Entry Detail
| General information | |
| Database: | DB00764 |
| Objective: | In the phase III, LUXLung 6 trial, afatinib prolonged progression free survival (PFS) versus cisplatin/gemcitabine in Asian patients with epidermal growth factor receptor (EGFR) mutationpositive non small cell lung cancer (non small cell lung cancer). This article provides detailed assessments of patientreported outcomes (PROs), a LUXLung 6 secondary end point, and explores the relationship between PFS and healthrelated quality of life (QoL) in these patients. |
| Authors: | Geater SL, et al |
| Title: | Symptom and Quality of Life Improvement in LUXLung 6: An OpenLabelphase III Study of Afatinib Versus Cisplatin/Gemcitabine in Asian Patients With EGFR MutationPositive Advanced non small cell Lung Cancer. |
| Journal: | J Thorac Oncol. |
| Year: | 2015 |
| PMID: | 25933111 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | afatinib |
| Target: | Receptor proteintyrosine kinase erbB2 Epidermal growth factor receptor |
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer harboring epidermal growth factor receptor mutations |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Symptom and Quality of Life Improvement in LUXLung 6: An OpenLabelphase III Study |
| Key Patients Feature: | Asian Patients With EGFR MutationPositive Advanced non small cell Lung Cancer |
| Biomarker: | EGFR MutationPositive |
| Biomark Analysis: | Afatinib improved PFS and PROs versus chemotherapy in EGFR mutationpositive non small cell lung cancer patients. |
| Control Group Info: | Afatinib Versus Cisplatin/Gemcitabine |
| Treatment Info: | Patients (n = 364) were randomized (2:1) to oral afatinib (40 mg/day) or up to six cycles of cisplatin/gemcitabine (21day cycle; cisplatin 75 mg/m(2) [d1]; gemcitabine 1000 mg/m(2) [d1, 8]). QoL was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and its lung cancerspecific module. The relationship between PFS (investigator assessment and independent review) and QoL was evaluated using analysis of covariance and a longitudinal model. |
| Primary End Point: | Symptom and Quality of Life Improvement |
| Secondary End Point: | NA |
| Patients Number: | 364 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | Afatinib improved PFS and PROs versus chemotherapy in EGFR mutationpositive non small cell lung cancer patients. Progression was associated with statistically significant worsening in QoL measured before tumor assessment, underscoring the value of PFS as a clinically relevant end point. |