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      老年肺癌患者的免疫治疗疗效分析 Translated title: Analysis of the Efficacy of Immunotherapy in Elderly Patients with Lung Cancer

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          Abstract

          背景与目的

          以免疫检查点抑制剂(immune checkpoint inhibitors, ICIs)为代表的免疫疗法成为驱动基因阴性晚期非小细胞肺癌(non-small cell lung cancer, NSCLC)的标准治疗方式。但是,肺癌高发于老年患者,而这部分患者很少被纳入重要的临床试验研究。我们旨在研究“真实世界”老年肺癌人群免疫治疗的疗效和安全性。

          方法

          回顾性分析2018年7月-2021年10月期间接受免疫治疗的老年NSCLC患者和同期的年轻患者,比较不同年龄分组(< 60岁组为中青年组,60岁-74岁为年轻老年组,75岁及以上为一般老年组)患者的客观缓解率(objective response rate, ORR)和无进展生存期(progression-free survival, PFS),并在各年龄亚组中分析不同临床特征对疗效的影响。

          结果

          共有21例中青年患者、70例年轻老年患者和15例一般老年患者被纳入本次研究,ORR分别为33.3%、52.8%和53.3%,差异无统计学意义( P=0.284);中位PFS分别9.1个月、7.6个月和10.9个月,差异无统计学意义( P=0.654)。进一步对各亚组免疫治疗的预测因素进行分析,发现在年轻老年组和中青年组中,一线接受免疫治疗的患者的PFS更长。三组不良反应的发生率差异无统计学意义( P>0.05)。

          结论

          老年患者接受免疫治疗后的有效性和安全性均与年轻患者相近,一线接受免疫治疗的PFS更长,仍需进一步的前瞻性研究来阐明免疫治疗对老年NSCLC患者的影响。

          Translated abstract

          Background and objective

          Immunotherapy represented by immune checkpoint inhibitors (ICIs) has become the standard treatment for patients with non-oncogenic advanced non-small cell lung cancer (NSCLC). While lung cancer is most prevalent in elderly patients, these patients are rarely included in pivotal clinical trial studies. We aimed to describe the efficacy and safety of immunotherapy for elderly patients in the "real-world".

          Methods

          The data of older NSCLC patients and younger patients who received immunotherapy between July 2018 to October 2021 were retrospectively analyzed and the objective response rate (ORR) and progression-free survival (PFS) in different age groups (less than 60 years old was defined as the young group, 60 years-74 years old was the young old group, 75 years old and above was the old old group) were compared. And the impact of different clinical characteristics on treatment response and prognosis were analyzed in each age subgroup.

          Results

          A total of 21 young patients, 70 young old patients and 15 old old patients were included in this study, with ORR of 33.3%, 52.8% and 53.3%, respectively, without statistically significant difference ( P=0.284). The median PFS was 9.1 mon, 7.6 mon and 10.9 mon, respectively, without statistically significant difference ( P=0.654). Further analysis of the predictors of immunotherapy in each subgroup revealed that patients in the young old group and young group who received immunotherapy in the first line had a longer PFS. The difference of the incidence of adverse events was not statistically significant among the three groups ( P>0.05).

          Conclusion

          The efficacy and safety of immunotherapy in elderly patients were similar to those in younger patients, and PFS was superior in the first-line immunotherapy. Further prospective studies are still needed to explore predictors of immunotherapy in elderly NSCLC patients.

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          Most cited references19

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          • Abstract: found
          • Article: not found
          Is Open Access

          Cancer statistics, 2022

          Each year, the American Cancer Society estimates the numbers of new cancer cases and deaths in the United States and compiles the most recent data on population-based cancer occurrence and outcomes. Incidence data (through 2018) were collected by the Surveillance, Epidemiology, and End Results program; the National Program of Cancer Registries; and the North American Association of Central Cancer Registries. Mortality data (through 2019) were collected by the National Center for Health Statistics. In 2022, 1,918,030 new cancer cases and 609,360 cancer deaths are projected to occur in the United States, including approximately 350 deaths per day from lung cancer, the leading cause of cancer death. Incidence during 2014 through 2018 continued a slow increase for female breast cancer (by 0.5% annually) and remained stable for prostate cancer, despite a 4% to 6% annual increase for advanced disease since 2011. Consequently, the proportion of prostate cancer diagnosed at a distant stage increased from 3.9% to 8.2% over the past decade. In contrast, lung cancer incidence continued to decline steeply for advanced disease while rates for localized-stage increased suddenly by 4.5% annually, contributing to gains both in the proportion of localized-stage diagnoses (from 17% in 2004 to 28% in 2018) and 3-year relative survival (from 21% to 31%). Mortality patterns reflect incidence trends, with declines accelerating for lung cancer, slowing for breast cancer, and stabilizing for prostate cancer. In summary, progress has stagnated for breast and prostate cancers but strengthened for lung cancer, coinciding with changes in medical practice related to cancer screening and/or treatment. More targeted cancer control interventions and investment in improved early detection and treatment would facilitate reductions in cancer mortality.
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            New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).

