Efficacy of Upfront Docetaxel With Androgen Deprivation Therapy for Castration-Sensitive Metastatic Prostate Cancer Among Minority Patients

Abstract

Background: Upfront docetaxel (UD) with androgen deprivation therapy (ADT) has been demonstrated to improve survival outcomes in metastatic castration-sensitive prostate cancer (mCSPC). However, existing studies have included predominantly Caucasian patients. Study Question: To compare the efficacy of addition of UD to ADT in mCSPC to ADT alone among minority patients. Study Design: Retrospective study of mCSPC patients. Measures and Outcomes: Patients treated with UD and ADT between January 2014 and December 2017 (UD + ADT, n = 44) were compared with those treated with ADT alone between January 2008 and January 2017 (ADT, n = 38); patients of Caucasian ethnicity were excluded. The outcome of interest was progression-free survival (PFS), which was estimated using Kaplan–Meier analysis and Cox proportional hazard analysis. Results: Overall, 63 (76.8%) patients were African American and 16 (19.5%) were Hispanic. Fifty-five (67%) patients had high-volume mCSPC. The median follow-up was 14 months [95% confidence interval (CI): 10.4–16.5] for UD + ADT and 42 months (95% CI: 17–66.9) for ADT. Median PFS did not differ between groups: UD + ADT: 16 versus ADT: 18 months [hazard ratio (HR) for UD + ADT = 0.88, 95% CI: 0.48–1.62; P = 0.70]. In patients with high-volume disease, median PFS remained similar (UD + ADT: 16 vs. ADT: 14 months (HR for UD + ADT = 0.64, 95% CI: 0.33–1.25; P = 0.19). On multivariable analysis, prolonged time to nadir PSA, HR = 0.83 (95% CI: 0.76–0.90), was independently associated with PFS. The most common toxicities in UD + ADT were anemia and fatigue. Major limitations include small sample size and potential for selection bias due to the retrospective study design. Conclusions: In this retrospective review of a minority mCSPC cohort, UD + ADT was not associated with improved PFS compared with ADT alone. Although further study with larger sample size is needed, these results underscore the importance of ensuring accrual of minorities in clinical trials, reflective of the real-world setting.

Real World Evaluation of Upfront Docetaxel in Metastatic Castrate Sensitive Prostate Cancer

“…To our knowledge, this is the rst study that systematically reports the real world outcome of upfront docetaxel in a Scandinavian context. Other real world studies, conducted in other countries and/or ethnical groups, largely corroborate our ndings; Lavoie et al assessed the clinical effectiveness of upfront docetaxel in a Canadian setting, showing a similar outcome and safety data to ours with 12 months OS of 91% and 26% experiencing a grade 3-4 febrile neutropenia [16], and comparable outcomes were also reported in a German study [17] and in Northern American non-white populations [18] The main strengths of the present study include the truly real world setup, covering all eligible patients in a reasonably large geographical region. As there are no non-governmental healthcare providers offering cancer chemotherapy in the South East Region in Sweden, every patient that was given the therapy and met the inclusion criteria were included.…”

Real-world evaluation of upfront docetaxel in metastatic castration-sensitive prostate cancer

“…Other real-world studies conducted in other countries and/or ethnic groups corroborate the results of this study. Lavoie et al [ 16 ] assessed the clinical effectiveness of upfront docetaxel in a Canadian setting, showing a similar outcome and safety data to those of this study, with 12-mo OS of 91% and 26% experiencing grade 3–4 febrile neutropenia[ 16 ], and comparable outcomes were also reported in a German study[ 17 ] and in Northern American non-white populations[ 18 ].…”

Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry

“…In particular, the inclusion and exclusion criteria may lead to under-representation of certain patient subgroups, such as patients with comorbidities or challenging disease characteristics, who are more difficult to treat [ 12 ]. Ethnic representation in RCTs may also differ from real-world settings, which can affect outcomes [ 13 ]. This may contribute to an overestimation of clinical benefit and underestimation of toxicity of therapies evaluated in RCTs [ 12 ].…”