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ASSOCIATION OF CLINICAL RESPONSE WITH SURVIVAL AND QUALITY OF LIFE (QOL) AFTER CARFILZOMIB AND DEXAMETHASONE (KD56) TREATMENT IN THE PHASE 3 ENDEAVOR TRIAL
Author(s): ,
David Siegel
Affiliations:
John Theurer Cancer Center, Hackensack University Medical Center,Hackensack,United States
,
Heinz Ludwig
Affiliations:
Wilhelminen Cancer Research Institute, Wilhelminenspital,Vienna,Austria
,
Philippe Moreau
Affiliations:
University Hospital Hotel-Dieu,Nantes,France
,
Maria-Victoria Mateos
Affiliations:
Hematology Service, University Hospital Salamanca,Salamanca,Spain
,
Ruben Niesvizky
Affiliations:
Center for Myeloma, New York Presbyterian Hospital-Weill Cornell Medical Center,New York,United States
,
Wee Joo Chng
Affiliations:
National University of Singapore,Singapore,Singapore
,
Khalid Mezzi
Affiliations:
Amgen Inc.,Thousand Oaks,United States
,
Zhao Yang
Affiliations:
Amgen Inc.,Thousand Oaks,United States
,
Sumeet Panjabi
Affiliations:
Amgen Inc.,Thousand Oaks,United States
Meletios Dimopoulos
Affiliations:
University Athens School of Medicine,Athens,Greece
(Abstract release date: 05/17/18) EHA Library. Siegel D. 06/14/18; 216431; PB2170
David Siegel
David Siegel
Contributions
Abstract

Abstract: PB2170

Type: Publication Only

Background
ENDEAVOR demonstrated superior response rates, depth of response, PFS, and OS with Kd56 vs Vd (bortezomib-dexamethasone).

Aims
Here, we assessed post-hoc the association between response and clinical outcomes/QoL.

Methods

PFS and OS were assessed for responders (≥partial response [PR]) vs non-responders (
landmark analysis was conducted; Kaplan-Meier [KM] estimates conditioned at the landmark) and by response status (KM estimates;
medians not adjusted for responder bias). QoL was assessed by the EORTC Global Health Status/QoL (GHS/QoL) subscale with
higher scores indicating better QoL. Changes from baseline in GHS/QoL scores by response status were explored using mixed models
for repeated measures.
PFS and OS were assessed for responders (≥partial response [PR]) vs non-responders (

Results
In the Kd56 arm, 77% of patients (pts) had a response: 13% ≥complete response (CR), 42% very good partial response (VGPR), and 22% PR.  In pts at risk at the 2-mo landmark, median PFS beyond the landmark was not estimable (NE; 95% CI: 20.2, NE) in responders vs 10.9 mos (95% CI: 7.6­, NE) in non-responders. Median OS beyond the landmark was 49.3 mos (95% CI: 45.6, NE) in responders vs 25.8 mos (95% CI: 19.8, 32.9) in non-responders. Simon-Makuch analysis indicated a significant difference in PFS and OS between responders and non-responders (p<0.001). For ≥CR, VGPR, or PR, median PFS (95% CI) was NE (NE, NE), 22.2 (18.7, NE), and 10.3 (8.8, 14.9) mos, respectively. Median OS (95% CI) was NE (NE, NE) for ≥CR, 51.3 (NE, NE) for VGPR, and 42.5 (33.6, 47.6) mos for PR. Kd56 responders had improved GHS/QoL scores vs Kd56 non-responders (difference in mean change [diff]: 7.22 [95% CI: −0.68, 15.12]). Among Kd56 responders, changes were similar by response depth (diff for ≥CR vs VGPR: 0.35; ≥CR vs PR: 1.59).

Conclusion
In the Kd56 arm, 77% of pts had a response and OS beyond the 2-mo landmark improved by 24 mos vs non-responders. Responders also had better GHS/QoL scores vs non-responders.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Multiple Myeloma, Proteasome inhibitor, Quality of Life, Survival

Abstract: PB2170

Type: Publication Only

Background
ENDEAVOR demonstrated superior response rates, depth of response, PFS, and OS with Kd56 vs Vd (bortezomib-dexamethasone).

Aims
Here, we assessed post-hoc the association between response and clinical outcomes/QoL.

Methods

PFS and OS were assessed for responders (≥partial response [PR]) vs non-responders (
landmark analysis was conducted; Kaplan-Meier [KM] estimates conditioned at the landmark) and by response status (KM estimates;
medians not adjusted for responder bias). QoL was assessed by the EORTC Global Health Status/QoL (GHS/QoL) subscale with
higher scores indicating better QoL. Changes from baseline in GHS/QoL scores by response status were explored using mixed models
for repeated measures.
PFS and OS were assessed for responders (≥partial response [PR]) vs non-responders (

Results
In the Kd56 arm, 77% of patients (pts) had a response: 13% ≥complete response (CR), 42% very good partial response (VGPR), and 22% PR.  In pts at risk at the 2-mo landmark, median PFS beyond the landmark was not estimable (NE; 95% CI: 20.2, NE) in responders vs 10.9 mos (95% CI: 7.6­, NE) in non-responders. Median OS beyond the landmark was 49.3 mos (95% CI: 45.6, NE) in responders vs 25.8 mos (95% CI: 19.8, 32.9) in non-responders. Simon-Makuch analysis indicated a significant difference in PFS and OS between responders and non-responders (p<0.001). For ≥CR, VGPR, or PR, median PFS (95% CI) was NE (NE, NE), 22.2 (18.7, NE), and 10.3 (8.8, 14.9) mos, respectively. Median OS (95% CI) was NE (NE, NE) for ≥CR, 51.3 (NE, NE) for VGPR, and 42.5 (33.6, 47.6) mos for PR. Kd56 responders had improved GHS/QoL scores vs Kd56 non-responders (difference in mean change [diff]: 7.22 [95% CI: −0.68, 15.12]). Among Kd56 responders, changes were similar by response depth (diff for ≥CR vs VGPR: 0.35; ≥CR vs PR: 1.59).

Conclusion
In the Kd56 arm, 77% of pts had a response and OS beyond the 2-mo landmark improved by 24 mos vs non-responders. Responders also had better GHS/QoL scores vs non-responders.

Session topic: 14. Myeloma and other monoclonal gammopathies - Clinical

Keyword(s): Multiple Myeloma, Proteasome inhibitor, Quality of Life, Survival

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