| General information |
| Database: | DB01011 |
| Objective: | Gefitinib was compared with pemetrexed as secondline therapy in a clinically selected population previously treated with platinumbased chemotherapy |
| Authors: | Sun JM, et al |
| Title: | Gefitinib versus pemetrexed as secondline treatment in patients with nonsmall cell lung cancer previously treated with platinumbased chemotherapy (KCSGLU0801): an openlabel, phase 3 trial. |
| Journal: | Cancer. |
| Year: | 2012 |
| PMID: | 22674612 |
| Trial Design |
| Clinical Trial Id: | NCT01066195 |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | non small cell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an openlabel, phase III trial |
| Key Patients Feature: | patients who had never smoked and who had advanced pulmonary adenocarcinoma treated with 1 previous platinumbased regimen. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | gefitinib versus pemetrexed |
| Treatment Info: | gefitinib (250 mg/day) versus pemetrexed (500 mg/m(2) on day 1, every 3 weeks) |
| Primary End Point: | progression free survival (PFS). |
| Secondary End Point: | NA |
| Patients Number: | 135 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 58.8% and 22.4% for gefitinib and pemetrexed, respectively |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | gefitinib group vs pemetrexed group: 9.0 versus 3.0 months (P = .0006). |
| Median OS A vs. C: | 22.2 vs 18.9 months |
| Adverse Event(agent arm): | Hematologic adverse events were rare in both the gefitinib and pemetrexed arms, consistent with previous studies.6, 12 According to our expectations, acneiform rash (45.6%), pruritus (30.9%), and diarrhea (26.5%) were more frequently seen in the gefitinib arm compared with the pemetrexed arm. however, grade 3/4 toxicities were noted in less than 3% of patients in both arms. Serious adverse events occurred in 19.1% of the patients treated with gefitinib and 14.9% of the patients treated with pemetrexed. There was 1 adverse event (interstitial pneumonitis) leading to study withdrawal in the gefitinib arm, but none in the pemetrexed arm. however, there was no treatmentrelated death in either arm. |
| Conclusions: | Gefitinib showed superior efficacy to pemetrexed as secondline therapy in Korean neversmokers with pulmonary adenocarcinoma |