Randomized trial of treatment with cisplatin and interleukin-2 either alone or in combination with interferon-α-2a in patients with metastatic melanoma : A Federation Nationale des Centres de Lutte Contre le Cancer Multicenter, parallel study
✍ Scribed by Thierry Dorval; Sylvie Négrier; Christine Chevreau; Marie-Françoise Avril; Daniel Baume; Didier Cupissol; Ralph Oskam; Ria de Peuter; Jan Vinke; Alain Herrera; Bernard Escudier
- Publisher
- John Wiley and Sons
- Year
- 1999
- Tongue
- English
- Weight
- 88 KB
- Volume
- 85
- Category
- Article
- ISSN
- 0008-543X
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✦ Synopsis
Background:
The objective of the current study was to evaluate the response rate, survival, and toxicity of treatment with cisplatin and high dose intravenous continuous infusion interleukin-2 (il-2) with or without interferon-alpha-2a (ifn) in patients with metastatic melanoma.
Methods:
One hundred and seventeen patients with metastatic melanoma randomly were assigned to receive cisplatin, 100 mg/m2, followed after a 3-day rest period by il-2, 18 x 10(6) iu/m2, on days 3-6 and days 17-21 (arm 1) or cisplatin and il-2 using an identical schedule plus subcutaneous ifn, 9 x 10(6) u, 3 times a week during il-2 administration (arm 2). in the absence of disease progression or undue toxicity, the cycle could be repeated on day 29. patients who responded after two cycles eventually could receive a third cycle. one hundred and one patients were evaluable for toxicity and efficacy.
Results:
On treatment arm 1, 3 patients (6%) achieved a complete response (cr) and 5 patients (10%) achieved a partial response (pr) with a median response duration of 3.8 months for the crs and 8.7 months for the prs. on treatment arm 2, 2 patients (3%) achieved a cr (durations of 5.9 and 33.1 months, respectively) and 11 patients (21%) a pr with a median response duration of 8.3 months. the median durations of overall survival were 10.4 months (range, 1.1-39.7+ months) and 10.9 months (range, 0.5-38.1+ months) for treatment arms 1 and 2, respectively. the toxicity profile was consistent with the known side effects of this il-2 intravenous regimen combined with cisplatin chemotherapy and ifn. toxicity was more pronounced in treatment arm 2 compared with treatment arm 1. there were 2 and 4 patients, respectively, in treatment arms 1 and 2 who died within 28 days after completion of treatment.
Conclusions:
The observed overall response rates of 16% and 25% in treatment arms 1 and 2, respectively, is lower than that expected with biochemotherapy; despite the fact that the objective of the trial was not to show any difference between the 2 treatment arms, our results indicate that the addition of ifn, at the dose and schedule used in this trial, fails to improve the activity of a cisplatin/il-2 regimen significantly in patients with metastatic melanoma. although response rates were relatively low, the median overall survival was nearly 1 year in both groups.