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Randomized Controlled Trial
. 2024 Jan;38(1):160-167.
doi: 10.1038/s41375-023-02064-y. Epub 2023 Oct 16.

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

Michael Fuchs #  1 , Anne Sophie Jacob #  1 , Helen Kaul  1 , Carsten Kobe  2 , Georg Kuhnert  3 , Thomas Pabst  4   5 , Richard Greil  6   7 , Paul J Bröckelmann  1 , Max S Topp  8 , Marianne Just  9 , Bernd Hertenstein  10 , Martin Soekler  11 , Martin Vogelhuber  12 , Josée M Zijlstra  13 , Ulrich Bernd Keller  14 , Stefan W Krause  15 , Ulrich Dührsen  16 , Julia Meissner  17 , Andreas Viardot  18 , Hans-Theodor Eich  19 , Christian Baues  20 , Volker Diehl  1 , Andreas Rosenwald  21 , Ina Buehnen  1 , Bastian von Tresckow  1   22 , Markus Dietlein  2 , Peter Borchmann  1 , Andreas Engert  1 , Dennis A Eichenauer  23
Affiliations
Randomized Controlled Trial

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

Michael Fuchs et al. Leukemia. 2024 Jan.

Abstract

The 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.

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Conflict of interest statement

MF: Employment/leadership position (University Hospital of Cologne, Head of the GHSG Trial Coordination Centre), honorarium (Celgene, BMS, Takeda, Affimed, Lukon, Janssen). ASJ: No personal disclosures. HK: No personal disclosures. CK: No personal disclosures. TP: No personal disclosures. PJB: Personal disclosures regarding consulting (BeiGene, Takeda), honorarium (BeiGene, BMS, MSD Stemline, Takeda), financing of scientific studies (BeiGene, BMS, MSD, Takeda), other financial relations (Celgene (travel)). MS: No personal disclosures. MV: No personal disclosures. UD: Personal disclosures regarding honorarium (Amgen, Avencell (DSMB activities)). JM: Personal disclosures regarding consulting (MSD) and other financial relations (Travel support Takeda, MSD, BMS). CB: No personal disclosures. VD: No personal disclosures. AR: No personal disclosures. BvT: Personal disclosures regarding consulting (Allogene, BMS/Celgene, Cerus, Incyte, IQVIA, Gilead Kite, Miltenyi, Novartis, Noscendo, Pentixapharm, Roche, Amgen, Pfizer, Takeda, Merck Sharp & Dohme, and Gilead Kite), honorarium (AstraZeneca, BMS, Incyte, Novartis, Roche Pharma AG, Takeda, and Merck Sharp & Dohme), financing of scientific studies (Novartis (Inst), Merck Sharp & Dohme (Inst), and Takeda (Inst)) and other financial relations (Travel support and congress fees: AbbVie, AstraZeneca, Gilead Kite, Merck Sharp & Dohme, Roche, Takeda, and Novartis). MD: No personal disclosures. DAE: Personal disclosures regarding honorarium (Sanofi-Genzyme, Takeda).

Figures

Fig. 1
Fig. 1. Trial profile.
Abbreviations: CMT combined-modality treatment, PET-2 positron emission tomography after two cycles of chemotherapy, HL Hodgkin lymphoma, ITT intention-to-treat, PP per-protocol. *Deauville score 1–2. **Deauville score ≥3.
Fig. 2
Fig. 2. Kaplan-Meier estimates for the PET-2-negative per-protocol population.
A Progression-free survival. B Cumulative incidence of in-field recurrences. C Cumulative incidence of second primary malignancies. D Overall survival. Abbreviations: PFS progression-free survival, CMT combined-modality treatment, ABVD doxorubicin, bleomycin, vinblastine, and dacarbazine, SPM second primary malignancy.
Fig. 3
Fig. 3. Kaplan-Meier estimates for PET-2-negative and PET-2-positive patients assigned to receive combined-modality treatment.
A Progression-free survival, DS 1–2 vs DS ≥ 3. B Overall survival, DS 1–2 vs DS ≥ 3. C Progression-free survival, DS 1–3 vs DS ≥ 4. D Overall survival, DS 1–3 vs DS ≥ 4. Abbreviations: PET-2 positron emission tomography after two cycles of chemotherapy, PFS progression-free survival, DS, Deauville score. *Cox model adjusted for stratification factors age, sex, B symptoms, disease localization (supra- vs. infra diaphragmatic), albumin level (<4 g/dL vs. ≥4 g/dL), and bulky disease.
Fig. 4
Fig. 4. Cumulative incidence of first childbirth among female patients aged 18–40 years at enrollment.
Abbreviations: CMT combined-modality treatment, PET-2 positron emission tomography after two cycles of chemotherapy.
See this image and copyright information in PMC

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