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Care Strategies

Reporting by Surabhi Dangi-Garimella, PhD, and Jaime Rosenberg
Care strategies updates from the American Society of Clinical Oncology's Annual Meeting, held June 2018.

Despite USPSTF Recommendations, Lung Screening Rates Low Among Heavy Smokers

Surabhi Dangi-Garimella, PhD

A retrospective analysisconducted by researchers at the University of Louisville, Kentucky, has found that less than 2% of more than 7.5 million eligible smokers were screened for lung cancer in 2016 despite recommendations by the United States Preventive Services Task Force (USPSTF). These results were presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

“This study makes a strong case that our country needs an effective public service campaign about encouraging lung cancer screening. Public service campaigns from the 1990s encouraged women to get mammograms, saving many lives in subsequent years. We need something similar to encourage current and former heavy smokers to get screened for lung cancer,” said ASCO President Bruce E. Johnson, MD, FASCO, in a press release that described the findings from the study.

A leading cause of cancer-related mortality, lung cancer is expected to be responsible for over 154,000 deaths in the United States in 2018, according to estimates by the American Cancer Society (ACS).2 This disease remains the most common cancer diagnosed in men and women.

In 2013, USPSTF rendered a B-grade recommendation3 for an annual lung cancer screening with low-dose computed tomography (LDCT) among adults aged 55 to 80 years who have a 30 pack-year history of smoking (defined as heavy smokers) and if they continue to smoke or did within the past 15 years (eligible smokers). The B recommendation means USPSTF expects a moderate to substantial net benefit from the LDCT screening service.

With their current study, the authors analyzed the impact of the USPSTF recommendation on screening rates using data from the Lung Cancer Screening Registry, which was acquired from the American College of Radiology in 2016. This registry spanned 1796 accredited radiographic screening sites. The data were compared with National Health Interview Survey estimates of eligible smokers who could be screened based on the USPSTF recommendations.

The geographic grid covered the Northeast, South, Midwest, and West, and the screening rate was derived by dividing the number of LDCT scans by the number of eligible smokers. Although the South had the most accredited screening sites (n = 663) and the highest number of eligible smokers, the screening rate in the region was the second lowest in the country (1.6%), with the West documenting the lowest screening rate (1%) and the fewest accredited screening sites (n = 232).

The overall national rate for screening among the potentially 7,612,965 eligible smokers was just under 2%: Only 141,260 individuals received LDCT screening.

Smoking cessation tools were offered to a significant portion (85%) of current smokers, and the authors report that the percentage of current and former smokers who were offered these tools was not influenced by the geographic location.

These results are not a surprise. A study4 commissioned by ACS and published in JAMA Oncology in early 2017 found that lung cancer screening rates remained low, and unchanged, following the USPSTF recommendations.

Several questions remain unanswered, according to lead study author Danh Pham, MD, a medical oncologist at the James Graham Brown Cancer Center, University of Louisville, who presented the results during a press cast organized by ASCO. “Are physicians not referring enough or do patients resist screening?” Pham asked. He added that there is stigma associated with this screening test, which could also be responsible for the low rates of screening.

Further initiatives are needed, including awareness programs and mandating lung cancer screening as a national quality measure, the authors conclude in their abstract. “Effective screening can prevent nearly 12,000 premature annual lung cancer deaths,” Pham said during the press cast.

Pointing out that Medicare approved payment for LDCT screening only in 2015,5 Johnson said that the outcome being measured by this study has not yet reached a steady state. A long- term follow-up might provide a more realistic picture of where screening rates stand.

  1. Pham D, Bhandari S, Oechsli M, Pinkston CM, Kloecker GH. Lung cancer screening rates: data from the lung cancer screening registry. J Clin Oncol. 2018;36(suppl; abstr 6504).
  2. 2018 estimates. ACS website. ga=2.234243678.1588221490.1527713306-433943973.1527625724#!/. Accessed May 31, 2018.
  3. Final recommendation statement: lung cancer: screening. USPSTF website. uspreventiveser- Published December 2013. Accessed May 31, 2018.
  4. Jemal A, Fedewa SA. Lung cancer screening with low-dose computed tomography in the United States—2010 to 2015. JAMA Oncol. 2017;3(9):1278-1281. doi: 10.1001/jamaon- col.2016.6416.
  5. National coverage determination (NCD) for screening for lung cancer with low dose com- puted tomography (LDCT) [press release]. Baltimore, MD: CMS; February 5, 2015. Newsroom/MediaReleaseDatabase/Press-releases/2015-Press-releases-items/2015-02-05. html. Accessed May 31, 2018.

