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1.  Medical Oncologists' Perceptions of Financial Incentives in Cancer Care 
Journal of Clinical Oncology  2012;31(5):530-535.
The cost of cancer care continues to increase at an unprecedented rate. Concerns have been raised about financial incentives associated with the chemotherapy concession in oncology practices and their impact on treatment recommendations.
The objective of this study was to measure the physician-reported effects of prescribing chemotherapy or growth factors or making referrals to other cancer specialists, hospice, or hospital admissions on medical oncologists' income. US medical oncologists involved in the care of a population-based cohort of patients with lung or colorectal cancer from the Cancer Care Outcomes Research and Surveillance (CanCORS) study were surveyed regarding their perceptions of the impact of prescribing practices or referrals on their income.
Although most oncologists reported that their incomes would be unaffected, compared with salaried oncologists, physicians in fee-for-service practice, and those paid a salary with productivity incentives were more likely to report that their income would increase from administering chemotherapy (odds ratios [ORs], 7.05 and 7.52, respectively; both P < .001) or administering growth factors (ORs, 5.60 and 6.03, respectively; both P < .001).
A substantial proportion of oncologists who are not paid a fixed salary report that their incomes increase when they administer chemotherapy and growth factors. Further research is needed to understand the impact of these financial incentives on both the quality and cost of care.
PMCID: PMC3565179  PMID: 23269996
2.  Palliative Radiation Therapy Practice in Patients With Metastatic Non–Small-Cell Lung Cancer: A Cancer Care Outcomes Research and Surveillance Consortium (CanCORS) Study 
Journal of Clinical Oncology  2013;31(5):558-564.
Randomized data suggest that single-fraction or short-course palliative radiation therapy (RT) is sufficient in the majority of patients with metastatic cancer. We investigated population-based patterns in the use of palliative RT among patients with metastatic non–small-cell lung cancer (NSCLC).
Patients and Methods
From patients diagnosed with lung cancer from 2003 to 2005 at a participating geographic or organizational site and who consented to the Cancer Care Outcomes Research and Surveillance Consortium study, we identified patients with metastatic NSCLC who had complete medical records abstractions. Patient characteristics and clinical factors associated with receipt of palliative RT and RT intensity (total dose and number of treatments) were evaluated with multivariable regression.
Of 1,574 patients with metastatic NSCLC, 780 (50%) received at least one course of RT, and 21% and 12% received RT to the chest and bone, respectively. Use of palliative RT was associated with younger age at diagnosis and receipt of chemotherapy and surgery to metastatic sites. Among patients receiving palliative bone RT, only 6% received single-fraction treatment. Among patients receiving palliative chest RT, 42% received more than 20 fractions. Patients treated in integrated networks were more likely to receive lower doses and fewer fractions to the bone and chest.
When palliative RT is used in patients with metastatic NSCLC, a substantial proportion of patients receive a greater number of treatments and higher doses than supported by current evidence, suggesting an opportunity to improve care delivery.
PMCID: PMC3565181  PMID: 23295799
3.  Associations Between End-of-Life Discussion Characteristics and Care Received Near Death: A Prospective Cohort Study 
Journal of Clinical Oncology  2012;30(35):4387-4395.
National guidelines recommend that discussions about end-of-life (EOL) care planning happen early for patients with incurable cancer. We do not know whether earlier EOL discussions lead to less aggressive care near death. We sought to evaluate the extent to which EOL discussion characteristics, such as timing, involved providers, and location, are associated with the aggressiveness of care received near death.
Patients and Methods
We studied 1,231 patients with stage IV lung or colorectal cancer in the Cancer Care Outcomes Research and Surveillance Consortium, a population- and health system–based prospective cohort study, who died during the 15-month study period but survived at least 1 month. Our main outcome measure was the aggressiveness of EOL care received.
Nearly half of patients received at least one marker of aggressive EOL care, including chemotherapy in the last 14 days of life (16%), intensive care unit care in the last 30 days of life (9%), and acute hospital-based care in the last 30 days of life (40%). Patients who had EOL discussions with their physicians before the last 30 days of life were less likely to receive aggressive measures at EOL, including chemotherapy (P = .003), acute care (P < .001), or any aggressive care (P < .001). Such patients were also more likely to receive hospice care (P < .001) and to have hospice initiated earlier (P < .001).
Early EOL discussions are prospectively associated with less aggressive care and greater use of hospice at EOL.
PMCID: PMC3675701  PMID: 23150700
4.  Long-Term Risk Perceptions of Women With Ductal Carcinoma In Situ 
The Oncologist  2013;18(4):362-368.
Recurrence risk perceptions after 5 years were evaluated in women with a history of ductal carcinoma in situ. Many women were found to harbor inaccurate perceptions of their risk for future breast cancer events even 5 years after diagnosis.
Learning Objectives
Identify predictors of excessive risk perception in women with a distant history of DCIS.Explain the importance of educating women with a history of DCIS about reasonable assessments of their risk for future breast cancer.
Previous research has demonstrated that many women with ductal carcinoma in situ (DCIS) overestimate their risk for future breast cancer at the time of diagnosis and soon thereafter. This study aims to evaluate risk perceptions after 5 years.
Patients and Methods.
