scholarly journals Adjuvant trastuzumab with or without chemotherapy in stage 1 pT1N0 HER2+ breast cancer: a National Cancer Database analysis

2021 ◽  
Author(s):  
Lifen Cao ◽  
Robert Shenk ◽  
Nickolas Stabellini ◽  
Megan E. Miller ◽  
Christopher W. Towe ◽  
...  
Keyword(s):  
Breast Cancer ◽  
National Cancer Database ◽  
Database Analysis ◽  
Adjuvant Trastuzumab ◽  
Her2 Breast Cancer ◽  
Stage 1

Commission on Cancer CP3R Compliance Rates for Treatment of Patients With Triple Negative and HER2+ Breast Cancer: A National Cancer Database Analysis

2021 ◽  
pp. 000313482110516
Author(s):  
Srivarshini C. Mohan ◽  
Joshua Tseng ◽  
Marissa Srour ◽  
Alice Chung ◽  
Ashley Marumoto ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Cox Regression ◽  
Quality Care ◽  
Private Insurance ◽  
National Cancer Database ◽  
Database Analysis ◽  
Her2 Breast Cancer ◽  
Academic Hospitals ◽  
Multi Agent

Background Cancer Program Practice Profile Reports (CP3R) metrics were released by the Commission on Cancer to provide standards for high-quality care. One metric is the recommendation of combination chemotherapy or chemo-immunotherapy (CIT) within 120 days of diagnosis for women under 70 with AJCC T1cN0M0 or Stage IB-III HER2+ or hormone receptor negative breast cancer ([Multi-agent chemotherapy] MAC). Our study assesses national concordance rates for MAC and CIT. Methods The National Cancer Database was queried from 2004-2014. Results 122,045 patients met criteria, of whom treatment for 101,800 (83.4%) patients was concordant with MAC and CIT. Treatment concordance increased from 75.7% in 2004 to 89.5% in 2014. For HER2+ patients, use of CIT treatment downtrended with progression of pathological stage, from 70.1% (stage I) to 58.1% (stage III). Mean overall survival of patients whose treatment was concordant with MAC and CIT was longer than that of patients who were non-concordant (146.6 vs 143.8 months, P <.01). On Cox regression, there was a survival benefit for concordant patients who were treated at academic hospitals (HR .89, 95% CI 0.802-.976) and had private insurance (HR .76, 95% CI 0.65-.89). Conclusion Compliance with MAC and CIT has improved over the past decade and is associated with a significant improvement in overall survival.

scholarly journals Adjuvant Trastuzumab with or without Chemotherapy in Stage 1 pT1N0 HER2+ Breast Cancer: A National Cancer Database Analysis

2021 ◽  
Author(s):  
Lifen Cao ◽  
Robert Shenk ◽  
Nickolas Stabellini ◽  
Megan E. Miller ◽  
Christopher W. Towe ◽  
...  
Keyword(s):  
Overall Survival ◽  
Disease Free Survival ◽  
Invasive Disease ◽  
Primary Diagnosis ◽  
National Cancer Database ◽  
Breast Cancers ◽  
Adjuvant Trastuzumab ◽  
Propensity Match ◽  
Her2 Breast Cancer ◽  
Stage 1

Abstract Purpose: Approximately 20% of all breast cancers (BC) are HER2 amplified. In the APT trial, weekly paclitaxel/ trastuzumab in node negative HER2+ BC with tumors <3 cm was associated with a 7-year invasive disease-free survival of 93%. However, this was in the context of a non-randomized trial, and for pT1N0 HER2+ BC it remains unclear whether HER2 monotherapy would provide similar clinical outcomes to chemo-HER2 therapy. We hypothesized that adjuvant chemo-HER2 therapy would be associated with a modestly improved overall survival compared to HER2 monotherapy in patients with tumors <2cm. Methods: In the National Cancer Database (2004-2017), patients with a primary diagnosis of pT1N0M0 HER2+ BC, were separated into two groups: (i) HER2 monotherapy, i.e. trastuzumab, and (ii) chemo-HER2 therapy. A 3:1 propensity match was performed to balance patient selection bias between the two different cohorts. Long-term overall survival (OS) was compared between both groups. Results: A total of 23, 281 patients met the criteria. 22,268 (96.7%) received chemo-HER2 therapy and 1,013 (4.4%) received HER2 monotherapy. Propensity match identified 1,995 patients who received chemo-HER2 therapy, and 666 who received HER2 monotherapy. After match, adjuvant chemo-HER2 therapy was associated with a modest survival advantage over HER2 monotherapy (5-year OS 94.1% vs. 90.6%, P=0.041). Conclusions: Even though there is a modest OS advantage favoring adjuvant chemo-HER2 therapy in pT1N0 HER2+ BC, HER2 monotherapy was associated with 5-year OS >90%. Therefore, in select patients who have contraindications for cytotoxic chemotherapy, or decline adjuvant chemotherapy, adjuvant trastuzumab monotherapy appears to be a reasonable alternative.

Clinical significance of crown-like structures to trastuzumab response in patients with primary invasive HER2+ breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e12533-e12533
Author(s):  
Constantinos Savva ◽  
Charles N Birts ◽  
Stéphanie A Laversin ◽  
Alicia Lefas ◽  
Jamie Krishnan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adipose Tissue ◽  
Cancer Patients ◽  
Metastatic Disease ◽  
Cox Regression ◽  
Prognostic Significance ◽  
Metabolic Reprogramming ◽  
Breast Cancer Patients ◽  
Adjuvant Trastuzumab ◽  
Her2 Breast Cancer

e12533 Background: Obesity is associated with breast cancer development and worse survival. Obesity can initiate, promote, and maintain systemic inflammation via metabolic reprogramming of macrophages that encircle adipocytes, termed crown-like structures (CLS). In breast cancer patients, CLS are present in 36-50% of patients and have been associated with anthropometric parameters. Here we focus on HER2+ breast cancer. The role of adiposity in HER2+ breast cancer is conflicting which may be attributed to the tumour heterogeneity. Adiposity has also been shown to affect the local immune environment of solid tumours. However, the prognostic significance of CLS in HER2+ breast cancer is still unknown. Methods: We investigated the prognostic significance of CLS in a cohort of 219 patients with primary HER2+ breast cancer who were diagnosed between 1982 to 2012 in Southampton General Hospital. This cohort includes 76 HER2+ trastuzumab naïve patients and 143 HER2+ patients treated with adjuvant trastuzumab. We stained FFPE tumour samples for the expression of CD68, CD16 and CD32B on CLS and correlated these to clinical outcomes. CLS were defined as CLS within distant adipose tissue, CLS within the adipose-tumour border (B-CLS) and intratumoural CLS. CLS were quantified manually in full face sections by two independent scorers and descriptive and Cox regression analysis was carried out. Results: A total of 201 tumours were suitable for CLS analyses. The median follow-up was 34.74 months (range, 0.43-299.08). In the trastuzumab naive cohort, B-CLS≤1 and B-CLS > 1 were present in 37 (52.11%) and 34 (47.89%), respectively. In the trastuzumab treated cohort, B-CLS≤1 were identified in 69 (53.08%) and B-CLS > 1 were found in 61 (46.92%) of the tumours. CLS were more commonly found in the adipose-tumour border (60.89%) rather than in the distant adipose tissue (36.14%) or intratumorally (14.36%). The presence of any CLS was significantly associated with BMI≥25 kg/m2 (p = 0.018). There was strong evidence of association between CD68+CD32B+ B-CLS and BMI≥25 kg/m2 (p = 0.007). Co-expression of CD16 and CD32B by B-CLS was more frequent in patients with BMI≥25 kg/m2 (p = 0.036). Survival analysis showed shorter time to metastatic disease in patients with CD68+ B-CLS > 1 (p = 0.011) in the trastuzumab treated cohort. Subgroup analysis revealed that in the BMI≥25 kg/m2 group, patients with CD68+ B-CLS > 1 had shorter time to metastatic disease compared to patients with B-CLS≤1 (p = 0.004). Multivariate cox regression showed that B-CLS > 1 is an independent prognostic factor for shorter time to metastatic disease in patients with primary HER2+ breast cancer that received adjuvant trastuzumab (HR 6.81, 95%CI (1.38-33.54), p = 0.018). Conclusions: B-CLS can be potentially used as a predictive biomarker to optimize the stratification and personalisation of treatment in HER2-overexpressed breast cancer patients.

