Entry Detail
| General information | |
| Database: | DB00059 |
| Objective: | Afatinib is an irreversible ErbBfamily blocker with preclinical activity in non small cell lung cancer (non small cell lung cancer) with EGFR mutations. they aimed to assess the efficacy of afatinib in patients with lung adenocarcinoma and EGFR mutations. |
| Authors: | Yang JC, et al |
| Title: | Afatinib for patients with lung adenocarcinoma and epidermal growth factor receptor mutations (LUXLung 2): a phase 2 trial. |
| Journal: | Lancet Oncol. |
| Year: | 2012 |
| PMID: | 22452895 |
| Trial Design | |
| Clinical Trial Id: | NCT00525148 |
| Agent: | afatinib |
| Target: | Receptor proteintyrosine kinase erbB2 Epidermal growth factor receptor |
| Cancer Type: | lung cancer |
| Cancer Subtype: | advanced lung adenocarcinoma and EGFR mutations |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | phase II LUXLung II |
| Key Patients Feature: | 30 centres in Taiwan and the USA |
| Biomarker: | EGFR mutations |
| Biomark Analysis: | Afatinib shows activity in the treatment of patients with advanced lung adenocarcinoma with EGFR mutations, especially in patients with deletion 19 or L858R mutations. |
| Control Group Info: | 2 different starting dosage: a starting dose of 50 mg and a starting dose of 40 mg |
| Treatment Info: | they tested two afatinib starting doses: 50 mg daily and subsequently 40 mg daily, introduced to establish whether tolerability could be improved with retention of antitumour activity. |
| Primary End Point: | the proportion of patients with a confirmed objective response (complete response or partial response), on the basis of Response Evaluation Criteria in Solid Tumors 1.0 (independent review). |
| Secondary End Point: | NA |
| Patients Number: | 129 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | 79 (61%) of 129 patients had an objective response (two complete responses, 77 partial responses). 70 (66%) of the 106 patients with the two common activating EGFR mutations (deletion 19 or L858R) had an objective response, as did nine (39%) of 23 patients with less common mutations. Similar proportions of patients had an objective response when analysed by starting dose (18 [60%] of 30 patients at 40 mg vs 61 [62%] of 99 patients at 50 mg). |
| Disease Control Rate: | Disease control was noted in 106 (82%) of patients byindependent review and 111 (86%) by investigatorassessment |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | diarrhoea and rash or acne;grade 3 events were more common in patients receiving a 50 mg starting dose |
| Conclusions: | Afatinib shows activity in the treatment of patients with advanced lung adenocarcinoma with EGFR mutations, especially in patients with deletion 19 or L858R mutations. The efficacy of afatinib 40 mg should be compared with chemotherapy or other EGFR tyrosinekinase inhibitors in EGFRmutationpositive non small cell lung cancer. |