title: Phase II study of concurrent chemoradiotherapy with high-dose-rate intracavitary brachytherapy in patients with locally advanced uterine cervical cancer: efficacy and toxicity of a low cumulative radiation dose schedule.
abstract: OBJECTIVE
  A multicenter phase II trial was conducted to assess the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) with high-dose-rate intracavitary brachytherapy (HDR-ICBT) using a low cumulative prescribed dose schedule in patients with locally advanced uterine cervical cancer.
  
  
  METHODS
  The Japanese Gynecologic Oncology Group (JGOG) study JGOG1066 enrolled patients with FIGO stages III-IVA uterine cervical cancer who had no para-aortic lymphadenopathy (>10 mm) assessed by CT. Patients received definitive radiotherapy (RT) consisting of external beam whole pelvic RT and HDR-ICBT. The cumulative linear quadratic equivalent dose (EQD2) was 62-65 Gy prescribed at point A. Cisplatin 40 mg/m(2) weekly was administered concurrently with RT for 5 courses.
  
  
  RESULTS
  Of the 72 patients registered, 71 were eligible. With a median follow-up of 28 months, the 2-year progression-free survival rate and pelvic disease progression-free rate were 66% (95% CI, 54% to 76%) and 73% (95% CI, 61% to 82%), respectively. Progression-free survival decreased significantly with increased central tumor size (P=0.036). The 2-year cumulative late complication rates were 24% for all grades, 9% for grade 1, 12% for grade 2, 3% for grade 3, and 0 for grades 4/5.
  
  
  CONCLUSIONS
  The JGOG1066 demonstrated that CCRT using HDR-ICBT with a low cumulative RT dose schedule achieved comparable outcome as those achieved with global dose schedules (EQD2=85 Gy) with a lower incidence of late toxicity for locally advanced uterine cervical cancer in a Japanese population.
authors.affiliation: Department of Radiology, Graduate School of Medical Science, University of the Ryukyus, Okinawa, Japan. b983255@med.u-ryukyu.ac.jp
authors.forename: Takafumi
authors.initials: T
authors.lastname: Toita
authors.forename: Ryo
authors.initials: R
authors.lastname: Kitagawa
authors.forename: Tetsutaro
authors.initials: T
authors.lastname: Hamano
authors.forename: Kenji
authors.initials: K
authors.lastname: Umayahara
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Hirashima
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Aoki
authors.forename: Masahiko
authors.initials: M
authors.lastname: Oguchi
authors.forename: Mikio
authors.initials: M
authors.lastname: Mikami
authors.forename: Ken
authors.initials: K
authors.lastname: Takizawa
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods*; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin