BRENTUXIMAB VEDOTIN CONSOLIDATION TO REDUCE RADIATION USE IN PATIENTS WITH LIMITED STAGE NON‐BULKY HODGKIN LYMPHOMA: AN UPDATE FROM a PHASE 2 CLINICAL TRIAL
Year: 2017
Type: article
Abstract: previously untreated HL stage 2 (with B symptoms and/or mediastinal bulk) to stage 4 with cardio-respiratory compromise (at any age), or ECOG PS ≤3 and considered unfit for standard chemotherapy (in pts ≥60 yrs).BV dose was 1.8 mg/kg every 3 weeks, reduced to 1.2 mg/kg for toxicity.Pts responding after 4 doses of BV continued to a maximum of 16 cycles if CT/PET-CT every 4 cycles confirmed ongoing response.Pts also underwent exploratory blinded PET-CT after cycle 2.Results: 38 pts were recruited from Feb 2014-Oct 2015 at 12 UK centres; demographics are shown in Table 1.35 treated pts were evaluable for toxicity, 31 were evaluable for response.A median of 4 cycles was given (range 1-16).Dose was reduced in 28 cycles across 14 pts due to toxicity and 11 pts stopped treatment due to adverse events (AEs).716 AEs were reported, 626 (88%) were grade 1/2.27 (77%) pts had at least one AE ≥ grade 3, most commonly infection, myelosuppression or neuropathy.CMR at PET4 was 26% (95% CI 14, 43) and overall objective response was 84% (95%CI: 67, 93).There was a significant correlation of interim PET2 with PET4 (Rho = 0.67, p < 0.001) with a CMR rate at PET 2 of 32% (95% CI 17, 52).To date 28 of 31 evaluable pts have progressed and median PFS is 7.4 months (95% CI 5.3, 10.2).Conclusions: In this study BV monotherapy produced a high overall response rate although the CMR rate after 4 cycles did not meet the pre-specified 40% level, and PFS was short.Toxicity was greater than in the pivotal study in a younger/fitter population and led to treatment termination in some pts.A follow-on study aims to improve CMR and PFS by using a lower dose of BV in combination with other agents.
Source: Hematological Oncology
DOI: 10.1002/hon.2437_69
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2621722347