Blood advances · 2026
EuroNet-PHL-LP1: complete resection or low-dose chemotherapy for pediatric low-risk nodular lymphocyte-predominant Hodgkin lymphoma.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Shankar Ananth, Landman-Parker Judith, Mascarin Maurizio, Attarbaschi Andishe, Boudjemaa Sabah, Burnelli Roberta, Beishuizen Auke, Cepelova Michaela, Ceppi Francesco, Georgi Thomas, Hall Georgina, Klapper Wolfram, Kluge Regine, Lopci Egesta, Metzger Monika L, Ramsay Alan, Steglich Jonas, Stoevesandt Dietrich, Kurch Lars, Körholz Dieter, Hasenclever Dirk, Mauz-Körholz Christine
Аннотация
Children and adolescents with early-stage nodular lymphocyte-predominant Hodgkin lymphoma (nLPHL) have a 5-year event-free survival (EFS) of ∼77% after complete lymph node resection and ∼89% with anthracycline-containing chemotherapy. We investigated whether those patients can be successfully treated with surgical resection alone or with low-intensity, anthracycline-free CVP (cyclophosphamide, vinblastine, and prednisone) chemotherapy. EuroNet-PHL-LP1 was a prospective phase 3 trial enrolling patients aged <18 years with stage IA/IIA nLPHL. Complete resection led to active surveillance. Patients with unresectable disease received 3 cycles CVP. In CVP cohort 1, treatment cessation required negative 2-deoxy-2-[fluorine-18]fluoro-d-glucose positron emission tomography (18F-FDG PET). An amendment in 2014 omitted PET for end-of-treatment response; computed tomography and/or magnetic resonance imaging alone defined response in CVP cohort 2. The primary endpoint was 5-year EFS, with death, relapse, second malignancy, and PET positivity counting as events; for CVP cohort 2, progression-free survival (PFS) was primary. Among 267 registered patients, 247 were evaluable. Seventy-eight underwent resection only; their 5-year EFS/PFS was 79.5%. Six of 18 patients who relapsed after surgical resection reentered the CVP arm. In CVP cohort 1, 51 of 82 (62%) achieved complete metabolic response (CMR). Five-year EFS was 56.4%, whereas 5-year PFS in the CMR group was 91.3%. In contrast, PFS in 84 patients in CVP cohort 2 was 64.7%. During CVP, 68.3% of patients experienced grade 3 to 4 neutropenia. No treatment-related deaths were reported. Excellent outcomes were achieved after complete resection and with low-intensity, anthracycline-free chemotherapy if in CMR after chemotherapy. This strategy now constitutes the EuroNet-PHL standard of care for early-stage nLPHL. The trial was registered at www.clinicaltrialsregister.eu as EudraCT 2007-004092-19.