skip to main content

Title: Preoperative Chemoradiation Therapy in Combination With Panitumumab for Patients With Resectable Esophageal Cancer: The PACT Study

Purpose: Preoperative chemoradiation therapy (CRT) has become the standard treatment strategy for patients with resectable esophageal cancer. This multicenter phase 2 study investigated the efficacy of the addition of the epidermal growth factor receptor (EGFR) inhibitor panitumumab to a preoperative CRT regimen with carboplatin, paclitaxel, and radiation therapy in patients with resectable esophageal cancer. Methods and Materials: Patients with resectable cT1N1M0 or cT2-3N0 to -2M0 tumors received preoperative CRT consisting of panitumumab (6 mg/kg) on days 1, 15, and 29, weekly administrations of carboplatin (area under the curve [AUC] = 2), and paclitaxel (50 mg/m{sup 2}) for 5 weeks and concurrent radiation therapy (41.4 Gy in 23 fractions, 5 days per week), followed by surgery. Primary endpoint was pathologic complete response (pCR) rate. We aimed at a pCR rate of more than 40%. Furthermore, we explored the predictive value of biomarkers (EGFR, HER 2, and P53) for pCR. Results: From January 2010 until December 2011, 90 patients were enrolled. Patients were diagnosed predominantly with adenocarcinoma (AC) (80%), T3 disease (89%), and were node positive (81%). Three patients were not resected due to progressive disease. The primary aim was unmet, with a pCR rate of 22%. Patients with AC and squamous cell carcinoma reached a pCR of 14% andmore » 47%, respectively. R0 resection was achieved in 95% of the patients. Main grade 3 toxicities were rash (12%), fatigue (11%), and nonfebrile neutropenia (11%). None of the biomarkers was predictive for response. Conclusions: The addition of panitumumab to CRT with carboplatin and paclitaxel was safe and well tolerated but could not improve pCR rate to the preset criterion of 40%.« less
Authors:
 [1] ;  [2] ;  [3] ;  [4] ;  [5] ;  [6] ; ;  [1] ;  [2] ;  [7] ;  [1]
  1. Department of Medical Oncology, Academic Medical Center, Amsterdam (Netherlands)
  2. Department of Surgery, Academic Medical Center, Amsterdam (Netherlands)
  3. Department of Radiotherapy, Academic Medical Center, Amsterdam (Netherlands)
  4. Department of Gastroenterology, Academic Medical Center, Amsterdam (Netherlands)
  5. Department of Medical Oncology, Vrije Universiteit Medical Center, Amsterdam (Netherlands)
  6. Department of Medical Oncology, Leiden University Medical Center, Leiden (Netherlands)
  7. Department of Pathology, Academic Medical Center, Amsterdam (Netherlands)
Publication Date:
OSTI Identifier:
22420425
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 90; Journal Issue: 1; Other Information: Copyright (c) 2014 Elsevier Science B.V., Amsterdam, The 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; BIOLOGICAL MARKERS; CARCINOMAS; CHEMOTHERAPY; DIAGNOSIS; ESOPHAGUS; FATIGUE; GROWTH FACTORS; PATIENTS; RADIOTHERAPY; RECEPTORS; SURGERY; TOXICITY