title: Randomized, Multicenter Study of Gefitinib Dose-escalation in Advanced Non-small-cell Lung Cancer Patients Achieved Stable Disease after One-month Gefitinib Treatment.
abstract: There is no consensus on the optimal treatment for patients with advanced non-small-cell lung cancer (NSCLC) and stable disease (SD) after gefitinib therapy. This randomized, open-label, multicenter study aimed to explore whether dose-escalation of gefitinib would improve response and survival in NSCLC patients who achieved SD after one-month of standard gefitinib dosage. Between May 2009 and January 2012, 466 patients were enrolled and 100 eligible patients were randomized (1:1) to receive either a higher dose (500 mg/d; H group) or to continue standard dose (250 mg/d; S group) of gefitinib. Objective response rate (ORR) was similar between the two groups (12.5% vs 12.5%, p = 1.000). There were no significant differences regarding progression-free survival (PFS) and overall survival (OS) between both arms (H group vs S group: median PFS, 5.30 months vs 6.23 months, p = 0.167; median OS, 13.70 months vs 18.87 months, p = 0.156). Therefore, dose-escalation of gefitinib does not confer a response or survival advantage in patients who achieve SD with one month of standard-dose gefitinib treatment.
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.
authors.forename: Cong
authors.initials: C
authors.lastname: Xue
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.
authors.forename: Shaodong
authors.initials: S
authors.lastname: Hong
authors.affiliation: Department of Oncology, Guangzhou Chest Hospital, Guangzhou, China.
authors.forename: Ning
authors.initials: N
authors.lastname: Li
authors.affiliation: Department of Medical Oncology, the First People's Hospital of Foshan, Foshan, China.
authors.forename: Weineng
authors.initials: W
authors.lastname: Feng
authors.affiliation: Department of Medical Oncology, Dongguan People's Hospital, Dongguan, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Jia
authors.affiliation: Cancer Center, Zhongshan People's Hospital, Zhongshan, China.
authors.forename: Jiewen
authors.initials: J
authors.lastname: Peng
authors.affiliation: Department of Oncology, Jiangmen Central Hospital, Jiangmen, China.
authors.forename: Daren
authors.initials: D
authors.lastname: Lin
authors.affiliation: Department of Oncology, Panyu District Central Hospital, Guangzhou, China.
authors.forename: Xiaolong
authors.initials: X
authors.lastname: Cao
authors.affiliation: Department of Oncology, the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China.
authors.forename: Siyang
authors.initials: S
authors.lastname: Wang
authors.affiliation: Department of Oncology, General Hospital of Guangzhou Military Command of PLA, Guangzhou, China.
authors.forename: Weimin
authors.initials: W
authors.lastname: Zhang
authors.affiliation: Department of Oncology, the Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, China.
authors.forename: Hongyu
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Department of Hematology and Rheumatism, the First People's Hospital of Shunde, Foshan, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Dong
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011799:Quinazolines / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000077156:Gefitinib