Median TTP by independent radiology review was 16.1 months for the R-CHOP arm compared with 30.5 months for the VR-CAP arm (HR, 0.58; P < 0.001) and, by investigator review, 16.8 months versus 35.0 months (HR, 0.47; P < 0.001, respectively). For the R-CHOP versus VR-CAP arms, respectively, median TTNT was 24.8 months versus 44.5 months (HR, 0.50; P < 0.001), and OS, 56.3 months versus not reached (HR, 0.80; P = 0.173). Four-year OS was 54% compared with 64%.
Median complete response plus unconfirmed complete response was 42% with R-CHOP versus 53% (odds ratio [OR], 1.69; P = 0.007) by independent radiology review and 28% versus 42% (OR, 1.9; P = 0.002) by investigator review.
“These data are not yet very mature. We have, up to now, about one-third of the expected events only, at a median follow-up of 40 months. The median overall survival of R-CHOP of 56 months has not yet been reached with the VR-CAP regimen,” said Dr. Cavalli. He added that the survival curves were widening between R-CHOP and VR-CAP, however, so this may mean that the mature data will indicate a difference in overall survival between the two arms.
Rates of grade 3 or higher adverse events (AEs) were 85% (R-CHOP) versus 93% (VR-CAP); serious AEs, 30% versus 38%; discontinuations due to AEs, 7% versus 9%; and on-treatment drug-related deaths, 3% versus 2%.
“VR-CAP could be considered a new standard of care for newly diagnosed [patients with] MCL not considered for intensive treatment and BMT,” Dr. Cavalli concluded.
- Cavalli F, Rooney B, Pei L et al. Abstract 8500. Presented at: 2014 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2014; Chicago, IL.