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Liposomal Mitoxantrone Shows Promise in Patients With Advanced Breast Cancer
According to data being presented at the virtual 2020 ASCO Annual Meeting, liposomal mitoxantrone led to improvements in objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS) when compared with mitoxantrone hydrochloride injection in patients with advanced breast cancer.
A total of 60 patients with advanced breast cancer were enrolled in the open-label, single-center, phase 2 study by Leiping Wang, MD, Fudan University Shanghai Cancer Center, China, and colleagues between October 2015 and July 2017.
These patients were randomized in a 1:1 ratio to receive liposomal mitoxantrone 20 mg/m2 (n = 30) or mitoxantrone hydrochloride injection 14 mg/m2 (n = 30) once every 4 weeks. Overall, 11 patients in the liposomal mitoxantrone arm (median age, 56.0 years) and 7 in the mitoxantrone hydrochloride injection arm (median age, 54.5 years) received ≥4 cycles of treatment.
The primary end point of the study was the ORR, and secondary end points were safety and PFS.
Ultimately, when liposomal mitoxantrone was compared with mitoxantrone hydrochloride injection, the ORR was observed to be 13.3% versus 6.7%, respectively; DCR was 50% versus 30%, respectively; and the median PFS was 2.30 months (95% CI, 1.74-3.91) versus 1.86 months (95% CI, 1.74-2.40; P >.05).
With regard to adverse events, liposomal mitoxantrone yielded a significantly lower incidence of all-grade decreased white blood cell count, decreased neutrophil count, increased conjugated bilirubin, increased aspartate aminotransferase, and increased troponin T increased than mitoxantrone hydrochloride injection.
However, a higher incidence of anemia, skin hyperpigmentation, and decreased platelet count was observed with liposomal mitoxantrone versus mitoxantrone hydrochloride injection.
“Liposomal mitoxantrone provided numerically better ORR, DCR, and PFS than mitoxantrone hydrochloride injection in advanced breast cancer. Lower incidence of troponin T increased might suggest lower cardiotoxicity of liposomal mitoxantrone,” Dr Wang and colleagues concluded.—Hina M. Porcelli
Wang L, Zhao Y, Li T, et al. Efficacy and safety of liposomal mitoxantrone (Lipo-MIT) in advanced breast cancer (ABC): A randomized, open label, active-controlled, single-center, phase II clinical trial. Presented at: the 2020 ASCO Annual Meeting; May 29-31, 2020. Abstract 1093.
