关键词: Small cell lung cancer (SCLC) immune checkpoint inhibitors (ICIs) immune-combination therapy sintilimab

来  源:   DOI:10.21037/jtd-24-769   PDF(Pubmed)

Abstract:
UNASSIGNED: Immune checkpoint inhibitors (ICIs) no longer are approved for second-line or later treatment of extensive-stage small cell lung cancer (ES-SCLC), and have not been studied in combination with chemotherapy. Exploring the efficacy and safety of second-line or later immunotherapy for ES-SCLC is an urgent clinical question that needs to be addressed, and combination therapies are an important research direction. This study intended to investigate the efficacy and safety of the sintilimab in combination with chemotherapy as a second-line and beyond treatment option for ES-SCLC.
UNASSIGNED: Medical records of patients who received treatment with sintilimab in combination with chemotherapy or chemotherapy alone as a second-line or beyond therapy were retrospectively analyzed. The study evaluated efficacy and safety. Indicators of efficacy included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). Safety indicators included adverse events (AEs).
UNASSIGNED: This cohort comprised of 46 patients: 24 in the sintilimab combination chemotherapy group and 22 in the chemotherapy group. Chemotherapy received by both groups was either albumin-bound paclitaxel or irinotecan. Compared with the chemotherapy group, the sintilimab combination chemotherapy group had higher ORR and DCR (ORR: 37.5% vs. 9.1%, P=0.04; DCR: 75.0% vs. 40.9%, P=0.04), and significantly prolonged PFS and OS [median PFS (mPFS): 5.07 vs. 2.45 months, P=0.006; median OS (mOS): 14.43 vs. 10.34 months, P=0.009]. Also, there was no significant increase in the incidence of AEs in the sintilimab combination chemotherapy group, which was well tolerated by patients.
UNASSIGNED: Sintilimab in combination with chemotherapy is superior to single-agent chemotherapeutic treatment as second-line or later therapy in ES-SCLC patients who have not received prior immunotherapy. These results need to be confirmed in future clinical trials.
摘要:
免疫检查点抑制剂(ICIs)不再被批准用于广泛期小细胞肺癌(ES-SCLC)的二线或后期治疗,并且尚未与化疗联合研究。探索ES-SCLC二线或后期免疫治疗的有效性和安全性是一个迫切需要解决的临床问题,联合治疗是一个重要的研究方向。这项研究旨在研究sintilimab联合化疗作为ES-SCLC的二线和超越治疗选择的有效性和安全性。
回顾性分析接受sintilimab联合化疗或单独化疗作为二线或非二线治疗的患者的病历。该研究评估了疗效和安全性。疗效指标包括客观反应率(ORR),疾病控制率(DCR),无进展生存期(PFS),总生存率(OS)。安全性指标包括不良事件(AE)。
该队列包括46名患者:sintilimab联合化疗组24名,化疗组22名。两组均接受白蛋白结合型紫杉醇或伊立替康的化疗。与化疗组相比,辛替利玛联合化疗组的ORR和DCR较高(ORR:37.5%vs.9.1%,P=0.04;DCR:75.0%vs.40.9%,P=0.04),显著延长PFS和OS[中位数PFS(mPFS):5.07vs.2.45个月,P=0.006;中位OS(mOS):14.43vs.10.34个月,P=0.009]。此外,sintilmab联合化疗组的AE发生率没有显著增加,患者耐受性良好。
Sintilimab联合化疗在未接受过免疫治疗的ES-SCLC患者中作为二线或后期治疗优于单药化疗治疗。这些结果需要在未来的临床试验中得到证实。
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