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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

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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.

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References

  1. Yamazaki K, Nagase M, Tamagawa H et al (2016) Randomized phase III study of bevacizumab plus FOLFIRI and bevacizumab plus mFOLFOX6 as first-line treatment for patients with metastatic colorectal cancer (WJOG4407G). Ann Oncol 27:1539–1546

    Article  CAS  Google Scholar 

  2. Satoh T, Sakata Y (2012) S-1 for the treatment of gastrointestinal cancer. Expert Opin Pharmacother 13:1943–1959

    Article  CAS  Google Scholar 

  3. Yamada Y, Takahari D, Matsumoto H et al (2013) Leucovorin, fluorouracil, and oxaliplatin plus bevacizumab versus S-1 and oxaliplatin plus bevacizumab in patients with metastatic colorectal cancer (SOFT): an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol 14:1278–1286

    Article  CAS  Google Scholar 

  4. Muro K, Boku N, Shimada Y et al (2010) Irinotecan plus S-1 (IRIS) versus fluorouracil and folinic acid plus irinotecan (FOLFIRI) as second-line chemotherapy for metastatic colorectal cancer: a randomised phase 2/3 noninferiority study (FIRIS study). Lancet Oncol 11:853–860

    Article  CAS  Google Scholar 

  5. Schmoll HJ, Van Cutsem E, Stein A et al (2012) ESMO Consensus Guidelines for management of patients with colon and rectal cancer: a personalized approach to clinical decision making. Ann Oncol 23:2479–2516

    Article  CAS  Google Scholar 

  6. Tournigand C, André T, Achille E et al (2004) FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol 22:229–237

    Article  CAS  Google Scholar 

  7. Fuchs CS, Marshall J, Mitchell E et al (2007) Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: results from the BICC-C study. J Clin Oncol 25:4779–4786

    Article  CAS  Google Scholar 

  8. Cassidy J, Clarke S, Diaz-Rubio E et al (2008) Randomized phase III study of capecitabine plus oxaliplatin compared with fluorouracil/folinic acid plus oxaliplatin as first-line therapy for metastatic colorectal cancer. J Clin Oncol 26:2006–2012

    Article  CAS  Google Scholar 

  9. Loupakis F, Cremolini C, Masi G et al (2014) Initial therapy with FOLFOXIRI and bevacizumab for metastatic colorectal cancer. N Engl J Med 371:1609–1618

    Article  Google Scholar 

  10. Heinemann V, von Weikersthal FL, Decker T et al (2014) FOLFIRI plus cetuximab versus FOLFIRI plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer (FIRE-3): a randomised, open-label, phase 3 trial. Lancet Oncol 15:1065–1075

    Article  CAS  Google Scholar 

  11. Venook AP, Niedzwiecki D, Innocenti F et al (2016) Impact of primary (1°) tumor location on overall survival (OS) and progression-free survival (PFS) in patients (pts) with metastatic colorectal cancer (mCRC): analysis of CALGB/SWOG 80405 (Alliance). J Clin Oncol 34(Suppl 15):3504

    Article  Google Scholar 

  12. Venook AP, Ou FS, Lenz HJ et al (2017) Impact of primary (1°) tumor location on overall survival (OS) and progression-free survival (PFS) in patients (pts) with metastatic colorectal cancer (mCRC): Analysis of CALGB/SWOG 80405 (Alliance). J Clin Oncol 35(Suppl 15):3503

    Article  Google Scholar 

  13. Komatsu Y, Yuki S, Sogabe S et al (2012) Phase II study of combined chemotherapy with irinotecan and S-1 (IRIS) plus bevacizumab in patients with inoperable recurrent or advanced colorectal cancer. Acta Oncol 51:867–872

    Article  CAS  Google Scholar 

  14. Minami H, Sai K, Saeki M et al (2007) Irinotecan pharmacokinetics/pharmacodynamics and UGT1A genetic polymorphisms in Japanese: roles of UGT1A1*6 and *28. Pharmacogenet Genomics 17:497–504

    Article  CAS  Google Scholar 

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Acknowledgements

We thank all the patients, their families, the investigators, and medical staff. A list of participating institution: Department of Surgery, Meiwa Hospital; Department of Surgery, Kobe City Medical Center West Hospital; Department of Surgery, Japan Post Kyoto Teishin Hospital; Department of Surgery, Himeji St. Mary's Hospital; Department of Surgery, Kakogawa City Hospital; Department of Surgery, Sanda City Hospital; Department of Surgery, Kawanishi City Hospital; Division of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine.

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Author notes

  1. Yoshihiko Nakamoto and Masafumi Noda have equally contributed to this work and are co-first authors.

Authors and Affiliations

  1. Department of Surgery, Meiwa Hospital, Nishinomiya, Hyogo, 663-8186, Japan

    Yoshihiko Nakamoto

  2. Division of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan

    Masafumi Noda & Naohiro Tomita

  3. Department of Surgery, Kobe City Medical Center West Hospital, Kobe, Japan

    Ryuichi Mikami

  4. Department of Surgery, Japan Post Kyoto Teishin Hospital, Kyoto, Japan

    Yukihiko Tokunaga

  5. Department of Surgery, Himeji St. Mary’s Hospital, Himeji, Japan

    Tatsuo Okumoto

  6. Department of Surgery, Kakogawa City Hospital, Kakogawa, Japan

    Takashi Kawamura

  7. Department of Surgery, Sanda City Hospital, Sanda, Japan

    Hidetoshi Fujiwara

  8. Department of Surgery, Kawanishi City Hospital, Kawanishi, Japan

    Sadayuki Doi

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  1. Yoshihiko Nakamoto
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  2. Masafumi Noda
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  9. Naohiro Tomita
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Correspondence to Yoshihiko Nakamoto.

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Conflict of interest

N. Tomita has received research funding from Taiho Pharmaceutical Co., Ltd and Chugai Pharmaceutical Co., Ltd. All other authors have no conflicts of interest to declare.

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All procedures were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Nakamoto, Y., Noda, M., Mikami, R. et al. 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. Int J Clin Oncol 25, 1285–1290 (2020). https://doi.org/10.1007/s10147-020-01657-2

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  • DOI: https://doi.org/10.1007/s10147-020-01657-2

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