Results of a Prospective Randomized Multicenter Study Comparing Indocyanine Green (ICG) Fluorescence Combined with a Standard Tracer Versus ICG Alone for Sentinel Lymph Node Biopsy in Early Breast Cancer: The INFLUENCE Trial.

BACKGROUND: For clinically node-negative early breast cancer patients, sentinel lymph node biopsy (SLNB) using dual localization with blue dye and radioisotope (RI) is currently standard of care. Documented disadvantages with these tracers have prompted exploration of alternative agents such as fluorescent indocyanine green (ICG), which demonstrates high detection rates combined with other tracers. Results of a randomized study evaluating ICG as a single tracer for SLN identification are presented. METHODS: Overall, 100 patients with unilateral, clinically node-negative, biopsy-proven invasive breast cancer (≤5 cm) scheduled for SLNB were recruited in two separate randomized cohorts, with 50 patients receiving ICG alone. Cohort 1 received ICG alone (n = 25) or combined with RI [Technetium99] (n = 25), while Cohort 2 received ICG alone (n = 25) or combined with blue dye (n = 25). The primary outcome was sensitivity for SLN identification. RESULTS: Among evaluable patients (n = 97), the overall SLN identification rate was 96.9% (ICG alone = 97.9%; ICG + RI = 100%; ICG + blue dye = 92%). Node positivity rates were 14.9% for ICG alone, 16% for ICG combined with RI, and 20% for ICG combined with blue dye. There were no significant differences (p < 0.05) in performance parameters, with ICG alone being non-inferior to tracer combinations for procedural node positivity rates when adjusted for specific factors. CONCLUSION: These results support potential use of ICG as a sole tracer agent for routine SLNB, thereby avoiding disadvantages of RI and/or blue dye. The latter can be safely withheld as a co-tracer without compromising detection of positive nodes in primary surgical patients.

How do women perceive their breast image before and after bilateral therapeutic mammoplasty for early breast cancer?

INTRODUCTION: Bilateral therapeutic mammoplasty (BTM) is commonly performed in the UK during treatment for breast cancer, and the available data show oncological safety. This study aims to compare patient-recorded outcome measures before and after surgery, as well as associated patient factors. METHODS: Between March 2018 and December 2019, patients undergoing BTM for breast cancer completed validated BREAST-Q reduction modules before and 3 months after surgery and a radiotherapy domain at 3 months. Scores were correlated with clinical data. For BREAST-Q scales, a higher score (0-100) represents greater satisfaction or quality of life. RESULTS: 28 patients were included, median age 58 years (IQR 52-64), BMI 32.0 (IQR 27.8-34.0). Of these, 1 had bilateral disease, 2 had multifocal disease, and the remaining had unilateral disease. Most (55%) underwent Wise pattern incision. At 3 months post-operatively, the following outcome scores improved based on the Wilcoxon signed-rank test: satisfaction with breasts (median 44 to 84; p < 0.001), psychosocial wellbeing (57.5 to 83; p < 0.001) and sexual wellbeing (48 to 61; p = 0.029). The improvement in satisfaction with breasts score correlated with the preoperative score (p = 0.011), with a larger increase in patients with a lower baseline score. Physical wellbeing was unchanged overall (median 71 to 72). In all solely post-operative domains (satisfaction with information, outcome, nipples and following radiation), patients reported high levels of satisfaction with outcomes. CONCLUSIONS: Patients reported improved levels of patient-related quality of life measures after therapeutic mammoplasty, including satisfaction with breasts and psychosocial and sexual wellbeing, with high post-operative outcomes in satisfaction with outcome, information and nipples, as well as radiation Q-score.

Indocyanine Green Is a Safe and Effective Alternative to Radioisotope in Breast Cancer Sentinel Lymph Node Biopsy regardless of Patient Body Mass Index.