In a longitudinal cohort study, we mailed long-term follow-up surveys to 315 women who had previously responded to a survey 18 months after they were diagnosed with DCIS, excluding those who had experienced recurrence and those not treated at our institution. We evaluated risk perceptions with items used previously in the cohort.
One hundred ninety-three women (61%) responded. The median time since diagnosis was 5.9 years. We excluded 12 because of recurrence. Of the 181 remaining, 32% perceived at least a moderate 5-year risk for developing DCIS again, 43% perceived at least a moderate lifetime risk for developing DCIS again, 27% perceived at least a moderate 5-year risk for invasive breast cancer, 38% perceived at least a moderate lifetime risk for invasive breast cancer, and 24% perceived at least a moderate risk for DCIS spreading to other body parts. In a multivariate model, worse financial status and higher perceived risk in the previous survey were the only predictors of at least a moderate perception of risk for DCIS spreading.
Women with a history of DCIS continue to harbor inaccurate perceptions of their risk for future breast cancer events even 5 years after diagnosis.
PMCID: PMC3639521  PMID: 23568001
Carcinoma; Intraductal; Noninfiltrating; Survivors; Anticipation; Psychological; Anxiety
5.  Relationship Between Reproductive History, Anthropometrics, Lifestyle Factors, and the Likelihood of Persistent Chemotherapy-Related Amenorrhea in Women with Premenopausal Breast Cancer 
Fertility and sterility  2012;97(1):154-159.
To determine the association between patient characteristics at diagnosis of premenopausal breast cancer including gravidity, parity, age at menarche, age at first birth, alcohol use, smoking history, weight, height, and body mass index (BMI) with the development of persistent chemotherapy-related amenorrhea (CRA) in follow-up.
Retrospective Cohort
Dana Farber Cancer Institute (DFCI) and Brigham and Women’s Hospital (BWH)
Premenopausal women with breast cancer
We identified all premenopausal women who received standard adjuvant chemotherapy from 1997-2005 for whom menstrual data were available. Multivariable logistic regression models evaluating persistent amenorrhea at ≥ 6 month after completing chemotherapy were conducted.
431 women met eligibility criteria and had ≥ 6 month follow-up. Women with older (age >13 years) versus younger (12-13 years) age at menarche were more than twice as likely to remain amenorreheic (p-value, test for linear trend = 0.03). Current smokers had 2.4 greater odds of CRA versus never smokers, although this association was not statistically significant (95% CI=0.86-6.75).
Few identifiable factors contribute to the variability in CRA among premenopausal women following adjuvant chemotherapy for breast cancer. Further research to improve the prediction of CRA, premature menopause and infertility in young breast cancer survivors is warranted.
PMCID: PMC3963606  PMID: 22192139
Chemotherapy-related amenorrhea; breast cancer; gravidity; parity; lifestyle factors; premature menopause
6.  Chemotherapy use and patient treatment preferences in advanced colorectal cancer: a prospective cohort study 
Cancer  2012;119(4):854-862.
Our objective was to determine how patient preferences guide the course of palliative chemotherapy for advanced colorectal cancer.
Eligible patients with metastatic colorectal cancer (mCRC) were enrolled nationwide in a prospective, population-based cohort study. Data were obtained via medical record abstraction and patient surveys. Logistic regression was used to evaluate: patient characteristics associated with seeing medical oncology and receiving chemotherapy; and patient characteristics, beliefs and preferences associated with receiving >1 line of chemotherapy and receiving combination chemotherapy.
Among 702 patients with mCRC, 91% saw a medical oncologist, and among those, 82% received chemotherapy. Patients 65-75 and ≥75 years were less likely to see an oncologist, as were patients who were too sick to complete their own survey. In adjusted analyses patients ≥75 years and with moderate or severe comorbidity were less likely to receive chemotherapy, as were patients who were too sick to complete their own survey. Patients received chemotherapy even if they believed chemotherapy would not extend their life (90%), chemotherapy would not likely help with cancer-related problems (89%), or preferred treatment focusing on comfort even if it meant not living as long (90%). Older patients were less likely to receive combination first-line therapy. Patient preferences and beliefs were not associated with receipt of >1 line of chemotherapy or combination chemotherapy.
The majority of patients received chemotherapy even if they expressed negative or marginal preferences or beliefs regarding chemotherapy. Patient preferences and beliefs were not associated with intensity or number of chemotherapy regimens.
PMCID: PMC3548062  PMID: 22972673
Colorectal cancer; decision making; patient preference; cohort studies; quality of healthcare
7.  Use of Adjuvant Trastuzumab in Women with Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer by Race/Ethnicity and Education within the National Comprehensive Cancer Network 
Cancer  2012;119(4):839-846.
Trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive breast cancer is highly efficacious yet costly and time-intensive, and few data are available about its utilization. We examined receipt and completion of adjuvant trastuzumab by race/ethnicity and education for women with HER2-positive disease.
Using the National Comprehensive Cancer Network (NCCN) Breast Cancer Outcomes Database, we identified 1,109 women diagnosed with stage I–III, HER2-positive breast cancer during September 2005 through December 2008 who were followed for ≥1 year. We assessed the association of race/ethnicity and education with receipt of trastuzumab, and among women who initiated trastuzumab, with completion of >270 days of therapy, using multivariable logistic regression.
