Manasee V. Shah, Caitlyn T. Solem, Kelly F. Bell, Amine Aziez, Xuezheng Sun, Mandy Du, Ella X. Du, Hongbo Yang, Hongjue Wang, Qi Hua, Umit Tapan
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引用次数: 0
Abstract
Introduction
Immuno-oncology (IO) agents and pemetrexed are approved for the first-line (1L) maintenance treatment (1LMT) of advanced/metastatic non-small cell lung cancer (a/mNSCLC). This international retrospective chart review assessed real-world treatment patterns and outcomes in patients with a/mNSCLC lacking targetable mutations.
Methods
Oncologists from seven countries (Canada, France, Germany, Italy, Spain, UK, USA) provided deidentified, medical chart-derived data on randomly selected adults with a/mNSCLC who remained stable or responded to 1L chemotherapy + IO. Treatment patterns, overall survival (OS), progression-free survival (PFS), and healthcare resource utilization (HCRU) were compared by maintenance treatment use following propensity score weighting. The effects of adding pemetrexed to IO-containing 1LMT was investigated in patients with non-squamous/mixed histology.
Results
Of 942 patients analyzed, 680 initiated 1LMT. After weighting, 1LMT was associated with longer median PFS (17.7 vs 7.1 months; HR [95% CI] 0.63 [0.41–0.85]), similar OS (31.7 vs 31.0 months; 0.82 [0.47–1.17]), and fewer mean monthly hospitalizations (0.03 vs 0.1; p < 0.01) versus no 1LMT. Among 469 patients with non-squamous/mixed histology who initiated an IO-containing 1LMT, 283 received IO only while 186 received IO + pemetrexed. Median time to treatment discontinuation (20.0 vs 11.0 months; p < 0.001), PFS (21.1 vs 11.1 months; HR [95% CI] 0.56 [0.37–0.76]), and OS (35.3 vs 27.3 months; 0.70 [0.41–0.98]) were longer for patients receiving IO only versus IO + pemetrexed. Fewer patients administered IO only experienced fatigue (28.3% vs 39.8% [IO + pemetrexed]; p < 0.05) and anemia (16.6% vs 31.2%; p < 0.001).
Conclusion
1LMT was associated with significantly longer PFS and similar OS, without substantially increasing HCRU, among the current study population with a/mNSCLC. Adding pemetrexed to 1LM IO did not confer significant clinical benefit in patients with non-squamous/mixed histology and these patients incurred more adverse events. Additional 1LMT options are needed to further improve clinical outcomes.
免疫肿瘤学(IO)药物和培美曲塞被批准用于晚期/转移性非小细胞肺癌(a/mNSCLC)的一线(1L)维持治疗(1LMT)。这项国际回顾性图表回顾评估了缺乏靶向突变的a/mNSCLC患者的现实世界治疗模式和结果。方法:来自七个国家(加拿大,法国,德国,意大利,西班牙,英国,美国)的肿瘤学家提供了随机选择的a/mNSCLC成人患者的确定的医学图表数据,这些患者保持稳定或对1L化疗+ IO有反应。通过倾向评分加权后的维持治疗使用情况,比较治疗模式、总生存期(OS)、无进展生存期(PFS)和医疗资源利用率(HCRU)。研究了非鳞状/混合组织学患者在含io的1LMT中加入培美曲塞的效果。结果:在分析的942例患者中,680例开始了lmt1。加权后,1LMT与更长的中位PFS相关(17.7 vs 7.1个月;HR [95% CI] 0.63 [0.41-0.85]), OS相似(31.7 vs 31.0个月;0.82[0.47-1.17]),平均每月住院次数更少(0.03 vs 0.1;结论:在当前的a/mNSCLC研究人群中,1LMT与更长的PFS和相似的OS相关,但没有显著增加HCRU。在非鳞状/混合组织学的患者中,将培美曲塞加入1LM IO并没有带来显著的临床益处,这些患者发生了更多的不良事件。需要额外的1LMT选项来进一步改善临床结果。
期刊介绍:
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.