Highlights from

EAU 2020

European Association of Urology annual congress

Virtual 17-19 July 2020

Docetaxel + hormonal therapy: improved prostate cancer PFS

Adding docetaxel to antiandrogen treatment improves progression-free survival (PFS) in prostate cancer patients with prostate-specific antigen (PSA) relapse.

Dr Andreas Josefsson (Sahlgrenska University Hospital, Göteborg, Sweden) presented the SPCG-14 study, a prospective, multicentre, phase 2 clinical trial of bicalutamide alone or with the addition of docetaxel in nonmetastatic prostate cancer with a rising PSA [1]. This trial assessed whether any benefit is gained by adding docetaxel-based chemotherapy to hormonal therapy alone in the population of prostate cancer patients who have only biochemically relapsed disease after curative treatment (PSA doubling time is <12 months). The investigators hypothesised further that the approach is likely to be more effective at a time of minimal tumour burden, prior to radiographic relapse, resulting in minimisation of the overall burden of therapy and better quality of life while on treatment.

A total of 345 patients were randomised 1:1. The control arm (n=174) received antiandrogen (bicalutamide 150 mg once daily) alone. The experimental arm (n=171) received treatment with docetaxel (75 mg/m2 every 3 weeks) for 10 cycles and antiandrogen (bicalutamide 150 mg once daily) treatment. The median participant age was 68 years and the majority of patients had Gleason grade ≤7 (73%) with 26% having Gleason grade ≥8. The primary endpoint was PFS, defined as a PSA of >2 mg/mL above nadir, metastasis, or death due to any cause.

With a median follow-up of 36 months, 5-year progression occurred in 46% of all patients; 15% developed metastatic disease and 10% of patients died. Among those with no progression, median follow-up was 47 months. The primary endpoint was met; improved PFS was reached by patients receiving bicalutamide plus docetaxel as compared with bicalutamide alone (HR 0.72; 95% CI 0.52-0.99; P=0.041). There were no differences between subgroups of patients based on prior curative-intent treatment, PSA doubling time <6 months, or based on age.

With regard to safety outcomes, toxicity was substantial. The most common serious adverse event was febrile neutropenia (26%). Notably, 62% participants in the investigation arm terminated docetaxel treatment as a result of adverse events or serious adverse events.

In the era of apalutamide, darolutamide, and enzalutamide, where demonstrated effects on metastasis-free survival and/or overall survival have been recently reported, the current data showing improvement in PFS may not appear practice changing. However, the wide access of docetaxel does place this regimen, with strong clinical evidence, as an acceptable option for some situations.

  1. Josefsson AS, et al. A prospective randomised study of bicalutamide +/- docetaxel for non-metastatic prostate cancer with a rising PSA (SPCG-14). EAU20 Virtual Congress, 17-26 July 2020, Game-changing Session 4.

Top image: © Mohammed Haneefa Nizamudeen

The content and interpretation of these conference highlights are the views and comments of the speakers/authors.