scholarly journals Vertebral Fractures After Denosumab Discontinuation in Breast Cancer Survivors: A Single Institution Experience

2021 ◽  
pp. 155633162199584
Author(s):  
Michele Yeung ◽  
Kaylee Ho ◽  
Monica N. Fornier ◽  
Azeez Farooki

Background: Denosumab is approved to prevent fragility fractures in patients with osteoporosis at high risk for fracture and to prevent bone loss in patients with breast and prostate cancer who receive endocrine therapy. The antiresorptive effect of denosumab rapidly dissipates when it is delayed or discontinued, but the risk for, and incidence of, multiple clinical vertebral fractures in patients with breast cancer after stopping denosumab is currently unclear. Question/Purposes: We sought to identify the incidence of clinical vertebral fractures in patients with breast cancer who received at least 2 doses of denosumab (60 mg) and then discontinued the medication. Methods: We conducted a retrospective chart review to identify patients with a history of breast cancer who were treated with denosumab between June 1, 2010, and July 18, 2018, at Memorial Sloan Kettering Cancer Center. We identified 335 postmenopausal women and 1 man with nonmetastatic breast cancer who received their final denosumab injection at least 6.5 months earlier. Data recorded included baseline bone density and the incidence of vertebral fractures after denosumab discontinuation. Results: The median age of patients was 62 years. Patients received between 2 and 13 denosumab doses before drug discontinuation. Most of the patients (310; 92.3%) were also treated with aromatase inhibitors. Of the 194 patients with baseline bone density data, 50 (25.8%) had normal bone density, 97 (50.0%) had osteopenia, and 47 (24.2%) had osteoporosis. The median follow-up duration from the last denosumab dose was 18.5 months. We identified 1 case of spontaneous vertebral fractures after denosumab stoppage. We found no cases of osteonecrosis of the jaw or atypical femur fracture. Most of the patients (88%) had a gap in denosumab dosing. Conclusions: Clinicians treating patients with breast cancer—especially those continuing to take aromatase inhibitors—should be aware of the possible risks of delaying doses of or discontinuing denosumab and should educate their patients accordingly. Prospective studies are needed to fully evaluate the risks of stopping or delaying denosumab.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS669-TPS669
Author(s):  
Melinda Irwin ◽  
Brenda Cartmel ◽  
Elizabeth Ercolano ◽  
Martha Fiellin ◽  
Marianna Rothbard ◽  
...  

TPS669 Background: A substantial number of breast cancer survivors who are taking aromatase inhibitors (AIs) complain of side effects including arthralgias. Given the efficacy of AIs, it is essential that we identify approaches to mitigate arthralgias. We are conducting an NCI-funded trial is to examine the impact of a year-long exercise intervention in 180 breast cancer survivors taking an AI and experiencing at least mild arthralgias. Outcomes include severity of arthralgias, endocrine-related quality of life, % body fat, bone mass, and serum markers of inflammation. The purpose of this abstract is to present preliminary recruitment and adherence results. Methods: Women are being recruited via the Connecticut Tumor Registry and Rapid Case Ascertainment Shared Resource of Yale Cancer Center into the Hormones and Physical Exercise (HOPE) Study. Participants are randomly assigned to exercise (n = 90) or usual care (n = 90). The exercise intervention includes supervised resistance and unsupervised aerobic exercise sessions over 12 months. Data are collected at baseline, 3-, 6-, 9 and 12-months. Results: Study recruitment began in April 2010 and will continue through December 2012. As of January 1, 2012, we have received 1605 names of potentially eligible women. Of these 1605, 777 women are waiting to be screened (e.g., letter mailed to patient or on hold because recently diagnosed), 244 women could not be screened (e.g., unable to contact by phone), and 584 women have completed a telephone screening. Of the 584 women screened, 24% were ineligible because of discontinuing AIs because of arthralgias or chose not to take AIs primarily because of this potential side effect; another 36% were ineligible for various reasons; 24% were not interested; 11% were randomized (n = 65 women); and 5% are undergoing baseline visits (n = 29). On average, women are 62 yrs old and have been taking an AI for 1.8 yrs. Twenty-three women have completed the trial, with high exercise adherence rates (attendance to supervised sessions = 82% ). Conclusions: A growing number of women are choosing to not take AIs or are discontinuing AIs because of side effects. Our study may prove beneficial for the growing number of women diagnosed with hormone receptor-positive breast cancer each year.


