In:
British Journal of Haematology, Wiley, Vol. 183, No. 3 ( 2018-11), p. 400-410
Kurzfassung:
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 (1·8 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 .
Materialart:
Online-Ressource
ISSN:
0007-1048
,
1365-2141
DOI:
10.1111/bjh.2018.183.issue-3
Sprache:
Englisch
Verlag:
Wiley
Publikationsdatum:
2018
ZDB Id:
1475751-5
