Completed Breast Cancer Treatment Research Articles

To explore options to support patients following completion of breast cancer treatment

To explore options to support patients following completion of breast cancer treatment

The Significance of Religion and Spirituality Among Turkish Women Surviving Breast Cancer Without Treatment: A Qualitative Study.

The health of breast cancer survivors is a global concern. It is crucial to adopt a holistic approach when understanding their journey from illness to wellness in order to ensure that the transition is as smooth as possible. This study focused on the experiences of Muslim women who had overcome breast cancer and were adapting to life post-treatment. Snowball sampling was used to select the participants for this qualitative study. Fifteen women who had successfully completed breast cancer treatment and been declared cancer-free were interviewed. These interviews were semi-structured, using open-ended questions to explore their experiences in-depth. The interviews were conducted by phone, and the data were analyzed using qualitative content analysis. The study identified four main themes, nine subthemes, and 41 codes. The main themes were as follows: (a) a life changed by cancer and the difficulties encountered; (b) transition from active treatment to treatment-free living; (c) coping mechanisms; and (d) future hopes and expectations. The findings highlighted the survivors' desire to move past their experience of cancer and normalize their lives, as well as emphasizing their need for support. The participants shared detailed accounts of their journey, the obstacles they encountered during this transition, and the critical role of religion and spirituality in overcoming these challenges. Understanding and effectively managing the experiences of women after breast cancer treatment is vital not only for improving survival rates but also for facilitating their healing process.

Lived experiences of breast cancer in patients under the age of 40: A phenomenological study.

The purpose of this study was to understand and describe the experiences of breast cancer in patients under age 40 years in South Korea. Data were collected from December 2020 to January 2021 through individual in-depth semi-structured interviews with 10 patients aged <40 years less than one year after they had completed treatment for breast cancer. We performed a qualitative study using Colaizzi's phenomenological method. The six theme clusters for intrapersonal, interpersonal, and sociocultural categories were as follows: 1) physical pain, 2) psychological response and need, 3) positive relationships with family members, 4) non-familial support system, 5) age stereotypes of cancer, and 6) Confucian culture in Korea. The study provides insights into the specific issues and major concerns of young breast cancer patients from multiple perspectives. Based on the results, optimized support should be developed to relieve the physical, psychological, and social burden on young breast cancer patients. Specific information and communication training should be offered to oncology nurses to provide counseling in order to reduce patient anxiety and fear related to these issues. The study emphasizes the importance of positive relationships with family and the non-familial support system and suggests that nursing intervention can help support these relationships to prevent social isolation.

Adherence to adjuvant tamoxifen and associated factors in breast cancer survivors

Adjuvant endocrine therapy reduces the recurrence and mortality of early hormone receptor-positive breast cancer in both pre- and postmenopausal women. The aim of this study was to investigate adjuvant tamoxifen adherence and associated factors in breast cancer survivors. This descriptive, prospective study was conducted in 2019-2020 with the participation of 531 women who survived breast cancer and were under follow-up at the Senology Institute of a hospital in Istanbul. Inclusion criteria were having completed treatment for early hormone receptor-positive breast cancer, being prescribed tamoxifen, and being 18years or older. Data were collected using a patient information form and the Morisky Medication Adherence Scale-8 (MMAS-8). The mean age of the participants was 44.9 ± 6.5years, and the mean duration of tamoxifen use was 834.4 ± 685.7days. The women's mean MMAS-8 score was 6.86 ± 1.39. Medication adherence was significantly positively correlated with current age (p = 0.006) and age at diagnosis (p = 0.002). There was a statistically significant difference between tamoxifen adherence according to participants' employment status (p = 0.028), chronic disease status (p = 0.018), loss of libido (p = 0.012), treatment-related changes in mood changes (p = 0.004), and having negative effects affecting daily life (p < 0.001). Overall, breast cancer survivors in this study reported moderate adherence to tamoxifen. The women's individual characteristics and the adverse effects of treatment influenced medication adherence. Healthcare professionals can help increase adherence to this treatment, which reduces the risk of mortality, by explaining the importance of the medication, identifying and eliminating barriers to adherence, and informing women about evidence-based interventions to increase medication compliance.

