Mitoxantrone hydrochloride liposome injection for the treatment of Recurrent/Metastatic head and neck squamous cell Carcinoma: A Multicenter, Open-label, Single-arm, phase 1b study

IF 4 2区医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE

Oral oncology Pub Date : 2025-02-13 DOI:10.1016/j.oraloncology.2025.107211

Hang Yang , Peng Sun , Yu Wang , Xicheng Wang , Yanyan Liu , Jiyong Peng , Hui Zhou , Yajun Li , Hong Zhang , Jianbing Hu , Bing Zhang , Shunhuan Lin , Chunwei Yang , Weidong Li , Yanping Liu , Meng Ji , Jinghua Zhao , Jianfei Xue , Jiajia Huang , Zhiming Li

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引用次数: 0

Abstract

Background

Mitoxantrone hydrochloride liposomes (PLM60) have been approved for the treatment of relapsed/refractory peripheral T-cell lymphoma (PTCL) in China. This study evaluated the safety and efficacy of PLM60 in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

Methods

Patients with histologically confirmed HNSCC (including nasopharyngeal carcinoma (NPC)) were enrolled. PLM60 was administered at a dose of 20 mg/m² by intravenous infusion every 21 days (one cycle) with a maximum of eight cycles. The primary objective was to determine the safety and the secondary objective was to assess the efficacy of PLM60 in this setting.

Results

A total of 45 patients with a median age of 50 years were enrolled (26 NPC and 19 non-NPC). Eleven patients completed the planned regimen. The most common hematological adverse events (AEs) were anemia (64.4 %), decreased white blood cell count (55.6 %), and decreased lymphocyte count (46.7 %). The most common non-hematologic AE was skin hyperpigmentation (37.8 %). Grade ≥ 3 AEs occurred in 30 patients (80.0 %), and most were hematologic. Four patients reported AEs leading to death, with two cases assessed as possibly related to the study drug. Of the 37 patients evaluable for efficacy, the overall objective response rate (ORR) was 24.3 % (95 % CI: 11.8–41.2 %) and the disease control rate was 62.2 % (95 % CI: 44.8–77.5 %). The proportion of patients with an overall response was higher in the NPC group (7/25, ORR: 28.0 %) than in the non-NPC group (2/12, ORR: 16.7 %).

Conclusions

PLM60 has demonstrated manageable safety and evidence of efficacy in patients with recurrent/metastatic HNSCC.

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来源期刊

Oral oncology 医学-牙科与口腔外科

CiteScore

8.70

自引率

10.40%

发文量

505

审稿时长

20 days

期刊介绍： Oral Oncology is an international interdisciplinary journal which publishes high quality original research, clinical trials and review articles, editorials, and commentaries relating to the etiopathogenesis, epidemiology, prevention, clinical features, diagnosis, treatment and management of patients with neoplasms in the head and neck. Oral Oncology is of interest to head and neck surgeons, radiation and medical oncologists, maxillo-facial surgeons, oto-rhino-laryngologists, plastic surgeons, pathologists, scientists, oral medical specialists, special care dentists, dental care professionals, general dental practitioners, public health physicians, palliative care physicians, nurses, radiologists, radiographers, dieticians, occupational therapists, speech and language therapists, nutritionists, clinical and health psychologists and counselors, professionals in end of life care, as well as others interested in these fields.