https://scholars.lib.ntu.edu.tw/handle/123456789/494934
標題: | Gefitinib plus chemotherapy versus chemotherapy in epidermal growth factor receptor mutation-positive non-small-cell lung cancer resistant to first-line gefitinib (IMPRESS): Overall survival and biomarker analyses | 作者: | Mok T.S.K Kim S.-W Wu Y.-L Nakagawa K Yang J.-J Ahn M.-J Wang J CHIH-HSIN YANG Lu Y Atagi S Ponce S Shi X Rukazenkov Y Haddad V Thress K.S Soria J.-C. |
公開日期: | 2017 | 出版社: | American Society of Clinical Oncology | 卷: | 35 | 期: | 36 | 起(迄)頁: | 4027-4034 | 來源出版物: | Journal of Clinical Oncology | 摘要: | Purpose: The Iressa Mutation-Positive Multicentre Treatment Beyond ProgRESsion Study (IMPRESS) compared the continuation of gefitinib plus chemotherapy with placebo plus chemotherapy in patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small-cell lung cancer with progression (Response Evaluation Criteria in Solid Tumors 1.1) after first-line gefitinib. Primary results indicated no difference between treatments in terms of progression-free survival (PFS). The current analysis presents final, mature, overall survival (OS) data, together with exploratory analyses that examined whether specific biomarkers, including T790M mutation status, were able to differentiate a relative treatment effect. Patients and Methods: Patients were randomly assigned to gefitinib 250 mg or placebo, in addition to cisplatin 75 mg/m2 plus pemetrexed 500 mg/m2 (maximum of six cycles of chemotherapy). EGFR mutation status was determined from plasma-derived circulating free tumor-derived DNA samples (beads, emulsification, amplification, and magnetics digital polymerase chain reaction assay, allelic fraction analysis). Results: A total of 265 patients with non-small-cell lung cancer were randomly assigned, and overall data maturity was 66%. Continuation of gefitinib plus cisplatin and pemetrexed was detrimental to OS when compared with placebo plus cisplatin and pemetrexed (hazard ratio [HR], 1.44; 95% CI, 1.07 to 1.94;P =.016; median OS, 13.4 v 19.5 months). The detriment was statistically significant inpatients with T790M mutation-positive plasma samples (HR, 1.49; 95% CI, 1.02 to 2.21), whereas statistical significance was not reached in T790M mutation-negative patients (HR, 1.15; 95% CI, 0.68 to 1.94). PFS in T790M mutation-positive patients was similar between treatments, and the difference observed in T790M mutation-negative patients did not reach statistical significance (HR, 0.67; 95% CI, 0.43 to 1.03; P =.0745). Conclusion: Final OS data from IMPRESS are supportive of earlier PFS results and are sufficient to warn physicians against the continuation of treatment with first-generation EGFR tyrosine kinase inhibitors beyond radiologic disease progression when chemotherapy is initiated. Plasma biomarker analyses suggest that this effect may be driven by T790M-positive status. ? 2017 by American Society of Clinical Oncology. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85038401779&doi=10.1200%2fJCO.2017.73.9250&partnerID=40&md5=79fc1afc90f6ba29ce874517df1cfed3 https://scholars.lib.ntu.edu.tw/handle/123456789/494934 |
ISSN: | 0732-183X | DOI: | 10.1200/JCO.2017.73.9250 | SDG/關鍵字: | cisplatin; epidermal growth factor receptor; gefitinib; pemetrexed; antineoplastic agent; cisplatin; EGFR protein, human; epidermal growth factor receptor; gefitinib; pemetrexed; placebo; quinazoline derivative; tumor marker; adult; aged; Article; brain metastasis; cancer combination chemotherapy; cancer growth; cancer resistance; controlled study; distant metastasis; female; gene mutation; human; intention to treat analysis; major clinical study; male; malignant pleura effusion; multiple cycle treatment; non small cell lung cancer; overall survival; priority journal; progression free survival; randomized controlled trial; unspecified side effect; blood; brain tumor; clinical trial; disease free survival; enzymology; genetics; lung tumor; middle aged; multicenter study; mutation; non small cell lung cancer; secondary; survival rate; Aged; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Brain Neoplasms; Carcinoma, Non-Small-Cell Lung; Cisplatin; Disease-Free Survival; Female; Humans; Lung Neoplasms; Male; Middle Aged; Mutation; Pemetrexed; Placebos; Quinazolines; Receptor, Epidermal Growth Factor; Survival Rate |
顯示於: | 腫瘤醫學研究所 |
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