Abstract P3-03-06: A pilot study of personal care product use and exposure to environmental chemicals among Black and Hispanic breast cancer survivors

Abstract Objectives and rationale: Racial and ethnic minorities are disproportionately exposed to environmental chemicals that have been linked to cardiovascular disease, cognitive decline, metabolic disease, and premature mortality. Recent evidence suggests that personal care products are a source of such exposures and that these products are more frequently used among Black and Hispanic women. Minoritized populations also tend to experience worse breast cancer outcomes compared to White patients. However, few studies have examined personal care product use and environmental exposures among minority cancer survivors. The aim of the present study was to describe personal care product use and chemical exposures, including ambient and dermal sources of exposure, in a pilot study of Black and Hispanic breast cancer survivors. Methods: In November 2020 – December 2021, self-identified Black and Hispanic breast cancer survivors aged ≥21 years were recruited in Washington, DC and Hackensack, NJ. Eligible survivors had been diagnosed with primary Stage I-III breast cancer and had completed breast cancer treatment except endocrine therapy. Surveys collected data on demographics, breast cancer diagnosis, personal care product use, and potential covariates. Participants wore silicone wristbands for 1 week for passive sampling of environmental exposures. Extracts from the wristbands were assessed using a gas chromatograph-mass spectrometer to detect chemical exposures. Values were adjusted for wear time and wristband size to provide sample concentrations of detected chemicals. Results: Among the 25 study participants, 17 were Black and 8 were Hispanic, with a mean age of 58 years. Most survivors (58%) had been diagnosed with Stage I breast cancer. Survivors reported using perfume (52%), make-up (80%), and nail polish (68%) during the week, with common daily use of facial creams, lotions, or moisturizers (60%) and body creams, lotions, or moisturizers (68%). Drinking bottled water every day (64%) or most days (24%); eating prepared food from a fast food restaurant at least once per week (88%); and eating food reheated in a plastic container at least once per week (71%) were also prevalent. However, the majority of survivors reported never using pesticides indoors (76%) or outdoors (79%). The wristbands detected 60 distinct chemicals. On average, 21.8 chemicals were detected per wristband and 19 chemicals were detected in more than half of the samples. Exposure to flame retardants and pesticides was ubiquitous. All participants were exposed to chemicals found in personal care products and in commercial products. Several of the most commonly detected chemicals, including benzyl salicylate (a UV light absorber and fragrance), diisobutyl phthalate (a plasticizer), and lilial (a perfume), are biologically active compounds with potential genotoxic or endocrine effects. Discussion: Exposure to environmental chemicals was ubiquitous among Black and Hispanic breast cancer survivors in DC and New Jersey. Frequent use of personal care products and commercial products suggest an opportunity to reduce potentially harmful exposures. Future studies are needed to investigate the role of environmental chemicals in health outcomes among breast cancer survivors and whether environmental exposures contribute to cancer health disparities. Citation Format: Traci N. Bethea, Jennifer Hicks, Erin Speiser, Adana Llanos, Gail E. Starr, Chiranjeev Dash, Lucile L. Adams-Campbell. A pilot study of personal care product use and exposure to environmental chemicals among Black and Hispanic breast cancer survivors [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-03-06.

Cancer-Related Stigma in Malawi: Narratives of Cancer Survivors.

Stigma is an impediment across the cancer care continuum, leading to delayed presentation to care, elevated morbidity and mortality, and reduced quality of life. The goal of this study was to qualitatively examine the drivers, manifestations, and impacts of cancer-related stigma among individuals who received cancer treatment in Malawi, and to identify opportunities to address stigma. Individuals who had completed treatment for lymphoma (n = 20) or breast cancer (n = 9) were recruited from observational cancer cohorts in Lilongwe, Malawi. Interviews explored the individual's cancer journey, from first symptoms through diagnosis, treatment, and recovery. Interviews were audio-recorded and translated from Chichewa to English. Data were coded for content related to stigma, and thematically analyzed to describe the drivers, manifestations, and impacts of stigma along the cancer journey. Drivers of cancer stigma included beliefs of cancer origin (cancer as infectious; cancer as a marker of HIV; cancer due to bewitchment), perceived changes in the individual with cancer (loss of social/economic role; physical changes), and expectations about the individual's future (cancer as death sentence). Cancer stigma manifested through gossip, isolation, and courtesy stigma toward family members. The impacts of cancer stigma included mental health distress, impediments to care engagement, lack of cancer disclosure, and self-isolation. Participants suggested the following programmatic needs: community education about cancer; counseling in health facilities; and peer support from cancer survivors. The results highlight multifactorial drivers, manifestations, and impacts of cancer-related stigma in Malawi, which may affect success of cancer screening and treatment programs. There is a clear need for multilevel interventions to improve community attitudes toward people with cancer, and to support individuals along the continuum of cancer care.