INTRODUCTION: A recent meta-analysis [Lancet Oncol. 2010;11:908-909] has confirmed high sensitivity of indocyanine green (ICG) fluorescence mapping for sentinel node detection in early breast cancer. Concerns have previously been raised regarding the efficacy in patients with high body mass index (BMI). MATERIALS AND METHODS: All consecutive patients undergoing sentinel lymph node biopsies (SLNBs) for early breast cancer in NHS Tayside were included in a prospective audit of surgical and pathology findings. All patients included in the study received dual injection of patent blue dye and ICG. Approval was obtained from the local Caldicott guardian for collection and use of personal data. RESULTS: Of 239 cases, all were female patients of mean age 62 years (range 27-93). In 4.2% (10/239) of cases, neither blue dye nor ICG was present in the axilla. Of the remaining 229 SLNB cases in this series, surgeons documented retrieval of 451 nodes, with a mean surgical nodal count per case of 1.97 (range 1-5) and pathological nodal count of 2.15 (range 0-7). Eighty three cases were performed in patients with BMI 30-39.9 and 21 cases with BMI ≥40, with nodal detection rates of 96.4% (80/83) and 95.2% (20/21), respectively, in these groups of patients. Twenty percent (48/229) of cases had nodal metastases on histopathology. CONCLUSIONS: This is a large single-center study which demonstrates the safety and accuracy of the combined ICG and blue dye technique for SLNB in breast cancer. This is represented by nodal detection rates and node positivity rates which are comparable to previous multicenter studies of standard SLNB regardless of BMI.

Age and cancer treatment factors influence patient-reported outcomes following therapeutic mammoplasty and contralateral symmetrisation for the treatment of breast cancer.

BACKGROUND: Oncoplastic surgery for breast cancer has increased in popularity over the last few years, with oncological safety confirmed in several studies. There are, however, limited published data on patient-reported outcomes from this surgical approach. This study assessed patient-reported outcomes of satisfaction following therapeutic mammoplasty and contralateral symmetrisation (TMCS) as part of breast cancer treatment in relation to other patient and treatment factors. METHODS: The validated BREAST-Q™ breast reduction module was sent to all surviving patients who had no documented cancer recurrence and had undergone TMCS in NHS Tayside between August 2013 and August 2017. The Q-score was used to analyse data and correlate with patient clinical information, surgical, pathology and treatment factors. Ethical approval was granted by the University of Dundee ethics committee. RESULTS: The patient response rate to the study was 64.5% (60 of 93 patients), with a mean age of 59 years (range 41-75 years). In all domains, patients reported high levels of satisfaction with outcomes. There were strong correlations between domains with the exception of physical symptoms. Younger patients reported poorer outcomes in domains that related to satisfaction with outcomes of surgery, psychosocial aspects, sexual function and physical symptoms. Treatment with chemotherapy and/or trastuzumab and lymph node positivity were associated with poorer outcomes in a number of domains. CONCLUSIONS: Our results demonstrate that patients report high levels of satisfaction after TMCS, but this is influenced by age. Patient-reported outcomes that include physical and psychosocial appear to be more strongly influenced by medical treatments than surgery.

A population-based audit of surgical practice and outcomes of oncoplastic breast conservations in Scotland - An analysis of 589 patients.

INTRODUCTION: Current evidence for oncoplastic breast conservation (OBC) is based on single institutional series. Therefore, we carried out a population-based audit of OBC practice and outcomes in Scotland. METHODS: A predefined database of patients treated with OBC was completed retrospectively in all breast units practicing OBC in Scotland. RESULTS: 589 patients were included from 11 units. Patients were diagnosed between September 2005 and March 2017. High volume units performed a mean of 19.3 OBCs per year vs. low volume units who did 11.1 (p = 0.012). 23 different surgical techniques were used. High volume units offered a wider range of techniques (8-14) than low volume units (3-6) (p = 0.004). OBC was carried out as a joint operation involving a breast and a plastic surgeon in 389 patients. Immediate contralateral symmetrisation rate was significantly higher when OBC was performed as a joint operation (70.7% vs. not joint operations: 29.8%; p < 0.001). The incomplete excision rate was 10.4% and was significantly higher after surgery for invasive lobular carcinoma (18.9%; p = 0.0292), but was significantly lower after neoadjuvant chemotherapy (3%; p = 0.031). 9.2% of patients developed major complications requiring hospital admission. Overall the complication rate was significantly lower after neoadjuvant chemotherapy (p = 0.035). The 5 year local recurrence rate was 2.7%, which was higher after OBC for DCIS (8.3%) than invasive ductal cancer (1.6%; p = 0.026). 5-year disease-free survival was 91.7%, overall survival was 93.8%, and cancer-specific survival was 96.1%. CONCLUSION: This study demonstrated that measured outcomes of OBC in a population-based multi-centre setting can be comparable to the outcomes of large volume single centre series.

Reconstructive and Oncoplastic Surgery for Giant Phyllodes Tumors: A Single Center's Experience.

Phyllodes tumors are biphasic fibroepithelial neoplasms of the breast. While the surgical management of these relatively uncommon tumors has been addressed in the literature, few reports have commented on the surgical approach to tumors greater than ten centimetres in diameter - the giant phyllodes tumor. We report a case of giant breast tumors and discuss the techniques utilized for pre-operative diagnosis, tumor removal, and breast reconstruction. A review of the literature on the surgical management of phyllodes tumors was performed. Management of the large phyllodes tumors presents the surgeon with unique challenges. The majority of these tumors can be managed by simple mastectomy but reconstruction and even oncoplastic conservative management is for selective consideration.

