Health-Related Quality-of-Life in a Randomized Phase III First-Line Study of Gefitinib Versus Carboplatin/Paclitaxel in Clinically Selected Patients from.

Slides:

Advertisements

Similar presentations

Thank You This PowerPoint document contains the images that you requested. Copyright Notice All Online Service materials, including, without limitation,

Advertisements

Biomarker analyses from a phase III, randomized, open-label, first-line study of gefitinib (G) versus carboplatin/paclitaxel (C/P)

A Randomized Trial Comparing Immediate versus Delayed Treatment of Anemia with Once-Weekly Epoetin Alfa in Patients with Non-small Cell Lung Cancer Scheduled.

Volume 104, Pages (February 2017)

Frances A Shepherd, MD, Rafael Rosell, MD Journal of Thoracic Oncology

Efficacy and Safety of Pemetrexed Maintenance Therapy versus Best Supportive Care in Patients from East Asia with Advanced, Nonsquamous Non-small Cell.

Clinical and Testing Protocols for the Analysis of Epidermal Growth Factor Receptor Mutations in East Asian Patients with Non-small Cell Lung Cancer:

Clinical and the Prognostic Characteristics of Lung Adenocarcinoma Patients with ROS1 Fusion in Comparison with Other Driver Mutations in East Asian Populations

Comparison of Clinical Outcomes Following Gefitinib and Erlotinib Treatment in Non– Small-Cell Lung Cancer Patients Harboring an Epidermal Growth Factor.

Elderly Patients with Advanced NSCLC in Phase III Clinical Trials: Are the Elderly Excluded from Practice-Changing Trials in Advanced NSCLC? Adrian G.

Phase II Study of Gefitinib, an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI), and Celecoxib, a Cyclooxygenase-2 (COX-2) Inhibitor,

Chee Khoon Lee, PhD, Johnathan Man, M. B. B. S

Pathway Targeted Immunotherapy: Rationale and Evidence of Durable Clinical Responses with a Novel, EGF-directed Agent for Advanced NSCLC Rafael Rosell,

Leptomeningeal Metastases in Patients with NSCLC with EGFR Mutations

A Randomized, Placebo-Controlled, Multicenter, Biomarker-Selected, Phase 2 Study of Apricoxib in Combination with Erlotinib in Patients with Advanced.

Erlotinib Response in an NSCLC Patient with a Novel Compound G719D+L861R Mutation in EGFR Eamon M. Berge, MD, Dara L. Aisner, MD, PhD, Robert C. Doebele,

Nicolas Girard, MD, Julie Teruya-Feldstein, MD, Eden C

A Randomized Phase 3 Trial Comparing Pemetrexed/Carboplatin and Docetaxel/Carboplatin as First-Line Treatment for Advanced, Nonsquamous Non-small Cell.

Susan C. Scott, MD, Nathan A. Pennell, MD, PhD

The Use of Systemic Treatment in the Maintenance of Patients with Non–Small Cell Lung Cancer: A Systematic Review Swati Kulkarni, MD, Emily T. Vella,

A Randomized Trial Comparing Immediate versus Delayed Treatment of Anemia with Once-Weekly Epoetin Alfa in Patients with Non-small Cell Lung Cancer Scheduled.

Patient-Reported Outcomes and Quality of Life in PROFILE 1007: A Randomized Trial of Crizotinib Compared with Chemotherapy in Previously Treated Patients.

Pooled Analysis of the Prognostic and Predictive Value of KRAS Mutation Status and Mutation Subtype in Patients with Non–Small Cell Lung Cancer Treated.

EGFR Mutation Analysis for Prospective Patient Selection in Two Phase II Registration Studies of Osimertinib Suzanne Jenkins, DPhil, James Chih-Hsin.

Tetsuya Mitsudomi, MD, Hirohito Tada, MD Journal of Thoracic Oncology

EML4-ALK Translocation Predicts Better Outcome in Lung Adenocarcinoma Patients with Wild-Type EGFR Shang-Gin Wu, MD, Yao-Wen Kuo, MD, Yih-Leong Chang,

First-Line Afatinib versus Chemotherapy in Patients with Non–Small Cell Lung Cancer and Common Epidermal Growth Factor Receptor Gene Mutations and Brain.