Body image in women diagnosed with breast cancer: A grounded theory study

Using a Straussian grounded theory methodology, we explored the meaning women attribute to body image and how they understand their breast cancer experience as influencing their body image to develop a grounded theory of body image for women diagnosed with breast cancer. Interviews were conducted with 27 women who had completed treatment for breast cancer in Canada. Data were analyzed through a process of open, axial, and selective coding using constant comparison techniques and memo-writing. A grounded theory of body image for women diagnosed with breast cancer was developed around the core category of body image: what it means to women, which was underpinned by six themes and 17 subthemes. This theory explains how women diagnosed with breast cancer define body image and illustrates intrapersonal and interpersonal factors that can undermine or support their body image, along with strategies they used to manage their body image. This theory can guide research and practice aimed at enhancing body image and minimizing its consequences for women diagnosed with breast cancer.

392 Adapting a randomized, placebo-controlled pilot study aimed to reduce anxiety symptoms to overcome recruitment barriers

OBJECTIVES/GOALS: Minimal human investigations have assessed the effect of synbiotics (combination of pre- and probiotics) on anxiety symptoms, despite evidence from preclinical research. Our study aimed to determine the feasibility of a randomized, placebo-controlled trial utilizing synbiotics to reduce anxiety symptoms in older female breast cancer survivors. METHODS/STUDY POPULATION: We aimed to recruit older female breast cancer survivors experiencing anxiety symptoms to a 4-week randomized, placebo-controlled clinical trial. At commencement of the project, participants were eligible if they : 1) were 50-75 years old; 2) completed primary treatment for breast cancer; 3) were experiencing clinical anxiety symptoms 4) agreed to not change dietary supplements 5) were willing to comply with daily supplement regimen; and 6) were able to read and speak English. Use of anxiolytic or microbiome-altering medications, or changes to anxiety treatment within 4 weeks of enrollment were criteria for exclusion. Due to budgetary limitations, we were unable to recruit from state cancer registries, and instead recruited via newspaper advertisements and flyer distribution. RESULTS/ANTICIPATED RESULTS: One participant has successfully been recruited and completed the duration of the clinical trial, and two others have expressed interest but were deemed ineligible. Barriers in recruitment resulted in the following modifications to protocol: we expanded our eligibility criteria by removing the upper age limit (now 50+ years old) and now are recruiting females with a personal or family history of breast cancer. We partnered with the Spencer Cancer Center of East Alabama Health to aid in recruitment. DISCUSSION/SIGNIFICANCE: Integrative approaches to improved patient outcomes are needed, however, recruitment remains a paramount barrier for clinical trials. Addressing our issues for recruitment has opened eligibility to more individuals and allows us to continue our investigations, answer our research questions, and advance translational science.

Impact of a randomized weight loss trial on breast tissue markers in breast cancer survivors

Few trials have examined the effect of lifestyle behavioral interventions on tissue markers in patients with cancer. The purpose of this study was to examine the feasibility and impact of a 6-month weight loss intervention on breast tissue and serum biomarkers in women with breast cancer. Fifty-one women who completed breast cancer treatment and had a BMI ≥ 25.0 kg/m2 were randomized to a weight loss intervention or usual care. Breast tissue biopsies, fasting blood draw and body composition were collected at baseline and 6 months, with between-group changes examined using analysis of covariance method. Baseline and post-intervention biopsies were conducted in 49 and 42 women, respectively, with pre- and post-epithelial tissue available from 25 tissue samples. Average 6-month weight loss was 6.7% for the weight loss group and 2.0% increase for the usual care group (p < 0.0001). At baseline, body fat and serum insulin levels were inversely associated with breast tissue insulin receptor levels and CD68 (p < 0.05). At 6 months, favorable changes were observed in serum leptin and adiponectin levels and tissue CD163 among women randomized to weight loss vs. adverse change in women randomized to usual care (p < 0.05). Breast tissue biopsies are feasible to collect in a clinical research setting among breast cancer survivors, with weight loss favorably impacting metabolic and inflammatory markers associated with breast cancer.

Noninvasive Measurements of Breast Cancer-Related Lymphedema.

Breast cancer-related lymphedema (BCRL) presents as swelling in the arm, hand, trunk, or breast at varying times after completion of breast cancer treatment. Its reported incidence varies widely in part due to its dependence on the type and extent of the treatment, co-present pre-treatment risk factors, and the criteria used to define its presence. Central to this issue is the quantitative measures that are variously used to specify lymphedema thresholds for its detection and tracking over time and during treatment. The goal of this paper is to discuss these issues and the methods available for the non-invasive quantitative assessment of BCRL. Operational principles and advantages and limitations of the various methods and their clinical history of use and effectiveness are discussed.

Time to Completion of Breast Cancer Treatment and Survival.

Breast cancer treatment delays are common. This study was designed to examine the association between the time interval from time of diagnosis to completion of all acute breast cancer treatment modalities (surgery, chemotherapy, and radiation therapy) and survival. A retrospective analysis was performed utilizing data from the National Cancer Database (NCDB) to determine an association between the duration of time from diagnosis to completing all acute breast cancer treatment (surgery, chemotherapy, and radiation therapy) and survival. Secondary survival analysis evaluated whether delay in treatment completion varied by differences in tumor receptor status. We analyzed 2010 NCDB data of stage I-III breast cancer patients. A subset of 28,284 patients received all three modalities (surgery, chemotherapy, and radiation) as their acute treatment. Median follow-up was 5.8 years. Cox proportional hazards model identified a cut-off showing the risk of delaying completion of all treatment beyond 38 weeks was associated with a decrease in overall survival (hazard ratio [HR] 1.21). This decrease in survival was significant regardless of the major tumor receptor status: triple-negative (HR 1.188, 95% confidence interval [CI] 1.06-1.34), estrogen receptor (ER)+/progesterone receptor (PR)+/human epidermal growth factor receptor 2 (HER2)- (HR 1.22, 95% CI 1.09-1.36), ER-/PR-/HER2+ (HR 1.29, 95% CI 1.004-1.67), and ER+/PR+/HER2+ (HR 1.32, 95% CI 1.01-1.72). Efforts to improve the efficiency of multimodality breast cancer treatment and reduce treatment delays should be a priority to optimize breast cancer patient outcomes.

Staging computerized tomography before delayed breast reconstruction could alter the management plan

Delayed breast reconstruction (DBR) comprises a significant proportion of breast reconstruction practice post completion of breast cancer treatment. The tumour's biology, staging, time constraints, ongoing treatment, and patient and surgeon's preference influence the decision to pursue DBR. There are no guidelines for assessing the oncological status before DBR in otherwise asymptomatic patients, particularly in those with a higher risk of recurrence. The purpose of this study was to identify the cohort of patients who could potentially benefit from staging CT scan before DBR regardless of the reconstructive modality and its impact on the overall management. A retrospective review on 207 consecutive patients, who underwent staging CT scan before DBR in the period between 2009 and 2019 was performed. The CT scan findings were correlated with the breast prognostication scoring model (Nottingham Prognostic Index [NPI]) as an indicator factor for staging reasons. Incidental findings were reported in 34% (71/207) of the reviewed CT scans (incidentaloma group). There was no statistical significance in the NPI scores between non incidentaloma and incidentaloma groups. However, 5.7% (12/207) had their DBR procedure cancelled or the surgical plan altered. The patients with moderate to poor prognosis (NPI score 3.4 and above) could benefit from CT staging scan before DBR. This scan could detect adverse prognostic features precluding major surgery, which saves patients from unnecessary surgical risks and discomfort, and direct them towards the relevant management pathway.

The development and initial validation of the Breast Cancer Recurrence instrument (BreastCaRe)—a patient-reported outcome measure for detecting symptoms of recurrence after breast cancer

