Phase II trial of neoadjuvant exemestane [EXE] and celecoxib [CELE] in breast cancer: Results of biomarkers

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 11056-11056 ◽  
Author(s):  
C. L. Shapiro ◽  
S. P. Povoski ◽  
R. Jiminez ◽  
J. Dehart ◽  
S. Ottman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Core Biopsy ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Small Sample ◽  
Rank Test ◽  
Ki 67 ◽  
Cancer History ◽  
Cox 2 ◽  
Tumor Measurements

11056 Background: Aromatase [CYP19] activity and expression is increased by prostaglandin E2, thus providing a rational for combining the COX-2 inhibitor, CELE, with an aromatase inhibitor. To evaluate the effects of these drugs on proliferation and other biomarkers, we conducted a neoadjuvant trial of EXE alone followed by the combination of EXE and CELE. The primary endpoint was the assessment of biomarkers and the secondary endpoint was toxicity. Methods: Clinical stages II/III, postmenopausal, estrogen [ER] and/or progesterone receptor [PR] positive, previously untreated, ECOG 0–1 were eligible. Excluded were inflammatory breast cancer, history of myocardial infarction, and documented allergy to aspirin, NSAIDs, or sulfonamides. After initial core biopsy pts received 8 weeks (wks) of EXE 25 mg daily. They then received a second core biopsy followed by 8 wks of EXE and CELE 400 mg twice daily. After 16 wks, pts had definitive surgery. Compliance was assessed by pill counts at study visists every 4 wks. At baseline, 8, and 16 wks, pts had tumor measurements by physical exam, mammogram, and ultrasound. A tissue microarray [TMA] was contructed and immunohistochemical [IHC] staining with commercially available antibodies for Ki-67, COX-2, HER-2, ER, and PR was performed. Two independent pathologists scored intensity and percentage of cells staining and were blinded to treatment and the timimg of specimen acquistion. Statistical analyses were performed using Wilcoxon signed-rank test Results: Twenty pts with a median age 62 (range 56–87) were enrolled. CELE was discontinued in 3 (15%) pts for grade 1 rash-1 pt; grade 1 creatinine elevation-1 pt; and grade 1 melena-1 pt. Three (15%) pts-partial response, 16 (80%)-stable disease, and 1 (5%)-progressive disease. None of the differences in biomarkers between 0 and 8 wks and 8 and 16 wks were significant. A trend toward decreasing mean Ki 67 was observed from 0 to 8 wks (20% vs 9%, p=0.19) and 8 to 16 wks (9% vs 7%, p=0.7) Conclusions: Neoadjuvant EXE followed by EXE/CELE was well tolerated with anti-tumor activity. Tumor cell proliferation decreased by about 50% during EXE, but small sample size precluded reaching statistical significance. Frozen tissue was collected and the results of CYP 19 mRNA expression will be presented. [Table: see text]

Effectiveness of online versus live multi-family psychoeducation group therapy for children and adolescents with mood or anxiety disorders: a pilot study

2016 ◽  
Vol 30 (4) ◽  
Author(s):  
Iman Sapru ◽  
Sarosh Khalid-Khan ◽  
Elaine Choi ◽  
Nazanin Alavi ◽  
Archana Patel ◽  
...  
Keyword(s):  
Anxiety Disorder ◽  
Group Therapy ◽  
Anxiety Disorders ◽  
Sample Size ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Relative Effectiveness ◽  
Small Sample ◽  
Rank Test ◽  
Family Psychoeducation

Abstract Objective: [1] To highlight the effectiveness of multi-family psychoeducation group therapy (MFPGT) in children with mood or anxiety disorders; [2] to measure change in knowledge and awareness of mood and anxiety disorders in families and children; and [3] to compare the relative effectiveness of online compared to live MFPGT. Method: Participants included families of children (12 years or younger) referred with a mood or anxiety disorder to the Division of Child and Adolescent Psychiatry at Queen’s University (n=16) who were on a waitlist to see a psychiatrist. Change was measured through questionnaires for all parents before and after the program. Using SPSS v22, comparisons between the online (n=6) and live (n=10) groups were made using the Mann-Whitney U test and within group comparisons were made using Wilcoxon signed-rank test. Results: The online and live education groups showed similar overall improvements in knowledge acquisition and expressed emotion in participating families. However, statistical significance must be interpreted with caution due to the small sample size. Conclusions: Online MFPGT may be an effective way to increase knowledge, provide resources and support and build on skills thus giving individuals more control and confidence when dealing with a mood or anxiety disorder while on a waitlist. MFPGT showed equal efficacy in live and online groups, indicating that the online program has the potential to be a more convenient and accessible program for families. More research is needed with a greater sample size.

