Clinical Advances in Hematology & Oncology

June 2014, Volume 12, Issue 6


The online edition of “Novel Treatments in Acute Lymphocytic Leukemia” with Anthony S. Stein, MD, that appeared in the April 2014 issue of Clinical Advances in Hematology & Oncology contains updated data on vincristine sulfate liposome injection. The new discussion and table are as follows:

A vincristine sulfate liposome injection (Marqibo, Spectrum Pharmaceuticals) was approved for acute lymphocytic leukemia (ALL) in 2012. In standard regimens of vincristine, the dosage does not exceed 2 mg to minimize the risk of neuropathy. With the liposomal formulation, the dosage of vincristine can be increased to 2.25 mg/m2 so that more of the drug can access the bone marrow and eradicate the leukemia. The US Food and Drug Administration indication of vincristine sulfate liposome injection is for the treatment of adults with Philadelphia chromosome–negative ALL in second or greater relapse or whose disease has progressed following at least 2 antileukemia therapies.

In a phase 2 study by O’Brien and colleagues of 65 patients with ALL (J Clin Oncol. 2013;31[6]:676-683), the overall response rate was 35% (see the table). The study’s primary endpoint, complete response or complete response with incomplete hematologic recovery, was reported in 20%. Among these patients, the median duration of documented remission was 23 weeks. A neuropathy-associated adverse event occurred in 86% of patients. Grade 3 treatment-related adverse events were reported in 39% of patients, and grade 4 events were reported in 19%. Grade 3 events related to peripheral neuropathy (eg, hypoesthesia, hyporeflexia, peripheral neuropathy, limb pain, and motor weakness) occurred in 23% of patients. There was 1 report of a grade 4 event related to peripheral neuropathy (sensory peripheral neuropathy). There were no reports of grade 3/4 nausea or vomiting.

Vincristine sulfate liposome injection is given once a week, so it can be administered in the outpatient setting. In patients with relapsed leukemia who have failed other treatments, vincristine sulfate liposome injection can be used as a bridge therapy to allow patients to get to transplant.


Table. Responses in a Phase 2 Trial of Vincristine Sulfate Liposome Injection in ALL

Number of Patients (%) 95% CI
Overall CR 13 (20) 11.1-31.8
CR 7 (11) 4.4-20.9
CRi 6 (9) 3.5-19.0
Partial remission 6 (9) 3.5-19.0
Bone marrow blast response 4 (6) 1.7-15.0
Overall response 23 (35) 23.8-48.3


ALL, acute lymphocytic leukemia; CR, complete response; CRi, complete response with incomplete hematologic recovery.

Data from O’Brien S et al. J Clin Oncol. 2013;31(6):676-683.