Entry Detail
| General information | |
| Database: | DB00011 |
| Objective: | The objective of thisphase III trial was to compare chemotherapy combined with bevacizumab versus chemotherapy alone in the treatment of patients with advanced colorectal cancer. |
| Authors: | Stathopoulos GP, et al |
| Title: | Treatment of colorectal cancer with and without bevacizumab: a phase III study. |
| Journal: | Oncology |
| Year: | 2010 |
| PMID: | 20798560 |
| Trial Design | |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab |
| Target: | Vascular endothelial growth factor Epidermal growth factor receptor |
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal adenocarcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | leucovorin+5fluorouracil+irinotecan+ bevacizumab |
| Study Type: | a singlecenterphase III randomized trial. |
| Key Patients Feature: | patients with advanced colorectal cancer, all patients were stage IV with histologically confirmed adenocarcinoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | leucovorin, 5fluorouracil plus irinotecan |
| Treatment Info: | treatmentnaive patients were enrolled and divided into 2 arms: 114 arm A patients were treated with leucovorin, 5fluorouracil plus irinotecan in combination with bevacizumab, and 108 arm B patients were treated as above without bevacizumab |
| Primary End Point: | The primary objective of the study was to determine survival |
| Secondary End Point: | the response rate and toxicity. |
| Patients Number: | 222 |
| Trial Results | |
| DLT_MTD: | NA |
| Objective Response Rate: | No statistically significant difference between the 2 arms regarding the response rate was observed: partial response, 42 patients (36.8%) and 38 patients (35.2%) for arms A and B, respectively. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 22.0 ms (95% CI: 18.125.9) vs 25.0 ms (CI: 18.131.9), there was no statistically significant difference between the 2 arms (p = 0.1391). |
| Adverse Event(agent arm): | Hematologic toxicity did not differ in the comparison of the 2 arms. Nonhematologic toxicity in arm A involved hypertension in 23 (20.2%) of the patients and proteinuria in 7 (6.1%); 3 patients experienced hemorrhage and 1 patient intestinal perforation. None of these side effects was observed in arm B patients. |
| Conclusions: | No statistically significant difference in median overall survival in patients with advanced colorectal cancer treated with bevacizumab plus a combination therapy (arm A) and those treated with the combination only, without bevacizumab (arm B), was observed. |