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Post docetaxel abiraterone in patients with mCRPC: Efficacy, safety and prognostic factors
8th European Multidisciplinary Meeting on Urological Cancers, 24-27 November 2016, Milan, Italy
P095
Post docetaxel abiraterone in patients with mCRPC: Efficacy, safety and prognostic factors Eur Urol Suppl 2016; 15(13);e1678
Detti B., Becherini C., Francolini G., Olmetto E., Topulli J., Trombetta L., Loi M., Baldazzi V., Livi L. Aou Careggi, Dept. of Radiation Oncology, Florence, Italy INTRODUCTION & OBJECTIVES: A significant percentage of patients with mCRPC progress after an initial response to treatment withLH-RH. Recent data suggest that the Androgen Receptor (AR) signalling pathway remains a keydriver of prostate cancer progression despite castrate levels of testosterone in advanced disease. Various drugs have been shown to benefit patients with mCRPC;the therapeutic approach is complex and less clear than in the past. Abiraterone is a potent, selective and irreversible inhibitor of CYP17, a key enzyme in the androgen and estrogen synthesis process, which has been shown to significantly prolong overall survival (OS) of patients with mCRPC, in post and in pre docetaxel setting. The aim of our retrospective study is to evaluate the efficacy and the safety of abiraterone in our patients affected by mCRPC and try to find predictive factors of response to treatment. MATERIAL & METHODS: We report data about 40 patients affected by mCRPC, progressed after a first line chemotherapy with docetaxel, treated with Abiraterone Acetate (AA) from September 2012 to January 2015. Abiraterone was administered at the standard dose of 1000 mg/day, given concurrently with prednisone 5 mg twice daily. 24 patients (60%) underwent concomitant hormonal therapy with LH RH agonist, while 16 patients (40%) with LH RH antagonists.All patient received a first line chemotherapy with docetaxel; 27 patients recived AA as a secondline therapy. Only 4 patients presented visceral metastases; the other had a bone/lymphonode involvement. We evaluated PFS defined as the time from beginning of AA to either biochemical or radiographic progression according to PCWGC 2. Other outcomes reported are PSA response and Adverse Events (AE), defined as any AE that requested suspension or interruption of AA therapy. RESULTS: With a median follow up of 12 months (range 0.7-29.5), 3 patients (7.5%) died and 22 patients(55%) had Progressive Disease (PD). The median time of duration of Abiraterone therapy was 8.33:months (range 1-20), and median PFS was 10.3 months (range 1.4-18.7). Results showed that four parameters were associated with a better PFS: response to docetaxel (p=0.031), baseline PSA (p=0.014), baseline Hb (p=0.008), and PSA reduction >25%. Univariate analysis confirmed the statistically significant effect of baseline PSA (p=0.027), Baseline Hb (p=0.016) and PSA reduction >25% (p=0.017). At the multivariate analysis, only baseline Hb > 10 mg/dl (p=.0.038) and PSA reduction >25% (p=0.002) remained significant. Of note, no difference was noted in terms of PFS (p=0.17) and OS (p=0.91) between patients treated with concomitant LH RH agonist or LH RH antagonist. Overall, treatment was well tolerated 5 patients (12.5%) interrupted therapy. Two patients due to cardiovascular events (1 NSTEMI, 1 arythmia), one patient had intestinal occlusion, one patienthad Herpetic dermatitis, and one had diffuse atopic erythema.
Eur Urol Suppl 2016; 15(13);e1678
8th European Multidisciplinary Meeting on Urological Cancers, 24-27 November 2016, Milan, Italy
P095
Post docetaxel abiraterone in patients with mCRPC: Efficacy, safety and prognostic factors Eur Urol Suppl 2016; 15(13);e1679
CONCLUSIONS: Our data show the safety and activity of AA and confirm the findings of the postdocetaxel pivotal trial in the patients as a whole population.Relationship between baseline PSA and treatment response makes it necessary to begin this therapy as early as possible in mCRPC. AA was a well tollerated therapy: no unexpected adverse events were found during the treatment.
