Abstract
ObjectiveThis multicenter, single-arm phase II study (UMIN000008429) aimed to evaluate the efficacy and safety of capecitabine plus oxaliplatin (CapOX) as postoperative adjuvant chemotherapy for patients with locally advanced rectal cancer.MethodsPatients with resectable clinical Stage II or III rectal cancer were enrolled to receive eight cycles of CapOX therapy (130 mg/m2 oxaliplatin on day 1 and 2000 mg/m2 oral capecitabine on days 1–14, every 3 weeks) after curative surgical resection. The primary endpoint was 3-year relapse-free survival (RFS) rate, and secondary endpoints were 3-year overall survival (OS) rate, treatment compliance, and safety.ResultsA total of 40 patients (Stage II, 21; Stage III, 19) were enrolled between September 2012 and November 2015 from seven institutions. Thirty-nine patients (97%) received R0 resection, and 32 patients (84%) received postoperative CapOX therapy. The completion rate of all eight cycles of CapOX therapy was 66%. Relative dose intensities were 87% for oxaliplatin and 84% for capecitabine. At a median follow-up period of 46 months, disease recurrence was observed in nine patients, including three with local recurrence. Three-year RFS and OS rates were 75% (95% CI 57–86%) and 96% (95% CI 80–99%), respectively. Frequencies of Grade ≥ 3 hematological and non-hematologic adverse events were 19% and 38%, respectively.ConclusionCapOX therapy is feasible as adjuvant chemotherapy for locally advanced rectal cancer.
Highlights
Colorectal cancer is one of the leading causes of cancer death, and rectal cancer represents about 40% of all colorectal cancers [1]
Preoperative CRT for advanced lower rectal cancer is commonly performed in Europe and the United States [3,4,5,6], and few reports exist on the outcomes of treatment comprising postoperative adjuvant chemotherapy alone
The 3-year relapse-free survival (RFS) rate of 80% was considered acceptable according to our hypothesis that assumes threshold and expected survival rates of 50% and 70%, respectively
Summary
Colorectal cancer is one of the leading causes of cancer death, and rectal cancer represents about 40% of all colorectal cancers [1]. The standard treatment for locally limited disease has been resection of the primary lesion with adequate lymphadenectomy. In Japan, a combination of surgery including lateral lymph node dissection and postoperative Several randomized controlled trials have shown that adjuvant chemotherapy with oxaliplatin in combination with fluoropyrimidine improves the survival of patients with resected Stage III colon cancer [9,10,11]
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