title: Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102).
abstract: BACKGROUND
  A phase III trial was conducted to determine whether neoadjuvant chemotherapy (NACT) before radical surgery (RS) improves overall survival.
  
  
  METHODS
  Patients with stage IB2, IIA2, or IIB squamous cell carcinoma of the uterine cervix were randomly assigned to receive either BOMP (bleomycin 7 mg days 1-5, vincristine 0.7 mg m(-2) day 5, mitomycin 7 mg m(-2) day 5, cisplatin 14 mg m(-2) days 1-5, every 3 weeks for 2 to 4 cycles) plus RS (NACT group) or RS alone (RS group). Patients with pathological high-risk factors received postoperative radiotherapy (RT). The primary end point was overall survival.
  
  
  RESULTS
  A total of 134 patients were randomly assigned to treatment. This study was prematurely terminated at the first planned interim analysis because overall survival in the NACT group was inferior to that in the RS group. Patients who received postoperative RT were significantly lower in the NACT group (58%) than in the RS group (80%; P=0.015). The 5-year overall survival was 70.0% in the NACT group and 74.4% in the RS group (P=0.85).
  
  
  CONCLUSIONS
  Neoadjuvant chemotherapy with BOMP regimen before RS did not improve overall survival, but reduced the number of patients who received postoperative RT.
authors: Department of Medical Oncology, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan. nkatsuma@nms.ac.jp
authors: N
authors: N
authors: Katsumata
authors: H
authors: H
authors: Yoshikawa
authors: H
authors: H
authors: Kobayashi
authors: T
authors: T
authors: Saito
authors: K
authors: K
authors: Kuzuya
authors: T
authors: T
authors: Nakanishi
authors: T
authors: T
authors: Yasugi
authors: N
authors: N
authors: Yaegashi
authors: H
authors: H
authors: Yokota
authors: S
authors: S
authors: Kodama
authors: T
authors: T
authors: Mizunoe
authors: M
authors: M
authors: Hiura
authors: T
authors: T
authors: Kasamatsu
authors: T
authors: T
authors: Shibata
authors: T
authors: T
authors: Kamura
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use; D001761:Bleomycin / Q000008:administration & dosage / Q000627:therapeutic use; D001918:Brachytherapy; D002294:Carcinoma, Squamous Cell / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D007044:Hysterectomy / Q000379:methods; D007564:Japan; D008495:Medical Oncology / Q000458:organization & administration; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000627:therapeutic use; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D014750:Vincristine / Q000008:administration & dosage / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D001761:Bleomycin; D016685:Mitomycin; D014750:Vincristine; D002945:Cisplatin
references: Obstet Gynecol. 1974 Aug;44(2):265-72
references: 4417035
references: Int J Radiat Oncol Biol Phys. 2000 Apr 1;47(1):13-47
references: 10758303
references: Eur J Cancer. 2003 Nov;39(17):2470-86
references: 14602133
references: J Obstet Gynaecol Res. 2006 Jun;32(3):315-23
references: 16764623
references: Gynecol Oncol. 2008 Sep;110(3):308-15
references: 18606439
references: Gynecol Oncol. 1997 Oct;67(1):61-9
references: 9345358
references: J Clin Oncol. 2004 Aug 1;22(15):3113-9
references: 15284262
references: Eur J Gynaecol Oncol. 2003;24(1):51-9
references: 12691318
references: J Clin Oncol. 1997 Jan;15(1):165-71
references: 8996138
references: J Clin Oncol. 1998 May;16(5):1869-78
references: 9586903
references: Gynecol Oncol. 2007 Oct;107(1):4-13
references: 17905140
references: Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007406
references: 20091632
references: Biometrics. 1982 Mar;38(1):163-70
references: 7082758
references: Gynecol Oncol. 2007 Aug;106(2):362-9
references: 17493669
references: J Clin Oncol. 2005 Jun 20;23(18):4137-45
references: 15961761
references: J Clin Oncol. 2005 Jul 20;23(21):4626-33
references: 15911865
references: J Clin Oncol. 2000 Apr;18(8):1606-13
references: 10764420
references: Gynecol Oncol. 2010 Nov;119(2):212-6
references: 20709382
references: Stat Med. 1993 Aug;12(15-16):1501-11; discussion 1513-7
references: 8248659
references: Int J Gynaecol Obstet. 2009 May;105(2):107-8
references: 19342051
references: J Natl Cancer Inst. 2000 Feb 2;92(3):205-16
references: 10655437