Adjuvant 5-flurouracil, alpha-interferon and interleukin-2 versus observation in patients at high risk of recurrence after nephrectomy for renal cell carcinoma: Results of a Phase III randomised European Organisation for Research and Treatment of Cancer (Genito-Urinary Cancers Group)/National Cancer Research Institute trial

作者：Aitchison M^*; Bray C A; Van Poppel H; Sylvester R; Graham J; Innes C; McMahon L; Vasey P A

来源：European Journal of Cancer, 2014, 50(1): 70-77.

DOI：10.1016/j.ejca.2013.08.019

• Renal cell carcinoma
• Adjuvant chemotherapy
• Nephrectomy

Background: The purpose of this trial was to compare adjuvant 5-flurouracil, alpha-interferon and interleukin-2 to observation in patients at high risk of recurrence after nephrectomy for renal cell carcinoma (RCC) in terms of disease free survival, overall survival and quality of life (QoL).
Patients and Methods: Patients 8 weeks post nephrectomy for RCC, without macroscopic residual disease, with stage T3b-c,T4 or any pT and pN1 or pN2 or positive microscopic margins or microscopic vascular invasion, and no metastases were randomised to receive adjuvant treatment or observation. QoL was assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-30 (QLQC-30). Treatment delivery and toxicity were monitored. The trial was designed to detect an increase in 3 year disease free survival (DFS) from 50% on observation to 65% on treatment (hazard ratio (HR) = 0.63) with 90% power and two-sided alpha = 0.05.
Results: From 1998 to 2007, 309 patients were randomised (155 to observation; 154 to treatment). 35% did not complete the treatment, primarily due to toxicity (92% of patients experienced >= grade 2, 41% >= grade 3). Statistically significant differences between the arms in QoL parameters at 2 months disappeared by 6 months although there was suggestion of a persistent deficit in fatigue and physical function. Median follow-up was 7 years (maximum 12.1 years). 182 patients relapsed or died. DFS at 3 years was 50% with observation and 61% with treatment (HR 0.84, 95% confidence interval (CI) 0.63-1.12, p = 0.233). 124 patients died. Overall survival (OS) at 5 years was 63% with observation and 70% with treatment (HR 0.87, 95% CI 0.61-1.23, p = 0.428).
Conclusions: The treatment is associated with significant toxicity. There is no statistically significant benefit for the regimen in terms of disease free or overall survival.

• 出版日期2014-1