Indocyanine green fluorescence mapping for sentinel lymph node biopsy in early breast cancer.

INTRODUCTION: A recent feasibility study (ICG-10) has confirmed high sensitivity of ICG fluorescence mapping for sentinel SLN detection in early breast cancer with 95% of nodes both blue and fluorescent. This follow-on study has specifically evaluated a combination of ICG and blue dye for SLN localization. METHODS: Fifty consecutive patients (49 female; 1 male) with unilateral clinically node negative invasive (37) and non-invasive (13) breast cancer underwent SLN biopsy with blue dye and ICG. Median patient age was 48 years and median invasive tumour size 19 mm for primary surgical patients. All patients had a normal pre-operative axillary ultrasound. Nodal and procedural detection rates were calculated for ICG alone and in combination with blue dye. RESULTS: A total of 87 nodes were retrieved with an average nodal count of 1.8 per patient (range 1-4). Eighty four nodes were blue and fluorescent and 3 fluorescent only. Nodal detection rates for ICG alone and combined with blue dye were 100% (87/87) and 96% (84/87) respectively. Metastases were present in 18 nodes (all blue and fluorescent) with 10 patients node positive overall (20%). The procedural detection rate for blue dye and ICG was 96% (48/50) and 2 patients had fluorescent only nodes which were deemed sentinel (4%). CONCLUSION: Fluorescent imaging with ICG is a sensitive, valuable and safe method for SLN biopsy. A combination of blue dye and ICG is useful dual approach when radioisotope is unavailable. ICG has the potential to be a sole tracer agent with improved patient convenience and costs.

Isolated jejunal perforation following blunt abdominal trauma.

Isolated jejunal perforation caused by blunt abdominal trauma is uncommon and most often seen after motor vehicle accidents. We present a case of "blowout" perforation of the jejunum in a young male who was admitted to our hospital with intense abdominal pain following a physical assault. The Injury Severity Score was 0. Although the erect chest radiograph was negative for free air, abdominal computed tomography scan revealed a large amount of free intraperitoneal air. The exploratory laparotomy that followed revealed only a 3 cm-long perforation of the jejunum, 20 cm from the ligament of Treitz. Although our experience as a trauma center is limited, clinical suspicion and timely exploration in this case led to prompt surgical intervention and a successful outcome.

Foreign body impaction: fifty years inside the nose.

An incidental finding of a foreign body in the nose is an infrequent event. When foreign bodies are discovered incidentally, they are usually detected during an investigation of chronic symptoms. We describe a case that is of interest because a nasal foreign body had remained clinically silent for more than 50 years.

Update on clinical role of tamoxifen.

PURPOSE OF REVIEW: Breast cancer is the most common malignancy amongst women in the United States and decreased mortality over the past decade has been attributed to a combination of screening and adjuvant therapies. There has been a resurgence of interest in hormonal therapies and this article discusses the clinical status of tamoxifen in the context of emerging alternative agents for treatment and prevention of breast cancer. RECENT FINDINGS: Tamoxifen has served as a prototype for the development of selective estrogen receptor modulators at the laboratory-clinical interface. Molecular technologies have permitted elucidation of mechanisms for tissue specific action and led to newer selective estrogen receptor modulators with potentially greater antitumour efficacy and attenuated uterotrophic profile. Publications over the past 12 months have emphasized the risks of thromboembolism and endometrial carcinoma associated with tamoxifen use which has accelerated application of other hormonal agents for treatment of advanced disease and as neoadjuvant therapy. This article reviews the current role of tamoxifen in the treatment of early and advanced breast cancer together with its potential for chemoprevention. Models for quantitative risk assessment are being developed to identify women for whom chemoprotection is justified. SUMMARY: Recent data showing a survival advantage for the aromatase inhibitor letrozole compared with tamoxifen in the advanced setting and improvement in disease-free survival for the aromatase inhibitor anastrozole versus tamoxifen as adjuvant treatment may herald a major shift in standard first-line endocrine therapies for both advanced and early disease and ultimately chemoprevention of breast cancer. Other agents including newer SERMs and pure antiestrogens are undergoing phase III clinical trials and future endocrine and biological therapies are likely to include more selective and targeted therapies, which may be efficacious in both hormone-sensitive and receptor-negative disease.