HealthStat Consulting Inc.

Seattle, WA, United States

HealthStat Consulting Inc.

Seattle, WA, United States
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Calip G.S.,University of Illinois at Chicago | Calip G.S.,Fred Hutchinson Cancer Research Center | Calip G.S.,University of Washington | Malmgren J.A.,University of Washington | And 5 more authors.
Breast Cancer Research and Treatment | Year: 2015

Risk of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) post-breast cancer treatment with adjuvant chemotherapy and granulocyte colony-stimulating factors (G-CSF) is not fully characterized. Our objective was to estimate MDS/AML risk associated with specific breast cancer treatments. We conducted a retrospective cohort study of women aged ≥66 years with stage I–III breast cancer between 2001 and 2009 using the Surveillance, Epidemiology, and End Results-Medicare database. Women were classified as receiving treatment with radiation, chemotherapy, and/or G-CSF. We used multivariable Cox proportional hazards models to estimate adjusted hazard ratios (HR) and 95 % confidence intervals (CI) for MDS/AML risk. Among 56,251 breast cancer cases, 1.2 % developed MDS/AML during median follow-up of 3.2 years. 47.1 % of women received radiation and 14.3 % received chemotherapy. Compared to breast cancer cases treated with surgery alone, those treated with chemotherapy (HR = 1.38, 95 %-CI 0.98–1.93) and chemotherapy/radiation (HR = 1.77, 95 %-CI 1.25–2.51) had increased risk of MDS/AML, but not radiation alone (HR = 1.08, 95 % CI 0.86–1.36). Among chemotherapy regimens and G-CSF, MDS/AML risk was differentially associated with anthracycline/cyclophosphamide-containing regimens (HR = 1.86, 95 %-CI 1.33–2.61) and filgrastim (HR = 1.47, 95 %-CI 1.05–2.06), but not pegfilgrastim (HR = 1.10, 95 %-CI 0.73–1.66). We observed increased MDS/AML risk among older breast cancer survivors treated with anthracycline/cyclophosphamide chemotherapy that was enhanced by G-CSF. Although small, this risk warrants consideration when determining adjuvant chemotherapy and neutropenia prophylaxis for breast cancer patients. © 2015, Springer Science+Business Media New York.


Kaplan H.,Swedish Cancer Institute | Malmgren J.,HealthStat Consulting Inc. | Malmgren J.,University of Washington | De Roos A.J.,University of Washington | De Roos A.J.,Fred Hutchinson Cancer Research Center
Breast Cancer Research and Treatment | Year: 2013

Ionizing radiation is a known cause of myeloid leukemia, but it is not known whether therapeutic doses for breast cancer (BC) pose an increased risk. We hypothesized that BC radiation treatment is associated with increased risk of myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) as seen in a previously conducted study. We used 2001-2009 Surveillance, Epidemiology, and End Results (SEER) database records to identify a cohort of women with first primary stage 0 BC who were treated with radiation, a group which is not treated with chemotherapy. We identified subsequent MDS/AML diagnoses in the cohort using SEER to query appropriate ICD-O-3 codes. We compared observed MDS/AML rates in the BC cohort to expected rates, estimated as first primary MDS/AML in the entire female population, and calculated observed/expected rate ratios with 95 % confidence intervals (CI). Overall, a very small number of cases of MDS/AML occurred in this cohort with 22 observed cases versus 9.4 expected cases using national incidence data. We estimated an increased risk of 2.34 for MDS/AML in stage 0 BC cases treated with radiation compared to the general population (95 % CI 1.49, 3.46, p < 0.001). The age adjusted relative risk is 1.46, (95 % CI 0.93, 2.16, p = 0.08). Our results suggest that radiation treatment for BC is associated with an increased risk of MDS/AML and affects a very small number of patients. © 2012 Springer Science+Business Media New York.


