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尼伏鲁单抗治疗预处理性胸膜间皮瘤:AIFA 5%基金治疗患者的观察性真实世界研究结果。

Nivolumab in pretreated pleural mesothelioma: Results from an observational real-world study of patients treated within the AIFA 5% Fund.

机构信息

Mesothelioma Unit AO SS, Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.

Projects, Investigation and Innovation Unit, Ospedale Michele e Pietro Ferrero, Verduno, Italy.

出版信息

Tumori. 2024 Jun;110(3):168-173. doi: 10.1177/03008916241229287. Epub 2024 Feb 19.

DOI:10.1177/03008916241229287
PMID:38372045
Abstract

BACKGROUND

Pleural mesothelioma is a rare cancer with a dismal prognosis and few therapeutic options, especially in the pretreated setting. Immunotherapy with checkpoint inhibitors as single agents yielded interesting results in refractory pleural mesothelioma, achieving a response rate between 10-20%, median progression-free survival of 2-5 months and median overall survival of 7-13 months.

PATIENTS AND METHODS

A retrospective, multi-institutional study of pleural mesothelioma patients treated with nivolumab in second and further line was performed. The endpoints of the study are response rate, disease control rate, progression free survival and overall survival.

RESULTS

Sixty-five patients with pleural mesothelioma treated with nivolumab in second and further line were enrolled at seven Italian institutions. The response rate was 8%, disease control rate was 37%, median progression free survival was 5.7 months (95% CI: 2.9-9.0) and median overall survival was 11.1 (95% CI 6.2-19.9) months. A higher neutrophils and neutrophils to lymphocytes ratio at baseline were associated with worse prognosis.

CONCLUSION

Nivolumab as a single agent is fairly active in a cohort of unselected pretreated pleural mesothelioma patients. Further investigations on clinical and translational factors are needed to define which patient might benefit most from nivolumab treatment in pleural mesothelioma.

摘要

背景

胸膜间皮瘤是一种罕见的癌症,预后较差,治疗选择有限,尤其是在预处理环境下。作为单一药物的免疫检查点抑制剂的免疫疗法在难治性胸膜间皮瘤中取得了有趣的结果,达到了 10-20%的缓解率,2-5 个月的无进展生存期中位数和 7-13 个月的总生存期中位数。

患者和方法

对接受纳武利尤单抗二线及以上治疗的胸膜间皮瘤患者进行了回顾性、多机构研究。该研究的终点是缓解率、疾病控制率、无进展生存期和总生存期。

结果

7 家意大利机构共纳入 65 例接受纳武利尤单抗二线及以上治疗的胸膜间皮瘤患者。缓解率为 8%,疾病控制率为 37%,中位无进展生存期为 5.7 个月(95%CI:2.9-9.0),中位总生存期为 11.1 个月(95%CI:6.2-19.9)。基线时较高的中性粒细胞和中性粒细胞与淋巴细胞比值与预后较差相关。

结论

纳武利尤单抗作为单一药物在未经选择的预处理胸膜间皮瘤患者队列中具有相当的活性。需要进一步研究临床和转化因素,以确定哪些患者最有可能从胸膜间皮瘤的纳武利尤单抗治疗中获益。

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