Skip to content
Bending the Curve Trial by Trial
?

TOSCA

A Randomized Trial Investigating the Role of FOLFOX-4 Regimen Duration (3 Versus 6 Months) and Bevacizumab as Adjuvant Therapy for Patients With Stage II/III Colon Cancer

Phase 3N = 3,759NCT00646607

Population
Patients with high-risk stage II or stage III colon cancer from 130 Italian sites; 3,759 accrued (64 percent FOLFOX, 36 percent CAPOX); two thirds had stage III disease.
Design
Open-label, multicentre phase III noninferiority trial randomising patients with high-risk stage II or stage III colon cancer to 3 or 6 months of FOLFOX or CAPOX. Primary endpoint relapse-free survival; noninferiority limit of 20 percent relative increase (HR 1.20).
Primary endpoint
RFS
Arms
  • 3 months (experimental): 3 months of adjuvant oxaliplatin-containing chemotherapy
  • 6 months (control): 6 months of adjuvant oxaliplatin-containing chemotherapy
People
Sobrero A
RFSHR 1.14 (95% CI 0.99–1.32)RFSHR 1.07 (95% CI 0.91–1.26)RFSHR 1.41 (95% CI 1.05–1.89)RFSHR 0.98 (95% CI 0.77–1.26)RFSHR 1.23 (95% CI 1.03–1.46)
Show the numbers
Results reported for TOSCA
EndpointAnalysis3 months6 monthsEffect
RFSAll accrued patients (3,759); analysis population not labelled in the abstractprimarymedian follow-up 62 monthsSobrero 2018——HR 1.14 (95% CI 0.99–1.32)P=0.514P value is for noninferiority; the confidence interval crossed the noninferiority limit of 1.20. 772 relapses or deaths. Absolute difference in 3-year RFS 1.9 percentage points (95% CI -0.7 to 4.4) as published; the abstract does not give the arm-level rates.
RFSStage III subgroupexploratorySobrero 2018——HR 1.07 (95% CI 0.91–1.26)
RFSHigh-risk stage II subgroupexploratorySobrero 2018——HR 1.41 (95% CI 1.05–1.89)
RFSPatients treated with CAPOX (regimen not randomised)exploratorySobrero 2018——HR 0.98 (95% CI 0.77–1.26)
RFSPatients treated with FOLFOX (regimen not randomised)exploratorySobrero 2018——HR 1.23 (95% CI 1.03–1.46)
Results reported for TOSCA
EndpointAnalysis3 months6 monthsEffect
RFSAll accrued patients (3,759); analysis population not labelled in the abstractprimarymedian follow-up 62 monthsSobrero 2018——HR 1.14 (95% CI 0.99–1.32)P=0.514P value is for noninferiority; the confidence interval crossed the noninferiority limit of 1.20. 772 relapses or deaths. Absolute difference in 3-year RFS 1.9 percentage points (95% CI -0.7 to 4.4) as published; the abstract does not give the arm-level rates.
RFSStage III subgroupexploratorySobrero 2018——HR 1.07 (95% CI 0.91–1.26)
RFSHigh-risk stage II subgroupexploratorySobrero 2018——HR 1.41 (95% CI 1.05–1.89)
RFSPatients treated with CAPOX (regimen not randomised)exploratorySobrero 2018——HR 0.98 (95% CI 0.77–1.26)
RFSPatients treated with FOLFOX (regimen not randomised)exploratorySobrero 2018——HR 1.23 (95% CI 1.03–1.46)
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
RFSRFSRFSRFSRFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
RFS1.140.99–1.32
RFS1.070.91–1.26
RFS1.411.05–1.89
RFS0.980.77–1.26
RFS1.231.03–1.46
Primary publication: Sobrero A, Lonardi S, Rosati G, Di Bartolomeo M, Ronzoni M, Pella N, et al. FOLFOX or CAPOX in Stage II to III Colon Cancer: Efficacy Results of the Italian Three or Six Colon Adjuvant Trial. J Clin Oncol. 2018;36(15):1478-1485. PubMedDOI

Appears in

Sources

  1. Sobrero A, Lonardi S, Rosati G, Di Bartolomeo M, Ronzoni M, Pella N, et al. FOLFOX or CAPOX in Stage II to III Colon Cancer: Efficacy Results of the Italian Three or Six Colon Adjuvant Trial. J Clin Oncol. 2018;36(15):1478-1485.

    PubMedDOI