Subcutaneous interleukin‐2 and interferon‐&agr; plus cisplatin with and without prophylactic cimetidine in patients with metastatic malignant melanoma: a phase II study
作者:
H. Schmidt,
P. Geertsen,
K. Fode,
C. Rytter,
L. Bastholt,
H. von der Maase,
期刊:
Melanoma Research
(OVID Available online 2000)
卷期:
Volume 10,
issue 1
页码: 66-77
ISSN:0960-8931
年代: 2000
出版商: OVID
关键词: chemoimmunotherapy;cimetidine;cisplatin;interferon;interleukin‐2;metastatic melanoma;survival;toxicity
数据来源: OVID
摘要:
&NA;A phase II study was performed to evaluate the efficacy of cisplatin combined with interleukin‐2 and interferon‐&agr;2b administered subcutaneously to patients with metastatic malignant melanoma (MMM). Between April 1994 and January 1999, 87 patients with MMM and a WHO performance status of ≤ 2 were entered into the study. The first 42 patients had prophylactic cimetidine; the other 45 patients did not. An overall response rate of 27% was achieved in the 82 patients evaluable for response. The median response duration was 7.0 months (range 4.4‐29.0 months). The median survival for all patients was 10.1 months (range 0.4‐64.9+ months). Toxicity was substantial but generally manageable and usually reversed on dose reduction or temporary interruption of treatment. Two patients (2%) died of treatment‐related toxicity. No difference in response or survival was seen in the patients treated with or without cimetidine. In multivariate analysis, lactate dehydrogenase level (P < 0.001), number of metastatic sites (P = 0.014) and performance status (P = 0.035) was shown to be independent prognostic factors for survival. This high dose interleukin‐2 subcutaneous regimen resulted in a small fraction of long‐term survivors. The response and survival results were not superior to other studies using lower and less toxic interleukin‐2 doses.
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