Positron Emission Tomography-Guided Treatment in Early-Stage Favorable Hodgkin Lymphoma: Final Results of the International, Randomized Phase III HD16 Trial by the German Hodgkin Study Group - PubMed (original) (raw)
Clinical Trial
. 2019 Nov 1;37(31):2835-2845.
doi: 10.1200/JCO.19.00964. Epub 2019 Sep 10.
Helen Goergen 1, Carsten Kobe 2, Georg Kuhnert 2, Andreas Lohri 3 4, Richard Greil 5 6, Stephanie Sasse 1, Max S Topp 7, Erhardt Schäfer 8, Bernd Hertenstein 9, Martin Soekler 10, Martin Vogelhuber 11, Josée M Zijlstra 12, Ulrich Bernd Keller [ 13](#full-view-affiliation-13 "Department of Internal Medicine III, Klinikum "Rechts der Isar", Munich, Germany."), Stefan W Krause 14, Martin Wilhelm 15, Georg Maschmeyer 16, Julia Thiemer 17, Ulrich Dührsen 18, Julia Meissner 19, Andreas Viardot 20, Hans Eich 21, Christian Baues 22, Volker Diehl 1, Andreas Rosenwald 23, Bastian von Tresckow 1, Markus Dietlein 2, Peter Borchmann 1, Andreas Engert 1
Affiliations
- PMID: 31498753
- DOI: 10.1200/JCO.19.00964
Clinical Trial
Positron Emission Tomography-Guided Treatment in Early-Stage Favorable Hodgkin Lymphoma: Final Results of the International, Randomized Phase III HD16 Trial by the German Hodgkin Study Group
Michael Fuchs et al. J Clin Oncol. 2019.
Abstract
Purpose: Combined-modality treatment (CMT) with 2× ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and small-field radiotherapy is standard of care for patients with early-stage favorable Hodgkin lymphoma (HL). However, the role of radiotherapy has been challenged. Positron emission tomography (PET) after 2× ABVD (PET-2) might help to predict individual outcomes and guide treatment.
Methods: Between November 2009 and December 2015, we recruited patients age 18 to 75 years with newly diagnosed, early-stage favorable HL for this international randomized phase III trial. Patients were assigned to standard CMT of 2× ABVD and 20-Gy involved-field radiotherapy or PET-guided treatment, omitting involved-field radiotherapy after negative PET-2 (Deauville score < 3). Primary objectives were to exclude inferiority of 10% or more in 5-year progression-free survival (PFS) of ABVD alone compared with CMT in a per-protocol analysis among PET-2-negative patients (noninferiority margin for hazard ratio, 3.01) and to confirm PET-2 positivity (Deauville score ≥ 3) as a risk factor for PFS among CMT-treated patients.
Results: We enrolled 1,150 patients. Median follow-up was 45 months. Among 628 PET-2-negative, per-protocol-treated patients, 5-year PFS was 93.4% (95% CI, 90.4% to 96.5%) with CMT and 86.1% (95% CI, 81.4% to 90.9%) with ABVD (difference 7.3% [95% CI, 1.6% to 13.0%]; hazard ratio, 1.78 [95% CI, 1.02 to 3.12]). Five-year overall survival was 98.1% (95% CI, 96.5% to 99.8%) with CMT and 98.4% (95% CI, 96.5% to 100.0%) with ABVD. Among 693 patients who were assigned to CMT, 5-year PFS was 93.2% (95% CI, 90.2% to 96.2%) among PET-2-negative patients and 88.4% (95% CI, 84.2% to 92.6%) in PET-2-positive patients (P = .047). When using the more common liver cutoff (Deauville score, 4) for PET-2 positivity, the difference was more pronounced (5-year PFS, 93.1% [95% CI, 90.7% to 95.5%] v 80.9% [95% CI, 72.2% to 89.7%]; P = .0011).
Conclusion: In early-stage favorable HL, a positive PET after two cycles ABVD indicates a high risk for treatment failure, particularly when a Deauville score of 4 is used as a cutoff for positivity. In PET-2-negative patients, radiotherapy cannot be omitted from CMT without clinically relevant loss of tumor control.
Trial registration: ClinicalTrials.gov NCT00736320.
Comment in
- Inability of Fluorodeoxyglucose Positron Emission Tomography to Detect Viable Hodgkin Lymphoma During and After Treatment.
Adams HJA, Kwee TC. Adams HJA, et al. J Clin Oncol. 2020 Apr 1;38(10):1115-1116. doi: 10.1200/JCO.19.02780. Epub 2020 Jan 30. J Clin Oncol. 2020. PMID: 31999497 No abstract available. - Reply to H.J.A. Adams et al.
Fuchs M, Goergen H, Kobe C, Borchmann P, Engert A. Fuchs M, et al. J Clin Oncol. 2020 Apr 1;38(10):1116-1117. doi: 10.1200/JCO.19.03081. Epub 2020 Jan 30. J Clin Oncol. 2020. PMID: 31999498 No abstract available. - PET Guided Therapy for Early Stage Hodgkin Lymphoma: Are We Positive About a Negative Interim Scan?
Bakst RL, Campbell BA, Pinnix CC. Bakst RL, et al. Int J Radiat Oncol Biol Phys. 2020 May 1;107(1):12-17. doi: 10.1016/j.ijrobp.2020.02.635. Epub 2020 Mar 4. Int J Radiat Oncol Biol Phys. 2020. PMID: 32142868 Review. No abstract available.
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