ASTRO’s RPT Work Group has been leading efforts since 2018 to promote radiation oncologists as key leaders in the burgeoning field of radiopharmaceuticals (RPTs). To this end, in March 2023, ASTRO hosted more than 40 individuals, including academic and community practice physicians, physician scientists and industry, to engage in a dialogue between radiation oncologists and industry thought leaders about key strategic issues and opportunities related to RPTs. There was excellent engagement from participants and several priority areas emerged from the conversation:
- Supply Chain Issues. The challenges of creating and distributing RPTs once an agent is approved for therapy is a global concern. Structural and regulatory barriers were reviewed and the need for broad investment in infrastructure and engagement with government agencies was supported.
- Dosimetry. There was agreement that better understanding of dosimetry is important to achieving the optimal therapeutic potential of RPTs. However, much remains to be learned and consensus guidance is needed on key aspects of dose response both for tumor and normal tissues.
- Rational Trials Design. Another important theme that emerged was the importance of trials. This discussion included questions such as whether animal studies are valuable in the context of RPTs and whether removal or liberalization of dose limits for Phase 1 trials should be considered instead of dose extrapolation from EBRT.
- Educational Needs. Another theme that was discussed was the need to educate various stakeholders on issues related to effective practices. Better understanding by regulatory agencies and other health care disciplines about appropriate risks regarding radiation dose limits and level setting on acceptable toxicities with RPT development is needed. Failure to educate relevant stakeholders may limit the application of these highly effective agents and is a concern for industry as they bring more agents to market.
Industry leaders indicated that they would be interested in learning more about how to leverage the existing infrastructure in RO departments both to improve standardization for dosimetry and for clinical trials. To help support research, ASTRO is assembling a list of centers interested in participating in clinical trials with RPTs. If your practice currently participates in RPT and in NIH or NCTN trials and would be interested in opening industry-funded RPT trials, please contact ASTRO staff.
In addition to this inaugural stakeholder discussion, in the first half of 2023, ASTRO offered the RPT Masterclass as an add-on to the Refresher Course, with over 100 members taking advantage of this opportunity. The winter issue of ASTROnews was dedicated to RPTs, providing members with firsthand accounts on how to set up a program and gain authorized user status, patient-centered treatments and emerging advances. ASTRO also submitted comments to the International Accreditation Committee (IAC) on its proposed standards for RPTS specifically asking that the standards be modified to:
- Address patient care and management;
- Allow radiation oncologists to be the medical director of an RPT practice; and
- Allow therapy medical physicists to be the technical director of an RPT practice.
ASTRO is also in the process of updating our APEx standards for accreditation and we have posted those proposed changes, including standards to evaluate practices that offer RPTs for public comment. Please review the proposed standards and provide your feedback.
In April, ASTRO surveyed the chairs of academic practices and learned that almost half (45%) of academic centers either have or are in the process of developing a multidisciplinary clinic for RPTs. ASTRO strongly supports multidisciplinary care and our Framework for Patient-Centered Care describes an idealized way to manage patients receiving RPT. This framework was developed to incorporate the strengths of both radiation oncologists and nuclear medicine physicians. A multidisciplinary approach requires enhanced coordination and collaboration among appropriately qualified personnel with diverse expertise in image acquisition, image interpretation, quantitative imaging, dosimetry calculation, radiation quality assurance and safety as well as oncology care and RPT-induced sequelae and response assessment. There is ample opportunity for our specialty to work alongside nuclear medicine physicians to realize the potential of these new agents.
The RPT Work Group continues to creatively advance the field of RPTs and radiation oncology’s role. If you have suggestions for other activities ASTRO can support to promote this field, please email me via ASTRO staff.
