A phase II clinical trial of recombinant human interleukin-2 in treatment of advanced melanoma
10.3781/j.issn.1000-7431.2011.11.015
- Author:
Bi-Xia TANG
1
Author Information
1. Department of Melanoma and Kidney Cancer
- Publication Type:Journal Article
- Keywords:
Interleukin-2;
Melanoma;
Survival analysis;
Treatment outcomes
- From:
Tumor
2011;31(11):1042-1045
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To investigate the efficacy and safety of high-dose recombinant human interleukin-2 (rhIL-2) in treatment of patients with advanced melanoma. Methods: Twenty Chinese patients with advanced melanoma were planned to be enrolled to receive high-dose rhIL-2 treatment. The overall response rare (ORR), progression-free survival (PFS), overall survival (OS) and incidence of toxicity were evaluated. Results: Fourteen patients were enrolled, of them twelve could be evaluated. One patient achieved partial response (PR), and the maintaining duration of response was 43.0 months; three patients achieved stable disease (SD); 8 patients achieved progressive disease (PD). The median PFS was 56.0±7.6 d, and the median OS was 11.0±2.6 months. The incidence rate of grade III-IV toxicity was 40.3%, mainly manifested as gastrointestinal reaction, fever and cardiovascular reaction. Conclusion: The efficacy of high-dose rhIL-2 for Chinese patients with advanced melanoma is not as good as those previously reported in studies abroad, with high incidence rate of adverse effects. The patients can get long response duration as rhIL-2 worked. It is necessary to perform further studies on how to make choice of administration dose and select potential patients who will benefit from the treatment. Copyright© 2011 by TUMOR.
