OBJECTIVES: To evaluate the effect of adjuvant thalidomide on recurrence-free survival (RFS) after nephrectomy for high-risk metastatic renal cell carcinoma (RCC). METHODS: Eligibility criteria for enrollment on this randomized trial included any histologic subtype, T2 (high grade, any N), T3/T4 (any grade, any N), or node-positive (any grade, any T) RCC. We randomized eligible patients to observation or to receive thalidomide 300 mg daily for 24 months. Patients were observed until disease recurrence or death. RESULTS: After we enrolled 46 patients, we stopped the trial at a median follow up of 43.9 months (range, 9.7-74.2 months). Patients on the thalidomide arm had inferior 2- and 3-year probabilities of RFS, compared with controls (47.8% vs 69.3% and 28.7% vs 69.3%, respectively; P = .022). The 2- and 3-year cancer-specific survival was similar for both groups. All observed deaths were attributable to RCC (P = .392). By multivariate analysis, tumor size and grade predicted recurrence (P = .001 and .013) and kidney cancer-specific death (P = .002 and .014). Thalidomide treatment, however, was not an independent predictor of recurrence or cancer-specific mortality. CONCLUSIONS: In this small, randomized, controlled trial, adjuvant thalidomide therapy after complete resection of high-risk RCC did not improve the 2- and 3-year RFS rates or cancer-specific death rates.
RCT Entities:
OBJECTIVES: To evaluate the effect of adjuvant thalidomide on recurrence-free survival (RFS) after nephrectomy for high-risk metastatic renal cell carcinoma (RCC). METHODS: Eligibility criteria for enrollment on this randomized trial included any histologic subtype, T2 (high grade, any N), T3/T4 (any grade, any N), or node-positive (any grade, any T) RCC. We randomized eligible patients to observation or to receive thalidomide 300 mg daily for 24 months. Patients were observed until disease recurrence or death. RESULTS: After we enrolled 46 patients, we stopped the trial at a median follow up of 43.9 months (range, 9.7-74.2 months). Patients on the thalidomide arm had inferior 2- and 3-year probabilities of RFS, compared with controls (47.8% vs 69.3% and 28.7% vs 69.3%, respectively; P = .022). The 2- and 3-year cancer-specific survival was similar for both groups. All observed deaths were attributable to RCC (P = .392). By multivariate analysis, tumor size and grade predicted recurrence (P = .001 and .013) and kidney cancer-specific death (P = .002 and .014). Thalidomide treatment, however, was not an independent predictor of recurrence or cancer-specific mortality. CONCLUSIONS: In this small, randomized, controlled trial, adjuvant thalidomide therapy after complete resection of high-risk RCC did not improve the 2- and 3-year RFS rates or cancer-specific death rates.
Authors: G Pizzocaro; L Piva; G Di Fronzo; A Giongo; A Cozzoli; E Dormia; S Minervini; A Zanollo; U Fontanella; G Longo Journal: J Urol Date: 1987-12 Impact factor: 7.450
Authors: Bernard Escudier; Tim Eisen; Walter M Stadler; Cezary Szczylik; Stéphane Oudard; Michael Siebels; Sylvie Negrier; Christine Chevreau; Ewa Solska; Apurva A Desai; Frédéric Rolland; Tomasz Demkow; Thomas E Hutson; Martin Gore; Scott Freeman; Brian Schwartz; Minghua Shan; Ronit Simantov; Ronald M Bukowski Journal: N Engl J Med Date: 2007-01-11 Impact factor: 91.245
Authors: Danai D Daliani; Christos N Papandreou; Peter F Thall; Xuemei Wang; Cherie Perez; Rose Oliva; Lance Pagliaro; Robert Amato Journal: Cancer Date: 2002-08-15 Impact factor: 6.860
Authors: Robert J Motzer; Jennifer Bacik; Lawrence H Schwartz; Victor Reuter; Paul Russo; Stephanie Marion; Madhu Mazumdar Journal: J Clin Oncol Date: 2004-02-01 Impact factor: 44.544
Authors: Joseph I Clark; Michael B Atkins; Walter J Urba; Steven Creech; Robert A Figlin; Janice P Dutcher; Larry Flaherty; Jeffrey A Sosman; Theodore F Logan; Richard White; Geoffrey R Weiss; Bruce G Redman; Christopher P G Tretter; David McDermott; John W Smith; Michael S Gordon; Kim A Margolin Journal: J Clin Oncol Date: 2003-06-16 Impact factor: 44.544
Authors: Adolfo J O Scherr; Joao Paulo S N Lima; Emma C Sasse; Carmen S P Lima; André D Sasse Journal: BMC Cancer Date: 2011-03-31 Impact factor: 4.430