skip to main content
OSTI.GOV title logo U.S. Department of Energy
Office of Scientific and Technical Information

Title: Phase I/II study of trastuzumab, paclitaxel, cisplatin and radiation for locally advanced, HER2 overexpressing, esophageal adenocarcinoma

Abstract

Purpose: To determine the overall survival for patients with locally advanced, HER2 overexpressing, esophageal adenocarcinoma receiving trastuzumab, paclitaxel, cisplatin, and radiation on a Phase I-II study. Methods and Materials: Patients with adenocarcinoma of the esophagus without distant organ metastases and 2+/3+ HER2 overexpression by immunohistochemistry (IHC) were eligible. All patients received cisplatin 25 mg/m{sup 2} and paclitaxel 50 mg/m{sup 2} weekly for 6 weeks with radiation therapy (RT) 50.4 Gy. Patients received trastuzumab at dose levels of 1, 1.5, or 2 mg/kg weekly for 5 weeks after an initial bolus of 2, 3, or 4 mg/kg. Results: Nineteen patients were entered: 7 (37%) had celiac adenopathy, and 7 (37%) had retroperitoneal, portal adenopathy, or scalene adenopathy. Fourteen of 19 patients (74%) had either 3+ HER2 expression by immunohistochemistry, or an increase in HER2 gene copy number by HER2 gene amplification or high polysomy by fluorescence in situ hybridization. The median survival of all patients was 24 months and the 2-year survival was 50%. Conclusions: Assessment of the effect of trastuzumab in the treatment of patients with esophageal adenocarcinoma overexpressing HER2 is limited by the small number of patients in this study. Overall survival, however, was similar to prior studies withoutmore » an increase in toxicity. Evaluation of HER2 status should be performed in future trials for patients with adenocarcinoma of the esophagus that investigate therapies targeting the HER family.« less

Authors:
 [1];  [2];  [2];  [2];  [2];  [2];  [2];  [2];  [2];  [2];  [2]
  1. Brown University Oncology Group, Providence, RI (United States). E-mail: hsafran@lifespan.org
  2. Brown University Oncology Group, Providence, RI (United States)
Publication Date:
OSTI Identifier:
20944680
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 67; Journal Issue: 2; Other Information: DOI: 10.1016/j.ijrobp.2006.08.076; PII: S0360-3016(06)02832-X; Copyright (c) 2007 Elsevier Science B.V., Amsterdam, Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CARCINOMAS; ESOPHAGUS; EVALUATION; FLUORESCENCE; GENE AMPLIFICATION; GENES; IN-SITU HYBRIDIZATION; METASTASES; PATIENTS; RADIATION DOSES; RADIOTHERAPY; TOXICITY

Citation Formats

Safran, Howard, Di Petrillo, Thomas, Akerman, Paul, Ng, Thomas, Evans, Devon, Steinhoff, Margaret, Benton, David, Purviance, John, Goldstein, Lisa, Tantravahi, Umadevi, and Kennedy, Teresa R.N. Phase I/II study of trastuzumab, paclitaxel, cisplatin and radiation for locally advanced, HER2 overexpressing, esophageal adenocarcinoma. United States: N. p., 2007. Web. doi:10.1016/j.ijrobp.2006.08.076.
Safran, Howard, Di Petrillo, Thomas, Akerman, Paul, Ng, Thomas, Evans, Devon, Steinhoff, Margaret, Benton, David, Purviance, John, Goldstein, Lisa, Tantravahi, Umadevi, & Kennedy, Teresa R.N. Phase I/II study of trastuzumab, paclitaxel, cisplatin and radiation for locally advanced, HER2 overexpressing, esophageal adenocarcinoma. United States. doi:10.1016/j.ijrobp.2006.08.076.
Safran, Howard, Di Petrillo, Thomas, Akerman, Paul, Ng, Thomas, Evans, Devon, Steinhoff, Margaret, Benton, David, Purviance, John, Goldstein, Lisa, Tantravahi, Umadevi, and Kennedy, Teresa R.N. Thu . "Phase I/II study of trastuzumab, paclitaxel, cisplatin and radiation for locally advanced, HER2 overexpressing, esophageal adenocarcinoma". United States. doi:10.1016/j.ijrobp.2006.08.076.
@article{osti_20944680,
title = {Phase I/II study of trastuzumab, paclitaxel, cisplatin and radiation for locally advanced, HER2 overexpressing, esophageal adenocarcinoma},
author = {Safran, Howard and Di Petrillo, Thomas and Akerman, Paul and Ng, Thomas and Evans, Devon and Steinhoff, Margaret and Benton, David and Purviance, John and Goldstein, Lisa and Tantravahi, Umadevi and Kennedy, Teresa R.N.},
abstractNote = {Purpose: To determine the overall survival for patients with locally advanced, HER2 overexpressing, esophageal adenocarcinoma receiving trastuzumab, paclitaxel, cisplatin, and radiation on a Phase I-II study. Methods and Materials: Patients with adenocarcinoma of the esophagus without distant organ metastases and 2+/3+ HER2 overexpression by immunohistochemistry (IHC) were eligible. All patients received cisplatin 25 mg/m{sup 2} and paclitaxel 50 mg/m{sup 2} weekly for 6 weeks with radiation therapy (RT) 50.4 Gy. Patients received trastuzumab at dose levels of 1, 1.5, or 2 mg/kg weekly for 5 weeks after an initial bolus of 2, 3, or 4 mg/kg. Results: Nineteen patients were entered: 7 (37%) had celiac adenopathy, and 7 (37%) had retroperitoneal, portal adenopathy, or scalene adenopathy. Fourteen of 19 patients (74%) had either 3+ HER2 expression by immunohistochemistry, or an increase in HER2 gene copy number by HER2 gene amplification or high polysomy by fluorescence in situ hybridization. The median survival of all patients was 24 months and the 2-year survival was 50%. Conclusions: Assessment of the effect of trastuzumab in the treatment of patients with esophageal adenocarcinoma overexpressing HER2 is limited by the small number of patients in this study. Overall survival, however, was similar to prior studies without an increase in toxicity. Evaluation of HER2 status should be performed in future trials for patients with adenocarcinoma of the esophagus that investigate therapies targeting the HER family.},
doi = {10.1016/j.ijrobp.2006.08.076},
journal = {International Journal of Radiation Oncology, Biology and Physics},
number = 2,
volume = 67,
place = {United States},
year = {Thu Feb 01 00:00:00 EST 2007},
month = {Thu Feb 01 00:00:00 EST 2007}
}