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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.  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
3.  Proton Versus Intensity-Modulated Radiotherapy for Prostate Cancer: Patterns of Care and Early Toxicity 
Proton radiotherapy (PRT) is an emerging treatment for prostate cancer despite limited knowledge of clinical benefit or potential harms compared with other types of radiotherapy. We therefore compared patterns of PRT use, cost, and early toxicity among Medicare beneficiaries with prostate cancer with those of intensity-modulated radiotherapy (IMRT).
We performed a retrospective study of all Medicare beneficiaries aged greater than or equal to 66 years who received PRT or IMRT for prostate cancer during 2008 and/or 2009. We used multivariable logistic regression to identify factors associated with receipt of PRT. To assess toxicity, each PRT patient was matched with two IMRT patients with similar clinical and sociodemographic characteristics. The main outcome measures were receipt of PRT or IMRT, Medicare reimbursement for each treatment, and early genitourinary, gastrointestinal, and other toxicity. All statistical tests were two-sided.
We identified 27,647 men; 553 (2%) received PRT and 27,094 (98%) received IMRT. Patients receiving PRT were younger, healthier, and from more affluent areas than patients receiving IMRT. Median Medicare reimbursement was $32,428 for PRT and $18,575 for IMRT. Although PRT was associated with a statistically significant reduction in genitourinary toxicity at 6 months compared with IMRT (5.9% vs 9.5%; odds ratio [OR] = 0.60, 95% confidence interval [CI] = 0.38 to 0.96, P = .03), at 12 months post-treatment there was no difference in genitourinary toxicity (18.8% vs 17.5%; OR = 1.08, 95% CI = 0.76 to 1.54, P = .66). There was no statistically significant difference in gastrointestinal or other toxicity at 6 months or 12 months post-treatment.
Although PRT is substantially more costly than IMRT, there was no difference in toxicity in a comprehensive cohort of Medicare beneficiaries with prostate cancer at 12 months post-treatment.
PMCID: PMC3536640  PMID: 23243199
4.  KRAS Testing and Epidermal Growth Factor Receptor Inhibitor Treatment for Colorectal Cancer in Community Settings 
In metastatic colorectal cancer (mCRC), mutations in the KRAS gene predict poor response to epidermal growth factor receptor (EGFR) inhibitors. Clinical treatment guidelines now recommend KRAS testing if EGFR inhibitors are considered. Our study investigates the clinical uptake and utilization of KRAS testing.
We included 1,188 patients with mCRC diagnosed from 2004 to 2009, from seven integrated health care delivery systems with a combined membership of 5.5 million. We used electronic medical records and targeted manual chart review to capture the complexity and breadth of real-world clinical oncology care.
Overall, 428 patients (36%) received KRAS testing during their clinical care, and 266 (22%) were treated with EGFR inhibitors. Age at diagnosis (p=0.0034), comorbid conditions (p=0.0316), and survival time from diagnosis (p<0.0001) influence KRAS testing and EGFR inhibitor prescribing. The proportion who received KRAS testing increased from 7% to 97% for those treated in 2006 and 2010, respectively, and 83% of all treated patients had a KRAS wild type genotype. Most patients with a KRAS mutation (86%) were not treated with EGFR inhibitors. The interval between mCRC diagnosis and receipt of KRAS testing decreased from 26 months (2006) to 10 months (2009).
These findings demonstrate rapid uptake and incorporation of this predictive biomarker into clinical oncology care.
In this delivery setting, KRAS testing is widely used to guide treatment decisions with EGFR inhibitors in patients with mCRC. An important future research goal is to evaluate utilization of KRAS testing in other delivery settings in the US.
PMCID: PMC3567775  PMID: 23155138
biomarker; utilization; colorectal neoplasms; managed care programs
5.  Impact of diagnosis and treatment of clinically-localized prostate cancer on health-related quality of life for older Americans: a population-based study 
Cancer  2012;118(22):5679-5687.
Few studies have measured the longitudinal change in health-related quality of life (HRQOL) of prostate cancer patients starting prior to cancer diagnosis, or provide simultaneous comparisons with a matched non-cancer cohort. Our study addresses these gaps by providing unique estimates of the effects of a cancer diagnosis on HRQOL accounting for the confounding effects of ageing and comorbidity.
