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1.
Front Endocrinol (Lausanne) ; 13: 829879, 2022.
Article in English | MEDLINE | ID: covidwho-1785327

ABSTRACT

Owing to the ongoing coronavirus disease 2019 (COVID-19) pandemic, we need to pay a particular focus on the impact of coronavirus infection on breast cancer patients. Approximately 70% of breast cancer patients express estrogen receptor (ER), and intervention therapy for ER has been the primary treatment strategy to prevent the development and metastasis of breast cancer. Recent studies have suggested that selective estrogen receptor modulators (SERMs) are a potential therapeutic strategy for COVID-19. With its anti-ER and anti-viral combined functions, SERMs may be an effective treatment for COVID-19 in patients with breast cancer. In this review, we explore the latent effect of SERMs, especially tamoxifen, and the mechanism between ER and virus susceptibility.


Subject(s)
Breast Neoplasms , COVID-19 , Breast Neoplasms/drug therapy , COVID-19/drug therapy , Estrogen Receptor Modulators/therapeutic use , Estrogens/therapeutic use , Female , Humans , Receptors, Estrogen , Selective Estrogen Receptor Modulators/therapeutic use
2.
Clin Cancer Res ; 27(16): 4486-4490, 2021 08 15.
Article in English | MEDLINE | ID: covidwho-1691214

ABSTRACT

While COVID-19 vaccine distribution has addressed vulnerabilities related to age and comorbidities, there is a need to ensure vaccination of patients with cancer receiving experimental and routine treatment, where interruption of treatment by infection is likely to result in inferior outcomes. Among patients with cancer, those undergoing neoadjuvant chemotherapy (NAC) or adjuvant chemotherapy (Adj chemo) for early breast cancer (EBC) are at particularly high risk for inferior outcomes, in part, because optimal timing of chemotherapy is essential for promoting distant disease-free survival. COVID-19 data from the ongoing multicenter I-SPY 2 trial of NAC for EBC provides a window into the magnitude of the problem of treatment interruption, not only for the trial itself but also for routine Adj chemo. In the I-SPY 2 trial, 4.5% of patients had disruption of therapy by COVID-19, prior to wide vaccine availability, suggesting that nationally up to 5,700 patients with EBC were at risk for adverse outcomes from COVID-19 infection in 2020. To address this problem, vaccine education and public engagement are essential to overcome hesitancy, while equity of distribution is needed to address access. To accomplish these goals, healthcare organizations (HCO) need to not only call out disinformation but also engage the public with vaccine education and find common ground for vaccine acceptance, while partnering with state/local governments to improve efficiency of vaccine distribution. These approaches are important to improve trial access and to reduce susceptibility to COVID-19, as the pandemic could continue to impact access to clinical trials and routine cancer treatment.


Subject(s)
Breast Neoplasms/drug therapy , COVID-19 Vaccines/immunology , COVID-19/prevention & control , SARS-CoV-2/immunology , Vaccination , Clinical Trials as Topic , Female , Health Education , Healthcare Disparities , Humans , Neoadjuvant Therapy
3.
BMJ Case Rep ; 15(1)2022 Jan 17.
Article in English | MEDLINE | ID: covidwho-1627521

ABSTRACT

Granulocyte colony stimulating factor (G-CSF) is used to prevent febrile neutropenia post chemotherapy. Usually well tolerated with minimal side effects but aortitis is an extremely rare side effect previously reported. A 64-year-old woman treated with adjuvant chemotherapy including G-CSF for left breast cancer was admitted with fevers, neutropenia and markedly raised inflammatory markers after 7 days of her first cycle. Initially diagnosed with neutropenic sepsis, she did not respond to broad spectrum antibiotics with subsequent CT imaging revealing marked periaortic inflammatory changes consistent with aortitis and periaortitis. Extensive investigations for other causes of large vessel vasculitis were negative and G-CSF was the only causative factor. She rapidly responded to steroids with almost complete resolution of inflammatory changes on repeat imaging within 4 weeks and no recurrence on tapering of steroids. This diagnosis must be considered in patients presenting with fever and raised inflammatory markers post G-CSF treatment.


