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Studio randomizzato di Fase II per la valutazione di un approccio di revisione chirurgica sistematica, associata a chemio-ipertermia intraperitoneale ed.

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Presentation on theme: "Studio randomizzato di Fase II per la valutazione di un approccio di revisione chirurgica sistematica, associata a chemio-ipertermia intraperitoneale ed."— Presentation transcript:

1 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 Società Lombarda di Chirurgia

2 Centro Nazionale per il Controllo e la Prevenzione delle Malattie Incidenza casi/anno (stima 2008) Carcinosi peritoneale ~ Carcinosi peritoneale isolata ~ Incidenza casi/anno (stima 2008) Carcinosi peritoneale ~ Carcinosi peritoneale isolata ~

3 Period January February randomized (1 completed) 47 studies 2 controlled 43 observational (3 multicentric) Median survival months 5-year survival 11-51% (median 19%) Operative morbidity % Operative death 0-12%

4 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 OS 29 months Median OS 5.4 months Mortality rate: 8%

5 Median survival: 30.1 mths 5yr OS: 27% Morbidity: 31% Mortality: 3%

6 1.The earlier the better 2.Not optimal sensitivity of clinical, tumor markers and imaging in detecting early PC

7 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

8 1. Singapore general hospital colorectal cancer (13%) developed PC synchronous metachronous Logistic regression analysis for development of metachronous PC

9 Population-based cohort study 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

10 Hazard ratios for metachronous PC after resection of stage I-III colon cancer

11 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

12 Syncr. PC n=25 Ovarian M n= 8 Perforated T N=8 TOTAL n=41 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% SUGERY + sCT Annals of surgery, 2011

13 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 Patients undergoing radical primary treatment and 3 months of adjuvant systemic CT

14 Colon cancer with high risk of PC Adjuvant systemic Folfox for 6 months Follow-up for 6 months Negative re-staging Second-look surgery Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in PrincipleHIPEC in Colorectal Patients A phase III multicentric French study (ProphyloCHIP) 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 Follow-up


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