title: Phase II study of capecitabine (Ro 09-1978) in patients who have failed first line treatment for locally advanced and/or metastatic cervical cancer.
abstract: OBJECTIVE
  The objective of this study is to evaluate the efficacy and safety of capecitabine in cervical cancer patients who have locoregional failure and/or distant metastasis and failed first line therapy. The efficacy of capecitabine is determined by the overall response rate (ORR) according to WHO criteria for response and the safety by adverse event (AE) and tolerability profiles according to NCI CTC version 2.0.
  
  
  METHODS
  Patients with loco-regional failure and/or metastatic cervical cancer who have failed first line therapy were enrolled into the study. The patient received capecitabine 1, 250 mg/m2 twice daily for 14 consecutive days with 7 days rest (21-day cycle). The treatment was continued for up to six cycles.
  
  
  RESULTS
  Forty-five patients previously treated by single or combination of surgery, or chemotherapy or radiotherapy were enrolled for study. Thirty-seven of 45 patients (82%) received at least 2 cycles of treatment and they were evaluated for response. The intention to treat analyses revealed 6/45(13%) ORR, 1/45 (2%) CR and 5/45 (11%) PR. Twenty-four patients (53%) had stable disease and 20% had progression of the disease. The median time to progression was 4. 1 months and the median overall survival was 9.3 months.
  
  
  CONCLUSIONS
  Capecitabine as a monotherapy has a modest response in locoregional failure and/or metastatic cervical cancer who have failed first line therapy.
authors.affiliation: Department of Radiology, Chiangmai University, Chiangmai, Thailand.
authors.forename: Vicharn
authors.initials: V
authors.lastname: Lorvidhaya
authors.forename: Imjai
authors.initials: I
authors.lastname: Chitapanarux
authors.forename: Pramook
authors.initials: P
authors.lastname: Phromratanapongse
authors.forename: Pimkhuan
authors.initials: P
authors.lastname: Kamnerdsupaphon
authors.forename: Ekkasit
authors.initials: E
authors.lastname: Tharavichitkul
authors.forename: Prasert
authors.initials: P
authors.lastname: Lertsanguansinchai
authors.forename: Chang-Yao
authors.initials: CY
authors.lastname: Hsieh
authors.forename: Vimol
authors.initials: V
authors.lastname: Sukthomya
mesh_terms: D000328:Adult; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D016879:Salvage Therapy; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil