More than 50% of maternal deaths in the United States occur during the first year following childbirth. Nearly 40% of these deaths occur between days 1 and 41 of the postpartum period. Historically, women receive less attention from healthcare providers during the postpartum period when compared with the care provided during pregnancy
Breast cancer treatments (Rx) are becoming more individualized; however, there remain patients (pts) who refuse recommended standard Rx. There is paucity of data defining the characteristics of these pts. Our study objective was to identify socioeconomic characteristics of pts who refuse recommended Rx and analyze their outcome. Female pts diagnosed with IBC from 2004-2014 were selected from the NCDB. Socioeconomic characteristics and overall survival (OS) of pts who refused standard Rx (surgery, chemotherapy, anti-estrogen therapy, or radiation) were compared with an exact number of randomly matched patients who received recommended Rx. Frequency statistics, Mann-Whitney U test and logistic regression were used in statistical analyses. There were 1772260 IBC pts; 11164 (0.6%) refused surgery; 108,486 (6.1%) refused chemotherapy; 68,995 (3.9%) refused anti-estrogen; 52,081 (2.9%) refused radiation. Pts who refused recommended Rx were significantly more likely to die, to be older, non-Caucasian race, lower income, and surprisingly higher education than pts who received recommended Rx (p<0.05). Results reveal that older age, non-Caucasian race, and lower income were correlated with refusal of recommended Rx for IBC and consequently significantly worse OS compared to matched pts that received recommended Rx. When putting this into national perspective, this data reveals that almost 10% (˜25,000/yr) of newly diagnosed pts with IBC may choose to refuse one or more of recommended standard Rx. Further study is necessary to identify reasons for refusal and ways to minimize these events. Surgery NOSurgery YESChemoRx NOChemoRx YESAnti-estrogen Rx NO†Anti-estrogen Rx YES†# pts11164Random 11164 / 1630429108486Random 108486 /73550168995Random 68995 / 1039320N %OSDead6004 60.91639 16.320339 21.717159 17.512445 20.58726 14.2Alive3855 398393 83.773362 78.380710 82.548254 79.552534 85.8Odds ratio for death (95%CI)7.9 (7.4-8.5)*1.3 (1.2-1.3)*1.5 (1.5-1.6)*Survival months (mean)60.87452.86053.359.1Age≤40225 2727 6.52602 2.411911 113210 4.73583 5.241-693507 31.4*7330 65.760764 56*84835 78.236477 52.9**46575 67.570+7432 66.6*3107 27.845120 41.6*11740 10.829308 42.5**18837 27.3RaceWhite8439 75.69414 84.392013 84.887256 80.459542 86.359448 86.2Black2162 19.4*1215 10.911190 10.3**15188 146408 9.3 NS6259 9.1Other408 3.7*423 3.84323 4**4953 4.62369 3.4**2639 3.8Unknown155 1.4112 1960 0.91089 1676 1649 0.9Income≤38K2239 20.31652 14.916393 15.217146 169282 13.69645 14.138K-479992580 23.4**2359 21.324195 22.5*23071 21.514594 21.3*14473 21.248K-629992845 25.8**2991 2729646 27.5*28524 26.619335 28.2*18504 2763K+3378 30.6**4067 36.737489 34.8 NS38678 3625282 36.9 NS25798 37.7% with NO high school diploma21+1834 16.61578 14.314619 13.617427 16.2809111.89354 13.713-20.92937 26.62668 24.126426 24.5*26095 24.315697 22.9*15756 237-12.93686 33.4**3695 33.437084 34.4*35198 32.823997 35*23260 34<72588 23.4**3131 28.329641 27.5*28738 26.720728 30.3*20080 29.3p<.05 *higher or **lower likelihood to refuse Rx (logistic regression, 1st category=referent) NS=Not significant; †Radiation Rx data not shown, similar trends to anti-estrogen Rx Citation Format: Orucevic A, Heidel RE, Bell JL. Outcomes of patients with invasive breast cancer (IBC) refusing standard cancer treatments: 10-year analysis of the National cancer data base (NCDB) [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-08-19.