Subject(s)
Aortitis , Breast Neoplasms , Neutropenia , Antineoplastic Combined Chemotherapy Protocols , Aortitis/chemically induced , Aortitis/diagnostic imaging , Aortitis/drug therapy , Breast Neoplasms/drug therapy , Chemotherapy, Adjuvant , Female , Granulocyte Colony-Stimulating Factor/therapeutic use , Humans , Middle Aged , Neutropenia/drug therapy
4.
Breast Dis ; 41(1): 1-3, 2022.
Article in English | MEDLINE | ID: covidwho-1604128

ABSTRACT

During the first hit of SARS-COVID pandemic, an important reorganization of Healthcare Services has been done, and new protocols and pathways to protect frail patients like oncological patients were designed. The second hit of pandemic had stressed these new pathways and suggests to health-workers some improvements for safer management of patents.We reported our experience in organizing the clinical pathway of neoadjuvant therapy candidate patients based on the execution of sentinel lympho-node biopsy and the placement of implantable venous access port in the same access to operating room before neoadjuvant chemotherapy suggesting a possible organizational model. In the period October-December 2020 we have included in this new type of path twelve patients and we have not registered any cases of COVID among the patients included. We think this new path, adopted amid the second hit, will be useful for all Breast Units that are facing the challenge of guaranteeing the highest standards of care in a historical moment where the health emergency occupies the efforts of health workers and the economic resources of health systems.


Subject(s)
Antineoplastic Agents/administration & dosage , Breast Neoplasms/drug therapy , COVID-19/prevention & control , Catheterization, Central Venous/methods , Infection Control/methods , Patient Safety , Sentinel Lymph Node Biopsy/methods , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/therapeutic use , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Catheterization, Central Venous/instrumentation , Catheterization, Central Venous/standards , Central Venous Catheters , Chemotherapy, Adjuvant , Critical Pathways , Female , Humans , Infection Control/standards , Mastectomy , Middle Aged , Neoadjuvant Therapy , Neoplasm Staging , Sentinel Lymph Node Biopsy/standards
5.
Clin Cancer Res ; 27(24): 6815-6823, 2021 12 15.
Article in English | MEDLINE | ID: covidwho-1582872

ABSTRACT

PURPOSE: We assessed the immunogenicity and safety of the BNT162b2 vaccine in a large cohort of patients with cancer (CP). EXPERIMENTAL DESIGN: From March 1, 2021 to March 20, 2021, this prospective cohort study included 816 CP afferent to our institution and eligible for the vaccination. A cohort of 274 health care workers (HCW) was used as age- and sex-matched control group. BNT162b2 was administered as a two-dose regimen given 21 days apart. Blood samples to analyze anti-Spike (S) IgG antibodies (Ab) were collected prevaccination [timepoint (TP) 0], and at 3 weeks (TP1) and 7 weeks (TP2) after the first dose. RESULTS: Patients characteristics: median age 62 (range, 21-97); breast/lung cancer/others (31/21/48%); active treatment/follow-up (90/10%). In the whole CP cohort, the serologic response rate (RR) and the titre of anti-S IgG significantly increased across the TPs; at TP2, the responders (IgG >15 AU/mL) were 94.2%. Active chemotherapy and chronic use of steroids were independent predictors of lower RR. Adverse events (AE) after the booster predicted higher likelihood of response (OR, 4.04; 95% confidence interval, 1.63-9.99; P = 0.003). Comparing the matched cohorts, the responders were significantly lower in CP than in HCW at TP1 (61.2% vs. 93.2%) and TP2 (93.3% vs. 100%), while the geometric mean concentration of IgG did not significantly differ at TP2 being significantly lower in CP (23.3) than in HCW (52.1) at TP1. BNT162b2 was well tolerated in CP; severe-grade AEs were 3.5% and 1.3% after the first and second doses, respectively. CONCLUSIONS: BNT162b2 assures serologic immunization without clinically significant toxicity in CP. The second dose is needed to reach a satisfactory humoral response.


Subject(s)
Antibodies, Viral/blood , Breast Neoplasms/drug therapy , COVID-19/prevention & control , Lung Neoplasms/drug therapy , SARS-CoV-2/immunology , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/therapeutic use , Comorbidity , Female , Humans , Immunization , Immunoglobulin G/blood , Male , Middle Aged , Prospective Studies , Spike Glycoprotein, Coronavirus/immunology , Young Adult
6.
BMJ ; 375: e066588, 2021 12 08.
Article in English | MEDLINE | ID: covidwho-1560914

