stomaco
Può essere utilizzata al posto della
doxorubicina da sola od in associazione nel
trattamento dei tumori solidi, sia in fase
precoce che avanzata
Bajetta E et al. 5-Fluorouracil, dacarbazine, and epirubicin in the
treatment of patients with neuroendocrine tumors. Cancer
1998;83:372-378
Bajetta E et al. Efficacy of a chemotherapy combination for the
treatment of metastatic neuroendocrine tumours. Ann Oncol
2002;13:614-621
-Carcinoma del fegato
-Carcinoma del pancreas
-Tumori neuroendocrini
-Carcinoma del sigma-retto
-Carcinoma dell’esofago
-Carcinoma del distretto cervicofacciale
-Carcinoma della prostata
Carcinoma dell’esofago
Choi IK et al. Epirubicin, cisplatin, oral UFT, and leucovorin
combination chemotherapy in advanced and metastatic
esophageal cancer. Med Oncol 2007;24:33-37
-Carcinoma della cervice uterina
Ross P et al. Prospective randomized trial comparing mitomycin,
cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU)
with epirubicin, cisplatin, and PVI 5-FU in advanced
esophagogastric cancer. J Clin Oncol 2002;20:1996-2004
-Carcinoma del polmone
-Carcinoma dell’ovaio
Carcinoma della prostata
-Leucemie
Petrioli R et al. Weekly docetaxel and epirubicin in treatment of
advanced hormone-refractory prostate cancer. Urology
2007;69:142-146
-Linfomi
-Carcinoma della vescica
superficiale
ETOPOSIDE
Tumori neuroendocrini
Carcinoma della cervice uterina
D'Agostino G et al. Neoadjuvant treatment of locally advanced
carcinoma of the uterine cervix with epirubicin, paclitaxel and
cisplatin. Cancer Chemother Pharmacol 2002;49:256-260
-Profilassi delle recidive dopo
intervento di resezione transuretrale
-Tumori del polmone a piccole
cellule
-Terapie ad alte dosi sequenziali
condizionamento pre-trapianto
-Carcinoma del testicolo non
seminomatoso resistente
-In associazione nella leucemia linfatica acuta
e nel mieloma multiplo
Marwaha S et al. The importance of the dose of etoposide in the
initial treatment of metastatic germ cell tumors and advances in
management of patients that relapse. Can J Urol 2007;14:36923696
-Linfoma di Hodgkin
-Sarcomi
Kondagunta V et al. Germ-cell tumors. N Engl J Med
2007;357:1773
-Linfomi non Hodgkin
-Tumori a cellule germinali
Carcinoma dello stomaco e dell’esofago
nel
Tumori a cellule germinali
Lokich JJ et al. Combined paclitaxel, cisplatin, and etoposide for
12
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
-Leucemie acute
-Carcinoma dello stomaco e dell’esofago
-Coriocarcinoma gestazionale
-Carcinoma del testicolo
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
patients with previously untreated esophageal
gastroesophageal carcinomas. Cancer 1999;85:2347-2351
and
-Tumori maligni intracranici
Chiou TJ et al. Treatment of advanced gastric cancer with a
modified regimen of etoposide/leucovorin/5-fluorouracil. Cancer
Invest 1996;14:197-201
-Tumori del distretto cervicale
Carcinoma del testicolo
-Tumori neuroendocrini
Bamias A et al. Two cycles of etoposide/cisplatin cured all
patients with stage I testicular seminoma: risk-adapted protocol
of the Hellenic Cooperative Oncology Group. Urology
2007;70:1179-1183
Tumori maligni intracranici
López-Aguilar E et al. Preirradiation ifosfamide, carboplatin, and
etoposide for the treatment of anaplastic astrocytomas and
glioblastoma multiforme: a phase II study. Arch Med Res
2000;31:186-190
Tumori del distretto cervicale
Tanaka T et al. Optimal combination chemotherapy and
chemoradiotherapy with etoposide for advanced cervical
squamous cancer cells in vitro. Oncol Rep 2006;15:939-947
Tumori neuroendocrini
Hainsworth JD et al. Phase II trial of paclitaxel, carboplatin, and
etoposide in advanced poorly differentiated neuroendocrine
carcinoma: a Minnie Pearl Cancer Research Network Study. J
Clin Oncol 2006;24:3548-3554
FLUOROURACILE
-Trattamento
palliativo
delPuò essere utilizzato, da solo o in associazione,
carcinoma della mammella, delnei tumori solidi (*)
colon, del retto, dello stomaco e del
pancreas
-Carcinoma del colon (adiuvante)
Carcinoma del colon (adiuvante)
Chung KY and Saltz LB. Adjuvant therapy of colon cancer:
current status and future directions. Cancer J 2007;13:192-197
-Tumori del fegato
-Carcinoma dell’esofago
Kuebler JP et al. Oxaliplatin combined with weekly bolus
fluorouracil and leucovorin as surgical adjuvant chemotherapy
for stage II and III colon cancer: results from NSABP C-07. J
Clin Oncol 2007;25:2198-2204
-Tumori dell’utero
-Carcinoma del pancreas (adiuvante)
De Gramont A et al. Targeted agents for adjuvant therapy of
13
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
-Tumori dell’ovaio
-Tumori maligni a cellule di Langerhans
-Tumori della vescica
-Carcinoma del pene
-Trattamento
profilattico
delle -Carcinoma della prostata
recidive di tumore del colon-retto
-Carcinoma gastrico (adiuvante
dopo chirurgia
adiuvante)
-Tumori del distretto cervico-facciale
-Tumori maligni nasofaringei
-Tumore dell’ano
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
colon cancer. Semin Oncol 2006; 33:42-45
Carcinoma dell’esofago
e
neo-
Lin CC et al. Multifractionated paclitaxel and cisplatin combined
with 5-fluorouracil and leucovorin in patients with metastatic or
recurrent esophageal squamous cell carcinoma. Anticancer Drugs
2007,18:703-708
O'Connor BM et al. Concurrent oxaliplatin, 5-fluorouracil, and
radiotherapy in the treatment of locally advanced esophageal
carcinoma. Cancer J 2007;13:119-124
Sasamoto R et al. Long-term results of chemoradiotherapy for
locally advanced esophageal cancer, using daily low-dose 5fluorouracil and cis-diammine-dichloro-platinum (CDDP). Int J
Clin Oncol 2007;12:25-30
Carcinoma del pancreas (adiuvante)
(*) La Commissione Terapeutica ha ritenuto Ghaneh P et al. Neoadjuvant and adjuvant strategies for
opportuno
documentare
meglio
alcune pancreatic cancer. Eur J Surg Oncol 2007 [Epub ahead of print]
indicazioni già presenti nella lista AIFA
Aung KL et al. Adjuvant therapy for pancreatic cancer. Expert
Opin Pharmacother 2007;8:2533-2541
Cantore M et al. Adjuvant intra-arterial 5-fluoruracil, leucovorin,
epirubicin and carboplatin with or without systemic gemcitabine
after curative resection for pancreatic adenocarcinoma. Cancer
Chemother Pharmacol 2006;58:504-508
Tumori maligni a cellule di Langerhans
Strosberg J et al. Effective treatment of locally advanced
endocrine tumors of the pancreas with chemoradiotherapy.
