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

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/m(2) 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/m(2)/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.

• Authors: M Tahara, H Minami, Y Hasegawa, K Tomita, A Watanabe, K Nibu, M Fujii, Y Onozawa, Y Kurono, D Sagae, T Seriu, M Tsukuda
• Journal: Cancer chemotherapy and pharmacology (Cancer Chemother Pharmacol) Vol. 68 Issue 3 Pg. 769-76 (Sep 2011) ISSN: 1432-0843 [Electronic] Germany
• PMID: 21181475 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Phytogenic
• Paclitaxel

Topics

• Adult
• Aged
• Antineoplastic Agents, Phytogenic (administration & dosage, adverse effects, therapeutic use)
• Carcinoma, Squamous Cell (drug therapy, pathology)
• Disease Progression
• Endpoint Determination
• Female
• Follow-Up Studies
• Head and Neck Neoplasms (drug therapy, pathology)
• Humans
• Male
• Middle Aged
• Neoplasm Metastasis (drug therapy)
• Neoplasm Recurrence, Local (drug therapy)
• Paclitaxel (administration & dosage, adverse effects, therapeutic use)
• Survival Analysis
• Treatment Outcome