Patient-reported outomes (PRO) may facilitate prompt treatment. We describe the development and psychometric properties of the first instrument to monitor for symptoms of breast cancer (BC) recurrence. This study is nested in the MyHealth randomized trial of nurse-led follow-up based on electronically-collected PROs. We constructed items assessing symptoms of potential recurrence through expert interviews with six BC specialists in Denmark. Semi-structured cognitive interviews were carried out with a patient panel to assess acceptability and comprehensibility. Items were subsequently tested in a population of 1170 women 1-10years after completing BC treatment. We carried out multiple-groups confirmatory factor analysis (CFA) and Rasch analysis to test dimensionality, local dependence (LD) and differential item functioning (DIF) according to sociodemographic and treatment-related factors. Clinical data was obtained from the Danish Breast Cancer Group registry. Twenty-two items were generated for the Breast Cancer Recurrence instrument (BreastCaRe). Cognitive testing resulted in clearer items. Seven subscales based on general, bone, liver, lung, brain, locoregional and contralateral recurrence symptoms were proposed. Both CFA and Rasch models confirmed the factor structure. No DIF was identified. Five item pairs showed LD but all items were retained to avoid loss of clinical information. Rasch models taking LD into account were used to generate a standardized scoring table for each subscale. The BreastCaRe has good content and structural validity, patient acceptability and measurement invariance. We are preparing to examine the predictive validity of this new instrument.

Abstract PS11-34: Time to completion of breast cancer treatment and survival

Abstract Background:Modern breast cancer (BC) treatment involves the use of multimodality therapy. Treatment delays are common and can be multifactorial. There are few studies examining the association between the duration of the time from diagnosis to completion of all acute BC treatment modalities and survival. This study is designed to determine if there is an association between time to complete treatment and survival. Study Design:A retrospective analysis was performed using data from The National Cancer Database (NCDB) to determine whether an association exists between the duration of time from diagnosis to completing all acute BC treatment (surgery, chemotherapy and radiation therapy) and survival. A second analysis was performed to determine if the association between treatment duration and survival varies by receptor status. Results:The NCDB data from BC patients diagnosed in 2010 was analyzed. The inclusion criteria included less than 80 years of age with a single cancer diagnosis, Stage I through III invasive breast cancer who required treatment with surgery, chemotherapy and radiation therapy. A total of 28,284 patients were included in the analysis. Median follow-up was 5.8 years. The order of treatment included 20,772 patients had treatment in the order of surgery, chemotherapy and radiation therapy and 7,512 patients had treatment order chemotherapy, surgery and radiation therapy. A Cox proportional hazards model was developed and identified a cut off showing the risk of delaying completion of all treatment beyond 38 weeks was associated with decrease in overall survival. This was statistically significant with an adjusted hazard Ratio of 1.21. This cut off of 38 weeks was found to be significant regardless of receptors type. The statistically significant Hazard ratios for receptor subtypes include: Triple negative (HR: 1.188, 95%CI: 1.06-1.34), ER+PR+Her2- (HR: 1.22, 95%CI: 1.09-1.36), ER-PR-Her2+ (HR: 1.29, 95%CI: 1.004-1.67) and ER+PR+Her2+ (HR: 1.32, 95%CI: 1.01-1.72). The patients with treatment duration greater than 38 weeks were comprised of 4768(63.47%) neo-adjuvant chemotherapy patients and 8191 (39.43%) of the surgery first group. Conclusion: Efforts to improve the efficiency of multimodality BC treatment and reduce treatment delays should be a priority to optimize BC patient outcomes. Citation Format: Debra Ann Pratt, Talia Burneikis, Chao Tu, Stephen R. Grobmyer. Time to completion of breast cancer treatment and survival [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS11-34.

Gonadotrophin stimulation and risk of relapse in breast cancer.

