OBJECTIVES. Brentuximab vedotin (BV) is a targeted antibody-drug conjugate (ADC) active against CD30-positive cancer cells such as those associated with classical Hodgkin lymphoma (HL). This is a single-center observational study to assess if BV represents an option for the management of patients who have failed high-dose chemotherapy/ASCT or at prior chemotherapy regimens and as post-ASCT consolidation therapy in patients who are at increased risk/high-risk of relapse or progression after ASCT. We aim to proof whether clinical trial results are confirmed in a real-life context over an 18-month period at institutional level in Guayaquil, Ecuador.

METHODS. Eleven patients with relapsed and two patients with refractory CD30-positive HL were identified from 2016Q1-2017Q3. Institutional experience was described using the Deauville criteria to assess patients’ treatment response: complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD). We also measured 18-month overall survival (OS), progression-free survival (PFS) and adverse events (AEs).

RESULTS. The study included 13 patients with HL (77% female; 85% at stage III/IV before treatment; more than 60% of patients with at least 2 prior chemotherapy regimens, 61% at ECOG level 3). 30% of patients were consolidated with high doses of chemotherapy and ASCT. In the 4th cycle, 54% had CR, 38% PR, and 8% PD. At the 8th cycle 77% had CR, 15% PR, and 8% PD. 31% of the patients progressed. At 18-months follow-up, OS and PFS were 100% and 77%, respectively. AEs were grade III and IV including hepatoxicity and encephalitis.

CONCLUSIONS. This study provides real-world evidence in Ecuador on the beneficial effects of BV therapy in terms of response to treatment, overall survival and progression-free survival. Outcomes were maintained during long-term follow-up and are comparable to international clinical trials. BV has also a good safety profile with low frequency of III and IV grade AEs.