Investigational New Drugs

, Volume 30, Issue 5, pp 2026–2031 | Cite as

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

  • Natsuko T. Okita
  • Taito Esaki
  • Eishi Baba
  • Daisuke Sakai
  • Shinya Tokunaga
  • Hiroya Takiuchi
  • Nobuyuki Mizunuma
  • Kengo Nagashima
  • Ken Kato


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.


Metastatic colorectal cancer Stop and go Modified FOLFOX6 Bevacizumab 



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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Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  • Natsuko T. Okita
    • 1
  • Taito Esaki
    • 2
  • Eishi Baba
    • 3
  • Daisuke Sakai
    • 4
  • Shinya Tokunaga
    • 5
  • Hiroya Takiuchi
    • 6
  • Nobuyuki Mizunuma
    • 7
  • Kengo Nagashima
    • 8
  • Ken Kato
    • 1
  1. 1.Gastrointestinal Oncology DivisionNational Cancer Center HospitalTokyoJapan
  2. 2.Gasrointestinal and Medical Oncology DivisionNational Kyushu Cancer CenterFukuokaJapan
  3. 3.Department of Medicine and Biosystemic ScienceKyushu University Graduate School of Medical SciencesFukuokaJapan
  4. 4.Department of Clinical OncologyOsaka Medical Center for Cancer and Cardiovascular DiseasesOsakaJapan
  5. 5.Department of Clinical OncologyOsaka City General HospitalOsakaJapan
  6. 6.Cancer Chemotherapy CenterOsaka Medical College HospitalOsakaJapan
  7. 7.Department of Medical OncologyCancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan
  8. 8.Faculty of Pharmaceutical SciencesJosai UniversitySaitamaJapan

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