Randomized Phase III Trial of Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma
2017; Lippincott Williams & Wilkins; Volume: 35; Issue: 35 Linguagem: Inglês
10.1200/jco.2017.73.5324
ISSN1527-7755
AutoresRobert J. Motzer, Naomi B. Haas, Frede Donskov, Marine Gross‐Goupil, Sergei Varlamov, Evgeny Kopyltsov, Jae‐Lyun Lee, Bohuslav Melichar, Brian I. Rini, Toni K. Choueiri, Milada Zemanová, Lori Wood, M. Neil Reaume, Arnulf Stenzl, Simon Chowdhury, Ho Yeong Lim, Ray McDermott, Agnieszka Michael, Weichao Bao, Marlene J. Carrasco-Alfonso, Paola Aimone, Maurizio Voi, Christian Doehn, Paul Russo, Cora N. Sternberg,
Tópico(s)Pancreatic and Hepatic Oncology Research
ResumoPurpose This phase III trial evaluated the efficacy and safety of pazopanib versus placebo in patients with locally advanced renal cell carcinoma (RCC) at high risk for relapse after nephrectomy. Patients and Methods A total of 1,538 patients with resected pT2 (high grade) or ≥ pT3, including N1, clear cell RCC were randomly assigned to pazopanib or placebo for 1 year; 403 patients received a starting dose of 800 mg or placebo. To address toxicity attrition, the 800-mg starting dose was lowered to 600 mg, and the primary end point analysis was changed to disease-free survival (DFS) for pazopanib 600 mg versus placebo (n = 1,135). Primary analysis was performed after 350 DFS events in the intent-to-treat (ITT) pazopanib 600 mg group (ITT
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