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1.  Population-Based Study of the Effect of Gene Expression Profiling on Adjuvant Chemotherapy Use in Breast Cancer Patients Under Age 65 
Cancer  2015;121(22):4062-4070.
Gene expression profiling (GEP) testing can help predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy for breast cancer. However, no prior US studies have evaluated the relationship between GEP testing and the use of adjuvant chemotherapy by women treated in general oncology practice.
Eligible patients were women under 65 newly diagnosed with their first stage I or II, hormone-receptor positive breast cancer between 2006–2011 (n=9,405). We conducted a retrospective study using a dataset consisting of registry data, health claims data, and GEP testing results. We report the distribution of GEP test results in terms of risk of recurrence predicted, and used logistic regression to assess the association of test results with chemotherapy use adjusting for multiple patient characteristics.
The proportions of tested women with low, intermediate, and high Recurrence Score results were 51%, 39%, and 10%, respectively. Among these women, 11%, 47%, and 88% received adjuvant chemotherapy, respectively. There was a significant, positive linear relationship of assay scores with chemotherapy use within the low and intermediate sub-groups after adjusting for all other factors (adjusted ORs = 1.17 and 1.20, respectively).
Adjuvant chemotherapy use following GEP testing is generally consistent with recommended test interpretation for women at high or low predicted risk of recurrence. Chemotherapy use in the intermediate risk group increased with Recurrence Score values, and evidence from ongoing randomized trials may help clarify whether this finding reflects optimal interpretation of GEP test results. These results demonstrate the principle that genomic testing, given research establishing its utility, can be applied appropriately in general practice following guideline recommendations.
PMCID: PMC4635042  PMID: 26291519
breast neoplasms; population based studies; practice patterns; gene expression profiling; chemotherapy
2.  Validation of the PROMIS Physical Function Measures in a Diverse U.S. Population-Based Cohort of Cancer Patients 
To evaluate the validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function measures in a diverse, population-based cancer sample.
Cancer patients 6–13 months post diagnosis (n=4,840) were recruited for the Measuring Your Health (MY-Health) study. Participants were diagnosed between 2010–2013 with non-Hodgkin lymphoma or cancers of the colorectum, lung, breast, uterus, cervix, or prostate. Four PROMIS Physical Function short forms (4a, 6b, 10a, and 16) were evaluated for validity and reliability across age and race-ethnicity groups. Covariates included gender, marital status, education level, cancer site and stage, comorbidities, and functional status.
PROMIS Physical Function short forms showed high internal consistency (Cronbach’s α =0.92 – 0.96), convergent validity (Fatigue, Pain Interference, FACT Physical Well-Being all r≥0.68) and discriminant validity (unrelated domains all r≤0.3) across survey short forms, age, and race-ethnicity. Known group differences by demographic, clinical, and functional characteristics performed as hypothesized. Ceiling effects for higher-functioning individuals were identified on most forms.
This study provides strong evidence that PROMIS Physical Function measures are valid and reliable in multiple race-ethnicity and age groups. Researchers selecting specific PROMIS short forms should consider the degree of functional disability in their patient population to ensure that length and content are tailored to limit response burden.
PMCID: PMC5079641  PMID: 25935353
Patient-Reported Outcomes; Oncology; Validation Studies; Physical Function
3.  Cardiovascular toxicity following anti-angiogenic therapy in persons over age 65 with advanced renal cell carcinoma 
Cancer  2015;122(1):124-130.
Sunitinib and sorafenib are oral vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) approved for treatment of patients with renal cell carcinoma (RCC) in 2005-2006. We conducted a population-based observational cohort study on the cardiovascular risk of VEGFR TKI therapy in elderly RCC patients.
We analyzed patients with RCC diagnosed from 2000-2009 ages 66 and older using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. We examined the incidence of cardiovascular adverse events through December 2010 including congestive heart failure and cardiomyopathy (CHF/CM), acute myocardial infarction (AMI), stroke, and cardiovascular deaths. We performed Cox-proportional hazard model to calculate the hazard ratio (HR) adjusting for age, sex, comorbidity, and use of other systemic therapy.
A total of 171 out of 670 patients who received sunitinib or sorafenib had cardiovascular events. The incidence rates for CHF/CM, AMI, and stroke were 0.87, 0.14, and 0.14 per 1000 person-days, respectively. Sunitinib or sorafenib use was associated with an increased risk of cardiovascular events (HR = 1.38 [95% CI: 1.02 – 1.87]), especially stroke (HR = 2.84 [95% CI: 1. 52 -5.31]) compared with 788 patients diagnosed with advanced RCC from 2007-2009 eligible for Part D but did not receive either agent. In subgroup analyses, we found that patients ages 66-74 at diagnosis had the highest increased risk of stroke associated with use of either or both drugs.
Sunitinib and sorafenib might be associated with an increased risk of cardiovascular events, particularly stroke.
PMCID: PMC4602387  PMID: 26439451
cardiovascular toxicity; stroke; sunitinib; sorafenib; renal cell carcinoma
4.  Use of androgen deprivation therapy as salvage treatment after primary therapy for clinically localized prostate cancer 
World journal of urology  2016;34(12):1611-1619.
