Erlotinib versus gemcitabine/cisplatin in Chinese patients with EGFR mutation-positive advanced non-small-cell lung cancer: Crossover extension and post-hoc analysis of the ENSURE study

Autor: Yunzhong Zhu, Ying Cheng, Xiaoqing Liu, Cheng Huang, E. Li, Houjie Liang, Yi-Long Wu, Shukui Qin, Gang Wu, Guo-Liang Jiang, Zhaoyang Zhong, Baohui Han, Caicun Zhou, Shun Lu, Lei Chen, Hongming Pan
Rok vydání: 2018
Předmět:
0301 basic medicine
Oncology
Male
Cancer Research
Lung Neoplasms
medicine.medical_treatment
Deoxycytidine
0302 clinical medicine
Carcinoma
Non-Small-Cell Lung
Antineoplastic Combined Chemotherapy Protocols
Medicine
Epidermal growth factor receptor
education.field_of_study
Cross-Over Studies
biology
Middle Aged
ErbB Receptors
Treatment Outcome
030220 oncology & carcinogenesis
Female
Erlotinib
medicine.drug
Pulmonary and Respiratory Medicine
Adult
medicine.medical_specialty
China
Population
03 medical and health sciences
Erlotinib Hydrochloride
Internal medicine
Humans
Lung cancer
education
Survival analysis
Aged
Neoplasm Staging
Chemotherapy
business.industry
medicine.disease
Survival Analysis
Gemcitabine
respiratory tract diseases
030104 developmental biology
Mutation
biology.protein
Cisplatin
business
Progressive disease
Follow-Up Studies
Zdroj: Lung cancer (Amsterdam, Netherlands). 130
ISSN: 1872-8332
Popis: Objectives Sequential combination of epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) and chemotherapy has shown greater benefits than either treatment alone in non-small-cell lung cancer (NSCLC). In this follow-up of the ENSURE study, we evaluated progression-free survival (PFS) with first-line erlotinib followed by chemotherapy at progression versus the inverse treatment sequence in 175 Chinese patients with EGFR mutation-positive NSCLC. Materials and methods Forty-five of the 175 patients included in the follow-up analysis experienced progressive disease (PD). Those with PD on first-line erlotinib (n = 24) received gemcitabine/cisplatin while those who failed first-line chemotherapy (n = 21) received erlotinib until second-line PD. The primary endpoint was PFS in the crossover subpopulation. Post-hoc analysis of survival outcomes was also measured for the overall population of 175 Chinese patients. Results Among patients who crossed over at progression, PFS was comparable between those who received second-line erlotinib and those who received second-line chemotherapy (median, 26.3 months and 23.4 months, respectively; P = 0.529). Regardless of the sequence in which the therapies were administered, patients in the crossover treatment subgroup benefited from either second-line therapy after progression with a median overall survival of 51.6 months versus 23.0 months achieved among patients in the non-crossover treatment subgroup. Post-hoc biomarker analyses of Kaplan–Meier survival curves and Cox regression showed that survival benefits with either treatment sequence were similar between patients with circulating free DNA EGFR mutations in exons 19 and 21; however, those with undetectable mutations achieved significantly greater survival benefits. Conclusion In advanced EGFR mutation-positive NSCLC, first-line erlotinib followed by chemotherapy at progression demonstrated comparable PFS benefit with the inverse treatment sequence, irrespective of mutation subtype. Utilizing both EGFR-TKIs and chemotherapy, irrespective of the sequence, maximizes survival benefits for patients.
Databáze: OpenAIRE
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