PMID- 24417913 OWN - NLM STAT- MEDLINE DCOM- 20150106 LR - 20151119 IS - 2152-2669 (Electronic) IS - 2152-2669 (Linking) VI - 14 IP - 3 DP - 2014 Jun TI - High-dose vincristine sulfate liposome injection (Marqibo) Is not associated with clinically meaningful hematologic toxicity. PG - 197-202 LID - S2152-2650(13)00474-6 [pii] LID - 10.1016/j.clml.2013.10.012 [doi] AB - BACKGROUND: Vincristine sulfate liposome injection (VSLI) facilitates vincristine dose intensification and densification, is active in untreated and relapsed lymphoma, and has been approved in the United States for relapsed and refractory acute lymphoblastic leukemia. Cancer- and concomitant chemotherapy-related anemia, neutropenia, and thrombocytopenia in patients with hematologic malignancy have complicated the evaluation of hematologic toxicity related to new drugs. PATIENTS AND METHODS: We assessed the hematologic toxicity of VSLI 2.25 mg/m(2) administered every 14 (cohort 1) or 7 (cohort 2) days in 54 patients with metastatic uveal melanoma, a cancer not known to involve the bone marrow. RESULTS: Cohort 2 received a greater median number of VSLI doses (6 vs. 4) within a shorter median period (5.7 vs. 8.7 weeks), resulting in a larger median cumulative exposure (22.6 vs. 17.7 mg) and near doubling of the median dose density (2.2 vs. 4.0 mg/wk) compared with cohort 1. Despite greater VSLI exposure and dose density, cohort 2 had a lower median decrease from baseline in the neutrophil count and a greater increase from baseline in the platelet count compared with cohort 1. Hematologic adverse events (AEs) were uncommon and mostly grade 1 or 2 in severity. No grade 4 hematologic AEs developed. CONCLUSION: VSLI at its approved dose resulted in a low incidence of clinically meaningful hematologic toxicity. A near doubling of the median dose density did not have an identifiable effect on the reported incidence and severity of hematologic AEs. VSLI could be well suited for use combined with myelosuppresive drugs and for patients unable to tolerate peripheral blood cytopenia. CI - Copyright (c) 2014 Elsevier Inc. All rights reserved. FAU - Deitcher, Olivia R AU - Deitcher OR AD - Talon Therapeutics, Inc, South San Francisco, CA. FAU - Glaspy, John AU - Glaspy J AD - University of California, Los Angeles, CA. FAU - Gonzalez, Rene AU - Gonzalez R AD - University of Colorado Denver, Aurora, CO. FAU - Sato, Takami AU - Sato T AD - Thomas Jefferson University, Philadelphia, PA. FAU - Bedikian, Agop Y AU - Bedikian AY AD - University of Texas MD Anderson Cancer Center, Houston, TX. FAU - Segarini, Karen AU - Segarini K AD - Talon Therapeutics, Inc, South San Francisco, CA. FAU - Silverman, Jeffrey AU - Silverman J AD - Talon Therapeutics, Inc, South San Francisco, CA. FAU - Deitcher, Steven R AU - Deitcher SR AD - Talon Therapeutics, Inc, South San Francisco, CA. Electronic address: srdeitcher@hotmail.com. LA - eng PT - Journal Article DEP - 20131115 PL - United States TA - Clin Lymphoma Myeloma Leuk JT - Clinical lymphoma, myeloma & leukemia JID - 101525386 RN - 0 (Antineoplastic Agents, Phytogenic) RN - 0 (Liposomes) RN - 5J49Q6B70F (Vincristine) RN - Uveal melanoma SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents, Phytogenic/*administration & dosage/*adverse effects MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use MH - *Blood Cell Count MH - Erythrocyte Indices/*drug effects MH - Female MH - Humans MH - Liposomes MH - Male MH - Melanoma/*blood/*drug therapy/pathology MH - Middle Aged MH - Neoplasm Metastasis MH - Treatment Outcome MH - Uveal Neoplasms/*blood/*drug therapy/pathology MH - Vincristine/*administration & dosage/*adverse effects OTO - NOTNLM OT - Anemia OT - Liposome OT - Neutropenia OT - Thrombocytopenia OT - Vincristine EDAT- 2014/01/15 06:00 MHDA- 2015/01/07 06:00 CRDT- 2014/01/15 06:00 PHST- 2013/06/24 00:00 [received] PHST- 2013/10/17 00:00 [revised] PHST- 2013/10/21 00:00 [accepted] PHST- 2014/01/15 06:00 [entrez] PHST- 2014/01/15 06:00 [pubmed] PHST- 2015/01/07 06:00 [medline] AID - S2152-2650(13)00474-6 [pii] AID - 10.1016/j.clml.2013.10.012 [doi] PST - ppublish SO - Clin Lymphoma Myeloma Leuk. 2014 Jun;14(3):197-202. doi: 10.1016/j.clml.2013.10.012. Epub 2013 Nov 15.