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• W2602792961 abstract "14585 Background: Rectal cancer presents unique therapeutic considerations due to competing concerns regarding sphincter preservation and local recurrence. Treatments using pre-operative chemoradiation are employed to decrease local recurrence and improve the probability of sphincter preservation. Agents, which improve the pathologic response rate may be of further benefit. Methods: TNFerade biologic is a replication deficient adenovirus expressing human TNF-alpha driven by a radiation inducible promoter. TNFerade biologic (4X10e10 pfu) is injected locally into rectal tumors once a week for 5 weeks. Patients receive concurrent chemoradiation utilizing oral capecitabene (937.50 mg/m 2 BID, Monday-Friday) and external beam radiotherapy (1.8 Gy/day, 5 days per week to a total dose of 45 Gy). A boost dose of 5.4–9 Gy is delivered to sites of gross disease. After treatment, patients recover for 6–9 weeks before surgery. Patients are scored prior to the start of neo-adjuvant therapy for the feasibility of a sphincter preserving operation versus an abdominal perineal resection (APR). Following surgery the specimen (entire area submitted for processing) is examined for the percent of viable tumor remaining. The goal of the study is to show a target pathologic response rate of <10% viable tumor in more than 30% of patients treated. Results: Six patients have been treated (4M, 2F). There has been no toxicity attributable to the TNFerade biologic, and the chemoradiation has been well tolerated with only mild, expected toxicities. Five of the six patients have undergone surgery (one is awaiting surgery). Three of these five patients were thought to require an APR prior to treatment due to the size and location of their tumor. All five patients have successfully undergone sphincter- preserving operations. On examination of the five specimens, 3 had less than 5% viable tumor while 2 had greater than 50% viable tumor. All resections were margin negative. The target pathologic response rate of <10% viable tumor was achieved in 60% of the patients evaluated. Conclusion: The addition of TNFerade biologic to pre-operative chemoradiation was well tolerated and a prospective randomized trial comparing the addition of this agent to chemoradiation is warranted. No significant financial relationships to disclose." @default.
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• W2602792961 date "2007-06-20" @default.
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• W2602792961 title "A pilot study of local injection of TNFerade biologic in addition to neo-adjuvant chemoradiation for the treatment of primary and recurrent rectal cancer" @default.
• W2602792961 doi "https://doi.org/10.1200/jco.2007.25.18_suppl.14585" @default.
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