title: Randomized clinical trial of weekly vs. triweekly cisplatin-based chemotherapy concurrent with radiotherapy in the treatment of locally advanced cervical cancer.
abstract: OBJECTIVE
  To compare compliance, toxicity, and outcome of weekly and triweekly cisplatin administration concurrent with radiotherapy in locally advanced cervical cancer.
  
  
  METHODS
  In this open-label, randomized trial, 104 patients with histologically proven Stage IIB-IVA cervical cancer were randomly assigned by a computer-generated procedure to weekly (weekly cisplatin 40 mg/m(2), six cycles) and triweekly (cisplatin 75 mg/m(2) every 3 weeks, three cycles) chemotherapy arms during concurrent radiotherapy. The difference of compliance and the toxicity profiles between the two arms were investigated, and the overall survival rate was analyzed after 5 years.
  
  
  RESULTS
  All patients tolerated both treatments very well, with a high completion rate of scheduled chemotherapy cycles. There was no statistically significant difference in compliance between the two arms (86.3% in the weekly arm, 92.5% in the triweekly arm, p > 0.05). Grade 3-4 neutropenia was more frequent in the weekly arm (39.2%) than in the triweekly arm (22.6%) (p = 0.03). The overall 5-year survival rate was significantly higher in the triweekly arm (88.7%) than in the weekly arm (66.5%) (hazard ratio 0.375; 95% confidence interval 0.154-0.914; p = 0.03).
  
  
  CONCLUSIONS
  Triweekly cisplatin 75-mg/m(2) chemotherapy concurrent with radiotherapy is more effective and feasible than the conventional weekly cisplatin 40-mg/m(2) regimen and may be a strong candidate for the optimal cisplatin dose and dosing schedule in the treatment of locally advanced cervical cancer.
authors.affiliation: Department of Obstetrics and Gynecology, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Korea. ryu@kcch.re.kr
authors.forename: Sang-Young
authors.initials: SY
authors.lastname: Ryu
authors.forename: Won-Moo
authors.initials: WM
authors.lastname: Lee
authors.forename: Kidong
authors.initials: K
authors.lastname: Kim
authors.forename: Sang-Il
authors.initials: SI
authors.lastname: Park
authors.forename: Beob-Jong
authors.initials: BJ
authors.lastname: Kim
authors.forename: Moon-Hong
authors.initials: MH
authors.lastname: Kim
authors.forename: Seok-Cheol
authors.initials: SC
authors.lastname: Choi
authors.forename: Chul-Koo
authors.initials: CK
authors.lastname: Cho
authors.forename: Byung-Ho
authors.initials: BH
authors.lastname: Nam
authors.forename: Eui-Don
authors.initials: ED
authors.lastname: Lee
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001918:Brachytherapy; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy / Q000379:methods; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D055118:Medication Adherence; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage* / Q000009:adverse effects; D011879:Radiotherapy Dosage; D012965:Sodium Chloride / Q000008:administration & dosage; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*
chemical_list: D000970:Antineoplastic Agents; D011838:Radiation-Sensitizing Agents; D012965:Sodium Chloride; D002945:Cisplatin