Background

Fluorouracil and leucovorin combined with oxaliplatin or irinotecan plus bevacizumab (Bmab) or cetuximab (Cmab) are now widely accepted treatment options as first-line or second-line chemotherapy for metastatic colorectal cancer (mCRC). Sequential chemotherapy with oral 5-FU backbone for mCRC without using central venous ports is beneficial for both patients and physicians. We designed the SOBIC trial to validate the effectiveness of the first- and second-line oral combination chemotherapy for mCRC.

Patients and methods

From May 2010 through March 2013, 52 patients were enrolled from 47 institutions in the Hyogo Colorectal Cancer Surgery Group. First-line chemotherapy was S-1 + oxaliplatin (SOX) plus Bmab, and second-line chemotherapy after first-line failure was irinotecan + S-1 (IRIS) + Cmab, IRIS + Bmab, or IRIS based on the KRAS status.

Results

The 50 finally included patients received first-line chemotherapy. Second-line therapy was administered to 20 patients (40%): 12 patients received IRIS + Cmab and 8 patients received IRIS + Bmab. The median follow-up period was 48.6 months (range 35–67 months). The median second progression-free survival was 24.2 months (95% confidence interval [CI] 17.7–35.2). The response rate after first- and second-line chemotherapy was 46.7% and 15%, respectively. The median overall survival was 35.2 months (95% CI: 27.8 to not reached). The main grade 3–4 adverse events were sensory neuropathy (18%) and fatigue (10%). There were no treatment-related deaths.

Conclusion

Sequential S-1-based combination regimens including oxaliplatin, irinotecan, Bmab, and Cmab were beneficial for patients with mCRC.

中文翻译：

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基于S-1的顺序联合化疗（包括奥沙利铂，贝伐单抗和伊立替康，有或没有西妥昔单抗）用于转移性结直肠癌的II期研究：SOBIC试验。

背景

氟尿嘧啶和亚叶酸钙与奥沙利铂或伊立替康联合贝伐单抗（Bmab）或西妥昔单抗（Cmab）的组合现已成为转移性结直肠癌（mCRC）的一线或二线化疗的广泛接受的治疗选择。在不使用中心静脉端口的情况下，口服5-FU主链用于mCRC的序贯化疗对患者和医生均有益。我们设计了SOBIC试验，以验证一线和二线口服联合化疗对mCRC的有效性。

患者和方法

从2010年5月到2013年3月，兵库县大肠癌外科组的47个机构招募了52位患者。根据KRA S状态，一线化疗为S-1 +奥沙利铂（SOX）加Bmab，一线失败后的二线化疗为依立替康+ S-1（IRIS）+ Cmab，IRIS + Bmab或IRIS 。

结果

最终纳入的50名患者接受了一线化疗。对20例患者（40％）进行了二线治疗：12例患者接受了IRIS + Cmab，8例患者接受了IRIS + Bmab。中位随访期为48.6个月（范围35-67个月）。中位无进展生存期为24.2个月（95％置信区间[CI] 17.7 – 35.2）。一线和二线化疗后的缓解率分别为46.7％和15％。中位总生存期为35.2个月（95％CI：27.8尚未达到）。主要的3-4级不良反应是感觉神经病（18％）和疲劳（10％）。没有与治疗有关的死亡。

结论

基于序贯S-1的联合方案包括奥沙利铂，伊立替康，Bmab和Cmab对mCRC患者有益。