EBCC-13 manifesto: Balancing pros and cons for contralateral prophylactic mastectomy.

After a diagnosis of unilateral breast cancer, increasing numbers of patients are requesting contralateral prophylactic mastectomy (CPM), the surgical removal of the healthy breast after diagnosis of unilateral breast cancer. It is important for the community of breast cancer specialists to provide meaningful guidance to women considering CPM. This manifesto discusses the issues and challenges of CPM and provides recommendations to improve oncological, surgical, physical and psychological outcomes for women presenting with unilateral breast cancer: (1) Communicate best available risks in manageable timeframes to prioritise actions; better risk stratification and implementation of risk-assessment tools combining family history, genetic and genomic information, and treatment and prognosis of the first breast cancer are required; (2) Reserve CPM for specific situations; in women not at high risk of contralateral breast cancer (CBC), ipsilateral breast-conserving surgery is the recommended option; (3) Encourage patients at low or intermediate risk of CBC to delay decisions on CPM until treatment for the primary cancer is complete, to focus on treating the existing disease first; (4) Provide patients with personalised information about the risk:benefit balance of CPM in manageable timeframes; (5) Ensure patients have an informed understanding of the competing risks for CBC and that there is a realistic plan for the patient; (6) Ensure patients understand the short- and long-term physical effects of CPM; (7) In patients considering CPM, offer psychological and surgical counselling before surgery; anxiety alone is not an indication for CPM; (8) Eliminate inequality between countries in reimbursement strategies; CPM should be reimbursed if it is considered a reasonable option resulting from multidisciplinary tumour board assessment; (9) Treat breast cancer patients at specialist breast units providing the entire patient-centred pathway.

Bilateral Mastectomy in Women With Unilateral Breast Cancer: A Review.

Importance: Rates of bilateral mastectomy continue to increase in average-risk women with unilateral in situ and invasive breast cancer. Contralateral prophylactic mastectomy rates increased from 5% to 12% of all operations for breast cancer in the US from 2004 to 2012. Among women having mastectomy, rates of contralateral prophylactic mastectomy have increased from less than 2% in 1998 to 30% in 2012. Observations: The increased use of breast magnetic resonance imaging and genetic testing has marginally increased the number of candidates for bilateral mastectomy. Most bilateral mastectomies are performed on women who are at no special risk for contralateral cancer. The true risk of contralateral breast cancer is not associated with the decision for contralateral prophylactic mastectomy; rather, the clinical factors associated with the probability of distant recurrence are associated with bilateral mastectomy. Several changes in society and health care delivery appear to act concurrently and synergistically. First, the anxiety engendered by a fear of cancer recurrence is focused on the contralateral cancer because this is most easily conceptualized and provides a ready target that can be acted upon. Second, the modern woman with breast cancer is supported by the surgeon and the social community of breast cancer survivors. Surgeons want to respect patient autonomy, despite guidelines discouraging bilateral mastectomy, and most women have their expenses covered by a third-party payer. Satisfaction with the results is high, but the association with improved psychosocial well-being remains to be fully understood. Conclusions and Relevance: Reducing the use of medically unnecessary contralateral prophylactic mastectomy in women with nonhereditary, unilateral breast cancer requires a social change that addresses patient-, physician-, cultural-, and systems-level enabling factors. Such a transformation begins with educating clinicians and patients. The concerns of women who want preventive contralateral mastectomy must be explored, and women need to be informed of the anticipated benefits (or lack thereof) and risks. Areas requiring further study are considered.

Patient Perceptions in a Nonblinded Randomized Trial of Radiation Therapy Technologies: A Novel Survey Study Exploring Therapeutic Misconception.

