Early-stage breast cancer (BC) patients: Factors associated with aromatase inhibitor-induced musculoskeletal symptoms.

525 Background: Hormone receptor positive (HR+) breast cancer comprises the largest subgroup of breast cancer. Aromatase Inhibitors (AI) are a key treatment for HR+ BC patients (pts) and reduce mortality. Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS), defined as myalgias, arthralgias, or joint stiffness, occur in up to 50% of pts leading to low adherence to and often discontinuation of therapy. Little is known of the mechanism of AIMSS or its predisposing risk factors. This study aims to identify risk factors associated with AIMSS development in BC patients on AI therapy. Methods: We conducted a medical record review of pts with non-metastatic HR+ BC on adjuvant AI therapy between January 2009 and June 2017 at the University of Maryland Comprehensive Cancer Center. This study included 194 ptswho were free of arthralgia prior to AI therapy. We analyzed pts’ demographics, lifestyle factors, reproductive history, tumor characteristics, medications, cancer treatment, co-morbidities, AI type, onset and severity of AIMSS. Severe AIMSS was defined as requiring change in AI therapy or discontinuation. Multivariable-adjusted logistic regression was used to identify risk factors for severe AIMSS. Results: The mean age of participants was 61. The mean BMI at diagnosis was 30 kg/m2. 41% of pts were White, 40% were Black, 7% other and 12% unknown. Most (79%) did not have a history of tamoxifen and 16% were on GnRH agonists. Most (71%) used letrozole as initial AI therapy; 18% anastrozole; and 11% exemestane. 56% experienced AIMSS while on AI therapy and 20% required change or hold of AI therapy. 4% permanently discontinued AI due to AIMSS severity. BMI at diagnosis was significantly positively associated with risk of AIMSS. Multivariate odds ratio (95% confidence intervals) comparing the highest to lowest tertile of body mass index (BMI) at diagnosis was 4.01 (1.07-10.90; Ptrend: 0.05). There were no significant associations with race, smoking, reproductive factors, type of AI therapy, tamoxifen use prior to AI therapy, medication use, experience of other cancer treatments, and tumor characteristics. Conclusions: 56% of BC pts on adjuvant AI therapy experienced AIMSS. 24% of these changed, held or discontinued AI regimen due to severe AIMSS. Higher BMI at diagnosis was associated with a higher risk of AIMSS. Our results confirm clinical significance of AIMSS among BC pts on AI therapy and suggest BMI as a modifiable factor for AIMSS. A larger study is warranted to replicate our findings and seek other possible risk factors for AIMSS.

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Abstract P5-12-13: Factors associated with aromatase inhibitor associated musculoskeletal symptoms in early stage breast cancer patients

10.1158/1538-7445.sabcs19-p5-12-13 ◽

2020 ◽

Author(s):

Yamin Sun ◽

Simran Elder ◽

Seungyoun Jung ◽

Candace Mainor ◽

Shruti Murali ◽

...

Keyword(s):

Breast Cancer ◽

Aromatase Inhibitor ◽

Cancer Patients ◽

Early Stage ◽

Early Stage Breast Cancer ◽

Musculoskeletal Symptoms ◽

Breast Cancer Patients ◽

Factors Associated

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321 Phase I clinical trial assessing the combination of systemic chemokine modulatory regimen targeting TLR3 with neoadjuvant chemotherapy in triple negative breast cancer

Journal for ImmunoTherapy of Cancer ◽

10.1136/jitc-2020-sitc2020.0321 ◽

2020 ◽

Vol 8 (Suppl 3) ◽

pp. A347-A347

Author(s):

Shipra Gandhi ◽

Mateusz Opyrchal ◽

Cayla Ford ◽

Victoria Fitzpatrick ◽

Melissa Grimm ◽

...

