Cancer Chemotherapy and Pharmacology

, Volume 79, Issue 3, pp 579–585 | Cite as

Phase II study of bevacizumab and irinotecan as second-line therapy for patients with metastatic colorectal cancer previously treated with fluoropyrimidines, oxaliplatin, and bevacizumab

  • Hidekazu Kuramochi
  • Masayuki Ando
  • Michio Itabashi
  • Go Nakajima
  • Kazuyuki Kawakami
  • Mie Hamano
  • Eiichi Hirai
  • Hajime Yokomizo
  • Ryuji Okuyama
  • Tatsuo Araida
  • Kazuhiko Yoshimatsu
  • Shingo Kameoka
  • Kazuhiko Hayashi
Original Article

Abstract

Purpose

Fluorouracil and folinic acid with irinotecan (FOLFIRI) plus bevacizumab (BV) is widely used as second-line chemotherapy for patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidines, oxaliplatin, and BV. FOLFIRI requires a CV catheter and an infusion pump, which are inconvenient for patients. Sufficient data are not available for characterizing the effectiveness of fluoropyrimidines beyond first disease progression. In this study, we evaluated the efficacy and safety of irinotecan (CPT-11) plus BV as second-line therapy.

Methods

Patients with mCRC previously treated with at least four courses of a fluoropyrimidine, oxaliplatin, and BV were designated to receive 150 mg/m2 of CPT-11 and 10 mg/kg of BV every 2 weeks as second-line therapy. The primary endpoint was progression-free survival (PFS), and secondary endpoints included response rate (RR), overall survival (OS), and adverse events.

Results

Thirty patients from six institutes were enrolled from March 2011 to January 2014. The median PFS was 5.7 months (95% CI 4.2–7.3 months), and the RR was 6.7% (range 0.8–22.1%). Grades 3–4 adverse events included leucopenia (36.7%), neutropenia (50%), thrombocytopenia (26.7%), anemia (30%), diarrhea (3.3%), anorexia (6.7%), and hypertension (3.3%). Relative dose intensities were 94.5 and 96.3% for CPT-11 and BV, respectively. The median OS was 11.8 months (6.3 months—not reached).

Conclusions

Administration of CPT-11 plus BV to patients with mCRC achieved comparable efficacies with relatively lower toxicities compared with the results of previous studies using FOLFIRI plus BV as second-line therapy. The dose intensity of CPT-11 was judged as satisfactory.

Clinical trial information

UMIN000005228

Keywords

Colorectal cancer Irinotecan (CPT-11) Bevacizumab Second-line 

Notes

Acknowledgements

We thank Naoko Kamba for data management and Edanz for English editing. This study was supported by funds from the Department of Chemotherapy and Palliative Care, Tokyo Women’s Medical University.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2017

Authors and Affiliations

  • Hidekazu Kuramochi
    • 1
    • 2
    • 3
  • Masayuki Ando
    • 4
  • Michio Itabashi
    • 5
  • Go Nakajima
    • 2
  • Kazuyuki Kawakami
    • 2
  • Mie Hamano
    • 1
  • Eiichi Hirai
    • 1
  • Hajime Yokomizo
    • 6
  • Ryuji Okuyama
    • 2
  • Tatsuo Araida
    • 1
  • Kazuhiko Yoshimatsu
    • 6
  • Shingo Kameoka
    • 5
  • Kazuhiko Hayashi
    • 2
  1. 1.Department of Surgery, Yachiyo Medical CenterTokyo Women’s Medical UniversityYachiyoJapan
  2. 2.Department of Chemotherapy and Palliative CareTokyo Women’s Medical UniversityTokyoJapan
  3. 3.Tsukuba Gastrointestinal HospitalTsukubaJapan
  4. 4.Department of SurgeryToshima Metropolitan HospitalTokyoJapan
  5. 5.Department of Surgery IITokyo Women’s Medical UniversityTokyoJapan
  6. 6.Department of Surgery, Medical Center EastTokyo Women’s Medical UniversityTokyoJapan

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