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胸部放疗联合厄洛替尼——一项2期随机试验的结果

Thoracic radiation in combination with erlotinib-results from a phase 2 randomized trial.

作者信息

Nymoen Hanne Marte, Alver Tine Norman, Horndalsveen Henrik, Eide Hanne Astrid, Bjaanæs Maria Moksnes, Brustugun Odd Terje, Grønberg Bjørn Henning, Haakensen Vilde Drageset, Helland Åslaug

机构信息

Institute for Cancer Research, Department of Cancer Genetics, Oslo University Hospital, Oslo, Norway.

Department of Clinical Medicine, University of Oslo, Oslo, Norway.

出版信息

Front Oncol. 2024 Aug 1;14:1412716. doi: 10.3389/fonc.2024.1412716. eCollection 2024.

DOI:10.3389/fonc.2024.1412716
PMID:39148905
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11324589/
Abstract

BACKGROUND

Radiotherapy (RT) can be used to reduce symptoms and maintain open airways for patients with non-small cell lung cancer when systemic treatment is not sufficient. For some patients, tumor control is not achieved due to radioresistance. Concurrent inhibition of epidermal growth factor receptors has been proposed as a strategy to overcome radioresistance but may increase toxicity. We performed a randomized trial to assess the efficacy, tolerance, and quality of life of concurrent erlotinib and palliative thoracic RT for patients with advanced non-small cell lung cancer.

METHODS

Patients were randomized 1:1 to RT alone (arm A) or in combination with erlotinib (arm B). A computed tomography (CT) scan at baseline and one at 4-12 weeks after inclusion was used to evaluate treatment response. Adverse events were registered during treatment and the subsequent 30 days. Health-related quality-of-life questionnaires were completed by the patients at baseline, weeks 2, 6, and 20.

RESULTS

A total of 114 patients were included. Of the 74 patients with CT scans available for evaluation of treatment effect, there were no significant differences in tumor size reduction between the two groups: median 14.5% reduction in the control arm A and 17.0% in the erlotinib arm B ( = 0.68). Overall survival was not significantly different between the two treatment arms: 7.0 and 7.8 months in arm A and arm B, respectively (log-rank = 0.32). There was no significant increase in adverse events in the experimental arm, other than what is expected from erlotinib treatment alone. Overall, patients reported similar quality of life in both treatment arms.

CONCLUSION

Concurrent erlotinib and palliative thoracic RT for patients with advanced non-small cell lung cancer was well tolerated but did not improve the efficacy of the RT.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, identifier NCT02714530.

摘要

背景

当全身治疗不足时,放射治疗(RT)可用于减轻非小细胞肺癌患者的症状并维持气道通畅。对于一些患者,由于放射抗性,无法实现肿瘤控制。同时抑制表皮生长因子受体已被提议作为克服放射抗性的策略,但可能会增加毒性。我们进行了一项随机试验,以评估厄洛替尼与姑息性胸部放疗联合应用于晚期非小细胞肺癌患者的疗效、耐受性和生活质量。

方法

患者按1:1随机分为单纯放疗组(A组)或放疗联合厄洛替尼组(B组)。在基线时进行计算机断层扫描(CT)扫描,并在纳入后4 - 12周进行一次扫描,以评估治疗反应。在治疗期间及随后30天记录不良事件。患者在基线、第2、6和20周完成与健康相关的生活质量问卷。

结果

共纳入114例患者。在74例可进行治疗效果评估的CT扫描患者中,两组间肿瘤大小缩小无显著差异:对照组A组中位数缩小14.5%,厄洛替尼组B组为17.0%(P = 0.68)。两个治疗组的总生存期无显著差异:A组和B组分别为7.0个月和7.8个月(对数秩检验P = 0.32)。除了厄洛替尼单独治疗预期的不良事件外,试验组不良事件无显著增加。总体而言,两组患者报告的生活质量相似。

结论

晚期非小细胞肺癌患者同时接受厄洛替尼和姑息性胸部放疗耐受性良好,但未提高放疗疗效。

临床试验注册

ClinicalTrials.gov,标识符NCT02714530。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2880/11324589/7ed15e33cbfa/fonc-14-1412716-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2880/11324589/cce92debdf8d/fonc-14-1412716-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2880/11324589/ca7580c3b862/fonc-14-1412716-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2880/11324589/7ed15e33cbfa/fonc-14-1412716-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2880/11324589/cce92debdf8d/fonc-14-1412716-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2880/11324589/ca7580c3b862/fonc-14-1412716-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2880/11324589/7ed15e33cbfa/fonc-14-1412716-g003.jpg

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本文引用的文献

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