The Surveillance, Epidemiology, and End Results registry data were linked with the Medicare Health Outcomes Survey (MHOS) data. Eligible patients (n=445) were Medicare beneficiaries, aged 65 years and older, from 1998–2003 whose first prostate cancer diagnosis occurred between their baseline and follow-up MHOS. Using propensity score matching, we identified 2225 participants without cancer in the MHOS. Analysis of covariance models were used to estimate changes in HRQOL as assessed with the Short Form-36 and activities of daily living scale.
Before diagnosis, prostate cancer patients reported similar HRQOL to men without cancer. Following diagnosis, men with prostate cancer experienced significant decrements in physical, mental, and social aspects of their lives relative to controls, especially within the first 6 months from diagnosis. For men surveyed beyond one year after diagnosis, HRQOL was similar to controls. However, we observed an increased risk for major depressive disorder among men undergoing either conservative management or external beam radiation.
These findings illustrate the time-sensitive nature of decline in HRQOL after a cancer diagnosis and enhance our understanding of the impact of prostate cancer diagnosis and treatment on older men’ physical, mental, and social well-being.
PMCID: PMC3410051  PMID: 22544633
Prostate Cancer; health-related quality of life; population-based; prospective; older Americans
6.  Physician Roles in the Cancer-Related Follow-Up Care of Cancer Survivors 
Family medicine  2013;45(7):463-474.
Information about primary care physicians’ (PCPs) and oncologists’ involvement in cancer-related follow-up care, and care coordination practices, is lacking but essential to improving cancer survivors’ care. This study assesses PCPs’ and oncologists’ self-reported roles in providing cancer-related follow-up care for survivors who are within five years of completing cancer treatment.
In 2009, the National Cancer Institute and American Cancer Society conducted a nationally-representative survey of PCPs (n=1014) and medical oncologists (n=1125) (response rate=57.6%; cooperation rate=65.1%). Mailed questionnaires obtained information on physicians’ roles in providing cancer-related follow-up care to early-stage breast and colon cancer survivors; personal and practice characteristics; beliefs about and preferences for follow-up care; and care coordination practices.
Over 50% of PCPs reported providing cancer-related follow-up care for survivors, mainly by co-managing with an oncologist. In contrast, over 70% of oncologists reported fulfilling these roles by providing the care themselves. In adjusted analyses, PCP co-management was associated with: specialty, training in late or long-term effects of cancer, higher cancer patient volume, favorable attitudes about PCP care involvement, preference for a shared model of survivorship care, and receipt of treatment summaries from oncologists. Among oncologists, only preference for a shared care model was associated with co-management with PCPs.
PCPs and oncologists differ in their involvement in cancer-related follow-up care of survivors, with co-management more often reported by PCPs than by oncologists. Given anticipated national shortages of PCPs and oncologists, study results suggest that improved communication and coordination between these providers is needed to ensure optimal delivery of follow-up care to cancer survivors.
PMCID: PMC3755767  PMID: 23846965
neoplasms; survivorship; physicians; primary health care; physicians’ practice patterns
7.  Long-Term Functional Outcomes after Treatment for Localized Prostate Cancer 
The New England journal of medicine  2013;368(5):436-445.
The purpose of this analysis was to compare long-term urinary, bowel, and sexual function after radical prostatectomy or external-beam radiation therapy.
The Prostate Cancer Outcomes Study (PCOS) enrolled 3533 men in whom prostate cancer had been diagnosed in 1994 or 1995. The current cohort comprised 1655 men in whom localized prostate cancer had been diagnosed between the ages of 55 and 74 years and who had undergone either surgery (1164 men) or radiotherapy (491 men). Functional status was assessed at baseline and at 2, 5, and 15 years after diagnosis. We used multivariable propensity scoring to compare functional outcomes according to treatment.
Patients undergoing prostatectomy were more likely to have urinary incontinence than were those undergoing radiotherapy at 2 years (odds ratio, 6.22; 95% confidence interval [CI], 1.92 to 20.29) and 5 years (odds ratio, 5.10; 95% CI, 2.29 to 11.36). However, no significant between-group difference in the odds of urinary incontinence was noted at 15 years. Similarly, although patients undergoing prostatectomy were more likely to have erectile dysfunction at 2 years (odds ratio, 3.46; 95% CI, 1.93 to 6.17) and 5 years (odds ratio, 1.96; 95% CI, 1.05 to 3.63), no significant between-group difference was noted at 15 years. Patients undergoing prostatectomy were less likely to have bowel urgency at 2 years (odds ratio, 0.39; 95% CI, 0.22 to 0.68) and 5 years (odds ratio, 0.47; 95% CI, 0.26 to 0.84), again with no significant between-group difference in the odds of bowel urgency at 15 years.
