Phase II Study of Bendamustine in Relapsed and Refractory Hodgkin Lymphoma

Abstract

A B S T R A C T PurposeLimited data exist regarding the activity of bendamustine in Hodgkin lymphoma (HL). This phase II study evaluated the efficacy of bendamustine in relapsed and refractory HL. Patients and MethodsPatients with relapsed and refractory HL who were ineligible for autologous stem-cell transplantation (ASCT), or for whom this treatment failed, received bendamustine 120 mg/m 2 as a 30-minute infusion on days 1 and 2 every 28 days with growth factor support. The primary end point was overall response rate (ORR). A secondary end point was referral rate to allogeneic stem-cell transplantation (alloSCT) for patients deemed eligible for alloSCT at the time of enrollment. ResultsOf the 36 patients enrolled, 34 were evaluable for response. Patients had received a median of four prior treatments, and 75% had relapsed after ASCT. The ORR by intent-to-treat analysis was 53%, including 12 complete responses (33%) and seven partial responses (19%). The response rate among evaluable patients was 56%. Responses were seen in patients with prior refractory disease, prior ASCT, and prior alloSCT; however, no responses were seen in patients who relapsed within 3 months of ASCT. The median response duration was 5 months. Five patients (20% of those eligible) proceeded to alloSCT after treatment with bendamustine. Grade Ն 3 adverse events were infrequent and most commonly included thrombocytopenia (20%), anemia (14%), and infection (14%). ConclusionThis study confirms the efficacy of bendamustine in heavily pretreated patients with HL. These results support current and future studies evaluating bendamustine combinations in relapsed and refractory HL.

Managing Hodgkin lymphoma relapsing after autologous hematopoietic cell transplantation: a not-so-good cancer after all!

“…20 The Memorial Sloan-Kettering Cancer Center group conducted a phase 2 study of bendamustine in 36 (75% had relapsed after a prior auto-HCT) patients with relapsed/refractory HL. 21 The ORR was 53% (CR ¼ 33%). 21 Responses were seen in cases with prior auto-HCT failure provided they did not relapse within 3 months of autografting.…”

“…21 The ORR was 53% (CR ¼ 33%). 21 Responses were seen in cases with prior auto-HCT failure provided they did not relapse within 3 months of autografting.…”

Új lehetőségek a refrakter és relabált Hodgkin-lymphomás betegek kezelésében

“…Hatásme-chanizmusa kettős, mivel apoptózist indukál a p53-dependens alkiláló aktivitásán keresztül, illetve DNS-káro-sító, ami erőteljesebb és hosszabban tartó, mint más alkilálószereké [34]. Relabáló és refrakter HL-ben több vizsgálat igazolta hatékonyságát [35,36,37], a bendamustint 120 mg/m 2 dózisban 2 napig, 28 naponta alkalmazva. Az ORR 53 és 78%, a CR 33 és 29% volt [36,37].…”

“…Relabáló és refrakter HL-ben több vizsgálat igazolta hatékonyságát [35,36,37], a bendamustint 120 mg/m 2 dózisban 2 napig, 28 naponta alkalmazva. Az ORR 53 és 78%, a CR 33 és 29% volt [36,37]. A leggyakoribb grade 3 vagy súlyosabb mellékhatá-sok a thrombocytopenia (20%), az anaemia (14%) és az infekciók (14%) voltak [36].…”

“…Az ORR 53 és 78%, a CR 33 és 29% volt [36,37]. A leggyakoribb grade 3 vagy súlyosabb mellékhatá-sok a thrombocytopenia (20%), az anaemia (14%) és az infekciók (14%) voltak [36]. Kombinációs kezelésként a BV és a bendamustin együttes alkalmazása is felmerül, egymástól eltérő hatásmechanizmusuk, kedvező mellék-hatásprofi ljuk alapján AHSCT után relabáló betegeknél [38].…”