Tolerability of ADXS11-001 Lm-LLO Listeria-Based mostly Immunotherapy With Mitomycin, Fluorouracil, and Radiation for Anal Most cancers.
Int J Radiat Oncol Biol Phys. 2018 Apr 01;100(5):1175-1178
Authors: Safran H, Leonard KL, Perez Ok, Vrees M, Klipfel A, Schechter S, Oldenburg N, Roth L, Shah N, Rosati Ok, Rajdev L, Mantripragada Ok, Sheng IY, Barth P, DiPetrillo TA
PURPOSE: To get hold of security and preliminary efficacy knowledge of the mix of ADXS11-001, stay attenuated Listeria monocytogenes bacterium, with mitomycin, 5-fluorouracil (5-FU), and depth modulated radiation remedy in regionally superior anal most cancers.
PATIENTS AND METHODS: Eligibility included sufferers with beforehand untreated, nonmetastatic anal most cancers with a main tumor >four cm or node-positive illness. Sufferers acquired 2 cycles of mitomycin and 5-FU concurrent with 54.zero Gy depth modulated radiation remedy. One intravenous dose of ADXS11-001 (1 × 109 colony-forming models) was administered earlier than chemoradiation; three further month-to-month doses got after chemoradiation.
RESULTS: Ten sufferers had been handled, together with 1 with N2 and four with N3 illness. Two sufferers had grade three acute toxicities after the preliminary dose of ADXS11-001, together with chills/rigors (n = 2), again ache (n = 1), and hyponatremia (n = 1). All ADXS11-001 toxicities occurred inside 24 hours of administration. There was no obvious improve in chemoradiation toxicities or myelosuppression. One affected person had a grade 5 cardiopulmonary occasion shortly after starting 5-FU remedy. All 9 assessable sufferers had full medical responses by sigmoidoscopy. Eight of 9 sufferers (89%) are progression-free at a median follow-up of 42 months.
CONCLUSIONS: Preliminary knowledge present that ADXS11-001 will be safely administered with customary chemoradiation for anal most cancers. Additional research of listeria-based immunotherapy with radiation are warranted.
PMID: 29722659 [PubMed – in process]