ABSTRACT

OBJECTIVE: To evaluate the effectiveness of remote proactive management of toxicities during chemotherapy for early stage breast cancer. DESIGN: Pragmatic, cluster randomised trial. SETTING: 20 cancer centres in Ontario, Canada, allocated by covariate constrained randomisation to remote management of toxicities or routine care. PARTICIPANTS: All patients starting adjuvant or neoadjuvant chemotherapy for early stage breast cancer at each centre. 25 patients from each centre completed patient reported outcome questionnaires. INTERVENTIONS: Proactive, standardised, nurse led telephone management of common toxicities at two time points after each chemotherapy cycle. MAIN OUTCOME MEASURES: The primary outcome, cluster level mean number of visits to the emergency department or admissions to hospital per patient during the whole course of chemotherapy treatment, was evaluated with routinely available administrative healthcare data. Secondary patient reported outcomes included toxicity, self-efficacy, and quality of life. RESULTS: Baseline characteristics of participants were similar in the intervention (n=944) and control arms (n=1214); 22% were older than 65 years. Penetration (that is, the percentage of patients who received the intervention at each centre) was 50-86%. Mean number of visits to the emergency department or admissions to hospital per patient was 0.91 (standard deviation 0.28) in the intervention arm and 0.94 (0.40) in the control arm (P=0.94); 47% (1014 of 2158 patients) had at least one visit to the emergency department or a hospital admission during chemotherapy. Among 580 participants who completed the patient reported outcome questionnaires, at least one grade 3 toxicity was reported by 48% (134 of 278 patients) in the intervention arm and by 58% (163 of 283) in the control arm. No differences in self-efficacy, anxiety, or depression were found. Compared with baseline, the functional assessment of cancer therapy trial outcome index decreased by 6.1 and 9.0 points in the intervention and control participants, respectively. CONCLUSIONS: Proactive, telephone based management of toxicities during chemotherapy did not result in fewer visits to the emergency department or hospital admissions. With the rapid rise in remote care because of the covid-19 pandemic, identifying scalable strategies for remote management of patients during cancer treatment is particularly relevant. TRIAL REGISTRATION: ClinicalTrials.gov NCT02485678.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Breast Neoplasms/drug therapy , Monitoring, Ambulatory/methods , Outpatients , Telemedicine , Telephone , Adult , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/psychology , COVID-19 , Chemotherapy, Adjuvant/adverse effects , Drug-Related Side Effects and Adverse Reactions , Emergency Service, Hospital/statistics & numerical data , Female , Humans , Middle Aged , Ontario , Pandemics , Quality of Life , SARS-CoV-2 , Surveys and Questionnaires , Treatment Outcome
7.
Breast Cancer Res Treat ; 191(2): 385-388, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1530340

ABSTRACT

PURPOSE: Breast cancer survivors take vitamins and supplements to bolster their general health and to decrease the risk of cancer recurrence. Healthcare providers are frequently unaware of their patients non-prescription supplement use. The aim of this study was to study the type and the documentation of patients' dietary supplements and vitamins in the electronic medical record (EMR). METHODS: 50/51 female breast cancer survivors seen over a 7 week period consented to the study. Mean age was 70 and mean years since diagnosis was 13.9. Informed consent and documentation of supplement and vitamin use was obtained by the nurse practitioner the day before the visit. Study data were collected and managed using REDCap electronic data capture tools hosted at Weill Cornell Medicine. RESULTS: Of the 50 study patients, 90% were taking one or more vitamins and/or supplements (mean = 2.4, range = 1-9). The most common were Vitamin D, calcium, and vitamin C. Reasons for vitamin and supplement use included the recommendation by their physician or friend and prevention of bone loss or catching a cold. Five patients mentioned immunity or prevention of COVID-19. The patient reported list was compared with the medication list used by multiple providers in the electronic medical record (EMR). None of the 50 study patients had an accurate list of their vitamins and supplements in the EMR. CONCLUSION: 90% of the breast cancer survivors in our study were taking dietary supplements for a variety of reasons. None had an accurate list in the EMR. We strongly recommend more attention to accurate and easily accessed vitamin and supplement recording by providers.


