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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
Kosty
MP, Fleishman SB, Herndon JE 2nd, Coughlin K, Kornblith AB, Scalzo A, Morris JC,
Mortimer J, Green MR
Division
of Hematology and Oncology, Ida M. and Cecil H. Green Cancer Center, Scripps
Clinic and Research Foundation, La Jolla, CA 92037
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.
PMID:
8201372 [PubMed - indexed for MEDLINE]
Source:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8201372&dopt=Abstract
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