Analysis to be reported at ASCO 2017 Annual Meeting includes adjustment for impact of crossover
- Phase III study randomly assigned participants to receive lenalidomide or plac
- Some patients had option to switch from placebo group to treatment arm
- Adjusted data show improved effect on progression-free and overall survival
BUFFALO, N.Y. — An international team of researchers has performed a follow-up analysis based on a large clinical study of a maintenance therapy for patients with multiple myeloma. Philip McCarthy, MD, of Roswell Park Comprehensive Cancer Center was principal investigator of a phase III study that showed that treatment with lenalidomide following autologous hematopoietic stem cell transplant improved both progression-free survival and overall survival for newly diagnosed multiple myeloma patients. He is also first author on an updated analysis to be presented during the American Society of Clinical Oncology (ASCO) 53rd Annual Meeting in Chicago that adjusts the data to account for the impact of crossover from the placebo arm to the treatment arm among a group of study participants.
The phase III study, Alliance for Clinical Trials in Oncology study CALGB/ECOG/BMT-CTN 100104, was unblinded in December 2009 following the release of interim study results demonstrating a progression-free-survival benefit from lenalidomide maintenance. Patients receiving no lenalidomide maintenance — those in the placebo arm — who showed no evidence of disease progression were offered active treatment with lenalidomide (Revlimid). The majority of eligible patients opted to cross over to receive lenalidomide maintenance therapy.
For the current analysis, the research team examined the effect of lenalidomide on both overall and progression-free survival, adjusting for the impact of the delayed initiation of treatment using an approach known as rank-preserving structural failure time modeling. When accounting for the placebo-arm patients who crossed over to lenalidomide treatment, they report, the maintenance treatment effect on both progression-free and overall survival improved.
“It’s notoriously difficult to tease out the effects of crossover and to fairly compare the impact of a medication in groups who weren’t treated for the same length of time. However, this analysis shows that the lenalidomide maintenance effect increased when we accounted for the placebo crossover effect,” says Dr. McCarthy, who is Director of the Blood and Marrow Transplant Center at Roswell Park.
The new analysis was performed in collaboration with researchers from the Alliance for Clinical Trials in Oncology, Eastern Cooperative Oncology Group, Blood and Marrow Transplant Clinical Trials Network, Duke University School of Medicine, BresMed Health Solutions Ltd., Celgene Corp., the Abramson Cancer Center and Dana-Farber Cancer Institute.
The poster, “CALGB/ECOG 100104 (Alliance) study: Lenalidomide (LEN) vs placebo (PBO) maintenance (maint) after stem cell transplant (SCT) for patients (pts) with multiple myeloma—Overall survival (OS) and progression-free survival (PFS) adjusted for treatment (tx) crossover (XO),” is ASCO 2017 abstract 8037 and will be presented Monday, June 5, from 8 a.m. to 11:30 a.m. CDT in McCormick Place, Hall A, as part of the Hematologic Malignancies—Plasma Cell Dyscrasia session.
The mission of Roswell Park Comprehensive Cancer Center is to understand, prevent and cure cancer. Founded in 1898, Roswell Park is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit www.roswellpark.org, call 1-877-ASK-Roswell Park (1-866-559-4838) or email AskRoswell@Roswellpark.org. Follow Roswell Park on Facebook and Twitter.
Annie Deck-Miller, Senior Media Relations Manager