At 15 years, no significant relative differences in disease-specific functional outcomes were observed among men undergoing prostatectomy or radiotherapy. Nonetheless, men treated for localized prostate cancer commonly had declines in all functional domains during 15 years of follow-up. (Funded by the National Cancer Institute.)
PMCID: PMC3742365  PMID: 23363497
9.  Differences Between Primary Care Physicians’ and Oncologists’ Knowledge, Attitudes and Practices Regarding the Care of Cancer Survivors 
Journal of General Internal Medicine  2011;26(12):1403-1410.
The growing number of cancer survivors combined with a looming shortage of oncology specialists will require greater coordination of post-treatment care responsibilities between oncologists and primary care physicians (PCPs). However, data are limited regarding these physicians’ views of cancer survivors’ care.
To compare PCPs and oncologists with regard to their knowledge, attitudes, and practices for follow-up care of breast and colon cancer survivors.
Design and Subjects
Mailed questionnaires were completed by a nationally representative sample of 1,072 PCPs and 1,130 medical oncologists in 2009 (cooperation rate = 65%). Sampling and non-response weights were used to calculate estimates to reflect practicing US PCPs and oncologists.
Main Measures
PCPs and oncologists reported their 1) preferred model for delivering cancer survivors’ care; 2) assessment of PCPs’ ability to perform follow-up care tasks; 3) confidence in their knowledge; and 4) cancer surveillance practices.
Key Results
Compared with PCPs, oncologists were less likely to believe PCPs had the skills to conduct appropriate testing for breast cancer recurrence (59% vs. 23%, P < 0.001) or to care for late effects of breast cancer (75% vs. 38%, P < 0.001). Only 40% of PCPs were very confident of their own knowledge of testing for recurrence. PCPs were more likely than oncologists to endorse routine use of non-recommended blood and imaging tests for detecting cancer recurrence, with both groups departing substantially from guideline recommendations.
There are significant differences in PCPs’ and oncologists’ knowledge, attitudes, and practices with respect to care of cancer survivors. Improving cancer survivors’ care may require more effective communication between these two groups to increase PCPs’ confidence in their knowledge, and must also address oncologists’ attitudes regarding PCPs’ ability to care for cancer survivors.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-011-1808-4) contains supplementary material, which is available to authorized users.
PMCID: PMC3235622  PMID: 21785923
cancer care; cancer survivorship; physician survey; physician attitudes
10.  Physician self-reported treatment of brain metastases according to patients’ clinical and demographic factors and physician practice setting 
Limited data guide radiotherapy choices for patients with brain metastases. This survey aimed to identify patient, physician, and practice setting variables associated with reported preferences for different treatment techniques.
277 members of the American Society for Radiation Oncology (6% of surveyed physicians) completed a survey regarding treatment preferences for 21 hypothetical patients with brain metastases. Treatment choices included combinations of whole brain radiation therapy (WBRT), stereotactic radiosurgery (SRS), and surgery. Vignettes varied histology, extracranial disease status, Karnofsky Performance Status (KPS), presence of neurologic deficits, lesion size and number. Multivariate generalized estimating equation regression models were used to estimate odds ratios.
For a hypothetical patient with 3 lesions or 8 lesions, 21% and 91% of physicians, respectively, chose WBRT alone, compared with 1% selecting WBRT alone for a patient with 1 lesion. 51% chose WBRT alone for a patient with active extracranial disease or KPS=50%. 40% chose SRS alone for an 80 year-old patient with 1 lesion, compared to 29% for a 55 year-old patient. Multivariate modeling detailed factors associated with SRS use, including availability of SRS within one’s practice (OR 2.22, 95% CI 1.46-3.37).
Poor prognostic factors, such as advanced age, poor performance status, or active extracranial disease, correspond with an increase in physicians’ reported preference for using WBRT. When controlling for clinical factors, equipment access was independently associated with choice of SRS. The large variability in preferences suggests that more information about the relative harms and benefits of these options is needed to guide decision-making.
PMCID: PMC3533820  PMID: 23136987
Brain metastases; Stereotactic radiosurgery; Whole brain radiation therapy; Treatment patterns; Physician survey
11.  Physicians' Decision-making Style and Psychosocial Outcomes Among Cancer Survivors 
Patient Education and Counseling  2009;77(3):404-412.
