Advancing the management of adult solid tumours in 2023, and beyond: Unlocking the potential of radiopharmaceuticals

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An independent medical education grant from Advanced Accelerator Applications International S.A, and is jointly provided by USF Health and touchIME.

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    Faculty & Disclosures
    Dr Stephen Graves

    Division of Nuclear Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA, USA

    Dr Graves is a medical physicist, certified by the American Board of Radiology in both nuclear medicine physics and radiation oncology physics, with extensive experience in radiopharmaceutical therapy (RPT), quantitative nuclear imaging, radiation dosimetry and nuclear metrology. read more

    His research has focused on development of new medical radioisotopes for imaging and translation of new radiopharmaceutical agents into the clinic. Dr Graves is the primary medical physicist supporting clinical needs of the University of Iowa Comprehensive Radiopharmaceutical Therapy Center of Excellence, USA.

    Dr Graves is internationally recognized for his expertise in RPT dosimetry, including nuclear detection and measurement, single photon imaging and optimal clinical use of approved therapies.

    Dr Stephen Graves discloses: Advisory board or panel fees from Isotope Technologies Munich, Novartis and Voximetry. Consultancy fees from CDE Dosimetry Services and RayzeBio. Grants/research support from Siemens. Other financial or material support (royalties, patent, etc.) from Wisconsin Alumni Research Foundation.
    Dr Ana Kiess

    Johns Hopkins University School of Medicine, Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA

    Ana Kiess is associate professor and residency program director in the Department of Radiation Oncology and Molecular Radiation Sciences at Johns Hopkins University, USA. read more

    Her research focuses on new radiopharmaceutical agents, combination therapies, radiopharmaceutical therapy (RPT) dosimetry and toxicities. Her clinical practice includes radiopharmaceutical agents for prostate cancer and other cancers, and she is active in multiple RPT education initiatives.

    Dr Ana Kiess discloses: Advisory board or panel fees from Novartis (relationship terminated) Consultancy fees from Novartis (relationship terminated). Grants/research support from Bayer, Merck and Novartis. Speaker’s bureau fees from POINT Biopharma (relationship terminated).
    Prof. Jorge Garcia

    University Hospitals Seidman Cancer Center, Case Western Reserve University, Cleveland, OH, USA

    Jorge A Garcia, MD, FACP, is a professor of medicine and urology at Case Western Reserve University in Cleveland, OH, USA. He is the George and Edith Richman Distinguished Scientist Chair and the current chair of the Solid Tumor Oncology Division at University Hospitals Seidman Cancer Center/Case Comprehensive Cancer Center. Prof. Garcia’s work focuses on genitourinary malignancies. He is the current director of the Genitourinary (GU) Medical Oncology clinical and research programmes at University Hospitals Seidman Cancer Center. read more

    Prof. Garcia’s primary research interests encompass prostate, kidney and bladder cancer, with a special focus on developmental therapeutics, immune oncology and targeted therapy.

    Prof. Garcia has been a voting committee member for the US Food and Drug Administration Oncology Drug Advisory Committee since 2019, and currently serves as the chair of the committee. He is a member of several professional societies, including the American College of Physicians, Association of Cancer Research, American Society of Clinical Oncology and the American Medical Association. Prof. Garcia is a fellow of the American College of Physicians and has served in the past as a reviewer for the American Board of Internal Medicine.

    Prof. Jorge Garcia has no interests/relationships or affiliations to disclose in relation to this activity.
    Dr Jason Starr

    Mayo Clinic, Jacksonville, FL, USA

    Jason Starr is an oncologist in the Division of Hematology/Oncology at Mayo Clinic hospital in Jacksonville, FL, USA. His practice is currently focused on caring for patients with gastrointestinal malignancies, with a particular interest and expertise in neuroendocrine neoplasms. read more

    Dr Starr served on the National Cancer Institute Neuroendocrine Tumor Task Force from 2018–2021. He is also a member of the North American Neuroendocrine Tumor Society and currently serves as the social media committee co-chair. Dr Starr is also active within the ALLIANCE cooperative group and is a member of the Neuroendocrine Tumor Committee.

    Dr Starr is a clinical investigator who serves as a principal investigator (PI) or co-PI on many gastrointestinal cancer clinical trials. Those trials include novel treatments for neuroendocrine neoplasms, including peptide radionuclide radiation therapy. Dr Starr is also passionate about education and is integrally involved with fellow education and wellbeing.