Clinical Trials: Sharing the Road With Real-World Evidence

Jaime Rosenberg

In the era of real-world data and evidence, and their growing roles in oncology, panelists discussed collecting and using these data in combination with clinical trials to inform evidence-based care during a session at the 2018 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois.

Although clinical trials remain the gold standard for the context in which they were designed and developed—evaluating efficacy in tightly controlled and highly annotated samples—there are some drawbacks to using clinical trial data alone, explained Kathryn Reeder-Hayes, MD, MBA, MSc, assistant professor, University of North Carolina at Chapel Hill.

“In this context, assuming they meet their accrual goals, there [are] almost never too little data for the job in terms of the level of detail and the completeness of the data,” she said. She also noted that clinical trials are a familiar and comfortable form of evidence generation for multiple key stakeholders who are involved in the development of novel therapies for oncology.

However, clinical trials can also be prohibitively expensive and may not be the best fit for every question relevant to clinical practice, Reeder-Hayes warned. In particular, they are not optimally suited for questions of application of the innovational treatments being studied within the trial to broad and diverse populations. Neither are they well adapted to answer post hoc questions about differences in efficacy across subgroups or treatment application to populations outside the clinical trials, often because the sample is either too small, too homogenous, or both, for the data to be able to answer these questions.

“In those contexts, clinical trials may in fact waste time and resources, both in terms of our economic sources and our patients’ time,” said Reeder-Hayes. “In those contexts, real-world evidence, I would argue, may be less expensive and more appropriate for some questions as they relate to post hoc analyses and diffusion into broad populations.”

According to Reeder-Hayes, real-world evidence can be beneficial in several places:
  • After a randomized clinical trial is conducted, to test the dissemination of the findings and if they are being adopted, in which patients they’re being adopted, and which patient populations are being left behind.
  • Alongside randomized clinical trials, to extend findings to broader populations and answer secondary questions about differences among subgroups.
  • Before anticipating trials, to inform the important problems and questions, quantify effect sizes, and identify the right population.
She concluded by cautioning that big data studies require expertise in handling and analyzing observational data with its unique challenges related to potential bias and the need for complex data management strategies. Similar to clinical trials, these studies are best performed by experienced cross-disciplinary teams and are most useful when they answer the questions important to physicians and patients.

Sean Khozin, MD, MPH, director, Information Exchange and Data Transformation (INFORMED), followed Reeder- Hayes with an introduction to the FDA’s recently launched INFORMED program.

“Big data [have] many difference dimensions,” said Khozin. To explore and address these dimensions, the FDA launched the INFORMED program in April as an incubator for collaborative oncology science research. The program pairs engineers and data scientists with medical reviewers and regulatory scientists to conduct regulatory research using a variety of data inputs, including: clinical trials, electronic health records, biometric monitoring devices, and applications.

From these inputs, results come in the form of publications, abstracts, and, more recently, codes and algorithms that can be incorporated into decision support tools, explained Khozin. Outputs also include policy positions and guidance documents that can disseminate findings to the community and inform development programs, he added.

Remote Monitoring Can Reduce Radiation-Related Symptoms in Head and Neck Cancer

Surabhi Dangi-Garimella, PhD

Use of the mobile and sensor technology CYCORE (CYberin- frastructure for COmparative Effectiveness Research) to remotely monitor symptoms in patients with head and neck cancer (HNC) undergoing radiation therapy found these patients had fewer symptoms overall and specific to HNC.

The study,1 presented at the 2018 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, was included in a press cast that was broadcast ahead of the meeting.

According to the National Cancer Institute, over 51,500 individualswill be get an HNC diagnosis in 2018, accounting for over 3% of new cancer diagnoses for the year. Although the 5-year survival rate of this cancer hovers close to 65%, a little over 10,000 patients are estimated to die from the disease this year in the United States. HNC patients have high risk of symptom burden and risk of dehydration.

Chemotherapy, surgery, and radiation therapy are the forms of treatment available for patients with HNC, but the treatment plan is determined based on disease stage, potential side effects, and the patient’s overall health and preferences. Patients who receive radiation therapy may experience significant treatment-related burden,3 including pain, difficulty swallowing, swelling and scarring at the site of treatment, and loss of appetite, all of which can lead to dehydration. Other side effects include dry mouth, bone pain, nausea, fatigue, mouth sores, and hearing loss.

Researchers from 4 institutions, who designed and implemented the current trial, used CYCORE to compare remote patient monitoring with usual patient care among 357 patients. A majority of the patients were male, and there were 169 patients in the CYCORE arm and 188 in the usual care arm of weekly doctor visits. Patients in the CYCORE arm were provided with blood pressure cuffs and weight scales that were Bluetooth-enabled and given mobile tablets with proprietary Wi-Fi. Sensor readouts were transmitted to firewall-protected computers through a secure mobile app to ensure data protection.

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