We evaluated pathways linking physicians' decision-making style with cancer survivors' health-related quality of life (HRQOL)
We analyzed survey data from 623 survivors diagnosed with leukemia, colorectal, or bladder cancer in Northern California, 2–5 years prior to the study. Of these, 395 reported making a medical decision in the past 12 months and were asked about their physician's decision-making style. We evaluated the association of physician style with proximal communication outcomes (trust, participation self-efficacy), intermediate cognitive outcomes (perceived control, uncertainty), and distal health outcomes (physical and mental HRQOL).
Overall, 54% of survivors reported a sub-optimal decision-making style for their physician. With the exception of physical health, physician style was associated with all proximal, intermediate, and distal outcomes (p≤0.01). We identified two significant pathways by which a participatory physician style may be associated with survivors' mental health: 1) by increasing survivors' participation self-efficacy and thereby enhancing their perceptions of personal control (p<0.01); 2) by enhancing survivors' level of trust and thereby reducing their perceptions of uncertainty (p<0.05).
A participatory physician style may improve survivors' mental health by a complex two step mechanism of improving survivors' proximal communication and intermediate cognitive outcomes.
Practice Implications
Physicians who adopt a participatory decision-making style are likely to facilitate patient empowerment and enhance patients' HRQOL.
PMCID: PMC3401045  PMID: 19892508
patient-physician communication; participatory decision-making style; cancer survivorship; health-related quality of life; patient outcomes; mediation analysis
12.  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
13.  A Population-Based Assessment of Specialty Physician Involvement in Cancer Clinical Trials 
Clinical trials are critical for evaluating new cancer therapies, but few adult patients participate in them. Physicians have an important role in facilitating patient participation in clinical trials. We examined the characteristics of specialty physicians who participate in clinical trials by enrolling or referring patients, the types of trials in which they participate, and factors associated with physicians who report greater involvement in clinical trials.
We analyzed data from the Cancer Care Outcomes Research and Surveillance Consortium. The study included 1533 specialty physicians who cared for colorectal and lung cancer patients (496 medical oncologists, 228 radiation oncologists, and 809 surgeons) and completed a survey conducted during 2005–2006 (response rate = 61.0%). Descriptive statistics were used to characterize physicians’ personal and practice characteristics, and regression models were used to examine associations between these characteristics and physician participation in clinical trials. All statistical tests were two-sided.
A total of 87.8% of medical oncologists, 66.1% of radiation oncologists, and 35.0% of surgeons reported referring or enrolling one or more patients in clinical trials during the previous 12 months. The mean number of patients referred or enrolled by these physicians was 17.2 (95% confidence interval [CI] = 15.5 to 18.9) for medical oncologists, 9.5 (95% CI = 7.7 to 11.3) for radiation oncologists, and 12.2 (95% CI = 9.8 to 14.6) for surgeons (P < .001). Specialty type, involvement in teaching, and affiliation with a Community Clinical Oncology Program (CCOP) and/or a National Cancer Institute–designated cancer center were associated with physician trial participation and enrolling more patients (all Ps < .05). Two-thirds of physicians with a CCOP or National Cancer Institute–designated cancer center affiliation reported participating in trials.
Features of specialty physicians’ practice environments are associated with their trial participation, but many physicians at CCOPs and cancer centers do not participate.
PMCID: PMC3107589  PMID: 21317382
14.  Comparative Effectiveness of Prostate Cancer Treatments: Evaluating Statistical Adjustments for Confounding in Observational Data 
Using observational data to assess the relative effectiveness of alternative cancer treatments is limited by patient selection into treatment, which often biases interpretation of outcomes. We evaluated methods for addressing confounding in treatment and survival of patients with early-stage prostate cancer in observational data and compared findings with those from a benchmark randomized clinical trial.
We selected 14 302 early-stage prostate cancer patients who were aged 66–74 years and had been treated with radical prostatectomy or conservative management from linked Surveillance, Epidemiology, and End Results–Medicare data from January 1, 1995, through December 31, 2003. Eligibility criteria were similar to those from a clinical trial used to benchmark our analyses. Survival was measured through December 31, 2007, by use of Cox proportional hazards models. We compared results from the benchmark trial with results from models with observational data by use of traditional multivariable survival analysis, propensity score adjustment, and instrumental variable analysis.