            Assessment of the change in tumour burden is an important feature of the clinical evaluation of cancer therapeutics: both tumour shrinkage (objective response) and disease progression are useful endpoints in clinical trials. Since RECIST was published in 2000, many investigators, cooperative groups, industry and government authorities have adopted these criteria in the assessment of treatment outcomes. However, a number of questions and issues have arisen which have led to the development of a revised RECIST guideline (version 1.1). Evidence for changes, summarised in separate papers in this special issue, has come from assessment of a large data warehouse (>6500 patients), simulation studies and literature reviews. HIGHLIGHTS OF REVISED RECIST 1.1: Major changes include: Number of lesions to be assessed: based on evidence from numerous trial databases merged into a data warehouse for analysis purposes, the number of lesions required to assess tumour burden for response determination has been reduced from a maximum of 10 to a maximum of five total (and from five to two per organ, maximum). Assessment of pathological lymph nodes is now incorporated: nodes with a short axis of 15 mm are considered measurable and assessable as target lesions. The short axis measurement should be included in the sum of lesions in calculation of tumour response. Nodes that shrink to <10mm short axis are considered normal. Confirmation of response is required for trials with response primary endpoint but is no longer required in randomised studies since the control arm serves as appropriate means of interpretation of data. Disease progression is clarified in several aspects: in addition to the previous definition of progression in target disease of 20% increase in sum, a 5mm absolute increase is now required as well to guard against over calling PD when the total sum is very small. Furthermore, there is guidance offered on what constitutes 'unequivocal progression' of non-measurable/non-target disease, a source of confusion in the original RECIST guideline. Finally, a section on detection of new lesions, including the interpretation of FDG-PET scan assessment is included. Imaging guidance: the revised RECIST includes a new imaging appendix with updated recommendations on the optimal anatomical assessment of lesions. A key question considered by the RECIST Working Group in developing RECIST 1.1 was whether it was appropriate to move from anatomic unidimensional assessment of tumour burden to either volumetric anatomical assessment or to functional assessment with PET or MRI. It was concluded that, at present, there is not sufficient standardisation or evidence to abandon anatomical assessment of tumour burden. The only exception to this is in the use of FDG-PET imaging as an adjunct to determination of progression. As is detailed in the final paper in this special issue, the use of these promising newer approaches requires appropriate clinical validation studies.
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              Pembrolizumab plus Chemotherapy in Metastatic Non–Small-Cell Lung Cancer

              First-line therapy for advanced non-small-cell lung cancer (NSCLC) that lacks targetable mutations is platinum-based chemotherapy. Among patients with a tumor proportion score for programmed death ligand 1 (PD-L1) of 50% or greater, pembrolizumab has replaced cytotoxic chemotherapy as the first-line treatment of choice. The addition of pembrolizumab to chemotherapy resulted in significantly higher rates of response and longer progression-free survival than chemotherapy alone in a phase 2 trial.
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                Author and article information

                Contributors
                Journal
                Zhongguo Fei Ai Za Zhi
                Zhongguo Fei Ai Za Zhi
                ZGFAZZ
                Chinese Journal of Lung Cancer
                中国肺癌杂志编辑部 (天津市和平区南京路228号300020 )
                1009-3419
                1999-6187
                20 June 2022
                : 25
                : 6
                : 401-408
                Affiliations
                [1 ] 101149 北京,北京市结核病胸部肿瘤研究所,首都医科大学附属北京胸科医院肿瘤内科 Department of Medical Oncology, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing Chest Hospital, Capital Medical University, Beijing 101149, China
                [2 ] 101149 北京,北京市结核病胸部肿瘤研究所,首都医科大学附属北京胸科医院肿瘤研究中心 Cancer Research Center, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing Chest Hospital, Capital Medical University, Beijing 101149, China
                Author notes
                马腾, Teng MA, E-mail: mateng82913@ 123456163.com
                王敬慧, Jinghui WANG, E-mail: jinghuiwang2006@ 123456163.com
                Article
                zgfazz-25-6-401
                10.3779/j.issn.1009-3419.2022.102.16
                9244504
                35747919
                a6cd4adb-24f9-4d4f-8ade-ee180c58ab49
                版权所有©《中国肺癌杂志》编辑部2022Copyright ©2022 Chinese Journal of Lung Cancer. All rights reserved.

                This is an open access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 3.0) License. See: https://creativecommons.org/licenses/by/3.0/.

                History
                : 4 March 2022
                : 28 April 2022
                : 12 May 2022
                Categories
                临床研究

                肺肿瘤,老年患者,免疫治疗,预后因素,安全性,lung neoplasms,elderly patient,immunotherapy,prognostic factor,safety

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