STUDY QUESTIONIs gonadotrophin stimulation as part of IVF associated with an increased risk of relapse in breast cancer?SUMMARY ANSWERControlled ovarian stimulation (COS) in connection with IVF in women with previous breast cancer was not associated with an increased risk of breast cancer relapse.WHAT IS KNOWN ALREADYBreast cancer is the most common malignancy among women worldwide and the leading cause of cancer death among females. The use of COS with gonadotrophins with subsequent cryopreservation of oocytes or embryos in order to enhance the chances of pregnancy after cancer treatment is the current most established fertility preservation method for women with breast cancer. To date, there are only a few small retrospective hospital-based controlled studies evaluating the risk of breast cancer relapse in patients undergoing fertility preservation with or without COS, showing no evident risk of relapse in breast cancer after the use of gonadotoxic agents.STUDY DESIGN, SIZE, DURATIONThis was a retrospective, population-based cohort study comprising 5857 women with previous breast cancer of whom 337 were exposed to COS. Exposure (COS) and outcomes (relapse and death) were identified for all patients from 2005 to 2014 by assessing the National Quality Register for Assisted Reproduction, the Swedish Medical Birth Register, the National Patient Register, the Swedish Prescribed Drug Register, the Swedish Cause of Death Register, the National Breast Cancer Register and the Swedish Cancer Register. Matching according to set criteria was possible for 334 women, who constituted the control group. A total of 274 women had undergone IVF after completing breast cancer treatment and 63 women had undergone COS for fertility preservation at the time of breast cancer diagnosis.PARTICIPANTS/MATERIALS, SETTING, METHODSWomen aged 20–44 years previously diagnosed with breast cancer and exposed to COS were matched for age at breast cancer diagnosis ±5 years, tumour size and lymph node involvement with a non-exposed control group, including women with known T- and N-stages. In a subsequent analysis, the matched cohort was assessed by also including women with unknown T- and N-stages. A secondary analysis comprised the entire non-matched cohort, including all women with known T- and N-stages. Also here, a subsequent analysis included women with missing data for T- and N-stages. The risk of relapse in breast cancer was estimated as crude hazard ratios (HRs) and 95% CI using Cox proportional hazards models in the primary and secondary analyses where T- and N-stages were known: otherwise the risks of relapse were only given descriptively.MAIN RESULTS AND THE ROLE OF CHANCEIn the primary matched analysis, relapse occurred in 20 of 126 women exposed to COS (15.9%) compared with 39 of 126 (31.0%) in the control cohort (HR = 0.70; 95% CI 0.39–1.45; P = 0.22). In the subsequent analysis, also including women with unknown T- and N-stages, relapse occurred in 27 of 337 (8.0%) women having undergone COS compared with 71/334 (21.3%) among the non-exposed. In the secondary adjusted analysis, relapse occurred in 20 of 126 (15.9%) exposed women and in 918 of 3729 (24.6%) non-exposed women (HR = 0.81; 95% CI 0.49–1.33; P = 0.70). In the subsequent analysis, including unknown T- and N-stages, relapse occurred in 27 of 337 (8.0%) women in the exposed group and 1176 of 5520 (21.3%) in the non-exposed cohort.LIMITATIONS, REASONS FOR CAUTIONA substantial degree of missing data on important prognostic variables was a limitation, particularly when analysing the total cohort. Furthermore, data on confounding factors, such as BMI, were not completely covered. Another limitation was that a pre-specified variable for relapse was not in use for the majority of the National Breast Cancer Register. Furthermore, the follow-up time from available register data (2005–2014) is rather short. Finally, we cannot be sure whether the prognostic information from receptor status, showing a lower incidence in the exposed group, is representative. Information on T- and N-stages was missing in more than half of the patients.WIDER IMPLICATIONS OF THE FINDINGSIn this large, retrospective, matched cohort study, we found no increased risk of relapse in breast cancer among women who had been exposed to gonadotrophins as part of IVF. This is reassuring but might be confounded by the selection of a group of women with a more favourable prognosis than those not undergoing IVF. The present study strengthens previous findings by being large, national and register based. Its results are applicable to women undergoing fertility preservation as well as to those undergoing regular IVF treatment.STUDY FUNDING/COMPETING INTEREST(S)Supported in part by grants from the Swedish state under the agreement between the Swedish government and the county councils the ALF-agreement (ALFGBG-720291), The Assar Gabrielsson Fund (FB 15-20), The Breast Cancer Fund and the Swedish Association of Local authorities and Regions, SKR. There are no conflicts of interest to declare.TRIAL REGISTRATIONN/A

Assessing the effect of hyperbaric oxygen therapy in breast cancer patients with late radiation toxicity (HONEY trial): a trial protocol using a trial within a cohort design

