| General information |
| Database: | DB00869 |
| Objective: | This is a phase 2 study of chemotherapynaive patients, 70 years of age or older, with non small cell lung cancer (non small cell lung cancer) who were treated with docetaxel and gefitinib. response rate (RR). Secondary endpoints were overall survival (OS) and progression free survival (PFS). |
| Authors: | Simon GR, et al |
| Title: | Phase 2 trial of docetaxel and gefitinib in the firstline treatment of patients with advanced non small cell lung cancer (non small cell lung cancer) who are 70 years of age or older. |
| Journal: | cancer |
| Year: | 2008 |
| PMID: | 18300255 |
| Trial Design |
| Clinical Trial Id: | NCT00231465 |
| 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: | docetaxel + gefitinib |
| Study Type: | Phase II trial |
| Key Patients Feature: | patients with advanced non small cell lung cancer (non small cell lung cancer) who are 70 years of age or older |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Eligible patients were treated with docetaxel 75 mg/m(2) every 3 weeks and gefitinib 250 mg orally, daily. Docetaxel and gefitinib were given for 2 cycles beyond maximal response. Gefitinib was continued until disease progression. Comorbidities and activities of daily living were assessed (IADL). |
| Primary End Point: | response rate (RR). |
| Secondary End Point: | overall survival (OS) and progression free survival (PFS). |
| Patients Number: | 44 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 40% (95% confidence interval [CI], 26%-57%) |
| Disease Control Rate: | 88% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 6.9 months (95% CI, 3.957.8 months) |
| Median OS A vs. C: | 9.6 months (95% CI, 4.616.3 months). |
| Adverse Event(agent arm): | Hyperglycemia was attributed to the use of steroid prophylaxis with docetaxel. The most common grade 1/2 adverse effects were fatigue (68%), alopecia (55%), rash (25%), hyperglycemia (20%), cough (18%), nail changes (16%), and dyspnea (14%). Notably, there was no grade 3 or 4 rash in this trial. |
| Conclusions: | Docetaxel combined with gefitinib is active and well tolerated in patients with advanced non small cell lung cancer who are 70 years of age and older. This paradigm of treatment merits further investigation as a firstline treatment strategy. Female sexspecific confirmatory clinical trials with this regimen may be warranted |