A phase III trial of mitomycin C alone versus mitomycin C, vinblastine, and cisplatin for metastatic squamous cell lung carcinoma.
BACKGROUND
In an effort to confirm the efficacy of mitomycin C against metastatic squamous cell lung carcinoma and to compare the efficacy of single-agent therapy with a combination containing cisplatin, the authors conducted a randomized Phase III trial of mitomycin C alone versus mitomycin C, vinblastine, and cisplatin (MVP).


METHODS
All patients had advanced squamous cell lung carcinoma, and survival was the primary end point. There were 133 eligible patients who received either mitomycin C alone (n = 64) or MVP (n = 69). The two groups were similar with respect to performance score, disease status, age, sex, and stage.


RESULTS
The major objective response rates were 30% (95% confidence interval [CI], 18-41%) and 43% (95% CI, 32-55%) for mitomycin C alone and MVP, respectively (P = 0.1). The median time to progression was 83 days for mitomycin C alone, compared with 119 days for MVP (P = 0.026). The median survival time was 114 days for mitomycin C and 163 days for MVP (P = 0.09). The 1-year survival rates were equivalent. Myelosuppression was the major toxicity, and there were significantly greater leukocyte nadirs with MVP therapy (P < 0.001).


CONCLUSIONS
Mitomycin C has antitumor activity against squamous cell lung carcinoma when used alone or in combination with MVP. The regimen containing cisplatin had marginally increased activity that did not translate into a clinically significant survival advantage.
Veeder
M H
MH
Illinois Oncology Research Association CCOP, Peoria.
Jett
J R
JR
Su
J Q
JQ
Mailliard
J A
JA
Foley
J F
JF
Dalton
R J
RJ
Etzell
P S
PS
Marschke
R F
RF
Kardinal
C G
CG
Maksymiuk
A W
AW
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000556:secondary; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012074:Remission Induction; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage* / Q000009:adverse effects
D016685:Mitomycin; D014747:Vinblastine; D002945:Cisplatin