The COVID-19 pandemic and its effects on follow-up of patients with early breast cancer: A patient survey.

PURPOSE: Despite limited evidence supporting its effectiveness, most guidelines recommend long-term, routinely scheduled in-person surveillance of patients with early breast cancer (EBC). The COVID-19 pandemic led to increased use of virtual care. This survey evaluated patient perspectives on follow-up care. METHODS: Patients with EBC undergoing surveillance were surveyed about follow-up protocols, perceptions, and interest in clinical trials assessing different follow-up strategies. RESULTS: Of 402 approached patients 270 completed the survey (response rate 67%). Median age 62.5 years (range 25-86) and median time since breast cancer diagnosis was 3.8 years (range < 1-33 years). Most (n = 148/244, 60%) were followed by more than one provider. Routine follow-ups with breast examination were mostly conducted by medical/radiation oncologists every 6 months (n = 110/236, 46%) or annually (n = 106/236, 44%). Participants felt routine follow-up was useful to monitor for recurrence, manage side effects of cancer treatment and to provide support/reassurance. Most participants felt regular follow-up care would detect recurrent cancer earlier (n = 214/255, 96%) and increase survival (n = 218/249, 88%). The COVID-19 pandemic reduced the number of in-person visits for 54% of patients (n = 63/117). Patients were concerned this reduction of in-person visits would lead to later detection of both local (n = 29/63, 46%) and distant recurrences (n = 25/63, 40%). While many felt their medical and radiation oncologists were the most suited to provide follow-up care, 55% felt comfortable having their primary care provider (PCP) conduct surveillance. When presented with a scenario where follow-up has no effect on earlier detection or survival, 70% of patients still wanted routine in-person follow-up for reassurance (63%) with the goal of earlier recurrence detection (56%). CONCLUSIONS: Despite limited evidence of effectiveness of routine in-person assessment, patients continue to place importance on regularly scheduled in-person follow-up.

How a Canadian federal organization integrated synoptic reporting and quality improvement tools to drive a national learning health system in cancer surgery.

Accurate and complete surgical and pathology reports are the cornerstone of treatment decisions and cancer care excellence. Synoptic reporting is a process for reporting specific data elements in a specific format in surgical and pathology reports. Since 2007, The Canadian Partnership Against Cancer has led the implementation of synoptic reporting mechanisms across multiple cancer disease sites and jurisdictions across Canada. While the implementation of synoptic reporting has been successful, its use to drive improvements in the quality of cancer care delivery has been lacking. Here we describe the Partnership's 4-year, national multi-jurisdictional quality improvement initiative to catalyse the use synoptic data to drive cancer system improvements. Resources provided to the jurisdictions included operational funding, training in quality improvement methodology, national forums, expert coaches, and ad hoc monitoring and support. The program emphasized foundational concepts including data literacy, audit and feedback reports, communities of practice, and positive deviance methodology.

Randomized trial of surveillance with abbreviated MRI in women with a personal history of breast cancer- impact on patient anxiety and cancer detection.

BACKGROUND: Abbreviated breast MRI (A-MRI) substantially reduces the image acquisition and reading times and has been reported to have similar diagnostic accuracy as a full diagnostic protocol but has not been evaluated prospectively with respect to impact on psychological distress in women with a prior history of breast cancer (PHBC). This study aimed to determine if surveillance mammography (MG) plus A-MRI reduced psychological distress and if A-MRI improved cancer detection rates (CDR) as compared to MG alone. METHODS: This prospective controlled trial of parallel design was performed at a tertiary cancer center on asymptomatic women with PHBC who were randomized into two groups: routine surveillance with MG or intervention of MG plus A-MRI in a 1:1 ratio. Primary outcome was anxiety measured by four validated questionnaires at three different time-points during the study. Other parameters including CDR and positive predictive value for biopsy (PPV3) were compared between imaging modalities of MG and A-MRI. Tissue diagnoses or 1 year of follow-up were used to establish the reference standard. Linear mixed models were used to analyze anxiety measures and Fisher's exact test to compare imaging outcomes. RESULTS: One hundred ninety-eight patients were allocated to either MG alone (94) or MG plus A-MRI (104). No significant group difference emerged for improvement in trait anxiety, worry and perceived health status (all Time-by-surveillance group interaction ps > .05). There was some advantage of A-MRI in reducing state anxiety at Time 2 (p < .05). Anxiety scores in all questionnaires were similarly elevated in both groups (50.99 ± 4.6 with MG alone vs 51.73 ± 2.56 with MG plus A-MRI, p > 0.05) and did not change over time. A-MRI detected 5 invasive cancers and 1 ductal carcinoma in situ (DCIS), and MG detected 1 DCIS. A-MRI had higher incremental CDR (48/1000(5/104) vs MG 5/1000(1/198, p = 0.01)) and higher biopsy rates (19.2% (20/104) vs MG 2.1% (2/94), p < 0.00001) with no difference in PPV3 (A-MRI 28.6% (6/21) vs MG 16.7% (1/6, p > .05). CONCLUSION: There was no significant impact of A-MRI to patient anxiety or perceived health status. Compared to MG alone, A-MRI had significantly higher incremental cancer detection in PHBC. Despite a higher rate of biopsies, A-MRI had no demonstrable impact on anxiety, worry, and perceived health status. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02244593 ). Prospectively registered on Sept. 14, 2014.

