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Plasma Cell Disorders
Autologous stem cell transplantation is safe and effective for fit, older myeloma patients: exploratory results from the Myeloma XI trial
Charlotte Pawlyn,1,2 David A. Cairns,3 Tom Menzies,3 John R. Jones,4 Matthew W. Jenner,5 Gordon Cook,3,6 Kevin D. Boyd,2 Mark T. Drayson,7 Martin F. Kaiser,1,2 Roger G. Owen,8 Walter Gregory,3 Gareth J. Morgan,9 Graham H. Jackson10 and Faith E. Davies9 on behalf of the UK NCRI Haemato-Oncology Clinical Studies Group.
1The Institute of Cancer Research, London, UK; 2The Royal Marsden Hospital, London, UK; 3Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK; 4King’s Hospital NHS Foundation Trust, London, UK; 5University Hospital Southampton NHS Foundation Trust, Southampton, UK; 6Leeds Cancer Centre, Leeds Teaching Hospitals Trust, Leeds, UK; 7Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK; 8HMDS, Leeds Cancer Centre, Leeds Teaching Hospitals Trust, Leeds, UK; 9Perlmutter Cancer Center, NYU Langone, New York, NY, USA and 10Department of Haematology, Newcastle University, Newcastle, UK
ABSTRACT
Autologous stem cell transplant (ASCT) remains the standard of care for consolidation after induction therapy for eligible patients with newly diagnosed myeloma. In recent clinical trials compar- ing ASCT to delayed ASCT, patients aged over 65 were excluded. In real-world practice stem cell transplants are not restricted to those aged under 65 and clinicians decide on transplant eligibility based on a patient’s fitness rather than a strict age cut-off. Data from the UK NCRI Myeloma XI trial, a large phase III randomized controlled trial with pathways for transplant-eligible and -ineligible patients, were used in an exploratory analysis to examine the efficacy and toxicity of ASCT in older patients including an analysis using an age-matched population to compare outcomes for patients receiving similar induction therapy with or without ASCT. Older patients within the transplant-eligible pathway were less likely to undergo stem cell harvest at the end of induction than younger patients and of those patients undergoing ASCT there was a reduction in progression-free survival associated with increasing age. ASCT in older patients was well tolerated with no difference in morbid- ity or mortality between patients aged <65, 65-69 and 70-75 years. In an age-matched population of patients including those in both the trans- plant-eligible and -ineligible pathways there was a significant advantage associated with undergoing ASCT with increases in progression-free survival (hazard ratio 0.41, P<0.0001) and overall survival (hazard ratio 0.51, P<0.0001), which persisted even after adjustment for baseline covariates including those related to frailty and response to induction. These findings support the use of ASCT for selected fit, older myeloma patients. EudraCT number, 2009-010956-93
Introduction
Autologous stem cell transplant (ASCT) is delivered as consolidation after induc- tion therapy for eligible patients with newly diagnosed myeloma. The use of ASCT became standard of care based on several randomized controlled trials that demon- strated progression-free (PFS) and overall survival (OS) benefits.1-4 The ongoing use of ASCT in the context of current induction treatment regimens continues to be sup- ported by data from two recent large phase III studies.5,6 Both these studies, however, excluded patients aged over 65 years old. In real-world practice stem cell transplants are not restricted to those aged under 65 and clinicians decide on transplant eligibility
Ferrata Storti Foundation
Haematologica 2022 Volume 107(1):231-242
Correspondence:
CHARLOTTE PAWLYN
charlotte.pawlyn@icr.ac.uk
Received: June 7, 2020. Accepted: November 25, 2020. Pre-published: December 3, 2020.
https://doi.org/10.3324/haematol.2020.262360 ©2022 Ferrata Storti Foundation
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