A low-dose combination therapy of interleukin-2 and interferon-α is effective for lung metastasis of renal cell carcinoma: A multicenter open study

被引:27
作者
Akaza H. [1 ]
Tsukamoto T. [2 ]
Onishi T. [3 ]
Miki T. [4 ]
Kinouchi T. [5 ]
Naito S. [6 ]
机构
[1] Department of Urology, Institute of Clinical Medicine, University of Tsukuba, Tsukuba 305-0005
[2] Department of Urology, Sapporo Medical University, Sapporo
[3] Department of Urology, Jikei University, School of Medicine, Tokyo
[4] Department of Urology, Kyoto Prefectural University of Medicine, Kyoto
[5] Department of Urology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka
[6] Kyushu University, School of Medicine, Fukuoka
关键词
Combination; IFN-α; Low-dose IL-2; Renal cell carcinoma;
D O I
10.1007/s10147-006-0596-z
中图分类号
学科分类号
摘要
Background. To confirm the usefulness of a combination therapy of interleukin-2 (IL-2) and interferon-α (IFN-α) against metastatic renal cell carcinoma, the recommended dose of IFN-α to use in combination with low-dose IL-2 was determined (phase 1). Efficacy and safety at this dose was evaluated (phase 2). Methods. In phase 1, the dose of IL-2 was fixed at 0.7 × 106 Japan reference unit (JRU)/person for 5 days a week. The dose of IFN-α was increased from 3 × 106 IU for 3 days a week (level I) to 6 × 106 IU for 3 days a week (level II) and to 6 × 106 IU for 5 days a week (level III). Results. In phase 1, 10 patients were registered, with 9 (3 at each level) able to be evaluated. Because grade 3 and grade 4 neutropenia were observed at level III in 1 patient each, level II was found to be the recommended regimen. The response rate in phase 1 was 44.4% (4/9). In phase 2, 46 patients were registered, with a response rate in 37 patients, classified as per protocol set (PPS), of 21.6% (8/37). Toxicities observed were primarily flu-like symptoms due to cytokines, and gastrointestinal symptoms. Leukocyte abnormalities were observed, but they were milder and tolerable. Conclusion. In the 46 patients evaluated in phase 1 and phase 2, the response rate was 26.1% (12/46), being highest in 38.7% (12/31) of those who were nephrectomized, and with only lung metastases. © 2006 The Japan Society of Clinical Oncology.
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页码:434 / 440
页数:6
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