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Analysis of Phase III Study of Revlimid/Dexamethasone vs. Dexamethasone Alone in Patients >65 Years
By Asher A. Chanan-Khan, MD
12.18.06





This multi-center study demonstrates that Revlimid (lenalidomide) and dexamethasone is superior to dex alone, is as effective in older patients as in those <65 years of age, and does not contribute to a higher level of side effects among elderly patients.

ABSTRACT:

Lenalidomide (L) in Combination with Dexamethasone (D) Improves Survival and Time to Progression in Elderly Patients (pts) with Relapsed or Refractory (rel/ref) Multiple Myeloma (MM). Session Type: Poster Session, Board #780-III

Asher Alban Chanan-Khan, Donna Weber, Meletius Dimopoulos, Christine Chen, Reuben Niesvizky, Michael Wang, Andrew Belch, Michel Attal, Andrew Spencer, Miles Prince, Marta Olesnyckyj, Jerome Zeldis, Zhinuan Yu, Robert Knight Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA; Celgene Corporation, Summitt, NJ, USA; University General Alexandras Hospital, Athens, Greece; Princess Margaret Hospital, Toronto, ON, Canada; Cornell Medical Center, Cornell, NY, USA; MD Anderson, Houston, TX, USA; The Alfred Hospital, Prahran, Victoria, Australia; Hopital Purpan, Toulouse, France; University of ALberta and Cross Cancer Institute, Edmonton, Canada; Peter MacCallum Cancer Institute, East Melbourne, Victoria, Australia

Introduction: Treatment of elderly pts (age >65 years) with rel/ref MM remains a challenge due to concurrent comorbid conditions and poor tolerability to chemotherapy limiting therapeutic options. Recently, 2 phase III randomized clinical trials (MM-090 and MM-010) demonstrated superiority of the LD combination over D alone in previously treated MM pts. We examined the clinical benefit of LD combination in elderly pts enrolled in these 2 clinical trials. Methods: This is a retrospective data analysis of pts enrolled on the MM-090 and MM-010. All elderly pts (>65 years) were identified and parameters of clinical outcome (overall response, OR; time to progression, TTP; overall survival, OS) recorded. To determine the clinical benefit of L in elderly pt population, we compared the group of elderly pts who received LD combination with those who received D + placebo as well as with the group of younger pts who received the LD combination in these studies. Results: Collectively, 704 pts were enrolled with 285 identified as elderly. In the elderly group, 146 pts were randomized to LD combination and 139 to D + placebo. There were no significant differences in baseline characteristics of these two groups. In the elderly group who received LD, median time from diagnosis was 3.3 yrs (range 0.5-14.7) and 77.4% had received > 2 prior therapies (prior D and/or thalidomide in 69% and 32% respectively). Using the Blade criteria, the overall response (ORR) was significantly better in pts on combination treatment vs. D alone (58.9% vs. 20.9%; p<0.001). On an intent-to-treat analysis, the median time to progression (TTP; primary endpoint) for pts treated with D alone was 20 vs. 60 wks on combination (p<0.001) and the median overall survival was 79 wks and has not been reached (p=<0.001) in the combination group, respectively. We then compared the elderly pts with the younger pts who received LD combination. The ORR and median TTP was (58.9% vs. 60.9%) and (60 wks vs. 47.3 wks), respectively. The OS was 128 wks in the younger pts and is not reached in the elderly. Conclusion: L when combined with D improves ORR, prolongs TTP and OS in elderly pts with rel/ref MM and thus offers an important treatment option for this pt population. This clinical benefit of L achieved in the elderly is comparable to that in the younger pts and thus is irrespective of age of the pt treated. The availability of L as an oral formulation provides an added benefit in the management of elderly pts population.
Abstract #3551 appears in Blood, Volume 108, issue 11, November 16, 2006


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