Neoadjuvant bevacizumab: Surgical complications of mastectomy with and without reconstruction.

1100 Background: Neoadjuvant therapy is commonly used in operable breast cancer. We prospectively evaluated the surgical complications in a cohort of patients who underwent mastectomy following neoadjuvant doxorubucin hydrochloride/cyclophosphamide/paclitaxel (AC/T) plus bevacizumab and compared the rate of complications to a matched cohort of neoadjuvant AC/T without bevacizumab. Methods: One hundred patients with HER2-negative breast cancer enrolled in a single-arm trial of neoadjuvant AC/T plus bevacizumab (cohort 1), 60 of these patients underwent mastectomy and were matched with 59 patients who received standard neoadjuvant AC/T (cohort 2) over a similar time period in the same healthcare system. All patients underwent mastectomy with or without reconstruction. Fisher’s exact tests were used to compare complication rates, with a p<0.05 was considered significant. Results: Patients were matched well in terms of demographics. The overall complication rate was 33% in cohort 1 and 31% in cohort 2 (P-value=0.84; Table). In cohort 1, 7 of 23 (30%) patients who underwent immediate expander/implant reconstruction had complications, including 2 patients who had explantation of their reconstructions. In cohort 2, 0 of 8 (0%) had complications (p value=0.15). Conclusions: Nearly a third of patients undergoing neoadjuvant therapy with AC/T with or without bevacizumab developed a postoperative complication after mastectomy. The use of bevacizumab was not associated with a significant increase in surgical complications, although this is a non-randomized data with a small sample size. As larger data sets become available with the use of neoadjuvant bevacizumab with mastectomy, further refinement may be necessary. [Table: see text]

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CDK4/6 Inhibitors and Arthralgia: A Single Institution Experience

Medical Sciences ◽

10.3390/medsci9020042 ◽

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%).

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

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e18687 ◽

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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Efficient prediction of a spatial transcriptomics profile better characterizes breast cancer tissue sections without costly experimentation

10.1101/2021.04.22.440763 ◽

2021 ◽

Author(s):

Taku Monjo ◽

Masaru Koido ◽

Satoi Nagasawa ◽

Yutaka Suzuki ◽

Yoichiro Kamatani

Keyword(s):

Breast Cancer ◽

Small Sample Size ◽

Expression Patterns ◽

Imputation Accuracy ◽

Gene Clusters ◽

Small Sample ◽

Breast Cancer Tissue ◽

Cancer Tissue ◽

Gene Expressions ◽

Tissue Sections

Spatial transcriptomics is an emerging technology requiring costly reagents and considerable skills, limiting the identification of transcriptional markers related to histology. Here, we show that predicted spatial gene-expressions in unmeasured regions and tissues can enhance biologists' histological interpretations. We developed the Deep learning model for Spatial gene Clusters and Expression, DeepSpaCE and confirmed its performance using the spatial-transcriptome profiles and immunohistochemistry images of consecutive human breast cancer tissue sections. For example, the predicted expression patterns of SPARC, an invasion marker, highlighted a small tumor-invasion region that is difficult to identify using raw data of spatial transcriptome alone because of a lack of measurements. We further developed semi-supervised DeepSpaCE using unlabeled histology images and increased the imputation accuracy of consecutive sections, enhancing applicability for a small sample size. Our method enables users to derive hidden histological characters via spatial transcriptome and gene annotations, leading to accelerated biological discoveries without additional experiments.

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Combining Bayesian Approaches and Evolutionary Techniques for the Inference of Breast Cancer Networks

10.1101/115261 ◽

2017 ◽

Author(s):

Stefano Beretta ◽

Mauro Castelli ◽

Ivo Gonçalves ◽

Ivan Merelli ◽

Daniele Ramazzotti

Keyword(s):

Breast Cancer ◽

Graphical Models ◽

Protein Interactions ◽

Large Scale ◽

Small Sample Size ◽

Small Sample ◽

Cancer Data ◽

Correlation Networks ◽

Model Complex ◽

Cancer Networks

AbstractGene and protein networks are very important to model complex large-scale systems in molecular biology. Inferring or reverseengineering such networks can be defined as the process of identifying gene/protein interactions from experimental data through computational analysis. However, this task is typically complicated by the enormously large scale of the unknowns in a rather small sample size. Furthermore, when the goal is to study causal relationships within the network, tools capable of overcoming the limitations of correlation networks are required. In this work, we make use of Bayesian Graphical Models to attach this problem and, specifically, we perform a comparative study of different state-of-the-art heuristics, analyzing their performance in inferring the structure of the Bayesian Network from breast cancer data.

