| General information |
| Database: | DB00786 |
| Objective: | Elderly patients prefer to receive lesstoxic therapy. Monotherapy using drugs such as vinorelbine, gemcitabine or docetaxel is a preferable chemotherapy in elderly patients with advanced non small cell lung cancer. Gefitinib shows remarkable efficacy in patients with advanced non small cell lung cancer, who have activating epidermal growth factor receptor mutations. Adenocarcinoma histology is related to these mutations. Therefore, they conducted a phase II study of gefitinib as a firstline therapy in elderly patients with pulmonary adenocarcinoma. |
| Authors: | Kobayashi M, et al |
| Title: | Phase II study of gefitinib as a firstline therapy in elderly patients with pulmonary adenocarcinoma: theyst Japan Thoracic Oncology Group Study 0402. |
| Journal: | Jpn J Clin Oncol. |
| Year: | 2011 |
| PMID: | 21715363 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | lung cancer |
| Cancer Subtype: | lung adenocarcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase II study |
| Key Patients Feature: | Eligible patients were 70 years or older, had pulmonary adenocarcinoma, stage IIIB or IV disease, an Eastern Cooperative Oncology Group performance status of 02 and adequate organ functions. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients were treated with oral gefitinib 250 mg daily until disease progression or unacceptable toxicity. |
| Primary End Point: | response rate. |
| Secondary End Point: | disease control rate, PFS, OS and toxicity |
| Patients Number: | 31 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 20% |
| Disease Control Rate: | 47% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2.7 months |
| Median OS A vs. C: | 11.9 months |
| Adverse Event(agent arm): | NA |
| Conclusions: | Gefitinib as a firstline therapy is active and well tolerated in elderly patients with pulmonary adenocarcinoma, especially in those who have never smoked. |