ASTRO Blog

ASTRO Blog

At NRC, Advocating for Radiation Oncologist Leadership in Radiopharms

By Theodore DeWeese, MD, FASTRO, ASTRO Board Chair

On Wednesday, November 20, I met with Nuclear Regulatory Commission (NRC) Chairman Kristine Svinicki and commissioners Jeff Baran and Annie Caputo, as well as with NRC staff, to preserve strong training and experience (T&E) requirements for radiopharmaceuticals.

Over the past several years, in response to external pressure, the NRC staff has been reviewing the current requirements found in 10 CFR § 35.300 and 10 CFR § 35.390 to determine whether changes should be made. Part of this review has included outreach to stakeholders, including ASTRO, for their opinion and analysis of possible changes. As ASTRO chair, one of my priorities is to ensure that radiation oncologists play a leading role in the administration of radiopharmaceuticals. Fending off potential ill-advised changes to training and experience requirements will help achieve that goal.

Current regulations require that an authorized user (AU) be either board certified or complete 700 hours of training. The relevant sections of the regulations can be found here: Training for the use of unsealed byproduct material for which a written directive is required and Training for the parenteral administration of unsealed byproduct material requiring a written directive.

On the surface, reviewing current requirements to ensure their relevance is important and necessary. However, we are concerned that this review could initiate rulemaking to loosen the current 700-hour requirement – something that ASTRO, and partner organizations, oppose because the current requirements are appropriate, protect the safety of patients, the public, and practitioners, and should not be changed.

The NRC staff has concluded its review and is preparing a report to the commissioners. This report will outline policy options, as well as a recommendation for commission action. A version of the report was made public in October, so we were able to see the options the staff laid out; however, it did not include the staff’s final recommendation.

In the draft paper, the staff outlines two different approaches, each with several options, as follows:

Approach 1: Revise the T&E regulatory framework to remove prescriptive requirements, and the NRC and Agreement States would no longer review and approve T&E for AUs.

  • Option 1a: Specialty Board Credentialing– Physicians must be certified by any medical specialty board.
  • Option 1b: Licensee Credentialing– Licensees develop their own policies and procedures for credentialing their physicians.
  • Option 1c: NRC-recognized Specialty Board Credentialing – Physicians must be certified by a medical specialty board that has been recognized by the NRC as meeting high-level board certification criteria.
 

Approach 2: Maintain or enhance the existing T&E regulatory framework.

  • Option 2a: Status Quo– No changes.
  • Option 2b: Tailored Requirements– T&E would be tailored and reduced for use of individual or categories of radiopharmaceuticals.
  • Option 2c: Emerging Radiopharmaceuticals– Individual reviews of each emerging radiopharmaceutical to determine drug specific T&E and other requirements.
  • Option 2d: Team-based Requirements– T&E would be reduced based on pairing AUs with other individuals with radiation safety training.
 

The staff paper also states: “The NRC regulates medical uses of byproduct material to ensure the safety of workers and the general public, and while patient access concerns were considered by the staff, the NRC cannot regulate T&E with a primary goal of increasing patient access to radiopharmaceuticals or improving geographic distribution of AUs.”

In response, the NRC’s Advisory Committee on the Medical Use of Isotopes (ACMUI), made the following ASTRO-supported recommendations:

  1. The Subcommittee recommends maintaining the status quo under 10 CFR § 35.390. While strongly affirming the structural superiority of the status quo over the other options proposed in the draft paper, we acknowledge there is room for a comprehensive review of the specific requirements in § 35.390 such as the seemingly arbitrary requirement of 700 hours. The Subcommittee (and likely, ACMUI) would welcome the opportunity to critically assess these details.
  2. If the NRC proceeds to grant AU status by NRC-recognized specialty boards, the T&E should be equivalent to § 35.390.
  3. The Subcommittee recognizes the value of an alternate pathway and is willing to review and evaluate the requisite knowledge, preceptor-reviewed experience and competency assessments.
 

ASTRO and I believe maintaining the status quo (Option 2a) for training and experience for radiopharmaceuticals is appropriate, protects the safety of patients, the public, and practitioners, and should not be changed. The NRC’s focus on patient safety and the safety of the general public as it develops training and experience requirements is appropriate. The classroom and clinical experiences encompassed by radiation oncology and nuclear medicine training programs provide appropriate levels of knowledge and skill for any current and future radioactive agents.

