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Sub-category:
Multidisciplinary Treatment
Category:
Cancers of the Esophagus and Stomach
Meeting:
2010 Gastrointestinal Cancers Symposium
Session Type and Session Title:
General Poster Session A: Cancers of the Esophagus and Stomach
Oral Abstract Session: Cancers of the Esophagus and Stomach
Abstract No:
45
Author(s):
K. J. Chang, N. N. Senzer, R. Soetikno, S. Swisher, T. R. Reid, A. Mauer, H. Pinto, A. Chak, M. O. Thornton, A. A. Forastiere; University of California Irvine Medical Center, Orange, CA; Mary Crowley Cancer Research Center, Dallas, TX; VA Palo Alto, Stanford University, California Pacific Interventional Endoscopy, Palo Alto, CA; University of Texas M. D. Anderson Cancer Center; University of California, San Diego, La Jolla, CA; The University of Chicago, Chicago, IL; Palo Alto VA Health Care System, Palo Alto, CA; University Hospitals of Cleveland, Cleveland, OH; Genvec Inc., Gaithersburg, MD; The Johns Hopkins University, Baltimore, MD
Abstract:
Background: Despite neoadjuvant therapy and aggressive surgical resections, the prognosis for esophageal cancer remains poor. TNF is a second-generation replication-deficient adenovector, carrying the transgene encoding human TNF-α, regulated by the radiation-inducible promoter Egr-1. This is the first clinical trial using TNF in patients with esophageal cancer. Updated efficacy and survival data is now reported. Methods: Multicenter dose-escalating study of TNF with concurrent neoadjuvant chemoradiation (45 Gy/25 fx/5 wks, with 5-FU [1000 mg/m2/d x 96 hrs] plus cisplatin [75 mg/m2] on Days 1 and 29) in patients with resectable stage II and III esophageal cancer staged by CT and EUS. TNF was administered in 1-log interpatient dose escalations from 4x108 - 4x1011 PU, via END or EUS once wkly x 5 wks. Resection was performed 5-11 wks after the end of radiation. Efficacy endpoints included pathologic complete response rate (pCR) and survival. Results: In the 24 pts, the majority of tumors were adenocarcinoma (20/24), T3 (23/24), and N1 (18/24) 5-year follow-up was reached in 3 out of 4 groups (4x108 - 4x1010 PU and showed a 5-year survival rate of 56%. The overall survival rate for the entire cohort was 42% and the overall median survival was 47.7 months. Literature review of historical controls indicate a range of median survival from 9.7 to 34.0 mo. At the 4x109 pu dose, pCR was seen in 3/3 (100%) resected tumors, with a radiographic CR in a fourth pt; all four (100%) remained disease free up to 48 mo. At 4x1010 PU dose, pCR was seen in 1/4 (25%) resected tumors and the median survival has not yet been reached. The median survival for the 4x108 and 4x1011 PU doses are 47.4 and 30.4 mo respectively. Conclusions: TNF in combination with chemoradiation in cohort of 24 pts resulted in a median survival of 47.7 mo and a 5-year survival in the three lower doses of 56% which represents an encouraging increase in survival relative to historical controls and therefore warrants additional evaluation.
Faculty Disclosures
Abstract Disclosures
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy
and are designated with a caret symbol (^) here and in the print version.
 Associated Presentation(s):
Other Abstracts in this Sub-Category:
Abstracts by K. J. Chang :
Presentations by K. J. Chang :
Educational Book Manuscripts by K. J. Chang :
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