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Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma.

Publication ,  Journal Article
Ratain, MJ; Eisen, T; Stadler, WM; Flaherty, KT; Kaye, SB; Rosner, GL; Gore, M; Desai, AA; Patnaik, A; Xiong, HQ; Rowinsky, E; Abbruzzese, JL ...
Published in: J Clin Oncol
June 1, 2006

PURPOSE: This phase II randomized discontinuation trial evaluated the effects of sorafenib (BAY 43-9006), an oral multikinase inhibitor targeting the tumor and vasculature, on tumor growth in patients with metastatic renal cell carcinoma. PATIENTS AND METHODS: Patients initially received oral sorafenib 400 mg twice daily during the initial run-in period. After 12 weeks, patients with changes in bidimensional tumor measurements that were less than 25% from baseline were randomly assigned to sorafenib or placebo for an additional 12 weeks; patients with > or = 25% tumor shrinkage continued open-label sorafenib; patients with > or = 25% tumor growth discontinued treatment. The primary end point was the percentage of randomly assigned patients remaining progression free at 24 weeks after the initiation of sorafenib. RESULTS: Of 202 patients treated during the run-in period, 73 patients had tumor shrinkage of > or = 25%. Sixty-five patients with stable disease at 12 weeks were randomly assigned to sorafenib (n = 32) or placebo (n = 33). At 24 weeks, 50% of the sorafenib-treated patients were progression free versus 18% of the placebo-treated patients (P = .0077). Median progression-free survival (PFS) from randomization was significantly longer with sorafenib (24 weeks) than placebo (6 weeks; P = .0087). Median overall PFS was 29 weeks for the entire renal cell carcinoma population (n = 202). Sorafenib was readministered in 28 patients whose disease progressed on placebo; these patients continued on sorafenib until further progression, for a median of 24 weeks. Common adverse events were skin rash/desquamation, hand-foot skin reaction, and fatigue; 9% of patients discontinued therapy, and no patients died from toxicity. CONCLUSION: Sorafenib has significant disease-stabilizing activity in metastatic renal cell carcinoma and is tolerable with chronic daily therapy.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

June 1, 2006

Volume

24

Issue

16

Start / End Page

2505 / 2512

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Sorafenib
  • Pyridines
  • Phenylurea Compounds
  • Oncology & Carcinogenesis
  • Niacinamide
  • Middle Aged
  • Male
  • Kidney Neoplasms
 

Citation

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Ratain, M. J., Eisen, T., Stadler, W. M., Flaherty, K. T., Kaye, S. B., Rosner, G. L., … O’Dwyer, P. J. (2006). Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol, 24(16), 2505–2512. https://doi.org/10.1200/JCO.2005.03.6723
Ratain, Mark J., Tim Eisen, Walter M. Stadler, Keith T. Flaherty, Stan B. Kaye, Gary L. Rosner, Martin Gore, et al. “Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma.J Clin Oncol 24, no. 16 (June 1, 2006): 2505–12. https://doi.org/10.1200/JCO.2005.03.6723.
Ratain MJ, Eisen T, Stadler WM, Flaherty KT, Kaye SB, Rosner GL, et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006 Jun 1;24(16):2505–12.
Ratain, Mark J., et al. “Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma.J Clin Oncol, vol. 24, no. 16, June 2006, pp. 2505–12. Pubmed, doi:10.1200/JCO.2005.03.6723.
Ratain MJ, Eisen T, Stadler WM, Flaherty KT, Kaye SB, Rosner GL, Gore M, Desai AA, Patnaik A, Xiong HQ, Rowinsky E, Abbruzzese JL, Xia C, Simantov R, Schwartz B, O’Dwyer PJ. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006 Jun 1;24(16):2505–2512.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

June 1, 2006

Volume

24

Issue

16

Start / End Page

2505 / 2512

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Sorafenib
  • Pyridines
  • Phenylurea Compounds
  • Oncology & Carcinogenesis
  • Niacinamide
  • Middle Aged
  • Male
  • Kidney Neoplasms