Care strategies updates from the American Society of Clinical Oncology's Annual Meeting, held June 2018.
Surabhi Dangi-Garimella, PhD
A retrospective analysis1 conducted 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.
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:
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.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 individuals2 will 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.
The real-time readouts were reviewed on a daily basis by physicians, which allowed for an early intervention if needed. Patients in both groups had a weekly in-person visit with their physician.
Patients filled out the 28-item MD Anderson Symptom Inventory (MDASI) survey4 prior to initiation of radiation treatment, at the end of therapy, and 6 to 8 weeks after radiation ended. A scale of 0 to 10 was used to rate symptom severity, with lower scores indicating better outcomes.
The study found that while there was no difference in self- reported health severity scores between the 2 groups at the start of the trial, MDASI scores of the CYCORE group were lower for severity of general (2.92 vs. 3.4; P = .003) and HNC-specific symptoms (4.21 vs 4.83; P = .009) at the completion of the radiation treatment. Similarly, MDASI scores were lower for the CYCORE group at 6 to 8 weeks after completing radiation, for general (1.69 vs 1.96; P = .003) and HNC-specific symptoms (1.78 vs. 2.11; P = .009).
“Our study generated evidence on how newer technologies can be integrated into cancer care relatively easily and improve patient outcomes without interfering too much in a person’s daily life,” said lead study author Susan K. Peterson, PhD, MPH, professor, Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, in a press release. “This study was done during a rather intense period in the patients’ care for head and neck cancer. The system helped their physicians to provide valuable support that ultimately resulted in lower symptom severity.”
An important observation was the high rate of adherence in a majority of patients, despite the intensity of treatment. “Using mobile tech for remote monitoring of patients during critical periods of outpatient treatment can provide timely info for clinical decision making and can improve [quality of life] and health outcomes,” the authors concluded.
Patients with cancer often have medical bills and other health costs significantly higher than those of others. Now, with cancer drugs becoming increasingly effective and more tolerable for patients, patients take these drugs for longer periods of time, leading to increased financial burden, said oncologist and health services researcher Ryan Nipp, MD, MPH, during a session at the 2018 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois. Nipp is with Massachusetts General Hospital Cancer Center in Boston.
In addition to out-of-pocket costs, such as co-payments, deductibles, and prescriptions, patients with cancer often experi- ence issues indirectly related to finances during cancer treatment, he said, including:
Patients with cancer experience financial burdens related to the disease and its treatment across all insurance types at higher rates than those with other chronic conditions and those with no chronic conditions, explained Nipp; 43% of privately insured patients with cancer spend more than 20% of their income on health-related costs, compared with 29.8% of such patients with another chronic condition and 16.4% of those with no chronic condition. For those with public insurance, 24% of patients with cancer spend more than 20% of their income on health-related spending, compared with 18.7% and 5.8% of the other groups, respectively.
“Increasingly, efforts are needed to foster appropriate patient—clinician communication about the cost of cancer care,” said Nipp. Such “discussions...have the potential to improve care delivery and outcomes for patients by fostering informed decision making.”
However, numerous barriers face both clinicians and patients, he explained. For clinicians, barriers include lack of knowledge about costs incurred by patients, potentially time-consuming discussions, concerns that providing information about cost may encourage patients to forgo care, and concerns that cost discussions may jeopardize the patient—clinician relationship.
Patients, for their part, may feel unsure of the appropriateness of discussing costs with their clinician team, and may feel embarrassed or self-conscious to raise the issue; they also may have a desire to respect their clinician’s time, are not sure their clinicians would have a solution for the concern, or may prioritize other concerns during a time-limited visit.
Ellen Miller Sonet, MBA, JD, chief strategy and policy officer, CancerCare, followed up Nipp by asking the audience, “Have you ever made a major purchase without knowing the price, be it a car, camera, or computer? Because that’s what cancer patients do. They agree to a cancer treatment plan, and they don’t know what it will cost them.”
Until there are some policy solutions, it’s the problem of the patient/physician relationship, she said. She outlined different solutions that can be implemented to alleviate the burden facing these patients.
First, clinicians should determine who within their office will address the issues with patients. “I think that, very often, the physician thinks the nurse is doing it, the nurse thinks the office manager is doing it, and sometimes nobody’s doing it,” she said.
Other strategies highlighted by Sonet included ensuring that patients know the major costs prior to treatment, considering lower-priced options and alternate dosing schedules, asking patients to discuss if treatment is too great a financial burden, and referring them to financial and psychosocial counseling.
She also outlined available resources available to patients, such as co-pay and patient assistance funds, hospital charity care, patient advocacy organizations, voluntary and faith-based resources within communities, and financial planning and insurance navigation.
CancerCare offers “A Helping Hand,” an online resource guide about financial assistance. There is a searchable database where patients can input a diagnosis and zip code and be presented with different resources available to them.
She also encouraged the use of patient portals for education and links. A patient will feel comfort knowing that if they’re up in the middle of the night worrying about something, they can go online to the website and learn about what’s troubling them, she explained.
“Patients’ learning styles may vary. Some people are visual learners, and some patients like to hear information. They will forget most of what their clinician tells them, because they’re anxious, and they’re upset, and they don’t really understand a lot of the information that’s being communicated,” Sonet said. “So, recognize that lots of different media can be very helpful.”
Although utilization management is generally a pain point for everyone, it’s a necessary evil in the United States, where we spend 18% of our gross domestic product on healthcare, explained Debra Patt, MD, MPH, MBA, vice president, Policy and Strategy, Texas Oncology, and medical director, Analytics, McKesson Specialty Health, during a session at the 2018 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois.
“We have real problems in our house of medicine, and they’re worse in oncology than they are in other places because we’ve been ripe with innovation, and a lot of that is tied to very expensive drugs,” she added.
There is a myriad of strategies used to control the cost of oncology drugs, including: prior authorization (PA), step therapy, drug quantity supply limitations, member cost sharing, closed specialty pharmacy networks, formulary tiering, and adjusted drug reimbursement to lower expenditures.
Patt highlighted step therapy, which is particularly common among commercial insurers. In 2014, nearly 75% of large employers reported offering employee plans that use step therapy. While it makes sense to lower costd by utilizing lower-cost thera- pies prior to higher-cost therapies, there’s a concern in oncology that preferring some drugs over others in a step-therapy strategy can have a negative impact on patients by not getting the optimal drug first, she explained. In response to these concerns, many states have passed laws against step therapy and fail-first therapy, stating that commercial insurers in those states cannot participate in such programs.
Patt then discussed the use of PA, its importance, and its consequences. “When I started in oncology practice 12 years ago, I would write a chemotherapy [prescription], and if we had the drug, the patient could be treated the same day; and if we didn’t have the drug, the patient could be treated the next day,” she said. “Now, I set the expectation to all my patients that there is just no way, in the absence of [an] emergency, that they’re going to get their drug within a week.”
Patt recognized that when PAs are denied, it is likely because the therapy is considered experimental, not compliant with guidelines, or there is a lack of adequate supporting evidence. In these cases, PA serves as a deterrent for having less than guideline-based care. However, she noted that there is a lack of transparency on what will lead to a successful authorization, and it’s often a significant administrative burden.
In regard to patient cost sharing, she noted that when patients have a higher stake in, or have to pay more for, their healthcare, they utilize it more efficiently, and that holds true with therapies as well.
The last utilization management strategy she highlighted were formularies. “In general, we don’t think they are a great strategy to get patients their optimal treatment,” said Patt. “However, I think there probably are some scenarios where they’re very useful.” She gave the example of a state Medicaid program that has a certain budget, where formulary drugs can be utilized to allow Medicaid to stay within the budget.
Patt ended her session by discussing a path forward. “As we think about utilization management in general, I do think there is a better solution,” she said. “In general, I think that because oncology decision making is sophisticated, the decision tree by which you make decisions has to be populated by many data elements. It’s not a blunt instrument, it’s a much more sophisticated tool.”
She urged for collaboration and investing in information solutions to provide the right information for approval early on. Instead of having an administrator call to go through the process of PA, using a support system embedded in the electronic health record can automatically move toward PA.
“When I’m in clinic and I see a patient with stage II breast cancer and I enter in all [of] their information, I come up with a set of choices of therapy through the decision support system embedded in my health record that gives me appropriate pathways,” Patt explained. She argued that the same should happen when going through PA. “We can use the information system in and of itself to communicate that information and make our machines work for us.Jaime Rosenberg
As the opioid epidemic persists in the United States, there are growing questions and concerns over how to manage cancer-related pain and aberrant opioid use. During a session at the 2018 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, Egidio Del Fabbro, MD, Virginia Commonwealth University Massey Cancer Center, discussed several management strategies that can be used to address these concerns.
The overuse of opioids can lead to intense and severe consequences, including opioid-induced neurotoxicity, poor quality of life, addiction, overdose, and death, Del Fabbro explained. “Ongoing vigilance is necessary, even with the patient that is successfully treated and successfully managed.”
Minimum steps to manage patients on opioids include:
“You need a lot of documentation when you see these patients: documentation of the treatment agreements, documentation of a prescription monitoring program, and that it’s being checked,” Del Fabbro explained. “Many states now regard this as mandatory or ask that this be mandatory.”
If a patient displays aberrant behavior or isn’t adhering to prescriptions, they need to be seen more frequently and the intervals between visits must be shorter. Adopt an interdisciplinary approach and refer the patient to a specialist team that frequently encounters these more complex patients and has more resources, he said Del Fabbro.
Who exactly should be referred? According to Del Fabbro, those taking high doses, having complex pain, taking complex opioid regimens, or exhibiting aberrant behavior. For physicians treating patients with cancer by prescribing opioids, he highlighted 4 management strategies.
“You have to start at the beginning and explain that opioids should only be used for pain,” said Del Fabbro. “It may seem obvious, but I had a health practitioner tell me that he was using opioids at night for his insomnia.”
Physicians also need to discuss the risks and adverse effects, as well as emphasize function as an outcome. It’s important that the patient know they will still experience pain but that they will be more functional. Education is also important because many patients don’t store or dispose of the opioids in an appropriate manner. Simple measures, such as a pamphlet, may be useful in combination with a personalized approach.
Ways to optimize harm reduction include using long-acting opioids and avoiding a rapid-acting opioid or prescribing excessive quantities. Physicians should also limit the number of days’ supply in both the outpatient and inpatient settings.
“We seldom prescribe naloxone for our patients,” said Del Fabbro. “My concern is that naloxone might be another pitfall, where we think there’s an easy fix with one prescription for the opioid epidemic. Much the same as we landed in this mess by assuming that opioids alone would be able to manage pain successfully.” He added that it should be indicated for those at very high risk or who have had an overdose in the past.
Del Fabbro also noted the use of opioid rotation, where a physician can switch a patient’s high dosage of an opioid to a lower dose by switching the opioid. Because of incomplete cross-tolerance, the patient can achieve better pain control at a lower dose.
Managing Psychological and Spiritual Distress
To manage distress, motivational interviewing has shown to be effective. The idea is to first express empathy for the patient, especially those struggling with substance use disorder. When encountering resistance, arguing with patients won’t help, as it will likely increase resistance.
The physician should ask patients their goals and explain that drug misuse will not help facilitate those goals, as well as push for self-efficacy. If this does not work, the physician should bring in a specialized interdisciplinary team to work with these patients.
Del Fabbro emphasized the importance of documentation: the pill counts, the education provided, and the plan that has been explained to the patient. He also reinforced the need for routine documentation of the prescription monitoring program and urine drug screenings.
“Adapted universal precautions, I think, unfortunately need to be expanded even further for these patients who have an opioid misuse problem or even the potential,” he said. “I think here, again, it’s going to be necessary to refer either to a supportive care clinical or to a pain service.”