1. Weekly paclitaxel in patients with recurrent or metastatic head and neck cancer.
- Author
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Tahara M, Minami H, Hasegawa Y, Tomita K, Watanabe A, Nibu K, Fujii M, Onozawa Y, Kurono Y, Sagae D, Seriu T, and Tsukuda M
- Subjects
- Adult, Aged, Antineoplastic Agents, Phytogenic adverse effects, Carcinoma, Squamous Cell pathology, Disease Progression, Endpoint Determination, Female, Follow-Up Studies, Head and Neck Neoplasms pathology, Humans, Male, Middle Aged, Neoplasm Metastasis drug therapy, Neoplasm Recurrence, Local drug therapy, Paclitaxel adverse effects, Survival Analysis, Treatment Outcome, Antineoplastic Agents, Phytogenic administration & dosage, Antineoplastic Agents, Phytogenic therapeutic use, Carcinoma, Squamous Cell drug therapy, Head and Neck Neoplasms drug therapy, Paclitaxel administration & dosage, Paclitaxel therapeutic use
- 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.
- Published
- 2011
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