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Bending the Curve Trial by Trial
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PRODIGE 7

Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial

Phase 3N = 265NCT00769405

Population
Patients aged 18 to 70 years with histologically proven colorectal cancer and peritoneal metastases, WHO performance status 0 or 1; 265 randomised between 2008 and 2014 (ClinicalTrials.gov lists 264).
Design
Randomised, open-label phase 3 trial at 17 French cancer centres. Patients with colorectal peritoneal metastases (Peritoneal Cancer Index 25 or less) in whom complete macroscopic resection, or resection leaving less than 1 mm of residual tumour, was completed were assigned 1:1 to cytoreductive surgery with or without oxaliplatin-based HIPEC (closed technique 360 mg/m2 or open technique 460 mg/m2, with intravenous fluorouracil and folinic acid). All patients received systemic chemotherapy. Primary endpoint overall survival, analysed by intention to treat.
Primary endpoint
OS
Arms
  • Cytoreductive surgery plus HIPEC (experimental, n = 133): Cytoreductive surgery plus oxaliplatin-based hyperthermic intraperitoneal chemotherapy
  • Cytoreductive surgery alone (control, n = 132): Cytoreductive surgery alone
People
Quénet F, UNICANCER-GI Group and BIG Renape Group
OSHR 1Δ median OS+0.5 monthsΔ Grade 3 or worse adverse events+11 points
Show the numbers
Results reported for PRODIGE 7
EndpointAnalysisCytoreductive surgery plus HIPECCytoreductive surgery aloneEffect
OSprimarymedian follow-up 63.8 monthsQuénet 2021median 41.7 months (36.2–53.8)median 41.2 months (35.1–49.7)HR 1P=0.99The abstract gives the confidence interval of the hazard ratio as a 95.37 percent interval (0.63 to 1.58), not a 95 percent interval.
Grade 3 or worse adverse eventsPatients with 60-day safety data (131 and 130)primaryQuénet 202126%15%P=0.035At 60 days, 34 of 131 versus 20 of 130. At 30 days the frequencies were 56 of 133 (42 percent) versus 42 of 132 (32 percent), p=0.083. Two treatment-related deaths (2 percent) occurred in each group at 30 days.
Results reported for PRODIGE 7
EndpointAnalysisCytoreductive surgery plus HIPECCytoreductive surgery aloneEffect
OSprimarymedian follow-up 63.8 monthsQuénet 2021median 41.7 months (36.2–53.8)median 41.2 months (35.1–49.7)HR 1P=0.99The abstract gives the confidence interval of the hazard ratio as a 95.37 percent interval (0.63 to 1.58), not a 95 percent interval.
Grade 3 or worse adverse eventsPatients with 60-day safety data (131 and 130)primaryQuénet 202126%15%P=0.035At 60 days, 34 of 131 versus 20 of 130. At 30 days the frequencies were 56 of 133 (42 percent) versus 42 of 132 (32 percent), p=0.083. Two treatment-related deaths (2 percent) occurred in each group at 30 days.
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%020406080100Months (modelled)
  • Cytoreductive surgery plus HIPEC (experimental)
  • Cytoreductive surgery alone (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsCytoreductive surgery plus HIPECCytoreductive surgery alone
0100.0%100.0%
2664.9%64.6%
5242.1%41.7%
7827.3%26.9%
10417.8%17.4%
Primary publication: Quénet F, Elias D, Roca L, Goéré D, Ghouti L, Pocard M, et al. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22(2):256-266. PubMedDOI

Appears in

Sources

  1. Quénet F, Elias D, Roca L, Goéré D, Ghouti L, Pocard M, et al. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy versus cytoreductive surgery alone for colorectal peritoneal metastases (PRODIGE 7): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22(2):256-266.

    PubMedDOI