| General information |
| Database: | DB00643 |
| Objective: | The aim of this paper is to explore the efficacy of whole brain radiotherapy (WBRT) versus WBRT concurrent with erlotinib in patients with multiple brain metastases of lung adenocarcinoma. |
| Authors: | Zhuang H, et al |
| Title: | Phase II study of whole brain radiotherapy with or without erlotinib in patients with multiple brain metastases from lung adenocarcinoma. |
| Journal: | Drug Des Devel Ther. |
| Year: | 2013 |
| PMID: | 24133369 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | erlotinib
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | advanced cancer with brain metastasis |
| Cancer Subtype: | brain metastases from lung adenocarcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 4 |
| Therapeutic Combination Content: | whole brain radiotherapy with or without erlotinib |
| Study Type: | Phase ii study |
| Key Patients Feature: | adenocarcinomaFirstline chemotherapy failureMultiple brain metastasesdiagnosed by cT/MrirPa class 1 or 2expected survival time «¡6 monthsOver 4 weeks after blood-brainbarriercrossing cytotoxic drugsmedicationhb «¡ 90; granulocyte count «¡1.5 ¡Á109/l; Platelet count «¡100 ¡Á 109/l;serum bilirubin ªÆ1.5 ¡Á Uln;asT and/or alT ªÆ 2 ¡Á Uln;serum creatinine ªÆ1.5 ¡Á Uln |
| Biomarker: | the epidermal growth factor receptor (EGFR) mutation |
| Biomark Analysis: | In the combination group, there were no differences of LPFS, PFS, and OS between the epidermal growth factor receptor (EGFR) mutation patients and EGFR wildtype patients. No Grade 4 or higher side effects were observed in either group. |
| Control Group Info: | radiotherapy alone VS radiotherapy + erlotinib |
| Treatment Info: | WBRT was administered at 30Gy/10f in both arms. In the combination arm, 150 mg erlotinib was given each day, starting the first day of radiotherapy and continuing for 1 month following the end of radiotherapy. Thereafter, pemetrexed or docetaxel monotherapy or the best supportive therapy was given to both arms. |
| Primary End Point: | The intracranial objective response rate and the local progression free survival (LPFS) |
| Secondary End Point: | Toxicity, progression free survival (PFS) and overall survival (OS) |
| Patients Number: | 54 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | In the WBRT and the combination arms, respectively, the objective response rate was 54.84% and 95.65% (P = 0.001), |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | In the WBRT and the combination arms, 5.2 months (range, 0-14.7 months). 6.8 months (range, 1.5-20.7 months) in the combination group. |
| Median OS A vs. C: | In the WBRT and the combination arms, median OS was 8.9 months (range, 4.5-19.7 months). 10.7 months (range, 5.3-29.7 months) in the combination group. |
| Adverse Event(agent arm): | Regarding the skin, gastrointestinal tract, eyes, headache, nausea, respiratory system, hematology, and hepatic and renal function, no side effects of Grade 4 or higher were observed. |
| Conclusions: | Data showed that erlotinib in combination with WBRT had a tolerable toxicity profile and prolonged the LPFS, PFS, and OS of lung adenocarcinoma patients with multiple brain metastases compared with WBRT monotherapy. |