| General information |
| Database: | DB00646 |
| Objective: | Thisphase II, openlabel study evaluated the efficacy and safety of erlotinib as secondline therapy in non small cell lung cancer (non small cell lung cancer) patients with brain metastases (BM). |
| Authors: | Wu YL, et al |
| Title: | Erlotinib as secondline treatment in patients with advanced non small cell lung cancer and asymptomatic brain metastases: a phase II study (CTONG0803). |
| Journal: | Ann Oncol. |
| Year: | 2013 |
| PMID: | 23129122 |
| Trial Design |
| Clinical Trial Id: | NCT00663689 |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | advanced cancer with brain metastasis |
| Cancer Subtype: | brain metastases from non-smallcell lung cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a Chinese, phase II, nonrandomized, openlabel, multicenter, singlearm clinical trial |
| Key Patients Feature: | aged 18-75years, of Asian origin, had an Eastern Cooperative Oncology Groupperformance status (ECOG PS) of 0-2, confirmed adenocarcinoma oractivating EGFR mutationpositive non small cell lung cancer (detected by DNA directsequencing), asymptomatic BM (one or more lesions of more than and equal to 10 mm diameteror more than three lesions of <10 mm) revealed during systemic screening, without extracranial progressive disease (PD) after 2-6 cycles of firstlineplatinumdoublet chemotherapy, and a life expectancy of >3 months. BMwere defined as asymptomatic if there were no signs of increasedintracranial pressure, nausea or vomiting, headache, cognitive and affectivedisorder, epilepsy, or focal neurologic symptoms. |
| Biomarker: | NA |
| Biomark Analysis: | Patients with EGFR mutationpositive disease had significantly longer median PFS versus EGFR wildtype disease [15.2 months (95% CI 8.322.2) versus 4.4 months (95% CI 0.011.6); P = 0.02]. |
| Control Group Info: | single arm |
| Treatment Info: | Treatment comprised erlotinib 150 mg/day. |
| Primary End Point: | progression free survival (PFS) |
| Secondary End Point: | NA |
| Patients Number: | 48 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | 0.751 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 10.1 months [95% confidence interval (CI) 7.1-12.3] for intracranial progression and 9.7 months (95% CI 2.5-17.8) for intracranial and systemic progression |
| Median OS A vs. C: | 18.9 months (95% CI 14.4-23.4) |
| Adverse Event(agent arm): | Most common adverse events were rash (77.1%), paronychia (20.8%), hyperbilirubinemia (16.7%), and diarrhea (14.6%); these were predominantly of grade 1/2. |
| Conclusions: | Singleagent erlotinib was active and well tolerated in non small cell lung cancer patients with BM. Further studies are warranted. |