A phase II trial of a new combination chemotherapy (cisplatin, bleomycin, VP-16 and methylprednisolone) in advanced recurrent squamous cell carcinoma of the head and neck.
With the aim of increasing complete responses and improving survival in advanced recurrent (after surgery and/or RXT) squamous cell carcinoma of the head and neck, we scheduled 31 patients to receive the following regimen: VP-16, 100 mg/m2 i.v. on days 1, 3 and 5; bleomycin, 10 mg/m2 i.v. on days 4, 11 and 18; cisplatin, 120 mg/m2 on day 6, and 6-methylprednisolone, 40 mg/m2 on days 1-7. Courses were repeated every 21 days. In all, 29 patients were evaluable.


RESULTS
complete responses (CR) were achieved in 7 cases (24%); partial responses (PR) in 7 cases (24%); the overall response rate was 48%; stable disease in 7 cases (24%), and progressive disease in 8 cases (27.5%). In 20 cases of the N3 category there were 4 CR (20%) and 6 PR (30%). Survival: entire groups, 32.7 weeks; CR 63.8 (22+28+72+); PR, 30.2; cases of no change, 29 weeks and in nonresponders, 10 weeks.


RESULTS
leukopenia, 5/29 (17%); thrombocytopenia, 3/29 (10.3%); anemia, 10/29 (34.4%); nephrotoxicity, 8/29 (10.3%), and alopecia, reversible, 100%.


CONCLUSIONS
this therapeutic regimen improves the CR rate and survival time with a tolerable toxicity.
Senra Varela
A
A
Department of Internal Medicine, Medical School, Cádiz, Spain.
Millan Nuñez-Cortes
J
J
Gallurt Moreira
P
P
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D004341:Drug Evaluation; D005047:Etoposide / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local
D005047:Etoposide; D002945:Cisplatin; D008775:Methylprednisolone