Subject(s)
Breast Neoplasms , COVID-19 , Cancer Survivors , Aged , Breast Neoplasms/drug therapy , Breast Neoplasms/epidemiology , Dietary Supplements , Documentation , Female , Humans , Neoplasm Recurrence, Local , SARS-CoV-2
8.
Ann Surg Oncol ; 29(4): 2231-2239, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1528704

ABSTRACT

INTRODUCTION: The COVID-19 pandemic caused delays in breast cancer management forcing clinicians to potentially alter treatment recommendations. This study compared breast cancer stage at diagnosis and rates of neoadjuvant therapy among women presenting to our institution before and during COVID-19. METHODS: Retrospective chart review of patients with a new breast cancer diagnosis from March 2020-August 2020 (during-COVID-19) were compared with March 2019-August 2019 (pre-COVID-19). We compared stage at diagnosis, clinical/demographic features, and neoadjuvant therapy use between the time periods. RESULTS: A total of 573 patients included: 376 pre-COVID-19, 197 during-COVID-19. Method of cancer detection was by imaging in 66% versus 63% and by physical findings/symptoms in 34% versus 37% of patients comparing pre-COVID-19 to during-COVID-19, p = 0.47. Overall clinical prognostic stage did not differ significantly (p = 0.39) between the time periods, nor did cM1 disease (2% in each period); 23% pre-COVID-19 and 27% during-COVID-19 presented with cN+ disease (p = 0.38). Neoadjuvant therapy use was significantly higher during-COVID-19 (39%) versus pre-COVID-19 (29%, p = 0.02) driven by increased neoadjuvant endocrine therapy (NET) use (7% to 16%, p = 0.002), whereas neoadjuvant chemotherapy use did not change (22% vs. 23%, p = 0.72). In HR+/HER2- disease, NET use increased from 10% pre-COVID-19 to 23% during-COVID-19 (p = 0.001) with a significant increase in stage I patients (7 to 22%, p < 0.001) and nonsignificant increases in stage II (18 to 23%, p = 0.63) and stage III (9 to 29%, p = 0.29). CONCLUSIONS: Breast cancer stage at diagnosis did not differ significantly during-COVID-19 compared with pre-COVID-19. More patients during-COVID-19 were treated with NET, which was significantly increased in stage I HR+/HER2- disease.


Subject(s)
Breast Neoplasms , COVID-19 , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/therapy , COVID-19/epidemiology , Female , Humans , Neoadjuvant Therapy , Pandemics , Receptor, ErbB-2 , Retrospective Studies
9.
Int J Biol Sci ; 17(12): 3224-3238, 2021.
Article in English | MEDLINE | ID: covidwho-1524470

ABSTRACT

Mechanisms of breast cancer progression and invasion, often involve alteration of hormonal signaling, and upregulation and/or activation of signal transduction pathways that input to cell cycle regulation. Herein, we describe a rationally designed first-in-class novel small molecule inhibitor for targeting oncogenic and hormonal signaling in ER-positive breast cancer. BC-N102 treatment exhibits dose-dependent cytotoxic effects against ER+ breast cancer cell lines. BC-N102 exhibited time course- and dose-dependent cell cycle arrest via downregulation of the estrogen receptor (ER), progesterone receptor (PR), androgen receptor (AR), phosphatidylinositol 3-kinase (PI3K), phosphorylated (p)-extracellular signal-regulated kinase (ERK), p-Akt, CDK2, and CDK4 while increasing p38 mitogen-activated protein kinase (MAPK), and mineralocorticoid receptor (MR) signaling in breast cancer cell line. In addition, we found that BC-N102 suppressed breast cancer tumorigenesis in vivo and prolonged the survival of animals. Our results suggest that the proper application of BC-N102 may be a beneficial chemotherapeutic strategy for ER+ breast cancer patients.


Subject(s)
Antineoplastic Agents/pharmacology , Breast Neoplasms/drug therapy , Cell Cycle Checkpoints/drug effects , Cell Cycle Proteins/metabolism , G1 Phase/drug effects , Receptors, Estrogen/metabolism , Resting Phase, Cell Cycle/drug effects , Animals , Biomarkers, Tumor/genetics , Blotting, Western , Breast Neoplasms/genetics , Breast Neoplasms/metabolism , Breast Neoplasms/pathology , Cell Division , Cell Line, Tumor , Cyclin-Dependent Kinase 2/genetics , Cyclin-Dependent Kinase 4/genetics , Female , Flow Cytometry , Gene Expression Regulation, Neoplastic/physiology , Humans , Maximum Tolerated Dose , Mice , Mice, Nude , Xenograft Model Antitumor Assays
10.
Surgery ; 171(3): 666-672, 2022 03.
Article in English | MEDLINE | ID: covidwho-1475071