Keyword(s):

Breast Cancer ◽

Neoadjuvant Chemotherapy ◽

Phase I ◽

Triple Negative Breast Cancer ◽

Triple Negative ◽

Early Stage ◽

Standard Dose ◽

Surrogate Marker ◽

Comprehensive Cancer Center ◽

Cancer Center

BackgroundNeoadjuvant chemotherapy (NAC) with taxanes is the standard of care in triple negative breast cancer (TNBC). Intratumoral prevalence of CD8+ cytotoxic T-lymphocytes (CTLs) is associated with an improvement in relapse-free survival (RFS) and overall survival (OS), while regulatory T-cells (Treg) and myeloid derived suppressor cells (MDSC) are associated with poor survival. Higher ratio of CTL/Treg is associated with higher probability of obtaining pathological complete response (pCR), a surrogate marker for RFS. Intratumoral production of CCL5, CXCL9, CXCL10 and CXCL11 is critical for local infiltration with CTLs, while CCL22 is responsible for Treg attraction. Previous studies have shown that CXCL9 expression in the pre-treatment breast tissue is associated with a three-fold higher rate of achieving pCR. Our preclinical data show that Chemokine modulating (CKM) regimen, combining rintatolimod (TLR3 agonist), interferon (IFN)-α2b, and celecoxib (COX-2 inhibitor) increases CTL-attracting, and decreases MDSC-, Treg-favoring chemokines, increasing CTL/Treg ratio in tumor microenvironment, with preferential tumor tissue activation than adjacent healthy tissues. We hypothesize that the combination of CKM with paclitaxel will result in infiltration of TNBC with CTLs, and along with doxorubicin/cyclophosphamide (AC), result in higher pCR, translating into improved RFS and OS.MethodsIn this phase I study NCT04081389, eligibility includes age ≥18 years, confirmed resectable TNBC, radiographically measurable disease ≥1 cm, ECOG PS ≤ 2, adequate organ and marrow function. Patients with autoimmune disease, serious mood disorders, invasive carcinoma within 3 years, history of peptic ulcers or hypersensitivity to NSAIDs will be excluded. We plan to treat three patients with early stage TNBC with paclitaxel 80 mg/m2 IV weekly for 12 weeks, rintatolimod 200 mg IV, celecoxib 200 mg oral twice daily, and accelerated titration of IFN-α2b at doses 0, 5, or 10 million units (MU)/m2 [Dose Levels (DL) 1, 2 and 3 respectively] on days 1–3 (no intra-patient dose escalation) in weeks 1–3. Dose-limiting toxicity (DLT) is defined as grade 3 or higher toxicities within the first 3 weeks. Any DLT will mandate recruitment per the 3+3 model. If no DLT, three patients will be enrolled at DL 4 at 20 MU/m2 IFN- α2b. This will be followed by standard dose-dense AC, and then surgery. The primary endpoint is safety and tolerability of combination and to identify the appropriate DL of CKM and paclitaxel for extended efficacy study. The secondary endpoints include investigation of efficacy (pCR and breast MRI response), along with RFS and OS. Intratumoral biomarkers will be analyzed in an exploratory manner.ResultsN/AConclusionsN/ATrial RegistrationNCT04081389Ethics ApprovalThe study was approved by Roswell Park Comprehensive Cancer Center Institution’s Ethics Board, approval number I-73718.

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Clinical findings and outcomes from MRI staging of breast cancers in women.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.1124 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 1124-1124

Author(s):

Akshara Raghavendra ◽

Charite Nicolette Ricker ◽

Lingyun Ji ◽

Terry Church ◽

Sujie Tang ◽

...

