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超越临床试验:免疫疗法对约旦非小细胞肺癌的现实世界影响。

Beyond clinical trials: real-world impact of immunotherapy on NSCLC in Jordan.

作者信息

Abu Hejleh Taher, AlSawalha Karim, Abdel Hafiz Sufian, Al-Batsh Tamer, Abu Hejleh Roaa, Yaser Sameer, Abu Jazar Husam, Khader Jamal, Alnsour Anoud, Mohamad Issa, Abdel Jalil Riad, Abu-Shanab Ahmad, Gharaibeh Azza, Abu Shattal Mohammad, Alibraheem Akram, Haddad Hussam, Mahmoud Naser, Obeidat Shadi, Al-Jaghbeer Mohammed J, Furqan Muhammad, Cortellini Alessio, Velcheti Vamsidhar, Al-Rabi Kamal

机构信息

Department of Internal Medicine, Medical Oncology, King Hussein Cancer Center, Amman, Jordan.

Department of Internal Medicine, Hematology, Oncology and Blood and Marrow Transplantation, University of Iowa, Iowa City, IA, United States.

出版信息

Front Oncol. 2024 Apr 30;14:1369126. doi: 10.3389/fonc.2024.1369126. eCollection 2024.

Abstract

BACKGROUND

This study aims to evaluate real-world (rw) outcomes of immunotherapy (IO) for advanced stage NSCLC at King Hussein Cancer Center (KHCC) in Jordan.

METHODS

Advanced stage NSCLC patients who received IO at KHCC between 2017 and 2022 were included. The data were retrospectively collected. PFS and OS were estimated for patients with ECOG performance status (ECOG PS) 0-1. Cox regression analyzed predictors of OS in first-line (1L) IO, regardless of performance status.

RESULTS

The total number of patients included was 244. Out of those, 160 (65%), 67 (28%), and 17 (7%) patients received IO as 1L, second-line (2L), or third-line or beyond (3L or beyond), respectively. The median age for all patients was 59 years. Male were 88%, and 77% were smokers. The median follow-up time was 12.5 months. The median PFS and OS for 1L IO were 7 [95% CI 5.8 - 10.3] and 11.8 [95% CI 8.8 - 14.4], months, respectively. In the first 3 months after starting 1L IO, 34/160 (21%) patients had died. For those who survived beyond 3 months after starting 1L IO, the median PFS and OS were 11.3 [95% CI 8.3 - 16.5] and 15.4 [95% CI 13.2 - 21] months, respectively. In the Cox regression model of 1L IO patients with any performance status, ECOG PS 2 was predictive of worse OS compared to ECOG PS 0-1 (= 0.005).

CONCLUSION

This real-world study of advanced-stage NSCLC patients treated with immunotherapy at KHCC reveals outcomes that fall short of those anticipated from clinical trials. The inclusion of Middle Eastern patients in lung cancer trials is essential to ensure adequate representation of various ethnicities in clinical research.

摘要

背景

本研究旨在评估约旦侯赛因国王癌症中心(KHCC)晚期非小细胞肺癌(NSCLC)免疫治疗(IO)的真实世界(rw)疗效。

方法

纳入2017年至2022年期间在KHCC接受IO治疗的晚期NSCLC患者。数据进行回顾性收集。对东部肿瘤协作组体能状态(ECOG PS)为0 - 1的患者评估无进展生存期(PFS)和总生存期(OS)。Cox回归分析一线(1L)IO治疗中OS的预测因素,不考虑体能状态。

结果

纳入患者总数为244例。其中,160例(65%)、67例(28%)和17例(7%)患者分别接受1L、二线(2L)或三线及以上(3L或以上)IO治疗。所有患者的中位年龄为59岁。男性占88%,77%为吸烟者。中位随访时间为12.5个月。1L IO治疗的中位PFS和OS分别为7[95%置信区间(CI)5.8 - 10.3]个月和11.8[95% CI 8.8 - 14.4]个月。在开始1L IO治疗后的前3个月,34/160(21%)例患者死亡。对于开始1L IO治疗后存活超过3个月的患者,中位PFS和OS分别为11.3[95% CI 8.3 - 16.5]个月和15.4[95% CI 13.2 - 21]个月。在任何体能状态的1L IO患者的Cox回归模型中,与ECOG PS 0 - 1相比,ECOG PS 2预测OS更差(= 0.005)。

结论

这项在KHCC对接受免疫治疗的晚期NSCLC患者进行的真实世界研究显示,其疗效低于临床试验预期。将中东患者纳入肺癌试验对于确保临床研究中各民族的充分代表性至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9698/11091385/a35f27a3f7e5/fonc-14-1369126-g001.jpg

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