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Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206.

Publication ,  Journal Article
Rini, BI; Halabi, S; Rosenberg, JE; Stadler, WM; Vaena, DA; Archer, L; Atkins, JN; Picus, J; Czaykowski, P; Dutcher, J; Small, EJ
Published in: J Clin Oncol
May 1, 2010

PURPOSE: Bevacizumab is an antibody that binds vascular endothelial growth factor and has activity in metastatic renal cell carcinoma (RCC). Interferon alfa (IFN-alpha) is the historic standard initial treatment for RCC. A prospective, randomized, phase III trial of bevacizumab plus IFN-alpha versus IFN-alpha monotherapy was conducted. PATIENTS AND METHODS: Patients with previously untreated, metastatic clear cell RCC were randomly assigned to receive either bevacizumab (10 mg/kg intravenously every 2 weeks) plus IFN-alpha (9 million units subcutaneously three times weekly) or the same dose and schedule of IFN-alpha monotherapy in a multicenter phase III trial. The primary end point was overall survival (OS). Secondary end points were progression-free survival (PFS), objective response rate, and safety. RESULTS: Seven hundred thirty-two patients were enrolled. The median OS time was 18.3 months (95% CI, 16.5 to 22.5 months) for bevacizumab plus IFN-alpha and 17.4 months (95% CI, 14.4 to 20.0 months) for IFN-alpha monotherapy (unstratified log-rank P = .097). Adjusting on stratification factors, the hazard ratio was 0.86 (95% CI, 0.73 to 1.01; stratified log-rank P = .069) favoring bevacizumab plus IFN-alpha. There was significantly more grade 3 to 4 hypertension (HTN), anorexia, fatigue, and proteinuria for bevacizumab plus IFN-alpha. Patients who developed HTN on bevacizumab plus IFN-alpha had a significantly improved PFS and OS versus patients without HTN. CONCLUSION: OS favored the bevacizumab plus IFN-alpha arm but did not meet the predefined criteria for significance. HTN may be a biomarker of outcome with bevacizumab plus IFN-alpha.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

May 1, 2010

Volume

28

Issue

13

Start / End Page

2137 / 2143

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Time Factors
  • Prospective Studies
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Kidney Neoplasms
  • Kaplan-Meier Estimate
  • Interferon-alpha
 

Citation

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Rini, B. I., Halabi, S., Rosenberg, J. E., Stadler, W. M., Vaena, D. A., Archer, L., … Small, E. J. (2010). Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206. J Clin Oncol, 28(13), 2137–2143. https://doi.org/10.1200/JCO.2009.26.5561
Rini, Brian I., Susan Halabi, Jonathan E. Rosenberg, Walter M. Stadler, Daniel A. Vaena, Laura Archer, James N. Atkins, et al. “Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206.J Clin Oncol 28, no. 13 (May 1, 2010): 2137–43. https://doi.org/10.1200/JCO.2009.26.5561.
Rini BI, Halabi S, Rosenberg JE, Stadler WM, Vaena DA, Archer L, et al. Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206. J Clin Oncol. 2010 May 1;28(13):2137–43.
Rini, Brian I., et al. “Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206.J Clin Oncol, vol. 28, no. 13, May 2010, pp. 2137–43. Pubmed, doi:10.1200/JCO.2009.26.5561.
Rini BI, Halabi S, Rosenberg JE, Stadler WM, Vaena DA, Archer L, Atkins JN, Picus J, Czaykowski P, Dutcher J, Small EJ. Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206. J Clin Oncol. 2010 May 1;28(13):2137–2143.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

May 1, 2010

Volume

28

Issue

13

Start / End Page

2137 / 2143

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Time Factors
  • Prospective Studies
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Kidney Neoplasms
  • Kaplan-Meier Estimate
  • Interferon-alpha