https://scholars.lib.ntu.edu.tw/handle/123456789/494920
標題: | Adjusted Indirect Comparison Using Propensity Score Matching of Osimertinib to Platinum-Based Doublet Chemotherapy in Patients with EGFRm T790M NSCLC Who Have Progressed after EGFR-TKI | 作者: | Mann H Andersohn F Bodnar C Mitsudomi T Mok T.S.K CHIH-HSIN YANG Hoyle C. |
公開日期: | 2018 | 出版社: | Springer International Publishing | 卷: | 38 | 期: | 4 | 起(迄)頁: | 319-331 | 來源出版物: | Clinical Drug Investigation | 摘要: | Background and objective: An adjusted indirect comparison was conducted to assess efficacy outcomes, particularly overall survival (OS), of osimertinib versus platinum-based doublet chemotherapy in patients with epidermal growth factor receptor-mutated (EGFRm) T790M mutation-positive non-small-cell lung cancer (NSCLC) who had progressed following an EGFR tyrosine kinase inhibitor (TKI). Analysis of treatment effect from two separate trials had the potential to more accurately estimate the magnitude of OS benefit due to absence of confounding due to treatment switching from the control arm to the osimertinib arm of the ongoing randomized control trial, AURA3. Methods: Two non-randomized individual datasets were compared: pooled patients from the AURA extension and AURA2 trials (osimertinib 80?mg, n?=?405, with a confirmed T790M mutation using tissue samples), and patients from the control arm of the IMPRESS study (platinum-based doublet chemotherapy, n?=?61, with a confirmed T790M mutation using plasma circulating tumour DNA [ctDNA]). A propensity score-based approach was used to account for differences in baseline demographics and disease characteristics. Results: After adjustment for baseline differences between the two groups, osimertinib demonstrated a statistically significant improvement in progression-free survival (PFS) versus platinum-based doublet chemotherapy (hazard ratio [HR]?=?0.278, 95% confidence interval [CI] 0.188–0.409, p?0.0001; median PFS 10.9 vs. 5.3?months). Improvements were also observed for objective response rate (ORR) and disease control rate (DCR) (ORR: 64.3 vs. 33.3%; odds ratio [OR]?=?5.31, 95% CI 2.47–11.40, p?0.001; DCR: 92.1 vs. 75.0%; OR?=?4.72, 95% CI 1.92–11.58, p?0.001). Similar results were obtained for patients who received osimertinib as second-line treatment only. A statistically significant improvement in OS was observed for the osimertinib group (HR?=?0.412, 95% CI 0.273–0.622, p?0.0001). Median OS for osimertinib was not reached. Conclusions: In this indirect comparison, osimertinib showed a statistically significant improvement in efficacy outcomes versus platinum-based doublet chemotherapy in patients with EGFRm T790M NSCLC who had progressed after EGFR-TKI therapy. ? 2017, The Author(s). |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85038089986&doi=10.1007%2fs40261-017-0611-3&partnerID=40&md5=4e26f95052bd3ea48326649dc73d96f8 https://scholars.lib.ntu.edu.tw/handle/123456789/494920 |
ISSN: | 1173-2563 | DOI: | 10.1007/s40261-017-0611-3 | SDG/關鍵字: | antineoplastic metal complex; circulating tumor DNA; cisplatin; epidermal growth factor receptor; epidermal growth factor receptor kinase inhibitor; gefitinib; osimertinib; pemetrexed; antineoplastic agent; epidermal growth factor receptor; osimertinib; piperazine derivative; platinum; protein kinase inhibitor; adult; aged; Article; cancer combination chemotherapy; cancer control; cancer growth; cancer size; comparative effectiveness; controlled study; drug efficacy; drug treatment failure; female; follow up; human; major clinical study; male; non small cell lung cancer; overall survival; phase 2 clinical trial (topic); priority journal; progression free survival; propensity score; randomized controlled trial (topic); treatment response; comparative study; controlled clinical trial; disease free survival; genetics; lung tumor; meta analysis (topic); metabolism; middle aged; mutation; non small cell lung cancer; propensity score; very elderly; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Non-Small-Cell Lung; Disease-Free Survival; Female; Humans; Lung Neoplasms; Male; Meta-Analysis as Topic; Middle Aged; Mutation; Piperazines; Platinum; Propensity Score; Protein Kinase Inhibitors; Receptor, Epidermal Growth Factor |
顯示於: | 腫瘤醫學研究所 |
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