ABSTRACT

BACKGROUND: During the COVID-19 pandemic, guidelines recommended that breast cancer centers delay estrogen receptor-positive breast cancer surgeries with neoadjuvant endocrine therapy. We aimed to evaluate pathologic upstaging of breast cancer patients affected by these guidelines. METHODS: Female patients with stage I/II breast cancer receiving neoadjuvant endocrine therapy were prospectively identified and were matched to a historical cohort of stage I/II estrogen receptor-positive breast cancer patients treated with upfront surgery ≤35 days. Primary outcomes were pathologic T and N upstaging versus clinical staging. RESULTS: After matching, 28 neoadjuvant endocrine therapy and 48 control patients remained. Median age in each group was 65 (P = .68). Most patients (78.6% and 79.2%) had invasive ductal carcinoma with a clinical tumor size of 0.9 cm vs 1.7 cm (P = .056). Time to surgery was 68 days in the neoadjuvant endocrine therapy group and 26.5 days in the control (P < .001). A total of 23 neoadjuvant endocrine therapy patients (82.1%) had the same or lower pT-stage compared with 31 (64.5%) control patients (P = .115). Only 3 (10.7%) neoadjuvant endocrine therapy patients had increased pN-stage vs 14 (29.2%) control patients (P = .063). CONCLUSION: Despite 2.5-times longer delays, patients with early-stage estrogen receptor-positive breast cancer receiving neoadjuvant endocrine therapy did not experience pathologic upstaging during the COVID-19 pandemic. These findings may support the use of neoadjuvant endocrine therapy in similar patients if delays to surgery are projected.


Subject(s)
Antineoplastic Agents, Hormonal/therapeutic use , Breast Neoplasms/surgery , COVID-19 , Carcinoma, Ductal, Breast/surgery , Time-to-Treatment/statistics & numerical data , Aged , Breast Neoplasms/drug therapy , Breast Neoplasms/metabolism , Carcinoma, Ductal, Breast/drug therapy , Carcinoma, Ductal, Breast/metabolism , Case-Control Studies , Female , Humans , Mastectomy/statistics & numerical data , Middle Aged , Neoadjuvant Therapy , Prospective Studies , Receptors, Estrogen/metabolism
11.
Ann Surg Oncol ; 29(3): 1683-1691, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1463293

ABSTRACT

BACKGROUND: Surgical delays are associated with invasive cancer for patients with ductal carcinoma in situ (DCIS). During the Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) pandemic, neoadjuvant endocrine therapy (NET) was used as a bridge until postponed surgeries resumed. This study sought to determine the impact of NET on the rate of invasive cancer for patients with a diagnosis of DCIS who have a surgical delay compared with those not treated with NET. METHODS: Using the National Cancer Database, the study identified women with hormone receptor-positive (HR+) DCIS. The presence of invasion on final pathology was evaluated after stratifying by receipt of NET and by intervals based on time from diagnosis to surgery (≤30, 31-60, 61-90, 91-120, or 121-365 days). RESULTS: Of 109,990 women identified with HR+ DCIS, 276 (0.3%) underwent NET. The mean duration of NET was 74.4 days. The overall unadjusted rate of invasive cancer was similar between those who received NET ((15.6%) and those who did not (12.3%) (p = 0.10). In the multivariable analysis, neither the use nor the duration of NET were independently associated with invasion, but the trend across time-to-surgery categories demonstrated a higher rate of upgrade to invasive cancer in the no-NET group (p < 0.001), but not in the NET group (p = 0.97). CONCLUSIONS: This analysis of a pre-COVID cohort showed evidence for a protective effect of NET in HR+ DCIS against the development of invasive cancer as the preoperative delay increased, although an appropriately powered prospective trial is needed for a definitive answer.


Subject(s)
Breast Neoplasms , COVID-19 , Carcinoma, Ductal, Breast , Carcinoma, Intraductal, Noninfiltrating , Breast Neoplasms/drug therapy , Breast Neoplasms/epidemiology , Breast Neoplasms/surgery , Carcinoma, Ductal, Breast/drug therapy , Carcinoma, Ductal, Breast/epidemiology , Carcinoma, Ductal, Breast/surgery , Carcinoma, Intraductal, Noninfiltrating/drug therapy , Carcinoma, Intraductal, Noninfiltrating/epidemiology , Carcinoma, Intraductal, Noninfiltrating/surgery , Female , Humans , Neoadjuvant Therapy , Pandemics , Prospective Studies , SARS-CoV-2
12.
Nurs Open ; 8(6): 3161-3169, 2021 11.
Article in English | MEDLINE | ID: covidwho-1460255