Eur Urol Suppl 2016; 15(13);e1679 Powered by TCPDF (www.tcpdf.org)
P095
Post docetaxel abiraterone in patients with mCRPC: Efficacy, safety and prognostic factors Eur Urol Suppl 2016; 15(13);e1678
Detti B., Becherini C., Francolini G., Olmetto E., Topulli J., Trombetta L., Loi M., Baldazzi V., Livi L. Aou Careggi, Dept. of Radiation Oncology, Florence, Italy INTRODUCTION & OBJECTIVES: A significant percentage of patients with mCRPC progress after an initial response to treatment withLH-RH. Recent data suggest that the Androgen Receptor (AR) signalling pathway remains a keydriver of prostate cancer progression despite castrate levels of testosterone in advanced disease. Various drugs have been shown to benefit patients with mCRPC;the therapeutic approach is complex and less clear than in the past. Abiraterone is a potent, selective and irreversible inhibitor of CYP17, a key enzyme in the androgen and estrogen synthesis process, which has been shown to significantly prolong overall survival (OS) of patients with mCRPC, in post and in pre docetaxel setting. The aim of our retrospective study is to evaluate the efficacy and the safety of abiraterone in our patients affected by mCRPC and try to find predictive factors of response to treatment. MATERIAL & METHODS: We report data about 40 patients affected by mCRPC, progressed after a first line chemotherapy with docetaxel, treated with Abiraterone Acetate (AA) from September 2012 to January 2015. Abiraterone was administered at the standard dose of 1000 mg/day, given concurrently with prednisone 5 mg twice daily. 24 patients (60%) underwent concomitant hormonal therapy with LH RH agonist, while 16 patients (40%) with LH RH antagonists.All patient received a first line chemotherapy with docetaxel; 27 patients recived AA as a secondline therapy. Only 4 patients presented visceral metastases; the other had a bone/lymphonode involvement. We evaluated PFS defined as the time from beginning of AA to either biochemical or radiographic progression according to PCWGC 2. Other outcomes reported are PSA response and Adverse Events (AE), defined as any AE that requested suspension or interruption of AA therapy. RESULTS: With a median follow up of 12 months (range 0.7-29.5), 3 patients (7.5%) died and 22 patients(55%) had Progressive Disease (PD). The median time of duration of Abiraterone therapy was 8.33:months (range 1-20), and median PFS was 10.3 months (range 1.4-18.7). Results showed that four parameters were associated with a better PFS: response to docetaxel (p=0.031), baseline PSA (p=0.014), baseline Hb (p=0.008), and PSA reduction >25%. Univariate analysis confirmed the statistically significant effect of baseline PSA (p=0.027), Baseline Hb (p=0.016) and PSA reduction >25% (p=0.017). At the multivariate analysis, only baseline Hb > 10 mg/dl (p=.0.038) and PSA reduction >25% (p=0.002) remained significant. Of note, no difference was noted in terms of PFS (p=0.17) and OS (p=0.91) between patients treated with concomitant LH RH agonist or LH RH antagonist. Overall, treatment was well tolerated 5 patients (12.5%) interrupted therapy. Two patients due to cardiovascular events (1 NSTEMI, 1 arythmia), one patient had intestinal occlusion, one patienthad Herpetic dermatitis, and one had diffuse atopic erythema.
Eur Urol Suppl 2016; 15(13);e1678
8th European Multidisciplinary Meeting on Urological Cancers, 24-27 November 2016, Milan, Italy
P095
Post docetaxel abiraterone in patients with mCRPC: Efficacy, safety and prognostic factors Eur Urol Suppl 2016; 15(13);e1679
CONCLUSIONS: Our data show the safety and activity of AA and confirm the findings of the postdocetaxel pivotal trial in the patients as a whole population.Relationship between baseline PSA and treatment response makes it necessary to begin this therapy as early as possible in mCRPC. AA was a well tollerated therapy: no unexpected adverse events were found during the treatment.
Eur Urol Suppl 2016; 15(13);e1679 Powered by TCPDF (www.tcpdf.org)