Kaplan H.G.,Swedish Cancer Institute | Malmgren J.A.,HealthStat Consulting Inc. | Malmgren J.A.,University of Washington | Li C.I.,University of Washington | And 3 more authors.
Breast Cancer Research and Treatment | Year: 2013

Increased incidence of acute myeloid leukemia (AML) has been identified among breast cancer (BC) survivors but measurement has not included myelodysplastic syndrome (MDS). Our aim is to identify age and stage related MDS/AML incidence post BC diagnosis. We used the 2001-2009 Surveillance, Epidemiology, and end results (SEER) database to identify first primary stage I-III BC patients. Subsequent MDS or AML diagnosis was identified with observed rates compared to expected MDS/AML incidence in the general population. Age adjusted observed/expected rate ratios and 95 % confidence intervals (CI) were calculated. The unadjusted all age and stage MDS/AML incidence rate was.15 % (470/306,691) with a progressively higher rate by age (age 20-49 =.11, age 50-64 =.14, age 65+ =.21, and age 75+ =.18) and stage (stage I =.11, stage II =.18, and stage III =.22). Compared to the general population, BC patients had a 2.75-fold [95 % CI 2.51-3.00] increased relative risk of being diagnosed with MDS/AML. Young age survivors had highest relative risk [age 20-49: relative risk (RR) = 10.60 (95 % CI 8.57-12.93); age 50-64: 5.96 (95 % CI 5.13, 6.88); age 65-74 year-olds: 2.94 (95 % CI 2.45, 3.50); and age ≥75 year-olds: 1.28 (95 % CI 1.03, 1.56)]. Separately MDS relative risk was highest among young women [30.44 (95 % CI = 19.63, 44.62)]. MDS/AML relative risk increased from 1.87 to 5.66 for stage I-III. Conclusions: Myelodysplastic syndrome and acute myeloid leukemia relative risk is substantially elevated among breast cancer survivors especially those aged 20-49. While the actual number is small, MDS/AML is a serious disease. More research is needed to identify the treatments that put women at risk and find less leukemogenic options, especially for young women. © 2013 Springer Science+Business Media New York.


Kaplan H.G.,Swedish Medical Center | Malmgren J.A.,HealthStat Consulting Inc | Malmgren J.A.,University of Washington | Atwood M.,Swedish Medical Center | Goldstein L.C.,PhenoPath Laboratories
Cancer Management and Research | Year: 2010

Purpose: Human epidermal growth factor receptor 2 (HER2)/neu, topoisomerase II alpha (TOP2A), and polysomy 17 may predict tumor responsiveness to doxorubicin (DOX) therapy. Methods: We identified neoadjuvant DOX/cyclophosphamide treated breast cancer patients in our registry from 1997 to 2008 with sufficient tissue for testing (n = 34). Fluorescence in situ hybridization (FISH) testing was done on deparaffinized tissue sections pretreated using vendor's standard protocol modification, and incubated with US Food and Drug Administration approved Abbott Diagnostics Vysis PathVysion TM probe set, including Spectrum-Green-conjugated probe to α-satellite DNA located at the centromere of chromosome 17 (17p11.1-q11.1) and a Spectrum-Orange-conjugated probe to the TOP2A gene. Morphometric analysis was performed using a MetaSystems image analysis system. Manual counting was performed on all samples in which autofluorescence and/or artifact prevented the counting of sufficient numbers of cells. A ratio. >2.0 was considered positive for TOP2A amplification. Polysomy 17 (PS17) presence was defined as signals of ≥2.5. Outcomes were pathological complete response (pCR), partial response (PR), and nonresponse (NR). Results: Of 34 patients tested, one was TOP2A amplified (hormone receptor negative/HER2 negative, partial responder). The subset of TOP2A nonamplified, HER2 negative, and PS17 absent (n = 23) patients had treatment response: pCR = 2 (9%), PR = 14 (61%), and NR = 7 (30%). Including the two PS17 present and HER2-positive patients (n = 33), 76% of TOP2A nonamplified patients had pCR or PR. Conclusions: We observed substantial treatment response in patients lacking three postulated predictors that would be difficult to attribute to cyclophosphamide alone. Patients who are HER2 negative and lack TOP2A amplification and PS17 should not be excluded from receiving DOX-containing regimens.©2010 Kaplan et al, publisher and licensee Dove Medical Press Ltd.