The cohort was 75% white, 8% black, and 9% Hispanic; 20% attained a high school degree or less. Most women (83%) received trastuzumab, with no significant differences by race/ethnicity or SES. Among women initiating trastuzumab, 73% of black women vs. 87% of white women (p=.007) and 70% of women with less than high school education vs. 90% of women with a college degree completed >270 days of therapy (p=.006). In adjusted analyses, black (vs. white) women and those without a high school degree (vs. college degree) had lower odds of completing therapy (odds ratio [OR]=.45, 95% confidence interval [CI]=.27–.74 and OR=0.27, 95% CI=.14–.51, respectively).
We observed differences in trastuzumab completion by race and educational attainment for women treated at NCCN centers. Efforts to assure appropriate utilization of trastuzumab and understand treatment barriers are needed and could lead to improved outcomes.
PMCID: PMC3565006  PMID: 23011924
breast cancer; disparities; trastuzumab; race; socioeconomic status
8.  Representativeness of Participants in the Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium Relative to the Surveillance, Epidemiology and End Results (SEER) Program 
Medical care  2013;51(2):e9-15.
The research goals of the Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium are to determine how characteristics and beliefs of patients, providers, and health-care organizations influence the treatments and outcomes of individuals with newly diagnosed lung and colorectal cancers. Because CanCORS results will inform national policy, it is important to know how they generalize to the United States population with these cancers.
Research Design
This study assessed the representativeness of the CanCORS cohort of 10,547 patients with lung cancer (LC) or colorectal cancer (CRC) enrolled between 2003 and 2005. We compared characteristics (gender, race, age and disease stage) to the Surveillance, Epidemiology and End Results (SEER) population of 234,464 patients with new onset of these cancers during the CanCORS recruitment period.
The CanCORS sample is well matched to the SEER Program for both cancers. In CanCORS, 41% LC / 47% CRC were female versus 47% LC / 49% CRC in SEER. African American, Hispanic and Asian cases differed by no more than 5 percentage points between CanCORS and SEER. The SEER population is slightly older, with the percentage of patients over 75 years 33.1% LC / 37.3% CRC in SEER versus 26.9% LC / 29.4% in CanCORS, and also has a slightly higher proportion of early stage patients. We also found that the CanCORS cohort was representative within specific SEER regions that map closely to CanCORS sites.
This study demonstrates that the CanCORS Consortium was successful in enrolling a demographically representative sample within the CanCORS regions.
PMCID: PMC3654676  PMID: 22406968
Lung Cancer; Colorectal Cancer; Cancer Populations
9.  Use of stereotactic radiosurgery for brain metastases from non-small cell lung cancer in the United States 
The indications for treatment of brain metastases from non-small cell lung cancer (NSCLC) with stereotactic radiosurgery (SRS) remain controversial. Here, we studied patterns, predictors, and cost of SRS utilization in elderly patients with NSCLC.
Methods and Materials
Using the Surveillance, Epidemiology, and End Results-Medicare (SEER-Medicare) database, we identified patients with NSCLC, who were diagnosed with brain metastases between 2000 and 2007. Our analytic cohort included patients treated with radiation therapy, and not surgical resection, as initial treatment for brain metastases.
We identified 7684 patients treated with radiation therapy within 2 months after brain metastases diagnosis, of whom 469 (6.1%) had billing codes for SRS. Annual SRS use increased from 3.0% in 2000 to 8.2% in 2005 and varied from 3.4% to 12.5% by specific registry site. After controlling for clinical and sociodemographic characteristics, SRS use was significantly associated with increasing year of diagnosis, specific SEER registry, higher socioeconomic status, admission at a teaching hospital, no history of participation in low-income state buy-in programs, no extracranial metastases, and longer interval from NSCLC diagnosis. The average cost per patient associated with radiation therapy was 2.19 times greater for those who received SRS compared to those who did not.
The use of SRS in patients with metastatic NSCLC increased almost 3- fold from 2000 to 2005. In addition, we found significant variation of SRS utilization across SEER registries and socioeconomic quartiles. National practice patterns suggest both a lack of consensus and overall limited use of the approach among elderly patients before 2008.
PMCID: PMC3728282  PMID: 23058058
Stereotactic Radiosurgery; Health Services Research; Cost Analysis; Brain Metastases; Non-Small Cell Lung Cancer
10.  Time to Adjuvant Chemotherapy for Breast Cancer in National Comprehensive Cancer Network Institutions 
High-quality care must be not only appropriate but also timely. We assessed time to initiation of adjuvant chemotherapy for breast cancer as well as factors associated with delay to help identify targets for future efforts to reduce unnecessary delays.
Using data from the National Comprehensive Cancer Network (NCCN) Outcomes Database, we assessed the time from pathological diagnosis to initiation of chemotherapy (TTC) among 6622 women with stage I to stage III breast cancer diagnosed from 2003 through 2009 and treated with adjuvant chemotherapy in nine NCCN centers. Multivariable models were constructed to examine factors associated with TTC. All statistical tests were two-sided.
