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 EGFR mutation-positive advanced non-small cell lung cancer (NSCLC).

Lung Cancer - Non-Small Cell Metastatic
Session Type and Session Title: 
Poster Discussion Session, Lung Cancer - Non-small Cell Metastatic
Abstract Number: 


J Clin Oncol 30, 2012 (suppl; abstr 7520)
Caicun Zhou, Yi Long Wu, Xiaoqing Liu, Changli Wang, Gongyan Chen, Ji Feng Feng, Shucai Zhang, Jie Wang, Songwen Zhou, Shengxiang Ren, Shun Lu, Li Zhang, Cheng-ping Hu, Yi Luo, Lei Chen, Ming Ye, Jianan Huang, Xiuyi Zhi, Yiping Zhang, Qingyu Xiu; Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China; Guangdong General Hospital, Guangzhou, China; 307 Hospital of the Academy of Military Medical Sciences, Cancer Center, Beijing, China; Tianjin Medical University Cancer Institute and Hospital, Tianjin, China; The Third Affiliated Hospital of Harbin Medical University, Harbin, China; Jiangsu Province Cancer Hospital, Nanjing, China; Bejiing Chest Hospital, Capital Medical University, Beijing, China; Peking University Cancer Hospital, Beijing, China; Shanghai Chest Hospital, Jiao Tong University, Shanghai, China; Sun Yat-sen University Cancer Center, Guangzhou, China; Xiang Ya Hospital of Central South University, Changsha, China; Hunan Province Tumor Hospital, Changsha, China; Cancer Hospital of Shantou University Medical College, Shantou, China; Renjin Hospital Affiliated to Shanghai Jiaotong University, Shanghai, China; The First Affiliated Hospital of Soochow University, Suzhou, China; Beijing Lung Cancer Center, Capital Medical University, Beijing, China; Zhejiang Cancer Hospital, Hangzhou, China; Changzheng Hospital, Second Military Medical University, Shanghai, China

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Abstract Disclosures


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.