Neuroendocrinology 2007;85:216-220
Carcinoma del pene
Culkin DJ and Beer TM. Advanced penile carcinoma. J Urol
2003;170:359-365
Roth AD et al. Intra-arterial chemotherapy in locally advanced or
recurrent carcinomas of the penis and anal canal: an active
treatment modality with curative potential. Br J Cancer
2000;83:1637-1642
Eisenberger MA, Chemotherapy for carcinomas of the penis and
urethra. Urol Clin North Am 1992;19:333-338
14
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Carcinoma della prostata
Lin CC et al. Weekly paclitaxel and high-dose 5-fluorouracil plus
leucovorin in hormone-refractory prostate cancer: in vitro
combined effects and a phase II trial. Urol Oncol 2007;25:207213
Swanson GP et al. Locally advanced prostate cancer treated with
concomitant radiation and 5-fluorouracil: Southwest Oncology
Group Study 9024. J Urol 2006;176:548-553
Birtle AJ et al. Epirubicin carboplatin and 5-fluorouracil
(ECarboF) chemotherapy in metastatic hormone refractory
prostate cancer. Br J Cancer 2004;91:1472-1476
Carcinoma gastrico (adiuvante e neo-adiuvante)
Ng K et al. Adjuvant and neoadjuvant approaches in gastric
cancer. Cancer J 2007;13:168-174
Saletti P et al. Adjuvant chemotherapy (ECF regimen) for
patients with gastric adenocarcinoma. Hepatogastroenterology
2007;54:969-972
Koo DH et al. Adjuvant chemotherapy with 5-fluorouracil,
doxorubicin and mitomycin-C (FAM) for 6 months after curative
resection of gastric carcinoma. Eur J Surg Oncol 2007;33:843848
Tumori del distretto cervico-facciale
Tulunay OE et al. Pilot study of intraoperative chemotherapy
with cisplatin and 5-fluorouracil in patients with advanced
squamous cell carcinoma of the head and neck. Head Neck
2007;29:267-271
Baghi M et al. Adjuvant docetaxel, cisplatin and 5-fluorouracil
(TPF) in locally advanced squamous cell carcinoma of the head
and neck. Anticancer Res 2006;26:559-563
Faivre S et al. Preoperative sequential chemotherapy in locally
advanced squamous cell carcinoma of the head and neck. Head
Neck 2005;27:311-319
Tumori maligni nasofaringei
Fuwa N et al. Treatment results of alternating chemoradiotherapy
for nasopharyngeal cancer using cisplatin and 5-fluorouracil--a
15
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
phase II study. Oral Oncol 2007;43:948-955
Yau TK et al. Treatment of Stage IV(A-B) nasopharyngeal
carcinoma by induction-concurrent chemoradiotherapy and
accelerated fractionation: impact of chemotherapy schemes. Int J
Radiat Oncol Biol Phys 2006;66:1004-1010
Wong AS et al. Paclitaxel, 5-fluorouracil and hydroxyurea
concurrent with radiation in locally advanced nasopharyngeal
carcinoma. Ann Oncol 2006;17:1152-1157
Tumore dell’ano
Das P et al. Current treatment for localized anal carcinoma. Curr
Opin Oncol 2007;19:396-400
Hatfield P et al. Involved-field, low-dose chemoradiotherapy for
early-stage anal carcinoma. Int J Radiat Oncol Biol Phys
2008;70:419-24
Charnley N et al. Effective treatment of anal cancer in the elderly
with low-dose chemoradiotherapy. Br J Cancer 2005;92:12211225
GEMCITABINA
-Carcinoma polmonare non a -Terapia di salvataggio della neoplasia Carcinoma del colon e del retto
piccole cellule localmente avanzato germinale del testicolo
Ziras N et al. Multicenter phase II study of gemcitabine and
oxaliplatin (GEMOX) as second-line chemotherapy in colorectal
o metastatico
-Sarcomi dei tessuti molli
cancer patients pretreated with 5-fluorouracil plus irinotecan.
