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Final Overall Survival Results from a Phase III, Randomized, Placebo-Controlled, Parallel-Group Study of Gefitinib Versus Placebo as Maintenance Therapy.

Published byἘφραίμ Λιάπης Modified over 5 years ago

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Presentation on theme: "Final Overall Survival Results from a Phase III, Randomized, Placebo-Controlled, Parallel-Group Study of Gefitinib Versus Placebo as Maintenance Therapy."— Presentation transcript:

1 Final Overall Survival Results from a Phase III, Randomized, Placebo-Controlled, Parallel-Group Study of Gefitinib Versus Placebo as Maintenance Therapy in Patients with Locally Advanced or Metastatic Non–Small-Cell Lung Cancer (INFORM; C-TONG 0804)  Hongyun Zhao, PhD, Yun Fan, BS, Shenglin Ma, MD, Xiangqun Song, MD, Baohui Han, PhD, Ying Cheng, BS, Cheng Huang, BS, Shujun Yang, BS, Xiaoqing Liu, PhD, Yunpeng Liu, PhD, Shun Lu, PhD, Jie Wang, PhD, Shucai Zhang, MD, Caicun Zhou, PhD, Mengzhao Wang, PhD, Li Zhang, MD  Journal of Thoracic Oncology  Volume 10, Issue 4, Pages (April 2015) DOI: /JTO Copyright © 2015 International Association for the Study of Lung Cancer Terms and Conditions

2 FIGURE 1 CONSORT diagram. †Cut off dates: June 17, 2014, for overall survival (OS) and progression-free survival. ‡All patients who were randomly assigned to a study group were included in the intent-to-treat analysis. ¶All patients who received at least one dose of study treatment were included in the safety analysis. |All patients in the intent-to-treat population with an evaluable tumor sample. Journal of Thoracic Oncology  , DOI: ( /JTO ) Copyright © 2015 International Association for the Study of Lung Cancer Terms and Conditions

3 FIGURE 2 Kaplan–Meier curves for overall survival in the overall population and by epidermal growth factor receptor (EGFR) mutation status (intent-to-treat population). Hazard ratio less than 1 implies a lower risk of death for patients treated with gefitinib. A, Overall population. B, Patients with EGFR mutation–positive tumors. C, Patients with EGFR mutation-negative tumors. D, Patients with EGFR mutation status unknown tumors. Journal of Thoracic Oncology  , DOI: ( /JTO ) Copyright © 2015 International Association for the Study of Lung Cancer Terms and Conditions

4 FIGURE 3 Forest plot of overall survival by clinical subgroup and epidermal growth factor receptor mutation status (intent-to-treat population). Hazard ratio less than 1 implies a lower risk of death for patients treated with gefitinib. The size of the point estimate reflects the number of events in the subgroup, with a larger circle indicating more events. Cox analysis with covariates (histology [adenocarcinoma vs. nonadenocarcinoma]; World Health Organization performance status [0, 1, vs. 2]; smoking history [never-smokers vs. smokers]; tumor epidermal growth factor receptor mutation status [positive vs. negative vs. unknown]; type of first-line chemotherapy [taxane vs. nontaxane]; previous response to chemotherapy [complete or partial response vs. stable disease]; sex; and disease stage at screening [IIIb vs. IV]). CR, complete response; PR, partial response; SD, stable disease; OS, overall survival; HR, hazard ratio. Journal of Thoracic Oncology  , DOI: ( /JTO ) Copyright © 2015 International Association for the Study of Lung Cancer Terms and Conditions

5 FIGURE 4 Kaplan–Meier curves for overall survival in the overall population and epidermal growth factor receptor (EGFR) mutation subgroup. Hazard ratio less than 1 implies a lower risk of death for patients treated with gefitinib. EGFR-TKI involved means patients received EGFR TKIs as maintenance or subsequent treatment since randomization; without EGFR TKI means patients never received any EGFR TKIs since randomization. A, Overall population. B, Patients with EGFR mutation–positive tumors. Journal of Thoracic Oncology  , DOI: ( /JTO ) Copyright © 2015 International Association for the Study of Lung Cancer Terms and Conditions

6 FIGURE 5 Forest plot of overall survival (OS) in two groups by clinical subgroup and epidermal growth factor receptor (EGFR) mutation status (intent-to-treat population). Hazard ratio less than 1 implies a lower risk of death for patients treated with gefitinib. The size of the point estimate reflects the number of events in the subgroup, with a larger circle indicating more events. Cox analysis with covariates (histology [adenocarcinoma vs. nonadenocarcinoma]; World Health Organization performance status [0, 1, vs. 2]; smoking history [never-smokers vs. smokers]; tumor EGFR mutation status [positive vs. negative vs. unknown]; type of first-line chemotherapy [taxane vs. nontaxane]; previous response to chemotherapy [complete or partial response vs. stable disease]; sex; and disease stage at screening [IIIb vs. IV]). CR, complete response; PR, partial response; SD, stable disease; OS, overall survival since randomization; HR, hazard ratio; TKIs, patients received EGFR TKIs as maintenance or subsequent treatment since randomization; no TKIs, patients never received any EGFR TKIs since randomization. Journal of Thoracic Oncology  , DOI: ( /JTO ) Copyright © 2015 International Association for the Study of Lung Cancer Terms and Conditions

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