%0 Journal Article
%T National Cancer Institute Programmatic Collaboration for Investigational Radiopharmaceuticals
%A Charles A. Kunos
%A Jacek Capala
%J About the Ed Book | ASCO Educational Book
%D 2018
%R https://doi.org/10.1200/EDBK_200199
%X INTRODUCTION Section: ChooseTop of pageAbstractINTRODUCTION <<RADIOPHARMACEUTICAL EXPLO...RADIOPHARMACEUTICAL CLINI...PROGRAMMATIC COLLABORATIO...RADIOPHARMACEUTICAL INFRA...RADIOPHARMACEUTICAL DOSIM...CONCLUSIONReferences Radiotherapy as cancer treatment remains an effective option for patient cure and palliation. It helps cure some cancers, such as localized breast, cervical, and prostate cancer.1 It provides long-lasting control for palliation of many others. More than 16.6 million American pediatric and adult cancer survivors are estimated alive as of January 1, 2018, half of whom underwent radiotherapy as cancer treatment at one time or another.2,3 Steady federal support of practice-altering basic science and clinical research ultimately has translated into enhanced cures and reduced morbidity. New insights in cancer biology, radiobiology, and radiochemistry have repositioned radiopharmaceutical therapies at the leading edge of personalized medicine oncology research. Existing and forthcoming programmatic initiatives at the National Cancer Institute (NCI) intend to prominently boost radiopharmaceutical clinical development in an era of personalized medicine. Forecasts for radiopharmaceutical trial success are better now than before. Yet the landscape for success has changed. Oncology clinical trials currently enrich for molecularly selected patient populations in an effort to gain supportive evidence for investigational agents in disease-specific treatment indications. This strategic approach can set the stage for rapid and efficient introduction of new drug therapies to patients. New or repurposed radiopharmaceutical therapies should adopt similar drug strategies (1) to appeal to patients and (2) to broaden clinical utility. And here a radiopharmaceutical therapy should be thought of as a drug therapy. Existing NCI Cancer Therapy Evaluation Program (CTEP) initiatives consider a radiopharmaceutical therapy to be a radionuclide delivered by vein, injection, or ingestion intending to irradiate targeted cancer cells while minimizing radiation dose to nearby normal cells (Fig. 1). There are factors that make it reasonable to consider radiopharmaceutical therapies drug like and amenable to development similar to that of investigational drugs. FIGURE 1. Antibody-Radionuclide Conjugates to Treat Cancer Specific antibodies carry radionuclide payloads to tumor to release energy-rich radiation locally at cancer cells. A radionuclide such as 227Th conjugated in a chelator conjugate linked to an antibody fits this intent. After drug product formulation,
%U http://ascopubs.org/doi/full/10.1200/EDBK_200199