| General information |
| Database: | DB00895 |
| Objective: | The efficacy and safety of pemetrexed, gefitinib, and erlotinib administration in previously treated patients with non small cell lung cancer (non small cell lung cancer) were compared |
| Authors: | Hong J, et al |
| Title: | Pemetrexed versus gefitinib versus erlotinib in previously treated patients with non small cell lung cancer. |
| Journal: | Korean J Intern Med. |
| Year: | 2010 |
| PMID: | 20830227 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | gefitinib erlotinib
|
| Target: | NA
|
| 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: | Phase II study |
| Key Patients Feature: | histologically confirmed, previously treated advanced (stage IIIB or IV) or recurrent non small cell lung cancer; a measurable lesion; more than and equal to 18 years of age; Eastern Cooperative Oncology Group Performance status 0 to 2; and no prior exposure to the three study drugs |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | Pemetrexed(arm A)versus gefitinib(arm B) versus erlotinib(arm C) |
| Treatment Info: | Patients received 500 mg/m(2) of pemetrexed intravenously every 3 weeks with vitamin supplementation, gefitinib (250 mg/day per os), or erlotinib (150 mg/day per os). |
| Primary End Point: | PFS, response rates (RRs), disease control rates;safety profiles of each group, and PFS according to clinical characteristics. |
| Secondary End Point: | NA |
| Patients Number: | 57 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 5.3%, 25.0%, and 12.5% (p = 0.22) |
| Disease Control Rate: | 5.3%, 40.0%, and 50.0%, respectively (p < 0.01). |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 1.7, 3.5, and 4.4 months |
| Median OS A vs. C: | 5.6, 21.8, and 21.5 months |
| Adverse Event(agent arm): | toxicities in the gefitinib and erlotinib groups were skin disorders (rash, dry skin, pruritus, and acne), diarrhea, and anorexia. |
| Conclusions: | Both oral epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) had comparable efficacy and safety. The superior PFS and OS of EGFR TKIs with more favorable baseline clinical characteristics than those of pemetrexed suggest the impact of baseline clinicopathological factors. |