PURPOSE: Therapeutic misconception is the tendency for a clinical trial participant to overlook the scientific objective of a clinical trial and instead believe that an experimental intervention is intended for personal therapeutic benefit. We sought to evaluate this tendency in the setting of a clinical trial of a new radiation therapy technology. METHODS: Patients with left-sided, node positive breast cancer enrolled in a randomized clinical trial evaluating intensity modulated radiation therapy with deep inspiration breath hold (IMRT-DIBH) versus 3-dimensional conformal radiation therapy (3DCRT). Patients who enrolled completed surveys at baseline, after randomization, and upon completion of radiation therapy to evaluate expectations, satisfaction, and experiences. RESULTS: Forty women participated in the survey study, with 20 in each arm. Most participants endorsed the perception that participation in the trial might result in better treatment than the current standard treatment (77%) and more medical attention than being off trial (54%). At baseline, most women (74%) believed that a new treatment technology is superior than an established one. Before randomization, 43% of participants believed IMRT-DIBH would be more effective than standard treatment with 3DCRT, none believed that 3DCRT would be more effective, 23% believed that they would be the same, and 34% did not know. None believed that IMRT-DIBH would cause worse long-term side effects, whereas 37% thought that 3DCRT would. Most (71%) reported that they would choose to be treated with IMRT-DIBH; none would have elected 3DCRT if given a choice. Nearly half (44%) in the 3DCRT arm wished that they had been assigned to the IMRT-DIBH arm; none in the IMRT-DIBH arm expressed a wish for crossover. CONCLUSIONS: Most participants reported the perception that trial participation would result in better treatment and more medical attention than off trial, hallmarks of therapeutic misconception. Our observations provide empirical evidence of a fixed belief in the superiority of new technology and highlight the importance of adjusting expectations through informed consent to mitigate therapeutic misconception.

Quality of Life and Body Image as a Function of Time from Mastectomy.

BACKGROUND: We sought to determine the impact of time after surgery on quality of life (QoL) and body image in breast cancer patients undergoing mastectomy. METHODS: Female patients with unilateral breast cancer who had undergone mastectomy were surveyed regarding their body image (Body Image After Breast Cancer Questionnaire; BIBCQ) and QoL (FACT-B). Data were analyzed using nonparametric statistics (SPSS version 24). RESULTS: Ninety-four of the 109 patients approached completed both surveys (86.2% response rate). Median patient age at the time of surgery was 49.5 (range 29-82); the survey was administered at a median of 14.2 months postoperatively (range 0.3-192.1 months). Seventy-four patients (78.7%) had reconstruction, and 52 patients (55.3%) chose to undergo contralateral prophylactic mastectomy. Patients who reported an above average overall body image perception on the BIBCQ tended to be further out from their surgery than those who reported a below average perception (median 20.9 vs. 8.1 months, respectively, p = 0.009). Patients who reported above average QoL also tended to be further out from their surgery compared with those with below average overall QoL (median 21.8 vs. 6.4 months, respectively, p = 0.004). Receipt of reconstruction, contralateral prophylactic mastectomy, disease stage, patient race, education, insurance type, income, marital status, employment status, and age at surgery did not significantly affect body image nor QoL in this cohort. CONCLUSIONS: Better body image perception and higher QoL were associated with being further out from surgery. These findings suggest that body image and QoL may improve with time, as patients acclimatize to their "new normal."

Effect of one comprehensive education course to lower anxiety and depression among Chinese breast cancer patients during the postoperative radiotherapy period - one randomized clinical trial.

BACKGROUND: We investigated the effectiveness of one education course to lower the severity of anxiety and depression symptoms among breast cancer (BC) patients during radiotherapy (RT). METHODS: All 290 one-sided BC patients were evenly randomized into intervention or control arm. "Intervention" patient was additionally provided with one three-hour course on psychological stresses and management skills. Changes of anxiety and depression score and their 3-level severity category ('normal', 'borderline' and 'abnormal' scored 0-7, 8-10 and 11-21, respectively) from HADS questionnaire over RT were evaluated by multivariable linear and ordinal logistic regressions. RESULTS: Response rates were 94 and 100% by "intervention" and "control" arm, respectively. Means of score changes by "intervention" and "control" (n = 145) were + 0.59 (SD = 2.47) and + 0.11 (SD = 2.55) for anxiety and + 0.81 (SD = 2.81) and + 0.45 (SD = 2.77) for depression scores, respectively. 'Abnormal' anxiety and depression patients were 4.1 and 6.9% at baseline and 4.8 and 6.9% at end of RT at 'control' arm; those rates were 6.6 and 7.4%, and 8.8 and 10.3% at 'intervention' arm, respectively. Both changes on anxiety and depression measurements between two arms were all insignificant (p > 0.20). CONCLUSIONS: One education course did not reduce the score and severity of anxiety and depression symptoms over RT period. TRIAL REGISTRATION: Chinese Clinical Trial Registry #: ChiCTR-IIR-16008818 at www.chictr.org.cn .

