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A Randomized Clinical Trial in Bronchogenic Small-Cell Carcinoma Evaluating Alternating Maintenance Therapy of Vincristine, Adriamycin, Procarbazine, and Etoposide (VAPE) with Cyclophosphamide, CCNU, and Methotrexate (CCM) versus CCM Maintenance Alone in Complete Responders Following VAPE Induction and Late Intensification

Broder, Lawrence E., M.D.; Sridhar, Kasi S., M.D.; Selawry, Oleg S., M.D.; Charyulu, Komanduri N., M.D.; Rao, Ramesh K., M.D.; Saldana, Mario J., M.D.; Donnelly, Elizabeth J., PA-C; Raub, William A. Jr., MSPH

American Journal of Clinical Oncology: December 1994 - Volume 17 - Issue 6 - p 527–537
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Initially, 109 evaluable patients with locally advanced or metastatic small cell lung cancer (SCLC) were treated with vincristine, Adriamycin, procarbazine, and etoposide (VAPE). Partial (PR) or nonresponders (NR) were crossed to CCM (cyclophosphamide, CCNU, and mcthotrexate) and then to HMiVe (hexamethylmelaminc, mitomycin C, vin-blastine) sequentially at maximum response. Complete responders (CR) were intensified by 50% with VAPE primarily and randomized to VAPE, alternating with CCM or CCM alone during maintenance. CR patients with limited disease received local thoracic irradiation and prophylactic cranial irradiation (PCI), whereas those with extensive disease received PCI alone. There were 45 patients (41%) who achieved a CR to chemotherapy, and 27 patients were eligible for randomization. Of 12 CR patients randomized to alternating therapy (VAPE/CCM), the median survival was 25.9 months compared to 12.9 months for 15 CR patients randomized to continuous CCM (P = .049). In addition, 35 patients achieved a PR (32%) and 29 were NR (27%). Overall median survivals were significantly different for the CR patients (13.0 months) as compared to PR (7.6 months) and NR patients (6.4 months). Late intensification did not appear to add substantially to survival while contributing to toxicity. In summary, VAPE is a new outpatient regimen for SCLC, which is highly effective as an induction regimen with moderate hematologic toxicity and predominantly gastrointestinal nonhematologic toxicity.

Departments of Oncology (L.E.B., K.S.S., O.S.S., E.J.D., W.A.R.), Medicine (L.E.B., K.S.S.), Radiology (K.N.C. R.K.R.). and Pathology (M.J.S.), Sylvester Comprehensive Cancer Center, University of Miami School of Medicine and the Veteran's Administration Medical Center Miami, Florida. U.S.A.

© Lippincott-Raven Publishers.