Mean TTC was 12.0 weeks overall and increased over the study period. A number of factors were associated with a longer TTC. The largest effects were associated with therapeutic factors, including immediate postmastectomy reconstruction (2.7 weeks; P < .001), re-excision (2.1 weeks; P < .001), and use of the 21-gene reverse-transcription polymerase chain reaction assay (2.2 weeks; P < .001). In comparison with white women, a longer TTC was observed among black (1.5 weeks; P < .001) and Hispanic (0.8 weeks; P < .001) women. For black women, the observed disparity was greater among women who transferred their care to the NCCN center after diagnosis (P interaction = .008) and among women with Medicare vs commercial insurance (P interaction < .001).
Most observed variation in TTC was related to use of appropriate therapeutic interventions. This suggests the importance of targeted efforts to minimize potentially preventable causes of delay, including inefficient transfers in care or prolonged appointment wait times.
PMCID: PMC3611850  PMID: 23264681
11.  Time to Diagnosis and Breast Cancer Stage by Race/Ethnicity 
We examined differences in time to diagnosis by race/ethnicity, the relationship between time to diagnosis and stage, and the extent to which it explains differences in stage at diagnosis across racial/ethnic groups. Our analytic sample includes 21,427 non-Hispanic White (White), Hispanic, non-Hispanic Black (Black) and non-Hispanic Asian/Pacific Islander (Asian) women diagnosed with stage I to IV breast cancer between January 1, 2000 and December 31, 2007 at one of eight National Comprehensive Cancer Network centers. We measured time from initial abnormal mammogram or symptom to breast cancer diagnosis. Stage was classified using AJCC criteria. Initial sign of breast cancer modified the association between race/ethnicity and time to diagnosis. Among symptomatic women median time to diagnosis ranged from 36 days among Whites to 53.6 for Blacks. Among women with abnormal mammograms median time to diagnosis ranged from 21 days among Whites to 29 for Blacks. Blacks had the highest proportion (26%) of Stage III or IV tumors. After accounting for time to diagnosis, the observed increased risk of stage III/IV breast cancer was reduced from 40% to 28% among Hispanics and from 113% to 100% among Blacks, but estimates remained statistically significant. We were unable to fully account for the higher proportion of late-stage tumors among Blacks. Blacks and Hispanics experienced longer time to diagnosis than Whites, and Blacks were more likely to be diagnosed with late-stage tumors. Longer time to diagnosis did not fully explain differences in stage between racial/ethnicity groups.
PMCID: PMC3513497  PMID: 23099438
12.  Incidence of severe pain in newly diagnosed ambulatory patients with stage IV cancer 
Pain is common among cancer patients.
To characterize the incidence of severe pain among newly diagnosed patients with stage IV cancer in ambulatory care.
A retrospective cohort of 505 ambulatory oncology patients with newly diagnosed stage IV solid tumours at a comprehensive cancer centre (Dana-Farber Cancer Institute, Boston, Massachusetts, USA) was followed from January 1, 2004, to December 31, 2006. Pain intensity scores were extracted from electronic medical records. The incidence of severe pain was calculated using the maximum monthly pain scores reported at outpatient visits.
Of the 505 patients included in the present study, 340 (67.3%) were pain-free at the initial visit, 90 (17.8%) experienced mild pain, 48 (9.5%) experienced moderate pain and 27 (5.4%) experienced severe pain. At least one episode of severe pain within one year of diagnosis was reported by 29.1% of patients. Patients with head and neck, gastrointestinal and thoracic malignancies were more likely to experience severe pain compared with patients with other types of cancer (52.6%, 33.9% and 30.5%, respectively). In the multivariable model, patients whose primary language was not English (OR 2.90 [95% CI 1.08 to 7.80]), patients who reported severe pain at the initial visit (OR 9.30 [95% CI 3.72 to 23.23]) and patients with head and neck (OR 10.17 [95% CI 2.87 to 36.00]) or gastrointestinal (OR 4.05 [95% CI 1.23 to 13.35]) cancers were more likely to report severe pain in the following year.
The incidence of severe pain was high in ambulatory patients with newly diagnosed stage IV cancer.
PMCID: PMC3465096  PMID: 23061086
Cancer; Electronic health record; Epidemiology; Incidence; Pain intensity; Palliative care; Risk factors
13.  High-Cost Imaging in Elderly Patients with Stage IV Cancer 
Medicare expenditures for high-cost diagnostic imaging have risen faster than those for total cancer care and have been targeted for potential cost reduction. We sought to determine recent and long-term patterns in high-cost diagnostic imaging use among elderly (aged ≥65 years) patients with stage IV cancer.
We identified claims within the Surveillance, Epidemiology, and End Results (SEER)-Medicare database with computed tomography, magnetic resonance imaging, positron emission tomography, and nuclear medicine scans between January 1994 and December 2009 for patients diagnosed with stage IV breast, colorectal, lung, or prostate cancer between January 1995 and December 2006 (N = 100 594 patients). The proportion of these patients imaged and rate of imaging per-patient per-month of survival were calculated for each phase of care in patients diagnosed between January 2002 and December 2006 (N = 55 253 patients). Logistic regression was used to estimate trends in imaging use in stage IV patients diagnosed between January 1995 and December 2006, which were compared with trends in imaging use in early-stage (stages I and II) patients with the same tumor types during the same period (N = 192 429 patients).