Reporting data also supports maintaining the status quo. While non-expert AUs would introduce significant radiation risks, radiopharmaceuticals — when administered under the supervision of comprehensively trained and experienced AUs — have an exemplary safety record, and the current regulations ensure that safety. In both 2017 and 2018, there was one event reported to the NRC using Ra-223. Between January 2014 and May 2019, only 16 out of 9,848 total events entered into RO-ILS: Radiation Oncology Incident Learning System® were related to radiopharmaceuticals. As indicated in the self-reported data, none of these events have been reported to either the NRC or an Agreement State.

Weakening AU T&E requirements would not create an influx of new licensed health care facilities providing these therapies in remote geographical areas. Rather, there are other considerations guiding facilities’ decisions, such as:

  • availability/preference for alternative therapies,
  • the high cost of these drugs,
  • complexity of the patient cases, and
  • financial and staff resources required (radiation safety officer services, technologists/therapists with appropriate licensure, license fees, etc.). 
 

I was very pleased with the meetings, and I came away hopeful that ultimately the NRC will keep the status quo and will not initiate new rulemaking to lessen the current T&E requirements.  ASTRO will keep up the pressure and continue reporting on developments.

ASTRO is interested in receiving your feedback regarding the T&E requirements for radiopharmaceuticals. Use the comments below to share your thoughts.

 

Posted: January 3, 2020 | 0 comments


Coming Soon to ASTRO Journals: Data Availability Statements in Published Articles

By Lisa Braverman, Journals Managing Editor

The ASTRO portfolio of journals has had a productive year, with Practical Radiation Oncology’s first-ever impact factor (IF) of 2.794 and a soaring 6.203 IF for the Red Journal. The journals saw special sections about payment policy and gender in radiation oncology, along with groundbreaking podcasts covering topics as wide-ranging as end of life care and machine learning. Looking ahead to 2020, there is another innovation on the horizon: the inclusion of data availability statements in published ASTRO journal articles.

The Journals team invites readers to learn about the new data sharing policy, which goes into effect for articles submitted January 1 and later, by reading the recent Advances in Radiation Oncology article. Readers may also wish to complete  the accompanying CME activity.

ASTRO journals are committed to enhancing research transparency through the inclusion of data availability statements in published works. Importantly, data sharing is not required. While there are many benefits to sharing data — including the potential for faster scientific advancement — we understand not all data can or should be shared. Rather, we are requiring a statement about data availability for all scientific articles. Data availability statements are short descriptions included with scientific publications that provide readers with the conditions surrounding access to data underlying the research being reported. These statements will appear alongside funding and disclosure statements.

In order to better understand how other societies have implemented data sharing policies, we spoke with Ken Kornfield, director of Editorial and Publishing at the American Society for Clinical Oncology (ASCO) and Annie Hill, associate publisher, Community Initiatives at the American Psychological Association (APA). Abridged interviews are below.

What is your data sharing policy?

Ken Kornfield, ASCO (KK): We are putting the finishing touches on a new policy which will include a data sharing statement requirement beginning January 1, 2020. Our current guidelines refer to data sets relevant to the development of predictive or prognostic markers, as well as those relevant to risk assessment. For such data, JCO requires that it be submitted along with the original work as a supplemental file. Whether submitted as a supplemental file, table or figure, the data must be anonymized so as to protect the identities of subjects involved in the research. The same requirement applies to all text, tables and figures submitted as part of the manuscript itself. These data will be published as supporting supplemental material if the manuscript is accepted for publication.

Prior to publication, data sets or sequences relevant to the research must be provided in full, including gene expression profiling data with clinical correlative information. Such data must be anonymized and may be provided either as a supplementary file or by depositing the data in a public database such as GenBank, Gene Expression Omnibus or Array Express, with the accession number provided in the text of the final manuscript. As a condition of publication, it is expected that authors will share all data relevant to the manuscript with readers who may wish to replicate the results.

Annie Hill, APA (AH): APA Journals is committed to openness and transparency and encourages authors to share data when possible (recognizing that it may not always be possible per confidentiality agreements or funder requirements). APA’s Ethics Code does require authors to share data with other professionals for reanalysis after publication (as long as participant confidentiality is protected and the data are not proprietary). Several APA-published journals offer open-science badges to authors who make their data and materials open, and some now require authors to provide data availability statements (indicating whether they will or will not make their data available, along with links to them or explanations as to why they are not available).

When did you implement your policy, and why?

KK: This policy has been in place for at least four years. The reason we did this was for biomarker studies; we wanted others to have access to the data behind the study.