Oncology 2006;70:106-114
-Adenocarcinoma del pancreas
-Colangiocarcinoma e carcinomi delle vie biliari
localmente avanzato o metastatico
Correale P et al. Chemo-immunotherapy of metastatic colorectal
carcinoma with gemcitabine plus FOLFOX 4 followed by
-Neoplasie del distretto cervico-facciale
-Carcinoma della vescica
subcutaneous granulocyte macrophage colony-stimulating factor
and interleukin-2 induces strong immunologic and antitumor
-Linfomi di Hodgkin e non Hodgkin
activity in metastatic colon cancer patients. J Clin Oncol
-Carcinoma della mammella non
2005;23:8950-8958
resecabile localmente ricorrente o
Correale P et al. A novel biweekly multidrug regimen of
metastatico
-Carcinoma del colon e del retto
-Carcinoma ricorrente dell'epitelio
-Mesotelioma maligno
dell'ovaio
-Carcinoma del polmone a piccole cellule
-Sarcoma (tutti gli istotipi)
-Tumori a cellule germinali
gemcitabine, oxaliplatin, 5-fluorouracil (5-FU), and folinic acid
(FA) in pretreated patients with advanced colorectal carcinoma.
Br J Cancer 2004;90:1710-1714
Mesotelioma maligno
Kalmadi SR et al. Gemcitabine and cisplatin in unresectable
malignant mesothelioma of the pleura: A phase II study of the
Southwest Oncology Group (SWOG 9810). Lung Cancer 2007,
16
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
[Epub ahead of print]
Lucchi M et al. Four-modality therapy in malignant pleural
mesothelioma: a phase II study. J Thorac Oncol 2007;2:237-242
Utkan G et al. Divided dose of cisplatin combined with
gemcitabine in malignant mesothelioma. Lung Cancer
2006;53:367-374
Carcinoma del polmone a piccole cellule
Ohyanagi F et al. Phase II trial of gemcitabine and irinotecan in
previously treated patients with small-cell lung cancer. Cancer
Chemother Pharmacol 2007 [Epub ahead of print]
Hesketh PJ et al. Phase II study of gemcitabine and cisplatin in
patients with previously untreated extensive stage small cell lung
cancer: Southwest Oncology Group Study 9718. J Thorac Oncol
2007;2:440-444
Schuette W et al. Phase II trial of gemcitabine/irinotecan in
refractory or relapsed small-cell lung cancer. Clin Lung Cancer
2005;7:133-137
Sarcoma
Maki RG. Gemcitabine and docetaxel in metastatic sarcoma:
past, present, and future. Oncologist 2007;12:999-1006
Maki RG et al. Randomized phase II study of gemcitabine and
docetaxel compared with gemcitabine alone in patients with
metastatic soft tissue sarcomas: results of sarcoma alliance for
research through collaboration study 002. J Clin Oncol
2007;25:2755-2763
Dileo P et al. Gemcitabine and vinorelbine combination
chemotherapy for patients with advanced soft tissue sarcomas:
results of a phase II trial. Cancer 2007;109:1863-1869
Tumori a cellule germinali
Einhorn LH et al. Phase II study of paclitaxel plus gemcitabine
salvage chemotherapy for germ cell tumors after progression
following high-dose chemotherapy with tandem transplant. J Clin
Oncol 2007;25:513-516
De Giorgi U et al. Phase II study of oxaliplatin and gemcitabine
salvage chemotherapy in patients with cisplatin-refractory
17
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
nonseminomatous germ cell tumor. Eur Urol 2006;50:1032-1038
Pectasides D et al. Gemcitabine and oxaliplatin (GEMOX) in
patients with cisplatin-refractory germ cell tumors: a phase II
study. Ann Oncol 2004;15:493-497
IDARUBICINA
-Leucemia acuta non linfoblastica
-Linfomi non-Hodgkin in prima linea o
-Cancro della mammella in stadio pretrattati, in combinazione con altri
avanzato
chemioterapici
-Leucemia
acuta
linfocitica
nell'adulto e nel bambino
Linfomi non-Hodgkin in prima linea o pretrattati, in
combinazione con altri chemioterapici
Zinzani PL et al. Effectiveness of fludarabine, idarubicin and
cyclophosphamide (FLUIC) combination regimen for young
patients with untreated non-follicular low-grade non-Hodgkin's
lymphoma. Leuk Lymphoma 2004;45:1815-1819
Morra E et al. Treatment of patients with high-grade nonHodgkin's lymphoma aged over 70 years with an all-oral regimen
combining idarubicin, etoposide and alkylators. Crit Rev Oncol
Hematol 2000;35:95-100
Oyan B et al. Ifosfamide, idarubicin, and etoposide in
relapsed/refractory Hodgkin disease or non-Hodgkin lymphoma:
a salvage regimen with high response rates before autologous
stem cell transplantation. Biol Blood Marrow Transplant
2005;11:688-697
IDROSSIUREA
Leucemia mieloide cronica
-Mielofibrosi
Mielofibrosi, trombocitemia essenziale, policitemia
vera
-Trombocitemia essenziale
Cervantes F et al. New and old treatment modalities in primary
myelofibrosis. Cancer J 2007;13:377-383
-Policitemia vera
Finazzi G et al. Expertise-based management in essential
thrombocythemia and polycythemia vera. Cancer J 2007;13:372376
Barbui T et al. Therapy for polycythemia vera and essential
thrombocythemia is driven by the cardiovascular risk. Semin
Thromb Hemost 2007;33:321-329
18
NOME COMPOSTO
IFOSFAMIDE
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
-Carcinoma bronchiale
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
-Tumori del testicolo
-Può essere utilizzato, da solo o in associazione,
nei tumori solidi sulla base delle evidenze
scientifiche presenti in letteratura ed in
particolare:
-Sarcomi delle parti molli
-Sarcomi (tutti gli istotipi)
-Carcinoma della mammella
-Regime di condizionamento pretrapianto di
cellule staminali emopoietiche
Gershenson DM. Update on malignant ovarian germ cell tumors.
