Prospective study of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma patients who are not suitable for stem cell transplant or multi‐agent chemotherapy

• DOI: 10.1111/bjh.15539
• Publication Date: 2018-08-31T07:22:15Z
• Authors: Jan Walewski; Andrzej Hellmann; Noppadol Siritana...; Guner Hayri Ozsan; Muhit Ozcan; Suporn Chuncharunee; Ai Sim Goh; Wojciech Jurczak; Jan Koren; Ewa Paszkiewicz‐K...; Bingxia Wang; Shalini Singh; Dirk Huebner; Andreas Engert; Bastian von Tresckow
• Keywords: Adult; Brentuximab Vedotin; Male; Immunoconjugates; Adolescent; Middle Aged; Hodgkin Disease; Disease-Free Survival; 3. Good health; Survival Rate; 03 medical and health sciences; 0302 clinical medicine; Risk Factors; Antineoplastic Combined Chemotherapy Protocols; Humans; Female; Prospective Studies; Aged; Follow-Up Studies; Stem Cell Transplantation

SummarySome patients with relapsed/refractory Hodgkin lymphoma (HL) are not considered suitable for stem cell transplant (SCT) and have a poor prognosis. This phase IV study (NCT01990534) evaluated brentuximab vedotin (1·8 mg/kg intravenously once every 3 weeks) in 60 patients (aged ≥18 years) with CD30‐positive relapsed/refractory HL, a history of ≥1 prior systemic chemotherapy regimen, who were considered unsuitable for SCT/multi‐agent chemotherapy. Primary endpoint was overall response rate (ORR) per independent review facility (IRF). Secondary endpoints included duration of response (DOR), progression‐free survival (PFS) per IRF, overall survival (OS), proportion proceeding to SCT and safety. The ORR was 50%, with 12% CR; 47% proceeded to SCT. Median DOR was 4·6 months and median duration of CR was 6·1 months. After a median follow‐up of 6·9 and 16·6 months, median PFS and OS were 4·8 months (95% confidence interval, 3·0–5·3) and not reached, respectively; estimated OS rate was 86% at 12 months. Most common adverse events (≥10%) were peripheral neuropathy (35%), pyrexia (18%), diarrhoea and neutropenia (each 10%). Brentuximab vedotin showed notable activity with a safety profile consistent with known toxicities, and may act as a bridge to SCT, enabling high‐risk patients who achieve suboptimal response to frontline/salvage chemotherapy/radiotherapy to receive potentially curative SCT.