Outcomes of metastatic synovial sarcoma with doxorubicin, pazopanib, and ifosfamide therapy.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e23552-e23552
Author(s):  
Priscila Barreto Coelho ◽  
Philippos Apolinario Costa ◽  
Andrea P. Espejo Freire ◽  
Deukwoo Kwon ◽  
Emily Jonczak ◽  
...  
Keyword(s):  
Synovial Sarcoma ◽  
Metastatic Disease ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Small Sample ◽  
Rank Test ◽  
High Dose ◽  
Entire Cohort ◽  
Significant Difference ◽  
Localized Disease

e23552 Background: Synovial sarcoma (SS) accounts for 5-10% of all soft tissue sarcoma. SS are aggressive tumors with a median 5-year survival of 60-70% when localized disease but also a propensity for metastatic spread with 40-45% of patients developing metastasis within 5 years. It is considered a chemotherapy-sensitive sarcoma and treatment options are increasing. Herein, we present the outcomes of SS patients by systemic regimen and multimodality approach. Methods: This is a single institution, retrospective cohort of 79 patients with histopathologically confirmed SS treated at from 2004 to 2019. Clinical characteristics, treatment, response and survival were analyzed. We estimated medians of progression-free survival (PFS) and overall survival (OS) using the method of Kaplan-Meier along with the Log-Rank test. All tests were two-sided and statistical significance was considered when p<0.05. Results: Median follow-up was 3.7 years (range 3.13 to 4.33), 59.5% were women and median age at diagnosis was 41 (range 5-77). At presentation, 60 patients (75.9%) had localized disease and 19 (24.1%) presented with metastatic disease. Among the entire cohort the three-year OS rate was 78.9% (95%CI = 66.3-87.3) and five-year OS rate 68.7% (95%CI = 53.5-79.9). OS between localized disease (N = 45) and metastatic (N = 12) was not statistically significant (log-rank p = 0.098). When comparing different regimens, doxorubicin-based regimens (DBR) showed longest median PFS of 10.1 months (95%CI = 3.97-21.16), while pazopanib had a median PFS of 7.45 (95%CI = 2.63-12.3), high dose ifosfamide (HDI) 6.4 months (95%CI = 2.79-15.5) and trabectedin 3.12 months (95%CI = 0.99-6.97). Conversely, patients with metastatic disease treated with pazopanib experienced a median PFS of 11.47 months (95%CI = 2.63-32.9) while those treated with a DBR 8.15 months (95%CI = 1.08-35.8). Conclusions: SS is highly aggressive and, in our cohort, patients with local presentation had non-significant difference in OS to the metastatic disease, this could be due to a small sample size or the high probability for relapse this tumor has. Chemotherapy with DBRs showed superiority to other regimens and pazopanib showed to be slightly superior when evaluating only metastatic disease. Addition of pazopanib maintenance therapy may improve PFS and OS. Continuous evaluation of these patients with further inclusion of SS on immunotherapy is warranted.

A retrospective comparison of contrast enhanced spectral mammography (CESM) to breast MRI in breast cancer detection: An initial study for sensitivity analysis.

2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 7-7
Author(s):  
Luna Li ◽  
Kristin Brill ◽  
Pauline Germaine ◽  
Elizabeth Tinney ◽  
Karen Hendershott ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Detection ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Small Sample ◽  
Breast Cancer Detection ◽  
Contrast Enhanced ◽  
Significant Difference ◽  
Mean Size ◽  
Index Cancer

