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Int J Clin Oncol. 2020 Mar 21. doi: 10.1007/s10147-020-01657-2. [Epub ahead of print]

Phase II study of S-1-based sequential combination chemotherapy including oxaliplatin plus bevacizumab and irinotecan with or without cetuximab for metastatic colorectal cancer: the SOBIC trial.

Author information

1
Department of Surgery, Meiwa Hospital, Nishinomiya, Hyogo, 663-8186, Japan. myy2000815@gmail.com.
2
Division of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.
3
Department of Surgery, Kobe City Medical Center West Hospital, Kobe, Japan.
4
Department of Surgery, Japan Post Kyoto Teishin Hospital, Kyoto, Japan.
5
Department of Surgery, Himeji St. Mary's Hospital, Himeji, Japan.
6
Department of Surgery, Kakogawa City Hospital, Kakogawa, Japan.
7
Department of Surgery, Sanda City Hospital, Sanda, Japan.
8
Department of Surgery, Kawanishi City Hospital, Kawanishi, Japan.

Abstract

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.

KEYWORDS:

IRIS; S-1; SOX; Sequential chemotherapy; mCRC

PMID:
32200481
DOI:
10.1007/s10147-020-01657-2

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