Kaplan H.G.,Swedish Medical Center | Malmgren J.A.,HealthStat Consulting Inc. | Malmgren J.A.,University of Washington | Atwood M.K.,Swedish Medical Center
BMC Cancer | Year: 2011

Background: Our objective was to measure myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML) risk associated with radiation and/or chemotherapy breast cancer (BC) treatment.Methods: Our study cohort was composed of BC patients diagnosed from 1990 to 2005 and followed up for blood disorders, mean length of follow up = 7.17 years, range 2-18 years. 5790 TNM stage 0-III patients treated with surgery alone, radiation and/or chemotherapy were included. Patients without surgery (n = 111), with stem cell transplantation (n = 98), unknown or non-standard chemotherapy regimens (n = 94), lost to follow up (n = 66) or 'cancer status unknown' (n = 67) were excluded. Rates observed at our community based cancer care institution were compared to SEER incidence data for rate ratio (RR) calculations.Results: 17 cases of MDS/AML (10 MDS/7 AML) occurred during the follow up period, crude rate .29% (95% CI = .17, .47), SEER comparison RR = 3.94 (95% CI = 2.34, 6.15). The RR of MDS in patients age < 65 comparing our cohort incidence to SEER incidence data was 10.88 (95% CI = 3.84, 24.03) and the RR of AML in patients age < 65 was 5.32 (95% CI = 1.31, 14.04). No significant increased risk of MDS or AML was observed in women ≥ 65 or the surgery/chemotherapy-only group. A RR of 3.32 (95% CI = 1.42, 6.45) was observed in the surgery/radiation-only group and a RR of 6.32 (95% CI = 3.03, 11.45) in the surgery/radiation/chemotherapy group. 3 out of 10 MDS cases died of disease at an average 3.8 months post diagnosis and five of seven AML cases died at an average 9 months post diagnosis.Conclusions: An elevated rate of MDS and AML was observed among breast cancer patients < 65, those treated with radiation and those treated with radiation and chemotherapy compared to available population incidence data. Although a small number of patients are affected, leukemia risk associated with treatment and younger age is significant. © 2011 Kaplan et al; licensee BioMed Central Ltd.


Kaplan H.G.,Swedish Cancer Institute | Malmgren J.A.,HealthStat Consulting Inc. | Malmgren J.A.,University of Washington | Atwood M.K.,Swedish Cancer Institute
Journal of Geriatric Oncology | Year: 2013

Objective: To assess adjuvant chemotherapy recommendations, administration and disease-specific survival for invasive breast cancer (BC) among patients 75. years and older compared with that of younger women. Materials and Methods: A cohort of patients with primary breast cancer, aged 65-94, stages I-III from 1990 to 2010 was identified and tracked by our breast cancer registry (n. =2329). Stage, treatment recommendations and outcomes were chart abstracted at diagnosis and follow-up. Associations were tested with logistic regression and the Kaplan-Meier method was used for disease-specific survival (DSS). Results: Seventy-five percent of patients aged 75. + were seen by an oncologist compared with 78% aged 70-74 and 84% aged 65-69. Women aged 75. + seen by an oncologist were more likely age 75-79, stage II/III, hormone receptor negative (HR. -) or her-2/neu positive. Of these patients, age, stage and HR status were related to a chemotherapy recommendation. Of 106 patients recommended for chemotherapy, 18 refused (17%) and 24 did not complete treatment due to complications, patient choice, disease progression or death not related to treatment. DSS was equivalent for patients 75 and older with stage I BC compared to 65-74. year olds, but significantly worse in stage II and III patients, respectively (stage II 5. year DSS 90% vs. 97%, stage III 5. year DSS 65% vs. 81%). Conclusion: Patients aged 75 and older with invasive breast cancer who were recommended for adjuvant chemotherapy have a high rate of refusal and complications from therapy. Their disease specific mortality disadvantage is restricted to stage II and III patients, a group in need of effective therapy to improve disease survival. © 2013 Elsevier Inc.


Malmgren J.A.,HealthStat Consulting Inc. | Malmgren J.A.,University of Washington | Calip G.S.,University of Illinois at Chicago | Pyott S.M.,PhenoPath Laboratories | And 2 more authors.
Leukemia Research | Year: 2016

Background Therapy-related myelodysplastic syndrome (t-MDS) is a serious clinical disease occurring after breast cancer treatment. Methods A cohort of 11,684 invasive breast cancer (BC) patients from 1990–2014 were followed for incidence of t-MDS through institutional and the Surveillance, Epidemiology and End Results (SEER) Program registries. t-MDS cases were identified using ICD-O SEER registry codes, pathology and chart reports. Treatment, cytogenetics, and time from BC diagnosis to t-MDS and t-MDS diagnosis to last follow up or death were obtained. Incidence rate ratios were calculated using SEER national incidence rates for comparison. Results 27 cases of t-MDS post BC treatment were confirmed. 96% of cases were breast cancer stage I–II at diagnosis. All patients had received radiation treatment and 59% received adjuvant chemotherapy. Two patients were alive with no evidence of disease after treatment with stem cell transplantation (age 33 and 46). t-MDS incidence was 30 times the expected population rate among patients <55 years (RR 31.8, 95% CI 15.0, 60.8) with shorter time from t-MDS diagnosis to death (median survival time: <55: 8 months, 55–74: 26 months, 75+: 23 months). Conclusion We found elevated t-MDS risk especially among younger BC patients with stem cell transplantation the only observed curative treatment. © 2016 Elsevier Ltd


