| General information |
| Database: | DB00739 |
| Objective: | In IPASS (NCT00322452), progression free survival (PFS, primary endpoint) was significantly longer with firstline gefitinib versus carboplatin/paclitaxel in never/light exsmokers with advanced pulmonary adenocarcinoma in Asia, both in the overall intenttotreat (ITT) population and in the EGFR mutationpositive subgroup. To further characterize the clinical relevance of these data, they investigated objective response rate (ORR) and healthrelated quality of life (HRQoL) in patients treated with gefitinib. |
| Authors: | Wu YL, et al |
| Title: | Tumor response and healthrelated quality of life in clinically selected patients from Asia with advanced non small cell lung cancer treated with firstline gefitinib: post hoc analyses from the IPASS study. |
| Journal: | Lung Cancer. |
| Year: | 2013 |
| PMID: | 23540718 |
| Trial Design |
| Clinical Trial Id: | NCT00322452 |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | post hoc analyses from the IPASS study |
| Key Patients Feature: | patients of IPASS study |
| Biomarker: | EGFR mutationpositive |
| Biomark Analysis: | In patients whose tumors responded to gefitinib, median time to response was 6.1 weeks in the ITT population (n = 262) and 6.0 weeks in the EGFR mutationpositive subgroup (n = 94); median duration of response was 9.7 and 8.7 months in these groups, respectively |
| Control Group Info: | gefitinib versus carboplatin/paclitaxel |
| Treatment Info: | NA |
| Primary End Point: | Post hoc assessments included median time to response, median duration of response and change in tumor size. |
| Secondary End Point: | NA |
| Patients Number: | 356 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | ORR for the gefitinib arm of the ITT 71.2% vs 1.1% |
| 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): | all 22 patients with PRs to gefitinib had some skin toxicity, but 65% of those who failed to respond also experienced this adverse event |
| Conclusions: | Patients whose tumors responded to firstline gefitinib experienced significant tumor shrinkage and a rapid, durable response. Deterioration in HRQoL and lung cancer symptoms at 4 months postrandomization was found to be associated with tumor progression, highlighting the role of patientreported outcomes in the evaluation of advanced non small cell lung cancer disease. Rash was not supported as a predictive marker of response to gefitinib. |