| General information |
| Database: | DB00454 |
| Objective: | They investigated the efficacy and tolerability of cisplatin and 5fluorouracil (5FU) plus bevacizumab as neoadjuvant therapy for patients with locally advanced resectable esophageal cancer. |
| Authors: | Idelevich E, et al |
| Title: | Prospectivephase II study of neoadjuvant therapy with cisplatin, 5fluorouracil, and bevacizumab for locally advanced resectable esophageal cancer. |
| Journal: | Onkologie. |
| Year: | 2012 |
| PMID: | 22846974 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab
|
| Target: | Vascular endothelial growth factor
|
| Cancer Type: | esophagusgastroesophageal junction cancer |
| Cancer Subtype: | squamous cell carcinoma or adenocarcinoma of the esophagus or esophagogastric junction |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | neoadjuvant therapy with cisplatin, 5fluorouracil, and bevacizumab |
| Study Type: | prospectivephase II study |
| Key Patients Feature: | Inclusion criteria were adult patients aged > 18 years, histologically proven squamous cell carcinoma (SCC) or adenocarcinoma of the esophagus or esophagogastric junction, no prior chemotherapy or immunologic treatment, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, disease stage II-III, and life expectancy more than and equal to 5 years. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | pts received 2 4day cycles of bevacizumab 7.5 mg/kg followed by cisplatin 80 mg/m(2) infusion on day 1 followed by 5FU 1, 000 mg/m(2) as a 96h continuous infusion on days 14, separated by a 3week interval. |
| Primary End Point: | the response rate, R0 resection rate, and tolerability. |
| Secondary End Point: | OS and PFS. |
| Patients Number: | 22 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The response rate was 39%, the R0 resection rate was 43%, and the median overall survival (OS) was 17 months. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 5 months (range 3-33 months) |
| Median OS A vs. C: | 17 months. In 37 patients previously treated with cisplatin and 5FU:23 months. |
| Adverse Event(agent arm): | The regimen was well tolerated, with the most common severe toxicities being venous thromboembolism (10%), nausea, and gastrointestinal bleeding (7% each). |
| Conclusions: | Adding bevacizumab to cisplatin and 5FU neoadjuvant chemotherapy was active and well tolerated but did not seem to improve the resection rate or OS compared with prior regimens, including the historical controls at our institution. |