Paclitaxel and gemcitabine in advanced non-nasopharyngeal head and neck cancer: A phase II study conducted by the Hellenic Cooperative Oncology Group

Background: Paclitaxel as monotherapy or in combination with other drugs ha s demonstrated significant activity in patients with squamous cell carcinom a of the head and neck region (SCCHN). Preclinical studies have shown gemci tabine to be highly active in SCCHN cell lines. Purpose of the study: To evaluate the activity and toxicity of the combinat ion of paclitaxel by three-hour infusion and gemcitabine as first-line chem otherapy in patients with recurrent and/or metastatic head and neck cancer (HNC). Patients and methods: From September 1996 until May 1998, 44 patients with non-nasopharyngeal recurrent and/or metastatic HNC entered the study. There were 37 men and seven women with a median age of 61 years (range 35-79) an d a median performance status of 1 (range 0-2). The location of the primary tumor in the majority of them was either the larynx or the oral cavity. Tr eatment consisted of six cycles of gemcitabine 1100 mg/m(2) over 30 min on days 1 and 8 immediately followed on day 1 by paclitaxel 200 mg/m(2) by thr ee-hour infusion. The treatment was repeated every three weeks. Results: Twenty-four (55%) patients completed all six cycles of treatment. A total of 205 cycles were administered, 165 (81%) of them at full dose. Th e median relative dose intensity (DI) of gemcitabine was 0.93 and of paclit axel 0.95. Except for alopecia, which was universal, grade 3-4 toxicities i ncluded neutropenia (21%), thrombocytopenia (5%), anemia (5%), infection (5 %), flu-like syndrome (5%) and peripheral neuropathy (2%). Five (11%) patie nts achieved complete and 13 (30%) partial responses, for an overall respon se rate of 41%. After a median follow-up of 13 months, the median time to p rogression was four months and median survival nine months. Conclusions: The combination of paclitaxel and gemcitabine is active and we ll tolerated in patients with recurrent and/or metastatic HNC - randomized studies comparing this combination with other regimens are warranted.