Implementation and preliminary validity of the Functional Assessment of Cancer Therapy – Radionuclide Therapy (FACT-RNT) in patients receiving radionuclide therapy for prostate cancer.
Abstract
118 Background: The Functional Assessment of Cancer Therapy-Radionuclide Therapy (FACT-RNT) is used in trials and clinical practice to monitor patient-reported RNT-relevant symptoms and toxicities in advanced metastatic castrate-resistant prostate cancer (mCRPC) patients receiving RNT. This study examined FACT-RNT feasibility and preliminary validity for U.S. patients receiving RNT. Methods: Patients scheduled to start 177Lu-PSMA-617 for advanced mCRPC at Moffitt Cancer Center from October 2023 – March 2024 completed patient-reported outcome (PRO) measures before each cycle. PROs included previously validated measures of prostate cancer specific-symptoms (NFPSI-17) and physical function (Scored Patient-Generated Subjective Global Assessment; PG-SGA) and the FACT-RNT, a 15-item measure of symptoms/toxicities with higher total scores (range: 0-60) indicating less symptom burden. Correlations between the FACT-RNT and other PROs were calculated. Results: Patients (N=17) were, on average, 69 years old (SD=11, range=43-90) at RNT cycle 1 and mostly non-Hispanic (76%) and White (82%). Gleason scores at diagnosis were 7-8 (30%) or 9-10 (71%). Patients had previously undergone surgery (35%), chemotherapy (94%), radiation (71%), hormone therapy (94%), targeted therapy (88%), and immunotherapy (29%). Fifteen patients (88%) received ≥2 RNT infusions; of these, 1 (6%) died and 1 (6%) discontinued RNT prior to cycle 2. Thirteen (87% of those with ≥2 infusions) completed the FACT-RNT at ≥2 cycles. Cycle 1 FACT-RNT total scores ranged from 31-58 (M=46.5, SD=8). The FACT-RNT was positively associated with symptoms as assessed by NFPSI-17 at cycles 1-3 ( p s≤.03) and negatively associated with physical function at cycles 1-2 ( p s≤.05). Conclusions: Preliminary results support FACT-RNT validity due to associations with validated PRO measures and the feasibility of FACT-RNT implementation in the U.S. The FACT-RNT may be helpful in clinical management and decision-making with RNT recipients. Future research will replicate and extend these findings in a larger longitudinal sample and examine validity with clinician-rated outcomes and RNT dosimetry.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (19)
Lisa Marie Gudenkauf
Brigham and Women's Hospital, Boston, MA
Tugce Telli
Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany
Astrid Delker
Department of Nuclear Medicine, LMU University Hospital, LMU Munich, Munich, Germany
Danielle F. Simon
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
Heather S.L. Jim
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
Laura B. Oswald
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
Xiaoyin Li
Aasha Hoogland
3Moffitt Cancer Center, Department of Blood and Marrow Transplantation and Cellular Immunotherapy, Tampa, United States
Adam P. Dicker
Scott T. Tagawa
Weill Cornell Medical Center, NewYork Presbyterian Hospital, New York, NY
David Cella
Michael S. Hofman
Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
Johannes Czernin
Ahmanson Translational Theranostics Division, University of California, Los Angeles, Los Angeles, CA
Jeremie Calais
Luca F. Valle, MD, Department of Radiation Oncology, University of California Los Angeles, Los Angeles, CA, Radiation Oncology Service, Greater Los Angeles VA Healthcare System, Los Angeles, CA, University of California Los Angeles Jonsson Comprehensive Cancer Center, Los Angeles, CA, Jeremie Calais, MD, PhD, University of California Los Angeles Jonsson Comprehensive Cancer Center, Los Angeles, CA, Department of Nuclear Medicine, University of California Los Angeles, Los Angeles, CA, Amar U. Kishan, MD, Department of Radiation Oncology, University of California Los Angeles, Los Angeles, CA, University of California Los Angeles Jonsson Comprehensive Cancer Center, Los Angeles, CA
Lena Unterrainer
Department of Nuclear Medicine, LMU University Hospital, LMU Munich, Munich, Germany
Wolfgang Peter Fendler
Ken Herrmann
Ghassan El-Haddad
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL
Brian D. Gonzalez