ABSTRACT

AIM: The study explored the experiences of women with breast cancer undergoing chemotherapy at Ho Teaching Hospital. DESIGN: A qualitative design which was exploratory and descriptive in nature was employed. METHODS: Purposive sampling was used to recruit participants. Data were collected using a semi-structured interview guide. Saturation of data was reached after the eighth participant was interviewed. The interviews were audio-recorded and lasted between 30-70 min, and the data were analysed concurrently with data collection using content analysis. Three major themes emerged. RESULTS: Participants experienced hair loss, changes in skin and nail pigmentation and social isolation. The study further revealed that inadequate access to information from healthcare providers and lack of resources coupled with financial constraints were among the major challenges participants faced. However, varied supports from significant others were of much help which enabled participants to go through their chemotherapy successfully.


Subject(s)
Breast Neoplasms , Breast Neoplasms/drug therapy , Female , Ghana/epidemiology , Hospitals, Teaching , Humans , Qualitative Research
13.
Psychooncology ; 30(8): 1262-1277, 2021 08.
Article in English | MEDLINE | ID: covidwho-1453646

ABSTRACT

OBJECTIVE: Breast cancer treatments bring adverse consequences that interfere with everyday functioning. Importantly, some of these treatments are associated with cognitive and language changes. Tamoxifen is a selective estrogen receptor modulator and is a common endocrine therapy treatment for breast cancer. The current review examines the specific domains of cognition and language affected by the use of tamoxifen in women with breast cancer. METHODS: We conducted a systematic search that examined cognitive and/or language functions in chemotherapy-naïve women with breast cancer taking tamoxifen. PubMed, Cochrane CENTRAL, CINAHL Complete, PsycINFO, Scopus, EMBASE, and the Grey Literature Report (greylit.org) were searched. Covidence Systematic Review software (covidence.org) was used to manage the screening process of study titles and abstracts as well as full texts. A total of 17 studies were included in the review. RESULTS: A range of cognitive and language domains were reported. These were grouped into seven broad domains: attention, memory, speed, executive functioning, verbal abilities, visual abilities, and language abilities. Results showed that there is compelling evidence that specific domains of memory and speed are negatively affected by the use of tamoxifen. In addition, there was a pattern of change in domains of executive functions and verbal abilities. CONCLUSIONS: Tamoxifen affects specific cognitive and language domains. Language domains beyond semantics have not been studied and thus conclusions related to these domains, and language in general, could not be made. Studies exploring the effects of tamoxifen on the different domains of language are recommended.


Subject(s)
Breast Neoplasms , Tamoxifen , Breast Neoplasms/drug therapy , Cognition , Executive Function , Female , Humans , Language , Tamoxifen/adverse effects
14.
Am Surg ; 88(3): 471-479, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1443706

ABSTRACT

BACKGROUND: The COVID-19 pandemic has required new treatment paradigms to limit exposures and optimize hospital resources, including the use of neoadjuvant endocrine therapy (NAET) as bridging therapy for HR+/HER2-invasive tumors and DCIS. While this approach has been used in locally advanced disease, it is unclear how it may affect outcomes in resectable HR+/HER2- tumors. METHODS: Women ≥18 years diagnosed with in situ (Tis) or non-metastatic HR+/HER2- breast cancer from March-May 2019 and 2020 were included. Fisher's exact test and two-sample t test were used to compare baseline characteristics and surgical outcomes between strata. Sub-analysis was performed between patients who received primary surgery vs a bridging NAET approach. RESULTS: Despite similar clinical characteristics, patients in 2019 were more likely to have a surgery-first approach (75% vs 42%, P-value = .0007), receive surgery sooner (22 vs 29 days, P-value < .001), and within 60 days from diagnosis date (100% vs 85%, P-value = .0301). Neoadjuvant endocrine therapy was a more prevalent approach in 2020 (48% vs 7%, P-value < .0001). Rates of clinical to pathologic up-staging remained consistent across primary surgery vs bridging NAET subgroups (P-value = .9253). DISCUSSION: Pandemic-driven treatment protocols provide a unique opportunity to assess the utility of bridging endocrine therapy for resectable HR+/HER2- tumors. Differences in clinical and pathologic staging were similar across groups and did not appear to be affected by receipt of NAET. Our limited cohort demonstrates this strategic therapeutic avenue can optimize health care utilization and may be a reasonable approach when delaying surgery is preferred.


