Long-term results of a phase II study with neoadjuvant docetaxel chemotherapy and complete androgen blockade in locally advanced and high-risk prostate cancer

摘要: Patients with locally advanced and high-risk prostate cancer (LAPC) are prone to experience biochemical recurrence despite radical prostatectomy (RP). We evaluated feasibility, safety activity of a neoadjuvant chemohormonal therapy (NCHT) 3-weekly full dose docetaxel complete androgen blockade (CAB) in patients undergoing RP. (n = 30) were selected by Kattans’ preoperative score received trimestral buserelin 9,45 mg, bicalutamide 50 mg/day 3 cycles (75 mg/m2) followed Primary endpoints (PSA) local downstaging. Secondary included toxicity operability assessments, pathological response (pCR), time PSA progression, 5-year free survival (bRFS) overall (OS). Median baseline was 25.8 ng/ml (2.1–293), the predicted probability bRFS 10% (0–55). NCHT induced PSA-reduction 97.3% (81.3-99.9%; p < 0.001) post-RP 96.7% responders, undetectable PSA-values. Post- vs. pretreatment MRI indicated median tumor volume reduction 46.4% (−31.3-82.8; p < 0.001). A downstaging observed 48.3%. Severe hematologic toxicities (≥CTC3) frequent 53.8% leucopenia, 90% neutropenia 13.3% febrile neutropenia. RP performed all patients. While resectability hindered 26.7%, continence achieved 96.7%. Pathologic analyses revealed no pCR. Lymph node- extracapsular involvement 36.7% 56.7% 33.3% positive surgical margins. After 48.6 (19.9-87.8) months, 55.2% responders experienced PSA-recurrence. The estimated PSA-progression 38.6 months (95%CI 30.9-46.4) 85.3 months 39.3–131.3) for OS. improved 40%, but limiting interpretation adjuvant treatment individualized. is feasible high hematotoxicity, excellent functional results. Significant without seems improve cohort adjusted bRFS, clinical value needs further investigation randomized trials.