Intrabeam

A total of 17 patients were treated with IORT (irradiated with a single dose of 10 Gy at a depth of 5 mm into the tumour bed) immediately after surgical resection, as previously described [20 (link)]. Patients were subjected to curative resection, either pylorus-preserving pancreatoduodenectomy (PPPD), distal pancreatectomy, or total pancreatectomy. A mobile 50-kV X-ray source (Intrabeam, Carl Zeiss, Germany) was used for IORT. The target volume included the tumour bed, the celiac and superior mesenteric arteries, the mesenteric root, and the portal vein; any areas deemed at risk by the surgeon and radiation oncologist were also included. A spherical applicator with a diameter of 3.5 cm was used. An additional shielding device was attached to the spherical applicator, leaving only the bottom surface unshielded from which the X-ray beam was delivered to the tumour bed. The target volume was irradiated with a single dose of 10 Gy, prescribed at a 5-mm depth into the tumour bed.

Since April 2010, IORT administered by a kilovoltage photon emitter (Intrabeam, Carl Zeiss, Oberkochen, Germany) has been used to treat our breast cancer patients. The patients were consulted twice in a multidisciplinary team meeting: before and after surgery. Finally, patients aged ≥ 60 years with no axillary lymph node metastasis; tumor < 3 cm; with no special type, tubular, mucinous type, or molecular luminal tumors were qualified for treatment according to the institutional IORT protocol. The surgical procedure included tumor resection, intraoperative radiological specimen analysis, sentinel lymph node biopsy, and IORT. A dose of 20 Gy using a surface applicator was prescribed. The procedure was conducted as previously described [20 (link)]. Following the postoperative histopathological report and a second MDT meeting, patients with no SLN metastases, no extensive ductal in situ component (>20%), no lobular type presence, no LVI, or a resection margin > 2 mm were spared AWBI. The other patients underwent AWBI to the whole breast and/or ipsilateral axillary, supraclavicular lymph nodes. The total dose ranged from 46.00 Gy to 50.00 Gy, with 2.00 Gy per fraction.

Eligibility for IORT is initially determined by preoperative screening of patients by breast surgeons, patients must have a screen detected, unifocal lesions < 3cm in size, which is hormone receptor positive, HER2 negative and clinically node negative. Radiation oncology sees each patient for consideration of IORT and if there is agreement on eligibility, the patient was enrolled onto our IRB-approved institutional prospective registry database AAAJ8512. For this analysis, we retrospectively identified from within this registry patients with biopsy-proven invasive breast cancer treated with TARGIT-IORT using the Zeiss Intrabeam ^® device between September 2013 and April 2020. We excluded patients from analysis with prior ipsilateral breast irradiation or pure ductal carcinoma in situ. Patients were classified as suitable, cautionary, or unsuitable according to the 2017 ASTRO APBI CG based on preoperative clinicopathologic data and then reclassified in the postoperative period based on results of the final surgical pathology.

In this study, 23 patients with low-risk breast cancer were treated with breast-conserving surgery. Of these patients, 11 received intraoperative radiotherapy in addition using a single 20 Gy fraction (50 kV X-ray; Intrabeam, Zeiss, Oberkochen, Germany) as described previously [5 (link), 7 (link)]. The age of the patients at treatment without IORT was 66 ±13, whereas the age of patients treated with IORT was 60 ± 12. After surgery, WF was drained from the wound for 24 h as described previously [52 ]. Thereafter, samples were collected, centrifuged with 800×g for 5 min and the supernatant was filtered through 40 μm filters (BD Falcon, Heidelberg, Germany). After a second centrifugation step (3500×g for 5 min.) the supernatant was subsequently filtered through 5, 0.8 and 0.22 μm filters and aliquots were stored at -80°C.

Kypho-IORT will be carried out under general anaesthesia as extensively described before [8 (link)–11 ]. All patients will be placed in prone position on a radiolucent table. An intraoperative low-energy x-ray device (Intrabeam®, Carl Zeiss Meditec AG, Oberkochen, Germany) will be used for intraoperative radiotherapy, the centre of the metastasis shall be chosen for the isocenter of the radiation.
The cement augmentation can be performed either as kyphoplasty or in a vertebroplasty technique. Each patient must receive early post-operative imaging of the treated vertebra to assess any leakage of cement. The direction of leakage and the clinical symptoms associated (symptomatic vs. asymptomatic) must be documented at this stage.