-Carcinoma dell’ovaio
-Carcinoma del pancreas
Tumore a cellule germinali dell’ovaio
Popadiuk S et al. Ovarian malignant tumours. Efficacy of germ
cell and sex cord tumour treatment protocol in Poland. Med
Wieku Rozwoj 2006;10:803-810
Balat O et al. Remission of recurrent mixed germ cell tumor of
the ovary after treatment with vincristine, carboplatin,
fluorouracil, and ifosfamide: a case report and review of the
literature. Eur J Gynaecol Oncol 1996;17:342-344
Cancer 1993;71:1581-1590
-Ipernefroma
Carcinoma del polmone a piccole cellule
-Carcinoma dell’endometrio
-Tumore a cellule germinali dell’ovaio
-Linfomi maligni
-Carcinoma del polmone a piccole cellule
-Tumori del distretto cervico-facciale
-Carcinoma nasofaringeo
-Tumori maligni del timo
-Tumore a cellule germinali
-Carcinoma della cervice uterina
Thatcher N et al. Ifosfamide, carboplatin, and etoposide with
midcycle vincristine versus standard chemotherapy in patients
with small-cell lung cancer and good performance status: clinical
and quality-of-life results of the British Medical Research
Council multicenter randomized LU21 trial. J Clin Oncol
2005;23:8371-8379
Iwasaki Y et al. Double-cycle, high-dose ifosfamide, carboplatin,
and etoposide followed by peripheral blood stem-cell
transplantation for small cell lung cancer. Chest 2005;128:22682273
Marangolo M and Giovanis P. Ifosfamide in small cell lung
cancer. Oncology 2003;65:46-49
Tumori del distretto cervico-facciale
Pai VR et al. Two- vs three-drug combination chemotherapy in
advanced or recurrent head and neck cancer: a single institution
experience of 361 patients. Med Oncol 2004;21:305-308
Airoldi M et al., Ifosfamide in the treatment of head and neck
cancer. Oncology 2003;65:37-43
Shin DM et al. Phase II study of induction chemotherapy with
paclitaxel, ifosfamide, and carboplatin (TIC) for patients with
locally advanced squamous cell carcinoma of the head and neck.
Cancer 2002;95:322-330
Carcinoma nasofaringeo
19
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Chua DT et al. A phase II study of ifosfamide, 5-fluorouracil and
leucovorin in patients with recurrent nasopharyngeal carcinoma
previously treated with platinum chemotherapy. Eur J Cancer
2000;36:736-741
Tumori maligni del timo
Iwasaki Y et al. Multidisciplinary therapy including high-dose
chemotherapy followed by peripheral blood stem cell
transplantation for invasive thymoma. Chest 2002;122:2249-2252
Geffen DB et al. Multimodal treatment of metastatic thymic
carcinoma including high-dose chemotherapy with autologous
stem cell transplantation: report of a case with more than 4-year
disease-free survival. Am J Clin Oncol 2001;24:566-569
Highley MS et al. Treatment of invasive thymoma with singleagent ifosfamide. J Clin Oncol 1999;17:2737-2744
Tumore a cellule germinali
Einhorn LH et al. High-dose chemotherapy and stem-cell rescue
for metastatic germ-cell tumors. N Engl J Med 2007;357:340-348
Lorch A et al. Single versus sequential high-dose chemotherapy
in patients with relapsed or refractory germ cell tumors: a
prospective randomized multicenter trial of the German
Testicular Cancer Study Group. J Clin Oncol 2007;25:2778-2784
Kondagunta GV et al. Paclitaxel plus ifosfamide followed by
high-dose carboplatin plus etoposide in previously treated germ
cell tumors. J Clin Oncol 2007;25:85-90
Carcinoma della cervice uterina
Serkies K et al. Chemotherapy with mitomycin C, ifosfamide and
cisplatin for recurrent or persistent cervical cancer. Int J Gynecol
Cancer 2006;16:1152-1156
Buda A et al. Randomized trial of neoadjuvant chemotherapy
comparing paclitaxel, ifosfamide and cisplatin with ifosfamide
and cisplatin followed by radical surgery in patients with locally
advanced squamous cell cervical carcinoma: the SNAP01 (Studio
Neo-Adjuvante Portio) Italian Collaborative Study. J Clin Oncol
2005;23:4137-4145
Buda A et al. Role of ifosfamide in cervical cancer: an overview.
Oncology 2003;65:63-66
20
NOME COMPOSTO
IMATINIB
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
-Leucemia mieloide cronica
-Sindrome ipereosinofila
Philadelphia positiva
-Mastocitosi sistemica
-Leucemia linfoblastica acuta
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Sindrome ipereosinofila
Baccarani M et al. The efficacy of imatinib mesylate in patients
with FIP1L1-PDGFRalpha-positive hypereosinophilic syndrome.
