| General information |
| Database: | DB00053 |
| Objective: | Patients with non small cell lung cancer harbouring mutations in the epidermal growth factor receptor (EGFR) gene respond well to the EGFRspecific tyrosine kinase inhibitor gefitinib. However, whether gefitinib is better than standard platinum doublet chemotherapy in patients selected by EGFR mutation is uncertain. |
| Authors: | Mitsudomi T, et al |
| Title: | Gefitinib versus cisplatin plus docetaxel in patients with non small cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomisedphase 3 trial. |
| Journal: | Lancet Oncol. |
| Year: | 2010 |
| PMID: | 20022809 |
| Trial Design |
| Clinical Trial Id: | UMIN (University Hospital Medical Information Network in Japan), number 000000539. |
| Agent: | gefitinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | non small cell lung cancer harboring epidermal growth factor receptor mutations |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Phase III (WJTOGIII405):an open label, randomised |
| Key Patients Feature: | Japan patients with non small cell lung cancer harbouring mutations in the EGFR gene |
| Biomarker: | harbouring EGFR mutations (either the exon 19 deletion or L858R point mutation) |
| Biomark Analysis: | Patients with lung cancer who are selected by EGFR mutations have longer progression free survival if they are treated with gefitinib than if they are treated with cisplatin plus docetaxel. |
| Control Group Info: | cisplatin, docetaxel |
| Treatment Info: | pts were randomly assigned, using a minimisation technique, to receive either gefitinib (250 mg/day orally; n=88) or cisplatin (80 mg/m(2), intravenously) plus docetaxel (60 mg/m(2), intravenously; n=89), administered every 21 days for three to six cycles. |
| Primary End Point: | progression free survival. |
| Secondary End Point: | NA |
| Patients Number: | 118 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The objective response rate in the overall populationwith measurable disease (n=117) was 62.1% (36 of 58 patients) in the gefitinib group and 32.2% (19 of 59 patients) in the cisplatin plus docetaxel group(p<0.0001). |
| Disease Control Rate: | The disease control rate was alsohigher in the gefi tinib group (54/58, 93.1%) than in thecisplatin plus docetaxel group (46/59, 78.0%; difference indisease control rate 15.1%, 95% CI 2.7-27.6, p=0.020;theybappendix). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 9.2 vs. 6.3;0.489, 0.3360.710;p<0.0001 |
| Median OS A vs. C: | imature |
| Adverse Event(agent arm): | skin toxicity, liver dysfunction, and diarrhoea |
| Conclusions: | Patients with lung cancer who are selected by EGFR mutations have longer progression free survival if they are treated with ge? tinib than if they are treated with cisplatin plus docetaxel. |