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UNICANCER-PRODIGE 23

Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial

Phase 3N = 461NCT01804790

Population
Adults aged 18 to 75 years with newly diagnosed, biopsy-proven cT3 or cT4 M0 rectal adenocarcinoma, WHO performance status 0-1
Design
Open-label, multicentre phase 3 trial at 35 hospitals in France: 461 patients aged 18 to 75 years with biopsy-proven cT3 or cT4 M0 rectal adenocarcinoma were randomly assigned (1:1, June 2012 to June 2017) to six cycles of neoadjuvant FOLFIRINOX, then chemoradiotherapy (50 Gy with capecitabine), total mesorectal excision and 3 months of adjuvant chemotherapy, or to chemoradiotherapy, total mesorectal excision and 6 months of adjuvant chemotherapy. Primary endpoint 3-year disease-free survival in the intention-to-treat population.
Primary endpoint
DFS
Arms
  • Standard of care (control, n = 230): Chemoradiotherapy (50 Gy with capecitabine), total mesorectal excision, 6 months of adjuvant chemotherapy
  • Neoadjuvant FOLFIRINOX (experimental, n = 231): Six cycles of FOLFIRINOX, then chemoradiotherapy (50 Gy with capecitabine), total mesorectal excision, 3 months of adjuvant mFOLFOX6 or capecitabine
People
Conroy T, Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group
DFSHR 0.69 (95% CI 0.49–0.97)Δ 36-month DFS+7 pointsΔ 84-month DFS+5.1 pointsΔ 84-month Metastasis-free survival+6.9 pointsΔ 84-month OS+5.8 points
Show the numbers
Results reported for UNICANCER-PRODIGE 23
EndpointAnalysisNeoadjuvant FOLFIRINOXStandard of careEffect
DFS3-year disease-free survival (primary endpoint)primarymedian follow-up 46.5 monthsConroy 202176% at 3 y (69–81%)69% at 3 y (62–74%)HR 0.69 (95% CI 0.49–0.97)P=0.034Stratified hazard ratio.
DFSRandomised patients (analysis population not stated in the abstract)7-year disease-free survival (long-term analysis)long term-updatemedian follow-up 82.2 monthsConroy 202467.6% at 7 y (60.7–73.9%)62.5% at 7 y (55.6–68.6%)P=0.048P value is for the restricted mean survival time difference of 5.73 months (95% CI 0.05 to 11.41).
Metastasis-free survivalRandomised patients (analysis population not stated in the abstract)7-year metastasis-free survival (key secondary endpoint)long term-updatemedian follow-up 82.2 monthsConroy 202479.2% at 7 y (73.0–84.4%)72.3% at 7 y (65.8–77.8%)P=0.021P value is for the restricted mean survival time difference of 6.1 months (95% CI 0.93 to 11.37).
OSRandomised patients (analysis population not stated in the abstract)7-year overall survival (key secondary endpoint)long term-updatemedian follow-up 82.2 monthsConroy 202481.9% at 7 y (75.8–86.6%)76.1% at 7 y (69.7–81.2%)P=0.033P value is for the restricted mean survival time difference of 4.37 months (95% CI 0.35 to 8.38).
Results reported for UNICANCER-PRODIGE 23
EndpointAnalysisNeoadjuvant FOLFIRINOXStandard of careEffect
DFS3-year disease-free survival (primary endpoint)primarymedian follow-up 46.5 monthsConroy 202176% at 3 y (69–81%)69% at 3 y (62–74%)HR 0.69 (95% CI 0.49–0.97)P=0.034Stratified hazard ratio.
DFSRandomised patients (analysis population not stated in the abstract)7-year disease-free survival (long-term analysis)long term-updatemedian follow-up 82.2 monthsConroy 202467.6% at 7 y (60.7–73.9%)62.5% at 7 y (55.6–68.6%)P=0.048P value is for the restricted mean survival time difference of 5.73 months (95% CI 0.05 to 11.41).
Metastasis-free survivalRandomised patients (analysis population not stated in the abstract)7-year metastasis-free survival (key secondary endpoint)long term-updatemedian follow-up 82.2 monthsConroy 202479.2% at 7 y (73.0–84.4%)72.3% at 7 y (65.8–77.8%)P=0.021P value is for the restricted mean survival time difference of 6.1 months (95% CI 0.93 to 11.37).
OSRandomised patients (analysis population not stated in the abstract)7-year overall survival (key secondary endpoint)long term-updatemedian follow-up 82.2 monthsConroy 202481.9% at 7 y (75.8–86.6%)76.1% at 7 y (69.7–81.2%)P=0.033P value is for the restricted mean survival time difference of 4.37 months (95% CI 0.35 to 8.38).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS0.690.49–0.97
Primary publication: Conroy T, Bosset JF, Etienne PL, Rio E, François É, Mesgouez-Nebout N, et al. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22(5):702-715. PubMedDOI

Appears in

Sources

  1. Conroy T, Bosset JF, Etienne PL, Rio E, François É, Mesgouez-Nebout N, et al. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021;22(5):702-715.

    PubMedDOI

  2. Conroy T, Castan F, Etienne PL, Rio E, Mesgouez-Nebout N, Evesque L, et al. Total neoadjuvant therapy with mFOLFIRINOX versus preoperative chemoradiotherapy in patients with locally advanced rectal cancer: long-term results of the UNICANCER-PRODIGE 23 trial. Ann Oncol. 2024;35(10):873-881.

    PubMedDOI