    Dr Jason Starr discloses: Advisory board or panel fees from Advanced Accelerator Applications, Canada Expert Now, Ipsen, Natera and TerSera. Consultancy fees from Tempus. Grants/research support from Amgen, Arcus Biosciences and Camurus. Other financial or material support (royalties, patent, etc.) from Camurus.
    Dr Erik Mittra

    Oregon Health and Science University Portland, OR, USA

    Erik Mittra is a professor of diagnostic radiology at Oregon Health & Science University, Portland, OR, USA, where he serves as chief of the Molecular Imaging and Therapy Section and director of the Targeted Radiopharmaceutical Therapy Program. read more

    Dr Mittra is interested in all aspects of nuclear medicine, with a focus on targeted radiopharmaceutical therapies. His research interests are focused on the translation of novel radioisotopes for imaging and therapy. He is involved with the Society of Nuclear Medicine and Molecular Imaging , the North American Neuroendocrine Tumor Society and the Healing NET Foundation, among others.

    Dr Erik Mittra discloses: Advisory board or panel fees from Isotope Technologies Munich and TerSera. Consultancy fees from Curium Pharma and Novartis. Grants/research support from Nordic Nanovector and Novartis.
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    Advancing the management of adult solid tumours in 2023, and beyond: Unlocking the potential of radiopharmaceuticals

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    Dr Graves is a medical physicist, certified by the American Board of Radiology in both nuclear medicine physics and radiation oncology physics, with extensive experience in radiopharmaceutical therapy (RPT), quantitative nuclear imaging, radiation dosimetry and nuclear metrology. read more

    His research has focused on development of new medical radioisotopes for imaging and translation of new radiopharmaceutical agents into the clinic. Dr Graves is the primary medical physicist supporting clinical needs of the University of Iowa Comprehensive Radiopharmaceutical Therapy Center of Excellence, USA.

    Dr Graves is internationally recognized for his expertise in RPT dosimetry, including nuclear detection and measurement, single photon imaging and optimal clinical use of approved therapies.

    Dr Stephen Graves discloses: Advisory board or panel fees from Isotope Technologies Munich, Novartis and Voximetry. Consultancy fees from CDE Dosimetry Services and RayzeBio. Grants/research support from Siemens. Other financial or material support (royalties, patent, etc.) from Wisconsin Alumni Research Foundation.

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    Ana Kiess is associate professor and residency program director in the Department of Radiation Oncology and Molecular Radiation Sciences at Johns Hopkins University, USA. read more

    Her research focuses on new radiopharmaceutical agents, combination therapies, radiopharmaceutical therapy (RPT) dosimetry and toxicities. Her clinical practice includes radiopharmaceutical agents for prostate cancer and other cancers, and she is active in multiple RPT education initiatives.

    Dr Ana Kiess discloses: Advisory board or panel fees from Novartis (relationship terminated) Consultancy fees from Novartis (relationship terminated). Grants/research support from Bayer, Merck and Novartis. Speaker’s bureau fees from POINT Biopharma (relationship terminated).

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    Jason Starr is an oncologist in the Division of Hematology/Oncology at Mayo Clinic hospital in Jacksonville, FL, USA. His practice is currently focused on caring for patients with gastrointestinal malignancies, with a particular interest and expertise in neuroendocrine neoplasms. read more

    Dr Starr served on the National Cancer Institute Neuroendocrine Tumor Task Force from 2018–2021. He is also a member of the North American Neuroendocrine Tumor Society and currently serves as the social media committee co-chair. Dr Starr is also active within the ALLIANCE cooperative group and is a member of the Neuroendocrine Tumor Committee.

    Dr Starr is a clinical investigator who serves as a principal investigator (PI) or co-PI on many gastrointestinal cancer clinical trials. Those trials include novel treatments for neuroendocrine neoplasms, including peptide radionuclide radiation therapy. Dr Starr is also passionate about education and is integrally involved with fellow education and wellbeing.

    Dr Jason Starr discloses: Advisory board or panel fees from Advanced Accelerator Applications, Canada Expert Now, Ipsen, Natera and TerSera. Consultancy fees from Tempus. Grants/research support from Amgen, Arcus Biosciences and Camurus. Other financial or material support (royalties, patent, etc.) from Camurus.