BackgroundBreast cancer treatment with radiotherapy can induce late radiation toxicity, characterized by pain, fibrosis, edema, impaired arm mobility, and poor cosmetic outcome. Hyperbaric oxygen therapy (HBOT) has been proposed as treatment for late radiation toxicity; however, high-level evidence of effectiveness is lacking. As HBOT is standard treatment and reimbursed by insurers, performing classic randomized controlled trials is difficult. The “Hyperbaric OxygeN therapy on brEast cancer patients with late radiation toxicity” (HONEY) trial aims to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the trial within cohorts (TwiCs) design.MethodsThe HONEY trial will be conducted within the Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaluation (UMBRELLA). Within UMBRELLA, breast cancer patients referred for radiotherapy to the University Medical Centre Utrecht are eligible for inclusion. Patients consent to collection of clinical data and patient-reported outcomes and provide broad consent for randomization into future intervention studies. Patients who meet the HONEY in- and exclusion criteria (participation ≥ 12 months in UMBRELLA, moderate/severe breast or chest wall pain, completed primary breast cancer treatment except hormonal treatment, no prior treatment with HBOT, no contraindications for HBOT, no clinical signs of metastatic or recurrent disease) will be randomized to HBOT or control group on a 2:1 ratio (n = 120). Patients in the control group will not be informed about participation in the trial. Patients in the intervention arm will undergo 30–40 HBOT treatment sessions in a high pressure chamber (2.4 atmospheres absolute) where they inhale 100% oxygen through a mask. Cohort outcome measures (i.e., physical outcomes, quality of life, fatigue, and cosmetic satisfaction) of the HBOT group will be compared to the control group at 3 months follow-up.DiscussionThis pragmatic trial within the UMBELLA cohort was designed to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the TwiCs design. Use of the TwiCs design is expected to address issues encountered in classic randomized controlled trials, such as contamination (i.e., HBOT in the control group) and disappointment bias, and generate information about acceptability of HBOT.Trial registrationClinicalTrials.gov. NCT04193722. Registered on 10 December 2019.

Skull Base Metastasis of Breast Cancer With Oculomotor and Trochlear Nerve Palsy

Skull base metastatic tumors are rare. Breast cancer in particular can cause bone metastases after a long period of time. A 70-year-old woman presented with multiple cranial nerve palsy. Magnetic resonance imaging revealed a lesion that extended from the orbit to the base of the skull, and the patient was referred to our department. Ophthalmological evaluation showed left visual acuity impairment, left oculomotor nerve palsy, and left trochlear nerve palsy. Endoscopic biopsy performed 5 years after the completion of breast cancer treatment revealed skull base metastases. In unilateral multiple cranial nerve palsy, the possibility of skull base metastases should be considered.

Effectiveness of a Global Multidisciplinary Supportive and Educational Intervention in Thermal Resort on Anthropometric and Biological Parameters, and the Disease-Free Survival after Breast Cancer Treatment Completion (PACThe).

A growing knowledge highlights the strong benefit of regular physical activity in the management of breast cancer patients, but few studies have considered biological parameters in their outcomes. In the prospective randomised trial after breast cancer treatment completion “PACThe,” we determined the effects of physical activity and nutritional intervention on the biological and anthropometric status of patients after one year of follow-up, and clarified the link between biomarkers at allocation and disease-free survival. 113 patients from the population of the “PACThe” study (n = 251) were analysed for biological parameters. Patients were randomized after chemotherapy in two arms: the intervention “SPA” receiving a 2-week session of physical training, dietary education, and physiotherapy (n = 57), and the control “CTR” (n = 56). Diet questionnaire, anthropometric measures, and blood parameters were determined at allocation and one year later. Survival and recurrence were checked over 7 years. Data were considered as a function of BMI, i.e., ≤25 for normal, 25–30 for overweight, and >30 for obese patients. At allocation, the large standard deviation for nutrient-intake values reflected an unbalanced diet for some patients in the three groups. At one-year follow-up, we noticed an increase in glucose (p < 10−6), insulin (p < 10−7), and adiponectin (p < 0.022) plasma levels for both intervention arms, which were more accentuated for the >30 groups. Using the Cox model, we demonstrated that the highest testosterone plasma values were linked to an increase of the recurrence risk (HR [CI–95%] = 5.06 [1.66–15.41]; p=0.004). One-year after a global multidisciplinary supportive and educational intervention, we found few anthropometric and biological changes, mainly related to the patient's initial BMI. We highlighted the importance of plasma testosterone in the evaluation of patient's recurrence risk. Future studies would help better understand the mechanisms by which such multidisciplinary interventions could interact with breast cancer recurrence and define the most effective modalities.

No increased risk of relapse of breast cancer for women who give birth after assisted conception.

