Contributions
Abstract: EP976
Type: E-Poster Presentation
Session title: Myeloma and other monoclonal gammopathies - Clinical
Background
Multiple myeloma (MM) typically affects older patients (pts) who are more vulnerable to toxicity with anti-MM treatments. These pts have significant morbidities resulting in a need for dose modifications or alternative suboptimal treatment options. Significant improvements were observed in the BOSTON study with XVd vs Vd in progression-free survival (PFS), overall response rate (ORR) and rates of peripheral neuropathy (PN); median overall survival (OS) trended in favor of XVd.
Aims
Here we report survival outcomes in the BOSTON study population based on age.
Methods
The phase 3 randomized BOSTON trial (NCT03110562) is a controlled, open-label study of once weekly XVd vs. twice weekly standard Vd in pts with MM and 1-3 prior treatment regimens. We performed post-hoc analyses to compare survival benefits in pts ≥65 vs <65 years of age.
Results
The BOSTON study enrolled a total of 402 pts between June 2017 and February 2019 who were randomized into XVd or Vd arms. The numbers of pts treated with XVd or Vd who were ≥65 were 109/132 and 86/75 who were <65, respectively. Baseline characteristics were similar by age although pts ≥65 years were less likely to have received ASCT than those <65 years (48.4% vs. 25.3%). Median PFS was prolonged with XVd compared with Vd across both age groups: ≥65 (HR, 0.55 [95% CI, 0.37-0.83] P=0.002) and <65, (HR, 0. 74 [95% CI, 0.49-1.11], P=0.07). Vd was associated with a lower ORR (64.4%) than treatment with XVd (76.1%) (OR, 1.77 [95% CI, 1.00-3.11], P=0.024) in pts ≥65, while the ORR in those <65 was 76.7% with XVd and 58.7% (OR, 2.33 [95% CI, 1.18-4.59], P=0.007) with Vd. As of Jan 2021, the median OS for the overall population was not reached for both arms (HR=0.86; p=0.193), with 61 and 75 deaths in the XVd and Vd arms, respectively. Median OS was not reached in pts ≥65 with XVd and was 28.6 months with Vd (HR=0.60; 95% CI, 0.38-0.94; p=0.012), while OS was similar for pts <65 (p=0.926). Pts ≥65 had a lower incidence of death on XVd as compared to Vd (29 vs 56) and there were 32 deaths with XVd and 19 with Vd in pts <65. Grade ≥3 treatment emergent adverse events (AEs) were not observed more often in older compared to younger pts. Amongst pts ≥65, PN of any grade was lower with XVd (32.1%) compared to Vd (46.5%); (OR 0.57 [95% CI 0.34-0.97], p=0.017), including a lower incidence of grade ≥3 PN (XVd 4.6% vs. Vd 11.6%). Pts <65 followed a similar trend of PN AEs of any grade: XVd, 32.6%; Vd, 48.0% (OR 0.42 [95% CI 0.21-0.82], p=0.006).
Conclusion
In an older patient population with a poor prognosis, XVd was associated with a significant survival benefit, improved PFS and ORR with reduced PN, and requires relatively short and infrequent clinic visits. XVd may be a simple, effective regimen for pts with previously treated MM including those ≥65 years of age.
Keyword(s): Clinical trial, Elderly, Multiple myeloma
Abstract: EP976
Type: E-Poster Presentation
Session title: Myeloma and other monoclonal gammopathies - Clinical
Background
Multiple myeloma (MM) typically affects older patients (pts) who are more vulnerable to toxicity with anti-MM treatments. These pts have significant morbidities resulting in a need for dose modifications or alternative suboptimal treatment options. Significant improvements were observed in the BOSTON study with XVd vs Vd in progression-free survival (PFS), overall response rate (ORR) and rates of peripheral neuropathy (PN); median overall survival (OS) trended in favor of XVd.
Aims
Here we report survival outcomes in the BOSTON study population based on age.
Methods
The phase 3 randomized BOSTON trial (NCT03110562) is a controlled, open-label study of once weekly XVd vs. twice weekly standard Vd in pts with MM and 1-3 prior treatment regimens. We performed post-hoc analyses to compare survival benefits in pts ≥65 vs <65 years of age.
Results
The BOSTON study enrolled a total of 402 pts between June 2017 and February 2019 who were randomized into XVd or Vd arms. The numbers of pts treated with XVd or Vd who were ≥65 were 109/132 and 86/75 who were <65, respectively. Baseline characteristics were similar by age although pts ≥65 years were less likely to have received ASCT than those <65 years (48.4% vs. 25.3%). Median PFS was prolonged with XVd compared with Vd across both age groups: ≥65 (HR, 0.55 [95% CI, 0.37-0.83] P=0.002) and <65, (HR, 0. 74 [95% CI, 0.49-1.11], P=0.07). Vd was associated with a lower ORR (64.4%) than treatment with XVd (76.1%) (OR, 1.77 [95% CI, 1.00-3.11], P=0.024) in pts ≥65, while the ORR in those <65 was 76.7% with XVd and 58.7% (OR, 2.33 [95% CI, 1.18-4.59], P=0.007) with Vd. As of Jan 2021, the median OS for the overall population was not reached for both arms (HR=0.86; p=0.193), with 61 and 75 deaths in the XVd and Vd arms, respectively. Median OS was not reached in pts ≥65 with XVd and was 28.6 months with Vd (HR=0.60; 95% CI, 0.38-0.94; p=0.012), while OS was similar for pts <65 (p=0.926). Pts ≥65 had a lower incidence of death on XVd as compared to Vd (29 vs 56) and there were 32 deaths with XVd and 19 with Vd in pts <65. Grade ≥3 treatment emergent adverse events (AEs) were not observed more often in older compared to younger pts. Amongst pts ≥65, PN of any grade was lower with XVd (32.1%) compared to Vd (46.5%); (OR 0.57 [95% CI 0.34-0.97], p=0.017), including a lower incidence of grade ≥3 PN (XVd 4.6% vs. Vd 11.6%). Pts <65 followed a similar trend of PN AEs of any grade: XVd, 32.6%; Vd, 48.0% (OR 0.42 [95% CI 0.21-0.82], p=0.006).
Conclusion
In an older patient population with a poor prognosis, XVd was associated with a significant survival benefit, improved PFS and ORR with reduced PN, and requires relatively short and infrequent clinic visits. XVd may be a simple, effective regimen for pts with previously treated MM including those ≥65 years of age.
Keyword(s): Clinical trial, Elderly, Multiple myeloma