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术前免疫化疗与化疗作为 I-IIIB 期小细胞肺癌患者的一线治疗方案比较

Preoperative immunochemotherapy versus chemotherapy as first-line treatment for patients with stage I-IIIB small-cell lung cancer.

作者信息

Zhu Linhai, Liu Jiacong, Huang Xuhua, Hu Jian

机构信息

Department of Thoracic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, 310003, China.

Key Laboratory of Clinical Evaluation Technology for Medical Device of Zhejiang Province, Hangzhou, 310003, China.

出版信息

BMC Cancer. 2025 Jan 3;25(1):8. doi: 10.1186/s12885-024-13405-0.

Abstract

BACKGROUND

To date, there remains a paucity of comparative investigations pertaining to preoperative immunochemotherapy and conventional chemotherapy in the context of limited-stage small-cell lung cancer (LS-SCLC) patients. This study conducted a comprehensive comparative assessment concerning the safety and efficacy profiles of preoperative immunochemotherapy and chemotherapy in individuals diagnosed with stage I-IIIB SCLC.

METHODS

This investigation collected 53 consecutive patients diagnosed with LS-SCLC spanning stage I to IIIB who underwent preoperative immunochemotherapy or conventional chemotherapy at our hospital from January 2019 to July 2021. Patients were allocated to receive 2-4 cycles of neoadjuvant immunochemotherapy or chemotherapy, with each cycle lasting three weeks. Comprehensive analyses encompassed baseline characteristics, clinical staging, tumor response, intraoperative and postoperative outcomes, and the assessment of treatment-related adverse events (trAEs). The follow-up period is extended for a minimum of one year after surgery. The primary endpoint embraced the evaluation of the pathological response [major pathological response (MPR) and pathological complete remission (pCR)], while secondary endpoints encompassed objective response rate (ORR), trAEs, surgical resection rates, and disease-free survival (DFS).

RESULTS

The objective response rate of the immunochemotherapy group was 89.5%, while that of the chemotherapy group was 75.0% (P = 0.206). A total of 19 patients underwent surgery among these 53 patients, with 14 patients in the neoadjuvant chemoimmunotherapy group and 5 patients in the chemotherapy group. And the surgical resection rate of the immunochemotherapy group was 48.3% (14/29), which was higher than the chemotherapy group (20.8%, 5/24, P = 0.038). The rate of MPR in the immunochemotherapy group was 57.1% (8/14) and 40.0% (2/5) in the chemotherapy group (P = 0.891). The rates of pCR in the immunochemotherapy and chemotherapy group were 50.0% (7/14) and 0.0% (0/5), respectively (P = 0.106).The median DFS for both groups were not reached (P = 0.43). The 2-year DFS rate was 21.4% for the immunochemotherapy group versus 40.0% for the chemotherapy group. There was no significant difference in the incidence of grade 3-4 adverse events between the immunochemotherapy group and the chemotherapy group.

CONCLUSIONS

For patients with stage I-IIIB SCLC, neoadjuvant immunochemotherapy is feasible and safe. Although immunochemotherapy did not significantly associated with longer DFS versus chemotherapy alone in patients with stage I-IIIB SCLC, it can produce significant downstaging and increase the possibility of surgery.

摘要

背景

迄今为止,关于局限期小细胞肺癌(LS-SCLC)患者术前免疫化疗与传统化疗的比较研究仍然匮乏。本研究对诊断为Ⅰ-ⅢB期小细胞肺癌患者的术前免疫化疗和化疗的安全性和疗效进行了全面的比较评估。

方法

本研究收集了2019年1月至2021年7月期间在我院接受术前免疫化疗或传统化疗的53例连续诊断为LS-SCLC且分期为Ⅰ至ⅢB期的患者。患者被分配接受2-4周期的新辅助免疫化疗或化疗,每个周期持续三周。综合分析包括基线特征、临床分期、肿瘤反应、术中和术后结果以及治疗相关不良事件(trAEs)的评估。术后随访期至少延长一年。主要终点是评估病理反应[主要病理反应(MPR)和病理完全缓解(pCR)],次要终点包括客观缓解率(ORR)、trAEs、手术切除率和无病生存期(DFS)。

结果

免疫化疗组的客观缓解率为89.5%,而化疗组为75.0%(P = 0.206)。这53例患者中共有19例接受了手术,新辅助化疗免疫治疗组14例,化疗组5例。免疫化疗组的手术切除率为48.3%(14/29),高于化疗组(20.8%,5/24,P = 0.038)。免疫化疗组的MPR率为57.1%(8/14),化疗组为40.0%(2/5)(P = 0.891)。免疫化疗组和化疗组的pCR率分别为50.0%(7/14)和0.0%(0/5)(P = 0.106)。两组的中位DFS均未达到(P = 0.43)。免疫化疗组的2年DFS率为21.4%,化疗组为40.0%。免疫化疗组和化疗组3-4级不良事件的发生率无显著差异。

结论

对于Ⅰ-ⅢB期小细胞肺癌患者,新辅助免疫化疗是可行且安全的。虽然在Ⅰ-ⅢB期小细胞肺癌患者中,免疫化疗与单独化疗相比并未显著延长DFS,但它可以显著降低分期并增加手术的可能性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4af6/11697882/99541d010c09/12885_2024_13405_Fig1_HTML.jpg

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