Lost in Transition? Thoughts on Retirement, Part 2. "Should I Stay or Should I Go Now?"

Although it is accepted that oncologists should plan for a future beyond full-time oncology, there is little practical guidance for a successful transition into retirement. Previously, we provided strategies for various aspects of retirement planning. However, this became significantly more complicated as we face newer issues such as the COVID-19 pandemic, the move to virtual patient care, greater awareness of burnout, and the increasing burden of regulatory issues such as the electronic medical record. It is evident that more prospective information is needed to guide oncologists in planning their retirement.

Can we rely on surgical clips placed during oncoplastic breast surgery to accurately delineate the tumor bed for targeted breast radiotherapy?

PURPOSE: Oncoplastic breast surgery (OBS) is gaining popularity among surgeons for breast-conserving surgery treatments. OBS relies on complex relocation and deformation of breast tissue involving the tumor bed (TB). In this study, we investigate the validity of using surgical clips with OBS for accurate TB delineation in adjuvant, targeted breast radiotherapy. METHODS: Different OBS techniques were simulated on realistic breast phantoms. Surgical clips were used to demarcate the TB. Following tumor resection and closure, the true TB (TBTrue) was extracted. Each phantom was CT imaged at several phases of surgery in order to record pre- and post-OBS closure surgical clip displacements. Two senior radiation oncologists (ROs) were asked to delineate TBs on CTs by relying on surgical clips placed as per standard protocol, and by referring to operative notes. Their original contours, as well as those expanded using 5-15 mm margins, were compared with the accurate TBTrue using the dice similarity coefficient (DSC), Hausdorff Distance (HD), and over- and under-contoured volumes. Inter- and intra-RO contour agreements were also evaluated. RESULTS: Post-OBS surgical clips were significantly displaced outside the original breast quadrant. Inter- and Intra-RO TB contours were consistent, yet systematically differed from TBTrue (DSC values range = 0.38 to 0.69, and maximum HD range = 17.8 mm to 38.0 mm). Using expansion margins did not improve contour congruence and caused significant over-contoured volumes. CONCLUSION: Following OBS, surgical clips alone are not reliable radiographic surrogates of TB locations and accurate TB delineation is challenging. For complex OBS cases, indication of any type of partial breast irradiation is very questionable.

A scoping review characterizing "Choosing Wisely®" recommendations for breast cancer management.

PURPOSE: Choosing Wisely (CW)® was created by the American Board of Internal Medicine (ABIM) to promote patient-physician conversations about unnecessary medical interventions. Similarly, other countries created their own panels of experts called "CW® campaigns" which review recommendations submitted by that country's oncology societies. We performed a scoping review to consolidate CW® recommendations from different groups with respect to breast cancer care. METHODS: A systematic search of Medline and Embase was designed by an information specialist for publications presenting CW® recommendations for breast cancer care practices from 2011-2020. We also reviewed the websites of all CW® campaigns and reference sections of each CW® recommendation. Two reviewers independently screened studies for inclusion and performed data extraction. Findings were summarized narratively. RESULTS: Review of ABIM CW® recommendations showed 19 breast cancer-related recommendations pertaining to; screening (n = 4), radiological staging (n = 2), treatment (n = 10), surveillance (n = 2), and miscellaneous (genetic testing; n = 1). Of 22 countries with CW® campaigns, 10 published recommendations for breast cancer. Over half (57%) of recommendations were supported by more than one country. No recommendations were refuted between campaigns. Two campaigns developed 3 novel recommendations on new topics, including chemotherapy in ductal carcinoma in situ (Italy) and comparison of screening imaging modalities (Portugal). CONCLUSIONS: CW® recommendations focus on reducing overutilization of investigations and treatments. There was a high rate of consensus between different CW® campaigns. As health care systems globally move attention to reduce low-value care, further studies are required to address adherence to these current recommendations and develop new recommendations.

