一线培美曲塞加卡铂维持治疗新诊断和转移性老年非鳞状非小细胞肺癌（NSCLC）的疗效和安全性：加利西亚和地中海肺癌组的真实世界数据（RWD）

IF 2.4 Q3 Medicine

Cancer treatment and research communications Pub Date : 2025-01-01 DOI:10.1016/j.ctarc.2025.100960

Arias Ron David , Álvarez Fernández Javier , García Benito Carme , Huidobro Vence Gerardo , García Lorenzo Carme , Santomé Couto Lucía , Amenedo Gancedo Margarita , Esquerdo Galiana Gaspar , Areses Manrique María Carmen , Fernández Núñez Natalia , Lázaro Quintela Martín , Casal Rubio Joaquín , Afonso Afonso Francisco Javier , Campos Balea Begoña , García Mata Jesús , Aversa Caterina , Vázquez Estévez Sergio , Fírvida Pérez Jose Luis

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引用次数: 0

摘要

培美曲塞联合铂化疗在新诊断和转移性非鳞状NSCLC中的作用自派拉蒙试验结果以来得到了明确的定义。目前，铂类化疗加免疫治疗已成为大多数患者的金标准治疗。老年患者在临床试验中的代表性通常不足，并且缺乏这方面的数据。我们分析了铂-培美曲塞化疗在一组新诊断和转移性老年非鳞状NSCLC患者中的疗效和安全性。患者和方法在这个多中心、回顾性、真实世界队列研究中，我们收集了所有年龄≥70岁的新诊断和转移性非鳞状NSCLC，并接受卡铂-培美曲塞化疗和培美曲塞维持治疗。描述了患者的特征、合并症和突变状态。我们的目的是分析双药方案在老年队列中的有效性和安全性。结果67例患者纳入分析。中位年龄为75岁（70-84岁），多数表现为表现状态（PS） 1(79%)， 36%表现为肺外转移。52%的患者至少有三种合并症。中位PFS为5.3个月（CI 95% 4-6.6, p = 0.66），中位OS为9.7个月（CI 95% 8.3-11.1, p = 0.72）。疲劳（14%）和中性粒细胞减少（12%）是最常见的3-4级不良事件（AE），而虚弱（64%）是最常见的1-2级AE。结论培美曲塞基础化疗加培美曲塞维持治疗对于≥70岁的新诊断和转移性非鳞状NSCLC患者是有效和安全的，在生存和毒性方面与关键试验的结果相似。因此，对于不适合铂化疗+免疫检查点抑制剂（ICIs）三重方案的患者，或者无法获得这些方案的患者，可以考虑将这种双重方案作为替代方案。

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Efficacy and safety of first-line pemetrexed plus carboplatin followed by pemetrexed maintenance in newly diagnosed and metastatic elderly non-squamous Non-Small Cell Lung Cancer (NSCLC): Real World Data (RWD) of a Galician and Mediterranean lung cancer group

Background

The role of Pemetrexed combined with platinum chemotherapy in newly diagnosed and metastatic non-squamous NSCLC is clearly defined since the results of Paramount trial. Currently, platinum chemotherapy plus immunotherapy has become the gold standard treatment in most of patients. Elderly patients are usually underrepresented in clinical trials and there is a lack of data in this setting. We analysed the efficacy and safety of platinum-pemetrexed chemotherapy in a cohort of newly diagnosed and metastatic elderly non-squamous NSCLC patients.

Patients and methods

In this multicentre, retrospective, real-world cohort, we collected all newly diagnosed and metastatic non-squamous NSCLC aged ≥70 years and treated with carboplatin-pemetrexed chemotherapy followed by pemetrexed maintenance. Patients characteristics, comorbidities and mutational status were described. Our objective is to analyse the efficacy and safety of doublet regimen in an elderly cohort.

Results

67 patients were included in the analysis. Median age was 75 years (70–84), mostly of them showed Performance status (PS) 1 (79 %) and 36 % presented with extrapulmonary metastases. 52 % of patients presented at least three comorbidities. Median PFS was 5.3 months (CI 95 % 4–6.6, p = 0.66) while median OS was 9.7 months (CI 95 % 8.3–11.1, p = 0.72). Fatigue (14 %) and neutropenia (12 %) were the most common grade 3–4 Adverse Event (AE), while asthenia (64 %) was the most common grade 1–2 AE.

Conclusion

Pemetrexed-based chemotherapy followed by pemetrexed maintenance is efficacious and safe in newly diagnosed and metastatic non-squamous NSCLC patients aged ≥70 years, achieving similar results in terms of survival and toxicity than pivotal trials. So, this doublet regimen may be considered as an alternative in patients who are not candidate for triplet regimen with platinum chemotherapy plus Immune Checkpoint Inhibitors (ICIs) or they don´t have access for them.

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来源期刊

Cancer treatment and research communications Medicine-Oncology

CiteScore

4.30

自引率

0.00%

发文量

148

审稿时长

56 days

期刊介绍： Cancer Treatment and Research Communications is an international peer-reviewed publication dedicated to providing comprehensive basic, translational, and clinical oncology research. The journal is devoted to articles on detection, diagnosis, prevention, policy, and treatment of cancer and provides a global forum for the nurturing and development of future generations of oncology scientists. Cancer Treatment and Research Communications publishes comprehensive reviews and original studies describing various aspects of basic through clinical research of all tumor types. The journal also accepts clinical studies in oncology, with an emphasis on prospective early phase clinical trials. Specific areas of interest include basic, translational, and clinical research and mechanistic approaches; cancer biology; molecular carcinogenesis; genetics and genomics; stem cell and developmental biology; immunology; molecular and cellular oncology; systems biology; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; cancer policy; and integration of various approaches. Our mission is to be the premier source of relevant information through promoting excellence in research and facilitating the timely translation of that science to health care and clinical practice.