title: A randomized trial comparing concurrent chemoradiotherapy with single-agent cisplatin versus cisplatin plus gemcitabine in patients with advanced cervical cancer: An Asian Gynecologic Oncology Group study.
abstract: OBJECTIVE
  A recent randomized trial demonstrated that concurrent chemoradiotherapy (CCRT) with weekly cisplatin and gemcitabine, followed by two adjuvant cycles of cisplatin and gemcitabine improved survival for advanced cervical cancer patients. An Asian Gynecologic Oncology Group (AGOG) study was designed to determine whether only adding gemcitabine in the chemoradiation phase without adjuvant chemotherapy could improve survival.
  
  
  METHODS
  Between March 2009 and March 2013, 74 eligible patients with International Federation of Obstetrics and Gynecology stage III/IVA cervical cancer or stage I/II with positive pelvic/para-aortic nodal metastasis were enrolled. Thirty-seven patients were randomized to arm C (weekly cisplatin 40mg/m(2)) and 37 patients were randomized to arm CG (weekly cisplatin 40mg/m(2) and gemcitabine 125mg/m(2)), for six cycles. Six eligible patients were excluded before the beginning of treatment.
  
  
  RESULTS
  An interim analysis showed superimposable progression-free (PFS) and overall survival (OS), a decision of closing accrual was made. A 3-year PFS was similar in both arms (arm C 65.1% vs. arm CG 71.0%, p=0.71), and a 3-year OS was 74.1% in arm C vs. 85.9% in arm CG (p=0.89), but crossed over at 5years. Grade 2-4 hematological toxicities, including neutropenia (p=0.028) and thrombocytopenia (p=0.001), were more frequent in arm CG than arm C.
  
  
  CONCLUSIONS
  Despite limitation in power, it suggests that only adding gemcitabine at the CCRT phase does not provide substantially superior results, but treatment toxicities could increase. Further studies are required to determine the role of post-CCRT adjuvant chemotherapy in advanced cervical cancer.
authors.affiliation: Department of Radiation Oncology, Chang Gung Memorial Hospital at Linkou and Chang Gung University College of Medicine, Taoyuan, Taiwan; Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
authors.forename: Chun-Chieh
authors.initials: CC
authors.lastname: Wang
authors.affiliation: Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital at Linkou and Chang Gung University College of Medicine, Taoyuan, Taiwan; Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
authors.forename: Hung-Hsueh
authors.initials: HH
authors.lastname: Chou
authors.affiliation: Clinical Trial Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan; Data Management and Biostatistical Core, Asian Gynecologic Oncology Group, Taiwan; Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
authors.forename: Lan-Yan
authors.initials: LY
authors.lastname: Yang
authors.affiliation: Department of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan; Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
authors.forename: Hao
authors.initials: H
authors.lastname: Lin
authors.affiliation: Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.
authors.forename: Wen-Shiung
authors.initials: WS
authors.lastname: Liou
authors.affiliation: Department of Obstetrics and Gynecology, Chiayi Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Chiayi, Taiwan.
authors.forename: Chih-Wen
authors.initials: CW
authors.lastname: Tseng
authors.affiliation: Department of Nuclear Medicine, Chang Gung Memorial Hospital at Linkou and Chang Gung University College of Medicine, Taoyuan, Taiwan; Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
authors.forename: Feng-Yuan
authors.initials: FY
authors.lastname: Liu
authors.affiliation: Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital at Linkou and Chang Gung University College of Medicine, Taoyuan, Taiwan; Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
authors.forename: Jui-Der
authors.initials: JD
authors.lastname: Liou
authors.affiliation: Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital at Linkou and Chang Gung University College of Medicine, Taoyuan, Taiwan; Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
authors.forename: Kuan-Gen
authors.initials: KG
authors.lastname: Huang
authors.affiliation: Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital at Linkou and Chang Gung University College of Medicine, Taoyuan, Taiwan; Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
authors.forename: Huei-Jean
authors.initials: HJ
authors.lastname: Huang
authors.affiliation: Department of Radiation Oncology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
authors.forename: Eng-Yen
authors.initials: EY
authors.lastname: Huang
authors.affiliation: Department of Radiation Oncology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.
authors.forename: Chien-Hsun
authors.initials: CH
authors.lastname: Chen
authors.affiliation: Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital at Linkou and Chang Gung University College of Medicine, Taoyuan, Taiwan; Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.
authors.forename: Ting-Chang
authors.initials: TC
authors.lastname: Chang
authors.affiliation: Data Management and Biostatistical Core, Asian Gynecologic Oncology Group, Taiwan; Research Center of Clinical Informatics and Medical Statistics, Chang Gung University, Taoyuan, Taiwan.
authors.forename: Chee-Jen
authors.initials: CJ
authors.lastname: Chang
authors.affiliation: Department of Radiation Oncology, Chang Gung Memorial Hospital at Linkou and Chang Gung University College of Medicine, Taoyuan, Taiwan; Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan. Electronic address: jihong@adm.cgmh.org.tw.
authors.forename: Ji-Hong
authors.initials: JH
authors.lastname: Hong
authors.affiliation: Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital at Linkou and Chang Gung University College of Medicine, Taoyuan, Taiwan; Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan. Electronic address: sh46erry@ms6.hinet.net.
authors.forename: Chyong-Huey
authors.initials: CH
authors.lastname: Lai
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D059248:Chemoradiotherapy / Q000379:methods; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine
keywords: Cervical cancer; Chemoradiotherapy; Cisplatin; Gemcitabine; Squamous cell carcinoma