Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma

Gary Hudes, Michael Carducci, Piotr Tomczak, Janice Dutcher, Robert Figlin, Anil Kapoor, Elzbieta Staroslawska, Jeffrey Sosman, David McDermott, I. Bodrogi, Zoran Kovacevic, Vladimir Lesovoy, Ingo G H Schmidt-Wolf, Olga Barbarash, Erhan Gokmen, Timothy O'Toole, Stephanie Lustgarten, Laurence Moore, Robert J. Motzer

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Abstract

BACKGROUND: Interferon alfa is widely used for metastatic renal-cell carcinoma but has limited efficacy and tolerability. Temsirolimus, a specific inhibitor of the mammalian target of rapamycin kinase, may benefit patients with this disease. METHODS: In this multicenter, phase 3 trial, we randomly assigned 626 patients with previously untreated, poor-prognosis metastatic renal-cell carcinoma to receive 25 mg of intravenous temsirolimus weekly, 3 million U of interferon alfa (with an increase to 18 million U) subcutaneously three times weekly, or combination therapy with 15 mg of temsirolimus weekly plus 6 million U of interferon alfa three times weekly. The primary end point was overall survival in comparisons of the temsirolimus group and the combination-therapy group with the interferon group. RESULTS: Patients who received temsirolimus alone had longer overall survival (hazard ratio for death, 0.73; 95% confidence interval [CI], 0.58 to 0.92; P = 0.008) and progression-free survival (P

Original languageEnglish
Pages (from-to)2271-2281
Number of pages11
JournalNew England Journal of Medicine
Volume356
Issue number22
DOIs
Publication statusPublished - May 31 2007

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Renal Cell Carcinoma
Interferon-alpha
Survival
Sirolimus
Group Psychotherapy
Interferons
Disease-Free Survival
Phosphotransferases
temsirolimus
Confidence Intervals
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

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Hudes, G., Carducci, M., Tomczak, P., Dutcher, J., Figlin, R., Kapoor, A., ... Motzer, R. J. (2007). Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. New England Journal of Medicine, 356(22), 2271-2281. https://doi.org/10.1056/NEJMoa066838

Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. / Hudes, Gary; Carducci, Michael; Tomczak, Piotr; Dutcher, Janice; Figlin, Robert; Kapoor, Anil; Staroslawska, Elzbieta; Sosman, Jeffrey; McDermott, David; Bodrogi, I.; Kovacevic, Zoran; Lesovoy, Vladimir; Schmidt-Wolf, Ingo G H; Barbarash, Olga; Gokmen, Erhan; O'Toole, Timothy; Lustgarten, Stephanie; Moore, Laurence; Motzer, Robert J.

In: New England Journal of Medicine, Vol. 356, No. 22, 31.05.2007, p. 2271-2281.

Research output: Contribution to journalArticle

Hudes, G, Carducci, M, Tomczak, P, Dutcher, J, Figlin, R, Kapoor, A, Staroslawska, E, Sosman, J, McDermott, D, Bodrogi, I, Kovacevic, Z, Lesovoy, V, Schmidt-Wolf, IGH, Barbarash, O, Gokmen, E, O'Toole, T, Lustgarten, S, Moore, L & Motzer, RJ 2007, 'Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma', New England Journal of Medicine, vol. 356, no. 22, pp. 2271-2281. https://doi.org/10.1056/NEJMoa066838
Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. New England Journal of Medicine. 2007 May 31;356(22):2271-2281. https://doi.org/10.1056/NEJMoa066838
Hudes, Gary ; Carducci, Michael ; Tomczak, Piotr ; Dutcher, Janice ; Figlin, Robert ; Kapoor, Anil ; Staroslawska, Elzbieta ; Sosman, Jeffrey ; McDermott, David ; Bodrogi, I. ; Kovacevic, Zoran ; Lesovoy, Vladimir ; Schmidt-Wolf, Ingo G H ; Barbarash, Olga ; Gokmen, Erhan ; O'Toole, Timothy ; Lustgarten, Stephanie ; Moore, Laurence ; Motzer, Robert J. / Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. In: New England Journal of Medicine. 2007 ; Vol. 356, No. 22. pp. 2271-2281.
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AU - Figlin, Robert

AU - Kapoor, Anil

AU - Staroslawska, Elzbieta

AU - Sosman, Jeffrey

AU - McDermott, David

AU - Bodrogi, I.

AU - Kovacevic, Zoran

AU - Lesovoy, Vladimir

AU - Schmidt-Wolf, Ingo G H

AU - Barbarash, Olga

AU - Gokmen, Erhan

AU - O'Toole, Timothy

AU - Lustgarten, Stephanie

AU - Moore, Laurence

AU - Motzer, Robert J.

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N2 - BACKGROUND: Interferon alfa is widely used for metastatic renal-cell carcinoma but has limited efficacy and tolerability. Temsirolimus, a specific inhibitor of the mammalian target of rapamycin kinase, may benefit patients with this disease. METHODS: In this multicenter, phase 3 trial, we randomly assigned 626 patients with previously untreated, poor-prognosis metastatic renal-cell carcinoma to receive 25 mg of intravenous temsirolimus weekly, 3 million U of interferon alfa (with an increase to 18 million U) subcutaneously three times weekly, or combination therapy with 15 mg of temsirolimus weekly plus 6 million U of interferon alfa three times weekly. The primary end point was overall survival in comparisons of the temsirolimus group and the combination-therapy group with the interferon group. RESULTS: Patients who received temsirolimus alone had longer overall survival (hazard ratio for death, 0.73; 95% confidence interval [CI], 0.58 to 0.92; P = 0.008) and progression-free survival (P

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