Fuchs, Michael and Goergen, Helen and Kobe, Carsten and Kuhnert, Georg and Lohri, Andreas and Greil, Richard and Sasse, Stephanie and Topp, Max S. and Schaefer, Erhardt and Hertenstein, Bernd and Soekler, Martin and Vogelhuber, Martin and Zijlstra, Josee M. and Keller, Ulrich Bernd and Krause, Stefan W. and Wilhelm, Martin and Maschmeyer, Georg and Thiemer, Julia and Duehrsen, Ulrich and Meissner, Julia and Viardot, Andreas and Eich, Hans and Baues, Christian and Diehl, Volker and Rosenwald, Andreas and von Tresckow, Bastian and Dietlein, Markus and Borchmann, Peter and Engert, Andreas (2019) 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. JOURNAL OF CLINICAL ONCOLOGY, 37 (31). 2835-+. ISSN 0732-183X, 1527-7755
Full text not available from this repository. (Request a copy)Abstract
PURPOSE Combined-modality treatment (CMT) with 2x 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 2x 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 2x 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | 2ND CANCER-RISK; BREAST-CANCER; INTERIM-PET; DISEASE; RADIOTHERAPY; CHEMOTHERAPY; VINBLASTINE; RADIATION; BLEOMYCIN; SURVIVORS; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 24 Mar 2020 13:20 |
| Last Modified: | 24 Mar 2020 13:20 |
| URI: | https://pred.uni-regensburg.de/id/eprint/25899 |
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