Prostate cancer patients receiving conservative management were more likely to be older, nonwhite, and single and to have more advanced disease than patients receiving radical prostatectomy. In a multivariable survival analysis, conservative management was associated with greater risk of prostate cancer–specific mortality (hazard ratio [HR] = 1.59, 95% confidence interval [CI] = 1.27 to 2.00) and all-cause mortality (HR = 1.47, 95% CI = 1.35 to 1.59) than radical prostatectomy. Propensity score adjustments resulted in similar patient characteristics across treatment groups, although survival results were similar to traditional multivariable survival analyses. Results for the same comparison from the instrumental variable approach, which theoretically equalizes both observed and unobserved patient characteristics across treatment groups, differed from the traditional multivariable and propensity score results but were consistent with findings from the subset of elderly patient with early-stage disease in the trial (ie, conservative management vs radical prostatectomy: for prostate cancer–specific mortality, HR = 0.73, 95% CI = 0.08 to 6.73; for all-cause mortality, HR = 1.09, 95% CI = 0.46 to 2.59).
Instrumental variable analysis may be a useful technique in comparative effectiveness studies of cancer treatments if an acceptable instrument can be identified.
PMCID: PMC2994860  PMID: 20944078
15.  Recruitment and follow-up of adolescent and young adult cancer survivors: the AYA HOPE Study 
Journal of Cancer Survivorship  2011;5(3):305-314.
Cancer is rare in adolescents and young adults (AYA), but these patients have seen little improvement in survival in contrast to most other age groups. Furthermore, participation in research by AYAs is typically low. We conducted a study to examine the feasibility of recruiting a population-based sample of AYA survivors to examine issues of treatment and health outcomes.
Individuals diagnosed in 2007–08 and age 15–39 at the time of diagnosis with acute lymphocytic leukemia, Hodgkin lymphoma, non-Hodgkin lymphoma, germ cell cancer or sarcoma were identified by 7 Surveillance, Epidemiology, and End-Results (SEER) cancer registries, mailed surveys within 14 months after diagnosis and again a year later, and had medical records reviewed.
525 (43%) of the eligible patients responded, 39% refused and 17% were lost to follow-up. Extensive efforts were required for most potential respondents (87%). 76% of respondents completed the paper rather than online survey version. In a multivariate model, age, cancer site, education and months from diagnosis to the first mailing of the survey were not associated with participation, although males (p < 0.01), Hispanics and non-Hispanic blacks (p < 0.001) were less likely to participate. 91% of survivors completing the initial survey completed the subsequent survey.
Despite the response rate, those who participated adequately reflected the population of AYA cancer survivors. The study demonstrates that cancer registries are valuable foundations for conducting observational, longitudinal population-based research on AYA cancer survivors.
Implications for Cancer Survivors
Achieving a reasonable response rate in this population is possible, but requires extensive resources.
PMCID: PMC3159756  PMID: 21274648
Adolescent cancer; Young adult cancer; Survey; Response rates; Medical records; Consent forms
16.  Cancer Pharmacogenomics and Pharmacoepidemiology: Setting a Research Agenda to Accelerate Translation 
Recent advances in genomic research have demonstrated a substantial role for genomic factors in predicting response to cancer therapies. Researchers in the fields of cancer pharmacogenomics and pharmacoepidemiology seek to understand why individuals respond differently to drug therapy, in terms of both adverse effects and treatment efficacy. To identify research priorities as well as the resources and infrastructure needed to advance these fields, the National Cancer Institute (NCI) sponsored a workshop titled “Cancer Pharmacogenomics: Setting a Research Agenda to Accelerate Translation” on July 21, 2009, in Bethesda, MD. In this commentary, we summarize and discuss five science-based recommendations and four infrastructure-based recommendations that were identified as a result of discussions held during this workshop. Key recommendations include 1) supporting the routine collection of germline and tumor biospecimens in NCI-sponsored clinical trials and in some observational and population-based studies; 2) incorporating pharmacogenomic markers into clinical trials; 3) addressing the ethical, legal, social, and biospecimen- and data-sharing implications of pharmacogenomic and pharmacoepidemiologic research; and 4) establishing partnerships across NCI, with other federal agencies, and with industry. Together, these recommendations will facilitate the discovery and validation of clinical, sociodemographic, lifestyle, and genomic markers related to cancer treatment response and adverse events, and they will improve both the speed and efficiency by which new pharmacogenomic and pharmacoepidemiologic information is translated into clinical practice.
PMCID: PMC2982809  PMID: 20944079
17.  Access to Information Sources and Treatment Considerations among Men with Local Stage Prostate Cancer 
Urology  2009;74(3):509-515.