Adjuvant radiotherapy (RT) and trastuzumab in stage I-IIA breast cancer: Toxicity data from North Central Cancer Treatment Group Phase III trial N9831

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 523-523 ◽  
Author(s):  
M. Y. Halyard ◽  
T. M. Pisansky ◽  
L. J. Solin ◽  
L. B. Marks ◽  
L. J. Pierce ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Phase Iii ◽  
Breast Cancer Patients ◽  
Cardiac Events ◽  
Concurrent Administration ◽  
Adjuvant Trastuzumab ◽  
Her2 Breast Cancer ◽  
Significant Difference

523 Background: Adjuvant trastuzumab (Herceptin [H]) with chemotherapy improves outcome in HER2+ breast cancer (BC). Preclinical studies suggest H may enhance RT. We herein assess if H given with adjuvant RT increases adverse events (AE) after breast conserving surgery or mastectomy. Methods: N9831 randomized 3505 women with pT1–3N1–2M0, pT2–3N0M0, or pT1cN0M0 (ER/PR negative) HER2+ BC to doxorubicin (A) and cyclophosphamide (C) followed by weekly paclitaxel (T), AC→T→H, or AC→TH→H. Post-lumpectomy breast ± nodal RT was recommended, as was post-mastectomy chest wall + nodal RT (>3 nodes +); internal mammary RT was prohibited. RT started within 5 weeks of completion of T and allowed concurrently with H. 2324 eligible patients were enrolled on study prior to April 25, 2004: 1460 patients receiving RT are available for analysis of RT-associated AEs. Also, 1286 patients on +H arms who completed T (908 +RT and 378 -RT) are available for analysis of clinical cardiac events (CE). Rates of RT-associated AEs were compared across treatment arms, and rates of CE were compared for +RT vs -RT patients within +H arms. All reported p-values are for chi-squared statistics. Results: With a median follow-up of 1.5 years, significant differences among arms in RT-associated AEs were not identified. No significant differences across arms in +RT patients existed in the incidence of skin reaction (p=0.78), pneumonitis (p=0.78), dyspnea (p=0.87), cough (p=0.54), esophageal dysphagia (p=0.26), or neutropenia (p=0.16). There was a significant difference in +RT patients in the incidence of leukopenia (p=0.02) with higher incidence rates in the arms receiving H. RT did not increase the frequency of CE. In the AC→T→H arm, the incidence of CE was 2.2% in +RT patients versus 2.9% in -RT patients. In the AC→TH→H arm, the incidence of CE was 1.5% in +RT patients versus 6.3% in -RT patients. No difference in CE was seen between left- and right-sided RT fields in +RT patients in either +H arm. Conclusion: Concurrent administration of adjuvant RT with H in early stage breast cancer patients is not associated with an increased incidence of acute RT AEs. Further follow-up is required to assess late AEs. No significant financial relationships to disclose.

Recommendation of adjuvant chemotherapy and trastuzumab in older adults with HER2-positive breast cancer: A survey of oncologists

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9547-9547
Author(s):  
S. K. Pal ◽  
A. Naeim ◽  
F. L. Wong ◽  
C. T. Chung ◽  
S. Bhatia ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Older Adults ◽  
Health Status ◽  
Online Survey ◽  
Patient Treatment ◽  
Her2 Positive ◽  
Adjuvant Trastuzumab ◽  
Her2 Positive Breast Cancer ◽  
Her2 Breast Cancer ◽  
Positive Breast Cancer

