A phase II trial of cisplatin and vinorelbine in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
OBJECTIVE
We assessed the response rate and the toxicity of cisplatin plus vinorelbine in patients with this condition.


METHODS
Forty-two patients were included. Therapy consisted of cisplatin, 100 mg/m(2) on day 1, and vinorelbine, 25 mg/m(2) on days 1 and 8, given every 21 days. Therapy was continued up to six courses or progressive disease.


RESULTS
One hundred fifty-nine courses were given (median, three per patient). Dose reduction was applied in 13% of courses and 43% of patients. Grade 3 to 4 neutropenia appeared in 11% of courses and 35% of the patients. One patient died of febrile neutropenia. Ten percent of patients attained a complete response, and 23% attained a partial response (overall 33%, 95%CI 19%-47%). The median duration of response and median survival were 6 months. Twenty-four percent of patients remain alive at 1 year.


CONCLUSIONS
The combination of cisplatin and vinorelbine is moderately active in patients with recurrent or metastatic carcinomas of the head and neck and avoids the inconvenience of prolonged infusions of 5-fluorouracil.
Espinosa
Enrique
E
Servicio de Oncología Médica, Hospital La Paz P de la Castellana, 261, 28046 Madrid, Spain. eespinosa00@hotmail.com
Zamora
Pilar
P
Millá
Alfredo
A
Morales
Serafin
S
Molina
Raquel
R
Mira
M
M
González Barón
Manuel
M
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D009362:Neoplasm Metastasis / Q000188:drug therapy; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009503:Neutropenia / Q000209:etiology; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D000077235:Vinorelbine
D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine