Entry Detail
| General information | |
| Database: | DB00738 |
| Objective: | Patientreported symptoms and healthrelated quality of life (QoL) benefits were investigated in a randomized, phase III trial of afatinib or cisplatin/pemetrexed. |
| Authors: | Yang JC, et al |
| Title: | Symptom control and quality of life in LUXLung 3: a phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations. |
| Journal: | J Clin Oncol. |
| Year: | 2013 |
| PMID: | 23816967 |
| Trial Design | |
| Clinical Trial Id: | NCT00949650 |
| Agent: | afatinib |
| Target: | Receptor proteintyrosine kinase erbB2 Epidermal growth factor receptor |
| Cancer Type: | lung cancer |
| Cancer Subtype: | advanced lung adenocarcinoma with EGFR mutations |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a randomized, phase III trial |
| Key Patients Feature: | NA |
| Biomarker: | EGFR mutations |
| Biomark Analysis: | In patients with lung adenocarcinoma with EGFR mutations, firstline afatinib was associated with better control of cough and dyspnea compared with chemotherapy, although diarrhea, dysphagia, and sore mouth were worse. |
| Control Group Info: | afatinib versus chemotherapy |
| Treatment Info: | patients with advanced epidermal growth factor receptor (EGFR) mutationpositive lung adenocarcinoma were randomly assigned 2:1 to afatinib 40 mg per day or up to six cycles of cisplatin/pemetrexed. Lung cancer symptoms and healthrelated QoL were assessed every 21 days until progression using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 and Lung Cancer13 questionnaires. Analyses of cough, dyspnea, and pain were preplanned, including percentage of patients who improved on therapy, time to deterioration of symptoms, and change in symptoms over time. |
| Primary End Point: | Symptom control and quality of life |
| Secondary End Point: | NA |
| Patients Number: | 345 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 11.1 months for afatinib and 6.9 months for chemotherapy (hazard ratio[HR], 0.58; 95% CI, 0.43 to 0.78; P < .001) in all patients and 13.6 months for afatinib and 6.9 months for chemotherapy (HR, 0.47; 95% CI, 0.34 to 0.65; P < .001) in patients with common EGFR mutations (Del 19/L858R). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | In patients with lung adenocarcinoma with EGFR mutations, firstline afatinib was associated with better control of cough and dyspnea compared with chemotherapy, although diarrhea, dysphagia, and sore mouth were worse. Global health statusQoL was also improved over time with afatinib compared with chemotherapy. |