Entry Detail
| General information | |
| Database: | DB00058 |
| Objective: | Afatiniban oral irreversible ErbB family blockerimproves progression free survival compared with pemetrexed and cisplatin for firstline treatment of patients with EGFR mutationpositive advanced non small cell lung cancer (non small cell lung cancer). they compared afatinib with gemcitabine and cisplatina chemotherapy regimen widely used in Asiafor firstline treatment of Asian patients with EGFR mutationpositive advanced non small cell lung cancer. |
| Authors: | Wu YL, et al |
| Title: | Afatinib versus cisplatin plus gemcitabine for firstline treatment of Asian patients with advanced non small cell lung cancer harbouring EGFR mutations (LUXLung 6): an openlabel, randomisedphase 3 trial. |
| Journal: | Lancet Oncol. |
| Year: | 2014 |
| PMID: | 24439929 |
| Trial Design | |
| Clinical Trial Id: | NCT01121393 |
| 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: | Phase III LUXLung 6 |
| Key Patients Feature: | 36 centres in China, Thailand, and South Korea |
| Biomarker: | EGFR mutation (Leu858Arg, exon 19 deletions, or other) |
| Biomark Analysis: | NA |
| Control Group Info: | gemcitabine and cisplatin |
| Treatment Info: | pts were randomly assigned (2:1) to receive either oral afatinib (40 mg per day) or intravenous gemcitabine 1000 mg/m(2) on day 1 and day 8 plus cisplatin 75 mg/m(2) on day 1 of a 3week schedule for up to six cycles. |
| Primary End Point: | progression free survival assessed by independent central review (intentiontotreat population). |
| Secondary End Point: | NA |
| Patients Number: | 364 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | A signifi cantly greater proportion of patients in theafatinib group had an objective response than in thegemcitabine and cisplatin group (162 of 242 [66.9%] vs28 of 122 [23.0%]) according to independent review (oddsratio [OR] 7.28, 95% CI 4.36 12.18; p<0.0001). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 11.0 vs 5.6;0.28, 95% CI 0.200.39; p<0.0001 |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | rash or acne, diarrhoea, stomatitis or mucositis |
| Conclusions: | Firstline afatinib significantly improves progression free survival with a tolerable and manageable safety profile in Asian patients with EGFR mutationpositive advanced lung non small cell lung cancer. Afatinib should be considered as a firstline treatment option for this patient population. |