A phase II study of a modified hyper-CVAD frontline therapy for patients with adverse risk diffuse large B-cell and peripheral T-cell non-Hodgkin lymphoma.

• 发表时间: 04 2019
• 来源期刊: Leuk Lymphoma
• DOI: 10.1080/10428194.2018.1516873
• PMID: 30547695
• 文章类型: Clinical Trial, Phase II
• 作者列表: Hapgood G,Stone JM,Zannino D,George A,Marlton P,Prince HM,Hui CH,Prosser I,Lewis ID,Bradstock K,Seymour JF,

关键词: Aggressive non-Hodgkin lymphoma; clinical trial; hyper-CVAD

Mesh: Adult; Antineoplastic Combined Chemotherapy Protocols / adverse effects therapeutic use; Cause of Death; Cyclophosphamide / adverse effects therapeutic use; Dexamethasone / adverse effects therapeutic use; Disease Progression; Doxorubicin / adverse effects therapeutic use; Female; Humans; Lymphoma, Large B-Cell, Diffuse / diagnosis drug therapy mortality; Lymphoma, T-Cell, Peripheral / diagnosis drug therapy mortality; Male; Middle Aged; Recurrence; Remission Induction; Survival Analysis; Treatment Outcome; Vincristine / adverse effects therapeutic use; Young Adult

Abstract

To improve complete remission (CR) rates by reducing toxicity and enhancing delivery, we created a modified hyper-CVAD/MA regimen (cyclophosphamide, vincristine, doxorubicin, dexamethasone/methotrexate, cytarabine) by reducing the cytarabine dose (3 g/m2 to 2 g/m2) and number of cycles (eight to six). We conducted a phase II trial in the pre-rituximab era in the intermediate-high international prognostic index (IPI) (≥2) de novo diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL) (ACTRN12605000105640). CR rates were compared with reported IPI-stratified rates. Sixty-three patients (n = 26 PTCL; n = 37 DLBCL) were evaluated; median follow-up of 30 months. CR rates for PTCL and DLBCL patients were 46% and 49%, respectively, similar with reported CR rates with CHOP-like chemotherapy (p = .6). Of the patients, 51 (81%) experienced ≥1 unplanned hospital admission; only 41 (65%) completed six cycles. The cytarabine modifications did not prevent significant toxicity. Modified hyper-CVAD/MA resulted in similar outcomes to CHOP-like chemotherapy in aggressive lymphomas and was associated with significant toxicity.