| General information |
| Database: | DB00596 |
| Objective: | As glioblastoma progresses, patients experience a decline in healthrelated quality of life (HRQoL). Delaying this decline is an important treatment goal. In newly diagnosed glioblastoma, progression free survival was prolonged when bevacizumab was added to radiotherapy plus temozolomide (RT/TMZ) versus placebo plus RT/TMZ (phase III AVAglio study; hazard ratio, 0.64; 95% CI, 0.55 to 0.74; P < .001). To ensure that addition of bevacizumab to standardofcare therapy was not associated with HRQoL detriment, HRQoL assessment was a secondary objective. |
| Authors: | Taphoorn MJ, et al |
| Title: | HealthRelated Quality of Life in a Randomizedphase III Study of Bevacizumab, Temozolomide, and Radiotherapy in Newly Diagnosed Glioblastoma. |
| Journal: | J Clin Oncol. |
| Year: | 2015 |
| PMID: | 26014298 |
| Trial Design |
| Clinical Trial Id: | NCT00943826 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | Tumors of the nervous system |
| Cancer Subtype: | glioblastoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | Bevacizumab, Temozolomide, and Radiotherapy |
| Study Type: | a randomized, doubleblind, placebocontrolled, multicenterphase III trial |
| Key Patients Feature: | eligible patientshad newly diagnosed supratentorial glioblastoma (histologically confirmed fromsurgical resection/biopsy tissue), were age 18 years or older, had a WHO performance status 2, a stable/decreasing corticosteroid dose within 5 days beforerandom assignment, adequate hematologic, hepatic, and renal function, and acceptable blood coagulation parameters. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | bevacizumab and placebo arms |
| Treatment Info: | Patients completed European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires C30 and BN20 at each tumor assessment (Appendix Table A1, online only). Raw scores were converted to a 100point scale and mean changes from baseline scores were evaluated (stable: < 10point change; clinically relevant deterioration/improvement: more than and equal to 10point change). Deteriorationfree survival was the time to deterioration/progression/death; time to deterioration was the time to deterioration/death. |
| Primary End Point: | investigatorassessed PFS or overall survival; |
| Secondary End Point: | betweenarm comparisons of independent review facility-assessed PFS, 1 and 2year survival rates, and safety. |
| Patients Number: | 26 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | No grade 3/4 adverse events were observed; three patients treated with bevacizumab+erlotinib displayed grade 1/2 rash not requiring dose reduction; one patient treated with bevacizumab developed intratumoral hemorrhage requiring treatment discontinuation. |
| Conclusions: | The addition of bevacizumab to standardofcare treatment for newly diagnosed glioblastoma had no impact on HRQoL during the progression free period. |