TY - JOUR
T1 - Impact of elotuzumab treatment on pain and health-related quality of life in patients with relapsed or refractory multiple myeloma
T2 - results from the ELOQUENT-2 study
AU - Cella, David
AU - McKendrick, Jan
AU - Kudlac, Amber
AU - Palumbo, Antonio
AU - Oukessou, Abderrahim
AU - Vij, Ravi
AU - Zyczynski, Teresa
AU - Davis, Catherine
N1 - Funding Information:
Study supported by Bristol-Myers Squibb and AbbVie Biotherapeutics. No NIH funding was received. The authors would like to thank Hayley Hill for providing assistance with preparing the manuscript and Caudex, Oxford, UK, for editorial assistance, on behalf of PRMA Consulting Ltd. and Bristol-Myers Squibb. Institutional review board or independent ethics committee approval and written informed consent from all patients for being included in the study were obtained. The study was performed in accordance with the ethical principles of the Declaration of Helsinki and in compliance with national laws. David Cella has served as a consultant for and/or received research funding from AbbVie, Alexion, Astellas, Bayer, Biogen Idec, Bristol-Myers Squibb, Celgene, Clovis Oncology, Daiichi Sankyo, Eli Lilly, Evidera, Exelixis, FibroGen, Genentech, GlaxoSmithKline, Helsinn Therapeutics, Immunogen, Ipsen Pharma, Janssen, Lexicon Pharmaceuticals, Merck, Novartis, Onconova, and Pfizer. Jan McKendrick and Amber Kudlac are employees of PRMA Consulting Ltd. Antonio Palumbo has received honoraria from Amgen, Bristol-Myers Squibb, Celgene, Genmab, Janssen-Cilag, Millennium, Novartis, Onyx, and Sanofi, and served in a consulting or advisory role for Amgen, Bristol-Myers Squibb, Celgene, Genmab, Janssen-Cilag, Millennium, and Onyx. Abderrahim Oukessou, Teresa Zyczynski, and Catherine Davis are employees of Bristol-Myers Squibb. Ravi Vij has received honoraria from Bristol-Myers Squibb, Celgene, Janssen, Merck, Novartis, Onyx, and Takeda; served in a consulting or advisory role for Bristol-Myers Squibb, Celgene, Janssen, Merck, Novartis, Onyx, and Takeda; received research funding from Onyx and Takeda; and received travel, accommodations, and/or expenses from Bristol-Myers Squibb, Celgene, Janssen, Merck, Novartis, Onyx, and Takeda.
Funding Information:
Acknowledgements Study supported by Bristol-Myers Squibb and AbbVie Biotherapeutics. No NIH funding was received. The authors would like to thank Hayley Hill for providing assistance with preparing the manuscript and Caudex, Oxford, UK, for editorial assistance, on behalf of PRMA Consulting Ltd. and Bristol-Myers Squibb.
Publisher Copyright:
© 2018, The Author(s).
PY - 2018/12/1
Y1 - 2018/12/1
N2 - Treatment of relapsed/refractory multiple myeloma (RRMM) aims to prolong survival while maintaining health-related quality of life (HRQoL) by managing disease-related symptoms and complications—one of the most frequent and debilitating being bone pain. In the ELOQUENT-2 study (NCT01239797), which evaluated the addition of elotuzumab to lenalidomide plus dexamethasone versus lenalidomide plus dexamethasone, pain and HRQoL were assessed in patients with relapsed/refractory disease using the Brief Pain Inventory–Short Form (BPI-SF) and the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Core 30 module (QLQ-C30) and myeloma-specific module (QLQ-MY20). Mean baseline pain scores were low and remained so throughout treatment with both regimens; mean HRQoL scores did not change substantially from baseline. A significantly higher proportion of patients with objective response than without had clinically meaningful improvements in worst pain over two consecutive treatment cycles (29 versus 12%; p < 0.001). Patients with very good partial response (VGPR) or better reported reduced scores for pain severity and worst pain; those with progressive disease reported increased scores for these domains and pain interference. These findings show that previously reported improvements in progression-free survival and response rate with elotuzumab are achieved without detriment to HRQoL, which is maintained over time.
AB - Treatment of relapsed/refractory multiple myeloma (RRMM) aims to prolong survival while maintaining health-related quality of life (HRQoL) by managing disease-related symptoms and complications—one of the most frequent and debilitating being bone pain. In the ELOQUENT-2 study (NCT01239797), which evaluated the addition of elotuzumab to lenalidomide plus dexamethasone versus lenalidomide plus dexamethasone, pain and HRQoL were assessed in patients with relapsed/refractory disease using the Brief Pain Inventory–Short Form (BPI-SF) and the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Core 30 module (QLQ-C30) and myeloma-specific module (QLQ-MY20). Mean baseline pain scores were low and remained so throughout treatment with both regimens; mean HRQoL scores did not change substantially from baseline. A significantly higher proportion of patients with objective response than without had clinically meaningful improvements in worst pain over two consecutive treatment cycles (29 versus 12%; p < 0.001). Patients with very good partial response (VGPR) or better reported reduced scores for pain severity and worst pain; those with progressive disease reported increased scores for these domains and pain interference. These findings show that previously reported improvements in progression-free survival and response rate with elotuzumab are achieved without detriment to HRQoL, which is maintained over time.
KW - Health-related quality of life
KW - Multiple myeloma
KW - Pain
KW - Patient-reported outcomes
UR - http://www.scopus.com/inward/record.url?scp=85053411429&partnerID=8YFLogxK
U2 - 10.1007/s00277-018-3469-4
DO - 10.1007/s00277-018-3469-4
M3 - Article
C2 - 30178193
AN - SCOPUS:85053411429
SN - 0939-5555
VL - 97
SP - 2455
EP - 2463
JO - Annals of Hematology
JF - Annals of Hematology
IS - 12
ER -