The effect of immediate breast reconstruction on adjuvant therapy delay, locoregional recurrence, and disease-free survival.

BACKGROUND: An important risk inherent to both alloplastic and autologous immediate breast reconstruction (IBR) is the higher incidence of postoperative complications and delays to adjuvant therapy. The main objective of this retrospective cohort study was to identify risk factors for locoregional recurrence after breast cancer mastectomy and IBR. METHODS: A 6-year retrospective study of breast cancer patients treated with mastectomy only (MO) or mastectomy and IBR (MIBR) was conducted from January 2013 to May 2019. The outcomes of interest included delay in adjuvant chemoradiotherapy, postoperative complications, and locoregional recurrence. Cox regression survival was used to estimate the risk of locoregional recurrence and time to adjuvant therapy. RESULTS: Of 1832 patients reviewed, 720 (38%) were included. The cohort consisted of 443 (62%) MO and 277 (38%) MIBR [140 (51%) direct-to-implant (MIBRi1), 96(35%) tissue expander to implant (MIBRi2), and 41(15%) autologous flap (MIBRf)]. MIBR had more delays to adjuvant therapy compared to MO [113 (70%) vs. 72 (80%) months, p = 0.022]. Kaplan-Meier analysis showed that MIBRi2 had significantly shorter DFS compared to MO [MIBRi2: 39.2 (15.6) vs MO: 41.7 (19.6) months, log-rank p-value = 0.01]. Cox regression indicated that MIBRi2 was associated with a 3.26-higher risk of locoregional recurrence compared to MO [HR: 3.26; 95% CI: 1.56, 9.24]. CONCLUSIONS: Cox regression showed MIBRi2 was significantly associated with increased risk of locoregional recurrence compared to MO. Neither delays nor postoperative complications were identified as significant risk factors for locoregional recurrence risk.

Population Trends in Lobular Carcinoma of the Breast: The Ontario Experience.

BACKGROUND: Invasive lobular carcinoma (ILC) is less common that invasive ductal carcinoma (IDC), and more challenging to diagnose by examination and screening mammography. This study evaluated current trends in ILC incidence, and described the 5-, 10-, and 15-year survival probabilities for women diagnosed with ILC in Ontario, Canada. METHODS: This retrospective cohort analysis included all women aged 18 years and older diagnosed with breast cancer between 1991 and 2015. Health administrative data from the Institute of Clinical Evaluative Sciences and the Ontario Cancer Registry were used to identify breast cancer cases. Age-adjusted incidence was plotted by year. Crude proportions were plotted by year of diagnosis for stage and hormone receptor status. Kaplan-Meier curves were generated to determine the 5-, 10-, and 15-year survival probabilities for ILC and IDC. RESULTS: From 1991 to 2015, there were 194,065 cases of breast cancer in Ontario, 14.7% of which were ILC. The age-adjusted incidence of breast cancer increased 1.04-fold, while ILC rates increased 1.53-fold. All bilateral breast cancers were of lobular origin. The proportion of stage 1 ILC decreased, while the proportion of stage 2-4 ILC increased. The 5-, 10-, and 15-year overall survival probabilities for women diagnosed with ILC were 82.7%, 65.3%, and 50.2%, respectively. CONCLUSIONS: This study contains the largest population dataset of ILC evaluated to date. While total breast cancer incidence rates in Ontario are largely unchanged, ILC incidence rates are steadily increasing and there is a trend towards diagnosis of ILC at a later stage. These trends highlight the ongoing diagnostic and treatment challenge ILC presents for patients and clinicians.

