Older patients (aged 60 years) with previously untreated advanced-stage classical Hodgkin lymphoma: A detailed analysis from the phase III ECHELON-1 study
Effective and tolerable treatments are needed for older patients with classical Hodgkin lymphoma. We report results for older patients with classical Hodgkin lymphoma treated in the large phase III ECHELON-1 study of frontline brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (A+AVD...
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| Veröffentlicht in: | Haematologica (Roma) Jg. 107; H. 5; S. 1086 - 1094 |
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
| Veröffentlicht: |
Italy
Fondazione Ferrata Storti
01.05.2022
Ferrata Storti Foundation |
| Schlagworte: | |
| ISSN: | 0390-6078, 1592-8721, 1592-8721 |
| Online-Zugang: | Volltext |
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| Zusammenfassung: | Effective and tolerable treatments are needed for older patients with classical Hodgkin lymphoma. We report results for older patients with classical Hodgkin lymphoma treated in the large phase III ECHELON-1 study of frontline brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (A+AVD) versus doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). Modified progression-free survival per independent review facility for older versus younger patients (aged ≥60 vs. <60 years) was a pre-specified subgroup analysis; as the ECHELON- 1 study was not powered for these analyses, reported P-values are descriptive. Of 1,334 enrolled patients, 186 (14%) were aged ≥60 years (A+AVD: n=84, ABVD: n=102); results below refer to this age group. Modified progression-free survival per independent review facility was similar in the two arms at 24 months (A+AVD: 70.3% [95% confidence interval (CI): 58.4–79.4], ABVD: 71.4% [95% CI: 60.5–79.8], hazard ratio (HR)=1.00 [95% CI: 0.58–1.72], P=0.993). After a median follow-up of 60.9 months, 5-year progression-free survival per investigator was 67.1% with A+AVD versus 61.6% with ABVD (HR=0.820 [95% CI: 0.494–1.362], P=0.443). Comparing A+AVD versus ABVD, grade 3/4 peripheral neuropathy occurred in 18% versus 3%; any-grade febrile neutropenia in 37% versus 17%; and any-grade pulmonary toxicity in 2% versus 13%, respectively, with three (3%) pulmonary toxicity-related deaths in patients receiving ABVD (none in those receiving A+AVD). Altogether, A+AVD showed overall similar efficacy to ABVD with survival rates in both arms comparing favorably to those of prior series in older patients with advanced-stage classical Hodgkin lymphoma. Compared to ABVD, A+AVD was associated with higher rates of neuropathy and neutropenia, but lower rates of pulmonary-related toxicity. Trials registered at ClinicalTrials.gov identifiers: NCT01712490; EudraCT number: 2011-005450-60. |
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| Bibliographie: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 The datasets, including the redacted study protocol, redacted statistical analysis plan, and individual participant’s data supporting the results reported in this article, will be made available within 3 months from initial request, to researchers who provide a methodologically sound proposal. The data will be provided after de-identification, in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization. Disclosures Contributions AME reports consultancy with honoraria for MorphoSys, Miltenyi, Seagen, and Epizyme; membership on an advisory committee with honoraria for Pharmacyclics and Novartis, Inc.; and research funding from Tesaro. JMC reports research funding from Merck, Amgen, Roche Canada, NanoString Technologies, Seagen, Janssen, F. Hoffmann-La Roche, Bayer Healthcare, Cephalon, Bristol Myers-Squibb, Lilly, Genentech, and Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited; being a named inventor on a patent licensed to NanoString Technologies; and honoraria from Seagen. AY reports research funding from J&J, Bristol Myers-Squibb, Curis, Genentech, Pharmacyclics, Janssen, Novartis, Roche, Abbvie, and Astra Zeneca; and honoraria from Celgene, Bristol Myers-Squibb, Sanofi, Abbvie, Merck, Bayer, Incyte, Seagen, Roche, and Takeda. SMA reports research funding from LAM Therapeutics, Regeneron, Pfizer, Bristol-Myers Squibb, Merck & Co, Trillium, Seagen, Celldex, Takeda, and Affimed. JR reports research funding from Celgene, ADC Therapeutics, Pfizer, and Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited; consultancy for ADC Therapeutics, Novartis, Takeda, Seagen, and Bristol Myers-Squibb; equity ownership in GlaxoSmithKline and AstraZeneca; and speakers bureau for Novartis, Takeda, Seagen, and Bristol Myers-Squibb. TF reports research funding from Seagen and Portola; and speakers bureau for Seagen, Janssen, Pharmacyclics, J&J, Celgene, and KITE. JT reports research funding from Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Genentech, Celgene, and Pharmacyclics; speakers bureau for Amgen, Seagen, and Celgene; and honoraria from Amgen, Seagen, and Celgene. KJS reports honoraria from and consulting for Seagen, Merck, Bristol Myers-Squibb, Abbvie, Astra Zeneca, Verastem, and Gilead Consulting Servier; and research funding from Seagen, Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company, Merck, Bristol Myers- Squibb, Beigene, and Roche Canada. YO reports employment with Genentech and research funding from Seagen and Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited; honoraria from Takeda Millennium; and employment with Jazz Pharmaceuticals. AGri reports membership on an entity's Board of Directors or advisory committees for Roche, Gilead, Bristol Myers-Squibb, and Takeda. CP reports employment with Kent & Canterbury Hospital. MD-D reports consultancy for Servier and Roche. KF reports employment with and equity ownership in Seagen, Inc. AF-T reports employment with Seagen, Inc. RL, HJ, and AGau report employment with Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. AGal reports consultancy and speakers bureau for Takeda. W-SK has declared no conflicts of interest. Data were verified by the sponsor, analyzed by sponsor statisticians, and interpreted by academic authors and sponsor representatives. The manuscript was prepared by the authors with the assistance of a medical writer funded by the sponsor. Data were collected, and study procedures were overseen by AME, JMC, AY, SMA, WSK, JR, TF, JT, KJS, YO, AG, CP, MD-D, and AGal; data were verified by KF, AF-T, RL, HT, and AGal, analyzed by RL, and interpreted by all authors. All authors had full access to the data during development of the manuscript. All authors vouch for completeness and accuracy of the data and had final responsibility for the manuscript content and decision to submit. Data-sharing statement |
| ISSN: | 0390-6078 1592-8721 1592-8721 |
| DOI: | 10.3324/haematol.2021.278438 |