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Retrospective, observational study on usage of evogliptin in T2DM patients: A real-World experience in Indian patients

Indian Journal of Pharmacy and Pharmacology ◽

10.18231/j.ijpp.2021.035 ◽

2021 ◽

Vol 8 (3) ◽

pp. 205-207

Author(s):

Abhijit Trailokya ◽

Amol Aiwale ◽

Roshan Pawar ◽

Suhas Erande

Keyword(s):

Real World ◽

Small Sample Size ◽

Small Sample ◽

Hypoglycemic Agents ◽

P Value ◽

Base Line ◽

Oral Hypoglycemic Agents ◽

Naive Patient ◽

Indian Patients ◽

Treatment Naïve

This study aimed to assess effectiveness and safety of Evogliptin 5 mg in patients with T2DM who were prescribed Evogliptin alone or with other oral hypoglycemic agents in real world scenario. Overall 20 patients who received Evogliptin as routine clinical practice in management of T2DM were analyzed retrospectively from single center. Data collected from past medical records. Primary endpoint was mean changes in HbA1c from baseline to weeks 24 and secondary endpoints were Change in HbA1c from baseline to weeks 12 Change from baseline in FPG & PPG at weeks 12 & 24.Significant reduction in HbA1c at the end of 12 and 24 weeks of Evogliptin therapy was - 0.9% and -1.45% respectively from the baseline of HbA1c 8.6% (p value <0.001). At the end of 12 and 24 weeks of addition of Evogliptin, significant reduction in FBG were seen i.e -49.5 mg/dl and -90.7mg/dl respectively from base line of 182 mg/dl and reduction in PPG was -79.4mg/dl and -116.6mg/dl respectively from base line 277 mg/dl (p value <0.001). Evogliptin was found to be effective when added to the patients who were uncontrolled on dual / triple oral anti-diabetic medications and even in treatment naïve patient. It effectively showed reduction in HbA1c, FBG and PPG and the end of 12 and 24 weeks when added to existing anti-diabetic medications & well tolerated in type 2 diabetes Indian patients.Small sample size and retrospective study

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Discrepancy of Blast Percentage between the Bone Marrow Aspirate and Flow Cytometry and Its Impact on Survival Outcomes in Patients with Myelodysplastic Syndromes Excess Blast (MDS-EB)

Blood ◽

10.1182/blood-2019-125439 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 5441-5441

Author(s):

Meera Yogarajah ◽

Phuong L. Nguyen ◽

Rong He ◽

Hassan B. Alkhateeb ◽

Mithun Vinod Shah ◽

...

Keyword(s):

Bone Marrow ◽

Flow Cytometry ◽

Small Sample Size ◽

Scoring Systems ◽

Standard Of Care ◽

Risk Groups ◽

Small Sample ◽

International Prognostic Scoring System ◽

P Value ◽

Number Of Patients

Background MDS is a heterogeneous disease and the revised International Prognostic Scoring System (IPSS-R) is utilized in prognostication. The percentage (%) of blasts in the bone marrow is determined in the aspirate morphologically. Though the former is the standard of care the blast percentage is also reported by flow cytometry and biopsy which can many times be inconsistent. We previously presented the utilization of biopsy based blast percentage which showed meaningful prognostic groups compared to aspirate. In this study we compare the blasts as reported by the aspirate and flow cytometry in MDS-EB in calculating IPSS-R. Methods The MDS database was reviewed for cases of MDS-EB after due IRB approval at the Mayo clinic. We calculated IPSS-R scores based on the aspirate blast % (IPSS-RAsp) and flow blast% (IPSS-Rfl). The aspirate blast percentage was reported morphologically. Suboptimal aspirates were excluded from the study. The flow blast percentage was determined by immunophenotyping. The overall survival (OS) was determined by IPSS-RAsp and IPSS-RFl. OS estimates were calculated by Kaplan-Meier curves and log-rank testing using JMP v.13. Uno's concordance statistic was used to compare the 2 risk scoring systems. Results Of 1322 patients, 431 (33%) cases were identified with MDS-EB out of which 120 (29%) cases had blasts reported in the aspirate and flow. Based on aspirate MDS EB1: 54% (n=65), MDS EB2 46% (n=55). The hematological, cytogenetic and R-IPSS categories were compared between MDS-EB1 and MDS- EB 2. The blast percentage and hemoglobin levels was significantly different between MDS-EB1 and EB2 as seen in table 1, however the IPSS-R risk groups were not significantly different. The flow cytometry was concordant with aspirate in 66/120 (55%) cases. Out of the dis-concordant cases only 20% (11/54) was upstaged by flow cytometry with most of the patients being down staged as expected by the techniques used in processing the blood and hence not reliable when reported low (Figure 1). The OS outcomes based on the IPSS- R asp, IPSS-Rfl areshown in figure 2A,2B .The p value with aspirate based R-IPSS was more significant than flow cytometry based R-IPSS (p= 0.0007 vs 0.0174). We compared the two models for observed OS differences using the Uno model which was not statistically significant. (p= 0.6) Conclusions Both models did not show a difference which is likely due to the very small sample size. However flow cytometry did down stage more patients when disconcordant and may have less value in that setting. It would be ideal to compare all 3 models aspirate, biopsy and flow cytometry however we did not have enough number of patients to do the comparison. Disclosures Patnaik: Stem Line Pharmaceuticals.: Membership on an entity's Board of Directors or advisory committees. Al-Kali:Astex Pharmaceuticals, Inc.: Research Funding.