The optimal use of androgen deprivation therapy as salvage treatment (sADT) for men after initial prostatectomy or radiotherapy for clinically localized prostate cancer is undefined. We describe patterns of sADT use and investigate clinical and sociodemographic characteristics of insured men who received sADT versus surveillance in managed care settings.
Using comprehensive electronic health records and cancer registry data from three integrated health plans, we identified all men with newly diagnosed clinically localized prostate cancer between 1995 and 2009 who received either prostatectomy (n = 16,445) or radiotherapy (n = 19,531) as their primary therapy. We defined sADT based on the timing of ADT following primary therapy and stage of cancer. We fit Cox proportional hazard models to identify sociodemographic characteristics and clinical factors associated with sADT.
With a median follow-up of 6 years (range 2–15 years), 13 % of men who underwent primary prostatectomy or radiotherapy received sADT. After adjusting for selected covariates, sADT was more likely to be used in men who were older (e.g., HR 1.70, 95 % CI 1.48–1.96 or HR 1.33, 95 % CI 1.17–1.52 for age 70+ relative to age 35–59 for primary prostatectomy or radiotherapy, respectively), were African-American, had a short PSA doubling time, had a higher pre-treatment risk of progression, had more comorbidities, and received adjuvant ADT for initial disease.
In men with localized prostate cancer in community practice initially treated with prostatectomy or radiotherapy, sADT after primary treatment was more frequent for men at greater risk of death from prostate cancer, consistent with practice guidelines.
PMCID: PMC5065786  PMID: 27084777
Androgen deprivation therapy; Salvage treatment; Localized prostate cancer
5.  Adoption of Gene Expression Profiling for Breast Cancer in US Oncology Practice for Women Under Age 65 
Four practice guidelines incorporate the use of gene expression profiling (GEP) tests for early-stage, hormone-receptor positive, HER2 negative breast tumors. Few studies describe factors associated with GEP testing in US oncology practice. We assessed the relationship between clinical, demographic, and group-level socioeconomic variables and test use in women under age 65.
Patients and Methods
Data from five state cancer registries were linked with insurance claims data and GEP test results. We assessed rates of testing and variables associated with test use in an incident cohort of 9444 commercially-insured women under age 65, newly-diagnosed with Stage I or II hormone-receptor positive breast cancer from 2006–2012.
Rates of testing for women with N0 disease increased from 20.4% in 2006 to 35.2% in 2011. Variables associated with higher rates of testing, beyond clinical factors such as nodal status (P < .001), included being diagnosed from 2008–2012 vs. 2006–2007 (adjusted odds ratio, 1.67; 95% CI, 1.47 to 1.90), having preexisting comorbidities (adjusted odds ratio, 1.35; 95% CI, 1.14 to 1.59), and higher out-of-pocket pharmacy costs (adjusted odds ratio, 1.66; 95% CI, 1.40 to 1.97). Women under age 50 were more likely to be tested if they had Stage I vs. Stage II disease (P < .0001).
In an insured population of women under age 65, GEP testing increased following its inclusion in guidelines and mounting evidence. Additional research is needed to better understand oncologists’ decision not to order GEP testing for their patients who are otherwise eligible.
PMCID: PMC4973473  PMID: 26483061
Breast cancer; gene expression profiling; genomic testing
6.  Effectiveness of Primary Androgen-Deprivation Therapy for Clinically Localized Prostate Cancer 
Journal of Clinical Oncology  2014;32(13):1324-1330.
Primary androgen-deprivation therapy (PADT) is often used to treat clinically localized prostate cancer, but its effects on cause-specific and overall mortality have not been established. Given the widespread use of PADT and the potential risks of serious adverse effects, accurate mortality data are needed to inform treatment decisions.
We conducted a retrospective cohort study using comprehensive utilization and cancer registry data from three integrated health plans. All men were newly diagnosed with clinically localized prostate cancer. Men who were diagnosed between 1995 and 2008, were not treated with curative intent therapy, and received follow-up through December 2010 were included in the study (n = 15,170). We examined all-cause and prostate cancer-specific mortality as our main outcomes. We used Cox proportional hazards models with and without propensity score analysis.
Overall, PADT was associated with neither a risk of all-cause mortality (hazard ratio [HR], 1.04; 95% CI, 0.97 to 1.11) nor prostate-cancer–specific mortality (HR, 1.03; 95% CI, 0.89 to 1.19) after adjusting for all sociodemographic and clinical characteristics. PADT was associated with decreased risk of all-cause mortality but not prostate-cancer–specific mortality. PADT was associated with decreased risk of all-cause mortality only among the subgroup of men with a high risk of cancer progression (HR, 0.88; 95% CI, 0.78 to 0.97).
We found no mortality benefit from PADT compared with no PADT for most men with clinically localized prostate cancer who did not receive curative intent therapy. Men with higher-risk disease may derive a small clinical benefit from PADT. Our study provides the best available contemporary evidence on the lack of survival benefit from PADT for most men with clinically localized prostate cancer.
