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Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.
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@#Liposome injection is one of the most successful special injections that use nanotechnology to enhance drug efficacy and reduce accompanied toxicity. New liposomes with special structures and functions have emerged since the first liposome injection containing doxorubicin was marketed. This review summarized the principles and research progress of Stealth liposome technology and cationic liposome technology, analyzed the structural and functional characteristics and clinical application advantages of liposome products that have been marketed from the perspective of pharmacology, introduced current research hotspots of new liposomes, and analyzed the current regulatory status of liposome injection at home and abroad, thereby providing theoretical reference for the research and development（R&D）, clinical translation and supervision of liposome injection.
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OBJECTIVE: To develop an HPLC-ELSD method for determination of MPEG-DSPE and HSPC in doxorubicin hydrochloride liposome injection. METHODS: The column was Waters Symmetry 300 C18(4.6 mm × 150 mm, 5 μm; pore size; 300 Å). The mobile phase was methonal-tetrahydrofuran-0.17 mol · L-1 ammonium acetate(93: 6:1). The flow rate was 1.0 mL · min-1. The column temperature was 25℃ and the injection volume was 10 μL. The ELSD conditions were as follows: Alltech 2000ES ELSD detector; drift temperature; 110℃; rate; 2.6 L · min-1. RESULTS: This method had good specificity. The linear ranges of the calibration curves for MPEG-DSPE and HSPC were 0.03-0.48 mg · mL-1 (r=0.999 8) and 0.1-1.0 mg · mL-1 (r=0.9998), respectively. The average recovery rates of MPEG-DSPE and HSPC were 100.0% (n=3 × 3) and 101.0% (n=3 × 3), respectively. The LODs of MPEG-DSPE and HSPC were 13 and 52 ng, respectively. The repeatability and intermediate precision of MPEG-DSPE were 0.9% (n=5) and ≤1.9% (n=3), respectively. The repeatability and intermediate precision of HSPC were 1.1% (n=5) and ≤1.3%(n=3), respectively. CONCLUSION: The established method is accurate, reliable, repeatable and suitable for the determination of MPEG-DSPE and HSPC in doxorubicin hydrochloride liposome injection.