Among the stage IV patients diagnosed between January 2002 and December 2006, 95.9% underwent a high-cost diagnostic imaging procedure, with a mean number of 9.79 (SD = 9.77) scans per patient and 1.38 (SD = 1.24) scans per-patient per-month of survival. After the diagnostic phase, 75.3% were scanned again; 34.3% of patients were scanned in the last month of life. Between January 1995 and December 2006, the proportion of stage IV cancer patients imaged increased (relative increase = 4.6%, 95% confidence interval [CI] = 3.7% to 5.6%), and the proportion of early-stage cancer patients imaged decreased (relative decrease = −2.5%, 95% CI = −3.2% to −1.9%).
Diagnostic imaging is used frequently in patients with stage IV disease, and its use increased more rapidly over the decade of study than that in patients with early-stage disease.
PMCID: PMC3611813  PMID: 22851271
14.  The MGH-HMS Lung Cancer Policy Model: Tobacco Control versus Screening 
The natural history model underlying the MGH Lung Cancer Policy Model (LCPM) does not include the two-stage clonal expansion model employed in other CISNET lung models. We used the LCPM to predict numbers of U.S. lung cancer deaths for ages 30–84 between 1975 and 2000 under 4 scenarios as part of the comparative modeling analysis described in this monograph.
The LCPM is a comprehensive microsimulation model of lung cancer development, progression, detection, treatment, and survival. Individual-level patient histories are aggregated to estimate cohort or population-level outcomes. Lung cancer states are defined according to underlying disease variables, test results, and clinical events. By simulating detailed clinical procedures, the LCPM can predict benefits and harms attributable to a variety of patient management practices, including annual screening programs.
Under the scenario of observed smoking patterns, predicted numbers of deaths from the calibrated LCPM were within 2% of observed over all years (1975–2000). The LCPM estimated that historical tobacco control policies achieved 28.6% (25.2% in men, 30.5% in women) of the potential reduction in U.S. lung cancer deaths had smoking had been eliminated entirely. The hypothetical adoption in 1975 of annual helical CT screening of all persons aged 55–74 with at least 30 pack-years of cigarette exposure to historical tobacco control would have yielded a proportion realized of 39.0% (42.0% in men, 33.3% in women).
The adoption of annual screening would have prevented less than half as many lung cancer deaths as the elimination of cigarette smoking.
PMCID: PMC3478757  PMID: 22882882
Lung cancer; Tobacco control; Mass screening; Microsimulation modeling
15.  Enrollment of Patients With Lung and Colorectal Cancers Onto Clinical Trials 
Journal of Oncology Practice  2012;9(2):e40-e47.
Both practice environment and patient clinical and demographic characteristics are associated with cancer clinical trial enrollment; simultaneous intervention may be required when trying to increase enrollment rates.
Only 2% to 5% of adult patients with cancer enroll onto clinical trials. We assessed simultaneously characteristics of patients and their physicians that may be independently associated with participation.
CanCORS, a National Cancer Institute (NCI) –funded population-based observational cohort study of newly diagnosed patients with lung and colorectal cancers, sampled patients across five geographic areas, five health care delivery systems, and 15 Veterans Administration hospitals. We linked patient survey and medical record data with physician survey data to examine correlates of trial enrollment.
Among 9,901 patients, 5.3% enrolled onto trials. Of the 9,901 patients, we linked 6,506 patients to one medical oncologist, surgeon, or radiation oncologist (physicians, N = 1,325) who responded to the physician survey and was considered their primary cancer clinician decision maker. Patient age, race, disease stage, geographic region, and health insurance were independently associated with trial enrollment. Physician factors independently associated with patient trial enrollment were being a medical oncologist, practicing at an NCI-designated cancer center, taking the lead in discussing trials with patients, and receiving increased income from trial enrollment. After simultaneously adjusting for patient and physician characteristics, only being a physician practicing at an NCI-designated cancer center (odds ratio [OR], 1.65; 95% CI, 1.19 to 2.27) and patient female sex (OR, 1.36; 95% CI, 1.10 to 1.68), age > 70 versus < 50 years (OR, 0.28; 95% CI, 0.16 to 0.48), and advanced disease (OR, 1.85; 95% CI, 1.45 to 2.37) remained independently associated with trial enrollment.
Both practice environment and patient clinical and demographic characteristics are associated with cancer clinical trial enrollment; simultaneous intervention may be required when trying to increase enrollment rates.
PMCID: PMC3595449  PMID: 23814523
16.  Adoption of Gene Expression Profile Testing and Association With Use of Chemotherapy Among Women With Breast Cancer 
Journal of Clinical Oncology  2012;30(18):2218-2226.
Gene expression profile (GEP) testing is a relatively new technology that offers the potential of personalized medicine to patients, yet little is known about its adoption into routine practice. One of the first commercially available GEP tests, a 21-gene profile, was developed to estimate the benefit of adjuvant chemotherapy for hormone receptor–positive breast cancer (HR-positive BC).
Patients and Methods
By using a prospective registry data set outlining the routine care provided to women diagnosed from 2006 to 2008 with HR-positive BC at 17 comprehensive and community-based cancer centers, we assessed GEP test adoption and the association between testing and chemotherapy use.
