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Phase III randomized trial of interleukin-2 with or without lymphokine-activated killer cells in the treatment of patients with advanced renal cell carcinoma.

Publication ,  Journal Article
Law, TM; Motzer, RJ; Mazumdar, M; Sell, KW; Walther, PJ; O'Connell, M; Khan, A; Vlamis, V; Vogelzang, NJ; Bajorin, DF
Published in: Cancer
September 1, 1995

BACKGROUND: Treatment with interleukin-2 (IL-2) and lymphokine-activated killer cells (LAK) resulted in responses in some patients with advanced renal cell carcinoma (RCC). However, the relative therapeutic benefit of the addition of LAK to IL-2 was unknown. METHODS: A randomized Phase III trial was conducted in patients with RCC comparing continuous intravenous infusion (CI) IL-2 alone with CI IL-2 plus LAK. Interleukin-2 was administered at 3 x 10(6) U/m2/day on days 1-5, 13-17, 21-24, and 28-31. Patients on the LAK treatment arm underwent leukapheresis on days 8-10 and LAK cell reinfusion on days 13-15. The results are reported with long-term follow-up. The published experience with IL-2 alone or with the addition of LAK was investigated in a quantitative literature survey. The response proportions were studied by schedule (high dose bolus, moderate dose, low dose) and by concomitant administration of LAK. RESULTS: Seventy-one patients were treated, 36 on the IL-2 arm and 35 on the IL-2 plus LAK arm. Four patients (6%) had major responses (two complete, two partial). The median survival of all patients was 13 months (95% confidence interval [CI], 9-18 months). There were no differences between treatment arms with regard to response (P = 0.61) and survival (P = 0.67). More patients on the LAK arm experienced pulmonary toxicity (P = 0.008). The overall weighted response proportion was 16% (95% CI, 8%-24%) for the 39 published series of 1291 patients treated with IL-2. The 95% confidence intervals for response proportion overlapped when compared by schedule and by administration of LAK. CONCLUSIONS: The dose and schedule of IL-2 used in this study resulted in a low level of antitumor activity and the addition of LAK did not improve the response rate against RCC. Given the infrequent, but reproducible, responses with IL-2 and interferon-based regimens, continued investigation of these agents is warranted as is the study of new cytokines. Alternative treatment strategies should be studied in RCC and new agents and treatment regimens that appear promising in Phase II studies must be studied in randomized trials.

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Published In

Cancer

DOI

ISSN

0008-543X

Publication Date

September 1, 1995

Volume

76

Issue

5

Start / End Page

824 / 832

Location

United States

Related Subject Headings

  • Survival Rate
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Leukapheresis
  • Killer Cells, Lymphokine-Activated
  • Kidney Neoplasms
  • Interleukin-2
  • Infusions, Intravenous
  • Immunotherapy, Adoptive
 

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Law, T. M., Motzer, R. J., Mazumdar, M., Sell, K. W., Walther, P. J., O’Connell, M., … Bajorin, D. F. (1995). Phase III randomized trial of interleukin-2 with or without lymphokine-activated killer cells in the treatment of patients with advanced renal cell carcinoma. Cancer, 76(5), 824–832. https://doi.org/10.1002/1097-0142(19950901)76:5<824::aid-cncr2820760517>3.0.co;2-n
Law, T. M., R. J. Motzer, M. Mazumdar, K. W. Sell, P. J. Walther, M. O’Connell, A. Khan, V. Vlamis, N. J. Vogelzang, and D. F. Bajorin. “Phase III randomized trial of interleukin-2 with or without lymphokine-activated killer cells in the treatment of patients with advanced renal cell carcinoma.Cancer 76, no. 5 (September 1, 1995): 824–32. https://doi.org/10.1002/1097-0142(19950901)76:5<824::aid-cncr2820760517>3.0.co;2-n.
Law TM, Motzer RJ, Mazumdar M, Sell KW, Walther PJ, O’Connell M, et al. Phase III randomized trial of interleukin-2 with or without lymphokine-activated killer cells in the treatment of patients with advanced renal cell carcinoma. Cancer. 1995 Sep 1;76(5):824–32.
Law, T. M., et al. “Phase III randomized trial of interleukin-2 with or without lymphokine-activated killer cells in the treatment of patients with advanced renal cell carcinoma.Cancer, vol. 76, no. 5, Sept. 1995, pp. 824–32. Pubmed, doi:10.1002/1097-0142(19950901)76:5<824::aid-cncr2820760517>3.0.co;2-n.
Law TM, Motzer RJ, Mazumdar M, Sell KW, Walther PJ, O’Connell M, Khan A, Vlamis V, Vogelzang NJ, Bajorin DF. Phase III randomized trial of interleukin-2 with or without lymphokine-activated killer cells in the treatment of patients with advanced renal cell carcinoma. Cancer. 1995 Sep 1;76(5):824–832.
Journal cover image

Published In

Cancer

DOI

ISSN

0008-543X

Publication Date

September 1, 1995

Volume

76

Issue

5

Start / End Page

824 / 832

Location

United States

Related Subject Headings

  • Survival Rate
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Leukapheresis
  • Killer Cells, Lymphokine-Activated
  • Kidney Neoplasms
  • Interleukin-2
  • Infusions, Intravenous
  • Immunotherapy, Adoptive