Follow-up of the GHSG HD16 trial of PET-guided treatment in early-stage favorable Hodgkin lymphoma

Author:

Fuchs Michael,Jacob Anne Sophie,Kaul Helen,Kobe CarstenORCID,Kuhnert Georg,Pabst ThomasORCID,Greil Richard,Bröckelmann Paul J.ORCID,Topp Max S.,Just Marianne,Hertenstein Bernd,Soekler Martin,Vogelhuber Martin,Zijlstra Josée M.,Keller Ulrich BerndORCID,Krause Stefan W.ORCID,Dührsen Ulrich,Meissner JuliaORCID,Viardot Andreas,Eich Hans-Theodor,Baues Christian,Diehl Volker,Rosenwald Andreas,Buehnen Ina,von Tresckow BastianORCID,Dietlein Markus,Borchmann Peter,Engert Andreas,Eichenauer Dennis A.ORCID

Abstract

AbstractThe primary analysis of the GHSG HD16 trial indicated a significant loss of tumor control with PET-guided omission of radiotherapy (RT) in patients with early-stage favorable Hodgkin lymphoma (HL). This analysis reports long-term outcomes. Overall, 1150 patients aged 18–75 years with newly diagnosed early-stage favorable HL were randomized between standard combined-modality treatment (CMT) (2x ABVD followed by PET/CT [PET-2] and 20 Gy involved-field RT) and PET-2-guided treatment omitting RT in case of PET-2 negativity (Deauville score [DS] < 3). The study aimed at excluding inferiority of PET-2-guided treatment and assessing the prognostic impact of PET-2 in patients receiving CMT. At a median follow-up of 64 months, PET-2-negative patients had a 5-year progression-free survival (PFS) of 94.2% after CMT (n = 328) and 86.7% after ABVD alone (n = 300; HR = 2.05 [1.20–3.51]; p = 0.0072). 5-year OS was 98.3% and 98.8%, respectively (p = 0.14); 4/12 documented deaths were caused by second primary malignancies and only one by HL. Among patients assigned to CMT, 5-year PFS was better in PET-2-negative (n = 353; 94.0%) than in PET-2-positive patients (n = 340; 90.3%; p = 0.012). The difference was more pronounced when using DS4 as cut-off (DS 1-3: n = 571; 94.0% vs. DS ≥ 4: n = 122; 83.6%; p < 0.0001). Taken together, CMT should be considered standard treatment for early-stage favorable HL irrespective of the PET-2-result.

Funder

Sanofi-Genzyme, Takeda

Employment/leadership position (University Hospital of Cologne, Head of the GHSG Trial Coordination Centre), honorarium

Takeda Medical Research Foundation

Bristol-Myers Squibb Company | Bristol-Myers Squibb Canada

BeiGene, MSD Stemline

Gilead Sciences

Miltenyi Biotec

Novartis

Roche

Amgen

Pfizer

Merck & Co., Inc. | Merck Sharp and Dohme

AbbVie

AstraZeneca

allogene, Cerus, incyte, IQVIA, Noscendo, Pentixapharm,

Publisher

Springer Science and Business Media LLC

Subject

Oncology,Cancer Research,Hematology

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