Skip to main content

Cisplatin, vinblastine, and hydrazine sulfate in advanced, non-small-cell lung cancer: a randomized placebo-controlled, double-blind phase III study of the Cancer and Leukemia Group B.

Publication ,  Journal Article
Kosty, MP; Fleishman, SB; Herndon, JE; Coughlin, K; Kornblith, AB; Scalzo, A; Morris, JC; Mortimer, J; Green, MR
Published in: J Clin Oncol
June 1994

PURPOSE: To assess the chemotherapy regimen of cisplatin, vinblastine, and hydrazine sulfate administered to patients with non-small-cell lung cancer (NSCLC) in a randomized, placebo-controlled double-blind phase III study. PATIENTS AND METHODS: Between July 25, 1989 and February 1, 1991, 291 patients with stage IIIB or IV NSCLC and performance status 0 or 1 were randomized to receive cisplatin 100 mg/m2 intravenously (IV) every 28 days, vinblastine 5 mg/m2 IV per week times five, then every 2 weeks; and either hydrazine sulfate 60 mg three times per day orally or placebo. The concurrent use of corticosteroids, medroxyprogesterone, or other appetite stimulants was not permitted. Treatment groups were comparable for known prognostic variables. The primary end point of this study was survival; however, the influence of hydrazine sulfate on nutritional status, performance status, and quality of life was also assessed. RESULTS: Analysis of 266 eligible patients showed a median survival duration of 7.78 months for the hydrazine sulfate-treated group compared with 7.70 months for the placebo-treated group (P = .65, log-rank). Objective response rates were similar for the two groups, with 4% complete responses, 20% partial responses, and 2% regressions in those treated with hydrazine sulfate; 3% complete responses, 23% partial responses, and 2% regressions in those who received placebo. The major toxicity was severe or life-threatening neutropenia, which occurred in 65% of hydrazine sulfate patients and 63% of placebo patients. There were no differences noted between the two groups in degree of anorexia, weight gain or loss, or overall nutritional status. Sensory and motor neuropathy occurred significantly more often in patients treated with hydrazine sulfate. Quality of life was significantly worse in patients who received hydrazine sulfate. CONCLUSION: This study suggests no benefit from the addition of hydrazine sulfate to an effective cytotoxic regimen.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

J Clin Oncol

DOI

ISSN

0732-183X

Publication Date

June 1994

Volume

12

Issue

6

Start / End Page

1113 / 1120

Location

United States

Related Subject Headings

  • Vinblastine
  • Survival Rate
  • Quality of Life
  • Prospective Studies
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Lung Neoplasms
  • Hydrazines
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Kosty, M. P., Fleishman, S. B., Herndon, J. E., Coughlin, K., Kornblith, A. B., Scalzo, A., … Green, M. R. (1994). Cisplatin, vinblastine, and hydrazine sulfate in advanced, non-small-cell lung cancer: a randomized placebo-controlled, double-blind phase III study of the Cancer and Leukemia Group B. J Clin Oncol, 12(6), 1113–1120. https://doi.org/10.1200/JCO.1994.12.6.1113
Kosty, M. P., S. B. Fleishman, J. E. Herndon, K. Coughlin, A. B. Kornblith, A. Scalzo, J. C. Morris, J. Mortimer, and M. R. Green. “Cisplatin, vinblastine, and hydrazine sulfate in advanced, non-small-cell lung cancer: a randomized placebo-controlled, double-blind phase III study of the Cancer and Leukemia Group B.J Clin Oncol 12, no. 6 (June 1994): 1113–20. https://doi.org/10.1200/JCO.1994.12.6.1113.
Kosty, M. P., et al. “Cisplatin, vinblastine, and hydrazine sulfate in advanced, non-small-cell lung cancer: a randomized placebo-controlled, double-blind phase III study of the Cancer and Leukemia Group B.J Clin Oncol, vol. 12, no. 6, June 1994, pp. 1113–20. Pubmed, doi:10.1200/JCO.1994.12.6.1113.
Kosty MP, Fleishman SB, Herndon JE, Coughlin K, Kornblith AB, Scalzo A, Morris JC, Mortimer J, Green MR. Cisplatin, vinblastine, and hydrazine sulfate in advanced, non-small-cell lung cancer: a randomized placebo-controlled, double-blind phase III study of the Cancer and Leukemia Group B. J Clin Oncol. 1994 Jun;12(6):1113–1120.

Published In

J Clin Oncol

DOI

ISSN

0732-183X

Publication Date

June 1994

Volume

12

Issue

6

Start / End Page

1113 / 1120

Location

United States

Related Subject Headings

  • Vinblastine
  • Survival Rate
  • Quality of Life
  • Prospective Studies
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Lung Neoplasms
  • Hydrazines
  • Humans