Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.
Department of Surgical Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Int J Clin Oncol. 2020 Jan;25(1):118-125. doi: 10.1007/s10147-019-01546-3. Epub 2019 Sep 21.
This 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.
Patients with resectable clinical Stage II or III rectal cancer were enrolled to receive eight cycles of CapOX therapy (130 mg/m oxaliplatin on day 1 and 2000 mg/m 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.
A 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.
CapOX therapy is feasible as adjuvant chemotherapy for locally advanced rectal cancer.
这项多中心、单臂 II 期研究（UMIN000008429）旨在评估卡培他滨联合奥沙利铂（CapOX）作为局部晚期直肠癌患者术后辅助化疗的疗效和安全性。
纳入可切除的临床 II 期或 III 期直肠癌患者，在根治性手术后接受 8 个周期的 CapOX 治疗（第 1 天和第 2 天给予 130mg/m²奥沙利铂，第 1-14 天给予 2000mg/m²口服卡培他滨，每 3 周 1 次）。主要终点为 3 年无复发生存率（RFS）率，次要终点为 3 年总生存率（OS）率、治疗依从性和安全性。
2012 年 9 月至 2015 年 11 月，来自 7 家机构的共 40 例患者（II 期 21 例，III 期 19 例）入组。39 例（97%）患者接受了 R0 切除，32 例（84%）患者接受了术后 CapOX 治疗。CapOX 治疗 8 个周期的完成率为 66%。奥沙利铂和卡培他滨的相对剂量强度分别为 87%和 84%。中位随访 46 个月时，9 例患者出现疾病复发，其中 3 例为局部复发。3 年 RFS 和 OS 率分别为 75%（95%CI 57-86%）和 96%（95%CI 80-99%）。≥3 级血液学和非血液学不良事件的发生率分别为 19%和 38%。
CapOX 治疗作为局部晚期直肠癌的辅助化疗是可行的。