Men with local stage prostate cancer have access to a large number of information sources about therapy, including print and broadcast media, the Internet, books, and friends with the disease. The purpose of this evaluation is to determine the role that information sources play in the treatment decision process.
Prospective survey of men in three geographically separate regions with local stage prostate cancer. Most men were surveyed following diagnosis but prior to starting therapy.
On average, men consulted nearly five separate sources of information prior to treatment. The most common source of information was the patient’s physician (97%), followed by lay-literature (pamphlets, videos) (76%), other health professionals (71%), friends with prostate cancer (67%), and the Internet (58%). Most men rated the sources they consulted as helpful. Consulting the Internet was associated with considering more treatment options. Several information sources were significantly associated with considering particular treatments, but the magnitude of association was small in relation to patient age, comorbidity, and Gleason score. More than 70% of men stated they were considering or planning only one type of therapy.
Men with local stage prostate cancer consult a wide range of information sources. Non-physician information sources appear to influence their treatment considerations, but to a smaller degree than clinical factors.
PMCID: PMC2748115  PMID: 19589564
prostate cancer; surgery; information sources; decision making
18.  Adjuvant Chemotherapy Use and Adverse Events among Older Patients with Stage III Colon Cancer 
Randomized trials suggest adjuvant chemotherapy is effective for elderly patients with stage III colon cancer. However, the elderly are less likely to receive this therapy than younger patients, perhaps because of concern about adverse effects.
To evaluate adjuvant chemotherapy use and outcomes for older patients with stage III colon cancer from well-defined population-based settings and healthcare systems.
Observational study of adjuvant chemotherapy use and outcomes by age, using Poisson regression to estimate the number of adverse events adjusted for demographic and clinical factors, including comorbid illness and specific elements of chemotherapy regimens documented with clinically detailed medical record reviews and patient and surrogate surveys.
Five geographically defined regions (Alabama, Iowa, Los Angeles County, Northern California, and North Carolina), five integrated health-care delivery systems, and 15 Veterans hospitals.
All 675 patients diagnosed with stage III colon cancer during 2003-2005 who underwent surgical resection were followed up to 15 months post-diagnosis.
Main outcome measures
Chemotherapy regimen, dose, duration and annualized mean number of adverse events stratified by age.
Half of the 202 patients >=75 years received adjuvant chemotherapy compared with 87% of 473 younger patients (diff 37%, 95% CI 30%-45%). Among adjuvant chemotherapy users, 14 (14%) of patients >=75 years and 178 (44%) of younger patients received a regimen containing oxaliplatin (diff 30%, 95% CI 21%-38%). Older patients were less likely to continue. By 150 days, 99 (40%) patients >= 65 years and 68 (25%) younger patients had discontinued chemotherapy (diff 15%, 95% CI 7%-23%). Overall, 162 (24%) patients had at least one adverse clinical event, with more events among patients treated with vs. without adjuvant chemotherapy (mean 0.394 vs. 0.160, diff 0.234, 95% CI 0.11-0.36, p<0.001). Among adjuvant chemotherapy users, adjusted rates of late clinical adverse events show a reverse U-distribution with lower rates for patients >= 75 years (0.277) versus for younger patients (0.345 for 18-54, 0.519 for 55-64, and 0.446 for 65-75 years, p=0.008 for any age effect).
Older patients in the community receive less toxic and shorter chemotherapy regimens, and those treated had fewer adverse events than younger patients. The effect of these differences on clinical outcomes is not clear.
PMCID: PMC2893553  PMID: 20233821
stage III colon caner; colorectal neoplasia; adjuvant chemotherapy; adverse events; community settings
19.  Impact of Cancer on Health-Related Quality of Life of Older Americans 
The impact of cancer on health-related quality of life (HRQOL) is poorly understood because of the lack of baseline HRQOL status before cancer diagnosis. To our knowledge, this is the first population-based study to quantify the nature and extent of HRQOL changes from before to after cancer diagnosis for nine types of cancer patients and to compare their health with individuals without cancer.
The Surveillance, Epidemiology, and End Results cancer registry data were linked with the Medicare Health Outcomes Survey (MHOS) data; data were collected from Medicare beneficiaries who were aged 65 years and older from 1998 through 2003. Cancer patients (n = 1432; with prostate, breast, colorectal, lung, bladder, endometrial, or kidney cancers; melanoma; or non-Hodgkin lymphoma [NHL]) were selected whose first cancer diagnosis occurred between their baseline and follow-up MHOS assessments. Control subjects without cancer (n = 7160) were matched to cancer patients by use of propensity scores that were estimated from demographics and comorbid medical conditions. Analysis of covariance models were used to estimate changes in HRQOL as assessed with the Medical Outcomes Study Short Form-36 survey (mean score = 50, SD = 10). All statistical tests were two-sided.
