PMID- 36877215 OWN - NLM STAT- MEDLINE DCOM- 20230501 LR - 20230501 IS - 1573-7217 (Electronic) IS - 0167-6806 (Print) IS - 0167-6806 (Linking) VI - 199 IP - 1 DP - 2023 May TI - Pegylated liposomal doxorubicin (Duomeisu((R))) monotherapy in patients with HER2-negative metastatic breast cancer heavily pretreated with anthracycline and taxanes: a single-arm, phase II study. PG - 67-79 LID - 10.1007/s10549-023-06894-3 [doi] AB - PURPOSE: To evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) in patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) heavily pretreated with anthracycline and taxanes. METHODS: In this single-arm, phase II study, patients with HER2-negative MBC previously treated with anthracycline and taxanes as second- to fifth chemotherapy received PLD (Duomeisu((R)), generic doxorubicin hydrochloride liposome) 40 mg/m(2) every 4 weeks until disease progression, unacceptable toxicity, or completion of six cycles. Primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), and safety. RESULTS: Of 44 enrolled patients (median age, 53.5 years; range, 34-69), 41 and 36 were evaluable for safety and efficacy, respectively. In total, 59.1% (26/44) of patients had >/= 3 metastatic sites, 86.4% (38/44) had visceral disease, and 63.6% (28/44) had liver metastases. Median PFS was 3.7 months (95% confidence interval [CI] 3.3-4.1) and median OS was 15.0 months (95% CI 12.1-17.9). ORR, DCR, and CBR were 16.7%, 63.9%, and 36.1%, respectively. The most common adverse events (AEs) were leukopenia (53.7%), fatigue (46.3%), and neutropenia (41.5%), with no grade 4/5 AEs. The most common grade 3 AEs were neutropenia (7.3%) and fatigue (4.9%). Patients experienced palmar-plantar-erythrodysesthesia (24.4%, 2.4% grade 3), stomatitis (19.5%, 7.3% grade 2), and alopecia (7.3%). One patient displayed a left ventricular ejection fraction decline of 11.4% from baseline after five cycles of PLD therapy. CONCLUSION: PLD (Duomeisu((R))) 40 mg/m(2) every 4 weeks was effective and well-tolerated in patients with HER2-negative MBC heavily pretreated with anthracycline and taxanes, revealing a potentially viable treatment option for this population. Trial registration Chinese Clinical Trial Registry: ChiCTR1900022568. CI - (c) 2023. The Author(s). FAU - Jiang, Hanfang AU - Jiang H AUID- ORCID: 0000-0002-3502-7073 AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China. FAU - Li, Huiping AU - Li H AUID- ORCID: 0000-0002-3331-647X AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China. huipingli2012@hotmail.com. FAU - Song, Guohong AU - Song G AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China. FAU - Di, Lijun AU - Di L AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China. FAU - Shao, Bin AU - Shao B AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China. FAU - Yan, Ying AU - Yan Y AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China. FAU - Liu, Xiaoran AU - Liu X AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China. FAU - Chen, Yifei AU - Chen Y AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China. FAU - Zhang, Ruyan AU - Zhang R AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China. FAU - Ran, Ran AU - Ran R AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China. FAU - Liu, Yaxin AU - Liu Y AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China. FAU - Gui, Xinyu AU - Gui X AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China. FAU - Wang, Nan AU - Wang N AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China. FAU - Wang, Huan AU - Wang H AD - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Breast Oncology, Peking University Cancer Hospital & Institute, Beijing, China. LA - eng PT - Clinical Trial, Phase II PT - Journal Article DEP - 20230306 PL - Netherlands TA - Breast Cancer Res Treat JT - Breast cancer research and treatment JID - 8111104 RN - 0 (liposomal doxorubicin) RN - 0 (Anthracyclines) RN - 0 (Taxoids) RN - 80168379AG (Doxorubicin) RN - 0 (Antibiotics, Antineoplastic) RN - 3WJQ0SDW1A (Polyethylene Glycols) SB - IM MH - Humans MH - Middle Aged MH - Female MH - *Breast Neoplasms/drug therapy/genetics MH - Anthracyclines/therapeutic use/pharmacology MH - Stroke Volume MH - Taxoids/therapeutic use MH - Ventricular Function, Left MH - Doxorubicin/adverse effects MH - Antibiotics, Antineoplastic/pharmacology MH - Polyethylene Glycols/adverse effects MH - *Neutropenia/drug therapy MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - Treatment Outcome MH - Neoplasm Metastasis/drug therapy PMC - PMC9986665 OTO - NOTNLM OT - Efficacy OT - HER2-negative OT - Metastatic breast cancer OT - Pegylated liposomal doxorubicin OT - Safety COIS- HPL received some part of the study drug for this trial from Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co. Ltd. All other authors declare that they have no potential conflicts of interest to disclose. EDAT- 2023/03/07 06:00 MHDA- 2023/05/01 06:42 PMCR- 2023/03/06 CRDT- 2023/03/06 11:03 PHST- 2022/12/10 00:00 [received] PHST- 2023/02/11 00:00 [accepted] PHST- 2023/05/01 06:42 [medline] PHST- 2023/03/07 06:00 [pubmed] PHST- 2023/03/06 11:03 [entrez] PHST- 2023/03/06 00:00 [pmc-release] AID - 10.1007/s10549-023-06894-3 [pii] AID - 6894 [pii] AID - 10.1007/s10549-023-06894-3 [doi] PST - ppublish SO - Breast Cancer Res Treat. 2023 May;199(1):67-79. doi: 10.1007/s10549-023-06894-3. Epub 2023 Mar 6.