EP-1317: Early results of implementation of IORT with INTRABEAM for early breast cancer in a private hospital

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Material and MethodsPreclinical studies and initial non-randomised clinical trials in Japan have suggested a significant radiosensitising effect of KORTUC, with published complete response (CR) rates of 79-100% at up to 5 years follow up in over 100 patients.In comparison, a contemporary Japanese cohort of 108 patients receiving systemic treatment and RT alone recorded a CR rate of 36%.A UK Phase 1 trial (n=12) commenced at our institution in January 2017 to confirm safety of this treatment (ClinicalTrials.govNCT02757651).Patients with locally advanced breast cancer ≥3cm were recruited.A radiotherapy schedule of 36Gy in 6 twiceweekly fractions, or 49.5Gy in 18 daily fractions was selected according to performance status.Twice-weekly intratumoural KORTUC injections were administered (1 hour prior to RT) under ultrasound guidance, commencing in the second week of RT. 2.5-5mls KORTUC was injected, depending on tumour size.Skin toxicity was recorded at baseline, and then weekly until 4 weeks post radiotherapy.Ultrasound (US) assessment was performed at 3 and 6 months post treatment.Results 7/12 patients (5 female, 2 male) have been recruited; 5/7 have completed treatment.The mean age of the patients was 75 years (median 78, range 53-89).5 patients had ER+/HER2-, 1 patient ER+/HER2+, and 1 patient ER-/PR-/HER2-disease. 4 patients received 36Gy/6# and 1 patient 49.5Gy/18#.6/7 received concurrent endocrine therapy.KORTUC was well tolerated with 100% compliance.3/5 patients experienced Grade 1 local tumour pain during injection not lasting more than 30 minutes.Skin toxicity (CTCAE v4.03) was scored as G0 in 1, G2 in 2, and G3 in 2 patients (treated with bolus).All resolved to <G3 by 4 weeks post-RT.3-month US assessment demonstrated partial response in 4 patients, and stable disease in 1 patient.Of 3 patients who have had 6-month US scans, all have shown ongoing partial response, as illustrated in the table below:

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