International Journal of Clinical Oncology

, Volume 17, Issue 6, pp 604–609 | Cite as

Phase II clinical trial of second-line FOLFIRI plus bevacizumab for patients with metastatic colorectal cancer: AVASIRI trial

  • Yosuke Horita
  • Yasuhide Yamada
  • Ken Kato
  • Yoshinori Hirashima
  • Kouhei Akiyoshi
  • Kengo Nagashima
  • Takako Nakajima
  • Tetsuya Hamaguchi
  • Yasuhiro Shimada
Original Article



FOLFIRI is a standard chemotherapy regimen for the treatment of metastatic colorectal cancer. Although some studies have shown its efficacy in combination with bevacizumab as first-line chemotherapy, there are no data to support FOLFIRI plus bevacizumab as second-line chemotherapy in patients with this form of cancer. The aim of this study was to evaluate the efficacy and safety of FOLFIRI and bevacizumab as second-line chemotherapy in patients with metastatic colorectal cancer.


Eligible patients were ≥20 years old, previously treated (except with irinotecan [CPT-11] and bevacizumab), with an Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and adequate organ function. Twenty-five eligible patients received FOLFIRI with bevacizumab at a dose of 10 mg/kg given intravenously on day 1. All therapy was administered every 2 weeks until disease progression. The primary endpoint was the response rate.


Twenty-five patients were enrolled between February 2008 and March 2009. The median age was 62 (range 38–73) years, the male/female distribution was 20/5, 16 patients had performance status 0 and 9 had performance status 1, and the proportion of patients who were oxaliplatin pretreated/untreated was 16/9. The overall response rate was 32% (90% confidence interval [CI]: 17.0–50.4%), with 8 patients showing partial responses, 15 with stable disease, and 2 with disease progression. Median progression-free survival was 11.6 months (95% CI: 6.9–16.4). Median overall survival was 21.4 months (95% CI: 12.0–30.8). The grade 3/4 adverse events with treatment were neutropenia (64%), leukopenia (16%), diarrhea (8%), anorexia (8%), and febrile neutropenia (8%). The bevacizumab-related grade 3/4 adverse event was hypertension, which was observed in 12% of patients.


The FOLFIRI plus bevacizumab regimen is an active, well-tolerated second-line chemotherapy treatment for patients with metastatic colorectal cancer.


FOLFIRI Bevacizumab Second-line Colorectal cancer 



We would like to thank Ms. Hideko Morita and Ms. Makiko Shinogi for their help in collecting and organizing the clinical samples, and Ms. Michiyo Tada and Mr Hiroshi Nagai for their help in data management for this study.

Conflict of interest

No author has any conflict of interest.


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Copyright information

© Japan Society of Clinical Oncology 2011

Authors and Affiliations

  • Yosuke Horita
    • 1
    • 2
  • Yasuhide Yamada
    • 1
  • Ken Kato
    • 1
  • Yoshinori Hirashima
    • 3
  • Kouhei Akiyoshi
    • 1
  • Kengo Nagashima
    • 4
  • Takako Nakajima
    • 1
  • Tetsuya Hamaguchi
    • 1
  • Yasuhiro Shimada
    • 1
  1. 1.Gastrointestinal Oncology DivisionNational Cancer Center HospitalTokyoJapan
  2. 2.Department of ChemotherapyToyama Prefectural Central HospitalToyamaJapan
  3. 3.Department of Medical Oncology, Faculty of MedicineOita UniversityOitaJapan
  4. 4.Laboratory of Biostatistics, Faculty of Pharmaceutical SciencesJosai UniversitySaitamaJapan

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