Quality-of-Life and Surgical Outcomes for Breast Cancer Patients Treated with Therapeutic Reduction Mammoplasty Versus Mastectomy with Immediate Reconstruction.

BACKGROUND: Therapeutic reduction mammoplasty (TRM) is a safe and effective surgical technique that has oncologic outcomes comparable with those achieved by mastectomy. This study aimed to compare surgical and patient-reported outcomes between breast cancer patients treated with TRM and those who had mastectomy with immediate reconstruction (MIR). METHODS: A 4-year, single-institution, retrospective cohort study analyzed breast cancer patients undergoing TRM and MIR. Patient characteristics and perioperative data were collected from electronic records. Patient-reported outcome data were collected via BREAST-Q questionnaires preoperatively, then 3 months and 12 months postoperatively. A subgroup analysis was performed on locally advanced breast cancer (LABC) patients for TRM and MIR. RESULTS: The study included 249 breast reconstructions, of which 77 (31%) were TRM and 172 (69%) were MIR. The mean follow-up time was 2.4 ± 1.2 years. Compared with MIR, TRM had significantly lower major complication rates (9% vs 21%; p = 0.02) and fewer revisionary surgeries (5% vs 37%; p < 0.0001). At 1 year postoperatively, TRM had a significantly greater change in satisfaction with breasts, (+ 27.7 vs + 4.6; p < 0.01) and sexual well-being (+ 20.0 vs - 5.5; p = 0.02) than MIR. CONCLUSION: For select breast cancer patients, TRM continues to be a safe and effective alternative to mastectomy. The current study demonstrated that TRM patients had fewer major complications and revisionary surgeries, as well as better patient-reported outcomes than MIR.

Randomized window of opportunity trial evaluating high-dose vitamin D in breast cancer patients.

PURPOSE: Epidemiologic and preclinical data suggest a potential role for vitamin D in breast cancer treatment and prevention. However, results of prospective randomized trials are inconsistent. The objective of this study was to assess the effects of high-dose cholecalciferol (vitamin D3) on breast tumour proliferation and apoptosis. METHODS: We conducted a prospective, randomized, phase 2, double-blinded pre-surgical window of opportunity trial. Newly diagnosed breast cancer patients were randomized to receive 40,000 IU of vitamin D3 per day or placebo for 2 to 6 weeks prior to breast surgery. The primary outcome was the relative change in proliferation (Ki67) and apoptosis (cleaved caspase 3 apoptotic assay [CC3]) in primary breast cancer cells pre and post treatment. RESULTS: Of 83 patients randomized, 80 completed the study (43 (53.8%) vitamin D and 37 (46.3%) placebo). Mean duration of drug intake was 19 days (range 9-28 days). There were no significant differences between the control arm and the vitamin D arm in percent changes of either Ki67 index (1.6% vs. 16.7%, p = 0.25) or CC3 (- 55.9% vs. - 45.9%, p = 0.28). Serum 25-hydroxyvitamin D (25-OHD) levels were 3 times higher in the vitamin D arm (62 nmol/L vs. 246 nmol/L, p < 0.001). Adverse effects were minimal and all classified as grade 1. CONCLUSIONS: Despite significantly higher levels of serum 25-OHD in the vitamin D-treated group, this was not associated with any significant effects on tumour proliferation or apoptosis. These findings are consistent with the lack of benefit observed in prospective prevention trials. TRIAL REGISTRY: Trial registration clinicaltrials.gov NCT01948128.

A randomized, double-blind, window of opportunity trial evaluating the effects of chloroquine in breast cancer patients.

