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 (

Aitchison, M., Bray, C. A., Van Poppel, H., Sylvester, R., Graham, J., Innes, C., McMahon, L. and Vasey, P. A. (2014) 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 (. European Journal of Cancer, 50 1: 70-77. doi:10.1016/j.ejca.2013.08.019


Author Aitchison, M.
Bray, C. A.
Van Poppel, H.
Sylvester, R.
Graham, J.
Innes, C.
McMahon, L.
Vasey, P. A.
Title 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 (
Journal name European Journal of Cancer   Check publisher's open access policy
ISSN 0959-8049
1879-0852
Publication date 2014-01-01
Year available 2013
Sub-type Article (original research)
DOI 10.1016/j.ejca.2013.08.019
Open Access Status Not Open Access
Volume 50
Issue 1
Start page 70
End page 77
Total pages 8
Place of publication Kidlington, Oxford, United Kingdom
Publisher Pergamon
Language eng
Formatted abstract
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.
Keyword Adjuvant chemotherapy
Nephrectomy
Renal cell carcinoma
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2014 Collection
School of Medicine Publications
 
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