title: Intermittent tri-weekly docetaxel plus bicalutamide in patients with castration-resistant prostate cancer: a single-arm prospective study using a historical control for comparison.
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.
authors: 1] Department of Urology, First Hospital of Xi'an Jiaotong University, Xi'an 710061, China [2] Department of Urology, Affiliated People's Hospital of Hubei Medical University, Shiyan 442000, China.
authors: Yun-Fei
authors: YF
authors: Li
authors: Shao-Feng
authors: SF
authors: Zhang
authors: Tao-Tao
authors: TT
authors: Zhang
authors: Lei
authors: L
authors: Li
authors: Wei
authors: W
authors: Gan
authors: Hong-Tao
authors: HT
authors: Jia
authors: Sheng
authors: S
authors: Xie
authors: Hui-Hua
authors: HH
authors: Ji
authors: Da-Lin
authors: DL
authors: He
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000813:Anilides / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016022:Case-Control Studies; D000077143:Docetaxel; D004334:Drug Administration Schedule; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage; D009919:Orchiectomy; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000601:surgery; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D014105:Tosyl Compounds / Q000008:administration & dosage
chemical_list: D000813:Anilides; D009570:Nitriles; D043823:Taxoids; D014105:Tosyl Compounds; D000077143:Docetaxel; C053541:bicalutamide; D017430:Prostate-Specific Antigen
references: Cancer Treat Res. 2002;112:1-26
references: 12481709
references: Br J Cancer. 2003 Sep 15;89(6):968-70
references: 12966410
references: N Engl J Med. 1991 Nov 7;325(19):1342-8
references: 1922236
references: Oncologist. 2005 Jun-Jul;10(6):370-81
references: 15967831
references: Am J Clin Oncol. 1984 Jun;7(3):231-9
references: 6375344
references: Cancer Res. 2001 Apr 1;61(7):2892-8
references: 11306464
references: Cancer Res. 2000 Apr 15;60(8):2132-5
references: 10786674
references: Urology. 2001 Jul;58(1):53-8
references: 11445479
references: Cancer Metastasis Rev. 2001;20(1-2):123-32
references: 11831640
references: J Clin Oncol. 2008 Jan 10;26(2):242-5
references: 18182665
references: J Urol. 1998 Jan;159(1):149-53
references: 9400459
references: Ann Oncol. 2001 Jan;12(1):23-7
references: 11249045
references: Lancet. 2003 Feb 8;361(9356):457-64
references: 12583944
references: CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90
references: 21296855
references: Clin Cancer Res. 2006 Mar 15;12(6):1665-71
references: 16551847
references: J Urol. 1995 Dec;154(6):2110-4
references: 7500470
references: Eur Urol. 2011 Jun;59(6):1066-7
references: 21531194
references: Cancer Sci. 2011 Apr;102(4):769-75
references: 21214673
references: Clin Cancer Res. 2011 Jun 15;17(12):3892-902
references: 21680545
references: Cancer. 2008 Jan 15;112(2):326-30
references: 17960793
references: Br J Cancer. 2004 Oct 18;91(8):1425-7
references: 15467765
references: N Engl J Med. 1998 Oct 8;339(15):1036-42
references: 9761805
references: Urology. 1996 Jan;47(1A Suppl):70-9; discussion 80-4
references: 8560681
references: Crit Rev Oncol Hematol. 2007 Mar;61(3):243-54
references: 17161610
references: Prostate Cancer. 2011;2011:647987
references: 22110995
references: N Engl J Med. 2004 Oct 7;351(15):1502-12
references: 15470213
references: Int J Clin Oncol. 2009 Apr;14(2):130-5
references: 19390944
references: BJU Int. 2010 Oct;106(7):974-8
references: 20230389
references: Ann Oncol. 1999 Jan;10(1):33-8
references: 10076719
references: Clin Cancer Res. 2003 Jan;9(1):370-6
references: 12538490
references: Jpn J Clin Oncol. 2010 Nov;40(11):1092-8
references: 20587613
references: Urology. 2011 Mar;77(3):682-7
references: 21256546
references: J Urol. 2008 Sep;180(3):921-7
references: 18635218
references: Am J Hosp Palliat Care. 2012 Nov;29(7):536-40
references: 22218915
references: BJU Int. 2012 Oct;110(8):1149-55
references: 22369348
references: Prostate. 2006 Nov 1;66(15):1585-91
references: 16927275
references: Nat Rev Cancer. 2001 Oct;1(1):34-45
references: 11900250