Overall survival (OS) results from OPTIMAL (CTONG0802), a phase III trial of erlotinib (E) versus carboplatin plus gemcitabine (GC) as first-line treatment for Chinese patients with <i>EGFR</i> mutation-positive advanced non-small cell lung cancer (NSCLC).
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- Caicun Zhou
- Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China
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- Yi Long Wu
- Guangdong General Hospital, Guangzhou, China
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- Xiaoqing Liu
- 307 Hospital of the Academy of Military Medical Sciences, Cancer Center, Beijing, China
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- Changli Wang
- Tianjin Medical University Cancer Institute and Hospital, Tianjin, China
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- Gongyan Chen
- The Third Affiliated Hospital of Harbin Medical University, Harbin, China
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- Ji Feng Feng
- Jiangsu Province Cancer Hospital, Nanjing, China
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- Shucai Zhang
- Bejiing Chest Hospital, Capital Medical University, Beijing, China
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- Jie Wang
- Peking University Cancer Hospital, Beijing, China
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- Songwen Zhou
- Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China
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- Shengxiang Ren
- Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China
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- Shun Lu
- Shanghai Chest Hospital, Jiao Tong University, Shanghai, China
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- Li Zhang
- Sun Yat-sen University Cancer Center, Guangzhou, China
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- Cheng-ping Hu
- Xiang Ya Hospital of Central South University, Changsha, China
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- Yi Luo
- Hunan Province Tumor Hospital, Changsha, China
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- Lei Chen
- Cancer Hospital of Shantou University Medical College, Shantou, China
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- Ming Ye
- Renjin Hospital Affiliated to Shanghai Jiaotong University, Shanghai, China
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- Jianan Huang
- The First Affiliated Hospital of Soochow University, Suzhou, China
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- Xiuyi Zhi
- Beijing Lung Cancer Center, Capital Medical University, Beijing, China
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- Yiping Zhang
- Zhejiang Cancer Hospital, Hangzhou, China
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- Qingyu Xiu
- Changzheng Hospital, Second Military Medical University, Shanghai, China
Abstract
<jats:p> 7520 </jats:p><jats:p> Background: The OPTIMAL study demonstrated significant superiority for E versus GC in terms of progression-free survival (PFS), objective response rate, tolerability and quality of life (QoL) in first-line advanced NSCLC patients with EGFR activating mutations (Act Mut+). Here we report OS data from OPTIMAL (ClinicalTrials.gov NCT00874419). Methods: Chemotherapy-naive Chinese patients with advanced NSCLC and EGFR Act Mut+, ECOG performance status (PS) 0–2 and measurable disease were randomized to E (150 mg/day), or GC, and stratified by histology, smoking status and mutation type. OS at final data cut-off (15 Nov 2011) was evaluated for the entire intent-to-treat (ITT) population. Subgroup analysis of OS by gender, histology, smoking status, PS, presence of skin rash and type of mutation was performed. Details of second- or later-line therapy were also documented for each patient. Results: A total of 165 patients were randomized to treatment and 154 patients received at least one dose of study drug (ITT population; E, n=82; GC, n=72). A total of 7 patients are still responding to erlotinib in the E arm. Post-study therapy included chemotherapy (doublet, n=38, or mono, n=8), or experimental drugs in clinical trials (n=10) in the E arm, and EGFR tyrosine kinase inhibitor (TKI) therapy (n=49) or chemotherapy (n=7) in the GC arm. Post-study treatment was not received by 26 and 16 patients in the E and GC arms, respectively. A total of 84 deaths were reported (E, n=47; GC, n=37). OS did not differ significantly between the two treatment arms (HR=1.065, p=0.6849), and no significant difference in OS was observed in the different subgroups. Conclusions: The lack of a statistically significant difference in OS in the OPTIMAL study was possibly due to a high level of cross-over to EGFR TKI therapy in the GC arm. However, the significant benefits reported with E in terms of PFS, QoL and tolerability in this study suggest that E should be considered as one of the standard first-line treatments for patients with advanced EGFR Act Mut+ NSCLC. </jats:p>
Journal
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 30 (15_suppl), 7520-7520, 2012-05-20
American Society of Clinical Oncology (ASCO)
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Details 詳細情報について
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- CRID
- 1361418518529278464
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- ISSN
- 15277755
- 0732183X
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- Data Source
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- Crossref