A real-world study of recombinant human endostatin continuous intravenous infusion combined with chemotherapy in the treatment of advanced mucosal melanoma.

Abstract

e21019 Background: There is no standard treatment for patients with advanced mucosal melanoma (AMM). Recombinant human endostatin (Endostar) combined with chemotherapy had been showed to improve the efficacy of advanced melanoma. This real world study was aimed to observe the efficacy and safety of endostar continuous intravenous infusion (Civ) combined with chemotherapy in patients with AMM. Methods: 23 patients with AMM treated with endostar plus dacarbazine or temozolomide plus cisplatin between April 2017 and December 2018 were collected. Endostar was given 105mg/m2 Civ168h (unlike the usual use of 7.5mg/m2/d d1-14) . 5 patients with local advanced disease received concurrent radiotherapy. Results: There were 11 males (48%) and 12 females (52%), with a median age of 58 years (30-72 years). Primary lesions were located in the nasal cavity and paranasal sinuses in 9 cases (39%), anorectum in 9 cases (39%), vagina in 3 cases (13%), esophagus in 1 case (4%), and choroid in 1 case (4%). There were 7 patients with local advanced disease and 16 patients with metastatic disease. 1 patient received prior anti-PD1 therapy, 1 patient received prior chemotherapy, the other 19 patients received no prior systemic therapy. A total of 21 patients underwent gene detection, there were 2 patients (10%) with BRAF mutation (one with V600E mutation, one with G606E mutation), 7 patients (33%) with NRAS mutation (3 with exon 2 mutation, 4 with exon 3 mutation), and 1 patient (5%) with KIT exon 11 mutation. Overall, 4 patients (13%) had CR, 4 patients (22%) had PR, 10 patients had SD (43%), and 5 patients (22%) had PD, resulting in a RR of 35% and a DCR of 78%. The 4 patients with CR were with localized disease and received concurrent radiotherapy. The RR were 44%, 33%, 33%, 0% and 0%, and the DCR were 100%, 67%, 67%, 0%, and 100% in patients with melanoma of the nasal cavity, anorectum, vagina, esophagus and choroid respectively. The median PFS was 7.5 months (95% CI: 1.0-14.0months). The median OS was 14.7 months (95% CI: 5.0-24.4months). Grade III/IV adverse events were leucopenia (13%), thrombocytopenia (13%), anemia (4%), nausea and vomiting (4%), elevated transaminase (4%), nasal hemorrhage (4%) and intestinal obstruction (4%). Conclusions: Endostar combined with chemotherapy is effective and safe in the treatment of AMM, especially for patients with melanoma of the nasal cavity and paranasal sinuses. For mucosal melanoma patients with local advanced disease, concurrent chemoradiotherapy may be a good choice. It deserves further study.