https://orcid.org/0000-0002-9438-621X
Key Points
Brentuximab addition to Gemcitabine safely increases ORR to 46.5% with 19.7% CR with a and 15.8 months DOR in 71 pts with R/R PTCL.
ALCL had the best results. In TFHL and PTCL-NOS pts, soluble CD30 appears strongly predictive of outcome whereas CD30 expression is not.
We aim to evaluate the efficacy of brentuximab vedotin (BV) combined with gemcitabine followed by BV maintenance in relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL). Patients (pts) with at least 5% CD30-positive cells by immunohistochemistry received 4 GBV induction (28d) cycles of gemcitabine 1000 mg/m2 (d1;d15) plus BV 1.8 mg/kg (d8) followed in responding pts by up to 12 BV maintenance (21d) cycles. Primary end point was overall response rate (ORR) after 4 induction cycles by CT-scan-based Lugano criteria. Of the 71 enrolled pts (median age of 66 years), 80.3% had received 1 prior line, 60.6% were refractory. The diagnoses per pathology central review were TFHL (47.9%), ALCL, [ALK- (19.7%) and ALK+ (7%)], PTCL-NOS (12.7%) and other entities (12.7%). In the intention-to-treat analysis, ORR was 46.5% with 19.7% complete response. Twenty-eight pts received maintenance. Grade 3-4 adverse events reported in ≥10% of pts during induction comprised: of neutropenia (55%), thrombocytopenia (14%), anemia (21%), infection (14%); during maintenance comprised of neutropenia (39%), thrombocytopenia (21%) and peripheral neuropathy (14%). With a median follow-up of 32.6 months, the median duration of response (DOR), progression-free (PFS) and overall survival were 15.8, 4.5 and 12.9 months, respectively. Efficacy, higher in ALCL, was present in the TFHL and PTCL-NOS group with and ORR, CR, PFS and DOR of 37.2%, 18.6%, 4 and 12.5 months, respectively. A negative association of high baseline soluble CD30 on both response and survival was found, which in ad hoc analysis appeared highly relevant in TFHL and PTCL-NOS patients. EudraCT 2017-000409-1 and NCT03496779
