Phase III trial comparing 3 to 6 months of adjuvant FOLFOX4/XELOX in stage II-III colon cancer: safety and compliance in the TOSCA trial

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作者：

S Lonardi，A Sobrero，G Rosati，MD Bartolomeo，M Ronzoni，G Aprile，M Scartozzi，M Banzi，MG Zampino，F Pasini

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摘要：

Six months of oxaliplatin-based adjuvant chemotherapy is standard of care for radically resected stage III colon cancer and an accepted option for high-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 (3 versus 6 months) regimen duration and bevacizumab as adjuvant therapy for patients with stage II/III colon cancer) is an open-label, phase III, multicenter, non-inferiority trial randomizing patients with high-risk stage II or stage III radically resected colon cancer to receive 3 months (arm 3m) vs 6 months (arm 6m) of FOLFOX4/XELOX. Primary end-point was relapse-free survival. We present here safety and compliance data. From June 2007 to March 2013, 3,759 patients were accrued from 130 Italian sites, 64% receiving FOLFOX4 and 36% XELOX in either arm. Treatment completion rate without any modification was 35% vs 12% and with delays or dose reduction 52% vs 44% in arm 3m and 6m. Treatment was permanently discontinued in 8% (arm 3m) and 33% (arm 6m). In arm 6m, 50% of patients discontinuing treatment did so after completing 80% of planned program. Grade 3+ toxicities were higher in arm 6m than 3m. 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 30 days from last treatment administration in arm 6m and 3 deaths in arm 3m were observed (0.3% vs 0.1%, p=0.34). TOSCA is the first trial comparing 3 vs 6 months of adjuvant chemotherapy completing accrual within the international initiative of treatment duration evaluation (International Duration Evaluation of Adjuvant, IDEA). High compliance to treatment in control arm will allow a correct assessment of potential differences between the two treatment durations. NCT00646607.

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关键词：

colon cancer adjuvant chemotherapy duration

DOI：

10.1093/annonc/mdw404

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年份：

2016