信迪利单抗注射液联合注射用紫杉醇 (白蛋白结合型) 治疗复发或难治性 ES-SCLC 的临床研究.

OBJECTIVE: To evaluate the efficacy and safety of sintilimab injection combined with paclitaxel injection (albumin-bound) in the second-line treatment of patients with relapsed or refractory extensive stage (ES) of small cell lung cancer (SCLC). METHODS: A total of 74 patients with ES-SCLC who progressed after first-line application of etoposide / platinum-based chemotherapy admitted into Beijing Friendship Hospital, Capital Medical University from Jan. 2022 to Jan. 2023 were selected to be divided into 38 cases in the research group and 36 cases in the control group via random number table method. The research group was given sintilimab injection combined with paclitaxel injection (albumin-bound), while the control group received topotecan hydrochloride injection. The objective remission rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and adverse drug reactions of both groups were observed. RESULTS: The ORR of research group and control group were 26. 3% (10 / 38) and 13. 9% (5 / 36) (P = 0. 035), the DCR were 84. 2% (32 / 38) and 72. 2% (26 / 36) (P = 0. 042), the median PFS were 6. 00 months and 3. 45 months (P = 0. 013), the median OS were 10. 30 months and 8. 75 months (P = 0. 007), respectively, with statistically significant differences. There was no statistically significant difference in the incidences of adverse drug reactions between two groups (P>0. 05). CONCLUSIONS: Compared with the topotecan hydrochloride injection, sindilizumab injection in combination with paclitaxel (albumin-bound) has prolonged survivals in patients with relapsed or refractory ES-SCLC with tolerable adverse drug reactions. [ABSTRACT FROM AUTHOR]