Background: There are few moderately active single-agents for the treatment of recurrent or metastatic head & neck cancer. Thus, the identification of novel active agents is warranted. We performed the present phase II trial to evaluate activity and toxicity of vinorelbine (VNB) in previously treated patients with advanced head & neck cancer.
Patients and methods: 16 patients entered the study, 15 of whom were evaluable. The main characteristics were: M/F = 14/1; median age of 58 yrs (18-67); median PS (Karnofsky score) of 70 (60-100); primitive tumor sites were: oropharynx in 5; larynx in 4, hypopharynx in 3, rhynopharynx in 2, and oral cavity in 1 patient; initial clinical stage was IV in 9, III in 4 and II in 2 patients. Previous treatments were: cisplatinum with concurrent radiotherapy in 6 and cisplatinum + fluorouracil (for at least 2 cycles) in 9 patients. VNB was given at the dose of 20 mg/m2 i.v. infusion for 1 hr, weekly, for a minimum of 8 doses. Response and toxicity were evaluated after at least 8 doses of VNB.
Results: Overall, 139 courses of VNB were given (median 9, range 8-19). Objective responses were: partial response in 1 patient (6%); stable disease, lasting at least 2 months, in 4 patients (27%) and progression in the other 10 patients (67%). Three patients had a one week delay in subsequent courses due to severe hematological toxicity. Toxicities observed were: leucopenia of grade IV (W.H.O.) in 2 patients and of grade I-II in 12 patients; granulocytopenia of grade III in 1 patient and of grade IV in 2 patients; grade I-II anemia in 4 patients; grade II phlebitis in 3 patients; grade II constipation in 2 patients, grade I-II peripheral neuropathy in 3 patients, grade I-II nausea and vomiting in 4 patients, and grade II stomatitis in 2 patients.
Conclusions: VNB, in this series of heavily pre-treated patients with head & neck cancer, did not reveal an antitumor activity of interest.