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    Jorge A Garcia, MD, FACP, is a professor of medicine and urology at Case Western Reserve University in Cleveland, OH, USA. He is the George and Edith Richman Distinguished Scientist Chair and the current chair of the Solid Tumor Oncology Division at University Hospitals Seidman Cancer Center/Case Comprehensive Cancer Center. Prof. Garcia’s work focuses on genitourinary malignancies. He is the current director of the Genitourinary (GU) Medical Oncology clinical and research programmes at University Hospitals Seidman Cancer Center. read more

    Prof. Garcia’s primary research interests encompass prostate, kidney and bladder cancer, with a special focus on developmental therapeutics, immune oncology and targeted therapy.

    Prof. Garcia has been a voting committee member for the US Food and Drug Administration Oncology Drug Advisory Committee since 2019, and currently serves as the chair of the committee. He is a member of several professional societies, including the American College of Physicians, Association of Cancer Research, American Society of Clinical Oncology and the American Medical Association. Prof. Garcia is a fellow of the American College of Physicians and has served in the past as a reviewer for the American Board of Internal Medicine.

    Prof. Jorge Garcia has no interests/relationships or affiliations to disclose in relation to this activity.

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    Erik Mittra is a professor of diagnostic radiology at Oregon Health & Science University, Portland, OR, USA, where he serves as chief of the Molecular Imaging and Therapy Section and director of the Targeted Radiopharmaceutical Therapy Program. read more

    Dr Mittra is interested in all aspects of nuclear medicine, with a focus on targeted radiopharmaceutical therapies. His research interests are focused on the translation of novel radioisotopes for imaging and therapy. He is involved with the Society of Nuclear Medicine and Molecular Imaging , the North American Neuroendocrine Tumor Society and the Healing NET Foundation, among others.

    Dr Erik Mittra discloses: Advisory board or panel fees from Isotope Technologies Munich and TerSera. Consultancy fees from Curium Pharma and Novartis. Grants/research support from Nordic Nanovector and Novartis.

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    Learning Objectives

    After watching this activity, participants should be better able to:

    • Describe the underlying rationale and mechanism of action for radiopharmaceuticals in adult oncology
    • Recall the different types of radiopharmaceuticals (approved and in clinical development), and their specific properties
    • Summarize the latest efficacy and safety data available for radiopharmaceuticals in the management of adult solid tumours, including potential implications for current and future clinical practice
    • Propose strategies to support integration of radiopharmaceuticals into adult oncology pathways to individualize clinical management, and ultimately, optimize patient outcomes
    Overview

    Leading experts share their insights on the role and use of radiopharmaceuticals in adult patients with solid tumours (with a focus on NETs and prostate cancer) and provide guidance for daily clinical practice to support their integration.

    This activity is jointly provided by USF Health and touchIME. read more

    Target Audience

    Oncologists (including gastro-oncologists and prostate cancer specialists), gastroenterologists, radiologists, endocrinologists, haematologists and pulmonologists involved in the management of adult solid tumours.

    Disclosures

    USF Health adheres to the Standards for Integrity and Independence in Accredited Continuing Education. All individuals in a position to influence content have disclosed to USF Health any financial relationship with an ineligible organization. USF Health has reviewed and mitigated all relevant financial relationships related to the content of the activity.  The relevant relationships are listed below. All individuals not listed have no relevant financial relationships.

    Faculty

    Dr Stephen Graves discloses: Advisory board or panel fees from Isotope Technologies Munich, Novartis and Voximetry. Consultancy fees from CDE Dosimetry Services and RayzeBio. Grants/research support from Siemens. Other financial or material support (royalties, patent, etc.) from Wisconsin Alumni Research Foundation.

    Dr Ana Kiess discloses: Advisory board or panel fees from Novartis (relationship terminated) Consultancy fees from Novartis (relationship terminated). Grants/research support from Bayer, Merck and Novartis. Speaker’s bureau fees from POINT Biopharma (relationship terminated).

    Prof. Jorge Garcia has no interests/relationships or affiliations to disclose in relation to this activity.

    Dr Jason Starr discloses: Advisory board or panel fees from Advanced Accelerator Applications, Canada Expert Now, Ipsen, Natera and TerSera. Consultancy fees from Tempus. Grants/research support from Amgen, Arcus Biosciences and Camurus. Other financial or material support (royalties, patent, etc.) from Camurus.

    Dr Erik Mittra discloses: Advisory board or panel fees from Isotope Technologies Munich and TerSera. Consultancy fees from Curium Pharma and Novartis. Grants/research support from Nordic Nanovector and Novartis.

