Brentuximab vedotin and AVD followed by involved-site radiotherapy in early stage, unfavorable risk Hodgkin lymphoma
Mené sur 30 patients atteints d'un lymphome hodgkinien classique de stade précoce avec caractéristiques défavorables, cet essai multicentrique évalue l'efficacité, du point de vue de la survie sans progression à 1 an, et la toxicité d'un traitement comportant le brentuximab védotine, une chimiothérapie de type AVD et une radiothérapie des champs impliqués
Brentuximab Vedotin and AVD followed by ISRT is well tolerated, without significant pulmonary toxicity.Brentuximab Vedotin and AVD followed by ISRT is an effective therapy for unfavorable risk early stage HL, including bulky disease. This multicenter pilot study assessed the safety and efficacy of Brentuximab Vedotin (BV) and AVD (adriamycin, vinblastine, and dacarbazine) followed by 30 Gray (Gy) involved site radiation therapy (ISRT). Patients with newly diagnosed, early stage classical Hodgkin lymphoma (HL) with unfavorable risk features were treated with 4 cycles of BV and AVD. Patients who achieved a negative positron emission tomography (PET) scan (Deauville score of 1-3) received 30 Gy ISRT. Thirty patients received treatment and were assessable for toxicity. Twenty-nine patients completed 4 cycles of BV+AVD and 25 patients BV+AVD+30Gy ISRT. No clinically significant non-infectious pneumonitis was observed. Serious adverse events (≥grade 3) were reported in 4 patients, including febrile neutropenia, peripheral neuropathy, and hypertension. After 2 and 4 cycles of BV+AVD, 90% (26 of 29) and 93% (27 or 29) of patients achieved a negative PET scan, respectively. Two patients with biopsy-proven primary refractory HL were treated off-study. All 25 patients who completed BV+AVD+ISRT achieved a complete response. With a median follow-up of 18.8 months, by intent to treat, the 1-year progression free survival is 93.3% (95% CI 84-102). Overall, the treatment was well-tolerated with no evidence of significant pulmonary toxicity. The majority of patients (≥90%) achieved negative interim PET scans after 2 and 4 cycles of BV + AVD. Excluding the 2 primary refractory patients, all patients are disease-free, suggesting this is a highly active treatment program even in patients with substantial disease bulk. This study is registered at www.ClinicalTrials.gov as # NCT01868451.