STUDY QUESTIONIs childbirth after IVF associated with a risk of relapse in breast cancer?SUMMARY ANSWERWomen who had been diagnosed with breast cancer and completed treatment had no increased risk of relapse if they gave birth after conceiving with IVF.WHAT IS KNOWN ALREADYPregnancy and childbirth have not been shown to increase the risk of relapse in breast cancer. Ovarian stimulation during IVF increases the oestrogen levels and could theoretically increase the risk of relapse in breast cancer.STUDY DESIGN, SIZE, DURATIONThis is a retrospective register study, using national Swedish register data from the National Patient Register, the Medical Birth Register, the Swedish National Cancer Register, the National Breast Cancer Register, the National Quality Registry of Assisted Reproduction (Q-IVF), the National IVF Dataset, the Swedish Prescribed Drug Register and the Cause of Death Register. All women diagnosed with breast cancer who were between 20 and 44 years of age during the years 1982 to 2014 and identified in the cancer registries were assessed.PARTICIPANTS/MATERIALS, SETTING, METHODSWomen, previously diagnosed with breast cancer, who had given birth after IVF (29 after completed breast cancer treatment and 8 after fertility preservation) were compared with a matched control group who had given birth after spontaneous conception. Matching was done in a ratio 1:4, based on T-stage (size of the tumour) and year of diagnosis +/−5 years.MAIN RESULTS AND THE ROLE OF CHANCEWe found 26 114 women that had been diagnosed with breast cancer when 20–44 years old and of those 860 had subsequently given birth, 823 after spontaneous and 37 after IVF conception. Follow-up time was similar between the groups, ranging from 2.6 to 24.0 years, with a mean follow-up time of 10.3 (SD 4.2) years in the IVF group and 10.7 (SD 4.4) years in the control group. There were no relapses (0/37) in the IVF group. The relapse rate for the matched controls was 36/148 (24.8%). Ten women who suffered relapse died due to breast cancer.LIMITATIONS, REASONS FOR CAUTIONThis is reassuring data; however, the result is based on a few cases. The poor coverage of important prognostic variables in the register resulted in uncertain comparability of the groups. The main limitation in this study is the extent of missing data on tumour-related variables, due to poor coverage from the early years of the National Breast Cancer Register. It is possible that the women accepted for IVF had a less aggressive breast cancer and were generally healthier than women delivering after conceiving spontaneously and therefore had a lower risk of relapse. Other limitations are the lack of information on the anticancer therapies used and type of disease relapse, plus the older of the two IVF registers did not hold information on unsuccessful IVF cycles, leaving only cycles leading to birth, to be analysed.WIDER IMPLICATIONS OF THE FINDINGSWe found no indication that women who had been diagnosed with breast cancer had an increased risk of relapse if they gave birth after conceiving with IVF. Based on our findings, there is no evidence to advise against IVF treatment in this group of women. More detailed registry data would be valuable for future studies, enabling proper matching of tumour characteristics between groups.STUDY FUNDING/COMPETING INTEREST(S)The study was financed by grants from the Swedish state under the agreement between the Swedish government and the county councils, the ALF-agreement (ALFGBG-720291), The Assar Gabrielsson Fund (FB 15-20), The Breast Cancer Fund and the Swedish Association of Local Authorities and Regions, SKL. There are no conflicts of interest to declare.

Planned and unplanned pregnancies in breast cancer survivors

BackgroundNearly 20% of women presenting with breast cancer in the UK are of reproductive age. The aim of our study was to assess fertility outcome in relation to intent to conceive in patients who had completed breast cancer treatment. MethodsBetween July 2011 and December 2013, women, aged less than 43 years at the time of diagnosis, were asked during their follow-up in breast cancer clinic, to complete a questionnaire on intentions to conceive and pregnancy outcome. ResultsA total of 175 women completed the questionnaire at a median time of 6 years from time of diagnosis. Their median age at the time of diagnosis was 37 years and at the time of the survey was 43 years. At the time of the survey, 42% (72/175) had completed their family, 41% (72/175) reported that they would like to have children and 4% (7/175) did not wish to have children. Twenty-seven respondents had actively tried to conceive, and of those 13 (48%) had a live birth. There were 12 unintended pregnancies; the majority of which were terminated (58% (7/12)) with only 3 live births. Among those who did not wish to conceive, only 32% (36/111) reported using contraception. ConclusionThis is a retrospective study investigating menstrual function, contraceptive methods and fertility outcomes of young breast cancer survivors. This study highlights the need for healthcare professionals to provide long-term contraceptive advice to women who do not wish to conceive.