| General information |
| Database: | DB00745 |
| Objective: | With use of EGFR tyrosinekinase inhibitor monotherapy for patients with activating EGFR mutationpositive non small cell lung cancer (non small cell lung cancer), median progression free survival has been extended to about 12 months. Nevertheless, new strategies are needed to further extend progression free survival and overall survival with acceptable toxicity and tolerability for this population. they aimed to compare the efficacy and safety of the combination of erlotinib and bevacizumab compared with erlotinib alone in patients with nonsquamous non small cell lung cancer with activating EGFR mutationpositive disease |
| Authors: | Seto T, et al |
| Title: | Erlotinib alone or with bevacizumab as firstline therapy in patients with advanced nonsquamous non small cell lung cancer harbouring EGFR mutations (JO25567): an openlabel, randomised, multicentre, phase 2 study. |
| Journal: | Lancet Oncol. |
| Year: | 2014 |
| PMID: | 25175099 |
| Trial Design |
| Clinical Trial Id: | CTI111390 |
| Agent: | Erlotinib plus bevacizumab
|
| Target: | NA
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced nonsquamous non small cell lung cancer harbouring EGFR mutations |
| Therapy Type: | com |
| Therapeutic Combination Type: | 1 |
| Therapeutic Combination Content: | Erlotinib+bevacizumab |
| Study Type: | an openlabel, randomised, multicentre, phase II study. |
| Key Patients Feature: | patients from 30 centres across Japan with stage IIIB/IV or recurrent nonsquamous non small cell lung cancer with activating EGFR mutations, Eastern Cooperative Oncology Group performance status 0 or 1, and no previous chemotherapy for advanced disease |
| Biomarker: | EGFR mutations |
| Biomark Analysis: | NA |
| Control Group Info: | erlotinib and bevacizumab verus erlotinib alone |
| Treatment Info: | pts received erlotinib 150 mg/day plus bevacizumab 15 mg/kg every 3 weeks or erlotinib 150 mg/day monotherapy as a firstline therapy until disease progression or unacceptable toxicity. |
| Primary End Point: | progression free survival, as determined by an independent review committee. |
| Secondary End Point: | NA |
| Patients Number: | 154 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 69% in the erlotinib plus bevacizumab group, 49 in the erlotinib alone group |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 16.0 months (95% CI 13.918.1) with erlotinib plus bevacizumab and 9.7 months (5.711.1) with erlotinib alone (hazard ratio 0.54, 95% CI 0.360.79; logrank test p=0.0015). |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | The most common adverse events of any grade in the erlotinib plus bevacizumab group were rash, diarrhoea, hypertension, and paronychia, and in the erlotininb alone group were rash, diarrhoea, and paronychia (table 3). The most common grade 3 or worse adverse events in the erlotinib plus bevacizumab group were hypertension, rash, proteinuria, and liver function disorder or abnormal hepatic function, and in the erlotinib group were rash, liver function disorder or abnormal hepatic function, and hypertension (table 3). |
| Conclusions: | Erlotinib plus bevacizumab combination could be a new firstline regimen in EGFR mutationpositive non small cell lung cancer. Further investigation of the regimen is warranted. |