肺癌患者的二线化疗再挑战:一项摩洛哥真实世界研究。

Second-line chemotherapy rechallenge in lung cancer patients: a Moroccan real-world study.

作者信息

Tafenzi Hassan Abdelilah, Choulli Farah, Essadi Ismail, Belbaraka Rhizlane

机构信息

Medical Oncology Department, Mohammed VI University Hospital of Marrakech, Marrakech, Morocco.

Biosciences and Health Laboratory, Faculty of Medicine and Pharmacy, Cadi Ayyad University, Marrakech, Morocco.

出版信息

Front Oncol. 2025 May 22;15:1489327. doi: 10.3389/fonc.2025.1489327. eCollection 2025.

Abstract

BACKGROUND

Immune checkpoint inhibitors are the go-to therapeutic option for relapsed non-small cell lung cancer (NSCLC) with unidentified oncogenic drivers when first-line platin doublet chemotherapy fails. Meanwhile, few options exist for the treatment of relapsed patients with small cell lung cancer (SCLC). Through the present study, we evaluate the efficacy and hematologic safety of rechallenging chemotherapy in the second line after the failure of platinum-based chemotherapy.

METHODS

In this retrospective study, we selected patients admitted to a single institution. Adults aged > 18 years with a pathologically proven diagnosis of either NSCLC or SCLC, a PS of 2 or lower, and whose disease progressed during or after a platin-based doublet chemotherapy-containing line of treatment were eligible. The primary outcomes were second-progression-free survival (PFS) and overall survival (OS). Secondary endpoints included the proportion of patients with an overall response (complete or partial response), the disease control rate (DCR), and hematological safety.

RESULTS

Between January 2013 and December 2022, 155 patients were enrolled and treated in the second line with different available regimens of whom 145 had NSCLC and 10 had SCLC. As of December 31, 2022, the median follow-up for the entire cohort was 4.6 [IQR: 2, 9.1] months. Overall, in the NSCLC patients, there was no statistical significance between the tested second-line regimens; the median PFS was 4.5 (95% CI: 3.6, 6.2) months (hazard ratio for progression: 1.1; 95% CI: 0.65, 1.86; p = 0.78), and the median OS was 10 (95% CI: 7.8, 16) months (hazard ratio for death: 1.49; 95% CI: 0.63, 3.54; p = 0.4). For the SCLC patients, we noticed the absence of statistical significance between treatment groups; the median PFS was 5.1 (95% CI: 1.9, Not Estimable [NE]) months (hazard ratio for progression: NE; p = 0.06), while statistical significance has been noticed between treatment groups in terms of proving OS; 5.1 (95% CI: 1.9, NE) months (hazard ratio for death: NE; p = 0.03). The overall response rate has not been reached (complete response = 0%; 2 patients have a partial response), and the disease control rate was 6.9% (n = 9) in the NSCLC population and 20% in the SCLC population. The most common grade 3-4 adverse hematological abnormalities were anemia (n = 30, 19.2%), neutropenia (n = 19, 12.3%), and thrombocytopenia (n = 14, 9.1%).

CONCLUSION

At progression during or after first-line chemotherapy plus platinum, re-challenging single-agent chemotherapy in monotherapy or erlotinib did not offer modest activity in the Moroccan population.

摘要

背景

对于一线铂类双药化疗失败且致癌驱动因素不明的复发非小细胞肺癌(NSCLC)患者,免疫检查点抑制剂是首选的治疗选择。与此同时,小细胞肺癌(SCLC)复发患者的治疗选择很少。通过本研究,我们评估了铂类化疗失败后二线再次挑战化疗的疗效和血液学安全性。

方法

在这项回顾性研究中,我们选取了一家机构收治的患者。年龄大于18岁、经病理证实为NSCLC或SCLC、体能状态(PS)为2或更低且在含铂双药化疗方案治疗期间或之后疾病进展的成年患者符合条件。主要结局为二次无进展生存期(PFS)和总生存期(OS)。次要终点包括总体缓解(完全或部分缓解)患者的比例、疾病控制率(DCR)和血液学安全性。

结果

2013年1月至2022年12月期间,155例患者入组并接受二线不同可用方案治疗,其中145例为NSCLC,10例为SCLC。截至2022年12月31日,整个队列的中位随访时间为4.6 [四分位间距:2,9.1] 个月。总体而言,在NSCLC患者中,所测试的二线方案之间无统计学意义;中位PFS为4.5(95%置信区间:3.6,6.2)个月(进展风险比:1.1;95%置信区间:0.65,1.86;p = 0.78),中位OS为10(95%置信区间:7.8,16)个月(死亡风险比:1.49;95%置信区间:0.63,3.54;p = 0.4)。对于SCLC患者,我们注意到治疗组之间无统计学意义;中位PFS为5.1(95%置信区间:1.9,不可估计 [NE])个月(进展风险比:NE;p = 0.06),而在OS方面治疗组之间存在统计学意义;5.1(95%置信区间:1.9,NE)个月(死亡风险比:NE;p = 0.03)。总体缓解率未达到(完全缓解 = 0%;2例患者部分缓解),NSCLC人群的疾病控制率为6.9%(n = 9),SCLC人群为20%。最常见的3 - 4级血液学异常为贫血(n = 30,19.2%)、中性粒细胞减少(n = 19,12.3%)和血小板减少(n = 14,9.1%)。

结论

在一线化疗加铂期间或之后疾病进展时,再次挑战单药化疗或厄洛替尼在摩洛哥人群中未显示出适度的活性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2fc1/12142062/0e496dbb8b71/fonc-15-1489327-g001.jpg

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