7 Background: CESM is a new study using contrast and dual energy digital mammographic technology to detect contrast enhanced cancer that may be invisible on conventional mammogram. Limited studies have shown that adding CESM to diagnostic workup adjunct with mammogram and breast ultrasound does increase sensitivity for breast cancer detection. More studies are needed to compare the sensitivity of CESM to BMRI to further define the role of CESM in breast cancer diagnosis. Methods: This study involved 50 malignant breasts in 48 women retrospectively chosen from of 960 patients in our institution during the period of October 2012 to March 2014. Both CESM and BMRI were done for each patient within 30 days. The cancer diagnoses were confirmed by tissue diagnoses. The size of lesions was classified into three categories based on standard of breast cancer stages: 1 (0.2cm - < = 2 cm), 2 (2 cm < lesion < = 5 cm), 3 (> 5 cm). The enhancement intensity of both lesions and background has been quantified based on a scale of 0-3. Statistical significance was analyzed using T test for mean size of index cancer and mean score of enhancement intensity of background and lesions on CESM and BMRI. Sensitivity and positive predictive value (PPV) were calculated for both CESM and BMRI. Morphology consistence was calculated on both studies. Results: Both CESM and BMRI have sensitivity of 100% for breast cancer detection. CESM has a PPV of 98% versus 93% for BMRI. No statistical significance was identified on mean size of index cancer. The enhancement intensity of background and lesions is significantly higher on CESM than on BMRI (p < 0.01). The smallest cancer can be detected by both CESM and BMRI is less than 0.5 cm. Morphology consistence was 46/50 (92%). Conclusions: Our study indicates that CESM and BMRI have comparable high sensitivity on breast cancer detection. CESM has a higher PPV than BMRI that may indicate a better specificity (no significant difference due to the small sample size). Significantly less background enhancement intensity on CESM than on BMRI reflect an increased specificity. More studies need to be conducted for further evaluation.

scholarly journals Patients’ characteristics, Cytochrome P4501A1 genetic polymorphisms and breast cancer risk in Sudanese women

2021 ◽  
Vol 5 ◽  
Author(s):  
Fatima Hamad ◽  
Sulma I. Mohammed ◽  
Abdelrahim O. Mohamed ◽  
Dafalla O. Abuidris Elmustafa
Keyword(s):  
Breast Cancer ◽  
Breast Cancer Risk ◽  
Cancer Risk ◽  
Small Sample Size ◽  
Menopausal Status ◽  
Premenopausal Women ◽  
Small Sample ◽  
Cancer History ◽  
Polycyclic Aromatic ◽  
History Of

Background: The CYP1A1 catalyses polycyclic aromatic hydrocarbons activation to reactive metabolites, causing deoxyribonucleic acid (DNA) damage and cancer. It is highly polymorphic and displays ethnic differences in various populations.Aim: To evaluate the association of three polymorphic variants in the CYP1A1 gene with breast cancer in Sudanese women.Sett ing: This is a case-control study.Methods: After consenting, the participants completed questionnaires consisting of sociodemographic data, gynaecological status, and breast cancer history. We recorded clinical data, weight, and height for each woman and drew blood for PCR and RFLP analyses for CYP1A1 genotyping.Results: The CYP1A1 M1 and CYP1A1 M3 genotypes and homozygous CYP1A1 M1 (C/C) and CYP1A1 M3 (C/C) genotypes are not associated with breast cancer risk and menopausal status in women. The homozygous CYP1A1 M2 (A/A) genotype had a significant association with a risk reduction of breast cancer in premenopausal women. In contrast, the heterozygous CYP1A1 M2 (A/G) and the homozygous (G/G) are associated with significant breast cancer risk.Conclusion: Despite the limitations encountered in this study that included the small sample size and availability of age-matched controls, the results suggest that the CYP1A1 M2 polymorphism, educational level, and family history of breast cancer may have an association with the risk of developing breast cancer amongst Sudanese women and warrant confirmation in more extensive studies.

Effect of celecoxib, a specific cyclooxygenase 2 inhibitor, on the apoptotic and mitotic indexes of breast cancer in patients with early stage disease

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 14132-14132
Author(s):  
A. H. Tfayli ◽  
M. Cherry ◽  
J. Yang ◽  
K. Kojouri ◽  
M. Jafari ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Metastatic Breast ◽  
Surgical Excision ◽  
Small Sample ◽  
Matched Pair ◽  
Ki 67 ◽  
Early Stage Disease ◽  
Days Of Therapy ◽  
Cox 2