AH: We entered a partnership with the Center for Open Science to offer open science badges to authors and create an APA data repository to ease sharing in 2017. We are also committed to providing resources for authors who are able to share data or materials – making data available can help with replication and facilitate collaboration among researchers, so it’s really a benefit to the field to make it easier to do. Some editors are now requiring data availability statements to further encourage sharing and to get researchers thinking about how to make data available as they plan their studies.

Has anything surprised you about your society’s data sharing policy implementation? If so, what?

KK: We haven’t had any surprises or complaints.

AH: We knew early on that building understanding and consensus would be key, especially for a society publisher with different constituents. What we didn’t anticipate was the depth of knowledge and experience so many constituents would provide! We have a real opportunity to collect this knowledge for the benefit of researchers at every stage of their careers.

ASTRO is committed to research integrity and transparency. Our goals in requiring data availability statements are to facilitate quick identification of relevant data in a study, to promote transparency in instances of access or restriction, and to increase awareness of data availability statement structures. We welcome questions and comments about data availability statements in the comments below or email journals@astro.org.

Posted: December 18, 2019 | 0 comments


New ASTRO Clinical Practice Guideline on the Use of Radiation Therapy to Treat Skin Cancer

The new ASTRO clinical practice guideline provides recommendations on the use of radiation therapy to treat patients diagnosed with the most common types of skin cancers

By Phillip M. Devlin, MD, FASTRO, and Anna Likhacheva, MD, PhD

Skin cancer is the most prevalent cancer in the United States, with more than five million cases diagnosed each year. More than 95% of these diagnoses are basal and cutaneous squamous cell carcinomas (BCC, cSCC), which, in contrast to melanomas, respond well to radiation therapy if treated promptly and properly. Although surgery to remove the lesion is considered the primary approach for definitive/curative treatment of these non-melanoma skin cancers, radiation therapy can play an integral role in both the curative and post-operative settings.

ASTRO's first guideline for skin cancer was published on December 9, 2019 in Practical Radiation Oncology. The guideline details when radiation treatments are appropriate as stand-alone therapy or following surgery for BCC or cSCC, and it suggests dosing and fractionation for these treatments. ASTRO developed the guideline to provide clarity about treatment options since there is wide variation in practice about when and how radiation should be used for non-melanoma skin cancers, largely because few randomized studies have compared modern treatment options head-to-head.

The guideline was based on a systematic literature review which produced more than 1,500 articles, of which 143 (published from May 1988 through June 2018) were then carefully evaluated. The task force included a multidisciplinary team of radiation, medical and surgical oncologists, a radiation oncology resident, medical physicist, dermatologists and dermatopathologists.

The guideline first defines appropriate indications for radiation therapy as the following: definitive/curative treatment for BCC and cSCC; adjuvant treatment following surgery; and definitive or adjuvant treatment for disease that has spread to a patient's regional lymph nodes.

Recommendations are as follows:

  • In the definitive/curative setting, radiation is strongly recommended for patients with BCC or cSCC who cannot undergo or decline surgical resection. It is conditionally recommended for patients with BCC or cSCC located in anatomically sensitive areas such as the nose or lips, where surgery could compromise function or cosmetic outcomes. Definitive radiation therapy is discouraged, however, for patients with genetic conditions that predispose them to be more sensitive to radiation.
  • In the adjuvant/post-operative setting, radiation following surgery is recommended for patients at high risk of cancer recurrence, including a strong recommendation when there is evidence that BCC or cSCC has spread to a patient's nerves. Post-operative radiation is also recommended for patients at high risk of recurrence following surgical resection, including strong recommendations for high-risk patients with cSCC and conditional recommendations for high-risk patients with the relatively less aggressive BCC. Recommendations also outline prognostic features that indicate which patients are at greater risk for recurrence and spread.
  • For patients with BCC or cSCC that has spread to regional lymph nodes, surgical removal of the affected lymph nodes followed by radiation is strongly recommended for both BCC and cSCC, although not for patients with one small involved lymph node without extracapsular spread. The guideline also strongly recommends definitive radiation for patients with regional cSCC spread who cannot undergo surgery.

 

The guidelines also address technical aspects of radiation therapy, suggest dosing and fractionation schedules and include a brief discussion of the different types of radiation delivery methods.

The task force concluded that the appropriate use of any of the major radiation modalities results in similar cancer control and cosmetic outcomes. The guideline also considers the use of drug therapies such as chemotherapy, biologic and immunotherapy agents in combination with radiation.

