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NSABP C-07

Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer

Phase 3N = 2,492NCT00004931

Population
Patients with stage II or III colon cancer who had a potentially curative resection; 2492 randomly assigned, 2407 (96.6 percent) eligible.
Design
Phase III randomised trial after potentially curative resection comparing weekly bolus fluorouracil plus leucovorin (FULV) with the same regimen plus oxaliplatin (FLOX), three 8-week cycles. The abstract states that the trial evaluated the effect of adding oxaliplatin on disease-free survival.
Arms
  • FULV (control): Fluorouracil 500 mg/m2 and leucovorin 500 mg/m2 IV weekly for 6 weeks of each 8-week cycle, three cycles
  • FLOX (experimental): FULV plus oxaliplatin 85 mg/m2 IV on weeks 1, 3 and 5 of each 8-week cycle, three cycles
People
Kuebler JP
DFSHR 0.80 (95% CI 0.69–0.93)Δ 36-month DFS+4.3 pointsΔ Grade 3 sensory neuropathy+7.5 points
Show the numbers
Results reported for NSABP C-07
EndpointAnalysisFLOXFULVEffect
DFSEligible patients (2407 of 2492 randomly assigned)primarymedian follow-up 42.5 monthsKuebler 200776.1% at 3 y71.8% at 3 yHR 0.80 (95% CI 0.69–0.93)P<.004Median follow-up of 42.5 months is stated for patients still alive. Four-year DFS rates: 67.0 percent (FULV) and 73.2 percent (FLOX).
Grade 3 sensory neuropathyPatients as analysed for toxicity; denominator not stated in the abstractprimaryKuebler 20078.2%0.7%P<.001Reported in the abstract as grade 3 neurosensory toxicity.
Results reported for NSABP C-07
EndpointAnalysisFLOXFULVEffect
DFSEligible patients (2407 of 2492 randomly assigned)primarymedian follow-up 42.5 monthsKuebler 200776.1% at 3 y71.8% at 3 yHR 0.80 (95% CI 0.69–0.93)P<.004Median follow-up of 42.5 months is stated for patients still alive. Four-year DFS rates: 67.0 percent (FULV) and 73.2 percent (FLOX).
Grade 3 sensory neuropathyPatients as analysed for toxicity; denominator not stated in the abstractprimaryKuebler 20078.2%0.7%P<.001Reported in the abstract as grade 3 neurosensory toxicity.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS0.80.69–0.93
Primary publication: Kuebler JP, Wieand HS, O'Connell MJ, Smith RE, Colangelo LH, Yothers G, et al. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol. 2007;25(16):2198-204. PubMedDOI

Appears in

Sources

  1. Kuebler JP, Wieand HS, O'Connell MJ, Smith RE, Colangelo LH, Yothers G, et al. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol. 2007;25(16):2198-204.

    PubMedDOI