Sunitinib Alone or after Nephrectomy in Renal Cancer

To the Editor: In the CARMENA (Cancer du Rein Metastatique Nephrectomie et Antiangiogeniques) trial, Mejean et al. (Aug. 2 issue)(1) determine the noninferiority of sunitinib alone, as compared with nephrectomy followed by sunitinib, on the basis of the observation that the 95% confidence interval for the hazard ratio of death did not exceed 1.20 (the noninferiority margin for the trial). This conclusion was derived from the second interim analysis, in which a criterion for statistical significance was defined according to the O'Brien-Fleming boundary; this boundary was not met, but the trial was terminated early because of slow enrollment. The confidence . . .