Abstract
ObjectiveRadium-223 (223Ra) has been approved for treatment in patients with metastatic castration-resistant prostatic cancer (mCRPC) and bone metastasis. This α-emitting radionuclide has a beneficial effect on pain and is also capable to increase overall survival (OS). Several studies evaluated the prognostic value of different biomarkers at baseline, such as serum values, imaging parameters or pain. To date, however, clinicians lack a validated and simple system to assess which patients will most likely benefit from 223Ra treatment. The 3-variable prognostic score (3-PS), proposed in a single-center study in 2017 classifies patients in five prognostic groups with a specific OS. This study aims to validate the 3-PS in a larger multicenter population.MethodsFour hundred and thirty mCRPC patients treated with 223Ra from six different centers were analyzed. The 3-PS score consists of the collection of baseline hemoglobin, prostatic specific antigen and Eastern cooperative oncology group performance status and was initially applied to the whole population (total group). The score was then validated on the 338 patient’s subgroup (clean group) obtained by subtracting the 92 patients enrolled for the original study of the 3-PS score. This purified group served as further validation evidence.ResultsStatistical analysis showed that the 3-PS score was valid on the total group as well as in the clean group as the AUC estimated (0.74) falls within the CI of the AUC calculated on the validation sample (95% CI 0.66–0.82).ConclusionThis study confirms the validity of the 3-PS score for mCRPC patients. This score is simple, noninvasive and affordable and can be easily used to select patients that will most probably complete 223Ra treatment. In addition, this tool provides an exact estimate of life expectancy in terms of OS.
Highlights
From its first validation in 2013 in the ALSYMPCA trial [1] radium 223-dichloride (223Ra) has been routinely used as a palliative treatment in patients with metastatic castration-resistant prostate cancer and symptomatic bone metastasis [2]
Median baseline Hb was 12.3 g/dl (9.6–15.9) and median baseline total alkaline phosphatase (tALP) was 145 U/l. 140 patients had a baseline prostatic specific antigen (PSA) value of < 20 ng/ml while 290 subjects had more than 20 ng/ml of PSA value. 265 patients (61.6%) received six cycles of 223Ra. 44 patients received five cycles of 223Ra, 36 patients four cycles, 33 three cycles, 27 two cycles and 27 patients one cycle
Taking into consideration the prognostic value of all baseline clinical variables, the univariate analysis showed that in the clean group, patients’ Eastern cooperative oncology group performance status (ECOG PS), PSA, tALP and Hb values were independently associated with overall survival (OS)
Summary
From its first validation in 2013 in the ALSYMPCA trial [1] radium 223-dichloride (223Ra) has been routinely used as a palliative treatment in patients with metastatic castration-resistant prostate cancer (mCRPC) and symptomatic bone metastasis [2]. A retrospective study [9] collected data from 92 patients from a single center and identified a 3-variable prognostic score (3-PS) to predict OS accurately in patients with mCRPC under treatment with 223Ra. A retrospective study [9] collected data from 92 patients from a single center and identified a 3-variable prognostic score (3-PS) to predict OS accurately in patients with mCRPC under treatment with 223Ra This score includes baseline Eastern cooperative oncology group performance status (ECOG PS), hemoglobin (Hb) and PSA. This multicenter study aims to evaluate and validate the 3-PS on a larger cohort to provide an effective and accessible tool that could be used to determine the suitability of mCRPC patients for 223Ra
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