Patients with all cancer types (except melanoma and endometrial cancer) reported statistically significant declines in physical health (mean scores: prostate cancer = −3.4, 95% confidence interval [CI] = −2.5 to −4.2; breast cancer = −3.5, 95% CI = −2.5 to −4.5; bladder cancer = −4.3, 95% CI = −2.5 to −6.1; colorectal cancer = −4.4, 95% CI = −3.3 to −5.5; kidney cancer = −5.7, 95% CI = −3.2 to −8.2; NHL = −6.7, 95% CI = −4.4 to −9.1; and lung cancer = −7.5, 95% CI = −5.9 to −9.2) compared with the control subjects (mean score = −1.8, 95% CI = −1.6 to −2.0) (all P < .05). However, only lung (mean score = −5.4, 95% CI = −3.5 to −7.2), colorectal (mean score = −3.5, 95% CI = −2.2 to −4.7), and prostate (mean score = −2.8, 95% CI = −1.8 to −3.7) cancer patients showed statistically significant decreases in mental health relative to the mean change of the control subjects (mean score = −1.2, 95% CI = −0.9 to −1.4) (all P < .05).
These findings provide validation of the specific deleterious effects of cancer on HRQOL and an evidence base for future research and clinical interventions aimed at understanding and remediating these effects.
PMCID: PMC2720781  PMID: 19509357
20.  Association of Preexisting Symptoms with Treatment Decisions among Newly Diagnosed Prostate Cancer Patients 
The patient  2008;1(3):189.
The choice between surgical versus non-surgical treatment options is a fundamental decision for men with local stage prostate cancer because of differences in risks of genitourinary side effects among available treatments.
We assessed whether preexisting genitourinary symptoms at the time of diagnosis influenced men’s preferences for surgery versus other management options.
We recruited 593 patients with newly diagnosed local stage prostate cancer prior to initiating treatment from an integrated health care system, an academic urology center, and community urology clinics. Using logistic regression we compared whether men had a preference for non-surgical options or only preferred surgery.
Nearly 60% indicated they were considering non-surgical options. Age and clinical characteristics but not preexisting genitourinary symptoms influenced the decision between preferences for surgical or non-surgical options. A total of 62% of men reported side effects as a main factor in their treatment decision. Men with more aggressive tumor types were less likely to consider side effects, however, men who reported poor ability to have an erection were more likely to consider side effects (p<0.001).
Sexual dysfunction at time of diagnosis, but not other genitourinary symptoms, is associated with men considering treatment-related side effects when considering surgery versus other options. Men who are not experiencing sexual dysfunction at diagnosis may discount the risks of side effects in the decision making process.
PMCID: PMC2812903  PMID: 20119493
prostate cancer; symptoms; treatment
21.  Differences between men with screening-detected versus clinically diagnosed prostate cancers in the USA 
BMC Cancer  2005;5:27.
The advent of prostate specific antigen (PSA) testing in the United States of America (USA) has led to a dramatic increase in the incidence of prostate cancer in the United States as well as the number of men undergoing aggressive treatment with radical prostatectomy and radiation therapy. We compared patient characteristics and treatment selection between American men with screening-detected versus clinically diagnosed prostate cancers.
We evaluated 3,173 men with prostate cancer in the USA. Surveys and medical records provided information on demographics, socioeconomic status, comorbidities, symptoms, tumor characteristics, and treatment. We classified men presenting with symptoms of advanced cancer – bone pain, weight loss, or hematuria – as "clinically diagnosed"; asymptomatic men and those with only lower urinary tract symptoms were considered "screening-detected." We used multivariate analyses to determine whether screening predicted receiving aggressive treatment for a clinically localized cancer.
We classified 11% of cancers as being clinically diagnosed. Men with screening-detected cancers were more often non-Hispanic white (77% vs. 65%, P < 0.01), younger (36% < 65 years vs. 25%, P ≤ 0.01), better educated (80% ≥ high school vs. 67%, P < 0.01), healthier (18% excellent health vs. 10%, P < 0.01), and diagnosed with localized disease (90% vs. 75%, P < 0.01). Men with screening-detected localized cancers more often underwent aggressive treatment, 76% vs. 70%, P = 0.05.
