Positron Emission Tomography-Guided Brentuximab Vedotin, Etoposide, Cyclophosphamide, Doxorubicin, Dacarbazine, and Dexamethasone in Older Patients With Advanced-Stage Classic Hodgkin Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Cohort of the German Hodgkin Study Group HD21 Trial.
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Ferdinandus Justin, Kaul Helen, Fosså Alexander, Hüttmann Andreas, Keil Felix, Ko Yon-Dschun, Hitz Felicitas, Schwarz Michaela, Trenker Corinna, Kerkhoff Andrea, Staib Peter, Wille Kai, Dresel Irmgard, Hahn Dennis, Hertenstein Bernd, Moosmann Peter, Mey Ulrich, Balabanov Stefan, Armytage Tasman, Roncolato Fernando, Hellmuth Johannes C, Hertzberg Mark, Kobe Carsten, Klapper Wolfram, Baues Christian, Eich Hans-Theodor, Kreissl Stefanie, Fuchs Michael, Jablonski Janina, Schneider Gundolf, Tharmaseelan Hishan, Eichenauer Dennis A, von Tresckow Bastian, Borchmann Peter, Bröckelmann Paul J
Аннотация
PATIENTS AND METHODS: Patients with AS-cHL aged 61-75 years were enrolled in a phase II single-arm cohort of the HD21 trial (ClinicalTrials.gov identifier: NCT02661503). Patients with negative PET/computed tomography after 2×BrECADD (PET2) received a total of 4×BrECADD, while PET2-positive patients received 6×BrECADD. The primary end point was the centrally reviewed complete remission (CR) rate after the end of chemotherapy (EOC). Secondary end points included feasibility, adverse events, treatment-related morbidity (TRMB), progression-free survival (PFS), overall survival (OS), and health-related quality of life (HRQoL).
RESULTS: Between June 2020 and April 2023, 85 patients were enrolled, of whom 83 with a median age of 67 years (range, 61-75) were analyzed in the intention-to-treat cohort. Most prevalent ≥grade 3 toxicities included leukopenia (n = 80 [96%]), thrombocytopenia (n = 71 [86%]), anemia (n = 57 [69%]), and febrile neutropenia (n = 46 [55%]). Forty-eight (60%) of 80 patients with centrally reviewed PET2 were scheduled for 4×BrECADD and 32 (40%) for 6×BrECADD. Of these, 71 patients (89%) received the target number of cycles. Sixty-eight patients (82%; 95% CI, 72 to 90) achieved CR at EOC. PFS and OS estimates at 2 years were 91.5% (95% CI, 85 to 98) and 90.8% (95% CI, 84 to 98), respectively. No death was attributed to study treatment. Initially, impaired HRQoL scores improved during follow up and on average reached population reference values.
CONCLUSION: PET-guided BrECADD in older patients is feasible and effective. With a PFS rate on par with that of younger patients, short duration, and limited anthracycline exposure, BrECADD is a valuable treatment option also for older patients with AS-cHL.