| General information |
| Database: | DB00374 |
| Objective: | To evaluate the efficacy of bevacizumab (Avastin, Genentech) and erlotinib (Tarceva, Genentech/Roche) when added to preoperative chemoradiation therapy with paclitaxel, carboplatin, and infusional 5fluorouracil (5FU) in the treatment of localized cancers of the esophagus or gastroesophageal (GE) junction. the pathologic complete response (pCR) rate. |
| Authors: | Bendell JC, et al |
| Title: | a phase II trial of preoperative concurrent chemotherapy/radiation therapy plus bevacizumab/erlotinib in the treatment of localized esophageal cancer. |
| Journal: | Clin Adv Hematol Oncol. |
| Year: | 2012 |
| PMID: | 22895283 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | bevacizumab/erlotinib
|
| Target: | NA
|
| Cancer Type: | esophageal cancer |
| Cancer Subtype: | localized esophageal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 14 |
| Therapeutic Combination Content: | bevacizumab+erlotinib+chemotherapy+radiation |
| Study Type: | a phase II trial |
| Key Patients Feature: | Eligible patients had previously untreated localized squamous cell, adenocarcinoma, or adenosquamous carcinoma of the esophagus or GE junction, and were considered surgical candidates at enrollment |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Daily erlotinib (100 mg orally) was administered on days 142 of preoperative treatment. Patients received paclitaxel (200 mg/m2 intravenously [IV]), carboplatin (area under the curve [AUC] 5.0 IV), and bevacizumab (15 mg/kg IV) on days 1 and 22, and 5FU by continuous infusion (225 mg/m2/day IV) on days 135, with radiation therapy in 1.8Gy single fractions, MondayFriday (to a total of 45 Gy). Those who were deemed surgical candidates proceeded to resection during weeks 1214. |
| Primary End Point: | efficacy and safety |
| Secondary End Point: | NA |
| Patients Number: | 62 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Eighteen patients (29%) achieved pCR, with partial pathologic remission in an additional 22 patients (35%). Common grade 3/4 toxicities included leukopenia (64%), neutropenia (44%), mucositis/stomatitis (42%), diarrhea (27%), and esophagitis (27%). There were 40 instances of treatmentrelated hospitalization, and 2 postoperative deaths. |
| 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): | Common grade 3/4 toxicities included leukopenia (64%), neutropenia (44%), mucositis/stomatitis (42%), diarrhea (27%), and esophagitis (27%). There were 40 instances of treatmentrelated hospitalization, and 2 postoperative deaths. |
| Conclusions: | The addition of bevacizumab and erlotinib to neoadjuvant chemoradiation did not demonstrate survival benefit or improved pCR rate over similar regimens. While the overall rates of toxicity they were not increased, targeted agentspecific toxicity was evident. Further study of this specific regimen is not warranted. |