PMCID: PMC3992722  PMID: 24638009
7.  Did Changes in Drug Reimbursement After the Medicare Modernization Act Affect Chemotherapy Prescribing? 
Journal of Clinical Oncology  2014;32(36):4042-4049.
The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) decreased fee-for-service (FFS) payments for outpatient chemotherapy. We assessed how this policy affected chemotherapy in FFS settings versus in integrated health networks (IHNs).
Patients and Methods
We examined 5,831 chemotherapy regimens for 3,613 patients from 2003 to 2006 with colorectal cancer (CRC) or lung cancers in the Cancer Care Outcomes Research Surveillance Consortium. Patients were from four geographically defined regions, seven large health maintenance organizations, and 15 Veterans Affairs Medical Centers. The outcome of interest was receipt of chemotherapy that included at least one drug for which reimbursement declined after the MMA.
The odds of receiving an MMA-affected drug were lower in the post-MMA era: the odds ratio (OR) was 0.73 (95% CI, 0.59 to 0.89). Important differences across cancers were detected: for CRC, the OR was 0.65 (95% CI, 0.46 to 0.92); for non–small-cell lung cancer (NSCLC), the OR was 1.60 (95% CI, 1.09 to 2.35); and for small-cell lung cancer, the OR was 0.63 (95% CI, 0.34 to 1.16). After the MMA, FFS patients were less likely to receive MMA-affected drugs: OR, 0.73 (95% CI, 0.59 to 0.89). No pre- versus post-MMA difference in the use of MMA-affected drugs was detected among IHN patients: OR, 1.01 (95% CI, 0.66 to 1.56). Patients with CRC were less likely to receive an MMA-affected drug in both FFS and IHN settings in the post- versus pre-MMA era, whereas patients with NSCLC were the opposite: OR, 1.60 (95% CI, 1.09 to 2.35) for FFS and 6.33 (95% CI, 2.09 to 19.11) for IHNs post- versus pre-MMA.
Changes in reimbursement after the passage of MMA appear to have had less of an impact on prescribing patterns in FFS settings than the introduction of new drugs and clinical evidence as well as other factors driving adoption of new practice patterns.
PMCID: PMC4265115  PMID: 25267762
8.  Self-Reported Health Status Predicts Other-Cause Mortality in Men with Localized Prostate Cancer: Results from the Prostate Cancer Outcomes Study 
Guidelines recommend against treating localized prostate cancer (PCa) in men with a greater than 10-year life expectancy. However, physicians have difficulty accurately estimating life expectancy.
We used data from a population-based observational study to develop a nomogram to estimate long-term other-cause mortality based on self-reported health status (SRHS), race/ethnicity, and age at diagnosis.
This was an observational study.
Men diagnosed with localized PCa from October 1994 through October 1995 participated in the study.
Initial measures obtained 6 months after diagnosis included sociodemographic and tumor characteristics, treatment, and a single item on the SRHS, with response options ranging from excellent to poor. We used Surveillance, Epidemiology, and End-Results program data to determine date and cause of death through December 2010. We estimated other-cause mortality with proportional hazards survival analyses, accounting for competing risks.
We evaluated 2,695 men, of whom 74 % underwent aggressive therapy (surgery or radiotherapy). At the initial survey, 18 % reported excellent (E), 36 % very good (VG), 31 % good (G), and 15 % fair/poor (F/P) health. Healthier men were younger, and more likely to be white, better educated, and to undergo surgery. At follow-up, 44 % of the cohort had died; 78 % of deaths were from causes other than PCa. SRHS predicted other-cause mortality; for men reporting E, VG, G, F/P health, the cumulative incidences of other-cause mortality were 20 %, 29 %, 40 %, and 53 %, respectively, p < 0.001. Compared to a reference of excellent SRHS, multivariable hazard ratios (95 % CI) for other-cause mortality for men reporting VG, G, and F/P health were 1.22 (0.97-1.54), 1.73 (1.38-2.17), and 2.71 (2.11-3.48), respectively.
Responses to a one-item SRHS measure were strongly associated with other-cause mortality 15 years after PCa diagnosis. Men reporting fair/poor health had substantial risks for other-cause mortality, suggesting limited benefit for undergoing aggressive treatment. SRHS can be considered in supporting informed decision-making about PCa treatment.
PMCID: PMC4471031  PMID: 25678374
prostatic neoplasms; cause of death; health status
9.  Use of Appropriate Initial Treatment Among Adolescents and Young Adults With Cancer 
There has been little improvement in the survival of adolescent and young adult (AYA) cancer patients aged 15 to 39 years relative to other age groups, raising the question of whether such patients receive appropriate initial treatment.
We examined receipt of initial cancer treatment for a population-based sample of 504 AYAs diagnosed in 2007–2008 with acute lymphoblastic leukemia (ALL), Hodgkin’s or non-Hodgkin’s lymphoma, germ cell cancer, or sarcoma. Registry data, patient surveys, and detailed medical record reviews were used to evaluate the association of patient demographic, socioeconomic, and health care setting characteristics with receipt of appropriate initial treatment, which was defined by clinical specialists in AYA oncology based on adult guidelines and published literature available before 2009 and analyzed with multivariable logistic regression. All statistical tests were two-sided.
