7/28/2014 Winship Cancer Institute of Emory University What Do We Really Know About Intraoperative Radiotherapy? Mylin A. Torres, M.D. Assistant Professor Department of Radiation Oncology Winship Cancer Institute Emory University Disclosures • Nothing relevant to report 1
7/28/2014 Background • 80-90% of patients with IBTR recur at same site or directly adjacent to the lumpectomy cavity 2
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7/28/2014 Inclusion/Exclusion Criteria • 45 years or older • Invasive ductal carcinoma – Lobular carcinoma excluded • Unifocal disease confirmed by imaging – MRI not required • Training required for center to enroll pts • Each center allowed to stipulate further exclusion criteria and pathologic criteria that would require supplemental EBRT in TARGIT pts – All pts with invasive lobular, + margins or EIC received supplemental EBRT • Also a “post-path” enrollment group • Clear margins 4
7/28/2014 Stratification Variables • Treatment Center – Each site had the option to restrict inclusion criteria beyond the core protocol – Each site determined EBRT fractionation and dose (40-56 Gy with a 10-16 Gy boost) whether it was given as a supplement to TARGIT or in the EBRT alone arm • Timing of delivery of TARGIT (at the time of lumpectomy vs. post-lumpectomy) • Previous contralateral breast cancer 5
7/28/2014 Endpoints • Primary endpoint – biopsy confirmed local recurrence within ipsilateral breast • Secondary endpoint: toxicity – Assessed frequency/grade of hematoma, seroma, skin breakdown, delayed wound healing, pain in RT field, telangectasia/dermatitis within RT field Initial Publication • No difference in ipsilateral breast tumor recurrence or significant side effects Vaidya et al. Lancet 2014 Lancet 2010 6
7/28/2014 Initial Publication • No difference in ipsilateral breast tumor recurrence or significant side effects – >80% had Grade I or II tumors – >80% had < 2.0cm tumors – >80% were > 55 years old – >80% were node negative – >80% without angiolymphatic invasion – >80% ER+ Lancet 2010 Initial Publication • No difference in ipsilateral breast tumor recurrence or significant side effects – >80% had Grade I or II tumors – >80% had < 2.0cm tumors – >80% were > 55 years old – >80% were node negative – >80% without angiolymphatic invasion – >80% ER+ • Outcomes reported at 4 years with only 1/3 of patients having reached a median follow-up of 4 years and <20% of subjects with longer follow-up Lancet 2010 7
7/28/2014 Study Aim • To report updated local recurrence and survival data from the TARGIT-A Trial with longer follow-up and a larger cohort of patients 8
7/28/2014 Follow-up • n=1222 patients with median f/u of 5 years • n=2020 patients with median f/u of 4 years • n=3451 patients with median f/u of 2 years 5 months 9
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7/28/2014 Take Home • With limited follow-up, TARGIT has a statistically higher rate of local recurrence than traditional external beam radiation in select, low risk patients with <2.0cm, low/intermediate grade tumors that are node negative. However, the absolute difference is only 2%. Unanswered Questions • Are the TARGIT results durable? – Only 1/3 of patients had >5 years of f/u • How much of an effect did the supplemental EBRT have on results? • Is the supplemental EBRT necessary following TARGIT? • Can TARGIT be applied to higher risk patients? • Do the included patients need XRT at all? 17
7/28/2014 ELIOT Trial 18
7/28/2014 Ipsilateral Breast Recurrence 19
7/28/2014 Overall Survival Side Effects 20
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