9547 Background: Though substantial evidence supports the use of adjuvant trastuzumab in patients with HER2-positive breast cancer, a lesser amount of data is available to guide use of this therapy in older adults. The objective of the current study is to understand how patient age and health status impact the oncologists' decision to recommend adjuvant therapy in older women with HER2-positive breast cancer. Methods: Medical oncologists (n=151) participated in an online survey comprised of case scenarios with patients of varying age (70, 75, 80, 85) and health status (good, average, poor) with a T2(4 cm) N2(4+ LN) ER(-), HER2(+) breast cancer. Oncologists could offer the hypothetical patient treatment with chemotherapy and trastuzumab, chemotherapy alone, trastuzumab alone, or no therapy. The influence of age and health status on treatment recommendations was assessed using a generalized linear mixed-effects model. Results: With increasing age and deterioration of health status, the recommendation for chemotherapy with trastuzumab decreased (P<0.0001 for both). In contrast, recommendation for trastuzumab alone or no therapy increased with advancing age (P<0.0001 for both) and deteriorating health status (P<0.0035 and P=0.059, respectively). Chemotherapy alone was not frequently recommended, irrespective of age or health status. Conclusions: Given the relative dearth of evidence-based data for adjuvant treatment of HER2-positive breast cancer in older adults of varying health, oncologists recommend a diverse array of therapeutic approaches for this subgroup. Increasing age and declining health status lead to more frequent recommendation of trastuzumab alone or no therapy, and less frequent recommendation of chemotherapy with trastuzumab. [Table: see text] [Table: see text]

Duration of second-line T-DM1 therapy: Is it associated with duration of first-line anti-Her2 therapy in metastatic HER2 + breast cancer?

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12512-e12512
Author(s):  
Daniela Katz ◽  
Ilan Feldhamer ◽  
Sari Greenberg-Dotan ◽  
Ariel Hammerman
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast ◽  
Her2 Overexpression ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Duration Of Treatment ◽  
Adjuvant Trastuzumab ◽  
Her2 Breast Cancer ◽  
Line Standard

e12512 Background: Tumors with HER2 overexpression usually respond to HER2-targeted therapies. Since the CLEOPATRA and EMILIA trials, a taxane plus trastuzumab and pertuzumab (TTP) are the first-line standard for the management of HER2 + metastatic breast cancer (MBC) and trastuzumab emtansine (TDM-1) is the second-line standard. Intrinsic subtypes existing within HER2+ tumors may impact the degree of a patient’s response to anti HER2 therapy; however HER2 subtyping for predicting response is still experimental and not in routine clinical use. In this retrospective population-based study, we aimed to assess whether duration of treatment (DOT) of second-line TDM1 is associated with the DOT of first-line TTP, and might serve as a hint for a HER2 subtype. Methods: Clalit Health Services (CHS) manages health care of 52% of the Israeli population. We identified 113 HER2+ CHS MBC patients, treated with TTP as first-line treatment that initiated TDM1 as second-line, until Dec. 31, 2016. Patient's (pts) demography, HER2 and HR status were recorded. A Cox proportional hazard model, stratified by HR status, adjusted for age and prior adjuvant trastuzumab, was used to explore the association between second-line and first-line DOT in HR positive and negative pts. Results: Pts baseline characteristics and DOT in first- and second-line treatment are presented in the table. A statistically significant association between DOT of both treatment lines was found in HR positive pts with a trend also in HR negative pts. Conclusions: The observed association between first- and second-line DOT, unrelated to hormonal status, may result from a primary characteristic of the intrinsic tumor subtype, that impacts acquired resistance. Longer observations in larger patient cohorts are required to confirm this observation. [Table: see text]