Risk-reducing mastectomy for the prevention of primary breast cancer.

BACKGROUND: Recent progress in understanding the genetic basis of breast cancer and widely publicized reports of celebrities undergoing risk-reducing mastectomy (RRM) have increased interest in RRM as a method of preventing breast cancer. This is an update of a Cochrane Review first published in 2004 and previously updated in 2006 and 2010. OBJECTIVES: (i) To determine whether risk-reducing mastectomy reduces death rates from any cause in women who have never had breast cancer and in women who have a history of breast cancer in one breast, and (ii) to examine the effect of risk-reducing mastectomy on other endpoints, including breast cancer incidence, breast cancer mortality, disease-free survival, physical morbidity, and psychosocial outcomes. SEARCH METHODS: For this Review update, we searched Cochrane Breast Cancer's Specialized Register, MEDLINE, Embase and the WHO International Clinical Trials Registry Platform (ICTRP) on 9 July 2016. We included studies in English. SELECTION CRITERIA: Participants included women at risk for breast cancer in at least one breast. Interventions included all types of mastectomy performed for the purpose of preventing breast cancer. DATA COLLECTION AND ANALYSIS: At least two review authors independently abstracted data from each report. We summarized data descriptively; quantitative meta-analysis was not feasible due to heterogeneity of study designs and insufficient reporting. We analyzed data separately for bilateral risk-reducing mastectomy (BRRM) and contralateral risk-reducing mastectomy (CRRM). Four review authors assessed the methodological quality to determine whether or not the methods used sufficiently minimized selection bias, performance bias, detection bias, and attrition bias. MAIN RESULTS: All 61 included studies were observational studies with some methodological limitations; randomized trials were absent. The studies presented data on 15,077 women with a wide range of risk factors for breast cancer, who underwent RRM.Twenty-one BRRM studies looking at the incidence of breast cancer or disease-specific mortality, or both, reported reductions after BRRM, particularly for those women with BRCA1/2 mutations. Twenty-six CRRM studies consistently reported reductions in incidence of contralateral breast cancer but were inconsistent about improvements in disease-specific survival. Seven studies attempted to control for multiple differences between intervention groups and showed no overall survival advantage for CRRM. Another study showed significantly improved survival following CRRM, but after adjusting for bilateral risk-reducing salpingo-oophorectomy (BRRSO), the CRRM effect on all-cause mortality was no longer significant.Twenty studies assessed psychosocial measures; most reported high levels of satisfaction with the decision to have RRM but greater variation in satisfaction with cosmetic results. Worry over breast cancer was significantly reduced after BRRM when compared both to baseline worry levels and to the groups who opted for surveillance rather than BRRM, but there was diminished satisfaction with body image and sexual feelings.Seventeen case series reporting on adverse events from RRM with or without reconstruction reported rates of unanticipated reoperations from 4% in those without reconstruction to 64% in participants with reconstruction.In women who have had cancer in one breast, removing the other breast may reduce the incidence of cancer in that other breast, but there is insufficient evidence that this improves survival because of the continuing risk of recurrence or metastases from the original cancer. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention, when considering RRM. AUTHORS' CONCLUSIONS: While published observational studies demonstrated that BRRM was effective in reducing both the incidence of, and death from, breast cancer, more rigorous prospective studies are suggested. BRRM should be considered only among those at high risk of disease, for example, BRCA1/2 carriers. CRRM was shown to reduce the incidence of contralateral breast cancer, but there is insufficient evidence that CRRM improves survival, and studies that control for multiple confounding variables are recommended. It is possible that selection bias in terms of healthier, younger women being recommended for or choosing CRRM produces better overall survival numbers for CRRM. Given the number of women who may be over-treated with BRRM/CRRM, it is critical that women and clinicians understand the true risk for each individual woman before considering surgery. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention when considering RRM.

