By Manisha Palta, MD, and Albert Koong, MD, PhD
The role of radiation therapy (RT) in pancreatic cancer is rapidly evolving. Until recently, 3-D conformal RT was the primary technique for treating patients. However, the emergence of intensity-modulated radiation therapy (IMRT) has allowed greater dose conformality, resulting in reduced dose to organs at risk. Together with advancements in simulation and image guidance, these developments have facilitated the use of hypofractionated RT, including stereotactic body RT. Simultaneously, more effective systemic therapies have also been developed. As these systemic therapies improve overall survival, local regional treatments like RT and surgery have become more important.
To address the questions surrounding RT for patients with pancreatic cancer, ASTRO launched a guideline on this topic, published online in Practical Radiation Oncology on August 29. The guideline task force comprised of not only radiation oncologists, including those working in community practice and Veterans Affairs and a resident representative, but also members from medical and surgical oncology, medical physics and the patient community. The guideline considered indications for RT in the adjuvant, neoadjuvant and definitive settings, along with doses, target volumes and sequencing with systemic therapies. It also made recommendations on simulation and treatment planning, technique and use of prophylactic medications to mitigate toxicity. Recommendations are rated as either strong or conditional, and the quality of the evidence is also graded for each recommendation.
For conventionally fractionated RT, the task force made a conditional recommendation supporting its use in the adjuvant setting if patients have high-risk features such as positive lymph nodes and margins. It conditionally recommended neoadjuvant RT in patients with borderline resectable tumors following chemotherapy, as well as RT as an option for definitive therapy in those with locally advanced disease. In addition, for borderline and locally advanced pancreatic cancer, SBRT is conditionally recommended. However, the task force recognized that ongoing clinical trials, including the Alliance for Clinical Trials in Oncology study, may provide new data for patients with borderline pancreatic cancer.
For RT simulation, the guideline recommends that patient-specific motion assessment should be utilized along with image guidance. Use of IMRT is recommended for treatment delivery.
Finally, there was strong consensus, even with limited clinical data, that patients undergoing RT for pancreatic cancer should receive prophylactic anti-nausea medications and agreement that patients may benefit from anti-acid or acid-reducing drugs.
Throughout the guideline, the task force sought to promote a patient-centered approach that integrates the patient's values, preferences and ability to tolerate short and late toxicities, and how those considerations are balanced against outcomes like local control. Given the many controversies and nuances of RT, it is especially important that every patient who might be appropriate for RT have a nuanced discussion with a radiation oncologist about the risks and benefits of RT, ideally in a multidisciplinary setting that also includes a surgeon and a medical oncologist.
Although many of the current guideline recommendations are conditional recommendations, reflecting limitations in the available data, ongoing and recently completed trials continue to add to the evidence available to make decisions on RT for pancreatic cancer and may alter the guideline in future years.
Posted: September 3, 2019
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By Fumiko Chino, MD
ASTRO's Committee on Health Equity, Diversity and Inclusion (CHEDI) has made recruitment and inclusion of underrepresented minorities into cancer clinical trials a top priority for the upcoming year.
Clinical trials are the mainstay in the development and validation of new cancer therapies and treatment options. Despite the potential for access to novel new treatments and technologies, less than one in 20 adult patients with cancer participate in a clinical trial.1 This disparity is even starker for racial and ethnic minorities1 with data showing that the clinical trial enrollment of racial/ethnic minorities has actually decreased over the past 14 years.2 In 2012, only 17% of patients enrolled in industry-sponsored clinical trials were of a racial or ethnic minority, despite these groups making up about one-third of the population.3 One evaluation found that black participation reached 10% for only two of the 31 cancer drugs studied.4 Clinical trial participants are disproportionately non-Hispanic white men with higher education levels and household incomes.1,5
With skewed enrollment and participation, conclusions of clinical trials may be questioned for how generalizable they may be to patients not fully represented in the trial cohort.6 As racial/ethnic minorities carry some of the highest cancer burdens in the United States, equitable participation in clinical trials becomes an important tool in the fight against health care disparities. Adequate representation in cancer research is essential in the development of therapies that are both effective and tolerable to patients from diverse backgrounds. Recurring themes in the assessment of barriers to clinical trial enrollment for racial/ethnic minorities include trust, costs and access/knowledge:
- Trust in medical providers and the health care establishment is a known obstacle for minority engagement. From infamous historical outrages like the Tuskegee Syphilis Study and forced sterilization in segregated hospitals, distrust has been a valid protective measure for many patients for centuries. One study looking at barriers to cancer research found that almost one-third of the black women surveyed agreed that scientists “cannot be trusted” (compared to 4% of white women).7 Trust concerns can be exacerbated by the lack of minority investigators,8 making workforce diversity9,10 an essential target action to improve trust.
- Costs remain a consistent barrier to clinical trial participation, particularly among racial/ethnic minorities.12 Lower income patients are much less likely to participate across all subgroups5 and increased out-of-pocket costs were consistently stated as a concern limiting enrollment.13 Although the costs of study drugs, tests and procedures are typically covered under protocol, there are many “hidden costs” including gas, hotels and missed work.14 Extra costs are in part due to more frequent clinic visits and travel as most comprehensive cancer centers leading clinical trials are in major metropolitan centers. Although there are fears that financial incentives may create a type of economic pressure for patients with lower socioeconomic status to participate, the additive costs of participation are often exclusionary for those with fewer resources.
- Access/knowledge continues to limit many patients who may be otherwise willing and eligible for clinical trial participation. Black/African American patients are less likely to be aware of clinical trials17 and provider referral may also be limited. In one study of black women, almost all participants stated their doctor had “never talked to them” about participating in a clinical trial.18
- Workforce: In addition to improving diversity in physician workforce, which is a long-term process, greater community involvement and use of culturally concordant staff (for example, Hispanic staff and Spanish language-based education materials) have led to improved enrollment in certain target populations.11
- Cost: One intervention of graded financial assistance demonstrated the ability to improve clinical trial equity with successful increased enrollment for those patients typically underrepresented in trials.15 Expanding trials into community cancer centers may also decrease travel costs and increase participation.16
- Access/Knowledge: Targeting enrollment toward specific cultural background and literacy levels may improve recruitment of underrepresented populations.12 Patient navigation programs also hold unique promise to help recruit and retain racial and ethnic minority populations in clinical trials. One study found that black/African American enrollment increased from 9% to 16% after initiating an education and tailored support program.19
CHEDI has highlighted ways that equity, diversity and inclusion can be improved within radiation oncology since its creation as a committee. By focusing this year on underrepresented minority clinical trial enrollment, we hope to raise awareness of this crucial issue and ultimately increase access and outcomes for our patients. Share your suggestions for how to encourage minorities to enroll in clinical trials in the comments below.
Fumiko Chino is transitioning from chief resident in Radiation Oncology at Duke Cancer Institute and the Teaching Value in Health Care Learning Network Fellow for the Costs of Care, a global NGO. She will join the faculty at Memorial Sloan Kettering Cancer Center in August 2019.
- Murthy VH, Krumholz HM, Gross CP: Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 291:2720-6,2004.
- Duma N, Vera Aguilera J, Paludo J, et al: Representation of Minorities and Women in Oncology Clinical Trials: Review of the Past 14 Years. J Oncol Pract. 14:e1-e10,2018.
- Proportion of Study Volunteers by Race and Ethnicity in Clinical Research Studies, 2012. JNCI: Journal of the National Cancer Institute. 109, 2017.
- Propublica. "Black Patients Miss Out On Promising Cancer Drugs" Published September 19, 2018, accessed June 23, 2019 at https://www.propublica.org/article/black-patients-miss-out-on-promising-cancer-drugs.
- Unger JM, Gralow JR, Albain KS, et al: Patient Income Level and Cancer Clinical Trial Participation: A Prospective Survey Study. JAMA Oncol. 2:137-9, 2016.
- Rothwell PM: External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet. 365:82-93, 2005.
- Mouton CP, Harris S, Rovi S, et al: Barriers to black women's participation in cancer clinical trials. J Natl Med Assoc. 89:721-7, 1997.
- McCaskill-Stevens W, Pinto H, Marcus AC, et al: Recruiting minority cancer patients into cancer clinical trials: a pilot project involving the Eastern Cooperative Oncology Group and the National Medical Association. J Clin Oncol. 17:1029-39, 1999.
- Winkfield KM, Flowers CR, Patel JD, et al: American Society of Clinical Oncology Strategic Plan for Increasing Racial and Ethnic Diversity in the Oncology Workforce. J Clin Oncol. 35:2576-2579, 2017.
- Winkfield KM, Gabeau D: Why workforce diversity in oncology matters. Int J Radiat Oncol Biol Phys. 85:900-1, 2013.