Keyword(s):

Breast Cancer ◽

Risk Factors ◽

Underserved Populations ◽

Preoperative Staging ◽

Case Series ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Minority Population ◽

Breast Cancers ◽

Mri Staging

1124 Background: For patients diagnosed with breast cancer, case series have shown that staging MRI can detect occult breast cancers in 1-10% of cases. Prevalence and risk factors in underserved populations remain unclear. Methods: We performed a retrospective analysis of all patients, newly diagnosed, with breast cancer who had a preoperative staging MRI seen at Norris Comprehensive Cancer Center and LAC +USC, that cares for an underserved and minority population, from 2006 to 2011. Demographic, clinicopathologic and imaging data were obtained through a review of electronic records. Non index lesions were defined as those not known to be malignant, not presenting with clinical, mammographic or ultrasound findings, in a different quadrant and given an MRI BIRADS score of 4 or 5. Results: A total of 718 patients were analyzed and 148 patients (21%) had a total of 187 non index lesions; 63% were ipsilateral, 26% contralateral and 11% bilateral. As initial evaluation of non-index ipsilateral lesions, 71 (38%) had biopsy, 24 (13%) had excision and 34 (18%) had mastectomy. For contralateral non-index lesions, 41 (22%) had contralateral biopsy, 6 (3%) had excision and 11(6%) had mastectomy. Among all non index lesions, 111 (59%) were benign, 14 (7%) DCIS and 62 (33%) invasive cancer. Occult ipsilateral cancer was detected in 50 (6.9%) of patients and contralateral in 10 (1.4%) and bilateral in 6 (0.8%). Conclusions: The occult cancer detection rate with staging MRI was in this 9.2% of this diverse population. No clear risk factors were identified, with detailed factors, including BRCA status to be updated and reanalyzed. [Table: see text]

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Use of diagnostic testing for patients with early-stage breast cancer in a multi-hospital quality collaborative in Michigan.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.34_suppl.242 ◽

2012 ◽

Vol 30 (34_suppl) ◽

pp. 242-242

Author(s):

Tara M. Breslin ◽

James Kubus ◽

Haythem Y. Ali ◽

T. Trevor Singh ◽

Paul T. Adams ◽

...

Keyword(s):

Breast Cancer ◽

Diagnostic Imaging ◽

Early Stage ◽

Diagnostic Testing ◽

Early Stage Breast Cancer ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Positron Emission ◽

Bone Scans

242 Background: In 2012, ASCO identified five opportunities to improve the quality of cancer care and reduce costs. Two of these recommendations focused on limiting use of advanced diagnostic imaging with computed tomography (CT), Positron Emission Tomography (PET), and radionuclide bone scans (BS) at diagnosis and during surveillance for women with early stage breast cancer with a low risk of metastasis. We describe the use of diagnostic imaging among patients with early stage breast cancer treated at hospitals in Michigan. Methods: The Michigan Breast Oncology Quality Initiative is a collaboration between Michigan hospitals, the University of Michigan Comprehensive Cancer Center, and the National Comprehensive Cancer Network (NCCN). This collaborative collects longitudinal demographic, staging, treatment, and follow up data using the NCCN Breast Outcomes Database platform. We analyzed use of advanced diagnostic testing with CT, PET, BS and contrast it with use of traditional imaging (mammography/ultrasound) at diagnosis and during follow up in patients with stage 0, I, II breast cancer between 1998 to 2009. Patients who died or recurred were excluded. Results: The cohort included 7,632 patients (19.6% stage 0, 48.1% stage I, 32.3% stage II) treated at 17 hospitals. Use of traditional imaging was documented in nearly 100% of patients at diagnosis and throughout the follow up period. With respect to advanced diagnostic imaging, 20.3 % underwent CT, 4.7% underwent PET, and 11.6% underwent BS at diagnosis. Advanced testing use decreased over time (Table). Conclusions: Despite published guidelines, which recommend against their routine use, advanced diagnostic imaging use was prevalent among patients treated for early breast cancer at MiBOQI hospitals. Education efforts should target physicians and patients on the lack of proven benefit and potential risks of using advanced diagnostic imaging in this population. [Table: see text]

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Breast Cancer: 2021 ASCO Annual Meeting Highlights for the Advanced Practitioner

Journal of the Advanced Practitioner in Oncology ◽

10.6004/jadpro.2021.12.6.3 ◽

2021 ◽

Vol 12 (6) ◽

Author(s):

Sheeba Cantanelli, MPAS, PA-C

Keyword(s):

