A pilot feasibility study of TNFerade™ biologic with capecitabine and radiation therapy followed by surgical resection for the treatment of rectal cancer.

Abstract

OBJECTIVE:

The purpose of this pilot study was to evaluate the feasibility and tolerability of weekly intratumoral TNFerade™ injections combined with concurrent capecitabine and radiotherapy in the treatment of patients with locally advanced rectal cancer.

METHODS:

Patients with T3, T4, or N+ rectal cancer received radiotherapy to a total dose of 50.4-54 Gy in combination with capecitabine 937.5 mg/m(2) p.o. b.i.d. TNFerade™ at a dose of 4 × 10(10) particle units was injected into the rectal tumor on the first day of radiotherapy and weekly for a total of 5 injections. Surgery was performed 5-10 weeks after the completion of chemoradiation.

RESULTS:

Nine patients were enrolled in this pilot trial. The stage was cT2 in 2 patients, cT3 in 6 patients, cT4 in 1 patient, N- in 7 patients and N+ in 2 patients. Eight patients completed all treatments. Grade 3 hematologic toxicity was observed in 2 patients. There was no toxicity directly attributable to the injection procedure. A complete pathologic response was observed in 2 of 9 patients.

CONCLUSIONS:

This study demonstrates the feasibility of weekly intratumoral TNFerade™ injections during chemoradiotherapy for locally advanced rectal cancer. Pathologic responses with this combination compare favorably to published rates.

• Authors: Deborah Citrin, Kevin Camphausen, Bradford J Wood, Martha Quezado, John Denobile, James F Pingpank, Richard E Royal, H Richard Alexander, Geoffrey Seidel, Seth M Steinberg, Yvonne Shuttack, Steven K Libutti
• Journal: Oncology (Oncology) Vol. 79 Issue 5-6 Pg. 382-8 ( 2010) ISSN: 1423-0232 [Electronic] Switzerland
• PMID: 21447969 (Publication Type: Clinical Trial, Journal Article, Research Support, N.I.H., Extramural, Research Support, N.I.H., Intramural)
• Copyright: Copyright © 2011 S. Karger AG, Basel.

Chemical References

• Tumor Necrosis Factor-alpha
• Deoxycytidine
• Capecitabine
• Fluorouracil

Topics

• Adult
• Capecitabine
• Combined Modality Therapy
• Deoxycytidine (analogs & derivatives, therapeutic use)
• Feasibility Studies
• Female
• Fluorouracil (analogs & derivatives, therapeutic use)
• Genetic Therapy
• Humans
• Male
• Middle Aged
• Neoadjuvant Therapy
• Pilot Projects
• Rectal Neoplasms (drug therapy, radiotherapy, surgery, therapy)
• Tumor Necrosis Factor-alpha (genetics)