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Rat embryonic stem cells (RESC-01) injected in rat blastocysts generate chimeras. Primary rat embryonic fibroblasts are the best source for the development of RESC-01 cells which are alkaline phosphatase positive and SSEA-1 and show increased differentiation in vitro. RESC-01 cells develop cystic embryoid bodies which exhibit rhythmic compression.

Background Completion of prescribed neoadjuvant chemotherapy for breast cancer is paramount to patients obtaining full benefit from the treatment; however, factors affecting neoadjuvant chemotherapy completion are not known. We hypothesized that race is a predictor of completion of neoadjuvant chemotherapy in patients with breast cancer. Methods All patients with breast cancer treated with neoadjuvant chemotherapy 2009–2016 at a single institution were stratified by completion of neoadjuvant chemotherapy and by race. Univariate analysis and multivariable logistic regression were used to identify patient and tumor characteristics that affected the rate of neoadjuvant chemotherapy completion. Results A total of 92 (74%) of 124 patients completed their prescribed neoadjuvant chemotherapy. On univariate analysis, white patients were more likely to complete neoadjuvant chemotherapy than non-white patients (76% vs 50%, P  = .006). Non-white patients were more likely to have government insurance and larger prechemotherapy tumors (both, P < .05), but these factors were not associated with rates of neoadjuvant chemotherapy completion. After controlling for age, insurance status, tumor size, and estrogen receptor status, whites remained associated with completion of neoadjuvant chemotherapy (OR 3.65, P  = .014). Conclusion At our institution, white patients with breast cancer were more likely than non-white patients to complete neoadjuvant chemotherapy. Further investigation into the underlying factors impacting this disparity is needed. [ABSTRACT FROM AUTHOR]

Abstract: Background: Breast cancer treatment beliefs in areas of scientific uncertainty may contribute to widely variable practices. We sought to better describe surgeons'' beliefs and to identify the relative importance of different information sources on surgeons'' decision-making. Methods: A total of 2,188 American College of Surgeons (ACoS) members were surveyed on their treatment beliefs in 4 controversial areas and on the perceived influence of various information sources on their decision-making. Responses were analyzed by sex, practice type, oncology training, professional society membership, and breast cancer patient volume. Results: Nine hundred twenty-three responses were received, with 459 eligible for analysis. Responses diverged most regarding significance of positive sentinel lymph node biopsy (SNLB) and role of post-lumpectomy radiation for low-risk ductal carcinoma-in-situ (DCIS). Overall, expert opinion ranked as the most influential information source. Conclusions: Axillary dissection after positive SLNB and post-lumpectomy radiation in low-risk DCIS denoted areas of greater uncertainty. Breast cancer opinion leaders have substantial influence when standard practice is uncertain. [Copyright &y& Elsevier]

Abstract: Background: Designing and prioritizing successful clinical trials benefits from increased community physician input. We surveyed practicing surgeons about current controversies in breast cancer surgery, reported practices of discussing trial participation, and perceived obstacles to trial participation. Methods: A 44-question survey was mailed in 2005–2006 to 2,187 randomly selected American College of Surgeons members actively seeing breast cancer patients. Responses were analyzed by surgeon sex, practice type, oncology training, professional society membership, and breast cancer patient volume. Results: A total of 923 responses were received, with 460 eligible responses remaining for analysis. Most surgeons infrequently or never discuss trial participation with breast cancer patients. Inadequate infrastructure presents the greatest physician obstacle to trial participation. Identifying proven indications for completion axillary dissection after positive sentinel node biopsy marks the highest-ranked research priority for surgeons providing breast care. Conclusions: Understanding topics of interest among practicing surgeons and addressing common obstacles to trial participation may result in improved breast cancer patient accrual through surgeons. [Copyright &y& Elsevier]

