Viviana Frantellizzi1,2, Alessio Farcomeni3, Giulia Anna Follacchio4, Massimiliano Pacilio5, Rosanna Pellegrini6, Roberto Pani7, Giuseppe De Vincentis4. 1. Department of Radiological Sciences, Oncology and Anatomo-Pathology, "Sapienza" University of Rome, Viale Regina Elena, 324, 00161, Rome, Italy. viviana.frantellizzi@uniroma1.it. 2. Angio-Cardio-Thoracic Pathophisiology and Imaging, "Sapienza" University of Rome, Rome, Italy. viviana.frantellizzi@uniroma1.it. 3. Department of Public Health and Infectious Diseases, "Sapienza" University of Rome, Piazzale Aldo Moro, 5, 00161, Rome, Italy. 4. Department of Radiological Sciences, Oncology and Anatomo-Pathology, "Sapienza" University of Rome, Viale Regina Elena, 324, 00161, Rome, Italy. 5. Department of Medical Physics, Azienda Ospedaliera Universitaria Policlinico Umberto I, Viale del Policlinico 155, 00161, Rome, Italy. 6. Department of Molecular Medicine, "Sapienza" University of Rome, Viale Regina Elena, 324, 00161, Rome, Italy. 7. Department of Sciences and Medico-Surgical Biotechnologies, "Sapienza" University of Rome, Viale Regina Elena, 324, 00161, Rome, Italy.
Abstract
OBJECTIVE: In mCRPC patients treated with 223Ra, a major issue is the validation of reliable prognostic and predictive biomarkers to maximize clinical benefit and minimize toxicities and costs. Bearing in mind how changes in tALP did not meet statistical requirements as surrogate marker for survival, aim of this single-center retrospective study was to characterize the prognostic and predictive role of baseline clinical variables associated with overall survival in patients receiving 223Ra treatment. METHODS: 92 consecutive CRPC patients with symptomatic bone metastases receiving 223Ra treatment were included. Available baseline clinical data relevant to the survival analysis were retrospectively collected. The primary end-point of the study was overall survival, which was established from the first 223Ra administration until date of death from any cause. RESULTS: Median follow-up time from the first 223Ra administration was 6 months (range 1-31 months). The univariate analysis evaluating the prognostic value of all baseline clinical variables showed that patients' weight, BMI, ECOG PS, Hb and tALP values were independently associated with OS. On multivariable analysis only baseline Hb value and ECOG PS remained significantly correlated with OS. To determine reliable baseline predictive factors for survival in patients receiving 223Ra treatment, we produced a predictive score. We tried all possible variable combinations, and found that the best score was obtained by combining baseline ECOG PS with Hb < 12 g/dl and PSA ≥ 20 ng/ml. This resulted in a score ranging from 0 to 4, with AUC 78.4% (p < 0.001). CONCLUSIONS: We propose a multidimensional clinical evaluation to select those mCRPC subjects suitable to receive the maximum benefit from 223Ra treatment.
OBJECTIVE: In mCRPC patients treated with 223Ra, a major issue is the validation of reliable prognostic and predictive biomarkers to maximize clinical benefit and minimize toxicities and costs. Bearing in mind how changes in tALP did not meet statistical requirements as surrogate marker for survival, aim of this single-center retrospective study was to characterize the prognostic and predictive role of baseline clinical variables associated with overall survival in patients receiving 223Ra treatment. METHODS: 92 consecutive CRPC patients with symptomatic bone metastases receiving 223Ra treatment were included. Available baseline clinical data relevant to the survival analysis were retrospectively collected. The primary end-point of the study was overall survival, which was established from the first 223Ra administration until date of death from any cause. RESULTS: Median follow-up time from the first 223Ra administration was 6 months (range 1-31 months). The univariate analysis evaluating the prognostic value of all baseline clinical variables showed that patients' weight, BMI, ECOG PS, Hb and tALP values were independently associated with OS. On multivariable analysis only baseline Hb value and ECOG PS remained significantly correlated with OS. To determine reliable baseline predictive factors for survival in patients receiving 223Ra treatment, we produced a predictive score. We tried all possible variable combinations, and found that the best score was obtained by combining baseline ECOG PS with Hb < 12 g/dl and PSA ≥ 20 ng/ml. This resulted in a score ranging from 0 to 4, with AUC 78.4% (p < 0.001). CONCLUSIONS: We propose a multidimensional clinical evaluation to select those mCRPC subjects suitable to receive the maximum benefit from 223Ra treatment.
Authors: Cédric Charrois-Durand; Fred Saad; Maroie Barkati; Jean-Baptiste Lattouf; Paul Perrotte; Pierre I Karakiewicz; Denis Soulières; Normand Blais; Zineb Hamilou; Daniel Juneau; Nicolas Plouznikoff; Daniel Taussky; Guila Delouya Journal: Can Urol Assoc J Date: 2022-06 Impact factor: 2.052