| General information |
| Database: | DB00451 |
| Objective: | In the AVAGAST study, fluoropyrimidine and cisplatin plus bevacizumab did not significantly improve overall survival (OS) versus fluoropyrimidine and cisplatin plus placebo in patients with advanced gastric cancer. Geographic differences in efficacy were observed in AVAGAST, but the study only included 12 Chinese patients. AVATAR, a study similar in design to AVAGAST, was a randomized, doubleblind, phase III study conducted in Chinese patients with advanced gastric cancer. |
| Authors: | Shen L, et al |
| Title: | Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable locally advanced or metastatic gastric or gastroesophageal junction cancer: randomized, doubleblind, phase III study (AVATAR study). |
| Journal: | Gastric Cancer. |
| Year: | 2015 |
| PMID: | 24557418 |
| Trial Design |
| Clinical Trial Id: | NCT00887822 |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | esophagusgastroesophageal junction cancer |
| Cancer Subtype: | advanced adenocarcinoma of the stomach or gastroesophageal junction |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | Bevacizumab plus capecitabine and cisplatin |
| Study Type: | a randomized, doubleblind, multicenter, phase III trial |
| Key Patients Feature: | patients were more than 18 years of age, with histologically confirmed, inoperable, locally advanced orrecurrent, and/or metastatic adenocarcinoma of the stomach or gastroesophageal junction. Patients with no priortreatment for advanced/metastatic disease, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, adequate organ function, and measurable or nonmeasurablebut evaluable disease were included in the study. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | capecitabinecisplatin plus either bevacizumab or placebo. |
| Treatment Info: | patients were randomized 1:1 to capecitabinecisplatin plus either bevacizumab or placebo. |
| Primary End Point: | OS |
| Secondary End Point: | PFS and safety. |
| Patients Number: | 202 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The proportion of patients with a response to treatment (confirmed complete or partial response) was numerically higher in the bevacizumab arm compared with the placebo arm, but this difference did not reach statistical significance [bevacizumab, 33 of 81 patients (41 %) vs. placebo, 29 of 86 patients (34 %), P = 0.35] |
| Disease Control Rate: | Placebo +capecitabinecisplatin: 72.2%. Bevacizumab+capecitabinecisplatin: 75.3% |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Placebo +capecitabinecisplatin:6.0 (4.9-7.4) months. Bevacizumab+capecitabinecisplatin: 6.3 (5.7-7.4) months |
| Median OS A vs. C: | Placebo +capecitabinecisplatin: 11.4 (8.6-16.0) months. Bevacizumab+capecitabinecisplatin: 10.5 (8.9-14.1) months |
| Adverse Event(agent arm): | Grade 3-5 adverse events (AEs) occurred in 60 % of bevacizumabtreated and 68 % of placebotreated patients, respectively. Grade 3-5 AEs of special interest with bevacizumab occurred in 8 % of bevacizumabtreated patients and 15 % of placebotreated patients, mainly grade 3-5 hemorrhage (bevacizumab 4 %, placebo 12 %). |
| Conclusions: | Addition of bevacizumab to capecitabinecisplatin in Chinese patients with advanced gastric cancer did not improve outcomes in AVATAR. There was no difference in OS bettheyen the two arms and PFS was similar in both arms. Safety findings they were as previously experienced with bevacizumab, including AVAGAST; no new safety signals they were reported. |