The task of breaking bad news, whether news of need for biopsy or a new breast cancer diagnosis, is increasingly performed by breast imaging radiologists. Most radiologists have little exposure to didactic teaching or modeling for learning methods of breaking bad news. Understanding barriers for communicating bad news and general improvements in communication, such as avoiding jargon and active listening, are initial steps in learning this important task. Bad news should be communicated to a patient in a supportive environment and directly in simple, but not blunt, terms. The amount of news delivered at any one time must be judged by a patient’s response. It may be preferable to deliver bad news in smaller portions to allow time for a patient to cope. The use of a “warning shot,” particularly at the time of diagnostic imaging, can be helpful to alert patients to forthcoming bad news. Common patient responses to bad news include shock, disbelief, denial, fear, anger, and guilt. An empathetic response from a physician demonstrates support. In breast imaging, providing a patient with perspective about her risk for breast cancer or the characteristics of the cancer if early may instill hope without giving false reassurance. Establishing a plan, typically an appointment with a breast surgeon in the setting of breast cancer, allows a patient to have a sense of control over her disease. Offering additional support also demonstrates empathy. The task of delivering bad news is an important task that, if done well, improves patients’ ability to cope with their disease. [Copyright &y& Elsevier]

Intraoperative radiation therapy (IORT), a form of accelerated partial breast irradiation (APBI), is an appealing alternative to postoperative whole breast irradiation for early-stage breast cancer. The purpose of this study was to examine the toxicity and cosmetic outcomes of patients treated with a novel form of breast IORT (precision breast IORT; PB -IORT), that delivers a targeted, higher dose of radiation than conventional IORT. The first 204 patients treated with PB -IORT in a Phase II clinical trial (NCT02400658) with 12 months of followup were included. Trial inclusion criteria were age ≥45 years, invasive or in situ breast cancer, tumor size ≤3 cm, and node negative. Toxicity and cosmetic scoring were performed at 6 and 12 months. 98 patients (48%; 95% CI, 41–55%) experienced toxicity. Seven Grade 3 toxicities occurred (3.4%; 95% CI, 1.4–6.9%). Most patients (95%) had excellent or good cosmetic outcomes (95% CI, 91–98%) at 12 months. Most patients (94%) had little or no pigmentation change (95% CI, 90–97%), 88% little to no size change (95% CI, 82–92%), and 87% experienced minimal shape change (95% CI, 82–92%). Overall, Grade 3+ toxicity was rare and cosmetic outcomes were excellent. Severe toxicity with PB -IORT is similar to that reported in the TARGIT trial (3.3% rate of major toxicity) but lower than APBI (NSABP-39, 10.1% Grade 3/4 toxicities). We propose that the toxicity of PB -IORT compared with TARGIT and NSABP-39 is related to the radiation dose and delivery schedule. PB -IORT offers low-toxicity and good cosmetic outcomes when compared with other forms of APBI. [ABSTRACT FROM AUTHOR]

A multidisciplinary team at our institution developed a novel method of intraoperative breast radiation therapy (precision breast intraoperative radiation therapy [PB-IORT]) that uses high-dose-rate brachytherapy with CT on-rails imaging to deliver high-dose, customized radiotherapy to patients with early-stage breast cancer. This report summarizes our program's experience developing and implementing PB-IORT. Literature on PB-IORT was reviewed including published articles and abstracts. To evaluate case volume, all patients with a breast cancer diagnosis who underwent breast surgery or breast radiation (2010–2017) at our academic institution were identified. Patients were stratified into pre-IORT and post-IORT eras with initiation of our PB-IORT program in October 2013. Overall trends in surgical and radiation therapy volume in each era were analyzed by linear regression. Travel distance for all surgical patients was calculated using Google Maps (Alphabet Inc.) and then compared between IORT and non-IORT patients. Data from a PB-IORT Phase 1 trial found that the primary endpoints were met and that PB-IORT is feasible and safe. The direct health system's delivery costs for PB-IORT exceed those of 16-fraction whole-breast irradiation when accounting for consumable supplies (multilumen balloon applicator = $2,750 per patient). There was a significant increase in yearly growth of breast cancer surgical volume with PB-IORT. Accrual rates for the ongoing Phase II trial have been quicker than expected in an area where more research is needed. The rapid accrual indicates patient interest and demand for this treatment and that it is very feasible to get more data from randomized trials. [ABSTRACT FROM AUTHOR]

