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Simple Summary: Radical prostatectomy, the standard treatment for localized or locally advanced prostate cancer, generally provides good disease control and favorable long-term survival. However, about 40% of patients experience biochemical recurrence, and a significant number of them develop clinical progression. If identified in advance, those patients could receive specially tailored follow-up and counseling. Current guidelines recommend the first prostate-specific antigen tests three months after surgery, but prostate-specific antigen levels should be undetectable within four weeks. Early testing at 4–8 weeks after surgery could thus be useful for determining patient prognosis. We reviewed the medical literature to study persistence of prostate-specific antigens, progression of prostate cancer, and survival of patients. We found that prostate cancer was more likely to recur in patients with or without lymph nodal involvement who had prostate-specific antigen persistence at 4–8 weeks. We performed a systematic review and meta-analysis to assess the prognostic value of prostate-specific antigen (PSA) persistence 4–8 weeks after radical prostatectomy (RP) in patients with prostate cancer, using studies from Medline, Scopus, and Cochrane Library, on 10 October 2020. Studies were eligible if they compared patients with postoperative PSA persistence 4–8 weeks after RP to those without such persistence to assess the value of PSA persistence in prognosticating biochemical recurrence (BCR), disease recurrence, cancer-specific mortality (CSM), and overall mortality (OM) by multivariable analysis. Our review and analysis included nine studies published between 2008 and 2019 with 14,455 patients. Of those studies, 12.0% showed postoperative PSA persistence. PSA persistence was associated with BCR (HR: 4.44, 95% CI: 2.84–6.93), disease recurrence (HR: 3.43, 95% CI: 1.62–7.25), and CSM (HR: 2.32, 95% CI: 1.83–2.95). We omitted meta-analysis on the association of PSA persistence with OM due to an insufficient number of studies. PSA persistence was associated with disease recurrence in a sub-group of patients with pathological nodal involvement (HR: 5.90, 95% CI: 3.76–9.24). Understanding detection of PSA persistence at 4–8 weeks after RP might be useful for patient counseling, follow-up scheduling, and clinical decision-making regarding adjuvant therapies. [ABSTRACT FROM AUTHOR]

Aim Breast International Group (BIG) 2–98 is a randomised phase III trial that tested the effect of adding docetaxel, either in sequence to or in combination with anthracycline-based adjuvant chemotherapy, in women with node-positive breast cancer (BC). Here, we present the 10-year final trial safety and efficacy analyses. We also report an exploratory analysis on the predictive value of Ki67 for docetaxel efficacy, in the BIG 2–98 and using a pooled analysis of three other randomised trials. Patients and methods 2887 patients were randomly assigned in a 2 × 2 trial design to one of four treatments. The primary objective was to evaluate the overall efficacy of docetaxel on disease free survival (DFS). Secondary objectives included comparisons of sequential docetaxel versus sequential control arm, safety and overall survival (OS). Ki67 expression was centrally evaluated by immunohistochemistry. Results After a median follow-up of 10.1 years, the addition of docetaxel did not significantly improve DFS or OS (hazard ratio (HR) = 0.91, 95% confidence interval (CI) = 0.81–1.04; P = 0.16 and HR = 0.88, 95% CI = 0.76–1.03; P = 0.11, respectively). Sequential docetaxel did not improve DFS compared to the sequential control arm (HR = 0.86, 95% CI = 0.72–1.03; P = 0.10). In oestrogen receptor (ER)-positive tumours with Ki67 ⩾ 14%, the addition of docetaxel resulted in 5.4% improvement in 10-year OS ( P = 0.03, test for interaction = 0.1). In a multivariate model, there was a trend for improved DFS and OS in ER-positive patients with high Ki67 and treated with docetaxel (HR = 0.79, 95% CI = 0.63–1.01; P = 0.05 and HR = 0.76, 95% CI = 0.57–1.01; P = 0.06, respectively). A pooled analysis of four randomised trials showed a benefit of taxanes in highly proliferative ER-positive disease but not in low proliferating tumours (interaction test P = 0.01). Conclusion The DFS benefit previously demonstrated with sequential docetaxel is no longer observed at 10 years. However, an exploratory analysis suggested a benefit of docetaxel in patients with highly proliferative ER-positive BC. [ABSTRACT FROM AUTHOR]