학술논문
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.
Document Type
Academic Journal
Author
Shaw B; Department of Haematology Monash Health Clayton Australia.; School of Public Health and Preventive Medicine, Monash University Melbourne Australia.; Chung E; School of Public Health and Preventive Medicine, Monash University Melbourne Australia.; Wellard C; School of Public Health and Preventive Medicine, Monash University Melbourne Australia.; Yoo E; Department of Haematology Sir Charles Gairdner Hospital Perth Australia.; Bennett R; Department of Haematology Peter MacCallum Cancer Centre Melbourne Australia.; Birks C; Concord Hospital Sydney Australia.; Johnston A; Department of Clinical Haematology Royal Hobart Hospital Hobart Australia.; Cheah CY; Department of Haematology Sir Charles Gairdner Hospital Perth Australia.; Medical School, University of Western Australia Nedlands Australia.; Hamad N; Department of Haematology St Vincent's Hospital Sydney Australia.; School of Clinical Medicine, Faculty of Medicine and Health UNSW Sydney Australia.; School of Medicine University of Notre Dame Australia Sydney Australia.; Simpson J; Department of Haematology Port Macquarie Base Hospital Port Macquarie Australia.; Barraclough A; Department of Haematology Fiona Stanley Hospital Perth Australia.; Ku M; Department of Haematology St Vincent's Hospital Melbourne Australia.; Faculty of Medicine University of Melbourne Melbourne Australia.; Viiala N; Department of Haematology Liverpool Hospital Sydney Australia.; South West Sydney Clinical Campus, School of Clinical Medicine, Faculty of Medicine and Health UNSW Sydney Australia.; Ratnasingam S; Department of Clinical Haematology University Hospital Geelong Geelong Australia.; Armytage T; Department of Haematology Gosford Hospital Gosford Australia.; Cochrane T; Department of Haematology Gold Coast University Hospital Gold Coast Australia.; Griffith University Gold Coast Australia.; Chong G; Department of Medical Oncology Grampians Health Ballarat Australia.; Lee D; Department of Haematology Eastern Health Melbourne Australia.; Manos K; Department of Haematology Flinders Medical Centre Adelaide Australia.; Keane C; Department of Haematology Princess Alexandra Hospital Brisbane Australia.; Wallwork S; Department of Haematology Princess Alexandra Hospital Brisbane Australia.; Opat S; Department of Haematology Monash Health Clayton Australia.; School of Public Health and Preventive Medicine, Monash University Melbourne Australia.; Hawkes EA; School of Public Health and Preventive Medicine, Monash University Melbourne Australia.; Department of Medical Oncology and Clinical Haematology Olivia Newton-John Cancer Research Institute at Austin Health Heidelberg Australia.
Source
Publisher: John Wiley & Sons, Inc Country of Publication: United States NLM ID: 101761942 Publication Model: eCollection Cited Medium: Internet ISSN: 2688-6146 (Electronic) Linking ISSN: 26886146 NLM ISO Abbreviation: EJHaem Subsets: PubMed not MEDLINE
Subject
Language
English
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.
