Abstract
Introduction:
In classical Hodgkin lymphoma (cHL), approximately a third of patients will relapse after first-line therapy and 15% will fail both first and second line therapies, and therapeutic options are still quite limited in these patients. Several studies have shown the efficacy of BV in relapsed/refractory HL patients .
We previously reported the primary results of 58 named patient program (NPP) patients, with an objective response rate (ORR) of 63.5% (CR rate: 26.5%) . Here we present the long-term results of cohort (Salihoglu et al. Ann Hematol 2015).
Design and Methods:
Eleven Turkish institutions participated in this multicenter, retrospective study. Patients were included without any limitations regarding performance status and organ function. All of the patients provided written informed consent. BV is imported via the named-patient-program. BV was given at approved standart dosage.
Results:
From March 2011 to July 2013, 58 patients were included in the named patient program (table 1) and they were treated with BV and followed-up until July 2017, 4 years after the last time of initiation of BV. Ten patients remained in remission (8 CRs and 2 PRs) without the initiation of new therapy other than stem cell transplantation (SCT). These 10 patients has a median observation time of 54.5 months (range: 10-64 months) and the median observation time for all patients from the first dose was 18.5 months (range: 4-66 months). The median OS and PFS were 19 months (95% CI:0.37-0.63) and 5.5 months (95% CI:0.34-0.59), respectively. The estimated 5-year OS and PFS rates were 25% (95% CI:0.15-0.37) and 12% (95% CI:0.03-0.27), respectively (Table 2; Figure 1 A&B).
Among our cohort, 36 (62%) received ≥1 anticancer therapy following BV. Twenty-four patients had SCT following BV treatment; 3, 11, and 8 auto-, allo-, and haplo-SCTs were performed, respectively; and 2, 4, 2 patients received auto-, allo- and haplo-SCT as consolidative therapy following BV, respectively. One and 1 patient received allo- and haplo-SCT as second-line treatment subsequent to BV, respectively. Excluding SCT conditioning regimens; 14 and 10 patients received single and multi agent therapy following BV, respectively. Excluding consolidative SCT, median numbers of subsequent treatments was 1 (range: 1-5).
Eighteen of 58 patients (31%) achieved a CR during the follow-up, and better survival outcomes were observed in this group. The median of duration of response was 42 months (range: 2-59 months). The estimated 5-year OS and PFS rates were 59% (95% CI:0.33-0.79) and 34% (95% CI:0.07-0.63), respectively (Figure 1 C&D).
Among 15 patients that were in remission at the time of analysis, of 7 patients that remained in the follow-up and in remission, three had consolidative SCT (1 auto- and 2 allo-SCTs) and 4 received no further cancer treatment (22% of all CR patients). Additionally, we should state that one patient, who received no further treatment after BV and who was in CR, died due to lung cancer an 41st month of follow-up.
Of the 18 patients who achieved CR after BV, six patients had a consolidative SCT as their next therapy following BV (2 auto-, 3 allo- and 1 haplo-SCT). Additionally, one CR patient underwent haplo-SCT after having had progressive disease. Among 6 patients that had consolidative SCT following achievement of CR, the estimated 5-years OS and PFS rates were 67% (95% CI:0.19-0.90) and 67% (95% CI:0.19-0.90), respectively. For the resting 12 CR patients, the estimated 5-years OS and PFS rates were 55% (95% CI:0.23-0.78) and 41% (95% CI:0.12-0.69), respectively. Among 6 patients who had undergone consolidative SCT, 3 are alive and 3 are dead due to relapsed lymphoma. Of 12 patients who had not received consolidative SCT, five were dead at the time of analysis (Figure 1 E&F).
A total of 381 adverse events (AEs) were observed in 49 patients (85%). In general the treatment was well tolerated with dose reduction required in 8 patients (3 due to cytopenias, 1 neutropenia, 1 renal failure, 1 peripheral neuropathy, 2 unknown).
In our cohort, we report that 10 patients (17%) had long term continuous response following BV therapy and 5 patients (8.6%) had long term continuous CR (median OS: 56 months; range: 41-64 months) without any additional consolidative therapy. Our results are close to the long term results of pivotal study (Chen et al. Blood 2016) and French study (Perrot et al. Haematologica 2016).
No relevant conflicts of interest to declare.
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