Suanna S. Bruinooge

Future Supply and Demand for Oncologists : Challenges to Assuring Access to Oncology Services

PURPOSE To conduct a comprehensive analysis of supply of and demand for oncology services through 2020. This study was commissioned by the Board of Directors of ASCO. METHODS New data on physician supply gathered from surveys of practicing oncologists, oncology fellows, and fellowship program directors were analyzed, along with 2005 American Medical Association Masterfile data on practicing medical oncologists, hematologists/oncologists, and gynecologic oncologists, to determine the baseline capacity and to forecast visit capacity through 2020. Demand for visits was calculated by applying age-, sex-, and time-from-diagnosis-visit rate data from the National Cancer Institutes analysis of the 1998 to 2002 Surveillance, Epidemiology and End Results (SEER) database to the National Cancer Institutes cancer incidence and prevalence projections. The cancer incidence and prevalence projections were calculated by applying a 3-year average (2000-2002) of age- and sex-specific cancer rates from SEER to the US Census Bureau population projections released on March 2004. The baseline supply and demand forecasts assume no change in cancer care delivery and physician practice patterns. Alternate scenarios were constructed by changing assumptions in the baseline models. RESULTS Demand for oncology services is expected to rise rapidly, driven by the aging and growth of the population and improvements in cancer survival rates, at the same time the oncology workforce is aging and retiring in increasing numbers. Demand is expected to rise 48% between 2005 and 2020. The supply of services provided by oncologists during this time is expected to grow more slowly, approximately 14%, based on the current age distribution and practice patterns of oncologists and the number of oncology fellowship positions. This translates into a shortage of 9.4 to 15.0 million visits, or 2,550 to 4,080 oncologists-roughly one-quarter to one-third of the 2005 supply. The baseline projections do not include any alterations based on changes in practice patterns, service use, or cancer treatments. Various alternate scenarios were also developed to show how supply and demand might change under different assumptions. CONCLUSIONS ASCO, policy makers, and the public have major challenges ahead of them to forestall likely shortages in the capacity to meet future demand for oncology services. A multifaceted strategy will be needed to ensure that Americans have access to oncology services in 2020, as no single action will fill the likely gap between supply and demand. Among the options to consider are increasing the number of oncology fellowship positions, increasing use of nonphysician clinicians, increasing the role of primary care physicians in the care of patients in remission, and redesigning service delivery.

Projected Supply of and Demand for Oncologists and Radiation Oncologists Through 2025: An Aging, Better-Insured Population Will Result in Shortage

PURPOSE The American Society of Clinical Oncology (ASCO) published a study in 2007 that anticipated a shortage of oncologists by 2020. This study aims to update and better assess the market for chemotherapy and radiation therapy and the impact of health reform on capacity of and demand for oncologists and radiation oncologists. METHODS The supply of oncologists and radiation oncologists, by age, sex, and specialty, was projected through 2025 with an input-output model. The Medical Expenditure Panel Survey, commercial claims, and Medicare claims were analyzed to determine patterns of use by patient characteristics such as age, sex, health insurance coverage, cancer site, physician specialty, and service type. Patterns of use were then applied to the projected prevalence of cancer, using data from the SEER Program of the National Cancer Institute. RESULTS Beginning in 2012, 16,347 oncologists and radiation oncologists were active and supplying 15,190 full-time equivalents (FTEs) of patient care. Without consideration of the Affordable Care Act (ACA), overall demand for oncologist services is projected to grow 40% (21,255 FTEs), whereas supply may grow only 25% (18,997 FTEs), generating a shortage of 2,258 FTEs in 2025. When fully implemented, the ACA could increase the demand for oncologists and radiation oncologists by 500,000 visits per year, increasing the shortage to 2,393 FTEs in 2025. CONCLUSION Anticipated shortages are largely consistent with the projections of the ASCO 2007 workforce study but somewhat more delayed. The ACA may modestly exacerbate the shortage. Unless oncologist productivity can be enhanced, the anticipated shortage will strain the ability to provide quality cancer care.

The National Cancer Institute–American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and Recommendations

INTRODUCTION Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions. METHODS The National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of accrual science related to patient/community, physician/provider, and site/organizational influences, and identify new interventions to facilitate clinical trial enrollment. The symposium featured breakout sessions, plenary sessions, and a poster session including 100 abstracts. Among the 358 attendees were clinical investigators, researchers of accrual strategies, research administrators, nurses, research coordinators, patient advocates, and educators. A bibliography of the accrual literature in these three major areas was provided to participants in advance of the meeting. After the symposium, the literature in these areas was revisited to determine if the symposium recommendations remained relevant within the context of the current literature. RESULTS Few rigorously conducted studies have tested interventions to address challenges to clinical trials accrual. Attendees developed recommendations for improving accrual and identified priority areas for future accrual research at the patient/community, physician/provider, and site/organizational levels. Current literature continues to support the symposium recommendations. CONCLUSIONS A combination of approaches addressing both the multifactorial nature of accrual challenges and the characteristics of the target population may be needed to improve accrual to cancer clinical trials. Recommendations for best practices and for future research developed from the symposium are provided.