Poor Prognosis Patients with Inoperable Locally Advanced NSCLC and Large Tumors Benefit from Palliative Chemoradiotherapy: A Subset Analysis from a Randomized.

Elderly Patients with Advanced NSCLC in Phase III Clinical Trials: Are the Elderly Excluded from Practice-Changing Trials in Advanced NSCLC? Adrian G.

Gefitinib Treatment in EGFR Mutated Caucasian NSCLC: Circulating-Free Tumor DNA as a Surrogate for Determination of EGFR Status Jean-Yves Douillard,

Effusion Immunocytochemistry as an Alternative Approach for the Selection of First-Line Targeted Therapy in Advanced Lung Adenocarcinoma Tzu-Hsiu Tsai,

Meta-Analysis of First-Line Therapies in Advanced Non–Small-Cell Lung Cancer Harboring EGFR-Activating Mutations Benjamin Haaland, PhD, Pui San Tan,

Pyrosequencing Analysis of EGFR and KRAS Mutations in EUS and EBUS-Derived Cytologic Samples of Adenocarcinomas of the Lung Jos A. Stigt, MD, Nils A.

Second-line or Subsequent Systemic Therapy for Recurrent or Progressive Non-Small Cell Lung Cancer: A Systematic Review and Practice Guideline J Noble,

Symptom and Quality of Life Improvement in LUX-Lung 6: An Open-Label Phase III Study of Afatinib Versus Cisplatin/Gemcitabine in Asian Patients With EGFR.

George Blumenschein, MD, John V. Heymach, MD, PhD

A Randomized Phase 2 Study Comparing the Combination of Ficlatuzumab and Gefitinib with Gefitinib Alone in Asian Patients with Advanced Stage Pulmonary.

Efficacy of Pemetrexed-Based Chemotherapy in Patients with ROS1 Fusion–Positive Lung Adenocarcinoma Compared with in Patients Harboring Other Driver Mutations.

Epidermal Growth Factor Receptor, C-kit, and Her2/neu Immunostaining in Advanced or Recurrent Thymic Epithelial Neoplasms Staged According to the 2004.

Comparative Efficacy of Ceritinib and Crizotinib as Initial ALK–Targeted Therapies in Previously Treated Advanced NSCLC: An Adjusted Comparison with External.

Modulation of Biomarker Expression by Osimertinib: Results of the Paired Tumor Biopsy Cohorts of the AURA Phase I Trial Kenneth S. Thress, PhD, Vivien.

First-Line Pemetrexed plus Cisplatin followed by Gefitinib Maintenance Therapy versus Gefitinib Monotherapy in East Asian Never-Smoker Patients with Locally.

A Prospective, Molecular Epidemiology Study of EGFR Mutations in Asian Patients with Advanced Non–Small-Cell Lung Cancer of Adenocarcinoma Histology (PIONEER)

Jamie A. Saxon, PhD, Lynette M. Sholl, MD, Pasi A. Jänne, MD, PhD

A Multicenter, Open-Label, Randomized Phase II Controlled Study of rh-Endostatin (Endostar) in Combination with Chemotherapy in Previously Untreated Extensive-Stage.

Jeffrey T. Yorio, MD, Yang Xie, PhD, Jingsheng Yan, PhD, David E

Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors for Non–Small-Cell Lung Cancer Patients with Leptomeningeal Carcinomatosis Bin-Chi Liao,

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

Erratum Journal of Thoracic Oncology

Phase II Randomized Trial of Erlotinib or Vinorelbine in Chemonaive, Advanced, Non- small Cell Lung Cancer Patients Aged 70 Years or Older Yuh-Min Chen,

Disease Control as a Predictor of Survival with Gefitinib and Docetaxel in a Phase III Study (V-15-32) in Advanced Non-small Cell Lung Cancer Patients

Comparison of Clinical Outcomes Following Gefitinib and Erlotinib Treatment in Non– Small-Cell Lung Cancer Patients Harboring an Epidermal Growth Factor.