Read the executive summary of Definitive and Postoperative Radiation Therapy for Basal and Squamous Cell Cancers of the Skin: An ASTRO Clinical Practice Guideline and the full-text of the guideline in PRO.

Phillip Devlin, MD, FASTRO, is a world renowned brachytherapist practicing medicine at Harvard Medical School. He is the author of two acclaimed textbooks and scores of academic articles regarding the development of brachytherapy and skin applications. He serves as chair of the task force that developed the guideline.

Anna Likhacheva, MD, is an internationally recognized radiation oncologist and brachytherapist who leads the teaching effort for ABS/ASTRO in the area of brachytherapy and skin cancer. She currently practices radiation oncology at Sutter Medical Center in Sacramento, California, and serves as vice-chair of the task force that developed the guideline.

Posted: December 10, 2019 | 0 comments


The Future of Prostate Radiation Therapy in the Era of Bundled Payment: Less is more?

By Daniel Spratt, MD, and Timur Mitin, MD, PhD

Prostate cancer is diagnosed in more than one million men worldwide each year. In countries with PSA screening, over 90% of cases are diagnosed when they are localized. The two most common treatments are radiation therapy and surgical removal of the prostate. One of the reasons men select surgery is the logistical barrier to undergo radiation therapy for eight to 10 weeks of daily, low-dose radiation therapy treatments (39 to 48 treatments). This can be a huge barrier for patients, especially those who are working, live a distance away, or have financial barriers to commute that often.

Fortunately, technology has improved over the past 30 years, and now there is increasing high-level evidence and guideline support to treat prostate cancer with many fewer treatments. This form of radiation therapy is often termed ultra or extreme hypofractionation, simply meaning fewer fractions of radiation therapy. More than 40 clinical trials have been published on this newer form of radiation therapy, including two large randomized trials. Nearly all the trials have used between four and seven fractions of radiation therapy, with the most common regimen being just five treatments. This is commonly termed stereotactic body radiation therapy (SBRT) or stereotactic ablative body radiotherapy (SABR).

To summarize the evidence of the >6,500 men who have been treated on trials using SABR, grade ≥3 toxicity is typically 0-2%, even with long-term follow-up, and appears to have equal or potentially superior tumor control when compared to conventional radiation therapy. Patients do not require anesthesia or any invasive procedure, as required with surgery or brachytherapy, and the logistical burden is minimal with just five outpatient treatment visits. Additionally, it costs less money to deliver SABR than conventional radiation therapy, uses less resources for departments, and is substantially more convenient for patients. For this reason, SABR is now considered “a” standard of care in National Comprehensive Cancer Network (NCCN) guidelines and used routinely in countries like the United States and Canada at centers capable of delivering the treatment. Recent estimates show 15-20% of patients who are treated with external beam radiation therapy receive it as SABR in the U.S.

Financial considerations unquestionably influence practice patterns, and radiation oncology is no exception. Historically, hypofractionation has been met with lukewarm enthusiasm among practices that bill per fraction. However, in the era of bundled payments that is rapidly approaching, fewer fractions may become more profitable as clinics will be able to treat a greater number of patients or reduce resource utilization. SBRT today in the U.S. is defined by insurance companies as a radiation treatment course with five or fewer fractions. Giving six fractions of the same radiation therapy plan means that the SBRT billing code no longer can be used, even if every single other aspect of the treatment was identical. Thus, six and seven fractions pays less than five fractions because of arbitrary billing code nomenclature. Next year, many centers will receive a set amount of reimbursement for a treatment course, no matter what the treatment is called. Widmark et al. have established a seven-fractions course of EBRT for men with both intermediate and high-risk prostate cancer as non-inferior to conventionally fractionated EBRT, with no rectal spacers and largely with 3-D planning. This regimen may indeed be the most cost-effective randomized trial-proven prostate-directed radiation therapy option for clinics to consider in the era of bundled payment.

We are all patiently waiting for the maturation and completion of Phase III trials, such as PACE-B and NRG GU005, respectively. If the results of these trials demonstrate similar efficacy and toxicity of SABR compared to older forms of radiation therapy at ≥5-years of follow-up, SABR will likely be deemed “the” standard of care for the treatment of localized prostate cancer. Other ongoing areas of investigation include the role of SABR for men with high-risk disease, and promising prospective data has been published from multiple groups demonstrating the safety and efficacy of this approach, even with simultaneous treatment of the pelvic lymph nodes. Finally, in Europe they are comparing SABR head-to-head to surgery. This will be a very informative trial to determine the difference in side effects and quality of life with modern non-invasive SABR compared to surgery.

