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Poster display session

2559 - Multicenter phase II study of biweekly XELIRI plus Bevacizumab as a second-line therapy in patients with metastatic colorectal cancer (JSWOG-C3 study)

Date

09 Sep 2017

Session

Poster display session

Presenters

Yoshiko Mori

Citation

Annals of Oncology (2017) 28 (suppl_5): v158-v208. 10.1093/annonc/mdx393

Authors

Y. Mori1, N. Suzuki2, T. Nagasaka1, H. Tanioka3, Y. Iwamoto4, Y. Neki5, T. Yamatsuji6, M. Kobayashi7, M. Nakajima8, Y. Ojima9, S. Ikeda10, K. Kawamoto11, K. Shinozaki12, A. Tsuji13, T. Hinoi14, Y. Yamaguchi15, K. Yamashita3, M. Shimokawa16, M. Okajima9, S. Hazama8

Author affiliations

  • 1 Department Of Gastroenterological Surgery, Okayama University Hospital, 700-8558 - Okayama/JP
  • 2 2) department Of Digestive Surgery And Surgical Oncology, Yamaguchi University Graduate School of Medicine, 755-8505 - Ube/JP
  • 3 Department Of Medical Oncology, Okayama rosai Hospital, 702-8055 - Okayama/JP
  • 4 Department Of Medical Oncology, Hiroshima City Hospital, 730-0011 - Hiroshima/JP
  • 5 Department Of Medical Oncology, Kochi Health Sciences Center, 781-0111 - Kochi/JP
  • 6 Department Of General Surgery, Kawasaki Medical School,Kawasaki Hospital, 700-8505 - Okayama/JP
  • 7 Department Of Human Health And Medical Sciences, Kochi Medical School Hospital, 783-8505 - Nangoku/JP
  • 8 Department Of Digestive Surgery And Surgical Oncology, Yamaguchi University Graduate School of Medicine, 755-8505 - Ube/JP
  • 9 Department Of Surgery, Hiroshima City Hiroshima Citizens Hospital, 730-8518 - Hiroshima/JP
  • 10 Surgery, Hiroshima Prefectural Hospital, 734-0004 - Hiroshima/JP
  • 11 Department Of Surgery, Kurashiki Central Hospital, 710-8602 - Kurashiki/JP
  • 12 Department Of Medical Oncology, Hiroshima Prefectural Hospital, 734-0004 - Hiroshima/JP
  • 13 Department Of Clinical Oncology Faculty Of Medicine, Kagawa University, 761-0793 - Kita-gun/JP
  • 14 Department Of Surgery, Kure Medical Center and Chugoku Cancer Center, 737-0023 - Kure/JP
  • 15 Department Of Clinical Oncology, Kawasaki Medical School, 701-0192 - Kurashiki/JP
  • 16 Clinical Research Institute, National Kyushu Cancer Center, 811-1395 - Fukuoka/JP
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Resources

Abstract 2559

Background

Triweekly capecitabine plus irinotecan (XELIRI) is not completely regarded as a valid substitute for fluorouracil, leucovorin, and irinotecan (FOLFIRI) in metastatic colorectal cancer (mCRC) because of the potential for greater toxicity. Therefore, we conducted a phase II study to assess the efficacy and safety of biweekly XELIRI plus bevacizumab (BV) as second-line chemotherapy for mCRC. High dose BV (10 mg/kg) combined biweekly XELIRI as second-line chemotherapy was one of the first trial in the world.

Methods

Patients with mCRC who had received prior chemotherapy including oxaliplatin based regimen were eligible for this study. Protocol treatment administrated capecitabine 1,000 mg/m2 twice daily from the evening of day 1 to the morning of day 8, intravenous irinotecan 150mg/m2 on day 1, and BV 10 mg/kg on day 1 every 2 weeks. The primary endpoint of this study were progression-free survival (PFS) and safety. The secondary endpoint were overall survival (OS), time to treatment failure (TTF), response rate (RR) and disease control rate (DCR).

Results

Between January 2013 and July 2015, 51 patients were enrolled in this study. The patients’ characteristics were as follows: median age, 66 years (range 41–82); male/female, 29/22; The median PFS was 5.7 months (95% confidence interval, 4.2–7.2 months). The median OS was 13.4 months (95%CI, 11.4–16.7 months). The median TTF was 5.2 months (95%CI, 3.9–7.2 months). The response rate was 14%, and the disease control rate was 78%. Grade 3 or higher adverse events were mainly febrile neutropenia in two patients and hypertension in 14 patients (28.6%). One patient had grade 4 intestinal pneumonia but improved by intensive treatment. There were no other severe adverse events or treatment-related deaths.

Conclusions

In mCRC patients, biweekly XELIRI + BV 10 mg/kg is effective and feasible as second-line chemotherapy. Biweekly XELIRI + BV is considered a useful substitute for FOLFIRI + BV in mCRC, and further study of this combination therapy is warranted.

Clinical trial identification

Legal entity responsible for the study

Japan Southwest Oncology Group

Funding

Japan Southwest Oncology Group

Disclosure

All authors have declared no conflicts of interest.

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