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

来源：

International Journal of Clinical Oncology | 2006年 / 11卷 / 6期

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.

引用

页码：434 / 440

页数：6

共 18 条

[1] Wirth M.P., Immunotherapy for metastatic renal cell carcinoma, Urol Clin North Am, 20, pp. 283-295, (1993)
[2] Horoszewicz J.S., Murphy G.P., An assessment of the current use of human interferons in therapy of urological cancers, J Urol, 142, pp. 1173-1180, (1989)
[3] Bukowski R.M., Natural history and therapy of metastatic renal cell carcinoma: The role of interleukin-2, Cancer, 80, pp. 1198-1220, (1997)
[4] Physicians' Desk Reference, pp. 801-804, (1994)
[5] Liang S.-M., Allet B., Rose K., Et al., Characterization of human interleukin 2 derived from Escherichia coli, Biochem J, 229, pp. 429-439, (1985)
[6] Aso Y., Tazaki H., Umeda T., Et al., A phase II study of S-6820 (recombinant interleukin 2) on renal cell carcinoma, Biotherapy, 3, pp. 999-1007, (1989)
[7] Aso Y., Homma Y., Tazaki H., Et al., A phase II trial of S-6820 (recombinant interleukin-2) on renal cell carcinoma refractory to interferon, Hinyokigeka, 8, pp. 75-86, (1995)
[8] Tsuchida T., Indication of activated units in recombinant interleukin-2. What is true or false?, Biotherapy Today, 1, pp. 41-43, (1994)
[9] Hank J.A., Surfus J., Gan J., Et al., Distinct clinical and laboratory activity of two recombinant interleukin-2 preparations, Clin Cancer Res, 5, pp. 281-289, (1999)
[10] WHO Handbook for reporting results of cancer treatment, WHO Offset Publication No.48, (1979)

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