Assessing the Effect of Lifetime Contralateral Breast Cancer Risk on the Selection of Contralateral Prophylactic Mastectomy for Unilateral Breast Cancer.

INTRODUCTION: Contralateral prophylactic mastectomy (CPM) rates are rising, with fear implicated as a contributing factor. This study used a contralateral breast cancer (CBC) risk stratification tool to assess whether the selection of CPM is reflective of future CBC risk. PATIENTS AND METHODS: This retrospective study evaluated 404 women with unilateral breast cancer treated with breast conservation, unilateral mastectomy, or bilateral mastectomy within a single multidisciplinary clinic. Women were evaluated by the Manchester risk tool to calculate lifetime CBC risk. Logistic regression analysis was used to evaluate whether CBC risk was associated with CPM, and the clinical rationale for prophylactic mastectomy justification was recorded. RESULTS: Sixty-two percent underwent breast conservation, 18% unilateral mastectomy, and 20% bilateral mastectomy. In the CPM cohort, 36% had > 20% calculated lifetime CBC risk. In the invasive cohort, younger age (odds ratio 2.65, P < .0001) and genetic mutation positivity (odds ratio 35.39, P = .019) independently predicted CPM. Other contributing factors included benign contralateral breast findings (29%) and recommendations against breast conservation due to disease burden (28%). Six percent selected CPM as a result of an unsubstantiated fear regarding breast cancer. CONCLUSION: The majority of women (63%) who selected CPM had < 20% CBC risk. In these lower-risk women selecting CPM, factors increasing reasonable fear dominated surgical choice (81% of this subset).

Women's preferences for contralateral prophylactic mastectomy: An investigation using protection motivation theory.

OBJECTIVE: Most women diagnosed with unilateral breast cancer without BRCA1 or BRCA2 mutations are at low risk of contralateral breast cancer. Contralateral Prophylactic Mastectomy (CPM) decreases the relative risk of contralateral breast cancer, but may not increase life expectancy; yet international uptake is increasing. This study applied protection motivation theory (PMT) to determine factors associated with women's intentions to undergo CPM. METHODS: Three hundred eighty-eight women previously diagnosed with unilateral breast cancer and of negative or unknown BRCA1 or BRCA2 status were recruited from an advocacy group's research database. Participants completed measures of PMT constructs based on a common hypothetical CPM decision-making scenario. RESULTS: PMT constructs explained 16% of variance in intentions to undergo CPM. Response efficacy (CPM's advantages) and response costs (CPM's disadvantages) were unique individual predictors of intentions. CONCLUSION: Decision-making appears driven by considerations of the psychological, cosmetic and emotional advantages and disadvantages of CPM. Overestimations of threat to life from contralateral breast cancer and survival benefit from CPM also appear influential factors. PRACTICE IMPLICATIONS: Patients require balanced and medically accurate information regarding the pros and cons of CPM, survival rates, and recurrence risks to ensure realistic and informed decision-making.

Impact that Timing of Genetic Mutation Diagnosis has on Surgical Decision Making and Outcome for BRCA1/BRCA2 Mutation Carriers with Breast Cancer.

