摘要：

Six months of oxaliplatin-based adjuvant chemotherapy is standard of carefor radically resected stage III colon cancer and an accepted option forhigh-risk stage II. A shorter duration of therapy, if equally efficacious,would be advantageous for patients and Health Care Systems.TOSCA (“Randomized trial investigating the role of FOLFOX-4 or XELOX (3versus 6 months) regimen duration and bevacizumab as adjuvant therapyfor patients with stage II/III colon cancer) is an open-label, phase III,multicenter, non-inferiority trial randomizing patients with high-risk stageII or stage III radically resected colon cancer to receive 3 months (arm3m) vs 6 months (arm 6m) of FOLFOX4/XELOX. Primary end-point wasrelapse-free survival. We present here safety and compliance data.From June 2007 to March 2013, 3,759 patients were accrued from 130Italian sites, 64% receiving FOLFOX4 and 36% XELOX in either arm.Treatment completion rate without any modification was 35% vs 12% andwith delays or dose reduction 52% vs 44% in arm 3m and 6m. Treatmentwas permanently discontinued in 8% (arm 3m) and 33% (arm 6m). Inarm 6m, 50% of patients discontinuing treatment did so after completing80% of planned program. Grade 3+ toxicities were higher in arm 6m than3m. Grade 2+ neuropathy was 31.2% vs 8.8% (p<.0001) while grade 3+was 8.4 vs 1.3 (p<.0001), in arm 3m and 6m. Seven deaths within 30days from last treatment administration in arm 6m and 3 deaths in arm 3mwere observed (0.3% vs 0.1%, p=0.34).TOSCA is the first trial comparing 3 vs 6 months of adjuvant chemotherapycompleting accrual within the international initiative of treatment durationevaluation (International Duration Evaluation of Adjuvant, IDEA). Highcompliance to treatment in control arm will allow a correct assessment ofpotential differences between the two treatment durations.

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