Results of a multicenter prospective study. Haematologica
2007;92:1173-1179
Fletcher S et al. Diagnosis and treatment of hypereosinophilic
syndromes. Curr Opin Hematol 2007;14:37-42
-Malattie mielodisplastiche e
mieloproliferative
Peros-Golubici T et al. Hypereosinophilic syndrome: diagnosis
and treatment. Curr Opin Pulm Med 2007;13:422-427
-Sindrome ipereosinofila avanzata
Mastocitosi sistemica
-Tumori stromali del tratto gastrointestinale maligni
Pardanani A. Systemic mastocytosis: bone marrow pathology,
classification, and current therapies. Acta Haematol 2005;114:4151
-Dermatofibrosarcoma protuberans
Droogendijk HJ et al. Imatinib mesylate in the treatment of
systemic mastocytosis: a phase II trial. Cancer 2006;107:345-351
Pardanani A et al. Imatinib for systemic mast-cell disease. Lancet
2003;362:535-536
INTERFERONE alfa
-Leucemia a cellule capellute
-Leucemia mieloide cronica
-Mieloma multiplo
-Linfoma follicolare
-Tumore carcinoide
-Terapia di prima linea della trombocitemia
essenziale in gravidanza e in pazienti di età
minore a 40 anni
-Terapia di seconda linea della trombocitemia
essenziale in pazienti tra 40 e 60 anni a basso
rischio di complicanze tromboemboliche
-Melanoma maligno
-Carcinoma a cellule renali
IRINOTECANO
-Carcinoma avanzato del colon e del-Trattamento di seconda linea dei carcinomi
retto, in combinazione con 5- avanzati del tratto gastroenterico (esofago,
fluorouracile e acido folinico (prima stomaco e pancreas)
linea); in monoterapia dopo 5-
Carcinoma a cellule renali
Ryan CW et al. Sorafenib with interferon alfa-2b as first-line
treatment of advanced renal carcinoma: a phase II study of the
Southwest Oncology Group. J Clin Oncol 2007;25:3296-3301
Gollob JA et al. Phase II trial of sorafenib plus interferon alfa-2b
as first- or second-line therapy in patients with metastatic renal
cell cancer. J Clin Oncol 2007;25:3288-3295
Tannir NM et al. Improved tolerability and quality of life with
maintained efficacy using twice-daily low-dose interferon-alpha2b: results of a randomized phase II trial of low-dose versus
intermediate-dose interferon-alpha-2b in patients with metastatic
renal cell carcinoma. Cancer 2006;107:2254-2261
Tumore a piccole cellule del polmone
Spigel DR et al. Irinotecan, carboplatin and imatinib in untreated
extensive-stage small-cell lung cancer: a phase II trial of the
Minnie Pearl Cancer Research Network. J Thorac Oncol
2007;29:854-861
21
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
fluorouracile (seconda linea)
-Carcinoma metastatico del colon e-Tumore a piccole cellule del polmone
del retto EGFR positivo dopo
-Carcinoma della cervice uterina
fallimento di terapia citotossica
contenente
irinotecano,
in
associazione a cetuximab
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Bae SH et al. A phase II study of biweekly irinotecan and
cisplatin for patients with extensive stage disease small cell lung
Cancer. Lung Cancer 2007, [Epub ahead of print]
Fennell DA et al. Phase II trial of irinotecan, cisplatin and
mitomycin for relapsed small cell lung cancer. Int J Cancer
2007;121:2575-2577
Carcinoma della cervice uterina
Umesaki N et al. Phase II study of irinotecan combined with
mitomycin-C for advanced or recurrent squamous cell carcinoma
of the uterine cervix: the JGOG study. Gynecol Oncol
2004;95:127-132
Tsuda H et al. Phase I-II study of irinotecan (CPT-11) plus
nedaplatin (254-S) with recombinant human granulocyte colonystimulating factor support in patients with advanced or recurrent
cervical cancer. Br J Cancer 2004;91:1032-1037
Verschraegen CF. Irinotecan for the treatment of cervical cancer.
Oncology (Williston Park) 2002;16:32-34
MEGESTROLO
ACETATO
-Carcinoma della mammella o
dell'endometrio in fase avanzata
Trattamento
maschile
del
tumore
-Anoressia e perdita di peso
secondarie a neoplasie
-Carcinoma dell’ovaio
della
mammella
Carcinoma dell’ovaio
Wilailak S et al. Phase II study of high-dose megestrol acetate in
platinum-refractory epithelial ovarian cancer. Anti-Cancer Drugs
2001;12:719-724
Markman M et al. Phase I trial of paclitaxel plus megestrol
acetate in patients with paclitaxel-refractory ovarian cancer. Clin
Cancer Res 2000;6:4201-4204
Wiernik PH et al. High-dose megestrol acetate in the treatment of
patients with ovarian cancer who have undergone previous
treatment: Eastern Cooperative Oncology Group Study PD884.
Am J Clin Oncol 1998;21:565-567
METOTRESSATO
-Coriocarcinoma
-Carcinoma della vescica
Carcinoma del pene
-Corionadenoma destruente
-Leucemie acute e linfomi non Hodgkin (ad alte
dosi)
Sheen MC et al. Penile verrucous carcinoma successfully treated
by intra-aortic infusion with methotrexate. Urology 2003;
61:1216-1220
-In associazione a ciclosporina nella profilassi
della Graft Versus Host Disease in pazienti
Sklaroff RB and Yagoda A. Methotrexate in the treatment of
penile carcinoma. Cancer 1980; 45:214-216
-Mola vescicolare o idatiforme
-Sarcomi
22
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
-Carcinomi cervico-facciali
sottoposti a trapianto di cellule staminali
emopoietiche
-Carcinoma della mammella
-Carcinoma del pene
-Linfomi
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Kattan J et al. Penile cancer chemotherapy: twelve years'
experience at Institut Gustave-Roussy. Urology 1993; 42:559-562
-Carcinoma del polmone
-Carcinoma della cervice uterina
-Leucemie acute
-Leucemia linfoblastica del bambino
-Linfosarcoma del bambino (III e IV
stadio
MITOMICINA C
-Carcinoma dello stomaco
-Carcinoma dell’ano
Carcinoma dell’esofago
-Carcinoma del pancreas
-Carcinoma dell’esofago
-Carcinoma dell’utero
-Carcinoma delle vie biliari
Stewart FM et al. Cisplatin, 5-fluorouracil, mitomycin C and
concurrent radiation therapy with and without esophagectomy for
esophageal
carcinoma.
