"There are patients who are very sick or elderly or debilitated, where the physician may want to start [bortezomib] at one milligram per meter squared, and the patient and the physician should have the confidence that this drug is quite effective [at that dose]."
Dr. Sundar Jagannath
To view the video full screen, click on the small button next to the volume control in the lower right hand corner. Updated Survival Analyses after Prolonged Follow-Up of the Phase 2, Multicenter CREST Study of Bortezomib in Relapsed or Refractory Multiple Myeloma. Session Type: Poster Session, Board #907-II
Sundar Jagannath, Bart Barlogie, James R. Berenson, David Siegel, D. Irwin, Paul Richardson, Ruben Niesvizky, Raymond Alexanian, Steven Limentani, Melissa Alsina, Dixie-Lee Esseltine, Kenneth C. Anderson St. Vincents Comprehensive Cancer Center, New York, NY, USA; Myeloma Institute for Research Therapy, Little Rock, AR, USA; Myeloma and Bone Cancer Research, West Hollywood, CA, USA; Hackensack University Medical Center, NJ, USA; Alta Bates Cancer Center, Berkeley, CA, USA; Dana-Farber Cancer Institute, Boston, MA, USA; Weill Medical College of Cornell University, New York, NY, USA; University of Texas M.D. Anderson Cancer Center, Houston, TX, USA; Carolinas Hematology/Oncology Associates, Charlotte, NC, USA; H. Lee Moffitt Cancer Center Research Institute, Tampa, FL, USA; Millennium Pharmaceuticals, Inc., Cambridge, MA, USA
Background: The initial report of the CREST phase 2 study (Br J Haematol 2004;127:16572) demonstrated the substantial activity of bortezomib (VELCADE, Vc) at two different dose levels in patients with relapsed or refractory multiple myeloma (MM). Here, we provide an updated analysis of overall survival (OS) after prolonged follow-up (median >5 years). Methods: 54 patients were enrolled to receive Vc 1.0 mg/m2 (n=28) or 1.3 mg/m2 (n=26) on days 1, 4, 8, and 11 of a 21-day cycle, for up to 8 cycles. Dexamethasone (dex) 20 mg on the day of and day after each Vc dose was added for 16 (57%) patients in the 1.0 mg/m2 group and 12 (46%) patients in the 1.3 mg/m2 group, upon suboptimal response to Vc alone. A total of 17 (31%) patients continued to receive Vc dex in an extension study, 12 (43%) from the 1.0 mg/m2 and 5 (19%) from the 1.3 mg/m2 groups. Patients received a median of 3 (range, 17) prior regimens. Median time from diagnosis to first Vc dose was 2 years. In the 1.0 and 1.3 mg/m2 groups, respectively, mean age was 64 vs 60 years, 50% vs 35% of patients were male, 54% vs 65% had IgG MM, 58% vs 48% had 2-microglobulin 4 mg/L, and 29% vs 48% had abnormal cytogenetics. Response rate (CR+PR, EBMT criteria) to Vc alone was 30% vs 38%, and to Vc dex was 37% vs 50% in the 1.0 and 1.3 mg/m2 groups. OS from first dose of Vc in each dose group was analyzed using the KaplanMeier method. Results: Median OS in the 1.0 and 1.3 mg/m2 groups was 26.8 months and 60.0 months, after median follow-up of 61 and 65 months, respectively (Figure). In the 1.0 mg/m2 group, 21 (75%) patients have died; the 1- and 2-year OS rates were 82% and 54%, respectively. In the 1.3 mg/m2 group, only 14/26 (54%) patients have died; 1- and 2-year OS rates were 81% and 69%, respectively. Conclusions: Vc dex was active in relapsed or refractory MM at both the 1.0 mg/m2 and 1.3 mg/m2 dose levels and was associated with notable OS, particularly in patients treated with the approved Vc dose of 1.3 mg/m2. The difference in OS between dose groups suggests that the higher dose of Vc is more active. Figure. KaplanMeier analyses of OS in patients who received Vc 1.0 mg/m2 (n=28) or 1.3 mg/m2 (n=26).
Abstract #2717 appears in Blood, Volume 110, issue 11, November 16, 2007
Disclosure: Employment: Millennium (D. Esseltine). Consultancy: Millennium, Celgene, Johnson Johnson (P. Richardson); Millennium (J. Berenson, R. Niesvizky); Millennium, Celgene, Novartis (K. Anderson). Ownership Interests:; Millennium (D. Esseltine). Research Funding: Millennium (J. Berenson, S. Limentani, K. Anderson, R. Niesvizky); National Institutes of Health (B. Barlogie); Celgene (K. Anderson, R. Niesvizky); Novartis (K. Anderson). Honoraria Information: Millennium (R. Alexanian, J. Berenson, K. Anderson); Celgene (S. Jagannath, B. Barlogie, R. Niesvizky, K. Anderson); Novartis (K. Anderson). Membership Information: Millennium, Celgene (S. Jagannath, P. Richardson, B. Barlogie); Johnson Johnson (P. Richardson); Millennium (R. Alexanian, J. Berenson, D. Siegel).
Sunday, December 9, 2007 6:00 PM
Session Info: Poster Session: Myeloma: Relapsed and Refractory Multiple Myeloma (6:00 p.m.-8:00 p.m.)