Competing Interests: Briony Shaw, Eliza Chung, Edward Yoo, Rory Bennett, Callum Birks, Jock Simpson, Sumita Ratnasingam, Tasman Armytage, Denise Lee, Colm Keane, Stephanie Wallwork all declare no conflicts of interest. Anna Johnston: Consulting or advisory role, honoraria: Merck Sharpe & Dohme, Roche, Link, BeiGene, Sanofi, EUSA Pharma, Novartis, Chan Y Cheah: Consulting or advisory role, honoraria: Roche, Janssen, Gilead, AstraZenecca, Lilly, TG therapeutics, BeiGene, Novartis, Menarini, Dizal, AbbVie, Genmab, Bristol Myers Quibb; Research funding: Bristol Myers Quibb, Roche, AbbVie, Merck Sharpe & Dohme, Lilly, Nada Hamad: Honoraria: Roche, Janssen, Gilead, AstraZenecca, BeiGene, Novartis, AbbVie, Genmab, Bristol Myers Quibb, Takeda, Jazz Pharmaceuticals, Incyte, Pfizer, Mallinckrodt Pharmaceuticals, Terumo, Allison Barraclough: Honoraria: Roche, Gilead, Novartis, BeiGene, Matthew Ku: Roche, Antengene, Genor BioPharma, Nicholas Viiala: Honoraria and advisory board: Novartis, Tara Cochrane: Consulting or advisory role: Janssen; Honoraria: Celgene (in 2019); Research funding: BeiGene, Geoffrey Chong: Research funding: Bristol Myers Quibb, Merck, AstraZeneca, Pharmacyclics, Regeneron, Hutchmed, Bayer, Incyte, Amgen, Kate Manos: Advisory/honoraria: AbbVie; Research funding: Roche, Stephen Opat: Honoraria: AbbVie, BeiGene, AstraZeneca, Bristol Myers Quibb, CSL Behring, Gilead, Janssen, Merck, Roche, Takeda; Research funding: AbbVie, BeiGene, AstraZeneca, CSL Behring, Gilead, Janssen, Merck, PharmaCytics, Roche, Takeda, Eliza A. Hawkes: Consulting or advisory role: Roche, Merck Sharpe & Dohme, AstraZeneca, Gilead, Antengene, Novartis, Regeneron, Janssen, Specialised Therapeutics; Research funding: Roche, Bristol Myers Squibb, Merck KGaA, AstraZeneca, Merck
(© 2024 The Authors. eJHaem published by British Society for Haematology and John Wiley & Sons Ltd.)
Competing Interests: Briony Shaw, Eliza Chung, Edward Yoo, Rory Bennett, Callum Birks, Jock Simpson, Sumita Ratnasingam, Tasman Armytage, Denise Lee, Colm Keane, Stephanie Wallwork all declare no conflicts of interest. Anna Johnston: Consulting or advisory role, honoraria: Merck Sharpe & Dohme, Roche, Link, BeiGene, Sanofi, EUSA Pharma, Novartis, Chan Y Cheah: Consulting or advisory role, honoraria: Roche, Janssen, Gilead, AstraZenecca, Lilly, TG therapeutics, BeiGene, Novartis, Menarini, Dizal, AbbVie, Genmab, Bristol Myers Quibb; Research funding: Bristol Myers Quibb, Roche, AbbVie, Merck Sharpe & Dohme, Lilly, Nada Hamad: Honoraria: Roche, Janssen, Gilead, AstraZenecca, BeiGene, Novartis, AbbVie, Genmab, Bristol Myers Quibb, Takeda, Jazz Pharmaceuticals, Incyte, Pfizer, Mallinckrodt Pharmaceuticals, Terumo, Allison Barraclough: Honoraria: Roche, Gilead, Novartis, BeiGene, Matthew Ku: Roche, Antengene, Genor BioPharma, Nicholas Viiala: Honoraria and advisory board: Novartis, Tara Cochrane: Consulting or advisory role: Janssen; Honoraria: Celgene (in 2019); Research funding: BeiGene, Geoffrey Chong: Research funding: Bristol Myers Quibb, Merck, AstraZeneca, Pharmacyclics, Regeneron, Hutchmed, Bayer, Incyte, Amgen, Kate Manos: Advisory/honoraria: AbbVie; Research funding: Roche, Stephen Opat: Honoraria: AbbVie, BeiGene, AstraZeneca, Bristol Myers Quibb, CSL Behring, Gilead, Janssen, Merck, Roche, Takeda; Research funding: AbbVie, BeiGene, AstraZeneca, CSL Behring, Gilead, Janssen, Merck, PharmaCytics, Roche, Takeda, Eliza A. Hawkes: Consulting or advisory role: Roche, Merck Sharpe & Dohme, AstraZeneca, Gilead, Antengene, Novartis, Regeneron, Janssen, Specialised Therapeutics; Research funding: Roche, Bristol Myers Squibb, Merck KGaA, AstraZeneca, Merck
(© 2024 The Authors. eJHaem published by British Society for Haematology and John Wiley & Sons Ltd.)