Of 7,375 women, 20.4% had GEP testing and 50.2% received chemotherapy. Over time, testing increased (14.7% in 2006 to 27.5% in 2008; P < .01) and use of chemotherapy decreased (53.9% in 2006 to 47.0% in 2008; P < .01). Characteristics independently associated with lower odds of testing included African American versus white race (odds ratio [OR], 0.70; 95% CI, 0.54 to 0.92) and high school or less versus more than high school education (OR, 0.63; 95% CI, 0.52 to 0.76). Overall, testing was associated with lower odds of chemotherapy use (OR, 0.70; 95% CI, 0.62 to 0.80). Stratified analyses demonstrated that for small, node-negative cancers, testing was associated with higher odds of chemotherapy use (OR, 11.13; 95% CI, 5.39 to 22.99), whereas for node-positive and large node-negative cancers, testing was associated with lower odds of chemotherapy use (OR, 0.11; 95% CI, 0.07 to 0.17).
There has been a progressive increase in use of this GEP test and an associated shift in the characteristics of and overall reduction in the proportion of women with HR-positive BC receiving adjuvant chemotherapy.
PMCID: PMC3397718  PMID: 22585699
17.  The Effect of Age on Delay in Diagnosis and Stage of Breast Cancer 
The Oncologist  2012;17(6):775-782.
The relationship among young age (≤40 years), the likelihood of a delay in diagnosis, and stage was examined in breast cancer patients using a National Comprehensive Cancer Network database. Young age was not an independent predictor of a delay in diagnosis and only modestly predicted higher disease stage.
Young women with breast cancer are more likely to present with more advanced disease and are more likely to die as a result of breast cancer than their older counterparts. We sought to examine the relationship among young age (≤40 years), the likelihood of a delay in diagnosis, and stage.
We examined data from women with newly diagnosed stage I–IV breast cancer presenting to one of eight National Comprehensive Cancer Network centers in January 2000 to December 2007. Delay in diagnosis was defined as time from initial sign or symptom to breast cancer diagnosis >60 days.
Among 21,818 women with breast cancer eligible for analysis, 2,445 were aged ≤40 years at diagnosis. Young women were not more likely to have a delay in diagnosis >60 days (odds ratio [OR], 1.08; 95% confidence interval [CI], 0.98–1.19) after adjustment for type of initial sign or symptom. Young women were only modestly more likely to present with higher stage disease after a similar adjustment (OR, 1.18; 95% CI, 1.07–1.31). Women presenting with symptomatic disease, more common in younger women, were more likely to have a delay in diagnosis (OR, 3.31; 95% CI, 3.08–3.56) and higher stage (OR, 4.31; 95% CI 4.05–4.58).
Young age is not an independent predictor of delay in diagnosis of breast cancer and only modestly is associated with higher stage disease. Presenting with symptoms of breast cancer predicts delay and higher stage at diagnosis.
PMCID: PMC3380876  PMID: 22554997
Breast cancer; Young age; Delay in diagnosis; Breast cancer screening
18.  Continued Use of Trastuzumab Beyond Disease Progression in the National Comprehensive Cancer Network: Should We Practice Ahead of the Evidence? 
The Oncologist  2011;16(5):559-565.
Data from the National Comprehensive Cancer Network's Breast Cancer Outcomes Database were used to characterize the use of trastuzumab beyond disease progression in National Comprehensive Cancer Network centers prior to the 2009 publication supporting it use.
The role of continued trastuzumab after progression in women with human epidermal growth factor receptor (HER)-2+ metastatic breast cancer is controversial. Controlled clinical trials that establish a benefit from continued trastuzumab have been difficult to complete.
In the National Comprehensive Cancer Center Network (NCCN) Breast Cancer Outcomes Database, we identified women treated with trastuzumab for metastatic or relapsed HER-2+ breast cancer at eight NCCN centers who subsequently progressed. Patients were eligible for this analysis if they initiated treatment at an NCCN institution between July 1997 and December 2004, received trastuzumab-containing treatment, and progressed while on therapy. We calculated the proportion of patients who received trastuzumab after progression, and in a multivariate analysis assessed the association of patient and provider characteristics with continued trastuzumab therapy.
Our final cohort consisted of 218 women who experienced disease progression while on trastuzumab-containing therapy. Of these, 168 (77%) continued trastuzumab. Of these, 36 patients (17%) received therapy as part of a clinical trial. The only factors significantly associated with continuation of trastuzumab beyond progression were the presence of bone metastases and more recent year of development of progressive disease.
Prior to the availability of any high-quality evidence supporting this practice, over three quarters of patients treated with trastuzumab for HER-2+ metastatic breast cancer at eight NCCN centers continued therapy beyond progression. Further work is needed to understand how physicians adopt new treatments when there is ambiguity surrounding their benefit.
PMCID: PMC3228199  PMID: 21450786
19.  The Role of National Cancer Institute–Designated Cancer Center Status 
Annals of surgery  2012;255(5):890-895.
We sought to evaluate differences in guideline concordance between National Cancer Institute (NCI)–designated and other centers and determine whether the level of available evidence influences the degree of variation in concordance.
The National Cancer Institute recognizes centers of excellence in the advancement of cancer care. These NCI-designated cancer centers have been shown to have better outcomes for cancer surgery; however, little work has compared surgical process measures.
A retrospective cohort study was conducted using Surveillance, Epidemiology and End Results registry linked to Medicare claims data. Fee-for-service Medicare patients with a definitive surgical resection for breast, colon, gastric, rectal, or thyroid cancers diagnosed between 2000 and 2005 were identified. Claims data from 1999 to 2006 were used. Our main outcome measure was guideline concordance at NCI-designated centers compared to other institutions, stratified by level of evidence as graded by National Comprehensive Cancer Network guideline panels.
