Abstract

5081 Background: To date there is no prospective survival data beyond 5 years for patients treated with ADT with or without docetaxel (D) when analyzed by well-defined baseline prognostic risk groups and treatment arms. In this updated analysis of the CHAARTED trial, we report the 8-year survival rate based on disease volume and metachronous vs. de novo metastatic disease status with ADT without or with docetaxel. Methods: An updated survival sweep was conducted in February 2022. Patients were prospectively identified by the state of metastatic disease as metachronous (prior local therapy) vs. de novo and low volume (LV) vs. high volume (HV; visceral and/or ≥4 bone metastases with one lesion beyond the vertebral bodies or pelvis) disease. Overall survival (OS) was defined as time from randomization to death or date last known alive and calculated using the Kaplan-Meier method. Results: Of the 790 patients randomized (last patient enrolled December 2012), 238 patients were still alive with a median follow up of 9.7 years for patients still alive. Median OS in the overall population was 60.4 and 47.2 mos in the ADT+ D and ADT arms respectively (Table; HR: 0.77; 95% CI: 0.65, 0.92; p=0.004). ADT+ D was associated with significantly higher 8-yr OS rate (28.5%) compared to ADT arm (15.4%; HR: 0.67; 95% CI: 0.53, 0.84; p=0.0005) in the de novo HV group (n=421). Notably, the 8-yr OS rates were almost doubled for patients with HV disease with early docetaxel (16% vs.30.2%, p<.0001) and this was seen in patients with both de novo and metachronous HV mHSPC. Conclusions: In this long-term updated analysis, ADT+D continued to demonstrate significantly improved OS in the overall population and this is still most clearly evident in patients with de novo HV mHSPC. Our findings highlight the role of baseline prognostic risk groups in predicting longer term survival and benefits from treatment intensification. Clinical trial information: NCT00309985. [Table: see text]

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