Efficacy and safety of docetaxel plus hormone therapy in metastatic prostate cancer / 中华泌尿外科杂志

ABSTRACT

Objective:To evaluate the efficacy and safety of docetaxel plus hormone therapy in metastatic prostate cancer.Methods:From April 2016 to April 2019, 204 cases with bone metastatic prostate cancer in the Second Hospital of Tianjin Medical University were analyzed retrospectively. There were 97 patients responded to hormone therapy including 92 cases with high-burden metastasis (more than 4 bone metastases with one or more beyond the axial skeleton) and 5 cases with low-burden metastasis, with average age of 70 years (range 42-87 years) and median prostate specific antigen (PSA) of 74.1 ng/ml (range 11.0-145.0 ng/ml). Among them, there were 35 patients (36.1%) with a Gleason score of 7 or lower, and 62 patients (63.9%) with a Gleason score of 8 or higher. There were 26 patients suffering from bone pain, with average numerical rating scales(NRS) score of 3.7. In addition, there were 107 patients being resistant to hormone therapy, with average age of 73 years (range 56-83 years), and median PSA of 84.5 ng/ml (range 12.4-490.2 ng/ml), including 32 patients (29.9%) with a Gleason score of 7 or lower, and 75 patients (70.1%) with a Gleason score of 8 or higher. Among them, there were 75 patients suffering from bone pain, with average NRS score of 5.4. All patients received continuous hormone therapy combined with docetaxel (at a dose of 75 mg per square meter of body-surface area every 3w, plus prednisone 5 mg twice a day), and PSA progression-free survival (PSA-PFS), NRS score, pain relief, and adverse events were analyzed. Additional analysis of the correlation between PSA-PFS and subgroups with age, PSA level and Gleason score were performed.Results:For patients with metastatic hormone sensitive prostate cancer (mHSPC), 6 (6.2%) cases only received 1-2 cycles of chemotherapy due to different reasons, and the others received 3-6 cycles(average 4.7)with the median follow-up of 15 months. Of patients who received ≥3 cycles, there were 36 cases presenting PSA progression, with the median PSA-PFS of 22 months, average NRS score decline from 3.9 to 3.0, and pain relief rate of 72.0%(18/25). For patients with metastatic castration-resistant prostate cancer (mCRPC), 9 (8.4%)cases only received 1-2 cycles of chemotherapy, and the others received 3-14 cycles (average 5.6). Of patients who received≥3 cycles, there were 51 cases with PSA progression, with the median PSA-PFS of 11 months, average NRS score decline from 5.6 to 4.4, and pain relief rate of 48.6%(35/72). Subgroup analysis showed a significant correlation between PSA level and PSA-PFS for patients with mCRPC( P=0.026). Age or Gleason score was not significantly correlated to PSA-PFS in mHSPC or mCRPC( P>0.05). For patients with mHSPC, grade 3 or 4 neutropenia occurred in 17 cases(17.5%), nausea and vomiting in 27 cases(27.8%), and fatigue in 25 cases(25.8%). For patients with mCRPC, grade 3 or 4 neutropenia occurred in 24 cases (22.4%), nausea and vomiting in 34 cases(31.8%), and fatigue in 26 cases(24.3%). Allergic reaction and sensory neuropathy toxicity were occasional. Conclusion:Efficacy of docetaxel plus hormone therapy was confirmed in metastatic prostate cancer and adverse events were tolerable.