| General information |
| Database: | DB00853 |
| Objective: | Both bevacizumab and erlotinib have clinical activity in non small cell lung cancer (non small cell lung cancer). Preclinical data suggest synergistic activity. |
| Authors: | Dingemans AM, et al |
| Title: | Firstline erlotinib and bevacizumab in patients with locally advanced and/or metastatic non small cell lung cancer: a phase II study including molecular imaging. |
| Journal: | Ann Oncol. |
| Year: | 2011 |
| PMID: | 20702788 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib and bevacizumab
|
| Target: | NA
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | erlotinib + bevacizumab |
| Study Type: | a phase II study |
| Key Patients Feature: | Chemonaive patients with stage IIIb or IV nonsquamous non small cell lung cancer |
| Biomarker: | The presence of KRAS or EGFR mutations |
| Biomark Analysis: | The presence of KRAS (n = 10) or EGFR mutations (n = 5) did not influence outcome. |
| Control Group Info: | single arm |
| Treatment Info: | patients were treated with bevacizumab 15 mg/kg every 3 weeks and erlotinib 150 mg daily until progression |
| Primary End Point: | Primary end point was nonprogression rate (NPR) at 6 weeks. |
| Secondary End Point: | NA |
| Patients Number: | 47 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.8 [95% confidence interval (CI) 2.35.4] months |
| Median OS A vs. C: | 6.9 (95% CI 5.58.4) months |
| Adverse Event(agent arm): | Table 2.Related adverse events occurring in >10% of patients or having CTC grade 3/4 |
| Conclusions: | Firstline treatment with bevacizumab and erlotinib in stage IIIbIV non small cell lung cancer resulted in an NPR of 75%. OS was hotheyver disappointing. Early response evaluation with FDGPET is the best predictive test for PFS. |