Most cancers were detected by screening in this American cohort. Appropriately, younger, healthier men were more likely to be diagnosed by screening. Minority status and lower socio-economic status appeared to be screening barriers. Screening detected earlier-stage cancers and was associated with receiving aggressive treatment.
PMCID: PMC555747  PMID: 15755329
22.  Race/Ethnicity and the Receipt of Watchful Waiting for the Initial Management of Prostate Cancer 
Several recent studies have noted that African Americans disproportionately receive “watchful waiting” for the initial management of their prostate cancer. To determine whether racial/ethnic differences in the receipt of watchful waiting are explained by differences in clinical presentation and life expectancy at the time of diagnosis, we examined Surveillance, Epidemiology, and End Results (SEER)-Medicare data for men diagnosed with prostate cancer in 1994 to 1996.
Race/ethnicity, comorbidity, stage, grade, age, and expected lifespan and their association with the receipt of watchful waiting were examined in multivariate logistic regression analyses. Race-stratified logistic regression analyses were also used to examine racial/ethnic variation in the association of clinical and demographic factors with the receipt of watchful waiting among African-American, Hispanic, and non-Hispanic white men.
African-American (odds ratio [OR], 1.4; 95% confidence interval [CI], 1.3 to 1.6) and Hispanic men (OR, 1.3; 95% CI, 1.1 to 1.5) were significantly more likely than non-Hispanic white men to receive watchful waiting in a multivariate model adjusted for age, comorbidity, stage, grade, and life expectancy. Advanced stage and grade, lower life expectancy, older age, and high comorbidity indices were also significantly associated with an increase in the odds of receipt of watchful waiting in multivariate analyses. In general, the association between the receipt of watchful waiting and the clinical characteristics (i.e., stage, grade, and age) were similar for the three racial/ethnic groups. In race-stratified logistic regression analyses, life expectancy was associated with an increase in the odds of receiving watchful waiting but results were statistically significant for whites only. There was also a statistically significant increase in the odds of receiving watchful waiting for African-American and white men with high comorbidity indices but not Hispanic men. The odds of receiving watchful waiting were also higher for African-American and Hispanic men who resided in census tracts where a large percentage of residents had not completed high school than for white men who resided in similar census tracts.
The disproportionate receipt of watchful waiting among African Americans and Hispanics is not completely explained by racial/ethnic variation in clinical characteristics or life expectancy as measured in this study. These data suggest that there are other factors that contribute to racial/ethnic differences in receipt of watchful waiting that warrant investigation.
PMCID: PMC1492143  PMID: 15009794
conservative management; ethnicity; health disparities; prostate cancer; race; watchful waiting
23.  Racial Differences in Initial Treatment for Clinically Localized Prostate Cancer 
We examined whether there were racial differences in initial treatment for clinically localized prostate cancer and investigated whether demographic, socioeconomic, clinical, or tumor characteristics could explain any racial differences.
Prospective cohort study.
Population-based tumor registries in Connecticut, Los Angeles, and Atlanta.
We evaluated 1144 African-American and non-Hispanic white men, aged 50 to 74 years, with clinically localized cancer diagnosed between October 1994 and October 1995.
We obtained demographic, socioeconomic, and clinical data from patient surveys and medical record abstractions. We reported adjusted percentages for receiving treatment derived from multinomial logistic regression. We found an interaction between race and tumor aggressiveness. Among men with more aggressive cancers (PSA ≥ 20 ng/mL or Gleason score ≥ 8), African Americans were less likely to undergo radical prostatectomy than non-Hispanic whites (35.2% vs 52.0%), but more likely to receive conservative management (38.9% vs 16.3%, P= .003). Among the 71% of subjects with less aggressive cancers, African Americans and non-Hispanic whites were equally likely to receive either radical prostatectomy or radiation therapy (80.0% vs 84.5%, P= .2).
African Americans with more aggressive cancers were less likely to undergo radical prostatectomy and more likely to be treated conservatively. These treatment differences may reflect African Americans’ greater likelihood for presenting with pathologically advanced cancer for which surgery has limited effectiveness. Among men with less aggressive cancers—the majority of cases—there were no racial differences in undergoing radical prostatectomy or radiation therapy.
PMCID: PMC1494937  PMID: 14521648
prostatic neoplasms; prostatectomy; radiation therapy; patient selection; African Americans
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

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