Subject(s)
Antineoplastic Agents, Hormonal/therapeutic use , Breast Neoplasms/drug therapy , COVID-19/epidemiology , Carcinoma, Intraductal, Noninfiltrating/drug therapy , Neoadjuvant Therapy/methods , Pandemics , Adult , Aged , Aged, 80 and over , Breast Neoplasms/chemistry , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Carcinoma, Intraductal, Noninfiltrating/chemistry , Carcinoma, Intraductal, Noninfiltrating/pathology , Carcinoma, Intraductal, Noninfiltrating/surgery , Female , Humans , Middle Aged , Neoplasm Staging , North Carolina , Probability , Receptor, ErbB-2 , Receptors, Estrogen , Receptors, Progesterone , Treatment Outcome
15.
Clin Cancer Res ; 27(24): 6815-6823, 2021 12 15.
Article in English | MEDLINE | ID: covidwho-1443678

ABSTRACT

PURPOSE: We assessed the immunogenicity and safety of the BNT162b2 vaccine in a large cohort of patients with cancer (CP). EXPERIMENTAL DESIGN: From March 1, 2021 to March 20, 2021, this prospective cohort study included 816 CP afferent to our institution and eligible for the vaccination. A cohort of 274 health care workers (HCW) was used as age- and sex-matched control group. BNT162b2 was administered as a two-dose regimen given 21 days apart. Blood samples to analyze anti-Spike (S) IgG antibodies (Ab) were collected prevaccination [timepoint (TP) 0], and at 3 weeks (TP1) and 7 weeks (TP2) after the first dose. RESULTS: Patients characteristics: median age 62 (range, 21-97); breast/lung cancer/others (31/21/48%); active treatment/follow-up (90/10%). In the whole CP cohort, the serologic response rate (RR) and the titre of anti-S IgG significantly increased across the TPs; at TP2, the responders (IgG >15 AU/mL) were 94.2%. Active chemotherapy and chronic use of steroids were independent predictors of lower RR. Adverse events (AE) after the booster predicted higher likelihood of response (OR, 4.04; 95% confidence interval, 1.63-9.99; P = 0.003). Comparing the matched cohorts, the responders were significantly lower in CP than in HCW at TP1 (61.2% vs. 93.2%) and TP2 (93.3% vs. 100%), while the geometric mean concentration of IgG did not significantly differ at TP2 being significantly lower in CP (23.3) than in HCW (52.1) at TP1. BNT162b2 was well tolerated in CP; severe-grade AEs were 3.5% and 1.3% after the first and second doses, respectively. CONCLUSIONS: BNT162b2 assures serologic immunization without clinically significant toxicity in CP. The second dose is needed to reach a satisfactory humoral response.


Subject(s)
Antibodies, Viral/blood , Breast Neoplasms/drug therapy , COVID-19/prevention & control , Lung Neoplasms/drug therapy , SARS-CoV-2/immunology , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/therapeutic use , Comorbidity , Female , Humans , Immunization , Immunoglobulin G/blood , Male , Middle Aged , Prospective Studies , Spike Glycoprotein, Coronavirus/immunology , Young Adult
16.
Anticancer Res ; 41(9): 4535-4542, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1395532

ABSTRACT

BACKGROUND/AIM: Due to the SARS-CoV-2 pandemic, many scientific committees proposed neoadjuvant therapy (NACT) bridging treatment as a novel strategy and indication. The aim of the study was to evaluate the impact of COVID-19 pandemic on breast cancer patients undergoing NACT. PATIENTS AND METHODS: All breast cancer patients referred to two Breast Units during COVID-19-pandemic were enrolled. RESULTS: Out of 814 patients, 43(5.3%) were enrolled in the COVID-19-group and compared with 94 (7.9%) similar Pre-COVID-19 patients. We observed a reduction in the number of patients undergoing NACT, p=0.0019. No difference was reported in terms of clinical presentation, indications, and tumor response. In contrast, a higher number of vascular adverse events was reported (6.9% vs. 0% p=0.029). Immediate breast cancer reconstructions following invasive surgery suffered a significant slowdown (5.9% vs. 47.7%, p=0.019). CONCLUSION: COVID-19 caused a reduction in the number of patients undergoing NACT, with no changes in terms of indications, clinical presentation, and tumor response. Furthermore, there was an increased incidence of vascular events.


