ASCO 2017- CALGB-ECOG 100104 Alliance study- Lenalidomide vs placebo maintenance after stem cell transplant
Description: Background: At a prespecified interim analysis (Dec 2009), the phase 3 CALGB study results surpassed the prespecified superiority boundary (significantly improved PFS for LEN maint vs PBO after SCT) and the majority of PBO arm pts without progressive disease (PD) crossed over to LEN maint. An updated analysis (cutoff Mar 2015), showed significantly longer OS with LEN maint (HR, 0.56; 95% CI, 0.42-0.76). We examined the effect of LEN vs PBO on OS and PFS from randomization, adjusting for XO effects.
Author(s): Philip L. McCarthy, Sarah A. Holstein, Sin-Ho Jung, Miranda Cooper, Craig J Gibson, Edward Allen Stadtmauer, Benjamin Winograd, Paul G. Richardson; Roswell Park Cancer Institute, Buffalo, NY; Duke University School of Medicine, Durham, NC; BresMed, Sheffield, United Kingdom; Celgene Corporation, Summit, NJ; Abramson Cancer Center, Philadelphia, PA; Dana-Farber Cancer Institute, Boston, MA
Clinical trial information: NCT00114101