    Content reviewer

    Danielle Walker, DNP, APRN, AGNP-C, has no financial interests/relationships or affiliations in relation to this activity.

    Touch Medical Director

    Kathy Day has no financial interests/relationships or affiliations in relation to this activity.

    USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

    Requirements for Successful Completion

    In order to receive credit for this activity, participants must review the content and complete the post-test and evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

    If you have questions regarding credit please contact cpdsupport@usf.edu.

    Accreditations

    Physicians

    This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

    USF Health designates this enduring material for a maximum of 1.0 AMA PRA Category 1 CreditTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    The European Union of Medical Specialists (UEMS) – European Accreditation Council for Continuing Medical Education (EACCME) has an agreement of mutual recognition of continuing medical education (CME) credit with the American Medical Association (AMA). European physicians interested in converting AMA PRA Category 1 CreditTM into European CME credit (ECMEC) should contact the UEMS (www.uems.eu).

    Advanced Practice Providers

    Physician Assistants may claim a maximum of 1.0 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 CreditTM from organizations accredited by ACCME or a recognized state medical society.

    The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 CreditTM by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

    Date of original release: 18 July 2023. Date credits expire: 18 July 2024.

    If you have any questions regarding credit please contact cpdsupport@usf.edu.

    This activity is CE/CME accredited

    To obtain the CE/CME credit(s) from this activity, please complete this post-activity test.

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    Topics covered in this activity

    Endocrine Oncology
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    This Activity Is Funded By:

    An independent medical education grant from Advanced Accelerator Applications International S.A, and is jointly provided by USF Health and touchIME.

    The information provided by this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

    USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

    USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CME to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

    Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

    This content is intended for healthcare professionals.

    Date of original release: 18 July 2023. Date credits expire: 18 July 2024.

    Claim Credit
    touchEXPERT OPINIONS
    Advancing the management of adult solid tumours in 2023, and beyond: Unlocking the potential of radiopharmaceuticals
    1 CE/CME credit
    Question 1/6
    Which of the following statements best describes the primary mode of DNA damage mediated by alpha (α)-particle-emitting radionuclides used in radiopharmaceutical constructs?

    Biological effects mediated by radionuclides depend on the nature of radiation emitted. Alpha (α)-particles have a high LET deposited over a short path length (~100 keV/μm). High-LET radiation (typified by α-emitting radionuclides) yields DNA damage primarily through direct induction of DNA double-strand breaks.

    Abbreviations

    LET, linear energy transfer.

    Reference

    Kunos CA, et al. Semin Radiat Oncol. 2021;31:3−11.

    Question 2/6
    Your patient is eligible for enrolment in a clinical trial evaluating a novel antibody-based radiopharmaceutical agent in adult solid tumours. During conversations with your patient regarding trial participation and potential considerations, which of the following would you discuss with them to manage their expectations?

    Antibody-mediated delivery of radiopharmaceuticals typically leads to prolonged retention in target tissue(s). However, as antibodies have a long circulating half-life leading to high bone marrow absorbed doses, this in turn may lead to greater off-target effects, particularly haematological toxicities.

    Reference

    Sgouros G, et al. Nat Rev Drug Discov. 2020;19:589–608.

    Question 3/6
    Which of the following statements best summarizes the preliminary findings of a phase I dose-escalation trial evaluating dual PSMA targeting with an alpha-labelled antibody and beta-labelled radioligand therapy in patients with progressive mCRPC (NCT04886986), presented at ASCO 2023?

    ASCO, American Society of Clinical Oncology; mCRPC, metastatic castration-resistant prostate cancer; PSA, prostate-specific antigen; PSMA, prostate-specific membrane antigen; TRAE, treatment-related adverse event.

    In a phase I dose-escalation study (NCT04886986) investigating dual PSMA targeting with 225Ac-J591 (an alpha-labelled antibody) and 177Lu-PSMA-I&T (PNT2002) (a beta-labelled radioligand), 94% of participants (n/N=17/18) experienced a PSA decline following therapy. No grade 4 TRAEs were reported and dose-limiting toxicities only occurred in the 225Ac-J591 at 40 kBq/kg cohort.

    Abbreviations

    PSA, prostate-specific antigen; PSMA, prostate-specific membrane antigen; TRAE, treatment-related adverse events.

    Reference

    Tagawa S, et al. J Clin Oncol. 2023;41(Suppl. 16):5018.

