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Background: Weekly paclitaxel in pts with a variety of cancers has demonstrated similar efficacy andbetter tolerability than standard 3-weekly paclitaxel. A prior phase II study (Brotherton TW, Proc. ASCO 921, 2001) performed with paclitaxel at 80mg/m2/week in 48 pts with chemotherapy-pretreated HNC reported a response rate of 9.3 %. We conducted an early phase II study to evaluate the efficacy and toxicity of weekly paclitaxel in pts with recurrent or metastatic HNC. Methods: Theeligibility required: histologically proven HNC with recurrent or metastatic lesion, measurable disease, PS 0-2, adequate organ function, and no more than one prior chemotherapy regimen. Pts were administered a weekly 1-hour infusion of paclitaxel 100 mg/m2, for 6 of 7 weeks until disease progression or unacceptable toxicities occurred. Results: Between Feb and Nov, 2004, 37 pts were enrolled and 36 pts (30 male, 6 female) were assessable for response and toxicity; median age 61 (range 44-74); PS 0-1 of 35 pts; 32 pts had previously received chemotherapy. 20 pts underwent surgery, and 30 pts received radiotherapy. In total, 105 cycles of weekly paclitaxel were administered (median 2 cycles; range 1-10). The median dose intensity was 82.1 mg/m2 per week. Most common non-hematological toxicities were neuropathy, alopecia and fatigue. The incidence of neuropathy of grade 3 or greater was 2.8%. Most common hematological toxicities were leucopenia and neutropenia. The incidence of neutropenia of grade 3 or greater was 36.1%. The overall response rate was 33.3 % (2 CR, 10 PR, 95% CI 18.6-51.0%) according to WHO criteria and 25.7% (2CR, 7 PR, 95%CI 12.5-43.3%) according to RECIST criteria. After a median follow up time of 196 days, median duration of response was 259 days (range 102-538) and time to progression was 96 days (95%CI 69-140days). Conclusion: Weekly paclitaxel demonstrated a promising activity with acceptable toxicity in recurrent or metastatic HNC pts.

98th AACR Annual Meeting-- Apr 14-18, 2007; Los Angeles, CA