Comments on “Abiraterone acetate plus prednisolone for metastatic patients starting hormone therapy: 5‐year follow‐up results from the STAMPEDE randomised trial (NCT00268476)”

Several systemic agents showed significant prolongation of overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC), and these drugs have been initially approved in that setting. 1 Subsequently, combinations of androgen-deprivation therapy (ADT) with chemotherapy or novel androgen-receptor signaling inhibitors (ARSi) demonstrated effi-cacy in the earlier setting of metastatic hormone-sensitive prostate cancer (mHSPC). The clinical validity of early treatment intensification has been recently confirmed by trials involving triplets with ADT, chemotherapy and ARSi in mHSPC, 2,3 and by the use of ADT plus ARSi in nonmetastatic castration-resistant prostate cancer (nmCRPC). James and colleagues recently reported updated results regarding the use of abiraterone acetate in patients with mHSPC enrolled in the STAMPEDE platform. 4 Adjusted hazard ratio (HR) favored abiraterone (0.60; 95% CI: 0.50-0.71) and 5-years survival improved from 41% of standard-of-care (SOC) alone to 60% of SOC plus abiraterone. Of note, estimated median survival was 46 months in the SOC-alone group and 79 months in the SOC plus abiraterone group (median gain in OS of 33 months). HRs are the most widely used parameter to design and inter-pret survival benefit in clinical trials. However, they are a relative measure. Median absolute gain in OS can be used to indirectly com-pare the overall impact of treatments in different settings, and represents a good indicator of clinical benefit. 5 The same HR translates in greater OS prolongation if the median OS of control arm is longer. In the present correspondence, we highlight that the median gain in OS (calculated as the difference in median OS between study arms) better represents clinical benefit that is pro-vided by approved drugs in patients with