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

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, measurabl...

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Bibliographic Details
Published in:Cancer chemotherapy and pharmacology 2011-09, Vol.68 (3), p.769-776
Main Authors: Tahara, M., Minami, H., Hasegawa, Y., Tomita, K., Watanabe, A., Nibu, K., Fujii, M., Onozawa, Y., Kurono, Y., Sagae, D., Seriu, T., Tsukuda, M.
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic agents
Antineoplastic Agents, Phytogenic - administration & dosage
Antineoplastic Agents, Phytogenic - adverse effects
Antineoplastic Agents, Phytogenic - therapeutic use
Biological and medical sciences
Cancer Research
Carcinoma, Squamous Cell - drug therapy
Carcinoma, Squamous Cell - pathology
Disease Progression
Endpoint Determination
Female
Follow-Up Studies
Head and Neck Neoplasms - drug therapy
Head and Neck Neoplasms - pathology
Humans
Male
Medical sciences
Medicine
Medicine & Public Health
Middle Aged
Neoplasm Metastasis - drug therapy
Neoplasm Recurrence, Local - drug therapy
Oncology
Original Article
Otorhinolaryngology (head neck, general aspects and miscellaneous)
Otorhinolaryngology. Stomatology
Paclitaxel - administration & dosage
Paclitaxel - adverse effects
Paclitaxel - therapeutic use
Pharmacology. Drug treatments
Pharmacology/Toxicology
Survival Analysis
Treatment Outcome
Tumors
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Summary: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.
ISSN:0344-5704
1432-0843
DOI:10.1007/s00280-010-1550-3