Subject(s)
Antineoplastic Agents/administration & dosage , Breast Neoplasms/drug therapy , Breast Neoplasms/surgery , COVID-19/epidemiology , Mammaplasty/statistics & numerical data , Neoadjuvant Therapy/statistics & numerical data , Adult , Aged , Antineoplastic Agents/adverse effects , Antineoplastic Agents, Hormonal/administration & dosage , Antineoplastic Agents, Hormonal/adverse effects , COVID-19/complications , Drug Therapy/statistics & numerical data , Female , Humans , Middle Aged , Neoadjuvant Therapy/adverse effects , Pandemics , Retrospective Studies , Treatment Outcome
17.
BMJ Case Rep ; 14(9)2021 Sep 03.
Article in English | MEDLINE | ID: covidwho-1394072

ABSTRACT

Ado-trastuzumab emtansine (T-DM1) is a monoclonal antibody drug conjugate approved for the treatment of HER2-positive breast cancers. Presented here is a case report of a patient who developed fatal pulmonary toxicity in the form of acute eosinophilic pneumonia while undergoing treatment with T-DM1. Prior to beginning T-DM1 therapy, this patient had been treated with two HER2-targeted agents (trastuzumab, pertuzumab) per National Comprehensive Cancer Network (NCCN) guidelines. This case represents a novel presentation of toxicity associated with T-DM1 while perhaps demonstrating additive toxicity associated with multiple lines of HER2 targeted therapies.


Subject(s)
Breast Neoplasms , Maytansine , Pulmonary Eosinophilia , Ado-Trastuzumab Emtansine , Breast Neoplasms/drug therapy , Female , Humans , Maytansine/adverse effects , Pulmonary Eosinophilia/chemically induced , Pulmonary Eosinophilia/diagnosis , Receptor, ErbB-2 , Trastuzumab/adverse effects
19.
Breast ; 60: 58-61, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1372899

ABSTRACT

Undoubtedly, the development of COVID-19 vaccines displays a critical step towards ending this devastating pandemic, considering their protective benefits in the general population. Yet, data regarding their efficacy and safety in cancer patients are limited. Herein we provide the initial analysis of immune responses after the first dose of vaccination in 21 breast cancer patients receiving cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors. The levels of neutralizing antibodies post vaccination were similar to the matched healthy controls, whereas no safety issues have been raised. Further exploration is needed to reduce the uncertainty of SARS-CoV-2 immunity among cancer patients under treatment.


Subject(s)
Antibodies, Neutralizing , Antibodies, Viral , Breast Neoplasms , COVID-19 Vaccines/immunology , COVID-19 , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , Antineoplastic Agents/therapeutic use , Breast Neoplasms/drug therapy , COVID-19/prevention & control , Cyclin-Dependent Kinase 4/antagonists & inhibitors , Cyclin-Dependent Kinase 6/antagonists & inhibitors , Female , Humans , SARS-CoV-2 , Vaccination
20.
BMJ Support Palliat Care ; 12(1): 33-37, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1356955

ABSTRACT

BACKGROUND: A strategy for maintaining and/or improving cardiorespiratory fitness (CRF) in the growing population of cancer survivors is of major clinical importance, especially in the COVID-19 era. The effect of unsupervised high-intensity interval training (HIIT) on increasing CRF in breast cancer survivors is unknown. PURPOSE: The purpose of this study was to determine whether the newly developed habit-B programme, which involves home-based smartphone-supported HIIT using body weight exercises, improves CRF in early-stage breast cancer survivors. METHODS: This single-centre, 12-week, parallel-group, single-blind, randomised controlled trial involved 50 women with stage I-IIa breast cancer, aged 20-59 years, who had completed initial treatment except for hormone therapy. Participants were randomised to either the exercise or control group. The primary outcome was the 12-week change in peak oxygen uptake [Formula: see text]. Other outcomes included muscle strength, 6 min walk test, resting heart rate, physical activity, fatigue, safety and quality of life. RESULTS: The change in [Formula: see text] and leg strength increased significantly in the exercise group compared with the control group (p<0.01). Changes in other outcomes were not significantly different between the groups. CONCLUSION: A home-based HIIT intervention can lead to improve CRF and muscle strength in early-stage breast cancer survivors.


Subject(s)
Breast Neoplasms , COVID-19 , Cancer Survivors , Cardiorespiratory Fitness , High-Intensity Interval Training , Adult , Breast Neoplasms/drug therapy , Female , Humans , Middle Aged , Quality of Life , SARS-CoV-2 , Single-Blind Method , Smartphone , Young Adult
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