Abstract:

Objective Effective regimens were relatively rare as the further line treatment for patients with advanced Esophageal Squamous Cell Carcinoma（ESCC）. The results of previous clinical study exhibited that anlotinib demonstrated superior efficacy and manageable safety profile as the second ⁃line treatment for advanced ESCC. However，preliminary clinical data in the real world are still not available. Consequently，the purpose of present study was to investigate the efficacy and safety of anlotinib monotherapy for patients with advanced ESCC in real world. Methods This study was designed as a retrospective study. A total of 63 patients with advanced ESCC who met the eligibility criteria and received anlotinib monotherapy from June 2018 to October 2020 were included. The initial dosage of anlotinib was 12 mg and 10 mg. Basic demographic data of patients，efficacy data of the treatment，survival status and safety profile during the treatment were documented and analyzed through the medical records of the patients in the department and the electronic medical record system in the hospital. The primary endpoint of this study was progression free survival （PFS），the secondary endpoints were objective response rate（ORR），disease control rate（DCR），overall survival（OS），safety profile and prognostic analysis according to adverse reaction. Results All the 63 patients corresponded with the eligibility criteria and were available for the evaluation of efficacy and adverse reactions. The best overall response of the patients indicated that partial response was observed in 6 patients，stable disease was noted in 35 patients and progressive disease was seen in 22 patients. Therefore，the ORR of the 63 patients receiving anlotinib monotherapy was 9.5% and DCR was 65.1%. Prognostic data suggested that the median PFS of the 63 patients with advanced ESCC was 3.6 months（95% CI：2.45 ~ 4.75），and the median OS was 7.5 months（95%CI：5.05 ~ 9.95）. In terms of the safety profile，the relatively common adverse reactions of the patients with advanced ESCC who were treated with anlotinib were hypertension（35 patients，55.6%），fatigue（33 patients，52.4%），loss of appetite（27 patients，42.9%）and hand⁃ foot syndrome（25 patients，39.7%）. Given that hypertension was the most common adverse reaction，we performed the association analysis between hypertension status and PFS. And the results suggested that the median PFS of the patients with hypertension was longer than that of those without hypertension（4.8 months vs. 2.8 months），and the difference was statistically significant（P = 0.03）. Conclusion Anlotinib monotherapy demonstrated potential and preliminary efficacy and tolerable safety as the further line treatment for patients with advanced ESCC.

Key words:

esophageal squamous cell carcinoma, anlotinib, efficacy, prognosis, safety, biomarker