M.A. Rodriguez and Jane Winter performed research, analyzed data, and wrote the paper. Robert Pytlik performed research for the paper. Biao Lu analyzed data and wrote the paper. Steven Deitcher analyzed the data.
Vincristine sulfate liposomes injection (Marqibo) in heavily pretreated patients with refractory aggressive non-Hodgkin lymphoma†
Report of the Pivotal Phase 2 Study
Article first published online: 17 JUN 2009
Copyright © 2009 American Cancer Society
Volume 115, Issue 15, pages 3475–3482, 1 August 2009
How to Cite
Rodriguez, M. A., Pytlik, R., Kozak, T., Chhanabhai, M., Gascoyne, R., Lu, B., Deitcher, S. R. and Winter, J. N. (2009), Vincristine sulfate liposomes injection (Marqibo) in heavily pretreated patients with refractory aggressive non-Hodgkin lymphoma. Cancer, 115: 3475–3482. doi: 10.1002/cncr.24359
- Issue published online: 20 JUL 2009
- Article first published online: 17 JUN 2009
- Manuscript Accepted: 12 DEC 2008
- Manuscript Revised: 19 SEP 2008
- Manuscript Received: 15 JUL 2008
- vincristine liposomes;
- vincristine sulfate;
Marqibo, a sphingosomal/cholesterol encapsulation of vincristine sulfate has targeted, increased, and sustained delivery of vincristine to tumor tissues. A phase 2, open-label, single-arm, and multinational study evaluated the efficacy and tolerability of Marqibo as a single agent in patients with multiply relapsed or refractory aggressive non-Hodgkin lymphoma (NHL).
Eligible patients had relapsed or refractory de novo or transformed aggressive NHL and prior treatment with at least 2 multiagent chemotherapy regimens. Marqibo was administered at 2 mg/m2, every 2 weeks, for a maximum of 12 cycles or until toxicity or disease progression.
One hundred and nineteen patients were enrolled and treated on trial. Ninety-six had histological confirmed de novo (N = 89) or transformed (N = 7) aggressive NHL. Median number of cycles was 4 (median dose/cycle 4 mg). Overall response (CR and complete response unconfirmed and PR) was 25% (95% confidence interval [CI], 17, 35), CR and complete response unconfirmed confirmed by external reviewers was 5%. Median overall survival was 6.6 months (Kaplan-Meier estimate, 95% CI, 4.7, 9.8). Grade 3 of 4 neurotoxicity occurred in 32% of patients. All patients had prior neurotoxic agents, and 85% had baseline residual neuropathy symptoms (grades 1-2) from prior treatment.
Marqibo is an active agent in patients with heavily pretreated aggressive NHL, and tolerated at approximately twice the dose intensity of standard vincristine. Its activity supports further investigation as a substitution for vincristine in combination treatment of lymphoid disorders. Cancer 2009. © 2009 American Cancer Society.