Real-world effectiveness and safety of PD-1 inhibitors combined with recombinant human endostatin and chemotherapy in refractory, recurrent/metastatic nasopharyngeal carcinoma.

person Shuang Huang Zhejiang Cancer Hospital, Hangzhou, China info_outline Shuang Huang, Caineng Cao, Mengyun Qiang, Yonghong Hua, Qifeng Jin, Ting Jin, Xiaozhong Chen

Authors person Shuang Huang Zhejiang Cancer Hospital, Hangzhou, China info_outline Shuang Huang, Caineng Cao, Mengyun Qiang, Yonghong Hua, Qifeng Jin, Ting Jin, Xiaozhong Chen Organizations Zhejiang Cancer Hospital, Hangzhou, China Abstract Disclosures Research Funding No funding sources reported Background: Nasopharyngeal carcinoma(NPC) is one of the most common head and neck malignancies with a high overall survival rate. However, the treatment of refractory, recurrent or metastatic NPC is complicated. This study aimed to evaluate the safety and effectiveness of GEP (Gemcitabine combined with recombinant human endostatin (Rh-endostatin) and anti-PD-1 antibody) in patients with refractory, recurrent or metastatic NPC that cannot be treated locally in the real-world setting. Methods: Patients with refractory, recurrent or metastatic NPC (Refractory patients were defined as those unsuitable for local treatment due to extensive tumor recurrence/metastasis or necrosis of ulcers) treated in our hospital from December 2022 to October 2023 were retrospectively reviewed and analyzed. with the GEP regimen. Patients received 1-6 cycles of GEP therapy, including Gemcitabine (1.0 g /m 2 ond1 and d8) combined with Rh-endostatin (180-210 mg/continuous intravenous pump 72-120h) and PD-1 antibody, Objective response rate (ORR) and disease control rate (DCR) were determined by Clopper-Pearson's method. The incidence of adverse events (AES). Results: A total of 25 patients who completed ≥ 2 cycles of treatment and at least one efficacy assessment were included in the efficacy analysis. The median age was 59 years (range: 33-75 years), 36% of patients ≥ 65 years. There was significant liquefaction necrosis in 17 cases (68%). 68% of the patients were treated with second-line or above GEP. 32% (8/25) of patients had tumor progression after anti-vascular therapy, and 44% (11/25) had disease progression after immunotherapy. Based on RECIST 1.1, the ORR was 44.00% (95%CI: 26.67%, 62.93%), and DCR was 92.00% (95%CI: 70.04%, 95.83%). The history of immunotherapy was a significant influence factor on ORR. 30 patients who received at least one course of GEP therapy were included in the safety analysis. Grade 3 AEs were observed in 7 patients (20%), with hematological toxicity (6/7) and hypertension (1/7). Other AEs with more than 20% incidence were hematological toxicity (93.0%), weight loss (67.0%), abdominal distension and constipation (47.0%), hypertension (47%), infection (33.0%), liver dysfunction (27.0%), nausea and vomiting (23.0%), and infusion reaction (20.0%). The recurrent lesions of 15 patients with recurrent NPC were accompanied by significant liquefaction necrosis and ulcers. The ORR was 46.7%, and DCR was 100%. Among them, 5 patients had grade 1 nosebleed, and the other grade 2 or above AEs were hematological toxicity, and there were no grade 4 treatment-related AEs. Conclusions: Real-world data demonstrated that GEP was well-tolerated, safe and effective in patients with refractory, recurrent or metastatic NPC.