Vinorelbine, bleomycin and methotrexate as a salvage therapy for patients with head and neck squamous carcinoma in relapse after cisplatin/fluorouracil

Background. Cisplatin (CDDP) and 5-fluorouracil (5-FU) represent the standard chemotherapy for advanced/recurrent head and neck squamous carcinoma (HNSC); however, the duration of response is often short, with a median survival of only five to six months. Patients and methods. Patients with HNSC were treated with vinorelbine 20 mg/m(2) and methotrexate 50 mg/m(2) every week and bleomycin 15 mg/m(2) every two weeks. All patients were previously treated with a CDDP/5-FU regimen. Results. Forty-eight patients were evaluable for response and toxicity. After a median follow-up of 15 months, 16 patients are still alive and 32 have died. We had one complete response (2%), 12 partial responses (25%) (overall response rate 27%; 95% CI: 14%-39%), 11 stabilizations (23%) and 24 progressions (50%) of disease. Neutropenia grade 3-4 was seen in 12 patients; peripheral neurotoxicity in two patients. There were no toxic deaths. Conclusions: This regimen, administered in an outpatient setting, revealed some activity as a second-line treatment inpatients with HNSC, with acceptable toxicity.