Cancer Chemotherapy and Pharmacology

, Volume 68, Issue 3, pp 769–776

Weekly paclitaxel in patients with recurrent or metastatic head and neck cancer

  • M. Tahara
  • H. Minami
  • Y. Hasegawa
  • K. Tomita
  • A. Watanabe
  • K. Nibu
  • M. Fujii
  • Y. Onozawa
  • Y. Kurono
  • D. Sagae
  • T. Seriu
  • M. Tsukuda
Original Article

DOI: 10.1007/s00280-010-1550-3

Cite this article as:
Tahara, M., Minami, H., Hasegawa, Y. et al. Cancer Chemother Pharmacol (2011) 68: 769. doi:10.1007/s00280-010-1550-3

Abstract

Purpose

To evaluate the efficacy and safety of weekly paclitaxel in patients with recurrent or metastatic head and neck cancer (HNC) by combined analysis of early and late phase II trials.

Methods

Eligibility criteria included histologically proven HNC with recurrent or metastatic disease, measurable disease, PS 0-2, and one or no prior chemotherapy regimens. Treatment consisted of a 1-h infusion of paclitaxel at a dose of 100 mg/m2 weekly for 6 weeks of a 7-week cycle. A total of 74 patients were enrolled: 37 between February and November 2004 in an early phase II trial and 37 between October 2005 and July 2006 in a late phase II trial.

Results

The median number of treatment cycles was two, and median dose intensity was 84.2 mg/m2/week. The most common grade 3–4 adverse events were leukopenia (37.5%), neutropenia (30.6%), anemia (12.5%), constipation (8.3%), peripheral neuropathy (5.6%), anorexia (5.6%), and pneumonitis (5.6%). Overall response rate was 29.0% according to RECIST. The median duration of response, median time to progression, and median survival time were 7.4, 3.4, and 14.3 months, respectively.

Conclusions

This study demonstrates that weekly paclitaxel has promising activity with acceptable toxicity in the treatment of recurrent or metastatic HNC.

Keywords

Paclitaxel Head and neck cancer Phase II study Weekly infusion 

Copyright information

© Springer-Verlag 2010

Authors and Affiliations

  • M. Tahara
    • 1
  • H. Minami
    • 2
  • Y. Hasegawa
    • 3
  • K. Tomita
    • 4
  • A. Watanabe
    • 5
  • K. Nibu
    • 6
  • M. Fujii
    • 7
  • Y. Onozawa
    • 8
  • Y. Kurono
    • 9
  • D. Sagae
    • 10
  • T. Seriu
    • 10
  • M. Tsukuda
    • 11
  1. 1.Department of Head and Neck Oncology and Plastic and Reconstructive SurgeryNational Cancer Center Hospital EastKashiwaJapan
  2. 2.Medical Oncology/Hematology, Department of MedicineKobe University HospitalKobeJapan
  3. 3.Department of Head and Neck SurgeryAichi Cancer CenterToyoakeJapan
  4. 4.Division of Head and Neck SurgeryNational Kyushu Cancer CenterFukuokaJapan
  5. 5.Department of OtolaryngologyKeiyukai Sapporo HospitalSapporoJapan
  6. 6.Department of Otolaryngology-Head and Neck SurgeryKobe University HospitalKobeJapan
  7. 7.Department of Otolaryngology, National Hospital OrganizationTokyo Medical CenterTokyoJapan
  8. 8.Division of Gastrointestinal Oncology and EndoscopyShizuoka Cancer CenterShizuokaJapan
  9. 9.Department of Otolaryngology-Head and Neck SurgeryKagoshima University HospitalKagoshimaJapan
  10. 10.Research and DevelopmentBristol-Myers K.K.TokyoJapan
  11. 11.Department of Otorhinolaryngology, and Head and Neck SurgeryYokohama City University School of MedicineYokohamaJapan

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