Società Lombarda di Chirurgia
Studio randomizzato di Fase II per la
valutazione di un approccio
di revisione chirurgica sistematica,
associata a chemio-ipertermia
intraperitoneale ed eventuale chirurgia
citoriduttiva,versus
follow-up standard in pazienti ad alto rischio
di sviluppare carcinosi
peritoneale da carcinoma colo-rettale
Shigeki Kusamura e Baratti Dario
Period January 1995 - February 2009
47 studies
Median survival
5-year survival
Operative morbidity
Operative death
2 randomized (1 completed)
2 controlled
43 observational (3 multicentric)
11.9-60.1 months
11-51% (median 19%)
14.8-76%
0-12%
Median OS 29 months
Median OS 5.4 months
Mortality rate: 8%
Most of the serious complications seem to be related to the extent of surgery, and
may be related to the extent of peritoneal involvement
Median survival: 30.1 mths
5yr OS: 27%
Morbidity: 31%
Mortality: 3%
1. The earlier the better
2. Not optimal sensitivity of
clinical, tumor markers and
imaging in detecting early
PC
Second-look surgery
Systematic use of planned reoperation in asymptomatic
patients with malignant disease who are theoretically at
risk for developing recurrent or metastatic disease
despite initial curative surgery
Largerly employed in Epithelial Ovarian Cancer during
the 90s
Which candidates?
Wangensteen OH Wis. Med J 1949
1. Singapore general hospital
2. 3019 colorectal cancer
3. 349 (13%) developed PC
- 214 synchronous
- 135 metachronous
Logistic regression analysis for development of metachronous PC
Population-based cohort study
11.124 patients with colorectal cancer in Stockholm County
924 patients (8·3 %) had synchronous or metachronous PC
Cumulative incidence of metachronous PC: 4.2%
PC was the sole site of meta at the time of diagnosis in 177 of 7799
Hazard ratios for metachronous PC after resection of stage I-III colon cancer
Macroscopically resected minimal PC
Macroscopically resected ovarian metastases
Perforated primary tumor
Adjuvant systemic oxaliplatin/ irinotecan for 6 months
Follow-up for 6 months
Negative re-staging
Second-look surgery
Annals of surgery, 2011
Syncr. PC
n=25
Ovarian M
n= 8
Perforated T
N=8
TOTAL
n=41
SUGERY + sCT
PC at second look operation
n=15 (60%)
PCI: 9+/-6
N=5 (62%)
PCI: 7+/-5
N=3 (37%)
PCI: 5+/-2
n=23 (56%)
5-year overall survival in 41 pts undergoing HIPEC±CRS= 90%
MORTALITY: 2%
Morbidity= 9.7%
Annals of surgery, 2011
Patients undergoing radical primary treatment and ≥3 months of
adjuvant systemic CT
INCLUSION CRITERIA
• resected minimal PC
• ovarian metastases
• perforated primary tumor
• T4
• obstruction
• bleeding
End-point: overall survival
Accrual: 35 pts per arm
Duration: 5 years
Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in
Principle“HIPEC in Colorectal Patients
A phase III multicentric French study (ProphyloCHIP)
Colon cancer with high risk of PC
Adjuvant systemic Folfox for 6 months
Follow-up for 6 months
Negative re-staging
Second-look surgery
Follow-up
• Minimal PC, resected at the same time as the
primary
•Ovarian metastases
• Rupture of the primary tumour
• Iatrogenic rupture of the primary tumour during
surgery