Rh-endostatin combined with chemotherapy in patients with advanced or recurrent mucosal melanoma: retrospective analysis of real-world data

• Published in: Investigational new drugs 2022-04, Vol.40 (2), p.453-460
• Main Authors: Zhang, Xiaowei, Jin, Feng, Jiang, Shiyu, Cao, Jun, Meng, Yanchun, Xu, Yu, ChunmengWang, Chen, Yong, Yang, Huijuan, Kong, Yunyi, Liu, Xin, Luo, Zhiguo
• Format: Article
• Language: English
• Subjects: Antineoplastic Combined Chemotherapy Protocols - adverse effects; Chemotherapy; China; Cisplatin; Cisplatin - therapeutic use; Dacarbazine; Disease control; Endostatin; Endostatins - adverse effects; Endostatins - therapeutic use; Gastrointestinal system; Gastrointestinal tract; Health services; Humans; Intravenous administration; Lymphocytes; Medicine; Medicine & Public Health; Melanoma; Melanoma - drug therapy; Melanoma - genetics; Melanoma, Cutaneous Malignant; Metastases; Monocytes; Mucosa; Mutation; Oncology; Patients; Pharmacology/Toxicology; Proto-Oncogene Proteins B-raf; Retrospective Studies; Short Reports; Skin Neoplasms; Survival; Temozolomide; Toxicity
• ISSN: 0167-6997; 1573-0646
• DOI: 10.1007/s10637-021-01172-9

Summary Background. Mucosal melanoma is rare and has distinct clinical and genetic features. Even with advances in targeted and immune therapies, the survival of patients with advanced or recurrent mucosal melanomas remains poor. The standard treatment remains controversial and we conducted this real-world study aimed to explore continuous intravenous recombinant human endostatin (Rh-endostatin) infusion plus chemotherapy in this population in the first-line setting. Methods. Overall, 43 patients with advanced or recurrent mucosal melanoma treated at Fudan University Shanghai Cancer Center between April 2017 and August 2020 were retrospectively included. Patients received dacarbazine plus cisplatin or temozolomide plus cisplatin per the investigators’ preference. Rh-endostatin (105 mg/m 2 ) was administered with continuous infusion for 168 h (Civ 168 h). Results. Of the 43 patients, 72.1% had metastatic disease, and the most common primary site was the gastrointestinal tract (51.2%). The most commonly observed mutations were NRAS (23.1%), BRAF (7.7%) and CKIT mutations (5.1%). An objective response was observed in 12 (30.0%) of the 40 evaluable patients, and disease control was achieved in 31 (77.5%) patients. With a median follow-up of 17.6 months, the median progression-free survival (PFS) and overall survival (OS) were 4.9 and 15.3 months, respectively. Additionally, high lymphocyte-to-monocyte ratio (LMR) (p = 0.023, HR 0.29, 95% CI: 0.10–0.84) and BRAF/KIT/RAS mutation (p = 0.028, HR 0.24, 95% CI: 0.07–0.86) were independently correlated with prolonged OS. Toxicity was manageable overall. Conclusion. Continuous Rh-endostatin infusion plus chemotherapy was effective and safe for the treatment of advanced or recurrent mucosal melanoma. High LMR was correlated with favorable PFS and OS in this patient population.