Cancer
1989;
64:622-628
-Carcinoma della mammella
Anderson SE et al. Combined modality chemoradiation in elderly
oesophageal cancer patients. Br J Cancer 2007;96:1823-1827
-Adenocarcinoma polmonare
-Carcinosi peritoneale
Coia LR et al. Long-term results of infusional 5-FU, mitomycinC and radiation as primary management of esophageal
carcinoma. Int J Radiat Oncol Biol Phys 1991;20:29-36
-Tumori del colon e del retto
Carcinoma delle vie biliari
-Tumori della vescica
Kornek GV et al. Mitomycin C in combination with capecitabine
or biweekly high-dose gemcitabine in patients with advanced
biliary tract cancer: a randomised phase II trial. Ann Oncol
2004;15:478-483
-Tumori della cute
-Sarcomi
-Epatocarcinomi
-Leucemie acute e croniche
23
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
-Linfoma di Hodgkin
OXALIPLATINO
-Trattamento adiuvante del cancro-Carcinoma del pancreas e delle vie biliari in
del colon di stadio III (C di Duke) associazione a gemcitabina
dopo resezione completa del tumore
-Tumori del colon e del retto metastatici in
primario in associazione con 5-FU e
associazione a farmaci alternativi al 5-FU
acido folinico
-Tumore dell’ovaio
-Cancro del colon e del retto
metastatico
-Carcinoma dello stomaco avanzato o
metastatico
-Tumore a cellule germinali
-Carcinoma della mammella metastatico dopo
fallimento di chemioterapia con taxani e
antracicline
-Linfomi non-Hodgkin
Tumore dell’ovaio
Germano D et al. Gemcitabine combined with oxaliplatin
(GEMOX) as salvage treatment in elderly patients with advanced
ovarian cancer refractory or resistant to platinum: a single
institution experience. J Chemother 2007;19:577-581
Ferrandina G et al. Docetaxel and oxaliplatin in the second-line
treatment of platinum-sensitive recurrent ovarian cancer: a phase
II study. Ann Oncol 2007;18:1348-1353
Raspagliesi F et al. Gemcitabine combined with oxaliplatin
(GEMOX) as second-line chemotherapy in patients with
advanced ovarian cancer refractory or resistant to platinum and
taxane. Oncology 2004;67:376-381
Carcinoma dello stomaco avanzato o metastatico
Chao Y et al. Phase II study of weekly oxaliplatin and 24-h
infusion of high-dose 5-fluorouracil and folinic acid in the
treatment of advanced gastric cancer. Br J Cancer 2004; 91:453458
Al-Batran SE et al. Phase II trial of biweekly infusional
fluorouracil, folinic acid, and oxaliplatin in patients with
advanced gastric cancer. J Clin Oncol 2004; 22:658-663
Kim JG et al. Multicenter phase II study of docetaxel plus
oxaliplatin combination chemotherapy in patients with advanced
gastric cancer: Daegu Gyeongbuk Oncology Group. Br J Cancer
2008 [Epub ahead of print]
Tumore a cellule germinali
Kollmannsberger C et al. Activity of oxaliplatin in patients with
relapsed or cisplatin-refractory germ cell cancer: a study of the
German testicular cancer study group. J Clin Oncol 2002;
20:2031-2037
Pectasides D et al. Gemcitabine and oxaliplatin (GEMOX) in
patients with cisplatin-refractory germ cell tumors: a phase II
study. Ann Oncol 2004;15:493-497
Carcinoma della mammella metastatico dopo
fallimento di chemioterapia con taxani e antracicline
24
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Delozier T et al. A phase II study of an oxaliplatin/vinorelbine/5fluorouracil combination in patients with anthracycline-pretreated
and taxane-pretreated metastatic breast cancer. Anticancer Drugs
2006;17:1067-1073
Martín M. Platinum compounds in the treatment of advanced
breast cancer. Clin Breast Cancer 2001;2:190-208
Pectasides D et al. Oxaliplatin plus high-dose leucovorin and 5fluorouracil in pretreated advanced breast cancer: a phase II
study. Ann Oncol 2003;14:537-542
Linfomi non-Hodgkin
Chau I et al. An oxaliplatin-based chemotherapy in patients with
relapsed or refractory intermediate and high-grade non-Hodgkin's
lymphoma. Br J Haematol 2001;115:786-792
PACLITAXEL
-Carcinoma ovarico
-Carcinoma del distretto cervico-facciale
Carcinoma delle tube di Falloppio
-Carcinoma della mammella
-Carcinoma dell'endometrio e della cervice
uterina
Gemignani ML et al. Paclitaxel-based chemotherapy in
carcinoma of the fallopian tube. Gynecol Oncol 2001;80:16-20
-Carcinoma del polmone non a
piccole cellule in stadio avanzato, in -Neoplasia germinale del testicolo
combinazione con cisplatino
-Carcinoma della vescica
-Sarcoma di Kaposi correlato
-Sarcomi dei tessuti molli
all'AIDS avanzato
-Carcinoma delle tube di Falloppio
Carcinoma dello stomaco
Kang HJ et al. A phase II study of paclitaxel and capecitabine as
a first-line combination chemotherapy for advanced gastric
cancer. Br J Cancer 2008;98:316-322
Yamaguchi K et al. Combination chemotherapy with 5fluorouracil, cisplatin and paclitaxel for pretreated patients with
advanced gastric cancer. Anticancer Res 2007;27:3535-3539
-Carcinoma dello stomaco
Ajani JA et al. Phase II study of taxol in patients with advanced
gastric carcinoma. Cancer J Sci Am 1998;4:269-274
-Glioma maligno
Glioma maligno
-Melanoma maligno
-Carcinoma del polmone non a piccole cellule
in monoterapia o combinato con agenti diversi
da cisplatino
Prados MD et al. Phase II study of paclitaxel in patients with
recurrent malignant glioma. J Clin Oncol 1996;14:2316-2321
Melanoma maligno
Einzig AI et al. A phase II study of taxol in patients with
malignant melanoma. Invest New Drugs 1991;9:59-64
Rao RD et al. Combination of paclitaxel and carboplatin as
second-line therapy for patients with metastatic melanoma.
