Continuing or ceasing bevacizumab beyond progression in recurrent glioblastoma: an exploratory randomized phase II trial
| Autor: | Pramit M. Phal, Helen Wheeler, Kate Sawkins, Lawrence Cher, Elizabeth Hovey, Christine Goh, Anna K. Nowak, Elizabeth H Barnes, Ann Livingstone, Mark Rosenthal, John Simes, Kathryn M. Field, Cogno investigators |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Oncology
medicine.medical_specialty Temozolomide Randomization genetic structures Bevacizumab business.industry Hazard ratio Medicine (miscellaneous) Phases of clinical research Original Articles Chemotherapy regimen eye diseases Carboplatin Irinotecan 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine chemistry 030220 oncology & carcinogenesis Internal medicine Medicine business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Neuro-Oncology Practice. 4:171-181 |
| ISSN: | 2054-2585 2054-2577 |
| DOI: | 10.1093/nop/npw025 |
| Popis: | BackgroundIn patients with recurrent glioblastoma, the benefit of bevacizumab beyond progression remains uncertain. We prospectively evaluated continuing or ceasing bevacizumab in patients who progressed while on bevacizumab.MethodsCABARET, a phase II study, initially randomized patients to bevacizumab with or without carboplatin (Part 1). At progression, eligible patients underwent a second randomization to continue or cease bevacizumab (Part 2). They could also receive additional chemotherapy regimens (carboplatin, temozolomide, or etoposide) or supportive care.ResultsOf 120 patients treated in Part 1, 48 (80% of the anticipated 60-patient sample size) continued to Part 2. Despite randomization, there were some imbalances in patient characteristics. The best response was stable disease in 7 (30%) patients who continued bevacizumab and 2 (8%) patients who stopped receiving bevacizumab. There were no radiological responses. Median progression-free survival was 1.8 vs 2.0 months (bevacizumab vs no bevacizumab; hazard ratio [HR], 1.08; 95% CI, .59–1.96; P = .81). Median overall survival was 3.4 vs 3.0 months (HR, .84; 95% CI, .47–1.50; P = .56 and HR .70; 95% CI .38–1.29; P = .25 after adjustment for baseline factors). Quality-of-life scores did not significantly differ between arms. While the maximum daily steroid dose was lower in the continuation arm, the difference was not statistically significant.ConclusionsPatients who continued bevacizumab beyond disease progression did not have clear survival improvements, although the study was not powered to detect other than very large differences. While these data provide the only randomized evidence related to continuing bevacizumab beyond progression in recurrent glioblastoma, the small sample size precludes definitive conclusions and suggests this remains an open question. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|