19 april 2005: Bron: J Clin Oncol. 1990 Jan;8(1):9-15 en J Clin Oncol. 1994 Jun;12(6):1113-20.

Hydrazine sulfaat vermindert significant bijwerkingen van chemo bij niet-klein-cellige longkanker en verlengt significant mediane levensduur naar 328 dagen tegenover 209 dagen in placebogroep (P = > 0.05) bij patiënten waarvan de lichamelijke conditie nog redelijk was te noemen bij aanvang van behandeling. De verbetering bij patiënten met slechte lichamelijke conditie was het verschil in overleving net niet significant maar ging ook nog altijd de mediane overleving naar 292 dagen tegenover 187 dagen in placebogroep. De studie werd uitgevoerd bij 65 patiënten. Echter een grotere fase III studie vier jaar later geeft geen enkel effect van hydrazine sulfaat bij niet-klein-cellige longkanker. Hier achtereenvolgens de twee abstracten van twee gerandomiseerde studies. Eerst de studie met negatieve uitkomst daarna de positieve studie. Het verschil zou kunnen zitten in het feit dat in de ene studie de patiënten nog geen enkele chemokuur hadden gekregen vooraf aan de onderzoeksstudie met hydrazine sulfaat en in de andere studie juist wel, maar kan niet geverifieerd worden omdat in de studie met negatieve uitkomsten hierover in het abstract niets gezegd wordt. Eerst een vermelding van een gerandomiseerde studie uit 1995 waarvan het abstract niet beschikbaar is.

J Clin Oncol. 1995 Jun;13(6):1529-30.

Comment on:
J Clin Oncol. 1994 Jun;12(6):1113-20. Abstract not available

Placebo-controlled randomized study of hydrazine sulfate in lung cancer.

Kosty MP, Herndon JE 2nd, Green MR, McIntyre OR.

Randomized Controlled Trial
J Clin Oncol. 1994 Jun;12(6):1113-20.

Comment in:
J Clin Oncol. 1994 Jun;12(6):1107-8.

J Clin Oncol. 1995 Jun;13(6):1529-30.

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.

Clinical Trial, Phase III
PMID: 8201372 [PubMed - indexed for MEDLINE]

J Clin Oncol. 1990 Jan;8(1):9-15

Hydrazine sulfate influence on nutritional status and survival in non-small-cell lung cancer.

Chlebowski RT, Bulcavage L, Grosvenor M, Oktay E, Block JB, Chlebowski JS, Ali I, Elashoff R. Department of Medicine, Harbor-UCLA Medical Center, Torrance 90509.

This randomized, prospective, placebo-controlled clinical trial compares the influence on nutritional status and survival of hydrazine sulfate with placebo addition to cisplatin-containing combination chemotherapy in patients with unresectable non-small-cell lung cancer (NSCLC). The trial consisted of 65 patients with advanced, unresectable NSCLC who had had no prior chemotherapy, were at least partially ambulatory (Eastern Cooperative Oncology Group performance status level 0-2), and who had adequate hematologic, renal, and hepatic function. All patients received the same defined combination chemotherapy (cisplatin, vinblastine, and bleomycin) and the same defined dietary counseling with the addition of either three times daily oral hydrazine sulfate (60 mg) or placebo capsules. Hydrazine sulfate compared with placebo addition to chemotherapy resulted in significantly greater caloric intake and albumin maintenance (P less than .05). Considering all patients, survival was greater for the hydrazine sulfate compared with placebo group (median survival, 292 v 187 days), but the difference did not achieve statistical significance. In favorable PS patients (PS 0-1), survival was significantly prolonged (median survival, 328 days v 209 days; P less than .05) for hydrazine sulfate compared with placebo addition. In a multifactor analysis, PS, weight loss, and liver involvement were the final variables. Objective response frequency and toxicity were comparable on both arms. Hydrazine sulfate may favorably influence nutritional status and clinical outcome of patients with NSCLC. Further definitive studies of hydrazine sulfate addition to therapeutic regimens in NSCLC are warranted.

Randomized Controlled Trial
PMID: 1688616 [PubMed - indexed for MEDLINE]

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