2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 240-240
Author(s):  
Anu Radha Neerukonda ◽  
Catherine Messina ◽  
Lisa Reagan ◽  
Michelle M. Stevens ◽  
Barbara Nemesure

240 Background: Although elevated levels of distress have been well documented among cancer patients receiving active treatment, the magnitude of and contributors to distress in cancer survivors are yet to be well established. The purpose of this investigation was to evaluate the presence of distress among breast cancer survivors (BCS) and to investigate demographic, psychosocial, tumor and treatment related variables that may be associated with distress in this population. Methods: A retrospective chart review was done that includes 81 female BCS, 21 years or older, who received care at the Stony Brook Cancer Center Survivorship Clinic and completed the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) form between October 2012 and June 2014. Descriptive statistics were used to describe the demographic, psychosocial, tumor and treatment characteristics for the study sample and logistic regression models were used to evaluate the relationship between elevated distress and the factors outlined above. The regression results are presented as odds ratios (ORs) and 95% confidence intervals (CIs). Data were analyzed using SPSS version 21. Results: Approximately one-half of BCS (50.6%) reported a clinically significant distress level (4 or higher). Those who were on an anxiolytic or anti-depressant medication tended to have higher levels of distress (OR: 3.10; 95% CI: 0.90-10.74; P = 0.07) and age greater than 60 years at the time of diagnosis was negatively correlated with distress (OR: 0.24; 95% CI: 0.07-0.84; P = 0.03). BCS with clinically significant distress (4 or greater) reported more problems in the emotional domain components of the DT, whereas patients with low distress (less than 4) reported more problems on the physical domains. Conclusions: Findings from this study indicate that more than half of BCS experienced distress during the survivorship phase, which frequently manifested as emotional and physical problems. Although preliminary, these data suggest the need to develop targeted screening strategies for early recognition and interventions to alleviate distress in this population.


2012 ◽  
Vol 21 (2) ◽  
pp. 97-105 ◽  
Author(s):  
Kathleen A Griffith ◽  
Renee Royak-Schaler ◽  
Kim Nesbitt ◽  
Min Zhan ◽  
Adriane Kozlovsky ◽  
...  

Breast cancer survival rates are lower in African Americans (AAs) than in Caucasians, owing in part to a higher prevalence of obesity in the former, which increases the risk of recurrence and mortality. The Women’s Intervention Nutrition Study (WINS) found that Caucasian women who followed a low-fat eating plan experienced a lower rate of cancer recurrence than women who maintained their usual diets. The purpose of this study was to test the feasibility of a WINS plan tailored to the cultural needs of AA breast cancer survivors. This feasibility pilot study was conducted at a university National Cancer Institute-designated comprehensive cancer center outpatient clinic with AA breast cancer survivors. The culturally specific WINS (WINS-c) plan included eight individual counseling sessions, five educational group meetings, and follow-up telephone calls over a 1-year period. Outcome measures included dietary fat, triglyceride, insulin and glucose levels, and fruit and vegetable intake. Participants ( n = 8) had a mean age of 61.1 years (standard error of the mean (SEM) 3.1 years) and a mean BMI of 32 kg/m2 (SEM 4.25 kg/m)2. Baseline daily fat consumption decreased from 64.6 g (range 36.8–119.6g) to 44.0 g (21.6–73.4g) at 52 weeks ( p = 0.07). Mean daily consumption of fruits and vegetables increased by 36% and 15%, respectively. Mean triglyceride levels decreased at 12 months ( p < 0.05). Sustained hyperinsulinemia was noted in most participants, including those without diabetes. Mean calcium and vitamin D consumption decreased over the 1-year study period. In AA breast cancer survivors, the WINS-c program resulted in a trend toward reduced fat consumption and may represent a sustainable approach in this population for improvement of diet quality after breast cancer.


2018 ◽  
Vol 25 (1) ◽  
pp. 107327481879795 ◽  
Author(s):  
Nancy Rihana ◽  
Sowmya Nanjappa ◽  
Cara Sullivan ◽  
Ana Paula Velez ◽  
Narach Tienchai ◽  
...  