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Impact of race on biomarker testing among HER2- advanced breast cancer (ABC) patients (pts) in the United States: Results from a real-world study.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.10598 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 10598-10598

Author(s):

Reshma L. Mahtani ◽

Alexander Niyazov ◽

Katie Lewis ◽

Lucy Massey ◽

Alex Rider ◽

...

Keyword(s):

Breast Cancer ◽

Targeted Therapies ◽

Small Sample Size ◽

The United States ◽

Small Sample ◽

Access To Treatment ◽

History Of ◽

Biomarker Testing ◽

Abstract Data ◽

The Impact

10598 Background: African Americans (AA) have the highest breast cancer (BC) mortality rate. Access to treatment is a known contributing factor. In the past 4 years, several targeted therapies for HER2- BC have become available which require testing for specific biomarkers. This study assessed the impact of race on biomarker testing rates in HER2- ABC pts receiving treatment in the US. Methods: Oncologists were recruited to abstract data from medical charts for the next 8-10 pts receiving treatment with HER2- ABC during Sept 2019-Apr 2020. Pts records were stratified by race and categorized into 3 mutually exclusive cohorts [White/Caucasian (White), AA, Other]. The other race cohort was excluded from this analysis due to small sample size. Differences in pt demographics/clinical characteristics were analyzed via Fisher’s exact tests. Testing rates for actionable biomarkers (i.e. BRCA1/2, PIK3CA, PD-L1) were compared between White and AA pts utilizing logistic regressions controlling for age, known family history of a BRCA-related cancer, hormone receptor (HR) status and practice setting (academic vs. community). Further analyses by age will be presented. Results: This analysis included 378 pts records, provided by 40 oncologists. Mean age was 64 years; 77% had HR+/HER2- ABC; 20% had advanced triple negative breast cancer (TNBC), 3% had ABC with an unknown HR status. Compared to White pts, AA pts were significantly more likely to have advanced TNBC (27% vs. 18%, p<0.05). Compared to White pts, AA pts had significantly lower BRCA1/2 mutation (mut) testing rates (Table). Numerically lower rates of PIK3CAmut and PD-L1 testing were observed among AA pts (Table). BRCA1/2mut positivity rate (germline [g] and/or somatic [s]) was higher among AA vs. White pts (30% vs. 22%). Positivity rate for PIK3CAmut was lower for AA vs. White pts (8% vs. 11%). Conclusions: A higher than expected BRCA1/2mut positivity rate was observed than previously reported in the literature. This is likely because this analysis included s BRCA1/2mut and represented a high risk pt population. Across all biomarkers assessed, AA pts had lower testing rates than White pts. This suggests racial disparities in testing rates of actionable biomarkers. Consistent with guidelines, and with the increased availability of targeted therapies, focused efforts should be developed to increase biomarker testing in AA pts. Funding: Pfizer Biomarker Testing Rates by Race.[Table: see text]

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Partial Least Square Analyses of Landscape and Surface Water Biota Associations in the Savannah River Basin

ISRN Ecology ◽

10.5402/2011/571749 ◽

2011 ◽

Vol 2011 ◽

pp. 1-11 ◽

Cited By ~ 6

Author(s):

Maliha S. Nash ◽

Deborah J. Chaloud

Keyword(s):

Surface Water ◽

Small Sample Size ◽

Surface Water Quality ◽

Spatial Location ◽

Small Sample ◽

Partial Least Square ◽

Least Square ◽

Data Sets ◽

Savannah River ◽

Remotely Sensed Data

Ecologists are often faced with problem of small sample size, correlated and large number of predictors, and high noise-to-signal relationships. This necessitates excluding important variables from the model when applying standard multiple or multivariate regression analyses. In this paper, we present the results of applying PLS to explore relationships among biotic indicators of surface water quality and landscape conditions accounting for the above problems. Available field sampling and remotely sensed data sets for the Savannah Basin are used. We were able to develop models and compare results for the whole basin and for each ecoregion (Blue Ridge, Piedmont, and Coastal Plain) in spite of the data constraints. The amount of variability in surface water biota explained by each model reflects the scale, spatial location, and the composition of contributing landscape metrics. The landscape-biota model developed for the whole basin using PLS explains 43% and 80% of the variation in water biota and landscape data sets, respectively. Models developed for each of the three ecoregions indicate dominance of landscape variables which reflect the geophysical characteristics of that ecoregion.