14132 Background: To assess whether the administration of celecoxib, a specific cyclooxegenease-2 (COX-2) inhibitor, to patients with breast cancer alters the proliferative and apoptotic indexes of their tumors. Methods: Women newly diagnosed with non metastatic breast cancer were enrolled into the study after undergoing a diagnostic core needle biopsy. Patients received celecoxib treatment at 400 mg orally twice a day for 14 days, and then underwent surgical excision of their tumor. Core biopsies obtained at the time of initial diagnostic procedure and surgical excision specimens were stained for Ki-67, as well as COX-2 and cleaved poly (ADP-ribose) polymerase (PARP) expression (as an apoptosis marker). Appropriate negative and positive controls were included. We assessed the difference in Ki- 67, COX-2 and cleaved PARP expression levels, before and after treatment using the Wilcoxon’s matched-pair ranks test and the McNemar’s test. Results: 16 patients were enrolled. The median age was 54.6 years. ER and/or PR expression was present in 81% of tumors; Her-2 neu overexpression was present in 25%. No significant change in COX-2 or cleaved PARP expression was noticed in the post intervention specimen compared to the core biopsies. Surprisingly, there was a significant increase in the Ki-67 expression (p < 0.009). Conclusions: we have conducted a short term prospective study to assess the effects of celecoxib, on the proliferative and apoptotic indexes in patients with early stage breast cancer. We have found an increase in the Ki-67 activity, with no significant down regulation of COX-2 or increase in cleaved PARP expression with 14 days of therapy. This could be partly due to the small sample size. [Table: see text]

Combination of AST to ALT and neutrophils to lymphocytes ratios as predictors of locally advanced disease in patients with bladder cancer subjected to radical cystectomy: Results from a single-institutional series

2021 ◽  
pp. 039156032110351
Author(s):  
Alessandro Uleri ◽  
Rodolfo Hurle ◽  
Roberto Contieri ◽  
Pietro Diana ◽  
Nicolòmaria Buffi ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Radical Cystectomy ◽  
Advanced Disease ◽  
Independent Predictor ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Locally Advanced ◽  
Small Sample ◽  
Locally Advanced Disease ◽  
Increased Risk

Background: Bladder cancer (BC) staging is challenging. There is an important need for available and affordable predictors to assess, in combination with imaging, the presence of locally-advanced disease. Objective: To determine the role of the De Ritis ratio (DRR) and neutrophils to lymphocytes ratio (NLR) in the prediction of locally-advanced disease defined as the presence of extravescical extension (pT ⩾ 3) and/or lymph node metastases (LNM) in patients with BC treated with radical cystectomy (RC). Methods: We retrospectively analyzed clinical and pathological data of 139 consecutive patients who underwent RC at our institution. Logistic regression models (LRMs) were fitted to test the above-mentioned outcomes. Results: A total of 139 consecutive patients underwent RC at our institution. Eighty-six (61.9%) patients had a locally-advanced disease. NLR (2.53 and 3.07; p = 0.005) and DRR (1 and 1.17; p = 0.01) were significantly higher in patients with locally-advanced disease as compared to organ-confined disease. In multivariable LRMs, an increasing DRR was an independent predictor of locally-advanced disease (OR = 3.91; 95% CI: 1.282–11.916; p = 0.017). Similarly, an increasing NLR was independently related to presence of locally-advanced disease (OR = 1.28; 95% CI: 1.027–1.591; p = 0.028). In univariate LRMs, patients with DRR > 1.21 had a higher risk of locally advanced disease (OR = 2.83; 95% CI: 1.312–6.128; p = 0.008). Similarly, in patients with NLR > 3.47 there was an increased risk of locally advanced disease (OR = 3.02; 95% CI: 1.374–6.651; p = 0.006). In multivariable LRMs, a DRR > 1.21 was an independent predictor of locally advanced disease (OR = 2.66; 95% CI: 1.12–6.35; p = 0.027). Similarly, an NLR > 3.47 was independently related to presence of locally advanced disease (OR = 2.24; 95% CI: 0.95–5.25; p = 0.065). No other covariates such as gender, BMI, neoadjuvant chemotherapy or diabetes reached statistical significance. The AUC of the multivariate LRM to assess the risk of locally advanced disease was 0.707 (95% CI: 0.623–0.795). Limitations include the retrospective nature of the study and the relatively small sample size.

scholarly journals CDK4/6 Inhibitors and Arthralgia: A Single Institution Experience