Approximately 75% of AYA cancer patients in our sample received appropriate treatment, 68% after excluding stage I male germ cell patients who all received appropriate treatment. After this exclusion, appropriate treatment ranged from 79% of sarcoma patients to 56% of ALL patients. Cancer type (P < .01) and clinical trial participation (P = .04) were statistically significantly associated with appropriate treatment in multivariable analyses. Patients enrolled in clinical trials were more likely to receive appropriate therapy relative to those not enrolled (78% vs 67%, adjusted odds ratio = 2.6, 95% confidence interval = 1.1 to 6.4).
Except for those with early stage male germ cell tumors, approximately 30% (or 3 in 10) AYA cancer patients did not receive appropriate therapy. Further investigation is required to understand the reasons for this potential shortfall in care delivery.
PMCID: PMC4200030  PMID: 25301964
10.  Utilization of bevacizumab in US elderly patients with colorectal cancer receiving chemotherapy 
Bevacizumab, the first FDA-approved anti-angiogenesis agent, has been used for metastatic colorectal cancer since 2004. This study evaluated the utilization of bevacizumab among elderly metastatic colorectal cancer patients in the United States.
Using Surveillance and Epidemiology and End Results (SEER)-Medicare data, this retrospective cohort study consisted of individuals aged 65 years or older with a colorectal cancer diagnosis between 2005 and 2009, who received chemotherapy any time through 2010. This included patients with newly diagnosed metastatic colorectal cancer and patients who progressed from initially diagnosed earlier-stage disease. We ascertained comorbid conditions using ICD-9 codes and conducted logistic regression to identify patients’ characteristics associated with bevacizumab use.
A total of 8645 patients were identified (mean age 74 years; 52% male); 57% of patients received bevacizumab with initially diagnosed metastatic colorectal cancer and 44% of patients with treated progressive or recurrent disease. After adjusting for other covariates, we found that patients aged ≥80 years were less likely to receive bevacizumab compared with those aged 65–69 years (odds ratio (OR), 0.64 (95% confidence interval (CI): 0.57–0.73)), or if they had evidence of comorbid cardiomyopathy/congestive heart failure (OR, 0.82 (CI: 0.70–0.95)) or arrhythmic disorder (OR, 0.85 (CI: 0.75–0.96)). Adoption of bevacizumab into practice was rapid following its approval, and the use increased from 36% to 40% from 2005 to 2010 (p = 0.013). There were significant regional variations in bevacizumab use.
Despite rapid uptake since its original approval, there appears to be low use of bevacizumab in elderly metastatic colorectal cancer patients in the United States. Regional variations and the strong effects of age and comorbidity suggest lack of consensus among oncologists regarding benefits and risks of bevacizumab in elderly patients.
PMCID: PMC4883010  PMID: 24122849
Bevacizumab utilization; colorectal cancer; elderly; SEER-Medicare
11.  Stereotactic Body Radiation Therapy Versus Intensity-Modulated Radiation Therapy for Prostate Cancer: Comparison of Toxicity 
Journal of Clinical Oncology  2014;32(12):1195-1201.
Stereotactic body radiation therapy (SBRT) is a technically demanding prostate cancer treatment that may be less expensive than intensity-modulated radiation therapy (IMRT). Because SBRT may deliver a greater biologic dose of radiation than IMRT, toxicity could be increased. Studies comparing treatment cost to the Medicare program and toxicity are needed.
We performed a retrospective study by using a national sample of Medicare beneficiaries age ≥ 66 years who received SBRT or IMRT as primary treatment for prostate cancer from 2008 to 2011. Each SBRT patient was matched to two IMRT patients with similar follow-up (6, 12, or 24 months). We calculated the cost of radiation therapy treatment to the Medicare program and toxicity as measured by Medicare claims; we used a random effects model to compare genitourinary (GU), GI, and other toxicity between matched patients.
The study sample consisted of 1,335 SBRT patients matched to 2,670 IMRT patients. The mean treatment cost was $13,645 for SBRT versus $21,023 for IMRT. In the 6 months after treatment initiation, 15.6% of SBRT versus 12.6% of IMRT patients experienced GU toxicity (odds ratio [OR], 1.29; 95% CI, 1.05 to 1.53; P = .009). At 24 months after treatment initiation, 43.9% of SBRT versus 36.3% of IMRT patients had GU toxicity (OR, 1.38; 95% CI, 1.12 to 1.63; P = .001). The increase in GU toxicity was due to claims indicative of urethritis, urinary incontinence, and/or obstruction.
Although SBRT was associated with lower treatment costs, there appears to be a greater rate of GU toxicity for patients undergoing SBRT compared with IMRT, and prospective correlation with randomized trials is needed.
PMCID: PMC3986382  PMID: 24616315
12.  Adoption of Intermittent Androgen Deprivation Therapy for Advanced Prostate Cancer: A Population Based Study in American Urology Practice 
Urology practice  2015;2(4):190-198.
In several developed countries intermittent androgen deprivation therapy has been accepted over continuous androgen deprivation therapy for advanced prostate cancer management. To our knowledge its adoption and predictors of use in American urology practice remain unknown.
Using SEER-Medicare data we identified a cohort of men 66 years old or older who were newly diagnosed with prostate cancer with metastasis or with treated recurrence in whom androgen deprivation therapy was started during 2003 to 2007. We determined intermittent androgen deprivation therapy receipt based on interruptions longer than 3 months between scheduled and actual therapy injections, and physician visits and prostate specific antigen tests during the interruption. Predictors included patient and physician characteristics. We performed logistic regression analysis separately in the metastatic and treated recurrence groups using generalized estimating equations to account for the clustering effect of patients treated by the same physician.
Our cohort included 4,281 men, of whom 2,487 with metastasis and 1,794 with treated recurrence received intermittent androgen deprivation therapy. In patients who received intermittent rather than continuous therapy the median duration of therapy was by 6.4 and 9.0 months longer in those with metastasis and treated recurrence, respectively. Each patient group showed significant variation in intermittent therapy use by region (p <0.0001). There was lower intermittent androgen deprivation therapy use in the Eastern and Central regions than in the Mountain and Pacific regions.
Intermittent androgen deprivation therapy has not been widely used in American urology practice. Its adoption shows substantial variation by geographic regions. These regional differences likely reflect uncertainty regarding the efficacy of this therapy among providers as well as differences in patient preferences and involvement in treatment decision making.
PMCID: PMC4768755  PMID: 26925454
prostatic neoplasms; gonadotropin-releasing hormone; physician's practice patterns; neoplasm recurrence; local; neoplasm metastasis
13.  Patient-Physician Communication About Health-Related Quality-of-Life Problems: Are Non-Hodgkin Lymphoma Survivors Willing to Talk? 
Journal of Clinical Oncology  2013;31(31):3964-3970.
To investigate non-Hodgkin lymphoma (NHL) survivors' willingness to discuss health-related quality-of-life (HRQOL) problems with their follow-up care physician.
Patients and Methods
Willingness to discuss HRQOL problems (physical, daily, emotional, social, and sexual functioning) was examined among 374 NHL survivors, 2 to 5 years postdiagnosis. Survivors were asked if they would bring up HRQOL problems with their physician and indicate reasons why not. Logistic regression models examined the association of patient sociodemographics, clinical characteristics, follow-up care variables, and current HRQOL scores with willingness to discuss HRQOL problems.
Overall, 94%, 82%, 76%, 43%, and 49% of survivors would initiate discussions of physical, daily, emotional, social, and sexual functioning, respectively. Survivors who indicated their physician “always” spent enough time with them or rated their care as “excellent” were more willing to discuss HRQOL problems (P < .05). Survivors reporting poorer physical health were less willing to discuss their daily functioning problems (P < .001). Men were more willing to discuss sexual problems than women (P < .001). One in three survivors cited “nothing can be done” as a reason for not discussing daily functioning problems, and at least one in four cited “this was not their doctor's job” and a preference to “talk to another clinician” as reasons for not discussing emotional, social, and sexual functioning.
NHL survivors' willingness to raise HRQOL problems with their physician varied by HRQOL domain. For some domains, even when survivors were experiencing problems, they may not discuss them. To deliver cancer care for the whole patient, interventions that facilitate survivor-clinician communication about survivors' HRQOL are needed.
PMCID: PMC3805931  PMID: 24062408
14.  Effects of Gender and Depressive Symptoms on Quality of Life among Colorectal and Lung Cancer Patients and Their Family Caregivers 
Psycho-oncology  2014;24(1):95-105.
Cancer patients and their family caregivers often report elevated levels of depressive symptoms, along with poorer mental and physical health (quality of life: QOL). Although the mutuality in distress between patients and their caregivers is relatively well known, unknown are the degree to which caregivers’ depressive symptoms independently predict their patient’s QOL and vice versa, and whether the relations vary by cancer type or gender.
Colorectal or lung cancer patients and their caregivers (398 dyads) provided complete data for study variables (212 colorectal cancer patient dyads, 186 lung cancer patient dyads; 257 male patient dyads, 141 female patient dyads). Patients’ depressive symptoms and QOL were measured approximately 4 and 12 months post-diagnosis; caregivers’ depressive symptoms and QOL were measured approximately 5 months post-diagnosis.
The Actor Partner Interdependence Model confirmed that each person’s depressive symptom level was uniquely associated with his/her own concurrent QOL. Female patients’ depressive symptoms were also related to their caregivers’ poorer physical and better mental health, particularly when the pair’s depressive symptoms were at similarly elevated level. On the other hand, male patients’ elevated depressive symptoms were related to their caregivers’ poorer mental health.
Findings suggest that QOL among patients and their family caregivers is interdependent. In light of this interdependency, psychosocial interventions for managing depressive symptoms should target both patients and their family caregivers, from which both may benefit by not only alleviating depressive symptoms but also improving quality of life.
PMCID: PMC4233199  PMID: 24831223
Depressive Symptoms; Quality of Life; Dyadic Adjustment; Gender; Cancer; Oncology
15.  A 22 Gene-expression Assay, Decipher® (GenomeDx Biosciences) to Predict Five-year Risk of Metastatic Prostate Cancer in Men Treated with Radical Prostatectomy 
PLoS Currents  2015;7:ecurrents.eogt.761b81608129ed61b0b48d42c04f92a4.
Among the estimated 230,000 men diagnosed with prostate cancer in the US each year there has been a rise in the number of radical prostatectomies (RP). There is some debate over the value of immediate adjuvant therapy following RP in men with high-risk pathological features versus delayed salvage radiation therapy when signs of disease progression are observed. Thus, it would be potentially useful to inform post-RP management strategies by more clearly identifying those patients at higher risk of progression and death from prostate cancer. A 22 gene-expression assay, Decipher® (GenomeDx Biosciences), has been developed in men treated with radical prostatectomy to predict the five-year risk of metastatic prostate cancer. Published and unpublished literature was evaluated to determine the analytic validity, clinical validity and clinical utility of Decipher. Limited information is available on the analytic validity of Decipher. In both discovery and validation studies, Decipher was shown to have good performance in discriminating men with metastasis from men without metastasis five years after surgery (AUC 0.75 to 0.90). In terms of clinical utility, no evidence was found reporting improved outcomes (lower prostate cancer specific mortality and treatment related adverse effects) from using this test to guide post-operative treatment. Four studies provided weak indirect evidence of clinical utility in which 31% to 43% of post-operative treatment recommendations were changed in men with high-risk prostate cancer based on test results, with 27% to 52% of treatment recommendations changing from any treatment to no treatment.
PMCID: PMC4659515  PMID: 26664778
16.  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
17.  Risk of Diabetes among Patients Receiving Primary Androgen Deprivation Therapy for Clinically Localized Prostate Cancer 
The Journal of urology  2014;193(6):1956-1962.
Androgen deprivation therapy may increase diabetes risk. As the benefits of primary androgen deprivation therapy for localized prostate cancer are controversial, and most prostate cancer survivors are of advanced age with comorbidities, it is important to determine if primary androgen deprivation therapy increases the risk of diabetes and to determine the susceptibility factors.
Materials and Methods
We conducted a retrospective cohort study of 12,191 men diagnosed with incident localized prostate cancer during 1995 to 2008, age 35 to 100 years, and without diabetes or receipt of prostatectomy or radiation 1 year after diagnosis. Patients were enrolled in 1 of 3 managed health plans and followed through 2010. Primary androgen deprivation therapy was defined as androgen deprivation therapy within 1 year after diagnosis. Incident diabetes was ascertained using inpatient and outpatient diagnosis codes, diabetes medications and hemoglobin A1c values. We estimated primary androgen deprivation therapy associated diabetes risk using Cox proportional hazard models in conventional and propensity score analyses.
Diabetes developed in 1,203 (9.9%) patients during followup (median 4.8 years) with incidence rates of 2.5 and 1.6 events per 100 person-years in the primary androgen deprivation therapy and nonprimary androgen deprivation therapy groups, respectively. Primary androgen deprivation therapy was associated with a 1.61-fold increased diabetes risk (95% CI 1.38–1.88). The number needed to harm was 29. The association was stronger in men age 70 or younger than in older men (HR 2.25 vs 1.40, p value for interaction = 0.008).
Primary androgen deprivation therapy may increase diabetes risk by 60% and should be used with caution when managing localized prostate cancer. Because of the consistent association between androgen deprivation therapy and greater diabetes risk across disease states, we recommend routine screening and lifestyle interventions to reduce the risk of diabetes in men receiving androgen deprivation therapy.
PMCID: PMC4543371  PMID: 25524243
prostatic neoplasms; androgens; diabetes mellitus; risk
18.  Review of Electronic Patient-Reported Outcomes Systems Used in Cancer Clinical Care 
Journal of Oncology Practice  2013;10(4):e215-e222.
The number of electronic patient-reported outcome (PRO) systems has increased; systems can be programmed to have numerous features that facilitate PRO assessment integration and routine monitoring in clinical care.
The use of electronic patient-reported outcomes (PRO) systems is increasing in cancer clinical care settings. This review comprehensively identifies existing PRO systems and explores how systems differ in the administration of PRO assessments, the integration of information into the clinic workflow and electronic health record (EHR) systems, and the reporting of PRO information.
Electronic PRO (e-PRO) systems were identified through a semistructured review of published studies, gray literature, and expert identification. System developers were contacted to provide detailed e-PRO system characteristics and clinical implementation information using a structured review form.
A total of 33 unique systems implemented in cancer clinical practice were identified. Of these, 81% provided detailed information about system characteristics. Two system classifications were established: treatment-centered systems designed for patient monitoring during active cancer treatment (n = 8) and patient-centered systems following patients across treatment and survivorship periods (n = 19). There was little consensus on administration, integration, or result reporting between these system types. Patient-centered systems were more likely to provide user-friendly features such as at-home assessments, integration into larger electronic system networks (eg, EHRs), and more robust score reporting options. Well-established systems were more likely to have features that increased assessment flexibility (eg, location, automated reminders) and better clinical integration.
The number of e-PRO systems has increased. Systems can be programmed to have numerous features that facilitate integration of PRO assessment and routine monitoring into clinical care. Important barriers to system usability and widespread adoption include assessment flexibility, clinical integration, and high-quality data collection and reporting.
PMCID: PMC4094646  PMID: 24301843
20.  Use of Colony-Stimulating Factors With Chemotherapy: Opportunities for Cost Savings and Improved Outcomes 
Myeloid colony-stimulating factors (CSFs) decrease the risk of febrile neutropenia (FN) from high-risk chemotherapy regimens administered to patients at 20% or greater risk of FN, but little is known about their use in clinical practice. We evaluated CSF use in a multiregional population-based cohort of lung and colorectal cancer patients (N = 1849). Only 17% (95% confidence interval [CI] = 8% to 26%) patients treated with high-risk chemotherapy regimens received CSFs, compared with 18% (95% CI = 16% to 20%) and 10% (95% CI = 8% to 12%) of patients treated with intermediate- (10%–20% risk of FN) and low-risk (<10% risk of FN) chemotherapy regimens, respectively. Using a generalized estimating equation model, we found that enrollment in a health maintenance organization (HMO) was strongly associated with a lower adjusted odds of discretionary CSF use, compared with non-HMO patients (odds ratio = 0.44, 95% CI = 0.32 to 0.60, P < .001). All statistical tests were two-sided. Overall, 96% (95% CI = 93% to 98%) of CSFs were administered in scenarios where CSF therapy is not recommended by evidence-based guidelines. This finding suggests that policies to decrease CSF use in patients at lower or intermediate risk of FN may yield substantial cost savings without compromising patient outcomes.
PMCID: PMC3119647  PMID: 21670423
21.  Radiation therapy at the end of life: a population-based study examining palliative treatment intensity 
To examine factors associated with the use of radiation therapy (RT) at the end of life in patients with breast, prostate, or colorectal cancer.
Using data from the Surveillance, Epidemiology, and End Results (SEER) – Medicare database, patients were over age 65 and diagnosed between January 1, 2004 and December 31, 2011 with any stage of cancer when the cause of death, as defined by SEER, was cancer; or with stage 4 cancer, who died of any cause. We employed multiple logistic regression models to identify patient and health systems factors associated with palliative radiation use.
50% of patients received RT in the last 6 months of life. RT was used less frequently in older patients and in non-Hispanic white patients. Similar patterns were observed in the last 14 days of life. Chemotherapy use in the last 6 months of life was strongly correlated with receiving RT in the last 6 months (OR 2.72, 95% CI: 2.59-2.88) and last 14 days of life (OR 1.55, 95% CI: 1.40-1.66). Patients receiving RT accrued more emergency department visits, radiographic exams and physician visits (all comparisons p < 0.0001).
Among patients with breast, colorectal, and prostate cancer, palliative RT use was common. End-of-life RT correlated with end-of-life chemotherapy use, including in the last 14 days of life, when treatment may cause increased treatment burden without improved quality of life. Research is needed optimize the role and timing of RT in palliative care.
Electronic supplementary material
The online version of this article (doi:10.1186/s13014-014-0305-4) contains supplementary material, which is available to authorized users.
PMCID: PMC4314753  PMID: 25582217
Palliative care; SEER-Medicare; Radiation therapy; Radiotherapy; Radiation oncology; End-of-life care
22.  Efficacy of Intermittent Androgen Deprivation Therapy vs Conventional Continuous Androgen Deprivation Therapy for Advanced Prostate Cancer: A Meta-analysis 
Urology  2013;82(2):327-333.
To compare the efficacy of intermittent androgen deprivation therapy (IADT) vs continuous androgen deprivation therapy (CADT) for the treatment of advanced prostate cancer; we performed a meta-analysis of randomized controlled trials (RCTs), assessing the risks of disease progression, all-cause, and disease-specific mortality.
We conducted a systematic search of several bibliographic systems to identify all RCTs of IADT in men with newly diagnosed metastatic or biochemical only prostate cancer. We abstracted outcome data, study characteristics, and participant demographics. We performed heterogeneity tests and calculated the summarized risk differences (RD) and risk ratios at 95% confidence intervals (CI), using inverse variance methods in random-effects approaches.
We identified 8 RCTs (N = 4664) comparing mortality between IADT and CADT. For all men combined, we observed small but nonsignificant differences in all-cause mortality (RD = 0.02, 95% CI = −0.02, 0.06), disease-specific mortality (RD = 0.04, 95% CI = −0.01, 0.08), and disease progression (RD = −0.03, 95% CI = −0.09, 0.04). Among the prespecified subgroup with histologically confirmed, newly diagnosed metastatic disease, we found no difference in overall survival (RD = 0.00, 95% CI = −0.09, 0.09).
We found no difference in overall survival, but a small increased risk in disease-specific survival for men treated with IADT relative to CADT was observed. IADT could be considered as an alternative to CADT because of better quality of life outcome. Patients should be informed of the possible risks and benefits of both therapies. More research confirming the benefits of IADT vs CADT is needed to inform treatment decisions.
PMCID: PMC4154705  PMID: 23896094
23.  Mortality After Radical Prostatectomy or External Beam Radiotherapy for Localized Prostate Cancer 
No randomized trials have compared survival outcomes for men with localized prostate cancer (PC) being treated with radical prostatectomy (RP) or external beam radiotherapy (EBRT). The goal of the study, therefore, was to estimate the association of RP (compared with EBRT) with overall and PC mortality.
We analyzed an observational cohort from the population-based Prostate Cancer Outcomes Study, which included men aged 55 to 74 years diagnosed with localized PC between October 1994 and October 1995 who underwent either RP (n = 1164) or EBRT (n = 491) within 1 year of diagnosis. Patients were followed until death or study end (December 31, 2010). Overall and disease-specific mortality were assessed with multivariable survival analysis, with propensity scores to adjust for potential treatment selection confounders (demographics, comorbidities, and tumor characteristics). All statistical tests were two-sided.
After 15 years of follow-up, there were 568 deaths, including 104 from PC. RP was associated with statistically significant advantages for overall (hazard ratio [HR] = 0.60, 95% confidence interval [CI] = 0.53 to 0.70, P <.0001.) and disease-specific mortality (HR = 0.35, 95% CI = 0.26 to 0.49, P <.0001.). Mortality benefits for RP were also observed within treatment propensity quintiles, when subjects were pair-matched on propensity scores, and in subgroup analyses based on age, tumor characteristics, and comorbidity.
Population-based observational data on men diagnosed with localized PC in the mid-1990s suggest a mortality benefit associated with RP vs EBRT. Possible explanations include residual selection bias or a true survival advantage. Results might be less applicable for men facing treatment decisions today.
PMCID: PMC3653822  PMID: 23615689
24.  Physicians’ beliefs about breast cancer surveillance testing are consistent with test overuse 
Medical care  2013;51(4):315-323.
Overuse of surveillance testing for breast cancer survivors is an important problem but its extent and determinants are incompletely understood. The objectives of this study were to determine the extent to which physicians’ breast cancer surveillance testing beliefs are consistent with test overuse, and to identify factors associated with these beliefs.
2009–2010 cross-sectional survey of US medical oncologists and primary care physicians (PCPs). Physicians responded to a clinical vignette ascertaining beliefs about appropriate breast cancer surveillance testing. Multivariable analyses examined the extent to which test beliefs were consistent with overuse and associated with physician and practice characteristics and physician perceptions, attitudes, and practices.
1098 medical oncologists and 980 PCPs completed the survey (response rate 57.5%). Eighty-four percent of PCPs (95% CI: 81.4%–86.5%) and 72% of oncologists (95% CI: 69.8%– 74.7%) reported beliefs consistent with blood test overuse, while 50% of PCPs (95% CI: 47.3%– 53.8%) and 27% of oncologists (95% CI: 23.9%–29.3%) reported beliefs consistent with imaging test overuse. Among PCPs, factors associated with these beliefs included smaller practice size, lower patient volume, and practice ownership. Among oncologists, factors included older age, international medical graduate status, lower self-efficacy (confidence in knowledge), and greater perceptions of ambiguity (conflicting expert recommendations) regarding survivorship care.
Beliefs consistent with breast cancer surveillance test overuse are common, greater for PCPs and blood tests than for oncologists and imaging tests, and associated with practice characteristics and perceived self-efficacy and ambiguity about testing. These results suggest modifiable targets for efforts to reduce surveillance test overuse.
PMCID: PMC3596481  PMID: 23269111
25.  Health-Related Quality of Life Among Survivors of Aggressive Non-Hodgkin Lymphoma 
Cancer  2012;119(3):672-680.
Non-Hodgkin Lymphoma (NHL) is the fifth most common cancer among men and women. Patients with aggressive NHL receive intense medical treatments that can significantly compromise health-related quality of life (HRQOL). However, knowledge of HRQOL and its correlates among aggressive NHL survivors is limited.
Self-reported data on HRQOL (physical and mental function, anxiety, depression, and fatigue) were analyzed for 319 survivors of aggressive NHL. Survivors, 2–5 years after diagnosis, were selected from the Los Angeles County Cancer Registry. Bivariate and multivariable methods were used to assess the influence of sociodemographic, clinical, and cognitive health appraisal factors on survivors’ HRQOL.
After accounting for other covariates, marital status was associated with all HRQOL outcomes (p<0.05). Younger survivors reported worse mental function and higher levels of depression, anxiety, and fatigue (p<0.01). Survivors who had more comorbid conditions or lacked private health insurance reported worse physical and mental function and higher levels of depression and fatigue (p<0.05). Survivors who experienced a recurrence reported worse physical function and higher levels of depression and fatigue (p<0.05). With the exception of a nonsignificant association between perceived control and physical function, greater perceptions of personal control and health competence were significantly associated with more positive HRQOL outcomes (p<0.01).
Survivors of aggressive NHL who are younger, are non-married, lack private insurance, or experience greater illness burden may be at risk for poorer HRQOL. Cognitive health appraisal factors were strongly related to HRQOL, suggesting potential benefits of interventions focused on these mutable factors for this population.
PMCID: PMC3552112  PMID: 22951588

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