title: A randomized controlled study of single-agent cisplatin and radiotherapy versus docetaxel/cisplatin and radiotherapy in high-risk early-stage cervical cancer after radical surgery.
abstract: BACKGROUND
  This study explored whether docetaxel/cisplatin and radiotherapy (TP-R) increases overall survival (OS) and recurrence-free survival (RFS) compared to single-agent cisplatin and radiotherapy (C-R) in patients with high-risk early-stage cervical cancer post surgery.
  
  
  METHODS
  Patients with clinical stage IB and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or the diameter of the primary tumor ≥4 cm and/or depth of interstitial infiltration ≥1/2 and/or lymphovascular space invasion were eligible for this study. Patients were randomized to receive C-R or TP-R. Radiotherapy in both groups was external radiation (46-54 Gy) followed by high-dose rate brachytherapy (12-24 Gy). Patients were given cisplatin (40 mg/m(2)) every week for five cycles (C-R group) or docetaxel (30 mg/m(2)) and cisplatin (30 mg/m(2)) every week for five cycles (TP-R group).
  
  
  RESULTS
  Between 2003 and 2008, 320 patients were entered onto the study. Final analyses included 285 patients. One hundred and forty patients comprised the C-R group and 145 were in the TP-R group. The 5-year OS were 74.3 % in the C-R group and 82.8 % in the TP-R group. The hazard ratio (HR) for death was 0.65 in the TP-R group (95 % CI: 0.39-1.09, P = 0.098). The RFS were 69.3 % in the C-R group and 79.3 % in the TP-R group, and the HR for recurrence was 0.64 in the TP-R group (95 % CI: 0.40-1.03, P = 0.061). Recurrence rates were similar in both groups (27 in the C-R group and 18 in the TP-R group, P = 0.112). The seriousness of late side effects was similar in the two groups, with a higher rate of reversible hematological effects in the TP-R group.
  
  
  CONCLUSIONS
  Compared with single-agent cisplatin and radiotherapy, docetaxel/cisplatin in combination with radiotherapy does not increase OS but has the trend of increasing RFS in patients with high-risk early-stage cervical cancer. However, docetaxel/cisplatin in combination with radiotherapy is associated with a higher incidence of side effects, this effect was reversible, and the incidence of late side effects was similar in the two treatment groups.
authors: Department of Radiation Oncology, Lianshui County People's Hospital, Huai'an 223300, Jiangsu, People's Republic of China.
authors: Juan
authors: J
authors: Pu
authors: Shan-shan
authors: SS
authors: Qin
authors: Jin-xia
authors: JX
authors: Ding
authors: Yan
authors: Y
authors: Zhang
authors: Wei-guo
authors: WG
authors: Zhu
authors: Chang-hua
authors: CH
authors: Yu
authors: Tao
authors: T
authors: Li
authors: Guang-zhou
authors: GZ
authors: Tao
authors: Fu-zhi
authors: FZ
authors: Ji
authors: Xi-lei
authors: XL
authors: Zhou
authors: Ji-hua
authors: JH
authors: Han
authors: Ya-lin
authors: YL
authors: Ji
authors: Jun-xia
authors: JX
authors: Sun
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007044:Hysterectomy; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D009367:Neoplasm Staging; D011379:Prognosis; D050397:Radiotherapy, Intensity-Modulated; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D002583:Uterine Cervical Neoplasms / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D055815:Young Adult
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin