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I期至III期非鳞状非小细胞肺癌切除患者的突变患病率:印度队列研究结果

Prevalence of Mutations in Patients With Resected Stage I to III Nonsquamous Non-Small Cell Lung Cancer: Results of India Cohort.

作者信息

Batra Ullas, Prabhash Kumar, Noronha Vanita, Deshpande Ramakant, Khurana Sachin, Bhat Gull Mohammad, Mistry Rajesh, Agarwala Vivek, Rajpurohit Sajjan, Poladia Bhavesh, Sharma Mansi, Banday Saquib Zaffar

机构信息

Thoracic Medical Oncology, Rajiv Gandhi Cancer Institute and Research Center, Rohini, India.

Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.

出版信息

JCO Glob Oncol. 2025 Jan;11:e2400353. doi: 10.1200/GO-24-00353. Epub 2025 Jan 7.

DOI:10.1200/GO-24-00353
PMID:39772802
Abstract

PURPOSE

The spectrum of is inadequately researched in patients with early-stage non-small cell lung cancer (NSCLC) in India. EARLY-epidermal growth factor receptor (EGFR) India (ClinicalTrials.gov identifier: NCT04742192), as part of a noninterventional, real-world global study, evaluated the prevalence of mutations in early-stage NSCLC in India.

METHODS

Prospective data from adult patients with surgically resected stage IA to IIIB (American Joint Committee on Cancer eighth edition) NSCLC between March 2021 and October 2022 were analyzed. In addition to descriptive statistics, Fisher's exact test with Monte Carlo was used to determine the association between mutations and clinicodemographic parameters.

RESULTS

Of 74 patients (median age, 57.0 [range, 33.0-77.0] years) enrolled from eight centers in India, 73.0% (54 of 74) were males, 56.1% (37 of 66) were nonsmokers, and 95.9% (71 of 74) had adenocarcinoma. The mutation prevalence was 26.0% (19 of 73), of which deletions were the predominant subtype (13, 68.4%) followed by (4, 21.1%), (1, 5.3%), and compound (1, 5.3%) mutations. Nearly half (48.6%, 36 of 74) of the patients underwent only surgical resection. The remaining 51.4% (38 of 74) of the patients were prescribed neoadjuvant (n = 12; 16.2%) and adjuvant (n = 31; 41.9%) systemic therapies, and one patient (1.4%) received radiotherapy along with systemic therapy. In 60 patients with stage IB to IIIB NSCLC, systemic therapies, mainly platinum-based chemotherapy, were prescribed in 36 (60.0%). Only 8.1% (6 of 74) of the patients were prescribed EGFR-tyrosine kinase inhibitor (TKI), of which two received neoadjuvant and four were planned for adjuvant EGFR-TKI. Two (2.7%) patients were prescribed adjuvant immunotherapy. The univariate analysis showed higher odds of mutation for females (odds ratio, 3.96; = .017).

CONCLUSION

EARLY-EGFR India results showed the prevalence of mutation to be 26%. The study emphasized the pressing need for up-front biomarker testing at diagnosis to ensure optimal and timely personalized treatment.

摘要

目的

在印度,早期非小细胞肺癌(NSCLC)患者中[具体基因名称未给出]的情况研究不足。印度早期表皮生长因子受体(EGFR)(临床试验.gov标识符:NCT04742192)作为一项非干预性、真实世界的全球研究的一部分,评估了印度早期NSCLC中[具体基因名称未给出]突变的患病率。

方法

分析了2021年3月至2022年10月间接受手术切除的IA至IIIB期(美国癌症联合委员会第八版)NSCLC成年患者的前瞻性数据。除描述性统计外,使用带有蒙特卡洛方法的Fisher精确检验来确定[具体基因名称未给出]突变与临床人口统计学参数之间的关联。

结果

在从印度8个中心招募的74例患者(中位年龄57.0[范围33.0 - 77.0]岁)中,73.0%(74例中的54例)为男性,56.1%(66例中的37例)为非吸烟者,95.9%(74例中的71例)患有腺癌。[具体基因名称未给出]突变患病率为26.0%(73例中的19例),其中[具体基因名称未给出]缺失是主要亚型(13例,68.4%),其次是[具体基因名称未给出](4例,21.1%)、[具体基因名称未给出](1例,5.3%)和复合(1例,5.3%)突变。近一半(48.6%,74例中的36例)患者仅接受了手术切除。其余51.4%(74例中的38例)患者接受了新辅助(n = 12;16.2%)和辅助(n = 31;41.9%)全身治疗,1例患者(1.4%)在接受全身治疗的同时接受了放疗。在60例IB至IIIB期NSCLC患者中,36例(60.0%)接受了全身治疗,主要是铂类化疗。仅8.1%(74例中的6例)患者接受了EGFR酪氨酸激酶抑制剂(TKI)治疗,其中2例接受新辅助治疗,4例计划接受辅助EGFR - TKI治疗。2例(2.7%)患者接受了辅助免疫治疗。单因素分析显示女性[具体基因名称未给出]突变的几率更高(优势比,3.96;P = 0.017)。

结论

印度早期EGFR研究结果显示[具体基因名称未给出]突变患病率为26%。该研究强调了在诊断时进行前期生物标志物检测以确保最佳和及时的个性化治疗的迫切需求。

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