Pb2007 preliminary Results of Using Brentuximab Vedotin in Relapse/Refractory Hodgkin's Lymphoma.

Abstract

Background: Hodgkin disease (HL) is curable disease in up to 80% of patients, but for the remaining relapse/refractory patients no standard salvage therapy exists. Brentuximab vedotin comprises an anti CD30 antibody conjugated by a protease-cleavable linker to a microtubule-disrupting agent. Aims: The aim of the study is to evaluate the outcome of patients with relapse/refractory form of HL, who received Brentuximab vedotin. Methods: In our Institute 21 patients with HL were treated, from 2015 till 2018 years. 17 (81%) patients had a primary-resistant form, four (19%) patients had relapse of the disease. The average age was 34.5 years (from 20 to 69 years), the average number of courses of therapy is 5.38 (from 3 to 8 courses). The mean follow-up period was 17.9 months (from 4.1 to 38.1 months). Results: We have analyzed the survival of patients who received treatment. 21 patients who entered the study at the time of collection of information, 15 (71.4%) patients were alive. Median survival was 33.2 months. The standard error (SE) is 3.3 months, with 95% CI (26.8 -39.6). Among patients with a primary resistant form, 13 (76.5%) patients were alive, with a median survival of 28.1 months, a SE of 2.3 months of 95% ). Among patients with a non-primary resistant form, two (50%) patients were alive, while the median survival was 9.1 months, SE 2.4 months 95% CI (4.5-13.7). Eleven patients had a partial response to treatment (52, 4%), ten of them (90.9%) were alive, while the median survival was 27.9 months, SE 2.3 months 95% CI (23.5 -32.4). In three (14.3%) patients, a complete response to treatment was noted, of which three (100%) patients were alive. Cancer progression was noted in seven (33.3%) patients, two of them (28.6%) were alive, while the median survival was 27.9 months, SE 2.3 months 95% CI (23.5 -32.4). In analyzing six (28.6%) patients had AutoSCT, and 15 (71.4%) patients did not, due to low stem cell growth. Among patients, which didn't have AutoSCT 11 (73.3%) patients were alive, with a median survival of 30.4 months, a SE of 2.7 months of 95% ). When analyzing the causes of mortality, all patients indicated the cause of death from the progression of cancer. Summary/Conclusion: The analysis of the results using Brentuximab Vedotin showed good results in treatment of relapse and refractory forms of HL. In patients who failed to perform autologous stem cell transplantation, showed median survival of 30.4 months. This indicates the possibility of using the drug as an alternative to this procedure for the primary resistant form of the disease or further therapy options.

Effectiveness of brentuximab vedotin monotherapy in relapsed or refractory Hodgkin lymphoma: a systematic review and meta-analysis

“…heavily pretreated patients refractory to previous salvage treatments or patients ineligible to ASCT due to the persistence of the disease). Similarly for CR rate, lower estimates reported in four case series (14.3% [42] to 16.7% [22,30]) can be explained by small sample sizes (n ¼ 21 [42], n ¼ 24 [30], and n ¼ 18 [22]) or specific patient populations (heavily pretreated patients who received a median of four prior regimens and were refractory to previous salvage therapies [31]). Of note, the majority of studies retained in this review assessed treatment response based on the 2007 International Working Group criteria, while these criteria have been updated in 2014, known as the Lugano Classification.…”

“…According to 22 studies, 21.1% [41] to 45.8% [21] R/R cHL patients treated with BV achieved CR. Lower estimates (14.3% [42] to 16.7% [21,22]) were found in four case series that included either small sample sizes (n ¼ 21 [27], n ¼ 24 [30], and n ¼ 18 [22]) or covered a specific population [31]. Conversely, in a conference proceeding that reported on a study conducted at the Memorial Sloan Kettering Cancer Center (MKSCC) in the United States, 13 (61.9%) of the 21 R/R cHL patients who received BV post-ASCT relapse achieved CR [38].…”

“…In these studies, the study populations were representative of patients who are eligible to BV, according to the approved indication. Specifically, the proportion of patients who received previous ASCT ranged from 25.5% [24] to 100% [8,17,36] and 37.5% [27] to 81% [42] patients had refractory HL, defined as stable or progressive disease during first-line or salvage chemotherapy. However, almost half studies (n ¼ 10; 41.7%) did not provide any details regarding the distribution of patients according to relapse or…”

“…Seven of these 12 studies were deemed of good methodological quality [8,14,15,20,22,28,36] and were included in the primary meta-analysis while the remaining five studies were of moderate methodological quality and hence, were only considered for the sensitivity analyses [16,21,26,27,41]. In addition, there were 14 studies which consisted of abstracts or conference proceedings that were included in a second set of sensitivity analyses [17][18][19][23][24][25][29][30][31][32]34,38,39,42].…”

“…A total of 18 publications reported estimates of OS in R/R cHL patients treated with BV, with five reporting median OS: 17.8 [16], 26.5 [14], 33.2 [42], 57.0 [33], and 91.5 months [43]. The lowest estimate was found in a case series of 136 R/R cHL patients ineligible to ASCT identified in Germany and the UK [16] and, the highest estimate was reported in a conference proceeding describing patients treated with BV following a relapse after ASCT over a median follow-up period of 49.4 months [43].…”