A prospective real life study evaluating abiraterone Acetate Plus Prednisone (AAP) for Metastatic Castration Resistant Prostate Cancer (mCRPC) (Abitude Study)

Sciarra, A.; Scarcia, Marcello; Cindolo, Luca; Verze, Paolo; Salciccia, Stefano; Ludovico, Giuseppe Mario; Castellan, Pietro; Battaglia, Michele; Carrieri, G.; Cicalese, V.; Lisa, Antonello De; Uricchio, Francis J.; Livi, Lorenzo; Santini, Daniele; Procopio, Giuseppe; Beccaglia, Patrizia; Gallucci, M.; Mirone, Vincenzo

doi:10.1016/s1569-9056(18)33248-2

Cited by 2 publications

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“…ABItude is an ongoing study, and in the first planned interim analysis (~9 months median follow-up) abiraterone was active and safe in an elderly population with a high level of comorbidities. 31 The 1-year rPFS was ~74% and adverse reactions occurred in 10% of patients, the vast majority being nonserious. In addition, abiraterone delayed functional decline and improved HRQoL and pain palliation.…”

Section: Introductionmentioning

confidence: 96%

Effectiveness of abiraterone acetate plus prednisone in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer in a large prospective real-world cohort: the ABItude study

et al. 2020

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Background: Real-world data on chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone plus prednisone are limited, largely deriving from small retrospective studies. Methods: ABitude is an Italian, observational, prospective, multicenter study of mCRPC patients receiving abiraterone plus prednisone in clinical practice. Chemotherapy-naïve mCRPC patients were consecutively enrolled at abiraterone start (February 2016 to June 2017) and are being followed for 3 years, with evaluation approximately every 6 months. Several clinical and patients reported outcomes were examined. Results: In this second interim analysis, among 481 enrolled patients, 453 were evaluable for analyses. At baseline, the median age was 77 years and ~69% of patients had comorbidities (mainly cardiovascular diseases). Metastases were located mainly at bones and lymph nodes; 8.4% of patients had visceral metastases. During a median follow-up of 18 months, 1- and 2-year probability of radiographic progression-free survival were 73.9% and 56.2%, respectively; the corresponding rates for overall survival were 87.3% and 70.4%. In multivariable analyses, the number of bone metastases significantly affected radiographic progression-free survival and overall survival. During abiraterone plus prednisone treatment, 65% of patients had a ⩾50% prostate-specific antigen decline, and quality of life remained appreciably high. Among symptomatic patients according to the Brief Pain Inventory) (32%), scores significantly declined after 6 months of treatment. Overall, eight patients (1.7%) had serious adverse reactions to abiraterone. Conclusions: Abiraterone plus prednisone is effective and safe for chemotherapy-naïve mCRPC patients in clinical practice.

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Section: Introductionmentioning

confidence: 96%