813PReal-world use of docetaxel for metastatic castration-resistant prostate cancer in China: Results from a large observational study

Background: This study investigated real-world patterns of docetaxel use for metastatic castration-resistant prostate cancer (mCRPC) in China. Methods: A prospective, multi-centre, observational study of Chinese adults (≥18 years) with histologically confirmed metastatic prostate adenocarcinoma who received ≥1 dose of docetaxel following hormonal therapy failure (disease progression and serum testosterone <50 ng/dL). The primary endpoint was patterns of docetaxel use. Secondary endpoints included median overall survival (mOS), prostate-specific antigen (PSA) response rate (RR) and reasons for docetaxel discontinuation. Variables are summarised as mean (SD) unless specified. All patients provided written informed consent. Results: From August 2011 to June 2016, 403 patients were enrolled at 32 centres and 315 (78.2%) completed the study. The mean number of docetaxel cycles and dose were 4.4 (2.86) and 66.9 mg/m2 (9.12), and treatment compliance was 94.0% (10.94%). mOS was similar for docetaxel after 1st- or 2nd-line hormonal therapy (Table), and was longer in patients without visceral metastases versus those with visceral metastases (23.3 months vs. 17.4 months, P = 0.019). Planned docetaxel treatment was completed by 30.8% (124) of patients; the most common reasons for discontinuation were ‘other reasons’ (23.3% [94]), cost of medical expenses (22.6% [91]), and tumor progression (14.1% [57]). Treatment-emergent AEs (TEAEs) occurred in 20.8% (84), and serious TEAEs in 4% (16), of patients.Table813PPattern of use of docetaxel in Chinese patients with mCRPCn (%)Median overall survival, months (95% CI)PSA response rate, % (n/naDenominator is the number of patients in each category who had PSA ≥20 ng/ml at baseline;)All patients403 (100)22.4 (20.4, 25.8)70.9 (168/237)After failure of 1st-line hormonal therapy170 (42.2)22.5 (19.2, 29.5)bp = 0.781 for median overall survival with initiation of docetaxel following failure of 1st- and 2nd-line hormonal therapy. mCRPC, metastatic castration-resistant prostate cancer; PSA, prostate specific antigen.73.6 (64/87)After failure of 2nd-line hormonal therapy125 (31.0)23.3 (18.1, 26.5)bp = 0.781 for median overall survival with initiation of docetaxel following failure of 1st- and 2nd-line hormonal therapy. mCRPC, metastatic castration-resistant prostate cancer; PSA, prostate specific antigen.67.1 (55/82)After failure of ≥ 3rd-line hormonal therapy51 (12.7)22.4 (19.0, 36.5)65.4 (17/26)After failure of estramustine therapy46 (11.4)20.2 (16.6, 27.7)69.7 (23/33)Other11 (2.7)28.6 (17.5, not evaluable)100.0 (9/9)a Denominator is the number of patients in each category who had PSA ≥20 ng/ml at baseline;b p = 0.781 for median overall survival with initiation of docetaxel following failure of 1st- and 2nd-line hormonal therapy. mCRPC, metastatic castration-resistant prostate cancer; PSA, prostate specific antigen. Open table in a new tab Conclusions: Around three-quarters of Chinese mCRPC patients treated with docetaxel initiate treatment after failure of 1st- or 2nd-line hormonal therapy and mOS and PSA RR are similar in both settings. Docetaxel was relatively well tolerated. Legal entity responsible for the study: Sanofi-Aventis Funding: Sanofi-Aventis Disclosure: All authors have declared no conflicts of interest.