Fuchs, Michael, Goergen, Helen, Kobe, Carsten, Kuhnert, Georg, Lohri, Andreas, Greil, Richard, Sasse, Stephanie, Topp, Max S., Schaefer, Erhardt, Hertenstein, Bernd, Soekler, Martin, Vogelhuber, Martin, Zijlstra, Josee M., Keller, Ulrich Bernd, Krause, Stefan W., Wilhelm, Martin, Maschmeyer, Georg, Thiemer, Julia, Duehrsen, Ulrich, Meissner, Julia, Viardot, Andreas, Eich, Hans, Baues, Christian, Diehl, Volker, Rosenwald, Andreas, von Tresckow, Bastian, Dietlein, Markus, 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. J. Clin. Oncol., 37 (31). S. 2835 - 2847. ALEXANDRIA: AMER SOC CLINICAL ONCOLOGY. ISSN 1527-7755

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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: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Fuchs, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goergen, HelenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kobe, CarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kuhnert, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lohri, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Greil, RichardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sasse, StephanieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Topp, Max S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schaefer, ErhardtUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hertenstein, BerndUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Soekler, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vogelhuber, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zijlstra, Josee M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Keller, Ulrich BerndUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krause, Stefan W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wilhelm, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maschmeyer, GeorgUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thiemer, JuliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Duehrsen, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meissner, JuliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Viardot, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eich, HansUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baues, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Diehl, VolkerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rosenwald, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Tresckow, BastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dietlein, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Borchmann, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Engert, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-128801
DOI: 10.1200/JCO.19.00964
Journal or Publication Title: J. Clin. Oncol.
Volume: 37
Number: 31
Page Range: S. 2835 - 2847
Date: 2019
Publisher: AMER SOC CLINICAL ONCOLOGY
Place of Publication: ALEXANDRIA
ISSN: 1527-7755
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
2ND CANCER-RISK; BREAST-CANCER; INTERIM-PET; DISEASE; RADIOTHERAPY; CHEMOTHERAPY; VINBLASTINE; RADIATION; BLEOMYCIN; SURVIVORSMultiple languages
OncologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/12880

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