All centers achieved at least 90%, and often 95%, concordance with guidelines based on level 1 evidence. Concordance rates for guidelines with lower-level evidence ranged from 30% to 97% and were higher at NCI-designated centers. The adjusted concordance ratios for category 1 guidelines were between 1.02 and 1.08, whereas concordance ratios for guidelines with lower-level evidence ranged from 0.97 to 2.19, primarily favoring NCI-designated centers.
When strong evidence supports a guideline, there is little variation in practice between NCI-designated centers and other hospitals, suggesting that all are providing appropriate care. Variation in care may exist, however, for guidelines that are based on expert consensus rather than strong evidence. This suggests that future efforts to generate needed evidence on the optimal approach to care may also reduce institutional variation.
PMCID: PMC3428029  PMID: 22504278
20.  Patients’ Expectations about Effects of Chemotherapy for Advanced Cancer 
The New England journal of medicine  2012;367(17):1616-1625.
Chemotherapy for metastatic lung or colorectal cancer can prolong life by weeks or months and may provide palliation, but it is not curative.
We studied 1193 patients participating in the Cancer Care Outcomes Research and Surveillance (CanCORS) study (a national, prospective, observational cohort study) who were alive 4 months after diagnosis and received chemotherapy for newly diagnosed metastatic (stage IV) lung or colorectal cancer. We sought to characterize the prevalence of the expectation that chemotherapy might be curative and to identify the clinical, sociodemographic, and health-system factors associated with this expectation. Data were obtained from a patient survey by professional interviewers in addition to a comprehensive review of medical records.
Overall, 69% of patients with lung cancer and 81% of those with colorectal cancer did not report understanding that chemotherapy was not at all likely to cure their cancer. In multivariable logistic regression, the risk of reporting inaccurate beliefs about chemotherapy was higher among patients with colorectal cancer, as compared with those with lung cancer (odds ratio, 1.75; 95% confidence interval [CI], 1.29 to 2.37); among nonwhite and Hispanic patients, as compared with non-Hispanic white patients (odds ratio for Hispanic patients, 2.82; 95% CI, 1.51 to 5.27; odds ratio for black patients, 2.93; 95% CI, 1.80 to 4.78); and among patients who rated their communication with their physician very favorably, as compared with less favorably (odds ratio for highest third vs. lowest third, 1.90; 95% CI, 1.33 to 2.72). Educational level, functional status, and the patient’s role in decision making were not associated with such inaccurate beliefs about chemotherapy.
Many patients receiving chemotherapy for incurable cancers may not understand that chemotherapy is unlikely to be curative, which could compromise their ability to make informed treatment decisions that are consonant with their preferences. Physicians may be able to improve patients’ understanding, but this may come at the cost of patients’ satisfaction with them. (Funded by the National Cancer Institute and others.)
PMCID: PMC3613151  PMID: 23094723
21.  End-of-life discussions among patients with advanced cancer: A cohort study 
Annals of internal medicine  2012;156(3):204-210.
National guidelines recommend that physicians discuss end-of-life (EOL) care planning with cancer patients whose life expectancy is less than one year.
To evaluate the incidence of EOL discussions for patients with stage IV lung or colorectal cancer, and where, when, and with whom discussions take place.
Prospective cohort study of patients diagnosed with lung or colorectal cancer from 2003 to 2005.
Subjects lived in Northern California, Los Angeles County, North Carolina, Iowa, or Alabama, or received care in one of five large health maintenance organizations or one of fifteen Veteran’s Health Administration sites.
2155 patients with stage IV lung or colorectal cancer.
EOL discussions reported in patient and surrogate interviews or documented in medical records through 15 months after diagnosis.
73% of patients had EOL discussions identified by at least one source. Among patients who died during follow-up (N=1470), 87% had EOL discussions, versus 41% of patients who were alive at the end of follow-up (N=685). Among first EOL discussions documented in records (N=1081), 55% occurred in the hospital. Oncologists documented EOL discussions with only 27% of their patients. Among patients with documented EOL discussions who died during follow-up (N=959), discussions took place a median of 33 days before death.
The depth and quality of EOL discussions was not evaluated. Much of the information about discussions came from surrogates of patients who died before baseline interviews could be obtained.
Although most patients with stage IV lung or colorectal cancer have discussions with physicians about EOL care planning before death, many discussions occur during acute hospital care, with non-oncology providers, and late in the course of illness.
PMCID: PMC3616320  PMID: 22312140
22.  Outpatient Use of Low Molecular Weight Heparin Monotherapy for First-Line Treatment of Venous Thromboembolism in Advanced Cancer 
The Oncologist  2012;17(3):419-427.
Evidence-based treatment guidelines recommend low molecular weight heparin monotherapy for cancer-associated venous thromboembolism (VTE). This analysis assessed the first-line treatment strategies for VTE in patients with advanced solid tumors and found that only 25% of patients received guideline-recommended low molecular weight heparin. Future studies should explore reasons underlying the underutilization of this preferred evidence-based treatment as well as the comparative effectiveness of low molecular weight heparin versus warfarin-based anticoagulation in real-world cancer patients with VTE.
