TY - JOUR
T1 - Continuous lenalidomide and low-dose dexamethasone in patients with transplant-ineligible newly diagnosed MM
T2 - FIRST trial subanalysis of Canadian/US patients
AU - Belch, Andrew
AU - Bahlis, Nizar
AU - White, Darrell
AU - Cheung, Matthew
AU - Chen, Christine
AU - Shustik, Chaim
AU - Song, Kevin
AU - Tosikyan, Axel
AU - Dispenzieri, Angela
AU - Anderson, Kenneth
AU - Brown, Diane
AU - Robinson, Suzanne
AU - Srinivasan, Shankar
AU - Facon, Thierry
N1 - Funding Information:
The authors thank Ruiyun Jiang of Bristol Myers Squibb for statistical support, Stanley Kotey for statistical support performed, while employed at Celgene, a Bristol Myers Squibb Company, and Peter J. Simon, PhD, CMPP, of MediTech Media, Ltd, for medical writing assistance, which was sponsored by Celgene, a Bristol Myers Squibb Company. The authors are fully responsible for all content and editorial decisions for this manuscript.
Funding Information:
AB, MCC, CS: nothing to disclose; NB: consultancy for and honoraria and research funding from Janssen, Bristol Myers Squibb Company, and Amgen; DW: honoraria from and board of directors or advisory committee participant for Amgen, Bristol Myers Squibb Company, Janssen, and Takeda; CC: honoraria from Bristol Myers Squibb Company; KS: honoraria and research funding from and board of directors or advisory committee participant for Bristol Myers Squibb Company; AT: consulting for Roche and Novartis; AD: research funding from Bristol Myers Squibb Company, Takeda, Alnylam, and Pfizer; advisory fees from Akcea, Janssen, Intellia, OncoTracker; KA: advisory board participant for Bristol Myers Squibb Company, Millennium, Takeda, Janssen, Gilead, and Sanofi; DB: employment with Bristol Myers Squibb Company; SR, SS: employment with and equity ownership in Celgene; TF: consulting/advisory fees from Amgen, Bristol Myers Squibb Company, Janssen, Karyopharm, PharmaMar, and Takeda; speakers bureau fees from Amgen, Bristol Myers Squibb Company, Janssen, and Takeda.
Publisher Copyright:
© 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
PY - 2020/12
Y1 - 2020/12
N2 - The phase 3 FIRST trial demonstrated significant improvement in progression-free survival (PFS) and overall survival (OS) with an immune-stimulatory agent, lenalidomide, in combination with low-dose dexamethasone until disease progression (Rd continuous) vs melphalan +prednisone + thalidomide (MPT) in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Rd continuous similarly extended PFS vs fixed-duration Rd for 18 cycles (Rd18). Outcomes in the Canadian/US subgroup (104 patients per arm) are reported in this analysis. Rd continuous demonstrated a significant improvement in PFS vs MPT (median, 29.3 vs 20.2 months; HR, 0.69 [95% CI, 0.49-0.97]; p = 0.03326) and an improvement vs Rd18 (median, 21.9 months). Median OS was 56.9 vs 46.8 months with Rd continuous vs MPT (p = 0.15346) and 59.5 months with Rd18. The overall response rate was higher with Rd continuous and Rd18 (78.8% and 79.8%) vs MPT (65.4%). In the 49.0%, 52.9%, and 29.8% of patients with at least very good partial response in the Rd continuous, Rd18, and MPT arms, respectively, the median PFS was 56.0, 30.9, and 40.2 months, respectively. The most common grade 3/4 treatment-emergent adverse events were neutropenia (28.4%, 30.1%, and 52.0%), anemia (23.5%, 21.4%, and 23.5%), and infections (37.3%, 30.1%, and 24.5%) with Rd continuous, Rd18, and MPT, respectively. These results were consistent with those in the intent-to-treat population, confirming the benefit of Rd continuous vs MPT in the Canadian/US subgroup and supporting the role of Rd continuous as a standard of care for transplant-ineligible patients with NDMM.
AB - The phase 3 FIRST trial demonstrated significant improvement in progression-free survival (PFS) and overall survival (OS) with an immune-stimulatory agent, lenalidomide, in combination with low-dose dexamethasone until disease progression (Rd continuous) vs melphalan +prednisone + thalidomide (MPT) in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). Rd continuous similarly extended PFS vs fixed-duration Rd for 18 cycles (Rd18). Outcomes in the Canadian/US subgroup (104 patients per arm) are reported in this analysis. Rd continuous demonstrated a significant improvement in PFS vs MPT (median, 29.3 vs 20.2 months; HR, 0.69 [95% CI, 0.49-0.97]; p = 0.03326) and an improvement vs Rd18 (median, 21.9 months). Median OS was 56.9 vs 46.8 months with Rd continuous vs MPT (p = 0.15346) and 59.5 months with Rd18. The overall response rate was higher with Rd continuous and Rd18 (78.8% and 79.8%) vs MPT (65.4%). In the 49.0%, 52.9%, and 29.8% of patients with at least very good partial response in the Rd continuous, Rd18, and MPT arms, respectively, the median PFS was 56.0, 30.9, and 40.2 months, respectively. The most common grade 3/4 treatment-emergent adverse events were neutropenia (28.4%, 30.1%, and 52.0%), anemia (23.5%, 21.4%, and 23.5%), and infections (37.3%, 30.1%, and 24.5%) with Rd continuous, Rd18, and MPT, respectively. These results were consistent with those in the intent-to-treat population, confirming the benefit of Rd continuous vs MPT in the Canadian/US subgroup and supporting the role of Rd continuous as a standard of care for transplant-ineligible patients with NDMM.
KW - Canada
KW - United States
KW - lenalidomide
KW - newly diagnosed multiple myeloma
KW - transplant-ineligible
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U2 - 10.1002/cam4.3511
DO - 10.1002/cam4.3511
M3 - Article
C2 - 33049118
AN - SCOPUS:85092348514
SN - 2045-7634
VL - 9
SP - 8923
EP - 8930
JO - Cancer Medicine
JF - Cancer Medicine
IS - 23
ER -