PURPOSE: Chloroquine has demonstrated anti-tumor activities through autophagy inhibition and cell cycle disruption. This study aimed to assess the effect of single-agent chloroquine on breast tumor cellular proliferation in a randomized, phase II, double-blind, placebo-controlled, pre-surgical window of opportunity trial. METHODS: Patients with newly diagnosed breast cancer were randomized 2:1 to chloroquine 500 mg daily or placebo for 2- to 6-weeks prior to their breast surgery. The primary outcome was the relative change in measures of proliferation (Ki67) in primary breast cancer cells pre- and post-treatment. Adverse events and toxicity profiles were also evaluated. RESULTS: From September 2015 to December 2016, 70 patients were randomized [46 (66%) chloroquine and 24 (34%) placebo]. Ten patients who were randomized to chloroquine withdrew from study due to adverse events. Mean duration of drug intake was 15 days (range 14-29 days). There were no significant differences between the chloroquine or placebo arms with respect to either the percentage change (- 0.4 vs. - 1.2, p = 0.088) or absolute change (- 2.0% vs. - 5.2%, p = 0.066) in Ki67 index pre- and post-drug treatment. Although adverse effects were minimal and all classified as grade 1, the effects were significant enough to cause nearly 15% of patients to discontinue therapy. CONCLUSIONS: Treatment with single-agent chloroquine 500 mg daily in the preoperative setting was not associated with any significant effects on breast cancer cellular proliferation. It was, however, associated with toxicity that may affect its broader use in oncology.

Creating a pragmatic trials program for breast cancer patients: Rethinking Clinical Trials (REaCT).

BACKGROUND: The proportion of breast cancer patients enrolled in clinical trials is falling. The Rethinking Clinical Trials (REaCT) program was developed to challenge some of the contemporary barriers responsible for this fall in accrual. In this article, we review the successes and challenges our program has faced. METHODS: The REaCT program was created to improve care and outcomes for cancer patients through surveys of patients and healthcare providers, systematic reviews, economic evaluations, and the performance of pragmatic randomized trials with patient-centered outcomes. Likely, the greatest difference to conventional trial methodologies has been our widespread use of the integrated consent model (ICM) incorporating oral consent. RESULTS: Between 2014 and 2018, the program has recruited over 2000 patients to 15 randomized studies at 11 Canadian cancer centers. The REaCT program has completed and published five patient surveys, six healthcare provider surveys, ten systematic reviews, performed four economic evaluations, opened 15 clinical trials comparing standard of care interventions (two surgical, two adjuvant chemotherapy, five adjuvant supportive care, one radiology, two vascular devices, two palliative supportive care, and one molecular diagnostics). Patient surveys have shown high levels of satisfaction with the ICM. CONCLUSION: The REaCT program was developed to tackle important practice questions that will better guide optimal practice and to increase the availability of pragmatic clinical trials. While many challenges remain, future strategies will involve including more study sites and efforts to integrate novel information technology strategies.

Paravertebral blocks in immediate breast reconstruction following mastectomy.

BACKGROUND: Postoperative pain remains a major challenge following immediate breast reconstruction with 40% of patients experiencing acute pain and up to 60% developing chronic pain. Paravertebral blocks (PVB's) have emerged as a promising adjunct to standard analgesic protocols. The aim of this study was to assess the utility of PVB's in immediate breast reconstruction following mastectomy. METHODS: A retrospective review of patients undergoing immediate breast reconstruction following mastectomy was performed. The primary outcome was postoperative pain measured by total oral morphine equivalent usage and self reported pain scores and secondary outcomes were length of stay in the PACU, complications, and OR delay. RESULTS: Of 298 patients undergoing immediate breast reconstruction, 112(38%) underwent standard analgesic protocols and 186(62%) underwent PVB in addition to the standard protocol. PVB's were associated with reductions in average postoperative pain scores (2.8 vs 3.3, P = 0.002), total opiate consumption (52 units vs 63 units, P = 0.038) and time spent in the PACU 92 vs 142 minutes, P = 0.0228) compared to patients who had general anesthesia alone. The overall complication rate was 3.7% (7/186 patients), all which were minor complications such as headache, bloody tap, vasovagal episode and temporary weakness. The use of PVBs delayed the OR start time on average by 15 minutes (34 vs 49 minutes). CONCLUSIONS: The present study offers one of the largest retrospective cohort studies to date evaluating the utility of PVB's in immediate breast reconstruction following mastectomy. We demonstrate that, PVB's in immediate breast reconstruction are associated with reductions in postoperative pain, narcotic usage and length of stay in PACU, but are associated with delays to the start time of the case. Anesthesiologists, plastic surgeons and hospital administrators must continue to work together to ensure this important and necessary service is administered in an efficient and cost effective manner.

