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)
机构:[1]Tumor Medicine, The Cancer Hospital of Harbin Medical University, Harbin[2]Medical Oncology, Jiangsu Province Cancer Hospital, Nanjing[3]Department of Oncology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai[4]Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou[5]Department of Pulmonary Oncology, 307 Hospital of the Academy of Military Medical Sciences, Cancer Center, Beijing[6]Department of Medical Oncology, Tianjin Cancer Hospital, Tianjin[7]Beijing Chest Hospital, Capital Medical University, Beijing[8]Peking University School of Oncology, Beijing Cancer Hospital, Beijing[9]Shanghai Chest Hospital, affiliated to Shanghai Jiao Tong University, Shanghai[10]Sun Yat-sen University Cancer Center, Guangzhou[11]Xiangya Hospital[12]Second Xiangya Hospital, Central South University, Changsha[13]Hunan Province Cancer Hospital, Changsha[14]Cancer Hospital Shantou University Medical College,[15]Renji Hospital, affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai[16]The First Affiliated Hospital of Suzhou University, Suzhou[17]Thoracic Surgery Department, Xuanwu Hospital of Capital Medical University, Beijing胸外科首都医科大学宣武医院[18]Zhejiang Cancer Hospital, Hangzhou[19]Changzhen Hospital, The Second Military Medical University, Shanghai[20]Harbin Institute of Hematology and Oncology, Harbin[21]Peking Union Medical College Hospital, Beijing[22]Nanfang Hospital, Southern Medical University, Guangzhou, China
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:
the Shanghai Pulmonary Hospital
the Chinese Thoracic Oncology Group (C-TONG)
F. Hoffmann-La Roche (China)
the Science and Technology Commission of Shanghai Municipality (Grant no. 06DZ19502)
第一作者机构:[1]Tumor Medicine, The Cancer Hospital of Harbin Medical University, Harbin
共同第一作者:
通讯作者:
通讯机构:[*1]Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai 200433, China.
推荐引用方式(GB/T 7714):
G. Chen,J. Feng,C. Zhou,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):doi:10.1093/annonc/mdt012.
APA:
G. Chen,J. Feng,C. Zhou,Y.-L. Wu,X.-Q. Liu...&C. You.(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:
G. Chen,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)