Risk of Treatment-Related Toxicities from EGFR Tyrosine Kinase Inhibitors: A Meta- analysis of Clinical Trials of Gefitinib, Erlotinib, and Afatinib in.

Symptom and Quality of Life Benefit of Afatinib in Advanced Non–Small-Cell Lung Cancer Patients Previously Treated with Erlotinib or Gefitinib: Results.

Clinical and the Prognostic Characteristics of Lung Adenocarcinoma Patients with ROS1 Fusion in Comparison with Other Driver Mutations in East Asian Populations

A Phase 2 Randomized Trial of Paclitaxel and Carboplatin with or without Panitumumab for First-Line Treatment of Advanced Non–Small-Cell Lung Cancer

Monotherapy Administration of Sorafenib in Patients With Non–Small Cell Lung Cancer (MISSION) Trial Luis Paz-Ares, MD, Vera Hirsh, MD, Li Zhang, MD,

Gefitinib (IRESSA) in Patients of Asian Origin with Refractory Advanced Non-small Cell Lung Cancer: Subset Analysis from the ISEL Study Alex Chang, MD,

Epidermal Growth Factor Receptor Mutation Status in Stage I Lung Adenocarcinoma with Different Image Patterns Kuo-Hsuan Hsu, MD, Kun-Chieh Chen, MD,

Compound Uncommon EGFR Mutations in a Patient with Advanced NSCLC and Durable Response to Sequential EGFR Targeted Therapies Mary Linton B Peters, MD,

Chemotherapy Response in East Asian Non-small Cell Lung Cancer Patients Harboring Wild-Type or Activating Mutation of Epidermal Growth Factor Receptors

BRIDGE: An Open-Label Phase II Trial Evaluating the Safety of Bevacizumab + Carboplatin/Paclitaxel as First-Line Treatment for Patients with Advanced,

Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed.

A Phase III Randomized Trial of Gemcitabine–Oxaliplatin versus Carboplatin–Paclitaxel as First-Line Therapy in Patients with Advanced Non-small Cell Lung.

Bcl-2-Like Protein 11 Deletion Polymorphism Predicts Survival in Advanced Non–Small- Cell Lung Cancer Jih-Hsiang Lee, MD, Yu-Lin Lin, MD, Wei-Hsun Hsu,

Efficacy and Safety of Cisplatin/Pemetrexed Versus Cisplatin/Gemcitabine as First-Line Treatment in East Asian Patients with Advanced Non-small Cell Lung.

Biomarker Analyses from a Randomized, Placebo-Controlled, Phase IIIb Trial Comparing Bevacizumab with or without Erlotinib as Maintenance Therapy for.

Antagonism between Gefitinib and Cisplatin in Non-small Cell Lung Cancer Cells: Why Randomized Trials Failed? Chun-Ming Tsai, MD, Jen-Ting Chen, MD,

Mark A. Socinski, MD Journal of Thoracic Oncology

Ana Luque, MD, Edurne Arriola, MD, PhD Journal of Thoracic Oncology

Presentation transcript:

Health-Related Quality-of-Life in a Randomized Phase III First-Line Study of Gefitinib Versus Carboplatin/Paclitaxel in Clinically Selected Patients from Asia with Advanced NSCLC (IPASS) Sumitra Thongprasert, MD, Emma Duffield, MSc, Nagahiro Saijo, MD, Yi-Long Wu, MD, James Chih-Hsin Yang, MD, Da-Tong Chu, MD, Meilin Liao, MD, Yuh-Min Chen, MD, Han-Pin Kuo, MD, Shunichi Negoro, MD, Kwok Chi Lam, MD, Alison Armour, MD, Patrick Magill, MD, Masahiro Fukuoka, MD Journal of Thoracic Oncology Volume 6, Issue 11, Pages 1872-1880 (November 2011) DOI: 10.1097/JTO.0b013e31822adaf7 Copyright © 2011 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 1. CONSORT diagram.a Among the 112 patients who failed screening, the main reasons for exclusion were abnormal serum creatinine (>1.5 times upper limit of reference range)/creatinine clearance (≤60 mL/min) levels; untreated central nervous system metastases; or low neutrophil (<2.0 × 109/L), platelet (<100 × 109/L), or hemoglobin (<10 g/dL) counts. bAll patients who were randomly assigned to a study group were included in the ITT analysis. c All patients who received at least one dose of study treatment were included in the safety analysis. dAll patients with a baseline and at least one postbaseline quality-of-life assessment that could be evaluated were included in the health-related quality-of-life analysis. eAll patients in the intent-to-treat population with an evaluable tumor sample. Of 683 (56%) patients who provided samples, 118 were cytology samples, and 128 histologic samples were of insufficient quality, and were therefore not included in the main analysis. fAll patients in the evaluable-for-quality-of-life population with an evaluable tumor sample. ITT, intent-to-treat; EFQ, evaluable-for-quality-of-life; EGFR, epidermal growth factor receptor; n, number of patients. Journal of Thoracic Oncology 2011 6, 1872-1880DOI: (10.1097/JTO.0b013e31822adaf7) Copyright © 2011 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 2. HRQoL and symptom improvement for FACT-L, TOI, and LCS for (A) patients with EGFR mutation-positive tumors and (B) patients with EGFR mutation-negative tumors (EFQ population). Posthoc analyses. HRQoL, health-related quality-of-life; FACT-L, Functional Assessment of Cancer Therapy-Lung; EGFR, epidermal growth factor receptor; TOI, Trial Outcome Index; LCS, Lung Cancer Subscale; EFQ, evaluable-for-quality-of-life; CI, confidence interval; OR, odds ratio. Journal of Thoracic Oncology 2011 6, 1872-1880DOI: (10.1097/JTO.0b013e31822adaf7) Copyright © 2011 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 3. Time-to-worsening in HRQoL and symptoms for (A) FACT-L in patients with EGFR mutation-positive tumors, (B) FACT-L in patients with EGFR mutation-negative tumors, (C) TOI in patients with EGFR mutation-positive tumors, (D) TOI in patients with EGFR mutation-negative tumors, (E) LCS in patients with EGFR mutation-positive tumors, and (F) LCS in patients with EGFR mutation-negative tumors (EFQ population). Posthoc calculations. HRQoL, health-related quality-of-life; FACT-L, Functional Assessment of Cancer Therapy-Lung; EGFR, epidermal growth factor receptor; TOI, Trial Outcome Index; LCS, Lung Cancer Subscale; EFQ, evaluable-for-quality-of-life; M+, mutation-positive; n, number of patients; G, gefitinib; CI, confidence interval; NC, not calculated; C/P, carboplatin/paclitaxel; M−, mutation negative. Journal of Thoracic Oncology 2011 6, 1872-1880DOI: (10.1097/JTO.0b013e31822adaf7) Copyright © 2011 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 4. Mean change from baseline in HRQoL and symptoms for (A) FACT-L in patients with EGFR mutation-positive tumors, (B) FACT-L in patients with EGFR mutation-negative tumors, (C) TOI in patients with EGFR mutation-positive tumors, (D) TOI in patients with EGFR mutation-negative tumors, (E) LCS in patients with EGFR mutation-positive tumors, and (F) LCS in patients with EGFR mutation-negative tumors (EFQ population). Posthoc calculations. Error bars are 95% CI of the mean. Data after week 54 (EGFR M+) and week 30 (EGFR M−) not presented as <20 patients remain. HRQoL, health-related quality-of-life; FACT-L, Functional Assessment of Cancer Therapy-Lung; EGFR, epidermal growth factor receptor; TOI, Trial Outcome Index; LCS, Lung Cancer Subscale; EFQ, evaluable-for-quality-of-life; M+, mutation-positive; n, number of patients at baseline; M−, mutation-negative; CI, confidence interval. Journal of Thoracic Oncology 2011 6, 1872-1880DOI: (10.1097/JTO.0b013e31822adaf7) Copyright © 2011 International Association for the Study of Lung Cancer Terms and Conditions