2021 ◽  
Vol 9 (2) ◽  
pp. 42
Author(s):  
Angeliki Andrikopoulou ◽  
Oraianthi Fiste ◽  
Kleoniki Apostolidou ◽  
Efthymia Skafida ◽  
Christos Markellos ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Small Sample Size ◽  
Small Sample ◽  
Musculoskeletal Symptoms ◽  
Hematological Toxicity ◽  
Breast Cancer Patients ◽  
Single Institution ◽  
Duration Of Treatment ◽  
Positive Breast Cancer

Background: Aromatase inhibitors (AIs) are associated with musculoskeletal pain in one third (20–47%) of breast cancer patients. Recently, CDK4/6 inhibitors have emerged as a new therapeutic approach in hormone receptor (HR)-positive breast cancer. While hematological and gastrointestinal toxicities are frequently reported during treatment with CDK4/6 inhibitors, musculoskeletal symptoms are less commonly encountered. Methods: Herein, we present a retrospective study of 47 breast cancer patients who received CDK4/6 inhibitors along with endocrine therapy in our department between 01/01/2018 and 01/09/2020. Results: Median age at diagnosis was 58 years (29–81). Median duration of treatment was 8.76 months (SD: 7.68; 0.47–30.13 months). Median PFS was 24.33 months (95% CI; 1.71–46.96). Overall, toxicity was reported in 61.7% of the cases (29/47). Arthralgia was reported in 6.4% (3/47) of the patients. Hematological toxicity was reported in 51.1% (24/47) of the patients. Neutropenia was the main hematological toxicity observed (86.8%; 22/47) along with anemia (4.3%; 2/47), thrombocytopenia (2.1%; 1/47), and leukopenia (4.2%; 1/24). Conclusions: Though our data reflect a small sample size, we report a reduced arthralgia rate (6.4%) during treatment with CDK4/6 inhibitors compared with that reported in studies of AIs (20–47%).

Association between androgen receptor expression, Ki-67 and the 21-gene recurrence score in non-metastatic, lymph node-negative, estrogen receptor-positive and HER2-negative breast cancer

2015 ◽  
Vol 68 (10) ◽  
pp. 839-843 ◽  
Author(s):  
Francisco E Vera-Badillo ◽  
Martin C Chang ◽  
Gordana Kuruzar ◽  
Alberto Ocana ◽  
Arnoud J Templeton ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Lymph Node ◽  
Androgen Receptor ◽  
Statistical Significance ◽  
Multivariable Analysis ◽  
Recurrence Score ◽  
Receptor Expression ◽  
Ki 67 ◽  
Node Negative

BackgroundThe mechanisms underlying the favourable prognosis of androgen receptor (AR) expression in breast cancer are unknown.MethodsThe associations between the 21-gene recurrence score (RS), AR, grade, mitotic score, Ki-67 and estrogen receptor (ER) and progesterone receptor (PgR) expression were explored in sequential women with lymph node-negative, ER-positive and HER2-negative breast cancer. Statistical significance of this exploratory study was defined as p<0.10.ResultsAnalysis comprised 70 women. Most tumours had high AR expression (97% had scores >3). Median RS was 15 (range 1–53). AR expression showed a minimally significant positive correlation with ER (R=0.37), but no correlation with Ki-67 (R=−0.18). In univariable analysis, AR (p=0.01), ER (p<0.001) and PgR (p<0.001) had significant negative associations with RS. Ki-67 (p=0.16), grade (p=0.40) and mitotic score (p=0.23) showed no association with RS. Multivariable analysis showed similar associations.ConclusionsAR is associated with lower RS, but not with Ki-67.

Internet-based intervention compared to brief intervention for smoking cessation in Brazil: a pilot study (Preprint)

2021 ◽  
Author(s):  
Nathalia Machado ◽  
Henrique Gomide ◽  
Heder Bernardino ◽  
Telmo Ronzani
Keyword(s):  
Smoking Cessation ◽  
Brief Intervention ◽  
Small Sample Size ◽  
Statistical Significance ◽  
Healthcare Providers ◽  
Intervention Group ◽  
Small Sample ◽  
The Internet ◽  
Intention To Treat ◽  
Internet Based Intervention

