Low-dose moderate hypofractionated radiotherapy for indolent non-Hodgkin lymphoma: a multicentre, single-arm, phase 2 trial
Mené sur 71 patients atteints d'un lymphome non hodgkinien indolent (durée médiane de suivi : 19 mois ; âge médian : 55 ans ; 59 % de femmes), cet essai multicentrique de phase II évalue l'efficacité, du point de vue du taux de réponse complète à 6 mois, et la sécurité d'une radiothérapie hypofractionnée à faible dose de rayonnements (12 Gy en 4 fractions)
Background: Radiotherapy for indolent non-Hodgkin lymphoma has evolved to optimise the definitive dose while minimising toxicity. We aimed to assess the activity and safety of a hypofractionated low-dose radiotherapy regimen of 12 Gy in four fractions in patients with indolent non-Hodgkin lymphoma.
Methods: This multicentre, single-arm, phase 2 trial study enrolled patients from four hospitals in China. Patients aged 18 years or older with newly diagnosed or relapsed stage I–IV indolent non-Hodgkin lymphoma (follicular lymphoma, marginal zone lymphoma, and low-grade lymphoma) and an Eastern Cooperative Oncology Group performance status of 0–3 were eligible. Patients underwent involved-site radiotherapy at a dose of 12 Gy in four fractions. The primary endpoint was the complete response rate 6 months after radiotherapy. All analyses were performed in the intention-to-treat population. This trial was registered with ClinicalTrials.gov, NCT05543070, with a four-month delay due to the COVID-19 pandemic; recruitment is complete and follow-up is ongoing.
Findings: Between May 8, 2022, and Nov 8, 2023, 71 patients (with 73 target sites) were enrolled (median age 55 years [IQR 48–65]; 29 [41%] male and 42 [59%] female; and all were Asian). With a median follow-up of 19 months (IQR 16–22), the 6-month complete response was 95% (95% CI 87–98; 69 of 73 sites). The most common acute adverse events were grade 1 lymphopenia (20 [28%] of 71 patients) and grade 1 nausea (14 [19%] of 73 sites). The sole grade 3 or higher adverse event was grade 3 lymphopenia (eight [11%] of 71 patients). No treatment-related deaths were noted.
Interpretation: The regimen of 12 Gy in four fractions is safe and shows promising activity as a local treatment for patients with indolent non-Hodgkin lymphoma. Given the retrospective registration of the trial, further studies evaluating the efficacy of this strategy are warranted.
The Lancet Haematology , résumé 2025