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一线阿法替尼治疗 EGFR 阳性非小细胞肺癌患者的临床分析:长野肺癌研究组。

Clinical analysis of EGFR-positive non-small cell lung cancer patients treated with first-line afatinib: A Nagano Lung Cancer Research Group.

机构信息

First Department of Internal Medicine, Shinshu University School of Medicine, Matsumoto City, Japan.

Department of Comprehensive Cancer Therapy, Shinshu University School of Medicine, Matsumoto City, Japan.

出版信息

Thorac Cancer. 2019 May;10(5):1078-1085. doi: 10.1111/1759-7714.13047. Epub 2019 Apr 20.

Abstract

BACKGROUND

In the LUX-Lung 3 and LUX-Lung 6 trials, afatinib improved overall survival in previously untreated patients with EGFR 19del mutated non-small cell lung cancer (NSCLC) compared to chemotherapy. The appropriate management of adverse events and dose reduction of afatinib are important for EGFR-positive NSCLC patients. We conducted a retrospective and observational study of patients treated with first-line afatinib for EGFR-positive NSCLC in Nagano prefecture, Japan, focusing on efficacy and toxicities.

METHODS

We retrospectively collected the medical records of NSCLC patients initially treated with afatinib between May 2014 and March 2018.

RESULTS

A total of 62 patients with a median age of 67 years and a median body surface area (BSA) of 1.57 m were included. The overall response rate was 87.7% and median progression-free survival (PFS) was 15.7 months. The median PFS was similar between standard initial dose (40 mg) and reduced initial doses (30 and 20 mg) (15.7 vs. 14.2 months; P = 0.978). The frequency of dose reduction and the discontinuation rate in the 40 mg daily dose group was higher in patients with BSA < 1.58 m (100%) compared to BSA ≥ 1.58 m (68.2%) (P = 0.014). The frequency of diarrhea was higher in patients with BSA < 1.58 m (93.5%) compared to BSA ≥ 1.58 m (71.0%) (P = 0.02).

CONCLUSION

In real-world clinical practice, first-line afatinib was well managed and was equally as effective as in previous clinical trials of EGFR-positive NSCLC. BSA is considered a predictive marker for appropriate afatinib dose reduction.

摘要

背景

在 LUX-Lung 3 和 LUX-Lung 6 试验中,与化疗相比,阿法替尼改善了未经治疗的 EGFR 19del 突变非小细胞肺癌(NSCLC)患者的总生存期。对于 EGFR 阳性 NSCLC 患者,不良事件的适当管理和阿法替尼的剂量减少是很重要的。我们对日本长野县接受一线阿法替尼治疗的 EGFR 阳性 NSCLC 患者进行了一项回顾性和观察性研究,重点关注疗效和毒性。

方法

我们回顾性收集了 2014 年 5 月至 2018 年 3 月期间首次接受阿法替尼治疗的 NSCLC 患者的病历。

结果

共纳入 62 例患者,中位年龄为 67 岁,中位体表面积(BSA)为 1.57m。总缓解率为 87.7%,中位无进展生存期(PFS)为 15.7 个月。标准初始剂量(40mg)和初始剂量降低(30mg 和 20mg)之间的中位 PFS 相似(15.7 与 14.2 个月;P=0.978)。BSA<1.58m 的患者中,每日 40mg 剂量组的剂量降低频率和停药率高于 BSA≥1.58m 的患者(100%比 68.2%;P=0.014)。BSA<1.58m 的患者腹泻发生率高于 BSA≥1.58m 的患者(93.5%比 71.0%;P=0.02)。

结论

在真实世界的临床实践中,一线阿法替尼得到了很好的管理,与之前 EGFR 阳性 NSCLC 的临床试验一样有效。BSA 被认为是适当阿法替尼剂量降低的预测标志物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2079/6501023/46422e689d4b/TCA-10-1078-g001.jpg

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