The introduction of antiretroviral therapy (ART) in 1995 had a dramatic impact on the morbidity and mortality of the HIV population, and subsequently, the natural history of cancer has changed. The purpose of our study was to review the prevalence of AIDS-defining malignancies and non-AIDS defining cancers (NADC), taking into consideration racial and gender variations. After the institutional review board approval, the study was conducted as a retrospective chart review of 279 HIV-infected patients who were treated at the Moffitt Cancer Center between January 1, 2000 and December 31, 2010. The demographic characteristics included gender, ethnicity, race, presence or absence of ART, and the type of malignancy reviewed. Of 233 men, 78 (33.5%) had AIDS-defining malignancies. AIDS-related non-Hodgkin lymphoma (NHL) was detected in 49 (21%) patients and Kaposi sarcoma (KS) in 29 (12%) patients. Two-thirds of male patients had NADC, with anal cancer being the most prevalent (8.5%), followed by Hodgkin lymphoma (6%). AIDS-related NHL was also the predominant malignancy for women with a prevalence of 19.5% followed by invasive cervical cancer (ICC) and breast cancer, both with a similar prevalence of 11%. Kaposi sarcoma and anal cancer were equally detected in 2% of women. The prevalence rates of AIDS-defining malignancies among those of white race were 34%, ranging from 21% for NHL to 13% for KS and 1.5% for ICC. Twenty-one (7.7%) patients had anal cancer. AIDS-defining malignancies were found in 36% of patients of black race and 60% had NHL. Non-AIDS-related NHL was the second most common malignancy, followed by breast cancer and anal cancer with a similar prevalence of 6.5%. Of 279 patients, 53% were taking ART; 39.4% were not taking ART; and in 7.5% of the patients, it was unknown if they were taking ART. In the ART era, our study found NADC to be more prevalent than AIDS-defining malignancies with 60% versus 40%, respectively. Non-Hodgkin lymphoma remained the most common AIDS-related malignancy in both genders. Among the patients with NADC, anal cancer was the predominant malignancy. The increasing incidence of some of the NADC is expected as this population is living longer with chronic exposure of viral replication of virus with oncogenic potential such as Human papillomavirus (HPV), Hepatitis B virus (HBV), Epstein-Barr virus (EBV), and Human herpesvirus 8 (HHV-8). Early ART initiation, aggressive vaccination, and judicious cancer screening are the cornerstone of cancer prevention of this growing population.


2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 90-90 ◽  
Author(s):  
Kathy Trotter ◽  
Susan M. Schneider

90 Background: Group medical appointments have been shown to improve access, health outcomes and health care utilization rates, as well as self-management skills. A new model of breast cancer survivor care was designed and piloted at Duke Cancer Center. Survivors attended the clinic together in groups of six. An interdisciplinary group visit format in the initial part of the appointment provided surveillance, education and support, as well as formation of an individualized survivorship care plan. The first hour included review of their personal care plan and a 45-minute facilitated discussion. Afterwards, individual visits with the nurse practitioner, and dietitian, physical therapist, or social worker occurred. Methods: A 22-item Likert-type questionnaire sought opinions regarding logistics and the style and function of care delivered. 122 surveys were collected. Descriptive statistics (via SPSS v19) using ANOVA type regression were accomplished. Secondly, a retrospective two-group study of clinic financial data for follow-up patients was done. Revenues from the group medical visit by the NP were compared to those seen traditionally by the MD (N=300). Review of time to third available appointment for each clinician was also recorded. Results: 122 surveys were collected with a 86% response rate. Mean scores for all questions rated at least 4.4 of 5, with the highest score given for the confidence felt in the nurse practitioner (4.93) and the lowest for the acceptability of the wait time in the breast imaging area (4.4). Overall, 98% felt the program provided quality care and 97% were likely to recommend the clinic to other breast cancer survivors. What participants liked most about the program was sharing with other survivors. Cost benefit analysis revealed that revenues and direct costs were nearly equal between delivery models. Time to third available appointment for the primary referring oncologist, dropped from 29.4 to 26.7 days, while the NPs time remained stable at 8.7 days. Conclusions: The group visit model applied to survivor care appears feasible and highly satisfactory to participants.


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