Quaity of life (QoL) analyses from OPTIMAL (CTONG-0802), a phase III, randomised, open-label study of first-line erlotinib versus chemotherapy in patients with advanced EGFR mutation-positive non-small-cell lung cancer (NSCLC)
Background: The OPTIMAL study found that erlotinib improved progression-free survival (PFS) versus standard chemotherapy in Chinese patients with advanced EGFR mutation-positive non-small-cell lung cancer (NSCLC). This report describes the quality of life (QoL) and updated PFS analyses from this study. Patients and methods: Chinese patients >= 18 years with histologically confirmed stage IIIB or IV NSCLC and a confirmed activating mutation of EGFR (exon 19 deletion or exon 21 L858R point mutation) received erlotinib (150 mg/day; n = 82) or gemcitabine-carboplatin (n = 72). The primary efficacy end point was PFS; QoL was assessed using the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, Trial Outcome Index (TOI) and Lung Cancer Subscale (LCS). Results: Patients receiving erlotinib experienced clinically relevant improvements in QoL compared with the chemotherapy group in total FACT-L, TOI and LCS (P < 0.0001 for all scales). Erlotinib scored better than chemotherapy for all FACT-L subscales from baseline to cycles 2 and 4 (non-significant). In the updated analysis, PFS was significantly longer for erlotinib than chemotherapy (median PFS 13.7 versus 4.6 months; HR = 0.164, 95% CI = 0.105-0.256; P < 0.0001), which was similar to the previously reported primary analysis. Conclusion: Erlotinib improves QoL compared with standard chemotherapy in the first-line treatment of patients with EGFR mutation-positive advanced NSCLC.
基金:
Shanghai Pulmonary Hospital; Chinese Thoracic Oncology Group (C-TONG); F. Hoffmann-La Roche (China); Science and Technology Commission of Shanghai Municipality [06DZ19502]
第一作者机构:[1]Harbin Med Univ, Canc Hosp, Harbin, Peoples R China
共同第一作者:
通讯作者:
通讯机构:[3]Tongji Univ, Sch Med, Shanghai Pulm Hosp, Dept Oncol, Shanghai 200433, Peoples R China[*1]Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai 200433, China
推荐引用方式(GB/T 7714):
Chen G.,Feng J.,Zhou C.,et al.Quaity of life (QoL) analyses from OPTIMAL (CTONG-0802), a phase III, randomised, open-label study of first-line erlotinib versus chemotherapy in patients with advanced EGFR mutation-positive non-small-cell lung cancer (NSCLC)[J].ANNALS OF ONCOLOGY.2013,24(6):1615-1622.doi:10.1093/annonc/mdt012.
APA:
Chen, G.,Feng, J.,Zhou, C.,Wu, Y. -L.,Liu, X. -Q....&You, C..(2013).Quaity of life (QoL) analyses from OPTIMAL (CTONG-0802), a phase III, randomised, open-label study of first-line erlotinib versus chemotherapy in patients with advanced EGFR mutation-positive non-small-cell lung cancer (NSCLC).ANNALS OF ONCOLOGY,24,(6)
MLA:
Chen, G.,et al."Quaity of life (QoL) analyses from OPTIMAL (CTONG-0802), a phase III, randomised, open-label study of first-line erlotinib versus chemotherapy in patients with advanced EGFR mutation-positive non-small-cell lung cancer (NSCLC)".ANNALS OF ONCOLOGY 24..6(2013):1615-1622