{"entity":{"id":"paper-quenet-prodige-7-hipec-peritoneal-colorectal-lancet-oncol-2021","kind":"paper","name":"Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7)","aka":[],"tldr":"The trial that took the heated chemotherapy away and found the survival was the same: 41.7 against 41.2 months. The benefit had always been in the surgery.","summary":"Quénet, Elias, Roca and colleagues ran a randomised open-label phase 3 trial at 17 cancer centres in France in patients aged 18 to 70 with histologically proven colorectal cancer and peritoneal metastases, WHO performance status 0 or 1, a Peritoneal Cancer Index of 25 or less, and eligibility for six months of systemic chemotherapy. Patients in whom complete macroscopic resection, or resection with less than 1 mm of residual tumour, was achieved were randomised 1:1 to cytoreductive surgery with or without oxaliplatin-based hyperthermic intraperitoneal chemotherapy. All patients received systemic chemotherapy with or without targeted therapy before or after surgery, or both. The primary endpoint was overall survival in the intention-to-treat population.\n\nBetween February 2008 and January 2014, 265 patients were randomised: 133 to surgery plus hyperthermic intraperitoneal chemotherapy and 132 to surgery alone.","asOf":"2026-09-24","links":[{"label":"Lancet Oncol 2021","url":"https://doi.org/10.1016/S1470-2045(20)30599-4"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/33476595/"}],"tags":["colorectal-evidence"],"related":["paper-verwaal-cytoreduction-hipec-peritoneal-colorectal-jco-2003"],"cancers":["colorectal"],"sections":["surgery","chemotherapy"],"technologies":["hipec"],"targets":[],"drugs":["oxaliplatin","fluorouracil","leucovorin"],"companies":["unicancer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-negative-results","b-surgery-radiation-innovation"],"keyPapers":[],"journals":["lancet-oncology"],"dependsOn":[],"notes":[],"journal":"The Lancet Oncology","year":2021,"doi":"10.1016/S1470-2045(20)30599-4","pmid":"33476595","authors":"Quénet F, Elias D, Roca L, et al.","paperType":"rct","findings":["After a median 63.8 months, median overall survival 41.7 months (95 percent CI 36.2 to 53.8) with hyperthermic intraperitoneal chemotherapy against 41.2 months (35.1 to 49.7) without: hazard ratio 1.00 (95.37 percent CI 0.63 to 1.58), stratified log-rank p=0.99.","Two treatment-related deaths at 30 days in each group.","Grade 3 or worse adverse events at 30 days were similar (56 of 133, 42 percent, against 42 of 132, 32 percent; p=0.083) but more common at 60 days with hyperthermic intraperitoneal chemotherapy (34 of 131, 26 percent, against 20 of 130, 15 percent; p=0.035)."],"whatItMeans":"Complete cytoreductive surgery with modern systemic chemotherapy gives a median survival over 40 months in selected patients with peritoneal metastases, and the heated intraperitoneal oxaliplatin adds only late complications.","caveats":["The trial tests oxaliplatin-based hyperthermic chemotherapy specifically; mitomycin-based regimens and pressurised aerosol delivery are not addressed.","Highly selected patients: Peritoneal Cancer Index 25 or less, under 70, fit for six months of chemotherapy, and randomised only after complete cytoreduction was achieved.","A 41-month median survival in both arms is far better than historic series and reflects that selection, not a general result for peritoneal disease."],"changedPractice":true,"participants":265},"route":"/key-papers/paper-quenet-prodige-7-hipec-peritoneal-colorectal-lancet-oncol-2021/","neighbours":{"paper":[{"id":"paper-verwaal-cytoreduction-hipec-peritoneal-colorectal-jco-2003","kind":"paper","name":"Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer","route":"/key-papers/paper-verwaal-cytoreduction-hipec-peritoneal-colorectal-jco-2003/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"},{"id":"surgery","kind":"section","name":"Surgery & Interventional","route":"/fronts/surgery/"}],"technology":[{"id":"hipec","kind":"technology","name":"HIPEC / PIPAC (intraperitoneal chemotherapy)","route":"/technologies/hipec/"}],"drug":[{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"},{"id":"oxaliplatin","kind":"drug","name":"Oxaliplatin","route":"/drugs/oxaliplatin/"}],"company":[{"id":"unicancer","kind":"company","name":"UNICANCER","route":"/companies/unicancer/"}],"bottleneck":[{"id":"b-negative-results","kind":"bottleneck","name":"Failures are hidden","route":"/bottlenecks/b-negative-results/"},{"id":"b-surgery-radiation-innovation","kind":"bottleneck","name":"Surgery and radiotherapy cure most, get least","route":"/bottlenecks/b-surgery-radiation-innovation/"}],"journal":[{"id":"lancet-oncology","kind":"journal","name":"The Lancet Oncology","route":"/journals/lancet-oncology/"}],"roadmap":[{"id":"colorectal-roadmap","kind":"roadmap","name":"Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation","route":"/roadmaps/colorectal-roadmap/"}],"idea":[{"id":"idea-crc-peritoneal-disease-found-early-and-treated-in-networks","kind":"idea","name":"Find peritoneal spread while it is still small, and run complete cytoreduction through networks rather than adding heated chemotherapy","route":"/ideas/idea-crc-peritoneal-disease-found-early-and-treated-in-networks/"}]}}