Volume 15, Issue 6 (November 2013) 15, 773–779; 10.1038/aja.2013.89
Intermittent tri-weekly docetaxel plus bicalutamide in patients with castration-resistant prostate cancer: a single-arm prospective study using a historical control for comparison
Yun-Fei Li1,2,*, Shao-Feng Zhang2,*, Tao-Tao Zhang2, Lei Li1, Wei Gan2, Hong-Tao Jia2, Sheng Xie2, Hui-Hua Ji2 and Da-Lin He1
1Department of Urology, First Hospital of Xi'an Jiaotong University, Xi'an 710061, China 2Department of Urology, Affiliated People's Hospital of Hubei Medical University, Shiyan 442000, China
Correspondence: Professor DL He, (urologist02@yahoo.cn)
Received 21 March 2013; Revised 11 May 2013; Accepted 9 June 2013 Advance online publication 19 August 2013
Abstract |
Whether continuous docetaxel (DTX) chemotherapy offers an advantage over intermittent therapy for castration-resistant prostate cancer (CRPC) is unknown. In this study, we evaluated the efficacy, toxicity and quality of life (QoL) of intermittent tri-weekly DTX with bicalutamide in CRPC. Forty-two patients (group A) with CRPC were enrolled. The patients received intravenous DTX (75 mg m−2) once tri-weekly with oral bicalutamide (50 mg) once daily. Patients had a DTX holiday when the prostate-specific antigen (PSA) level declined ≥50%. DTX was restarted in patients with a PSA increase ≥25%. Sixty patients (group B) who had matching characteristics and had continuously received DTX without bicalutamide for 10–12 cycles were also enrolled. There were no statistically significant differences in progression-free survival (8 months vs. 9 months, P=0.866) or overall survival (19 months vs. 21 months, P=0.753) between groups A and B; however, the proportions of patients in group A with all grades of neutropenia (33% vs. 58%, P=0.013) and nausea/vomiting (11% vs. 29%, P=0.024) were significantly less compared to group B. A significant improvement in the global health and fatigue scores was recorded for group A post-chemotherapy compared to pre-chemotherapy (P<0.05). The fatigue, nausea/vomiting and appetite loss scores in group B were increased post-chemotherapy compared to pre-chemotherapy (P<0.05). In conclusion, intermittent tri-weekly DTX plus bicalutamide is well tolerated and has the potential to achieve comparable disease control with an improvement in QoL for patients with CRPC.
Keywords: androgen; chemotherapy; docetaxel; prostate cancer; safety
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