Phase I evaluation of TNFerade Biologic plus chemoradiotherapy before esophagectomy for locally advanced resectable esophageal cancer
Gastrointestinal Endoscopy,  Clinical Article

Chang KJ et al. – Preoperative TNFerade, in combination with chemoradiotherapy, is active and safe at doses up to 4 × 1010 particle units (PU) and is associated with long survival. This regimen warrants additional studies.

Methods
  • Five weekly injections of TNFerade biologic, dose-escalated logarithmically from 4 × 108 to 4 × 1011 particle units (PU), were given in combination with cisplatin 75 mg/m2 and intravenous 5-fluorouracil 1000 mg/m2/d for 96 hours on days 1 and 29, and concurrent radiation therapy to 45 Gy.
  • Surgery was performed 9 to 15 weeks after treatment.
  • U.S. multicenter study.
  • Primary outcome measures were safety, feasibility, tolerability, and rate of pCR.
  • Secondary outcome measures were overall survival (OS) and disease-free survival.

Results
  • Twenty-four patients with a median age of 61 years were enrolled; 88% of the patients were men, 21% were stage II, and 79% were stage III.
  • Six (29%) had a pCR, observed among 21 patients (20 who underwent esophagectomy and 1 at autopsy).
  • Dose-limiting toxicities were not observed.
  • The most frequent potentially related adverse events were fatigue (54%), fever (38%), nausea (29%), vomiting (21%), esophagitis (21%), and chills (21%).
  • At the top dose of 4 × 1011 PU, thromboembolic events developed in 5 of 8 patients.
  • The median OS was 47.8 months.
  • The 3- and 5-year OS rates and disease-free survival rates were 54% and 41% and 38% and 38%, respectively.

Please login or register to follow this author.
► Click here to access PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

Your Unread Messages in Gastroenterology

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Gastroenterology Articles

1 Screening prior to biological therapy in Crohn's disease: Adherence to guidelines and prevalence of infections. Results from a multicentre retrospective study Digestive and Liver Diseases, August 4, 2014    Clinical Article

2 Risk of lymphoma in patients with inflammatory bowel disease treated with azathioprine and 6-mercaptopurine: a meta-analysis Clinical Gastroenterology and Hepatology , June 25, 2014    Evidence Based Medicine    Clinical Article

3 Clinical utility and diagnostic accuracy of faecal calprotectin for IBD at first presentation to gastroenterology services in adults aged 16-50years Journal of Crohn's and Colitis, September 8, 2014    Clinical Article

4 Predictors of response to steroid therapy for eosinophilic esophagitis and treatment of steroid-refractory patients Clinical Gastroenterology and Hepatology , September 19, 2014    Clinical Article

5 Risk of lymphoma in patients with inflammatory bowel disease treated with azathioprine and 6-mercaptopurine: a meta-analysis Clinical Gastroenterology and Hepatology , September 25, 2014    Clinical Article

6 Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study Gut, October 21, 2014    Clinical Article

7 Colesevelam for the treatment of bile acid malabsorption-associated diarrhea in patients with Crohn's disease: A randomized, double-blind, placebo-controlled study Journal of Crohn's and Colitis, August 27, 2014    Clinical Article

8 Long intestinal tube splinting really prevent recurrence of postoperative adhesive small bowel obstruction? A study of 1071 cases The American Journal of Surgery, July 23, 2014    Clinical Article

9 Sleep duration affects risk for ulcerative colitis: a prospective cohort study Clinical Gastroenterology and Hepatology , October 1, 2014    Clinical Article

10 Diet and inflammatory bowel disease: review of patient-targeted recommendations Clinical Gastroenterology and Hepatology , October 10, 2014    Review Article

11 Fibrosis stage is the strongest predictor for disease-specific mortality in NAFLD after up to 33 years of follow-up Hepatology, August 22, 2014    Clinical Article

12 The risk of colorectal cancer in patients with ulcerative colitis Digestive Diseases and Sciences, October 16, 2014    Clinical Article

13 Adalimumab in Crohn's disease patients: pharmacokinetics in the first 6 months of treatment Alimentary Pharmacology and Therapeutics, October 9, 2014    Clinical Article

14 Increased intake of vegetables, but not fruit, reduces risk for hepatocellular carcinoma: a meta-analysis Gastroenterology, October 7, 2014    Evidence Based Medicine

15 Thiopurines and risk of colorectal neoplasia in patients with inflammatory bowel disease: A meta-analysis Clinical Gastroenterology and Hepatology , September 26, 2014    Evidence Based Medicine

16 Salt tea consumption and esophageal cancer, a possible role of alkaline beverages in esophageal carcinogenesis International Journal of Cancer, September 12, 2014    Clinical Article

17 Comparative effectiveness of immunosuppressant and biologics for inducing and maintaining remission in Crohn's disease: a network meta-analysis Gastroenterology, October 29, 2014    Evidence Based Medicine

18 Fecal lactoferrin in discriminating inflammatory bowel disease from irritable bowel syndrome: A diagnostic meta-analysis Full Text BMC Gastroenterology, July 14, 2014    Free full text    Evidence Based Medicine

19 Mesalamine dose escalation reduces fecal calprotectin in patients with quiescent ulcerative colitis Clinical Gastroenterology and Hepatology , October 2, 2014    Clinical Article

20 Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: data from ultra 1, 2, and 3 The American Journal of Gastroenterology, September 10, 2014    Clinical Article

Indexed Journals in Gastroenterology: Gastroenterology, American Journal of Gastroenterology, Gutmore