Frontline brentuximab vedotin in combination with dacarbazine or bendamustine in patients aged ≥60 years with HL
Mené sur 42 patients atteints d'un lymphome hodgkinien et âgés de plus de 60 ans, cet essai de phase II analyse l'efficacité, du point de vue du taux de réponse objective, du taux de rémission et de la survie sans progression, et la toxicité du brentuximab védotin utilisé en monothérapie, en combinaison avec la bendamustine et en combinaison avec la dacarbazine
BV+DTIC is an active and well-tolerated combination for patients aged ≥60 years with HL.Though highly active at the doses evaluated, BV+bendamustine has unacceptable toxicity in patients aged ≥60 years with HL. Patients aged ≥60 years with treatment-naïve Hodgkin lymphoma (HL) have few treatment options and inferior survival due to treatment-related toxicities and comorbidities. This phase 2, non-randomized, open-label study evaluated tolerability, activity, and response duration with brentuximab vedotin (BV) monotherapy (results previously reported), BV+dacarbazine (DTIC), and BV+bendamustine. Patients had classical HL and were ineligible for or declined frontline chemotherapy. Twenty-two patients received 1.8 mg/kg BV+375 mg/m2 DTIC for up to 12 cycles, then 20 more received 1.8 mg/kg BV+90/70 mg/m2 bendamustine for up to 6 cycles (dose reduced due to toxicity). Subsequent BV monotherapy was allowed. Approximately 30 patients were to receive BV+bendamustine; however, serious adverse event incidence (65%) and 2 deaths on study led to discontinuation of bendamustine treatment and cessation of enrollment in this arm. Most patients had Stage III/IV disease and approximately half had ≥3 comorbidities or were impaired in ≥1 aspect that significantly interfered with quality of life. For BV+DTIC, objective response rate (ORR) was 100% and complete remission (CR) rate was 62%. To date, median progression-free survival (PFS) was 17.9 months (range, 4.2+, 29+) and median overall survival (OS) was not reached (range, 14.8+, 29+ months). For BV+bendamustine, ORR was 100% and CR rate was 88%. Neither the median PFS nor OS were reached (ranges, 2.9, 18+ months, and 2.9, 18.2+ months, respectively). For elderly patients with HL, BV+DTIC may be a frontline option based on tolerability and response duration. Despite activity, BV+bendamustine is not a tolerable regimen in these patients.
Blood 2017