Treatment and risk of mortality for 58,953 cases of stage 1, ER+/PR+/HER2- breast cancer in four mutually exclusive race/ethnicities.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12101-e12101
Author(s):  
Vincent Caggiano ◽  
Carol Parise
Keyword(s):  
Breast Cancer ◽  
Hormone Therapy ◽  
White Women ◽  
Cox Regression ◽  
Treatment Modalities ◽  
Her2 Breast Cancer ◽  
Risk Of Mortality ◽  
Increased Risk ◽  
Race Ethnicity ◽  
Stage 1

e12101 Background: The estrogen receptor positive (ER+), progesterone receptor positive (PR+), human epidermal growth factor 2 negative (HER2-) subtype is the most common. Cases of stage 1, ER+/PR+/HER2- are most often treated with hormone therapy alone, although this is not universal. The purpose of this study was to determine if there were differences in mortality for patients with stage 1, ER+/PR+/HER2- breast cancer given no treatment, chemotherapy alone, or both chemotherapy and hormone therapy when compared with hormone therapy alone for four mutually exclusive race/ethnicities. Methods: We identified 58,953cases of Stage 1, ER+/PR+/HER2- first primary female invasive breast cancer from the California Cancer Registry 2000-2014. Cases were stratified into white (n = 41,716), black (n = 2,310), Hispanic (n = 8,186) and Asian/Pacific Islander (API) (n = 6,741). Treatment was categorized as none, hormone therapy alone, chemotherapy alone, or both chemotherapy and hormone therapy. Kaplan Meier survival analysis and Cox Regression were used to assess the risk of mortality associated with treatment using hormone therapy alone as the reference category. Treatment was considered a risk for mortality and hazard ratios (HR) and 95% confidence intervals reported if the Wald χ2 was statistically significant (p < 0.05). Models were adjusted for age, grade, socioeconomic status, and tumor size. Separate analyses were conducted for each race/ethnicity. Results: White women, having no treatment (HR = 1.33; 1.14-1.54), or chemotherapy alone (HR = 1.49; 1.10-2.00) was associated with an increased risk of mortality. For API women, having the combination of chemotherapy and hormone therapy was associated with increased risk of mortality (HR = 2.47; 1.34-4.56). For black and Hispanic women, there was no difference in risk of morality for any combination of treatment when compared with hormone therapy. Conclusions: The effectiveness of treatment modalities for the Stage 1, ER+/ER+/HER2- subtype varies considerably by race/ethnicity.

Electronic calculation of quality measures in the EMR and dependence on data capture in structured fields: The OCM quality reporting experience.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18278-e18278
Author(s):  
James Hamrick ◽  
Cindy Revol ◽  
Rohit Parulkar ◽  
Olaf Lemmers ◽  
James Gippetti ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Quality Measures ◽  
Quality Measure ◽  
Data Element ◽  
Adjuvant Trastuzumab ◽  
Quality Reporting ◽  
Her2 Breast Cancer ◽  
Feasible Alternative ◽  
Data Elements

e18278 Background: Reporting of quality measures is ideally achieved electronically. This is dependent on presence of data elements in structured fields. We report on the variability of quality measure reporting in the OCM for quality measures OCM 8 (adjuvant chemotherapy in stage 3 colon cancer), 9 (adjuvant chemotherapy in HR- breast cancer), 10 (adjuvant trastuzumab for Her2+ breast cancer), and 11 (adjuvant hormonal therapy for HR+ breast cancer). Methods: Quality measures were calculated for 30,524 patients across 35 practices participating in the OCM. We examined the calculation of quality metrics OCM-8, 9, 10, and 11 based on presence or absence of data elements in the medical record. Results: For quality measures OCM-8 and 9 that require documentation of date of surgery, only 1.3% and 1.6%, respectively, of patients could be included in the calculation due to absence of surgical date in a structured field. For quality measures OCM 9 and 11 that require attestation of surgical staging of breast cancer, this data element was documented in 0% of patients. For OCM 9 and 10 that require stage documentation of breast cancer, this data element was documented in 63% and 75%, respectively, of patients (range 12-100%). In cases where staging criteria were not met, 58% and 44%, respectively, of patients were removed due to total absence of staging data in structured fields. Conclusions: Quality measure calculation and reporting is highly dependent on documentation of data elements in structured fields. Lack of documentation of key elements distorts calculation of the measure. Modification of physician workflow or restructuring of measure calculation to optimize use of well documented structured elements will improve generalizability of quality measure reporting. Manual abstraction of data does not represent a feasible alternative.

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