Evidence-based treatment guidelines recommend low molecular weight heparin (LMWH) monotherapy for cancer-associated venous thromboembolism (VTE). This analysis assessed the first-line treatment strategies for VTE in patients with advanced solid tumors.
Using administrative data from advanced lung, prostate, colon, or breast cancer patients diagnosed between January 2000 and December 2007 at four HMOs with integrated delivery systems, patients with an inpatient or outpatient VTE diagnosed within 2 years after cancer diagnosis and an outpatient purchase of warfarin, LMWH, and/or fondaparinux anticoagulant within 7 days of the VTE diagnosis were identified. First-line outpatient VTE pharmacological treatment and factors independently associated with receipt/non-receipt of LMWH monotherapy were assessed.
Overall, 25% of the 1,089 eligible patients received LMWH monotherapy as primary VTE treatment. The percentage increased steadily over time from 18% among patients diagnosed in 2000 to 31% among those diagnosed in 2007. Factors associated with LMWH monotherapy included VTE diagnosis year, chemotherapy within 60 days prior to VTE diagnosis, history of VTE prior to cancer diagnosis, and invasive surgery in the 90 days following VTE diagnosis. Colorectal and prostate cancer patients versus lung cancer patients and stage III versus stage IV patients were less likely to be treated with LMWH monotherapy.
Adoption of LMWH monotherapy as initial treatment for cancer-associated VTE was low but increased steadily over the study period. Future studies should explore reasons underlying the underutilization of this preferred evidence-based treatment as well as the comparative effectiveness of LMWH versus warfarin-based anticoagulation in real-world cancer patients with VTE.
PMCID: PMC3316928  PMID: 22334451
Venous thromboembolism; Anticoagulants; Neoplasms; Ambulatory care
23.  Attitudes of Patients With Cancer About Personalized Medicine and Somatic Genetic Testing 
Journal of Oncology Practice  2012;8(6):329-335.
Patients have relayed misunderstandings about somatic testing and a reluctance to have full sequencing; oncologists must consider how they present testing to patients so concerns over discrimination and psychological harm do not hinder test uptake.
Dramatic advances in genomic technology stand to revolutionize cancer care; however, little is known about patients' understanding and acceptance of personalized medicine and widespread genetic testing (GT).
Patients and Methods:
We conducted a formative, semi-structured interview study with a random sample of patients with lung, colorectal, and breast cancers to assess awareness of personalized medicine and GT and attitudes about somatic GT. Willingness to undergo GT was elicited through hypothetic scenarios.
Sixty-nine patients participated; 71% were women; 42% were black; median age was 59 years; and 42% had an education level ≥ college. We found that a majority of patients either were not aware of the term “personalized medicine” or defined it in unexpected ways. Although many patients identified relevant benefits of somatic testing (eg, informs treatment), many patients also expressed significant concerns (ie, psychological harm and discrimination). A majority of patients expressed a willingness to undergo somatic (predictive, 96%, prognostic, 93%) and germline (cancer risk without incidental information, 87%; cancer risk with incidental information, 81%; pharmacogenetic, 91%) testing; however, far fewer patients expressed a willingness to undergo full genome sequencing (62%). Reluctance was attributed to concerns over incidental findings, information overload, and the lack of a clear benefit.
Many patients relayed misunderstandings about somatic testing and a reluctance to undergo full sequencing; oncologists must carefully consider how they present testing to patients so that concerns over discrimination and psychological harm do not hinder test uptake. More work is needed to identify effective ways to communicate complex genomic concepts to patients and research participants.
PMCID: PMC3500475  PMID: 23598841
24.  Radiation therapy for ductal carcinoma in situ: A decision analysis 
Cancer  2011;118(3):603-611.
The benefit of adding radiation therapy after excision of ductal carcinoma in situ (DCIS) is widely debated. Randomized clinical trials are underpowered to delineate long-term outcomes following radiation.
We constructed a Markov decision model to simulate the clinical course of DCIS in a 60 year-old woman treated with either of two breast-conserving strategies: excision alone or excision plus radiation therapy. Sensitivity analyses were used to study the influence of risk of local recurrence, likelihood of invasive disease at recurrence, surgical choice at recurrence, and patient age at diagnosis on treatment outcomes.
The addition of radiation therapy was associated with slight improvements in invasive disease-free and overall survival. However radiation therapy decreased the chance of having both breasts intact over a patient’s lifetime. Radiation therapy improved survival by 2.1 months for women diagnosed with DCIS at age 60 but decreased the chance of having both breasts by 8.6% relative to excision alone. The differences in outcomes between the treatment strategies became smaller with increasing age at diagnosis. Sensitivity analyses revealed greater benefit for radiation with increased likelihood of invasive recurrence. The decrement in breast preservation with radiation therapy was mitigated with increased likelihood of mastectomy at time of recurrence or new breast cancer diagnosis.
Our analysis quantifies the benefits of radiation following excision of DCIS but also reveals that radiation therapy may increase the likelihood of eventual mastectomy. Patient age and preferences should therefore be considered when making the decision to add or forgo radiation for DCIS.
PMCID: PMC3189439  PMID: 21720992
breast cancer; ductal carcinoma in situ; radiation therapy; decision analysis

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