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

Walewski J., Hellmann A., Siritanaratkul N., ÖZSAN G. H., ÖZCAN M., Chuncharunee S., ...More

BRITISH JOURNAL OF HAEMATOLOGY, vol.183, no.3, pp.400-410, 2018 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 183 Issue: 3
  • Publication Date: 2018
  • Doi Number: 10.1111/bjh.15539
  • Journal Name: BRITISH JOURNAL OF HAEMATOLOGY
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.400-410
  • Keywords: Hodgkin lymphoma, relapsed/refractory, novel anti-tumour agents, brentuximab vedotin, phase IV, PHASE-II, MULTICENTER, EFFICACY, SINGLE, UK, GEMCITABINE, NIVOLUMAB, DIAGNOSIS, SAFETY, SGN-35
  • Dokuz Eylül University Affiliated: Yes

Abstract

Some 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 center dot 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 center dot 6 months and median duration of CR was 6 center dot 1 months. After a median follow-up of 6 center dot 9 and 16 center dot 6 months, median PFS and OS were 4 center dot 8 months (95% confidence interval, 3 center dot 0-5 center dot 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.