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ACHIEVE

Efficacy and long-term peripheral sensory neuropathy of 3 vs 6 months of oxaliplatin-based adjuvant chemotherapy for colon cancer: the ACHIEVE phase 3 randomized clinical trial

Phase 3N = 1,313

Population
1313 Asian patients with stage III colon cancer randomised; 1291 treated (650 in the 3-month arm and 641 in the 6-month arm), of whom 969 (75 percent) received CAPOX.
Design
Open-label, multicentre phase 3 randomised trial in Asian patients with stage III colon cancer comparing 3 with 6 months of adjuvant mFOLFOX6 or CAPOX (physician's choice). Primary outcome disease-free survival; secondary endpoints included peripheral sensory neuropathy for up to 3 years and overall survival. The full text states that no noninferiority margin was defined for the study.
Primary endpoint
DFS
Arms
  • 3 months (experimental, n = 650): 3 months of adjuvant oxaliplatin-containing chemotherapy
  • 6 months (control, n = 641): 6 months of adjuvant oxaliplatin-containing chemotherapy
People
Yoshino T
DFSHR 0.95 (95% CI 0.76–1.20)DFSHR 0.95 (95% CI 0.76–1.20)Δ 36-month DFS+1.6 pointsΔ Peripheral sensory neuropathy lasting 3 years−14.6 points
Show the numbers
Results reported for ACHIEVE
EndpointAnalysis3 months6 monthsEffect
DFSPatients treated (1291); the full text describes a modified intention-to-treat analysis of randomised patients who received at least one doseprimaryYoshino 2019——HR 0.95 (95% CI 0.76–1.20)Subgroup hazard ratios as published: mFOLFOX6 1.07 (95% CI 0.71 to 1.60); CAPOX 0.90 (0.68 to 1.20); low-risk (T1-3 N1) 0.81 (0.53 to 1.24); high-risk (T4 or N2) 1.07 (0.81 to 1.40).
DFSModified intention-to-treat population (1291)primaryYoshino 201979.5% at 3 y (76.2–82.4%)77.9% at 3 y (74.4–80.9%)HR 0.95 (95% CI 0.76–1.20)The paper states that no noninferiority margin was defined for ACHIEVE; the IDEA margin of 1.12 is cited in the Discussion.
Peripheral sensory neuropathy lasting 3 yearsPatients treated (1291)primaryYoshino 20199.7%24.3%P<0.001Any grade. In the 3-month arm 7.9 percent with CAPOX versus 15.7 percent with mFOLFOX6; in the 6-month arm 21.0 percent versus 34.1 percent.
Results reported for ACHIEVE
EndpointAnalysis3 months6 monthsEffect
DFSPatients treated (1291); the full text describes a modified intention-to-treat analysis of randomised patients who received at least one doseprimaryYoshino 2019——HR 0.95 (95% CI 0.76–1.20)Subgroup hazard ratios as published: mFOLFOX6 1.07 (95% CI 0.71 to 1.60); CAPOX 0.90 (0.68 to 1.20); low-risk (T1-3 N1) 0.81 (0.53 to 1.24); high-risk (T4 or N2) 1.07 (0.81 to 1.40).
DFSModified intention-to-treat population (1291)primaryYoshino 201979.5% at 3 y (76.2–82.4%)77.9% at 3 y (74.4–80.9%)HR 0.95 (95% CI 0.76–1.20)The paper states that no noninferiority margin was defined for ACHIEVE; the IDEA margin of 1.12 is cited in the Discussion.
Peripheral sensory neuropathy lasting 3 yearsPatients treated (1291)primaryYoshino 20199.7%24.3%P<0.001Any grade. In the 3-month arm 7.9 percent with CAPOX versus 15.7 percent with mFOLFOX6; in the 6-month arm 21.0 percent versus 34.1 percent.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFSDFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS0.950.76–1.2
DFS0.950.76–1.2
Primary publication: Yoshino T, Yamanaka T, Oki E, Kotaka M, Manaka D, Eto T, et al. Efficacy and Long-term Peripheral Sensory Neuropathy of 3 vs 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Colon Cancer: The ACHIEVE Phase 3 Randomized Clinical Trial. JAMA Oncol. 2019;5(11):1574-1581. PubMedDOI

Appears in

Sources

  1. Yoshino T, Yamanaka T, Oki E, Kotaka M, Manaka D, Eto T, et al. Efficacy and Long-term Peripheral Sensory Neuropathy of 3 vs 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Colon Cancer: The ACHIEVE Phase 3 Randomized Clinical Trial. JAMA Oncol. 2019;5(11):1574-1581.

    PubMedDOI