| General information |
| Database: | DB01018 |
| Objective: | The ISTANA (IRESSA as Secondline Therapy in Advanced non small cell lung cancerKoreA) study compared gefitinib with docetaxel in patients with advanced or metastatic nonsmall cell lung carcinoma (non small cell lung cancer) pretreated with platinumbased chemotherapy. |
| Authors: | Lee DH, et al |
| Title: | Randomizedphase III trial of gefitinib versus docetaxel in non small cell lung cancer patients who have previously received platinumbased chemotherapy. |
| Journal: | Clin Cancer Res. |
| Year: | 2010 |
| PMID: | 20145166 |
| Trial Design |
| Clinical Trial Id: | NCT00478049 |
| 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: | a multicenter, randomized, openlabelphase III trial |
| Key Patients Feature: | patients with advanced or metastatic non small cell lung cancer treated with one previous platinumbased chemotherapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | docetaxel |
| Treatment Info: | gefitinib (250 mg/d) versus docetaxel (75 mg/m(2) day 1 every 3 weeks) |
| Primary End Point: | progression free survival. |
| Secondary End Point: | NA |
| Patients Number: | 161 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 28.1% versus 7.6% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.3 months in the gefitinib group and 3.4 months in the docetaxel group |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Serious adverse events were reported by 16% of gefitinibtreated patients and 25% of docetaxeltreated patients. There were four adverse events leading to death in the gefitinib arm (pneumonia, septic shock, interstitial lung disease; two cases, one considered possibly treatment related) and two in the docetaxel arm (pneumonia and aspiration pneumonia). The incidence of interstitial lung disease-type adverse events was 3.7% (three patients) with gefitinib and 3.9% (three patients) with docetaxel. No interstitial lung disease-type adverse events resulted in death in the docetaxel arm. Fetheyr dose modifications due to toxicity occurred with gefitinib (4.9% dose interruptions) than with docetaxel (17.1% dose reductions or delays). |
| Conclusions: | The primary endpoint of progression free survival was longer with gefitinib than docetaxel, and the secondary endpoints showed superior objective response rate, good tolerability, and similar quality of life improvement rates for gefitinib than docetaxel. Therefore, gefitinib is an important valid treatment option for secondline therapy for Korean non small cell lung cancer patients. |