25
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Cancer 2006;106:375-382
Walker L et al. Phase II trial of weekly paclitaxel in patients with
advanced melanoma. Melanoma Res 2005;15:453-459
Carcinoma del polmone non a piccole cellule in
monoterapia o combinato con agenti diversi da
cisplatino
Androulakis N et al. Salvage treatment with paclitaxel and
gemcitabine for patients with non-small-cell lung cancer after
cisplatin- or docetaxel-based chemotherapy: a multicenter phase
II study. Ann Oncol 1998;9:1127-1130
Hainsworth JD et al. One-hour paclitaxel plus carboplatin in the
treatment of advanced non-small cell lung cancer: results of a
multicentre, phase II trial. Eur J Cancer 1998;34:654-658
Scagliotti GV et al. Randomized study of adjuvant chemotherapy
for completely resected stage I, II, or IIIA non-small-cell lung
cancer. J Natl Cancer Inst 2003;95:1453-1461
PEMETREXED
-Mesotelioma pleurico maligno non Altri mesoteliomi maligni (tutti gli istotipi)
resecabile non pretrattato
-Carcinoma polmonare non a
piccole cellule localmente avanzato
o metastatico
RITUXIMAB
-Linfoma non Hodgkin
- Linfomi non Hodgkin a cellule B: tutti gli
istotipi CD 20- positivi in prima linea, in cicli di
-Linfoma follicolare in III-IV stadio,
salvataggio, inclusi i regimi di condizionamento
in recidiva o refrattario
-Leucemia linfatica cronica
-Linfoma non Hodgkin CD20
positivo
-Disordini linfoproliferativi EBV-correlati in
soggetti trapiantati
-Terapia della Graft Versus Host Disease acuta e
cronica steroido-resistente
-Macroglobulinemia di Waldenström
Altri mesoteliomi maligni
Vogelzang NJ et al. New agents in the management of advanced
mesothelioma. Semin Oncol 2005;32:336-350
Macroglobulinemia di Waldenström
Dimopoulos MA et al. Primary treatment of Waldenström
macroglobulinemia with dexamethasone, rituximab, and
cyclophosphamide. J Clin Oncol 2007;25:3344-3349
Treon SP et al. Novel agents in the treatment of Waldenström's
macroglobulinemia. Clin Lymphoma Myeloma 2007;7 :199-206
Treon SP et al. Extended rituximab therapy in Waldenström's
macroglobulinemia. Ann Oncol 2005;16:132-138
Leucemia a cellule capellute
Else M et al. The role of rituximab in combination with
pentostatin or cladribine for the treatment of recurrent/refractory
hairy cell leukemia. Cancer 2007;110:2240-2247
26
NOME COMPOSTO
TAMOXIFENE
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
-Carcinoma mammario
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
-Leucemia a cellule capellute
Robak T. Current treatment options in hairy cell leukemia and
hairy cell leukemia variant. Cancer Treat Rev 2006;32:365-376
-Tumore della mammella maschile
Carcinoma ovarico avanzato
-Fibromatosi aggressive
Perez-Gracia JL and Carrasco EM: Tamoxifen therapy for
ovarian cancer in the adjuvant and advanced settings: Systemic
review of the literature and implications for future research.
Gynecol Oncol 2002;84:201-209
-Carcinoma ovarico avanzato
Hatch KD et al. Responsiveness of patients with advanced
ovarian carcinoma to tamoxifen. Cancer 1991;68:269-271
van der Vange N et al. Experience with hormonal therapy in
advanced epithelial ovarian cancer. Acta Oncol 1995;3 4:813-820
TEMOZOLOMIDE
-Glioblastoma multiforme
-Gliomi maligni
-Melanoma maligno quando non si ritenga
opportuno un trattamento con dacarbazina
-Linfomi primitivi del sistema nervoso
centrale
Linfomi primitivi del sistema nervoso centrale
Santisteban M et al. Primary central nervous system lymphoma
treated with rituximab plus temozolomide in a second line
schedule. Clin Transl Oncol 2007;9 :465-467
Reni M et al. Temozolomide as salvage treatment in primary
brain lymphomas. Br J Cancer 2007;9 6:864-867
Pitini V et al. Salvage therapy for primary central nervous system
lymphoma with (90)Y-Ibritumomab and temozolomide. J
Neurooncol 2007;83:291-293
TENIPOSIDE
-Linfomi maligni
-Mieloma multiplo
Mieloma multiplo
Leoni F et al. Continuous-infusion cyclophosphamide in
combination with teniposide and dexamethasone in refractory
myeloma. Leuk Lymphoma 1992;7 :481-487
-Tumori del SNC
-Tumori della vescica
Tirelli U et al. Phase II study of teniposide (VM-26) in multiple
myeloma. Am J Clin Oncol 1985;8 :329-331
TOPOTECANO
-Carcinoma metastatizzato
dell’ovaio (in seconda linea o
successive)
-Carcinoma del polmone a piccole cellule in
prima linea e/o in pazienti non candidati alla
terapia con cisplatino
-Carcinoma polmonare a piccole
-Carcinoma
della
cervice
uterina:
cellule recidivante (in seconda linea) monoterapia nello stadio IVB recidivato o
resistente
-Carcinoma della cervice uterina
recidivante dopo radioterapia e nelle -Neuroblastoma resistente alla terapia di
Carcinoma del polmone a piccole cellule in prima linea
e/o in pazienti non candidati alla terapia con cisplatino
Schiller JH. Topotecan in small cell lung cancer. Semin Oncol
1997;24:27-33
Eckardt JR et al. Open-label, multicenter, randomized, phase III
study
comparing
oral
topotecan/cisplatin
versus
etoposide/cisplatin as treatment for chemotherapy-naive patients
with extensive-disease small-cell lung cancer. J Clin Oncol
27
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
pazienti allo stadio IVB della
malattia (in associazione con
cisplatino)
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
prima linea
2006;24:2044-2051
-Sarcoma di Ewing resistente alla terapia di
prima linea
O'Brien ME et al. Phase III trial comparing supportive care alone
with supportive care with oral topotecan in patients with relapsed
small-cell lung cancer. J Clin Oncol 2006; 24:5441-5447
-Rabdomiosarcoma resistente alla terapia di
Carcinoma della cervice in monoterapia nello stadio
IVB recidivato o persistente
prima linea
-Leucemia acuta
-Sindromi mielodisplastiche
Bookman MA et al. Topotecan in squamous cell carcinoma of
the cervix: A Phase II study of the Gynecologic Oncology Group.
