Randomized comparison of two combination regimens versus minimal chemotherapy in nonsmall-cell lung cancer: A southeastern cancer study group trial

Dan W. Luedke, Lawrence Einhorn, George A. Omura, P. Ravi Sarma, Alfred A. Bartolucci, Robert Birch, F. Anthony Greco

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Abstract

Patients with advanced nonsmall-cell lung cancer (NSCLC), good performance status, and no prior chemotherapy were randomized to receive one of three regimens: intravenous vindesine (V) 3 mg/m2 every 2 weeks; V 3 mg/m2 weekly for 5 weeks, followed by a dose every 2 weeks plus mitomycin (VM) 20 mg/m2 day 1 and then 15 mg/m2 every 6 weeks; or V at the more intensive dose rate plus cisplatin (VC) 120 mg/m2 with forced diuresis on days 1 and 29 and then every 6 weeks. A total of 435 patients were enrolled in the trial, with 410 (94%) assessable for prognostic characteristics and survival. Among the 375 patients assessable for response, only 58 (15%) achieved objective response. Single-agent V every 2 weeks was inactive (response rate <1%), effectively acting as a no-treatment arm. Among assessable patients receiving VM, 33 (27%) responded;among patients receiving VC, 24 (19%) responded. There was no statistically significant survival difference among the treatment arms, with median survival among those treated with V 14.8 weeks, VM 20.4 weeks, and VC 24.7 weeks; VC achieved borderline signficance (P = .06) compared with V. In a prognostic factor analysis, treatment was not a significant factor (P = .447) for survival. Thus, in this large multicenter trial, neither a high-dose cisplatin combination nor a noncisplatin regimen (VM) with a comparable response rate had a significant survival advantage over minimal chemotherapy. New approaches are needed in advanced NSCLC.

Original languageEnglish (US)
Pages (from-to)886-891
Number of pages6
JournalJournal of Clinical Oncology
Volume8
Issue number5
StatePublished - 1990
Externally publishedYes

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Non-Small Cell Lung Carcinoma
Drug Therapy
Survival
Neoplasms
Cisplatin
Vindesine
Diuresis
Mitomycin
Statistical Factor Analysis
Multicenter Studies
Therapeutics

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Randomized comparison of two combination regimens versus minimal chemotherapy in nonsmall-cell lung cancer : A southeastern cancer study group trial. / Luedke, Dan W.; Einhorn, Lawrence; Omura, George A.; Sarma, P. Ravi; Bartolucci, Alfred A.; Birch, Robert; Greco, F. Anthony.

In: Journal of Clinical Oncology, Vol. 8, No. 5, 1990, p. 886-891.

Research output: Contribution to journalArticle

Luedke, Dan W. ; Einhorn, Lawrence ; Omura, George A. ; Sarma, P. Ravi ; Bartolucci, Alfred A. ; Birch, Robert ; Greco, F. Anthony. / Randomized comparison of two combination regimens versus minimal chemotherapy in nonsmall-cell lung cancer : A southeastern cancer study group trial. In: Journal of Clinical Oncology. 1990 ; Vol. 8, No. 5. pp. 886-891.
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abstract = "Patients with advanced nonsmall-cell lung cancer (NSCLC), good performance status, and no prior chemotherapy were randomized to receive one of three regimens: intravenous vindesine (V) 3 mg/m2 every 2 weeks; V 3 mg/m2 weekly for 5 weeks, followed by a dose every 2 weeks plus mitomycin (VM) 20 mg/m2 day 1 and then 15 mg/m2 every 6 weeks; or V at the more intensive dose rate plus cisplatin (VC) 120 mg/m2 with forced diuresis on days 1 and 29 and then every 6 weeks. A total of 435 patients were enrolled in the trial, with 410 (94{\%}) assessable for prognostic characteristics and survival. Among the 375 patients assessable for response, only 58 (15{\%}) achieved objective response. Single-agent V every 2 weeks was inactive (response rate <1{\%}), effectively acting as a no-treatment arm. Among assessable patients receiving VM, 33 (27{\%}) responded;among patients receiving VC, 24 (19{\%}) responded. There was no statistically significant survival difference among the treatment arms, with median survival among those treated with V 14.8 weeks, VM 20.4 weeks, and VC 24.7 weeks; VC achieved borderline signficance (P = .06) compared with V. In a prognostic factor analysis, treatment was not a significant factor (P = .447) for survival. Thus, in this large multicenter trial, neither a high-dose cisplatin combination nor a noncisplatin regimen (VM) with a comparable response rate had a significant survival advantage over minimal chemotherapy. New approaches are needed in advanced NSCLC.",
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