title: A phase II clinical trial evaluating the use of two sequential, four-drug combination chemotherapy regimens in ambulatory bronchogenic adenocarcinoma patients.
abstract: Forty-three ambulatory patients with locally advanced or metastatic bronchogenic adenocarcinoma were sequentially treated with two potentially mutually non-cross-resistant chemotherapy regimens. A new regimen, MVPF (mitomycin-c, vinblastine, procarbazine, and 5-fluorouracil), was given until progressive disease occurred. Then, a second regimen--MOCC (methotrexate, vincristine [Oncovin], cyclophosphamide, and CCNU)--was initiated. At further progression, regional disease patients received radiotherapy, whereas extensive disease patients received Phase II agents. Of the 43 patients entered on the study, 40 were evaluable. Three patients withdrew early due to poor tolerance of the regimen. The response rate for MVPF was 33% (12 of 40 PR, 1 of 40 CR) compared to a 4% (1 of 23 PR) response for MOCC (difference: p < or = .03), for a total response rate of 35%. Although there was an initial improvement in survival for responders (31.7 weeks) versus nonresponders (15.7 weeks) at the 75th percentile (p < or = .05), there was no significant difference in median survival. The hematologic toxicity was equivalent for both groups, whereas nonhematologic toxicity revealed a high incidence of nausea and vomiting in the MVPF group. It is concluded that this approach lent itself well to ambulatory care, and MVPF could be considered an alternative to cyclophosphamide-based regimens. However, the absence of a meaningful CR rate and lack of influence of response on median survival were factors limiting its effectiveness.
authors.affiliation: Department of Oncology, Sylvester Comprehensive Cancer Center, University of Miami School of Medicine, Florida 33101.
authors.forename: L E
authors.initials: LE
authors.lastname: Broder
authors.forename: K S
authors.initials: KS
authors.lastname: Sridhar
authors.forename: O S
authors.initials: OS
authors.lastname: Selawry
authors.forename: K N
authors.initials: KN
authors.lastname: Charyulu
authors.forename: R K
authors.initials: RK
authors.lastname: Rao
authors.forename: M J
authors.initials: MJ
authors.lastname: Saldana
authors.forename: C
authors.initials: C
authors.lastname: Lenz
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy; D000553:Ambulatory Care; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002283:Carcinoma, Bronchogenic / Q000145:classification / Q000188:drug therapy* / Q000532:radiotherapy; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008130:Lomustine / Q000008:administration & dosage; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D011344:Procarbazine / Q000008:administration & dosage; D011829:Radiation Dosage; D012074:Remission Induction; D016019:Survival Analysis; D014747:Vinblastine / Q000008:administration & dosage; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D011344:Procarbazine; D016685:Mitomycin; D014750:Vincristine; D014747:Vinblastine; D008130:Lomustine; D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate