Abstract
Oxaliplatin-based adjuvant chemotherapy may be associated with debilitating peripheral sensory neuropathy (PSN) in patients with high-risk stage II colon cancer. This open-label, multicenter, randomized phase III trial was conducted as a prospective pooled analysis to investigate the non-inferiority of 3 versus 6 months of adjuvant oxaliplatin-based chemotherapy. From 12 February 2014 to 31 January 2017, 525 Asian patients with high-risk stage II colon cancer were randomly assigned to 3- and 6-month treatment arms. The treatment consisted of either modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or capecitabine combined with oxaliplatin (CAPOX). The primary end point was disease-free survival (DFS). The secondary end points were treatment compliance and safety. Of the 525 randomized patients, 11 were not treated. Among the 514 participating patients (255 in the 3-month arm; 259 in the 6-month arm), 432 (84%) received CAPOX, and 184 (36%) presented with T4 as a high-risk factor for recurrence. The 3-year DFS rate was 88.2% in the 3-month arm and 87.9% in the 6-month arm [hazard ratio (HR), 1.12; 95% confidence interval (CI), 0.67-1.87]. With CAPOX, the 3-year DFS rate was 88.2% in the 3-month arm and 88.4% in the 6-month arm (HR, 1.13; 95% CI, 0.65-1.96). The discontinuation rate in the 3- and 6-month arms was 10% and 31% for mFOLFOX6 (P= 0.0193), and 15% and 35% for CAPOX (P < 0.0001), respectively. The incidence of grade ≥2 PSN was significantly lower in the 3-month arm than in the 6-month arm (16% and 43%, respectively, P < 0.0001). Three months of combination therapy presented significantly less grade ≥2 PSN than the respective 6-month regimen. The shortened therapy duration did not affect the 3-year DFS rate, suggesting that a 3-month course of CAPOX can be an effective treatment option. UMIN Clinical Trials Registry, UMIN000013036 and Japan Registry of Clinical Trials, jRCTs031180128.
Highlights
Adjuvant chemotherapy is the standard of care for patients with stage III colon cancer following surgery.[1,2,3] whether adjuvant chemotherapy improves clinical outcomes of patients with curatively resected stage II colon cancer is still controversial
peripheral sensory neuropathy (PSN) is a burden in daily life,[13,14,15,16] and we recently reported that the incidence of long-lasting PSN was significantly lower with 3-month therapy than with 6-month therapy and significantly lower with CAPOX than with mFOLFOX6.17
Between 12 February 2014 and 31 January 2017, 525 patients were enrolled in 102 centers across Japan and randomly assigned to receive either 6 months or 3 months of adjuvant oxaliplatin-based mFOLFOX6 or CAPOX therapy at the discretion of the treating physician as outlined in the CONSORT diagram (Figure 1)
Summary
Adjuvant chemotherapy is the standard of care for patients with stage III colon cancer following surgery.[1,2,3] whether adjuvant chemotherapy improves clinical outcomes of patients with curatively resected stage II colon cancer is still controversial. Annals of Oncology adjuvant 5-fluorouracil (5-FU)-containing treatment trials revealed an increase in the 8-year overall survival (OS) from 66.8% to 72.2% in patients with stage II colon cancer receiving adjuvant chemotherapy.[4] In the QUASAR study, which enrolled patients with stage II colon cancer and stage I and III colon cancer, and rectal cancer, the OS was improved by adjuvant 5-FU in combination with leucovorin, compared with that by surgery alone, based on the hazard ratio (HR) [HR 0.82, 95% confidence interval (CI) 0.70-0.95].5. Oxaliplatin-based adjuvant chemotherapy is considered an option for patients with high-risk stage II colon cancer. Oxaliplatin-based adjuvant chemotherapy may be associated with debilitating peripheral sensory neuropathy (PSN) in patients with high-risk stage II colon cancer. This open-label, multicenter, randomized phase III trial was conducted as a prospective pooled analysis to investigate the non-inferiority of 3 versus 6 months of adjuvant oxaliplatin-based chemotherapy.
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