Breast Cancer ◽

Triple Negative Breast Cancer ◽

Triple Negative ◽

Early Stage ◽

Parp Inhibitor ◽

Metastatic Breast ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Vitamin D Levels ◽

The Impact

Sheeba Cantanelli, MPAS, PA-C, of UT Southwestern Medical Center, Simmons Comprehensive Cancer Center, discusses results from studies evaluating adjuvant therapy with a PARP inhibitor in BRCA-mutated HER2-negative metastatic breast cancer; immunotherapy in the treatment of early-stage triple-negative breast cancer; adjuvant capecitabine after neoadjuvant chemotherapy in triple-negative breast cancer; the addition of palbociclib to fulvestrant in HR-positive, HER2-negative advanced breast cancer; and the impact of vitamin D levels on outcomes. Reporting is provided by The ASCO Post.

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Factors Associated With Breast Cancer Clinical Trials Participation and Enrollment at a Large Academic Medical Center

Journal of Clinical Oncology ◽

10.1200/jco.2004.03.005 ◽

2004 ◽

Vol 22 (11) ◽

pp. 2046-2052 ◽

Cited By ~ 103

Author(s):

Michael S. Simon ◽

Wei Du ◽

Lawrence Flaherty ◽

Philip A. Philip ◽

Patricia Lorusso ◽

...

Keyword(s):

Breast Cancer ◽

Clinical Trials ◽

Medical Center ◽

Performance Status ◽

Academic Medical Center ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Poor Performance Status ◽

Cancer Clinical Trials ◽

Factors Associated

Purpose The practice patterns of medical oncologists at a large National Cancer Institute Comprehensive Cancer Center in Detroit, MI were evaluated to better understand factors associated with accrual to breast cancer clinical trials. Patients and Methods From 1996 to 1997, physicians completed surveys on 319 of 344 newly evaluated female breast cancer patients. The 19-item survey included clinical data, whether patients were offered clinical trial (CT) participation and enrollment, and when applicable, reasons why they were not. Multivariate analyses using logistic regression were performed to evaluate predictors of an offer and enrollment. Results The patients were 57% white, 32% black, and 11% other/unknown race. One hundred six (33%) were offered participation and 36 (34%) were enrolled. In multivariate analysis, CTs were less likely offered to older women (mean age, 52 years for those offered v 57 years for those not offered; P = .0005) and black women (21% of blacks offered v 42% of whites; P = .0009). Women with stage 1 disease, poor performance status, and those who were previously diagnosed were also less likely to be offered trials. None of these factors were significant predictors of enrollment. Women were not offered trials because of ineligibility (57%), lack of available trials (41%), and noncompliance (2%). Reasons for failed enrollment included patient refusal (88%) and failed eligibility (12%). Conclusion It is important for cooperative groups to design studies that will accommodate a broader spectrum of patients. Further work is needed to assess ways to improve communication about breast cancer CT participation to all eligible women.

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Identifying benchmarks for ASCO's “Choosing Wisely” measures that address low-value imaging in early-stage prostate and breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.31_suppl.194 ◽

2013 ◽

Vol 31 (31_suppl) ◽

pp. 194-194

Author(s):

Steve Power ◽

Rhonda Lynn Bitting ◽

P. Kelly Marcom ◽

Arif Kamal

Keyword(s):

Breast Cancer ◽

Early Stage ◽

Low Risk ◽

Choosing Wisely ◽

Clinical Indication ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Advanced Imaging ◽

