Please use this identifier to cite or link to this item: http://hdl.handle.net/11054/2765
Title: Poor outcomes for trial-ineligible patients receiving polatuzumab for relapsed/refractory diffuse large B-cell lymphoma in routine care: An Australian Lymphoma and Related Diseases Registry project.
Author: Shaw, B.
Chung, E.
Wellard, C.
Yoo, E.
Bennett, R.
Birks, C.
Johnston, A.
Cheah, C.
Hamad, N.
Simpson, J.
Barraclough, A.
Ku, M.
Viiala, N.
Ratnasingam, S.
Armytage, T.
Cochrane, T.
Chong, Geoffrey
Lee, D.
Manos, K.
Keane, C.
Wallwork, S.
Opat, S.
Hawkes, S.
Issue Date: 2024
Publication Title: EJHaem
Volume: 5
Issue: 2
Start Page: 325
End Page: 332
Abstract: Polatuzumab vedotin (Pola) is an approved therapy in combination with rituximab and bendamustine for relapsed or refractory diffuse large B-cell lymphoma (RR-DLBCL) based on positive results of the landmark phase II randomised G029365 trial. However, trial results for many approved novel therapies in RR-DLBCL have not been replicated in routine care cohorts, as RR-DLBCL patient populations are heterogeneous and trial eligibility is increasingly restrictive. We evaluated outcomes from pola ± bendamustine and rituximab in patients with RR-DLBCL enrolled in a compassionate access program with no alternative treatment options identified via the Australasian Lymphoma and Related Diseases Registry according to their eligibility for the original phase II published study. Of 58 eligible patients, 74% met the criteria deeming them ineligible for the G029365 original study at the time of pola's commencement. Median progression-free survival and overall survival in our cohort were 2.3 and 3.5 months, respectively. In contrast to the landmark trial cohort, more of our patients ceased therapy prior to completion, the majority due to progressive disease and only 8/58 received any subsequent treatment. Dismal outcomes in this Australian real-world population demonstrate trial eligibility is challenging to meet, and newer treatments can be difficult to deliver in routine care. Clinically applicable results from therapeutic studies require trial cohorts to reflect representative clinical populations wherever possible, and more research is required to address the benefit of novel agents in the increasing majority who are ineligible for modern studies.
URI: http://hdl.handle.net/11054/2765
DOI: https://doi.org/10.1002/jha2.870
Internal ID Number: 02746
Health Subject: ANTIBODY-DRUG CONJUGATES
DIFFUSE LARGE B-CELL LYMPHOMA
IMMUNOTHERAPY
POLATUZUMAB VEDOTIN
RELAPSE
TRIAL ELIGIBILITY
Type: Journal Article
Article
Appears in Collections:Research Output

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