J Clin Oncol 31, 2013 (suppl; abstr 8531)
Melissa Alsina, Paul Gerard Guy Richardson, Robert L. Schlossman, Donna M. Weber, Steven E. Coutre, Cristina Gasparetto, Sutapa Mukhopadhyay, Michael S. Ondovik, Mahmudul H Khan, Carole S. Paley, Sagar Lonial; H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL; Dana-Farber Cancer Institute, Boston, MA; The University of Texas MD Anderson Cancer Center, Houston, TX; Stanford Cancer Institute, Stanford, CA; Duke University Medical Center, Durham, NC; Novartis Pharmaceuticals Corp, East Hanover, NJ; Emory University School of Medicine, Atlanta, GA
Background: In PANORAMA 2, PAN + BTZ + DEX recaptured responses in heavily pretreated pts with BTZ-refractory MM; overall response rate (ORR), clinical benefit rate (CBR), and progression-free survival (PFS) were 34.5%, 52.7%, and 5.4 months, respectively. Here, we evaluate clinical response per baseline characteristics.
Methods: Response was based on European Group of Blood and Marrow Transplantation 1998 criteria. High-risk cytogenetics was defined as del(17p), t(4;14), or t(14;16). Quality of life (QoL) was measured with Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) v4.0 scale.
Results: Response rate trended higher in pts whose prior BTZ therapy was not their last line of therapy (Table). Although no trend in response rate was noted, PFS appeared longer in pts progressing within 60 days of their last BTZ-containing regimen than in those progressing on their last BTZ-containing regimen. In the 14 pts with high-risk cytogenetics, ORR was 42.9% and CBR was 71.4%. The mean FACT/GOG-Ntx subscale did not exhibit a clinically meaningful change from baseline (mean ± standard deviation [SD], 114.2 ± 21.1; n = 41) to cycle 9 day 1 (day 169; 104.2 ± 15.4; n = 16) as determined by 50% SD threshold for minimally important difference. Other QoL parameters were similarly unchanged.
Conclusions: PAN + BTZ + DEX demonstrated activity regardless of baseline demographics in heavily pretreated pts with BTZ-refractory MM.
Clinical trial information: NCT01083602