Malmgren J.,HealthStat Consulting Inc. | Malmgren J.,University of Washington | Atwood M.,Swedish Cancer Institute | Kaplan H.,Swedish Cancer Institute | Kaplan H.,University of Washington
Breast Journal | Year: 2012

Our research goal is to report on method of breast cancer detection among young women from a prospective cohort study of primary breast cancer patients, aged 20-49 years, 1990-2008 (n = 2579). Clinical presentation characteristics including race, TNM stage, first degree relative family history, histologic type and method of detection by patient (PtD), physician (PhysD), or mammography (MamD) were chart abstracted. Forward conditional stepwise regression was used to for association with detection method and Kaplan-Meier for relapse free survival (RFS) analysis. Among 20- to 39-year olds (n = 602) no change in detection method occurred over time with 12% MamD, 7% PhysD, and 81% PtD. Among 40- to 49-year olds, MamD BC increased over time (28% to 58%) and PtD BC decreased (63-36%) (Pearson X2= 72.72, p <.001). Among 20-39/40- to 49-year old MamD cases 31%/32% were stage 0 versus 2%/6% of the PhysD/PtD cases. In two separate conditional logistic regression models, older age at diagnosis and first degree relative BC history were associated with MamD BC for 20- to 39- and 40- to 49-year olds. Five-year MamD BC RFS was superior for both age groups (20-39: 94%, 40-49: 94%) compared to PtD BC rates (20-39: 80%, p =.016; 40-49: 88%, p <.001). For PtD BC 20- to 39-year olds had worse RFS (5 year 80%, 10 year 75%) than 40- to 49-year olds (5 year 88%, 10 year 82%) (p =.002) but RFS was equivalent for MamD cases by age. The majority of breast cancers among women 20-49 years were patient detected and mammography detection occurred rarely among youngest women. Lower stage and superior survival among MamD patients support mammography for detecting disease in high risk women aged 30-39 years and 40-49 years. © 2012 Wiley Periodicals, Inc.


PubMed | HealthStat Consulting Inc.
Type: Journal Article | Journal: The breast journal | Year: 2012

Our research goal is to report on method of breast cancer detection among young women from a prospective cohort study of primary breast cancer patients, aged 20-49years, 1990-2008 (n=2579). Clinical presentation characteristics including race, TNM stage, first degree relative family history, histologic type and method of detection by patient (PtD), physician (PhysD), or mammography (MamD) were chart abstracted. Forward conditional stepwise regression was used to for association with detection method and Kaplan-Meier for relapse free survival (RFS) analysis. Among 20- to 39-year olds (n=602) no change in detection method occurred over time with 12% MamD, 7% PhysD, and 81% PtD. Among 40- to 49-year olds, MamD BC increased over time (28% to 58%) and PtD BC decreased (63-36%) (Pearson X(2) =72.72, p<.001). Among 20-39/40- to 49-year old MamD cases 31%/32% were stage 0 versus 2%/6% of the PhysD/PtD cases. In two separate conditional logistic regression models, older age at diagnosis and first degree relative BC history were associated with MamD BC for 20- to 39- and 40- to 49-year olds. Five-year MamD BC RFS was superior for both age groups (20-39: 94%, 40-49: 94%) compared to PtD BC rates (20-39: 80%, p=.016; 40-49: 88%, p<.001). For PtD BC 20- to 39-year olds had worse RFS (5year 80%, 10year 75%) than 40- to 49-year olds (5year 88%, 10year 82%) (p=.002) but RFS was equivalent for MamD cases by age. The majority of breast cancers among women 20-49years were patient detected and mammography detection occurred rarely among youngest women. Lower stage and superior survival among MamD patients support mammography for detecting disease in high risk women aged 30-39years and 40-49years.

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