A survey of Canadian breast health professionals' recommendations for high-risk benign breast disease

Summary: The management of high-risk benign breast disease (BBD) is changing because of improvements in radiological and pathological analysis. We sought to determine the current practice recommendations of breast health professionals in managing patients with high-risk BBD. We surveyed members of the Canadian Society of Surgical Oncology, Canadian Association of General Surgeons and Canadian Association of Radiologists. The survey contained demographic and case-based questions concerning management of high-risk benign breast lesions. Participants were asked for their recommendations and opinions regarding future risk of breast cancer as well as the role of chemoprevention. There was no consistency among the 41 respondents in the treatment recommendations for any of the high-risk benign conditions, and the lifetime risk associated with classic lobular carcinoma in situ was vastly underestimated. Education and evidenced-based guidelines are urgently needed to ensure more uniform practice nationally.

Radioactive Seed Localization Versus Wire-Guided Localization for Nonpalpable Breast Cancer: A Cost and Operating Room Efficiency Analysis.

BACKGROUND: This study aimed to compare the cost and resource use between our first-year experience using breast-conserving surgery (BCS) with radioactive seed localization (RSL) and the previous-year standard practice of BCS with wire-guided localization (WGL) for patients with nonpalpable breast cancer at a large Canadian tertiary center. METHODS: For this retrospective cohort study, data for BCS cases with RSL was collected from 1 April 2015 to 31 March 2016 and for BCS cases with WGL from 1 April 2014 to 31 March 2015. RESULTS: The study compared 153 WGL patients with 194 RSL patients. The two groups had no significant demographic differences. The average cost per patient for RSL, including opportunity costs, was $250.90 versus $1130.41 for WGL. Dedicated allocated radiology appointments to RSL increased (9 per day), and fewer radiologists were required for these procedures per day. Patients were transported to the operating room more quickly for RSL procedures (120 vs. 254 min; p < 0.001). Fewer vasovagal reactions occurred after insertion of RSL versus WGL (p = 0.05). No significant differences were observed in terms of surgical time, specimen volume, positive margins, or margin reexcision rates. No significant differences in postoperative complication rates were observed. CONCLUSIONS: In this study, RSL had lower costs than WGL, allowed for more efficient use of radiology scheduling and resources, and had shorter wait times for patients on their day of surgery. In addition, RSL led to fewer vasovagal reactions at insertion. Therefore, RSL should be used instead of WGL given the reduced cost, decreased need of human resources, improved efficiency, and potential benefits to the patient experience.

Training Canadian surgeons in oncoplastic breast surgery: Where do we stand?

SUMMARY: Breast-conserving surgery with adjuvant radiation therapy is widely accepted as a universal standard of care for women with early-stage breast cancer. Oncoplastic breast-conserving surgery (OPS) techniques have emerged in recent years, facilitating the achievement of better cosmetic results while adhering to good oncological principles. Compared with the rest of the international community, Canada has been fairly slow in its clinical uptake of OPS. This commentary discusses how Canada can increase its capacity for OPS.

Issues Affecting the Loco-regional and Systemic Management of Patients with Invasive Lobular Carcinoma of the Breast.

Invasive lobular carcinoma (ILC) of the breast is the second most common type of invasive breast carcinoma accounting for 8-14% of all breast cancers. Traditional management of ILC has followed similar paradigms as that for invasive ductal carcinoma (IDC). However, ILC represents a pathologically, clinically and biologically unique variant of breast cancer with particular management challenges. These challenges are seen in both the loco-regional management of ILC; where ILC tumors tend to avoid detection and hence present as more clinically advanced and surgically challenging carcinomas, and the systemic management with a unique response pattern to standard systemic therapies. Because of these challenges, the outcome for patients with ILC has likely lagged behind the continued improvements seen in outcome for patients with IDC. Here, we discuss some of the unique challenges ILC presents and discuss possible management strategies to best overcome the difficulties in the loco-regional and systemic management of patients with ILC.

The Web-based CanMEDS Resident Learning Portfolio Project (WEBCAM): how we got started.

SUMMARY: The CanMEDS framework is ubiquitous in Canadian postgraduate medical education; however, training programs do not have a universal method of assessing competence. We set out to develop a novel portfolio that allowed trainees to generate a longitudinal record of their training and development within the framework. The portfolio provided an objective means for the residency program director to document and evaluate resident progress within the CanMEDS roles.