Association Between Geographic Access to Cancer Care, Insurance, and Receipt of Chemotherapy: Geographic Distribution of Oncologists and Travel Distance

PURPOSE Geographic access to care may be associated with receipt of chemotherapy but has not been fully examined. This study sought to evaluate the association between density of oncologists and travel distance and receipt of adjuvant chemotherapy for colon cancer within 90 days of colectomy. PATIENTS AND METHODS Patients in the National Cancer Data Base with stage III colon cancer, diagnosed between 2007 and 2010, and age 18 to 80 years were selected. Generalized estimating equation clustering by hospital service area was conducted to examine the association between geographic access and receipt of oncology services, controlling for patient sociodemographic and clinical characteristics. RESULTS Of 34,694 patients in the study cohort, 75.7% received adjuvant chemotherapy within 90 days of colectomy. Compared with travel distance less than 12.5 miles, patients who traveled 50 to 249 miles (odds ratio [OR], 0.87; P=.009) or ≥250 miles (OR, 0.36; P<.001) had decreased likelihood of receiving adjuvant chemotherapy. Density level of oncologists was not statistically associated with receipt of adjuvant chemotherapy (low v high density: OR, 0.98; P=.77). When stratifying analyses by insurance status, non-privately insured patients who resided in areas with low density of oncologists were less likely to receive adjuvant chemotherapy (OR, 0.85; P=.03). CONCLUSION Increased travel burden was associated with a decreased likelihood of receiving adjuvant chemotherapy, regardless of insurance status. Patients with nonprivate insurance who resided in low-density oncologist areas were less likely to receive adjuvant chemotherapy. If these findings are validated prospectively, interventions to decrease geographic barriers may improve the timeliness and quality of colon cancer treatment.

Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement

Purpose The primary purposes of eligibility criteria are to protect the safety of trial participants and define the trial population. Excessive or overly restrictive eligibility criteria can slow trial accrual, jeopardize the generalizability of results, and limit understanding of the interventions benefit-risk profile. Methods ASCO, Friends of Cancer Research, and the US Food and Drug Administration examined specific eligibility criteria (ie, brain metastases, minimum age, HIV infection, and organ dysfunction and prior and concurrent malignancies) to determine whether to modify definitions to extend trials to a broader population. Working groups developed consensus recommendations based on review of evidence, consideration of the patient population, and consultation with the research community. Results Patients with treated or clinically stable brain metastases should be routinely included in trials and only excluded if there is compelling rationale. In initial dose-finding trials, pediatric-specific cohorts should be included based on strong scientific rationale for benefit. Later phase trials in diseases that span adult and pediatric populations should include patients older than age 12 years. HIV-infected patients who are healthy and have low risk of AIDS-related outcomes should be included absent specific rationale for exclusion. Renal function criteria should enable liberal creatinine clearance, unless the investigational agent involves renal excretion. Patients with prior or concurrent malignancies should be included, especially when the risk of the malignancy interfering with either safety or efficacy endpoints is very low. Conclusion To maximize generalizability of results, trial enrollment criteria should strive for inclusiveness. Rationale for excluding patients should be clearly articulated and reflect expected toxicities associated with the therapy under investigation.

Modernizing Eligibility Criteria for Molecularly Driven Trials.

As more clinical trials of molecularly targeted agents evolve, the number of eligibility criteria seems to be increasing. The importance and utility of eligibility criteria must be considered in the context of the fundamental goal of a clinical trial: to understand the risks and benefits of a treatment in the intended-use patient population. Although eligibility criteria are necessary to define the population under study and conduct trials safely, excessive requirements may severely restrict the population available for study, and often, this population is not reflective of the general population for which the drug would be prescribed. The American Society of Clinical Oncology Cancer Research Committee, which comprises academic faculty, industry representatives, and patient advocates, evaluated this issue. Evaluation results were mixed. Most physicians agreed that excessive eligibility criterias slow study enrollment rates and prolong the duration of enrollment; however, this hypothesis was difficult to validate with the data examined. We propose the organization of a public workshop, with input from regulatory bodies and key stakeholders, with the goal of developing an algorithmic approach to determining eligibility criteria for individual study protocols, which may help guide future investigators and companies in streamlining eligibility criteria in the era of molecularly driven therapy.

The impact of insurance on access to cancer clinical trials at a comprehensive cancer center.

Purpose: Cancer patients at Johns Hopkins undergo insurance clearance to verify coverage for enrollment to interventional clinical trials. We sought to explore the impact of insurance clearance on disparities in access to cancer clinical trials at this urban comprehensive cancer center. Experimental Design: We evaluated the frequency of insurance-based denial of access to cancer clinical trials over a 5-year period after initiation of a formal insurance clearance process. We used a case-control design to compare demographic and clinical parameters of patients denied or approved for clinical trials participation by their insurance company in a 3-year interval. Results: From July 2003 to July 2008, insurance requests for clinical trial participation were submitted on 4,617 consented cancer patients at Johns Hopkins. A total of 628 patients (13.6%) with health insurance were denied therapeutic trial enrollment owing to lack of insurance coverage for participation. A total of 254 patients denied enrollment from 2005 to 2007 were selected for further analysis. Two-hundred sixty randomly selected patients approved for clinical trial participation served as controls. Patients approved were on average older (59.2 versus 54.9 years) than patients denied (P = 0.0001). Residents of Pennsylvania, which lacks a state law mandating cancer clinical trial coverage for residents, were overrepresented among the denied patients (P = 0.0009). No statistically significant variance in the likelihood of insurance denial was found on the basis of sex, race, stage of disease, or presence of comorbidities. Conclusions: Denial of access to therapeutic clinical trials, even among insured patients, is a significant barrier to clinical cancer research. This barrier spans racial, ethnic, and gender categories. Clin Cancer Res; 16(24); 5997–6003. ©2010 AACR.