Gynecol Oncol 2000;77:446-449
Abu-Rustum NR et al. Topotecan for recurrent cervical cancer
after platinum-based therapy. Int J Gynecol Cancer 2000;10:285288
Muderspach LI et al. A Phase II study of topotecan in patients
with squamous cell carcinoma of the cervix: a gynecologic
oncology group study. Gynecol Oncol 2001;81:213-215
Neuroblastoma resistente alla terapia di prima linea
Simon T et al. Topotecan, cyclophosphamide and etoposide
(TCE) in the treatment of high-risk neuroblastoma. Results of a
phase-II trial. J Cancer Res Clin Oncol 2007;133:653-661
Sarcoma di Ewing resistente alla terapia di prima
linea e Rabdomiosarcoma resistente alla terapia di
prima linea
Budd GT et al. Phase II trial of topotecan by continuous infusion
in patients with advanced soft tissue sarcomas, a SWOG study.
Southwest Oncology Group. Invest New Drugs 2002;20:129-132
Hunold A et al. Topotecan and cyclophosphamide in patients
with refractory or relapsed Ewing tumors. Pediatr Blood Cancer
2006;47:795-800
Leucemia acuta
Cortes J et al. Cyclophosphamide, ara-C and topotecan (CAT) for
patients with refractory or relapsed acute leukemia. Leukemia
and Lymphoma 2000;36:479-484
Sindromi mielodisplastiche
28
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
Kantarjian H et al. Long-term follow-up results of the
combination of topotecan and cytarabine and other intensive
chemotherapy regimens in myelodysplastic syndrome. Cancer
2006;106:1099-1109
Beran M et al. Topotecan, a topoisomerase I inhibitor, is active in
the treatment of myelodysplastic syndrome and chronic
myelomonocytic leukemia. Blood 1996;88:2473-2479
Rosenthal CJ and Thapper A. Sequential therapy with amifostine,
topotecan, and etoposide induced repeated responses in patients
with myelodysplastic syndrome. Leuk Res 1999;23:S77
VINBLASTINA
-Linfoma di Hodgkin (stadio III e
IV)
-Linfoma linfocitico
-Carcinomi della vescica
Linfoma di Hodgkin in stadio I e II
-Carcinoma a cellule renali
Press OW et al. Phase III randomized intergroup trial of subtotal
lymphoid irradiation versus doxorubicin, vinblastine, and subtotal
lymphoid irradiation for stage IA to IIA Hodgkin's disease. J Clin
Oncol 2001;19:4238-4244
-Linfoma di Hodgkin in stadio I e II
-Linfoma istiocitico
Engert A et al. Two cycles of doxorubicin, bleomycin,
vinblastine, and dacarbazine plus extended-field radiotherapy is
superior to radiotherapy alone in early favorable Hodgkin's
lymphoma: final results of the GHSG HD7 trial. J Clin Oncol
2007;25:3495-3502
-Micosi fungoide
-Carcinoma del testicolo
-Sarcoma di Kaposi
-Coriocarcinoma
-Carcinoma della mammella
-Morbo di Letterer-Siwe (Istiocitosi
X)
VINCRISTINA
-Leucemie acute
-Osteosarcoma
Osteosarcoma
-Linfomi maligni
-Sarcoma di Ewing
Gasparini M et al. Continuous cisplatin infusion in combination
with vincristine and high-dose methotrexate for advanced
osteogenic sarcoma. Am J Clin Oncol 1987;10:152-155
-Mieloma multiplo
-Leucemia linfatica cronica
-Leucemia mieloide cronica in fase blastica
-Carcinoma del polmone a piccole cellule
Sarcoma di Ewing
Bernstein ML et al. Intensive therapy with growth factor support
for patients with Ewing tumor metastatic at diagnosis: Pediatric
Oncology Group/Children's Cancer Group Phase II Study 9457-a
report from the Children's Oncology Group. J Clin Oncol
29
NOME COMPOSTO
SINTESI DELLE INDICAZIONI
GIÀ AUTORIZZATE
ESTENSIONE DELLE INDICAZIONI
SULLA BASE DELLA DELIBERA AIFA
(corsivo) E DI NUOVE EVIDENZE
SCIENTIFICHE (grassetto)
-Carcinoma della cervice uterina
BIBLIOGRAFIA
a sostegno dell’estensione dell’indicazione
2006;24:152-159
Milano GM et al. High histologic and overall response to dose
intensification of ifosfamide, carboplatin and etoposide with
cyclophosphamide, doxorubicin and vincristine in patients with
high-risk Ewing sarcoma family tumors: the Bambino Gesù
Children's Hospital experience. Cancer 2006;106:1838-1845
Navid F et al. Concomitant administration of vincristine,
doxorubicin, cyclophosphamide, ifosfamide and etoposide for
high-risk sarcomas: the St. Jude Children's Research Hospital
experience. Cancer 2006;106:1846-1856
Mieloma multiplo
Zervas K et al. Primary treatment of multiple myeloma with
thalidomide,
vincristine,
liposomal
doxorubicin
and
dexamethasone (T-VAD doxil); a phase II multicenter study. Ann
Oncol 2004; 15:134-138
Zervas K
et al. Comparison of vincristine, carmustine,
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32