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Lower rates of mortality, readmission and reoperation in patients receiving acupuncture after hip fracture: a population-based analysis

Acupuncture in Medicine ◽

10.1177/0964528420911664 ◽

2020 ◽

Vol 38 (5) ◽

pp. 352-360

Author(s):

Jeff Chien-Fu Lin ◽

Tzu-Chieh Lin ◽

Chi-Fung Cheng ◽

Ying-Ju Lin ◽

Sophia Liang ◽

...

Keyword(s):

Hip Fracture ◽

Lower Risk ◽

Small Sample Size ◽

Population Based ◽

Small Sample ◽

Acupuncture Group ◽

Research Database ◽

Complication Rates ◽

Using Data ◽

Reoperation Rates

Background: Studies on the effects of acupuncture on mortality and complication rates in hip fracture patients are limited by small sample size and short follow-up time. We aimed to assess the associations of acupuncture use with mortality, readmission and reoperation rates in hip fracture patients using a longitudinal population-based database. Methods: A retrospective matched cohort study was conducted using data for the years 1996–2012 from Taiwan’s National Health Insurance Research Database. Hip fracture patients were divided into an acupuncture group consisting of 292 subjects who received at least 6 acupuncture treatments within 183 days of hip fracture, and a propensity score matched “no acupuncture” group of 876 subjects who did not receive any acupuncture treatment and who functioned as controls. The two groups were compared using survival analysis and competing risk analysis. Results: Compared to non-treated subjects, subjects treated with acupuncture had a lower risk of overall death (hazard ratio (HR): 0.41, 95% confidence interval (CI): 0.24–0.73, p = 0.002), a lower risk of readmission due to medical complications (subdistribution HR (sHR): 0.64, 95% CI: 0.44–0.93, p = 0.019) and a lower risk of reoperation due to surgical complications (sHR: 0.62, 95% CI: 0.40–0.96, p = 0.034). Conclusion: This is the first study to suggest that postoperative acupuncture in hip fracture patients is associated with significantly lower mortality, readmission and reoperation rates compared with those of matched controls.

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The Implementation of a Complication Avoidance Care Bundle Significantly Reduces Adverse Surgical Outcomes in Orthopedic Trauma Patients

Journal of Clinical Medicine ◽

10.3390/jcm9124006 ◽

2020 ◽

Vol 9 (12) ◽

pp. 4006

Author(s):

Thomas Lustenberger ◽

Simon Lars Meier ◽

René Danilo Verboket ◽

Philipp Störmann ◽

Maren Janko ◽

...

Keyword(s):

Complication Rate ◽

Surgical Outcomes ◽

Surgical Complications ◽

Situational Awareness ◽

Surgical Complication ◽

Surgical Site Infections ◽

Care Bundle ◽

Trauma Patients ◽

Complication Rates ◽

Time Period

Background: Surgical complications are associated with a significant burden to patients and hospitals and are increasingly discussed in recent literature. This cohort study reviewed surgery-related complications in a Level I trauma center. The effect of a complication avoidance care bundle on the rate of surgical complications was analyzed. Methods: All complications (surgical and nonsurgical) that occur in our trauma department are prospectively captured using a standardized documentation form and are discussed and analyzed in a weekly trauma Morbidity and Mortality (M&M) conference. Surgical complication rates are calculated using the annual surgical procedure numbers. Based on discussions in the M&M conference, a complication avoidance care bundle consisting of five measures was established: (1) Improving team situational awareness; (2) reducing operating room traffic by staff members and limiting door-opening events; (3) preoperative screening for infectious foci; (4) adapted preoperative antibiotic prophylaxis in anatomic regions with a high risk of infectious complications; and (5) use of iodine-impregnated adhesive drape. Results: The number of surgical procedures steadily increased over the study years, from 3587 in 2015 to 3962 in 2019 (an increase of 10.5%). Within this 5-year study period, the overall rate of surgical complications was 0.8%. Surgical site infections were the most frequently found complications (n = 40, 24.8% of all surgical complications), followed by screw malposition (n = 20, 12.4%), postoperative dislocations of arthroplasties (n = 18, 11.2%), and suboptimal fracture reduction (n = 18, 11.2%). Following implementation of the complication avoidance care bundle, the overall rate of surgical complications significantly decreased, from 1.14% in the year 2016 to 0.56% in the study year 2019, which represents a reduction of 51% within a 3-year time period. Conclusions: A multimodal strategy targeted at reducing the surgical complication rate can be successfully established based on a transparent discussion of adverse surgical outcomes. The combination of the different preventive measures was associated with reducing the overall complication rate by half within a 3-year time period.

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