Tracking the Workforce: The American Society of Clinical Oncology Workforce Information System

PURPOSE In anticipation of oncologist workforce shortages projected as part of a 2007 study, the American Society of Clinical Oncology (ASCO) worked with a contractor to create a workforce information system (WIS) to assemble the latest available data on oncologist supply and cancer incidence and prevalence. ASCO plans to publish findings annually, reporting on new data and tracking trends over time. METHODS THE WIS REPORT IS COMPOSED OF THREE SECTIONS: supply, new entrants, and cancer incidence and prevalence. Tabulations of the number of oncologists in the United States are derived mainly from the American Medical Association Physician Masterfile. Information on fellows and residents in the oncology workforce pipeline come from published sources such as Journal of the American Medical Association. Incidence and prevalence estimates are published by the American Cancer Society and National Cancer Institute. RESULTS The WIS reports a total of 13,084 oncologists working in the United States in 2011. Oncologists are defined as those physicians who designate hematology, hematology/oncology, or medical oncology as their specialty. The WIS compares the characteristics of these oncologists with those of all physicians and tracks emerging trends in the physician training pipeline. CONCLUSION Observing characteristics of the oncologist workforce over time allows ASCO to identify, prioritize, and evaluate its workforce initiatives. Accessible figures and reports generated by the WIS can be used by ASCO and others in the oncology community to advocate for needed health care system and policy changes to help offset future workforce shortages.

Circulating tumor DNA analysis in patients with cancer: American society of clinical oncology and college of American pathologists joint review

Purpose Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from ASCO and the College of American Pathologists summarizes current information about clinical ctDNA assays and provides a framework for future research. Methods An Expert Panel conducted a literature review on the use of ctDNA assays for solid tumors, including pre-analytical variables, analytical validity, interpretation and reporting, and clinical validity and utility. Results The literature search identified 1,338 references. Of those, 390, plus 31 references supplied by the Expert Panel, were selected for full-text review. There were 77 articles selected for inclusion. Conclusion The evidence indicates that testing for ctDNA is optimally performed on plasma collected in cell stabilization or EDTA tubes, with EDTA tubes processed within 6 hours of collection. Some ctDNA assays have demonstrated clinical validity and utility with certain types of advanced cancer; however, there is insufficient evidence of clinical validity and utility for the majority of ctDNA assays in advanced cancer. Evidence shows discordance between the results of ctDNA assays and genotyping tumor specimens and supports tumor tissue genotyping to confirm undetected results from ctDNA tests. There is no evidence of clinical utility and little evidence of clinical validity of ctDNA assays in early-stage cancer, treatment monitoring, or residual disease detection. There is no evidence of clinical validity and clinical utility to suggest that ctDNA assays are useful for cancer screening, outside of a clinical trial. Given the rapid pace of research, re-evaluation of the literature will shortly be required, along with the development of tools and guidance for clinical practice.

Enhancing the American Society of Clinical Oncology Workforce Information System With Geographic Distribution of Oncologists and Comparison of Data Sources for the Number of Practicing Oncologists

PURPOSE The American Society of Clinical Oncology (ASCO) 2007 workforce report projected US oncologist shortages by 2020. Intervening years have witnessed shifting trends in both supply and demand, demonstrating the need to capture data in a dynamic manner. The ASCO Workforce Information System (WIS) provides an infrastructure to update annually emerging characteristics of US oncologists (medical oncologists, hematologist/oncologists, and hematologists). METHODS Several possible data sources exist to capture the number of oncologists in the United States. The WIS primarily uses the American Medical Association Physician Masterfile database because it provides detailed demographics. This analysis also compares total counts of oncologists from American Board of Internal Medicine (ABIM) certification reports, the National Provider Identifier (NPI) database, and Medicare Physician Compare data. The analysis also examines geographic distribution of oncologists by age and US population data. RESULTS For each of the data sources, we pulled 2013 data. The Masterfile identified 13,409 oncologists. ABIM reported 13,757 oncologists. NPI listed 11,664 oncologists. Physician Compare identified 11,343 oncologists. Mapping of these data identifies distinct areas (primarily in central United States, Alaska, and Hawaii) that seem to lack ready access to oncologists. DISCUSSION Efforts to survey oncologists about practice patterns will help determine if productivity and service delivery will change significantly. ASCO is committed to tracking oncologist supply and demand, as well as to providing timely analysis of strategies that will help address any shortages that may occur in specific regions or practice settings.