The bottom-line: Prostate SBRT is here, and we anticipate it will only become increasingly utilized in the U.S. given the convergence of prospective and new level one evidence and financial incentives from the new bundled payment model. We anticipate that learning to safely deliver prostate SBRT will become very important in the not too distant future.

Daniel Spratt, MD, is an associate professor, Laurie Snow Endowed professor, associate chair for Research, and chair of the Genitourinary Clinical Research Division at the Rogel Cancer Center at University of Michigan.

Timur Mitin, MD, PhD, is an associate professor at Oregon Health and Science University. Dr. Mitin co-authored a recently published Red Journal article, SBRT for Localized Prostate Cancer: Is it Ready for Take-Off? on which this blogpost is based.

Posted: December 3, 2019 | 0 comments


ASTRO’s Minority Summer Fellowships Offer Lasting Connections

By Michael LeCompte, MS

The Committee of Health Equity, Diversity, and Inclusion (CHEDI) of ASTRO developed the Minority Summer Fellowship (MSF) as an opportunity to introduce medical students from backgrounds that are underrepresented in medicine to the field of radiation oncology. The program provides a framework for medical students to gain meaningful early exposure to the specialty that both encourages interest and provides mentorship within the field. MSF awardees work with a mentor on a research project and are required to submit their work for presentation at the subsequent ASTRO Annual Meeting. For the 2020 cycle, four students will be offered a package of $5,000: a $4,000 stipend for the eight-week training program and a $1,000 grant toward travel to the 2021 ASTRO Annual Meeting.

I first learned of the MSF through my school’s Student Affairs office. At this point, I had previously shadowed within the Wake Forest Department of Radiation Oncology and had collected data for a few residents’ research projects. I had a basic understanding of certain elements within radiation oncology and was fascinated by all I had seen thus far. Radiation oncology allows physicians to help patients process the uncertainty associated with a cancer diagnosis and build actionable, evidence-based treatment plans. This blend of social support and scientific application resonated with what I was looking for in a specialty, and the MSF was the avenue that would permit me to explore this specialty further.

The MSF allows the recipient to design a research project with a mentor to be completed over the eight-week training program. I was fortunate to find mentors who empowered me to identify my own research questions. Through conversations with Dr. Karen Winkfield and Dr. Michael Chan, we found ways to leverage my prior knowledge within diabetes research and investigate topics I was already personally interested in. This allowed me to more easily take an active role in designing our research project. We investigated the impact of diabetes mellitus and anti-diabetic drugs on the clinical outcomes of brain metastasis patients treated with stereotactic radiosurgery. The research completed through this experience was presented at the 2018 ASTRO Annual Meeting and has been published in the Red Journal and the Journal of Radiosurgery and SBRT.

The MSF training program may last for just a summer, but the connections I made during this experience continue to influence my career plans. I was able to make lasting connections with mentors both inside and outside my home institution. During the training program, I continued shadowing Dr. William Blackstock, who has always been there to offer advice and guidance along my path in medicine. Under the guidance of Dr. Chan, I have continued my research in clinical outcomes of brain metastasis patients, specifically the study of the concept of brain metastasis velocity. My project with CHEDI served as a stepping stone to a research experience that has seen me present at the inaugural Conference on Brain Metastases sponsored by the Society of Neuro-Oncology.

CHEDI also provides MSF awardees a liaison. For me, that person is Dr. Christian Okoye of St. Bernards Cancer Center, who has been there to check in on my progress in medical training and offer encouraging words. Other members of CHEDI have also served as mentors. I have been able to discuss my research and career plans with members of CHEDI over phone calls and in person at national meetings. Through mentorship, the MSF helps medical students further develop their career goals and grow toward their true potential.

This experience affirmed my fascination with the specialty and ultimately helped me in choosing to apply for residency in radiation oncology. I cannot express how appreciative I am to the members of CHEDI for offering me this wonderful opportunity, and I encourage others to apply. The application for the 2020 cycle is currently open with a deadline of Friday, February 7, 2020.

Michael LeCompte, MS, is a fourth-year medical student at Wake Forest School of Medicine. He was one of two recipients of the 2017 ASTRO Minority Summer Fellowship Award.

Posted: November 19, 2019 | 0 comments


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