TARGETED DRUG BRENTUXIMAB VEDOTIN FOR TREATMENT OF RELAPSED OR REFRACTORY CD30-POSITIVE HODGKIN’S LYMPHOMA

Objective. To perform literature review of clinical trials reporting on the use of single-agent brentuximab vedotin (BV) 1.8 mg/kg therapy in adult patients with relapsed/refractory (R/R) CD30-positive Hodgkin lymphoma (HL).

Methods. A literature search was performed in Pubmed and eLIBRARY. RU databases to identify all studies published from 1 July 2007 until 1 July 2017. We used the key words “brentuximab vedotin” and “Hodgkin lymphoma” simultaneously. The inclusion criteria required that study population included ≥ 20 adult patients with R/R HL. We included clinical trials, systematic reviews, meta-analysis, pharmacoeconomic studies: total 25 publications met inclusion criteria. Publications were grouped by 3 BV indications in instruction for use: adult patient with relapsed/refractory CD30-positive Hodgkin lymphoma post-autologous stem cell transplantation (postASCT), adult patient with refractory CD30-positive HL after failure of at least 2 prior multiagent chemotherapy regimens in patients who are not candidates for ASCT, adult patient with classical HL at high risk of relapse or progression post-ASCT.

Results. Overall response rate (ORR) and complete rate (CR) were 75% and 34% respectively in adult patients with R/R CD30-positive HL post-ASCT in SGN35–0003 study. In patients with refractory HL after failure of at least 2 prior multiagent chemotherapy regimens who are not candidates for auto-SCT ORR and CR were 40% and 30% respectively. In mixed population ORR were 56-80%, CR – 10-46.5%. In patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT ORR was not evaluated, median progression-free survival was improved in patients in BV group compared with those in placebo group (42.9 and 24.1 months respectively). Overall survival in both group was similar. In patients with R/R CD30-positive HL the incremental cost-effectiveness ratio per quality-adjusted life year (ICER/QALY) was 6.7 million rub. и 3 million rub. from a Russian and a Scottish healthcare payer respectively. ICER/QALY when BV compared with best supportive care was 9.79 million rubles. In patients who were at risk for HL repapse after ASCT if BV consolidation compared with active surveillance ICER/QALY was 8.86 million rub.

Conclusion. As a result of the literature review, it was found that the response rate, the complete response to BV therapy, and the overall survival and progression-free survival with use of BV in different patient populations differ; in most cases, the result of effectiveness favors BV. The found safety data indicated a good tolerability of the drug. The results of the found pharmacoeconomic studies differ depending on the comparison therapy and the accepted pharmacoeconomic indicator.

brentuximab vedotin, relapsed or refractory CD30-positive Hodgkin’s lymphoma, relapse, clinical trial

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