title: QoL analyses from INFORM study, a phase III study of gefitinib versus placebo as maintenance therapy in advanced NSCLC.
abstract: This report aimed to provide the full results of QoL assessment in INFORM study. QoL was assessed by FACT-L questionnaire. QoL improvement ratio in gefitinib arm was higher than placebo arm (FACT-L: 46% vs. 22%, p < 0.001; TOI: 41% vs. 18%, p < 0.001; LCS: 46% vs. 22%, p < 0.001). Gefitinib prolonged time-to-worsening of QoL (FACT-L: 2.8 m vs 1.4 m, p = 0.019; TOI: 3.5 m vs 1.4 m, p = 0.006; LCS: 2.8 vs 1.4 m, p = 0.028). Patients with an improvement in QoL had longer PFS (FACT-L: 9.4 m vs. 2.8 m vs. 2.7 m, P < 0.001; TOI: 9.9 m vs. 2.8 m vs. 2.1 m, P < 0.001; LCS: 9.4 m vs. 2.9 m vs. 2.1 m, P < 0.001) and OS (FACT-L: 25.4 m vs. 19.9 m vs. 14.4 m, P = 0.003; TOI: 25.7 m vs. 19.0 m vs. 12.7 m, P = 0.002; LCS: 25.4 m vs. 19.3 m vs. 14.7 m, P = 0.004) compared with patients with stable or worsened QoL. Furthermore, in patients with good QoL at baseline, the treatment of gefitinib couldn't improve OS compared to placebo, whereas patients with low QoL experienced marginal significant improvement in OS (20.6 m vs 14.4, p = 0.051). Our study indicated that gefitinib could improve patients' QoL, confirmed the prognostic value of QoL changes during treatment, and implied patients with low QoL at baseline may be the potential population which will gain OS benefit from maintenance EGFR-TKI therapy.
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
authors.forename: Yun-Peng
authors.initials: YP
authors.lastname: Yang
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
authors.forename: Yu-Xiang
authors.initials: YX
authors.lastname: Ma
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Huang
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
authors.forename: Yuan-Yuan
authors.initials: YY
authors.lastname: Zhao
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
authors.forename: Wen-Feng
authors.initials: WF
authors.lastname: Fang
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
authors.forename: Shao-Dong
authors.initials: SD
authors.lastname: Hong
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Tian
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 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, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
authors.forename: Jin
authors.initials: J
authors.lastname: Sheng
authors.affiliation: State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D000077156:Gefitinib; D006801:Humans; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011788:Quality of Life; D011799:Quinazolines / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D000077156:Gefitinib