title: Phase II study of concurrent chemoradiotherapy with weekly cisplatin and paclitaxel in patients with locally advanced uterine cervical cancer: The JACCRO GY-01 trial.
abstract: OBJECTIVE
  A multicenter phase II trial was conducted to assess the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) with weekly cisplatin (CDDP) and paclitaxel (PTX) in patients with locally advanced uterine cervical cancer.
  
  
  METHODS
  Patients with FIGO stage III-IVA uterine cervical cancer without para-aortic lymphadenopathy were enrolled. Patients received definitive radiotherapy (RT) consisting of external beam whole-pelvic RT and high-dose-rate intracavitary brachytherapy. The cumulative linear quadratic equivalent dose was 62-65Gy prescribed at point A. weekly CDDP at 30mg/m(2) and PTX at 50mg/m(2) were administered concurrently with RT for ≥5 courses.
  
  
  RESULTS
  Sixty-eight of the 70 registered patients were eligible. The complete response rate was 76.5% (95% confidence interval [CI], 66.4-86.6%). With a median follow-up of 27months (range, 7.9-33.5), the 2-year cumulative progression-free survival and the 2-year cumulative overall survival rates were 83.8% (95% CI, 75.1-92.6%) and 92.7% (95% CI, 86.4-98.9%), respectively. The pelvic cumulative disease progression-free and the 2-year cumulative distant metastasis rates were 89.6% (95% CI, 82.3-96.9%) and 13.2% (95% CI, 5.2-21.3%), respectively. The 2-year cumulative late complication rates were 25% for all grades, 13.2% for grade 1, 5.9% for grade 2, 2.9% for grade 3, and 2.9% for grade 4.
  
  
  CONCLUSIONS
  For locally advanced cervical cancer, CCRT with weekly CDDP 30mg/m(2) and PTX at 50mg/m(2) demonstrated favorable antitumor activity, and was feasible and safe with respect to the protocol-specified serious adverse reactions and events. Evaluation of this regimen in phase III trials is warranted.
authors.affiliation: Department of Gynecology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan. Electronic address: kenji.umayahara@jfcr.or.jp.
authors.forename: Kenji
authors.initials: K
authors.lastname: Umayahara
authors.affiliation: Department of Gynecology, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Munetaka
authors.initials: M
authors.lastname: Takekuma
authors.affiliation: Department of Gynecology, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Hirashima
authors.affiliation: Department of Radiation Oncology, Gunma University Hospital, Gunma, Japan.
authors.forename: Shin-Ei
authors.initials: SE
authors.lastname: Noda
authors.affiliation: Department of Radiation Oncology, Gunma University Hospital, Gunma, Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Ohno
authors.affiliation: Department of Obstetrics and Gynecology, Yokohama City University Hospital, Yokohama, Japan.
authors.forename: Etsuko
authors.initials: E
authors.lastname: Miyagi
authors.affiliation: Department of Obstetrics and Gynecology, Yokohama City University Hospital, Yokohama, Japan.
authors.forename: Fumiki
authors.initials: F
authors.lastname: Hirahara
authors.affiliation: Department of Obstetrics and Gynecology, Hiroshima University Hospital, Hiroshima, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Hirata
authors.affiliation: Department of Obstetrics and Gynecology, Mie University Hospital, Mie, Japan.
authors.forename: Eiji
authors.initials: E
authors.lastname: Kondo
authors.affiliation: Department of Obstetrics and Gynecology, Mie University Hospital, Mie, Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Tabata
authors.affiliation: Department of Obstetrics and Gynecology, Ryukyus University Hospital, Okinawa, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Nagai
authors.affiliation: Department of Obstetrics and Gynecology, Ryukyus University Hospital, Okinawa, Japan.
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Aoki
authors.affiliation: Research Center for Charged Particle Therapy, National Institute of Radiological Sciences, Chiba, Japan.
authors.forename: Masaru
authors.initials: M
authors.lastname: Wakatsuki
authors.affiliation: Department of Clinical Medicine (Biostatistics & Pharmaceutical Medicine), School of Pharmacy, Kitasato University, Tokyo, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Takeuchi
authors.affiliation: Department of Radiology, Ryukyus University Hospital, Okinawa, Japan.
authors.forename: Takafumi
authors.initials: T
authors.lastname: Toita
authors.affiliation: Department of Gynecology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Takeshima
authors.affiliation: Department of Gynecology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Takizawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*
chemical_list: D017239:Paclitaxel; D002945:Cisplatin