Chi Square ◽

Early Stage Disease

194 Background: ASCO has recently selected “Choosing Wisely” measures that identify physician health behaviors of low value in cancer care. Two of these measures address the use of advanced imaging for early stage disease. These measures aim to reduce imaging in patients at low risk for metastatic disease unless there is a clinical indication. To date, no evidence-based benchmarks for meeting these measures have been reported. Methods: We analyzed all patients from January 2010 to June 2012 at the Duke Cancer Institute (DCI), an NCI-designated, comprehensive cancer center. We investigated conformance to two Choosing Wisely measures: avoiding imaging for staging in early stage (ES) prostate cancer (PC) and ES breast cancer (BC). ES was defined by Choosing Wisely as Stage IIb or less for BC and Gleason <7 or PSA <10 ng/mL for PC. Advanced imaging was defined as bone scan, computed tomography (CT) scan, or positron emission tomography (PET) performed at the DCI within 60 days of cancer diagnosis. Descriptive statistics and chi-square were performed. Results: Total 1143 BC and 29 PC were identified. Median age was 58 and 61 years, respectively. 0% (0/29) of PC cases had advanced imaging. Within BC, 20.6% (235/1143) had at least one imaging procedure performed; 16.5% had two or more. Patients with imaging were more likely hormone receptor negative, triple negative, younger (<50), and higher stage (Stage IIb), (all p<0.0001). Of imaging performed in BC, 41% were CT only, 22% were PET or PET/CT, and 36% were bone scans. Ongoing chart abstractions are identifying clinical indications for the ordering of imaging and associated clinical consequences. Conclusions: We have established internal benchmarks for conformance to two Choosing Wisely measures. The lack of advanced imaging for low-risk PC patients demonstrates the feasibility of this measure even in a multi-disciplinary setting. Imaging in <25% low-risk BC patients suggests that these are performed for clinical rather than staging purposes. Further data sharing and comparisons are needed to establish oncology-wide benchmarks.

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Bone mineral density and FRAX as predictors of fracture risk in women with breast cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.26_suppl.121 ◽

2013 ◽

Vol 31 (26_suppl) ◽

pp. 121-121

Author(s):

Beatrice J. Edwards ◽

William John Gradishar ◽

Maureen Smith ◽

Jennifer A. Pacheco ◽

Jaimee S Holbrook ◽

...

Keyword(s):

Breast Cancer ◽

Risk Factors ◽

Cancer Therapy ◽

Fracture Risk ◽

Cancer Survivors ◽

World Health ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Mineral Density ◽

T Score

121 Background: The number of cancer survivors is rising in the USA, the 2007 CDC analysis of the SEER database estimated 11 million cancer survivors, with 90% being over the age of 65 years. Of these, 70% are women, and the most common cancer in survivors is breast cancer. Cancer therapy induced bone loss (CTIBL) contributes to an increase in fracture risk in women with breast cancer. Fractures are responsible for considerable morbidity, disability, hopitalizations and mortality in older adults. Fractures are often the cause for nursing home placement in seniors. Our objective was to analyze the prevalence of fractures after breast cancer therapy and to assess the effect of cancer therapy, clinical risk factors, bone density and the World Health Oragnization (WHO) fracture risk assessment [FRAX] as predictors of fracture occurrence. Methods: The study population consisted of breast cancer patients with invasive breast cancer who participated in a genetic databank within a NCI-Comprehensive Cancer Center. Demographic and clinical characteristics were abstracted from the EMR. Participants were followed for 6-12 years. Results: A total of 439 women with breast cancer were assessed; 79 had sustained fractures during the observation period (116 fractures), fractures occurred at multiple skeletal sites in 27 cases. The prevalence of fractures was 18%. Baseline characteristics revealed that women who sustained fractures were mostly Caucasian (91%, p=0.08), and had a family history of osteoporosis (36.9%, p=0.03). The time to fracture was 4.0 years (range 0-12 years) from diagnosis. Fracture cases had lower BMD at the femoral neck 0.86 ± 0.13 gm/cm2 (T-score= -1.0, p=0.04) than non- fracture cases, although BMD was in the low normal range. Eight cases of hip fractures were identified with a median age of 55 years (32-67 years) Median T-score -0.75. Cox proportional hazard analysis failed to identify any specific risk factors for fractures. Conclusions: Fractures occur shortly after commencing cancer therapy. BMD and FRAX risk calculation were not able to identify women who fractured. Occurrence of fractures in breast cancer raises the possibility of cancer-induced impairment in bone quality.

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