Pegylated liposomal doxorubicin replacing conventional doxorubicin in standard R-CHOP chemotherapy for elderly patients with diffuse large B-cell lymphoma: An open label, single arm, phase II trial

Yasuhiro Oki*, Michael S. Ewer, Daniel J. Lenihan, Michael J. Fisch, Fredrick B. Hagemeister, Michelle Fanale, Jorge Romaguera, Barbara Pro, Nathan Fowler, Anas Younes, Alan B. Astrow, Xuelin Huang, Larry W. Kwak, Felipe Samaniego, Peter McLaughlin, Sattva S. Neelapu, Michael Wang, Luis E. Fayad, Jean Bernard Durand, M. Alma Rodriguez

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

24 Scopus citations

Abstract

Background The present multicenter phase II trial evaluated the safety and efficacy of pegylated liposomal doxorubicin (PLD) instead of conventional doxorubicin in standard R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine [Oncovin], and prednisone) therapy for elderly patients with diffuse large B-cell lymphoma. Materials and Methods Patients aged > 60 years who had stage II to IV disease were included. Treatment consisted of rituximab 375 mg/m2 intravenously (I.V.); cyclophosphamide 750 mg/m2 IV; PLD 40 mg/m2 (maximum, 90 mg) I.V. over 1 hour; and vincristine 2.0 mg I.V., all on day 1. Additionally prednisone, 40 mg/m2, was given orally on days 1 to 1 to 5 (DRCOP [rituximab, cyclophosphamide, PLD, vincristine, and prednisone]). The cycles were repeated every 3 weeks for 6 to 8 cycles. Results Eighty patients were enrolled and were evaluable for toxicity. The median age was 69 years. All except 1 had additional cardiac risk factors for anthracycline-induced cardiac toxicity beyond advanced age. From the intent-to-treat analysis of 79 eligible patients, the overall response rate was 86%, and the complete response rate was 78%. Cardiac events greater than grade 3 were identified in 3 patients (4%); grade 1 to 2 events, mostly asymptomatic declines in ejection fraction, were noted in another 16 patients. One death was attributed to cardiac failure. The estimated 5-year event-free and overall survival rate was 52% and 70%, respectively. Conclusion DRCOP represents an effective strategy for potentially mitigating cardiotoxicity in elderly patients with aggressive B-cell lymphoma. Future studies incorporating baseline cardiac risk assessments, long-term follow-up data, and biospecimen collection for correlative science should be undertaken.

Original languageEnglish (US)
Pages (from-to)152-158
Number of pages7
JournalClinical Lymphoma, Myeloma and Leukemia
Volume15
Issue number3
DOIs
StatePublished - Mar 1 2015

Keywords

  • Anthracycline
  • Cardiac toxicity
  • Diffuse large B-cell lymphoma
  • Elderly patients
  • Pegylated liposomal doxorubicin

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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