Background Adenosquamous carcinomas (ASQ) of the breast is rare, with a reported incidence of <1%. This tumor is considered to belong to the metaplastic breast carcinoma category and is commonly low grade. It has a distinct adenocarcinomatous component comprised of infiltrating small glands with varying degrees of squamous differentiation. The significance of ASQ differentiation and its impact on diagnosis, treatment and prognosis is based primarily on results from small retrospective case series reports. The objective of our study is to define prevalence, clinicopathologic characteristics, treatment patterns and prognosis of ASQ and compare these to the most frequent invasive breast carcinoma (BC), ductal (IDC), through analysis of the National Cancer Data Base (NCDB). Methods A retrospective observational study of NCDB patients (pts) compared all ASQ pts to the same number of randomly selected IDC pts (ICD-O-3 diagnosis codes 8560 and 8500, respectively) using SPSS software. Patients' clinicopathologic characteristics, treatment, and overall survival (OS) were analyzed using frequency statistics, t-tests, Mann-Whitney U tests, chi-square, Kaplan-Meier and logistic regression. Results From 1,932,688 female pts with invasive BC, 1,421,250 had IDC (73.5%); 453 had ASQ (0.0002%). ASQ pts were significantly (p<0.05) more likely to be: older, have grade 1 tumors, negative lymph nodes, ER, PR, and HER2-negative tumors when compared to IDC. No significant difference was found in tumor size, TNM stage, or treatment. ASQ pts had significantly worse 5-year OS than IDC pts (p<0.025; 73% vs 82% at 60 months, respectively). Conclusion Our study is the largest study to date on ASQ revealing that this unique disease is an aggressive carcinoma and carries a significantly worse prognosis than IDC. Since prospective randomized clinical trial(s) are unlikely, further studies on the genomic make-up of ASQ are needed in order to understand biology and personalize treatment of pts with this uncommon BC. Clinicopathologic characteristics of pts with ASQ & IDC - NCDB analysis (2004-2015)DemographicsASQIDC (random sample)Adjusted Odds Ratio95% CI Lower95% CI Upper N=453N=453 N%N% Age Average63.50*60.62 Tumor Size (mm) Median18.018.0 Interquartile Range2419 Grade 1202*88Referent 44.619.4 271*185.17.12.24 15.740.8 3136*147.40.29.57 3032.5 Unknown4433 9.77.3 # of node(s) positive 0296*267Referent 65.358.9 1 to 350*72.63.42.93 11.015.9 4 to 914*31.41.21.78 3.16.8 >10910.81.332.02 2.02.2 Unknown8473 18.516.1 TNM Stage I227223Referent 50.250.2 II1461301.1.821.49 32.329.3 III3855.68.431.07 8.412.4 IV1622.71.371.40 3.55.0 Unknown2514 5.53.2 ER (+)135*359 31.481 (-)295*849.36.812.8 68.619 PR (+)61*313 14.371.1 (-)367*12714.810.520.8 85.728.9 HER2 (+)8*44 3.218 (-)240*2016.63.014.3 96.882 Surgery Yes427424 94.794.2 No2426.92.521.62 5.35.8 Chemotherapy No199206 51.751.8 Yes1861921.00.761.33 48.348.2 Hormone Therapy No308131 76.832.7 Yes93270.15.11.2 23.267.3 Radiation No210200 46.944.3 Yes238251.90.71.17 53.155.7 5-year Overall Survival Alive137*165.65.43.98 64.974 Dead74*58 35.126 *Significant (p<.05) Citation Format: Cochrane K, Heidel RE, Bell JL, Orucevic A. Adenosquamous carcinoma of the breast, an uncommon diagnosis with poor prognosis – Lessons learned from analysis of the National Cancer Data Base 2004-2015 [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-08-22.
Oncotype DX (ODX) recurrence score (RS) breast cancer (BC) assay provides prognostic and predictive BC recurrence information for hormone(+)/node(-) patients (pts). Pts with low ODXRS (0-10) can safely forego adjuvant chemotherapy (ACH), while ACH is recommended for high ODXRS (≥26). No ACH recommendations were previously available for intermediate (11-25) ODXRS until 6/3/2018, when the TAILORx clinical trial results were presented and e-published. According to the new data, pts with ODXRS 11-25 can now safely forego ACH, although some benefit of ACH was found in pts ≤50 with ODXRS 16-25. These new data now allow us to categorize ODXRS as a binary variable. Since ODX is a costly assay, we previously developed and published a user-friendly nomogram based on clinicopathologic characteristics (CPC) of ODX tested patients captured by the National Cancer Data Base (NCDB) as a surrogate prediction model for the ODX assay. As intermediate score patients were excluded from our previously created nomogram, the objective of this update is to test the predictive value of CPC variables for forecasting the new TAILORx binary ODXRS stratification using the entire NCDB population of ODX tested pts. Five CPC variables (age, tumor size, grade, progesterone receptor status (PR) and the 4 most frequent BC histologic types) were assessed with logistic regression to predict for a low- or high-risk ODXRS test results using 0-15 or 0-25 and 16-100 or 26-100 for a low- and high-ODXRS, respectively. These ranges were used in the TAILORx trial. A training cohort consisted of 65,754 ODX tested ER+/HER2-/lymph-node-negative pts with 6-50mm tumor size, captured by the NCDB from 2010-2014; 18,585 ODX tested pts in 2015 served as an external validation cohort. The predictive accuracy of the regression model was yielded using a Receiver Operator Characteristic (ROC) analysis. Model fit was analyzed by plotting the predicted probabilities against the actual probabilities. Grade and PR are the most significant predictors for a low- or high-risk ODXRS, followed by tumor size, histologic tumor type and age for any of the tested cut-off values. The ROC curves showed the best agreement between the nomogram prediction and actual observation for 0-25 (low) and 26-100 (high) ODXRS cut-off value (C-index=0.81). Overall, our model correctly predicted for 99.2% of low-risk and 18.6% of high-risk ODX cases. These cut-off values were used for building the updated nomogram model. Predicting for Low-risk (LR) ODXRSTraining cohort N=65,754Points assignedAge (19-90)0-9Tumor Size (6-50mm)31-0G1100G262G30PR+ ≥1%70PR- <1%0IDC0ILC31IDC+ILC21IDC+other6 Total Points 0-241Probability LR ODXRS% accurately predicted LR ODX160.9195132.893112.79298.69024.1595% accurate for High-risk ODXRSIDC=Invasive ductal BC ILC=invasive lobular BC G=grade An updated nomogram is now available, created and validated based on the entire population of ODX tested pts (84,339) captured by the NCDB from 2010-2015. The updated nomogram correctly predicts for 99.2% of a low ODXRS with a 0.81 C-index. This revised calculator will continue serving as a surrogate for BC pts older than 50 for which ODX testing is not necessary, affordable or available. Citation Format: Orucevic A, McNeil ML, Bell JL, McNabb AP, Heidel RE. Nomogram update based on TAILORx clinical trial results - Oncotype DX breast cancer recurrence score can be predicted using clinicopathologic data [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P2-08-09.
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