    Question 4/6
    Your patient with mCRPC is due to commence treatment with 177Lu-PSMA RLT. Based on the most recent 68Ga-PSMA PET-imaging results, the calculated overall SUVmean for sites of active disease was 14.8 (arbitrary units). Based on available clinical evidence, what might this result suggest in terms of risk–benefit considerations for this patient?

    mCRPC, metastatic castration-resistant prostate cancer; PET, positron emission tomography; PSA, prostate-specific antigen; PSMA, prostate-specific membrane antigen; RLT, radioligand therapy; rPFS, radiographic progression-free survival; SUV, standardized uptake value.

    Post hoc biomarker analysis of TheraP trial participants by PSMA-PET imaging thresholds demonstrated that odds of achieving a PSA response to 177Lu-PSMA-617 vs cabazitaxel were higher for men with SUVmean ≥10 compared with those with SUVmean <10 (OR 12.19 [95% CI 3.42–58.76] vs 2.22 [95% CI 1.11–4.51]; adjusted p=0.039 for treatment by SUVmean interaction).1

    In the TheraP trial, RLT with 177Lu-PSMA-617 yielded a higher PSA response (≥50% reduction in PSA from baseline) in men with mCRPC (66% [n=99; 95% CI 56–75]) compared with cabazitaxel (37% [n=101; 95% CI 27–46]). Participants receiving 177Lu-PSMA-617 experienced fewer grade 3 or 4 AEs (33%; n/N=32/98) compared with those receiving cabazitaxel (53%; n/N=45/85).2

    Abbreviations

    AE, adverse event; CI, confidence interval; mCRPC, metastatic castration-resistant prostate cancer; OR, odds ratio; PET, positron emission tomography; PSA, prostate-specific antigen; PSMA, prostate-specific membrane antigen; RLT, radioligand therapy; SUV, standardized uptake value.

    References

    1. Buteau P, et al. Lancet Oncol. 2022;23:1389–97.
    2. Hofman MS, et al. Lancet. 2021;397:797–804.
    Question 5/6
    Your patient has a well-differentiated inoperable grade 2 midgut neuroendocrine tumour that has progressed on first-line therapy with a somatostatin analogue. Following discussion of the case with the multidisciplinary tumour board for possible PRRT, what would you do next to support eligibility of the patient?

    PRRT, peptide receptor radionuclide therapy.

    PRRT, a targeted treatment approach to GEP-NETs, involves conjugation of a beta-emitting radionuclide (177Lu) to a high-affinity somatostatin analogue (octreotate) via the DOTA chelator molecule.1 Diagnostic imaging using SSTR-binding agents will help predict the degree to which 177Lu-DOTATATE will be taken up by malignant cells.2 Patient selection for PRRT is primarily based on SSTR positron emission tomography.3 Once eligibility for the therapy is confirmed, laboratory values are reviewed to assess renal, hepatic and bone marrow function, with specific cut-off values used to approve patients for therapy.2

    Abbreviations

    GEP-NET, gastroenteropancreatic neuroendocrine tumour; PRRT, peptide receptor radionuclide therapy; SSTR, somatostatin receptor.

    References

    1. Strosberg JR, et al. Lancet Oncol. 2021;22:1752–63.
    2. Burkett BJ, et al. Radiology. 2021;298:261–74.
    3. Hope TA, et al. J Clin Oncol. 2022;40:2818–29.
    Question 6/6
    Which of the following steps might you recommend to support broader adoption of radiopharmaceuticals amongst healthcare professional colleagues at your institution?

    Interspeciality relations have been identified as a frequent barrier to RPT use. As no single HCP group predominates RPT use, this can lead to a lack of clarity with referral patterns and pathways.1,2 Frameworks to guide and clarify patient-centred pathways for RPT are emerging, and support the need to define roles and responsibilities along the patient management journey.1,3

    Abbreviations

    HCP, healthcare professional; RPT, radiopharmaceutical therapy.

    References

    1. Hermann K, et al. Eur J Nucl Med. 2022:49;2300–9.
    2. Shukla U, et al. Adv Radiat Oncol. 2022;7:100827.
    3. Buatti JM, et al. Int J Radiat Oncol Biol Phys. 2021;109:913–22.
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    This Activity Is Funded By:

    An independent medical education grant from Advanced Accelerator Applications International S.A, and is jointly provided by USF Health and touchIME.

    The information provided by this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

    USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

    USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CME to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

    Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

    This content is intended for healthcare professionals.

    Date of original release: 18 July 2023. Date credits expire: 18 July 2024.

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