SURVIVAL AMONG OLDER PATIENTS WITH PREVIOUSLY TREATED MULTIPLE MYELOMA TREATED WITH SELINEXOR, BORTEZOMIB, AND DEXAMETHASONE (XVD) IN THE BOSTON STUDY
Author(s): ,
Thierry Facon
Affiliations:
University Hospital,Lille,France
,
Holger Auner
Affiliations:
Imperial College London,London,United Kingdom
,
Maria Gavriatopoulou
Affiliations:
Alexandra Hospital, School of Medicine, National and Kapodistrian University of Athens,Athens,Greece
,
Sosana Delimpasi
Affiliations:
General Hospital Evangelismos,Athens,Greece
,
Maryana Simonova
Affiliations:
Institute of Blood Pathology & Transfusion Medicine of National Academy of Medical Sciences of Ukraine,Lviv,Ukraine
,
Ivan Spicka
Affiliations:
General University Hospital,Prague,Czech Republic
,
Ludek Pour
Affiliations:
University Hospital Brno,Brno,Czech Republic
,
Meletios Dimopoulos
Affiliations:
National and Kapodistrian University of Athens School of Medicine,Athens,Greece
,
Iryna Kriachok
Affiliations:
ational Cancer Institute MPH of Ukraine,Kiev,Ukraine
,
Halyna Pylypenko
Affiliations:
CE 'Cherkasy Regional Oncology Dispensary' of Cherkasy Regional Council, Regional Treatment and Diagnostic Hematology Center,Cherkasy,Ukraine
,
Xavier Leleu
Affiliations:
CHU de Poitiers, Hôpital La Mileterie,Poitiers,France
,
Hang Quach
Affiliations:
St. Vincent’s Hospital, University of Melbourne,Melbourne,Australia
,
Reuben Benjamin
Affiliations:
King’s College Hospital NHS Foundation Trust,London,United Kingdom
,
Tuphan Kanti Dolai
Affiliations:
Nil Ratan Sircar Medical College and Hospital,Kolkata,India
,
Dinesh Kumar Sinha
Affiliations:
State Cancer Institute, Indira Gandhi Institute of Medical Sciences,Patna,India
,
Mamta Garg
Affiliations:
University Hospitals of Leicester NHS Trust,Leicester,United Kingdom
,
Don Ambrose Stevens
Affiliations:
Norton Cancer Institute, St. Matthews Campus,Louisville,United States
,
Jatin Shah
Affiliations:
Karyopharm Therapeutics,Newton,United States
,
Paul Richardson
Affiliations:
Dana-Farber Cancer Institute,Boston,United States
Sebastian Grosicki
Affiliations:
Zespól Szpitałi Miejskich w Chorzowie, Chorzów,Chorzów,Poland
EHA Library. Facon T. 06/09/21; 325734; EP976
Thierry Facon
Thierry Facon
Contributions
Abstract
Presentation during EHA2021: All e-poster presentations will be made available as of Friday, June 11, 2021 (09:00 CEST) and will be accessible for on-demand viewing until August 15, 2021 on the Virtual Congress platform.

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

Presentation during EHA2021: All e-poster presentations will be made available as of Friday, June 11, 2021 (09:00 CEST) and will be accessible for on-demand viewing until August 15, 2021 on the Virtual Congress platform.

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

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