Department of Digestive Tract and General Surgery Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Department of Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, 2360004, Japan.
Cancer Chemother Pharmacol. 2021 May;87(5):665-672. doi: 10.1007/s00280-021-04232-2. Epub 2021 Feb 8.
The aim of this study was to evaluate the efficacy and safety of first-line chemotherapy with re-introduction of oxaliplatin (OX) more than 6 months after adjuvant chemotherapy including OX.
Stage II/III colon cancer patients with neuropathies of grade ≤ 1 who relapsed more than 6 months after adjuvant chemotherapy including OX were considered eligible. Eligible patients were treated with 5-fluorouracil, l-leucovorin and OX plus molecularly targeted agents or capecitabine and OX plus bevacizumab (BV) or S-1 and OX plus BV. The primary endpoint was the progression-free survival (PFS), and the secondary endpoints were the overall survival (OS), response rate (RR) and toxicity.
A total of 50 patients were enrolled between September 2013 and May 2019. Twelve patients received 5-fluorouracil, l-leucovorin and OX (FOLFOX) plus BV, 21 patients received capecitabine and OX plus BV, 10 patients received S-1 and OX plus BV and 7 patients received FOLFOX plus cetuximab or panitumumab. The median PFS was 11.5 months (95% confidence interval [CI] 8.3-16.0), the median OS was 45.4 months (95% CI 37.4-NA), and the RR was 56.0% (95% CI 42.3-68.8). Adverse events of grade ≥ 3 that occurred in ≥ 5% of cases were neutropenia in 6 patients (12%), peripheral sensory neuropathy in 5 patients (10%), diarrhea in 4 patients (8%), hypertension in 4 patients (8%), anorexia in 3 patients (6%) and allergic reactions in 3 patients (6%).
First-line chemotherapy with re-introduction of OX more than 6 months after adjuvant chemotherapy including OX can be used safely with expected efficacy for relapsed colon cancer patients.
本研究旨在评估在辅助化疗中加入奥沙利铂（OX）超过 6 个月后，重新引入 OX 的一线化疗的疗效和安全性。
患有神经病变程度≤1 级的 II/III 期结肠癌患者，在辅助化疗中加入 OX 后超过 6 个月复发，被认为符合条件。符合条件的患者接受氟尿嘧啶、左亚叶酸钙和 OX 联合分子靶向药物或卡培他滨和 OX 联合贝伐珠单抗（BV）或 S-1 和 OX 联合 BV 治疗。主要终点是无进展生存期（PFS），次要终点是总生存期（OS）、反应率（RR）和毒性。
2013 年 9 月至 2019 年 5 月期间共纳入 50 例患者。12 例患者接受氟尿嘧啶、左亚叶酸钙和 OX（FOLFOX）联合 BV，21 例患者接受卡培他滨和 OX 联合 BV，10 例患者接受 S-1 和 OX 联合 BV，7 例患者接受 FOLFOX 联合西妥昔单抗或帕尼单抗。中位 PFS 为 11.5 个月（95%置信区间 [CI] 8.3-16.0），中位 OS 为 45.4 个月（95% CI 37.4-NA），RR 为 56.0%（95% CI 42.3-68.8）。发生率≥5%的≥3 级不良事件包括 6 例（12%）中性粒细胞减少、5 例（10%）周围感觉神经病变、4 例（8%）腹泻、4 例（8%）高血压、3 例（6%）厌食和 3 例（6%）过敏反应。
在辅助化疗中加入 OX 超过 6 个月后，重新引入 OX 的一线化疗对于复发的结肠癌患者是安全的，且疗效可预期。