BACKGROUND Smoking is still the leading cause of preventable death. Governments and healthcare providers should make available more and accessible resources to help tobacco users stop. OBJECTIVE This study describes a pilot longitudinal study that evaluated the efficacy of a computerized intervention compared to the brief intervention for smoking cessation among Brazilians. METHODS Smokers were recruited and randomly assigned to one of the two intervention groups. RESULTS The results showed similar rates of cessation and reduction for both intervention groups. The internet-based intervention was a little more effective for smoking cessation, while the brief intervention was more effective in reducing the number of cigarettes smoked per day. Despite this, this difference was small and had no statistical significance even after adjusting for intention-to-treat analysis. These results should be interpreted with caution, especially due to the small sample size. CONCLUSIONS Forty-nine smokers were enrolled in this study (25 in the brief intervention group; 24 in the internet-based intervention group). The mean age was 44.46 years old; most were male (59.2%), had elementary school (44.9%), smoked an average of 14.5 cigarettes per day, had a mean score of 4.65 for nicotine dependence, and score of 5.7 for motivation to quit. Measures were drawn from comparing cessation rate, motivation score and sought treatment between groups. Thirty-five participants answered the follow up 1 and 19 answered to the second.

The feasibility of same day pegfilgrastim-cbqv administration in breast cancer patients receiving myelosuppressive chemotherapy regimens at a northern Virginia cancer center.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18687-e18687
Author(s):  
Maya Leiva ◽  
Angela Pennisi ◽  
Kathleen Kiernan Harnden ◽  
Patricia Conrad Rizzo ◽  
Lauren Ann Mauro
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Small Sample Size ◽  
Standard Of Care ◽  
Secondary Prophylaxis ◽  
Small Sample ◽  
Cancer Center ◽  
Breast Cancer Patients ◽  
Curative Intent ◽  
Myelosuppressive Chemotherapy

e18687 Background: The long-acting injectable G-CSF, pegfilgrastim and its biosimilars have historically been given to patients 24 hours following the administration of myelosuppressive chemotherapy for either primary or secondary prophylaxis of febrile neutropenia (FN). Previous literature has indicated that pegfilgrastim administration prior to 24 hours post chemotherapy, may result in a deepened and prolonged neutropenia due to the increase in circulating granulocytes exposed to chemotherapy. With the onset of the COVID-19 pandemic and to reduce potential SAR-CoV-2 exposure to cancer patients on therapy, we implemented same day administration of injectable pegfilgrastim-cbqv among select breast cancer patients receiving myelosuppressive chemotherapy regimens from March 2020 – February 2021. Methods: Utilizing retrospective EHR chart reviews, 55 patients among 4 medical oncologists in our breast cancer group were identified as meeting the criteria of same day pegfilgrastim-cbqv administration. Inclusion was based on completion of at least 2 consecutive cycles of same day pegfilgrastim-cbqv 6 mg subcutaneous injection for primary or secondary prophylaxis. The selected patient charts were reviewed for the incidence and severity of FN. Among the patients who had documented FN, further subgroup analyses were done regarding baseline characteristics, timing of neutropenia, regimens, regimen sequence, and reported ADRs associated with pegfilgrastim-cbqv. Results: 9 (16.4%) of the 55 patients experienced FN (Grades 3-4) and 6 (10.9%) patients were hospitalized. There were no Grade 5 events and none had therapy discontinued due to FN. 8 (88.9%) of the patients experienced FN between cycles 1 and 2. Of note, there were no cases of COVID-19 among the 9 patients who had an episode of FN. 52 (94.5%) of the 55 patients received treatment with curative intent and 3 (5.5%) had metastatic disease on a subsequent line of therapy. The median age was 49.1 years (range 29-71) and patients were 56.4% Caucasian, 18.1% Black or African American, 12.7% Asian, and 12.7% Hispanic/Latina. Conclusions: Based on the retrospective data analysis, same day pegfilgrastim-cbqv appears to be a safe and effective option in the primary and secondary prophylaxis of FN with myelosuppressive standard of care chemotherapy used in breast cancer treatment. Though our review was limited by a relatively small sample size and confined to younger (49.1 median age) breast cancer patients, this opens the door to further re-evaluation of same day pegfilgrastim-cbqv administration in other patient populations. In a post pandemic treatment world, this slight change in practice has the potential to reduce patient financial toxicity associated with multiple medical visits, provide an alternative to on-body injector formulations, and ensure treatment adherence.

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