Purpose: Existing intraoperative radiation therapy (IORT) techniques are criticized for the lack of image guided treatment planning and energy deposition with, at times, poor resultant dosimetry and low radiation dose. We pioneered a novel method of IORT that incorporates customized, computed tomography (CT)-based treatment planning and high-dose-rate (HDR) brachytherapy to overcome these drawbacks: CT-HDR-IORT.Methods and Materials: A phase 1 study was conducted to demonstrate the feasibility and safety of CT-HDR-IORT. Eligibility criteria included age ≥50 years, invasive or in situ breast cancer, tumor size <3 cm, and N0 disease. Patients were eligible before or within 30 days of breast-conserving surgery (BCS). BCS was performed, and a multilumen balloon catheter was placed. CT images were obtained, a customized HDR brachytherapy plan was created, and a dose of 12.5 Gy was delivered to 1-cm depth from the balloon surface. The catheter was removed, and the skin was closed. The primary endpoints were feasibility and acute toxicity. Feasibility was defined as IORT treatment interval (time from CT acquisition until IORT completion) ≤90 minutes. The secondary endpoints included dosimetry, cosmetic outcome, quality of life, and late toxicity.Results: Twenty-eight patients were enrolled. The 6-month follow-up assessments were completed by 93% of enrollees. The median IORT treatment interval was 67.2 minutes (range, 50-108 minutes). The treatment met feasibility criteria in 26 women (93%). The dosimetric goals were met in 22 patients (79%). There were no Radiation Therapy Oncology Group grade 3+ toxicities; 6 patients (21%) experienced grade 2 events. Most patients (93%) had good/excellent cosmetic outcomes at the last follow-up visit.Conclusions: CT-HDR-IORT is feasible and safe. This promising approach for a conformal, image-based, higher-dose breast IORT is being evaluated in a phase 2 trial. [ABSTRACT FROM AUTHOR]

Purpose Intraoperative radiation therapy (IORT) is an increasingly popular approach to breast conserving therapy in the treatment of early-stage breast cancer. A drawback to IORT compared with postoperative adjuvant radiation therapy is that it is not performed using image guidance. Our aim was to report on how our institution's unique IORT workflow integrates CT image guidance and how these CT images were used intraoperatively to change applicator positioning. Methods and Materials We retrospectively reviewed the first 29 patients who participated in a prospective clinical trial of breast IORT at our institution. All patients underwent lumpectomy, multicatheter balloon placement, intraoperative CT scan, and high-dose-rate brachytherapy treatment delivery to 12.5 Gy to 1 cm from the balloon surface. This report focuses on the intraoperative CT findings that led to clinical changes, followed by repeat CT for IORT treatment planning. Results After initial intraoperative CT, 7 patients underwent an additional intraoperative CT scan (24.1%). In 6 patients, the initial intraoperative CT scan identified large air cavities and/or poor tissue conformity. This defect could be improved in all patients with adjustment of the balloon applicator before planning and delivering IORT. Intraoperative CT scan was used in one patient to localize a biopsy clip and aided in excision to negative margin. Conclusions In our study, intraoperative CT identifies actionable findings in breast IORT, including residual tumor or errors in applicator positioning, in almost 25% of patients. Clinical results of the described trial will serve to further validate this image-guided approach to IORT. [ABSTRACT FROM AUTHOR]

Purpose: At our institution, the availability of a shielded procedure room with in-room CT-on-rails imaging allows for the exploration of a high-dose-rate (HDR) brachytherapy approach for breast intraoperative radiation therapy (IORT). We hypothesize that HDR brachytherapy will permit a higher prescription dose without increasing toxicity. In this study, we compare the dosimetry of intraoperative HDR brachytherapy, using multilumen balloon applicator, to IORT with a 50 kV source and then select a prescription dose for a subsequent clinical trial. Methods and Materials: The CT scans of 14 patients who had previously received multilumen balloon-based breast brachytherapy were replanned to a standard prescription to the target volume. The same 14 cases were planned to the specifications of a 50 kV x-ray system. Uniform volume optimization and prescription doses were used to permit direct comparisons. All plans were evaluated for the dose homogeneity index, tumor coverage, and dose to normal tissues, including skin, ribs, and heart (for left breast plans). Results: The HDR brachytherapy plans were superior to 50 kV superficial photon plans for IORT in all dosimetric parameters except for the heart and rib dosimetric parameters. Prescription dose of 12.5 Gy to the planning target volume for evaluation yielded a dose to 95 percent of the balloon surface of 19.7 Gy. Conclusions: Image-guided HDR intraoperative brachytherapy with a multilumen balloon applicator provides superior target volume coverage compared with 50 kV photons, while maintaining doses within tolerance limits for normal tissues. An ongoing prospective clinical trial will evaluate the safety and feasibility of this technique. [ABSTRACT FROM AUTHOR]