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The trial that made cytoreductive surgery with a heated chemotherapy wash a treatment rather than an experiment. Twenty years later PRODIGE 7 showed the surgery, not the wash, was doing the work.
Verwaal and colleagues at the Netherlands Cancer Institute randomised 105 patients with peritoneal carcinomatosis of colorectal origin to cytoreductive surgery with mitomycin C hyperthermic intraperitoneal chemotherapy followed by systemic fluorouracil and leucovorin, or to systemic fluorouracil and leucovorin with palliative surgery when needed. Median survival was 22.3 against 12.6 months (p=0.032) after a median 21.6 months of follow-up. Treatment-related mortality in the aggressive arm was 8 percent, most complications coming from bowel leakage, and patients with six or seven of the seven abdominal regions involved, or an incomplete cytoreduction, did badly. This trial created the specialist peritoneal surface malignancy services that exist today. PRODIGE 7 later showed that oxaliplatin HIPEC adds nothing to complete cytoreduction, so what this trial really demonstrated is the value of the operation and of selecting patients with limited disease.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
105 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Cytoreductive surgery plus mitomycin HIPEC and systemic chemotherapy | - | 22.3 months | - | 0.032 | link |
| Systemic chemotherapy with or without palliative surgery | - | 12.6 months |
Shares HIPEC / PIPAC (intraperitoneal chemotherapy), Netherlands Cancer Institute (NKI-AvL), Leucovorin (folinic acid), Fluorouracil (5-FU).
Shares Mitomycin C, HIPEC / PIPAC (intraperitoneal chemotherapy), Leucovorin (folinic acid), Fluorouracil (5-FU).
Shares COLOPEC, PROPHYLOCHIP-PRODIGE 15, PRODIGE 7, Colorectal cancer.
Shares Debulking (cytoreductive surgery), HIPEC perfusion pumps and PIPAC nebulisers, HIPEC / PIPAC (intraperitoneal chemotherapy), Colorectal cancer.
Shares HIPEC perfusion pumps and PIPAC nebulisers, HIPEC / PIPAC (intraperitoneal chemotherapy), Colorectal cancer.
Shares HIPEC perfusion pumps and PIPAC nebulisers, HIPEC / PIPAC (intraperitoneal chemotherapy), Colorectal cancer.
Shares HIPEC / PIPAC (intraperitoneal chemotherapy), Leucovorin (folinic acid), Fluorouracil (5-FU), Colorectal cancer.
Shares Leucovorin (folinic acid), Fluorouracil (5-FU), Colorectal cancer.