- Symonds RP, Lord K, Mitchell AJ, et al: Recruitment of ethnic minorities into cancer clinical trials: experience from the front lines. Br J Cancer. 107:1017-21, 2012.
- Ford JG, Howerton MW, Lai GY, et al: Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer. 112:228-42, 2008.
- Unger JM, Hershman DL, Albain KS, et al: Patient income level and cancer clinical trial participation. J Clin Oncol. 31:536-42, 2013.
- Chino F, Zafar SY: Financial Toxicity and Equitable Access to Clinical Trials. Am Soc Clin Oncol Educ Book. 39:11-18, 2019.
- Nipp RD, Lee H, Powell E, et al: Financial Burden of Cancer Clinical Trial Participation and the Impact of a Cancer Care Equity Program. Oncologist. 21:467-74, 2016.
- Copur MS, Ramaekers R, Gonen M, et al: Impact of the National Cancer Institute Community Cancer Centers Program on Clinical Trial and Related Activities at a Community Cancer Center in Rural Nebraska. J Oncol Pract. 12:67-8, e44-51, 2016.
- Lara PN, Jr., Paterniti DA, Chiechi C, et al: Evaluation of factors affecting awareness of and willingness to participate in cancer clinical trials. J Clin Oncol. 23:9282-9, 2005.
- Trauth JM, Jernigan JC, Siminoff LA, et al: Factors affecting older African American women's decisions to join the PLCO Cancer Screening Trial. J Clin Oncol. 23:8730-8, 2005.
- Fouad MN, Acemgil A, Bae S, et al: Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials. J Oncol Pract. 12:556-63, 2016.
Posted: August 21, 2019
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By Mary Feng, MD, Department of Radiation Oncology, University of California San Francisco, and Björn Hårdemark, MSc, RaySearch Laboratories AB, Sweden
Radiation oncology is a highly specialized field in which dozens of complex hardware and software systems are needed to provide the best possible care. Within these systems, information is exchanged and if these exchanges are not clearly defined, the safety and efficiency of clinical care can be compromised. To address this issue, ASTRO created Integrating the Healthcare Enterprise-Radiation Oncology (IHE-RO) in 2004, as an initiative that helps to ensure safe, efficient radiation treatments by improving system-to-system connections.
IHE-RO, now operated by the American Association of Medical Physicists (AAPM) in collaboration with ASTRO and other organizations, is composed of physicists, physicians, software engineers and others from private practice, academics and industry, working together to identify and solve connectivity issues in radiation oncology. To assess and prioritize what technical challenges are most pressing to the radiation oncology community, biennial surveys are conducted of ASTRO and AAPM members. This feedback is used to develop new use cases, which are the basis for the technical committee to develop industry standards for vendors to improve the system integration of their products, resulting in safer and more efficient patient care. Vendors can meet in annual Connectathons to test the success of product development and their ability to integrate with other hardware and software.
In the latest biennial survey, 295 responses were submitted by individuals from six continents. Of those surveyed, 67% reported difficulties with specific clinical workflows due to systems not working well together and entered up to three specific interoperability issues. Not surprisingly, common themes and issues emerged. These items were reviewed by the technical committee and categorized as the following:
- Challenges with oncology information system (rad onc OIS) and health information system interfacing (HIS).
- Challenges with oncology information system and treatment machine integration.
- Software features of individual products or classes of products.
Poor interoperability between radiation oncology and health information systems was noted as a frequent challenge, resulting in potentially degraded quality and efficacy of clinical care. In the past year, IHE-RO has already been defining the problem and developing testing tools, which we anticipate making available in the coming year, so that vendors can initiate software enhancements to facilitate data sharing, supporting ASTRO’s Minimum Data Elements initiative.
Based on the most recent survey, new use cases for the coming year include:
- Information transfer (including dose, shifts and imaging data) from the treatment machine to the oncology information system for treatment dose verification.
- Radiation simulation scan and spatial dose information transfer to Radiology PACS to assist in tumor response/toxicity assessment and subsequent patient care.
- Beam data file format standardization for more efficient commissioning of treatment planning systems and machines.
IHE-RO is a partnership between end users in the clinic and vendors, all working together to advance patient care in a safe and streamlined way. Please share your clinic’s interoperability issues with us so that we can help. Visit the IHE-RO webpage for more information.
Posted: August 13, 2019
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By Kekoa Taparra, PhD, and Nadia Laack, MD
The American Society for Radiation Oncology (ASTRO) has long supported avenues for building prosperous mentor-mentee relationships. As a relatively small specialty with nearly 6,000 physicians, fostering strong communities through mentorship is imperative. With recent data highlighting the disparities in geographic, gender and ethnic representation of radiation oncologists, ASTRO has made great strides in promoting scholastic mentorship programs, particularly with the intention of promoting diversity.
One such program is the ASTRO Minority Summer Fellowship (MSF) program. Established a decade ago, more than 20 scholars have been awarded this research fellowship designed to support medical students interested in conducting either original clinical or basic science research in radiation oncology.
From the mentee: Kekoa Taparra, PhD, Mayo Clinic, MS4
I was first introduced to the radiation oncology community from my graduate school advisor, Phuoc Tran, MD, PhD, at Johns Hopkins. He was one of the first physicians I had ever met in my life and he encouraged me to consider a career in medicine. Despite knowing little about medicine at the time, Dr. Tran introduced me to other inspirational radiation oncologists, including current ASTRO President Ted DeWeese, MD, FASTRO.
I first learned of the MSF program through my medical school. Through a recent graduate, Chika Nwachukwu, MD, PhD, I had the fortune of meeting Nadia Laack, MD, who graciously agreed to serve as my ASTRO fellowship research mentor. I am incredibly grateful for Dr. Laack for her commitment to advancing research projects to the next stage. Dr. Laack remains an important advocate and role model in my life as an aspiring radiation oncologist. Dr. Laack truly cares for me as a mentee, ensuring I am on track for my maximum success going into fourth year and the MATCH.
After the fellowship, I had the privilege of presenting two oral abstracts at the 2018 ASTRO Annual Meeting. I shared our team’s research on cardiac substructure sparing optimization comparing proton and photon treatment planning for patients with mediastinal Hodgkin Lymphoma. The fellowship exceeded my expectations and even provided a $4,500 package that provided travel funding for the Annual Meeting. This experience provided me with vital research opportunities and clinical experience in the department with Dr. Laack and senior resident Scott Lester, MD.
Particularly as an indigenous Native Hawaiian, this fellowship symbolizes a step closer in my path toward caring for my people back in the islands. Having 10 Native Hawaiian family members who struggled with various malignancies, from neuroblastoma to endometrial cancer, I have seen firsthand the negative connotation radiation can have for some cancer patients. Native Hawaiians have statistically the worse cancer rates and outcomes among all ethnicities in our islands. Unfortunately, Native Hawaiians are also the least represented in this specialty and medicine as a whole. Thus, this fellowship allowed me the opportunity to further engage in a field highly pertinent to my family back home. I continue to be so grateful for ASTRO and all the radiation oncologists who have helped me get to where I am today.
From the mentor: Nadia Laack, MD, Mayo Clinic Department of Radiation Oncology, Chair
I find that mentoring students interested in radiation oncology is an incredibly rewarding experience. This is especially true when you have enthusiastic, motivated students like Kekoa that search out scholarship opportunities like the ASTRO Minority Summer Fellowship Program. Applying for the fellowship is an excellent experience for a mentor as it forces you to get to know your mentee and helps refine and focus their project.
Mentorship is extremely important in a field that students have little exposure to, like radiation oncology. Sharing why I chose radiation oncology reminds me of why I love all aspects of radiation oncology and how thankful I am to have found a career that is the perfect combination of meaningful patient interactions, multi-disciplinary collaboration, technical challenge and research focus.
Research is so integral to our field and it is critically important that students have research mentors who take time to help them develop a strong foundation of research methods and ask important questions. This relationship can ignite the spark to fire up in the next generation of brilliant radiation oncologists who will advance the field further than we could ever imagine.
For those who are interested in mentorship, I would encourage you to work with your medical student clerkship director who can help you share your project ideas. Medical students often rely on the radiation oncology residents for advice and information about what staff or projects would be a good fit, so it is also helpful to have a history of mentoring residents. Although it is a significant time commitment, the rewards personally and to our field are well worth the effort.
Have you participated in a mentorship? Share your story in the comments below.
Posted: August 7, 2019
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By Dave Adler, Vice-President, Advocacy
ASTRO leaders, staff and consultants have been analyzing closely the radiation oncology alternative payment model (RO Model) unveiled July 10 and have identified several preliminary key issues.
ASTRO has hired an analytics firm to help analyze the model, but we are still weeks away from getting a clearer picture on whether CMS priced the RO model episodes appropriately and what impact the various model parameters will have on ASTRO members and patients. Analyzing the complex and comprehensive model is a massive undertaking with a rapidly approaching comment deadline of September 16.
While ASTRO is just beginning to digest the model, here are some preliminary perspectives:
- Stable Payments, Higher Quality. ASTRO is pleased that the Centers for Medicare and Medicaid Services (CMS) is moving forward with a model that provides an opportunity for some radiation oncologists to participate in value-based care arrangements, and we see some strong potential for it to achieve our goals of incentivizing higher quality care and stabilizing payments in the long term. The model construct overall will help drive more guideline concordant care, and ASTRO is committed to working constructively with CMS and Congress to improve the model before it’s implemented.
- Mandatory Participation. The model would be mandatory for more than 1,000 radiation oncology practices, which is a significant concern. While ASTRO understands CMS rationale for making the model mandatory, we believe the model should at least start as voluntary until we better understand how it works. Should CMS persist with a mandatory model, 40% of episodes is unwarranted and far beyond what is needed to adequately evaluate the model while still achieving savings.
- Opt Out/In. If the model is mandatory, there should be consideration of a hardship exemption for practices to opt out and an opportunity for practices that want to participate to opt in to the model. Both can be done without compromising the evaluation of the model or savings. Radiation oncology practices deserve an opportunity to choose whether to test their participation in value-based care arrangements.
- Timing. It’s very difficult to imagine that more than 1,000 practices will be notified in early November of their required participation and then start in the model on January 1, 2020. Participating in the model will take far more effort than flipping a switch. CMS should delay implementation until at least April 1, 2020, or consider a rolling start.
- Discounts and Withholds. While the prospective payment is a positive, the discount factors of 4% and 5%, respectively for professional and technical payments, combined with additional withhold requirements for quality (2%), incorrect payments (2%) and, in the future, patient experience (1%), seem excessive and could create cash flow issues for many practices, particularly those with small margins, and undermine the value of prospective payments. In addition, we’re concerned that the adjustments could disadvantage efficient practices.
- APM Incentive Payment. The 5% Advanced APM incentive payment would apply only to professional component services, despite technical payments being subject to the discounts and withholds. According to the Medicare Access and CHIP Reauthorization Act (MACRA) definition of “professional covered services,” the APM incentive payment should apply to payments based on the physician fee schedule, which should include freestanding technical payments. CMS is waiving that requirement due to concerns about a shift in site of service. CMS should find an approach that allows for the incentive payment to be applied to these technical payments, as MACRA intended.
- Episode Payment. We must carefully assess how CMS is calculating the episode-based national payment rates and numerous adjustments to ensure that these payments are fair for a diverse group of radiation oncology practices and different modalities. While some national base rates appear reasonable, others seem low. In particular, we need to better understand whether the base rates properly account for certain common procedures, such as brachytherapy as a boost to external beam treatments, and referrals to other radiation oncologists for specialized services.
- Innovation. The model does not seem to account for the adoption of new technology and new service lines during the term of the model and beyond. This needs further examination, as it could stifle innovation in a rapidly advancing field. There should be consideration of an adjustment to the episode or paying fee-for-service (FFS) for new technology/service lines until there’s enough cost data to incorporate into the episode payment.
- Quality. We believe the selection of quality measures is appropriate, and we are particularly pleased with the emphasis on a patient safety organization that collects radiation oncology specific information.
- Compliance Burden. It’s likely that CMS is underestimating the burden on participating practices, particularly in terms of collecting additional clinical data and monitoring information. It will be critical that CMS only collects what it absolutely needs and does so in the least burdensome way, particularly if the Agency is forcing practices to take on this additional burden by mandating participation.
- All Payer. The model is Medicare FFS only and not an all-payer model. It’s not clear to us why it’s limited in this way. We are concerned about the proliferation of different models among different payers and the confusion and difficulty this will cause for radiation oncology practices.
- Site Neutral. We need to further examine the way CMS is proposing to create national base rates for episodes in a site-neutral manner to ensure an even-handed approach that does not disadvantage freestanding or hospital-based clinics.
ASTRO is looking for input from members and radiation oncology stakeholders on these issues and others. Please send your suggestions to email@example.com.
In addition, ASTRO has begun engaging congressional leaders and radiation oncology’s legislative champions to inform them of the model and ASTRO’s initial concerns, and to consider next steps to improve the RO Model before it’s finalized in November.
Posted: July 24, 2019
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