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A multicenter phase II study of the stop-and-go modified FOLFOX6 with bevacizumab for first-line treatment of patients with metastatic colorectal cancer

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Summary

Currently, no prospective data exists to support a “stop-and-go” modified FOLFOX6 regimen with bevacizumab in metastatic colorectal cancer (mCRC) patients. This study aimed to evaluate the efficacy and safety of this regimen in first-line mCRC patients. Eligible patients (age ≥20 years) had previously untreated mCRC; Eastern Cooperative Oncology Group performance status of 0–2; and adequate hematologic, hepatic, and renal function. The modified FOLFOX6 regimen and bevacizumab (5 mg/kg) was administered intravenously every 2 weeks. After 8 cycles, patients received maintenance therapy with simplified LV5FU2 and bevacizumab until completion of 8 cycles or disease progression. After maintenance therapy, patients received another 8 cycles of modified FOLFOX6 with bevacizumab until completion of 8 cycles or disease progression. We recruited 50 patients between August 2007 and January 2009. The overall response rate was 48% (80% confidence interval [CI]; 38.2–58) with outcomes as follows: complete response, n = 1; partial response, n = 23; stable disease, n = 21; progression, n = 1; and not evaluated, n = 4. Median time to treatment failure was 7.7 months (80% CI: 6.2–8.0), and median progression-free survival was 12.8 months (80% CI: 10.8–14). Grade 3/4 toxicities included neutropenia (40%), nausea (4%), diarrhea (14%), thrombosis (4%), and hypertension (4%) et al. Grade 1, 2, or 3 peripheral neuropathy was reported in 38%, 40%, and 10% of patients, respectively. The stop-and-go modified FOLFOX6 and bevacizumab regimen is effective and well tolerated as first-line chemotherapy for mCRC patients.

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Acknowledgements

We thank Hiroshi Yoshida, Aasako Sakamoto and Makiko Shinogi for data collection, and Yushi Nagai and Michiyo Tada for data management. This work was supported by Grants-in-Aid for Cancer Research from the Ministry of Health, Labour and Welfare of Japan [grant number 20S-3].

Conflict of interest statements

The authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Gastrointestinal Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

    Natsuko T. Okita & Ken Kato

  2. Gasrointestinal and Medical Oncology Division, National Kyushu Cancer Center, Fukuoka, Japan

    Taito Esaki

  3. Department of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan

    Eishi Baba

  4. Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

    Daisuke Sakai

  5. Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan

    Shinya Tokunaga

  6. Cancer Chemotherapy Center, Osaka Medical College Hospital, Osaka, Japan

    Hiroya Takiuchi

  7. Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan

    Nobuyuki Mizunuma

  8. Faculty of Pharmaceutical Sciences, Josai University, Saitama, Japan

    Kengo Nagashima

Authors
  1. Natsuko T. Okita
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  2. Taito Esaki
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  3. Eishi Baba
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  4. Daisuke Sakai
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  5. Shinya Tokunaga
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  6. Hiroya Takiuchi
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  7. Nobuyuki Mizunuma
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  8. Kengo Nagashima
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  9. Ken Kato
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Correspondence to Natsuko T. Okita.

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Okita, N.T., Esaki, T., Baba, E. et al. A multicenter phase II study of the stop-and-go modified FOLFOX6 with bevacizumab for first-line treatment of patients with metastatic colorectal cancer. Invest New Drugs 30, 2026–2031 (2012). https://doi.org/10.1007/s10637-011-9779-1

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  • DOI: https://doi.org/10.1007/s10637-011-9779-1

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