| General information |
| Database: | DB00775 |
| Objective: | The purpose of this study was to determine whether the addition of the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib (Iressa, ZD1839; AstraZeneca, Wilmington, DE) to standard firstline gemcitabine and cisplatin provides clinical benefit over gemcitabine and cisplatin alone in patients with advanced or metastatic non small cell lung cancer (non small cell lung cancer). Gefitinib has demonstrated encouraging efficacy in advanced non small cell lung cancer inphase II trials in pretreated patients, and a phase I trial of gefitinib in combination with gemcitabine and cisplatin showed favorable tolerability. |
| Authors: | Giaccone G, et al |
| Title: | Gefitinib in combination with gemcitabine and cisplatin in advanced non small cell lung cancer: a phase III trialINTACT 1. |
| Journal: | J Clin Oncol. |
| Year: | 2004 |
| PMID: | 14990632 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Gefitinib + gemcitabine + cisplatin |
| Study Type: | a phase III randomized, doubleblind, placebocontrolled, multicenter trial |
| Key Patients Feature: | chemotherapynaive patients with unresectable stage III or IV non small cell lung cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | chemotherapy (cisplatin 80 mg/m(2) on day 1 and gemcitabine 1, 250 mg/m(2) on days 1 and 8 of the 3week cycle) plus either gefitinib 500 mg/d, gefitinib 250 mg/d, or placebo |
| Treatment Info: | All patients received up to six cycles of chemotherapy (cisplatin 80 mg/m(2) on day 1 and gemcitabine 1, 250 mg/m(2) on days 1 and 8 of the 3week cycle) plus either gefitinib 500 mg/d, gefitinib 250 mg/d, or placebo. Daily gefitinib or placebo was continued until disease progression. |
| Primary End Point: | overall survival (primary), time to progression, response rates, and safety evaluation |
| Secondary End Point: | NA |
| Patients Number: | 1093 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 49.7%, 50.3%, and 44.8% for the gefitinib 500 mg/d, gefitinib 250 mg/d, and placebo groups |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5.5, 5.8, and 6.0 months for the gefitinib 500 mg/d, gefitinib 250 mg/d, and placebo groups |
| Median OS A vs. C: | 9.9, 9.9, and 10.9 months for the gefitinib 500 mg/d, gefitinib 250 mg/d, and placebo groups |
| Adverse Event(agent arm): | Most adverse events occurred during the combinationphase of the trial and many were consistent with the known toxicities of the chemotherapy agents. |
| Conclusions: | Gefitinib in combination with gemcitabine and cisplatin in chemotherapynaive patients with advanced non small cell lung cancer did not have improved efficacy over gemcitabine and cisplatin alone. The reasons for this remain obscure and require further preclinical testing. |