Clinical outcome (CO) and predictive factors (PRE) evaluation of young (≤ 60 years) castration-resistant prostate cancer (CRPC) patients, treated with docetaxel (DOC): Preliminary results of an Italian multicenter retrospective study (CYCLOP study).

Abstract

e16031 Background: CRPC is rare in pts ≤ 60 yrs and clinical outcomes of these pts are not clearly defined despite there is a common feeling of a worse prognosis for them. The present study is aimed to assess CO and PRE in this specific population. Methods: In this multicentric retrospective study, after Ethical Committee approval, we have reviewed the clinical records of all < 60 yrs CRPC pts from participating institutions, treated with DOC. We recorded the pre and post-DOC clinical history, the DOC treatment details and outcomes. We have also assessed the ability of a series of selected 18 clinical factors to predict DOC response through a logistic regression analysis. Continuous variables were categorized by quartiles and chosen for the initial model after a univariate chi-square analysis. Results: To date we have collected a consecutive series of 98 pts from 16 Italian hospitals. The median age was 57 yrs (range 41-60). The median baseline PSA was 84 ng/ml (range 2-2721); 93% of the pts had bone metastases while 49%, 9%, and 13% showed nodal, liver and lung metastases, respectively. All but 8 pts received DOC with a 3-week standard schedule: the median number of received DOC courses was 8 (range 1-14). The main grade 3-4 toxicities were anemia (4 pts), neutropenia (15 pts), febrile neutropenia (1 pt), peripheral neuropathy(1 pt). A PSA reduction > 50% was observed in 61% of the pts while 14% and 7% of the cases showed a partial and complete response, respectively. Having a Gleason score (GS) <8 [p= 0.032], a hemoglobin initial value >12 [p= 0.052], no nodal involvement [p= 0.101], resulted to be independently predictive of a PSA reduction > 50%. The median PFS and OS were 7 mos and 19 mos, while the 1-year PFS and OS rates were 17.3% and 70%, respectively. Conclusions: From these preliminary results, we failed to confirm a worse prognosis for younger CRPC since their survival outcomes are similar to those observed in the pivotal trials. Low GS, absence of nodal involvement and good hemoglobin levels are the only predictive factors.