Key Points• BV and AVD followed by ISRT is well tolerated, without significant pulmonary toxicity. • BV and AVD followed by ISRT is an effective therapy for unfavorable-risk early stage HL, including bulky disease.This multicenter pilot study assessed the safety and efficacy of brentuximab vedotin (BV) and AVD (adriamycin, vinblastine, and dacarbazine) followed by 30 Gy involved site radiation therapy (ISRT). Patients with newly diagnosed, early stage classical Hodgkin lymphoma (HL) with unfavorable-risk features were treated with 4 cycles of BV and AVD.Patients who achieved a negative positron emission tomography (PET) scan (Deauville score of 1-3) received 30 Gy ISRT. Thirty patients received treatment and were assessable for toxicity. Twenty-nine patients completed 4 cycles of BV 1 AVD, and 25 patients BV 1 AVD 1 30 Gy ISRT. No clinically significant noninfectious pneumonitis was observed. Serious adverse events ( ‡grade 3) were reported in 4 patients, including febrile neutropenia, peripheral neuropathy, and hypertension. After 2 and 4 cycles of BV 1 AVD, 90% (26 of 29) and 93% (27 or 29) of patients achieved a negative PET scan, respectively. Two patients with biopsy-proven primary refractory HL were treated off-study. All 25 patients who completed BV 1 AVD 1 ISRT achieved a complete response. With a median follow-up of 18.8 months, by intent to treat, the 1-year progression-free survival is 93.3% (95% confidence interval, 84-102). Overall, the treatment was well-tolerated with no evidence of significant pulmonary toxicity. The majority of patients ( ‡90%) achieved negative interim PET scans after 2 and 4 cycles of BV 1 AVD. Excluding the 2 primary refractory patients, all patients are disease free, suggesting that this is a highly active treatment program even in patients with substantial disease bulk. This trial was
Results: Two hundred thirty-four CD30+ HL patients were treated.Best response was observed after a median of 4 cycles in 140 patients (59.8%): 74 (31.6%) patients obtained a complete response (CR) and 66 (28.2%) achieved a partial response (PR); overall response rate at the end of the treatment was 48.3% (62 CR and 51 PR). The best response rate was higher in the elderly subset (>60 y): 14 (50%) CR and 5 (17.8%) PR. Disease free survival was 26.3% at 3 years and progression free survival 31.9% at 4.5 years. We identified 30 long-term responders (patients with a response ≥12 months) of whom 18 are still in CR, 7 with a consolidative SCT, and 11 without any consolidative procedure. Duration of response did not differ who achieved at least PR and then either did or did not undergo consolidative SCT. Overall, the treatment was well tolerated in everyday clinical practice, and the toxicity profile was closely similar to the previously published data; no death has been linked to BV-induced toxicity. Conclusions:The results of this large retrospective study of 234 relapse/refractory HL in the daily practice support the BV efficacy with manageable toxicity superimposable to the one reported in clinical trials results; in particular, there is the confirmation of the similar activity in different settings, eg, in elderly patients, and of the response duration independently by the transplant consolidation. The relevance of the CR status after 4 cycles and the role of BV as a bridge to ASCT for the chemorefractory patients were also pointed up.
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