BACKGROUND: Deleterious BRCA mutation carriers with breast cancer are at increased risk for additional breast cancer events. This study evaluated the impact that timing of identification of BRCA+ status has on surgical decision and outcome. METHODS: The authors reviewed all BRCA carriers at their institution whose breast cancer was diagnosed between January 1996 and June 2015. Patient surveys, medical records, and institutional databases were used to collect data. Differences in surgical choice were analyzed using the chi-square test, and rates of subsequent breast cancer events were estimated using the Kaplan-Meier method. RESULTS: The study investigated 173 BRCA carriers with breast cancer (100 BRCA1, 73 BRCA2). Of the women with known BRCA mutation before surgery and unilateral stages 0 to 3 breast cancer (n = 63), 12.7 % underwent lumpectomy, 4.8 % underwent unilateral mastectomy (UM), and 82.5 % underwent bilateral mastectomy (BM). These surgical choices differed significantly (p < 0.0001) from those of patients unaware of their mutation at the time of surgery (n = 93) (51.6 % had lumpectomy, 19.4 % had UM, 29 % had BM). Of the patients with BRCA mutation identified after surgery who underwent lumpectomy or UM, 36 (59 %) of 66 underwent delayed BM. The patients with BRCA+ known before diagnosis presented with significantly lower-stage disease (p = 0.02) at diagnosis (69 % stage 0 or 1) than those whose BRCA mutation was identified after cancer diagnosis (40 % stage 0 or 1). CONCLUSIONS: The study findings showed that BRCA mutation status influences surgical decision. The rates of BM were higher for the patients with BRCA mutation known before surgery. Identification of BRCA mutation after surgery frequently leads to subsequent breast surgery. Genetic testing before surgery is important for patients at elevated risk for BRCA mutation.

Cuidado de enfermería en paciente postoperada de mastectomía: estudio de caso / Nursing care in postoperative mastectomy patient: a case study

Introducción: El cáncer de mama es una de las neoplasias más frecuentes en mujeres a nivel mundial y causan más muertes cada año. El diagnóstico oportuno es muy importante ya que es de relevancia en la elección y eficacia del tratamiento, teniendo mayor éxito cuando se detecta temprano. La mejor estrategia para la detección temprana es a través de la prevención primaria mediante información, orientación y educación a la población femenina acerca de los factores de riesgo y la promoción de conductas favorables a la salud. El objetivo del estudio fue identificar dominios y clases afectadas en paciente postoperada de mastectomía. Materiales y Métodos: Estudio de caso en paciente femenina de 47 años de edad diagnosticada con cáncer de mama izquierda, realizándole mastectomía radical izquierda en una institución de salud del sector privado de Tampico, Tamaulipas, México. Se aplicó el proceso enfermero, realizando la valoración de enfermería con la Taxonomía II de Diagnósticos de enfermería, se describen los dominios y clases afectadas en el periodo posoperatorio, implementándose el plan de cuidados de enfermería con las interrelaciones diagnósticos, intervenciones y resultados. Resultados: La paciente evolucionó favorablemente, egresando al tercer día de la intervención quirúrgica, se proporcionó educación para sus cuidados en el domicilio. Discusión y Conclusiones: Al finalizar la investigación del caso, se observó la importancia de llevar a cabo el plan de cuidados de enfermería con las respectivas interrelaciones para brindar atención de calidad.

Introduction: Breast cancer is one of the most common cancers in women worldwide and causes more deaths each year. Early diagnosis is very important because it is relevant in the choice and treatment efficacy, with greater success when caught early. The best strategy for early detection is through primary prevention through information, guidance and education to the female population about risk factors and promoting positive health behaviors. The aim of the study was to identify domains and affected classes in a postoperative mastectomy patient. Materials and Methods: A case study in female patients of 47 years of age diagnosed with left breast cancer, performing left radical mastectomy in a private health institution in Tampico, Tamaulipas, Mexico. The nursing process was applied, making the nursing assessment with Taxonomy II Nursing Diagnoses, domains and affected classes in the postoperative period are described, implementing the nursing care plan with interrelationships, diagnoses, interventions and outcomes. Results: The patient improved, egressing the third day after surgery, education was provided for care at home. Discussion and Conclusions: After investigating the case, the importance of carrying out the plan of nursing care with the respective relationships to provide quality care was observed.