title: Randomized phase II study of capecitabine with or without oxaliplatin as first-line treatment for elderly or fragile patients with metastatic colorectal cancer: a prospective, multicenter trial of the Korean Cancer Study Group CO06-01.
abstract: BACKGROUND
  To compare 2 different strategies of chemotherapy for elderly metastatic colorectal cancer patients.
  
  
  METHODS
  This randomized, multicenter phase II study involved 80 metastatic colorectal cancer patients aged 70 years and above (performance status [PS] 0-2) or 65 years and above (PS 2), randomly assigned to arm A (capecitabine 1250 mg/m twice daily on days 1-14) or arm B (capecitabine 1000 mg/m twice daily on days 1-14, oxaliplatin 100 mg/m on day 1 initially, 130 mg/m for subsequent cycles). Primary endpoint was response rate, and secondary endpoints were toxicity, progression-free survival, overall survival, and quality of life (QoL), which was assessed with the EORTC QLQ-C30 questionnaire.
  
  
  RESULTS
  Confirmed response rates were 22.5% and 35.0% (P=0.217), progression-free survival were 4.4 and 6.6 months (P=0.335), and overall survival were 14.2 and 11.0 months (P=0.106). Hematologic toxicities were frequently observed in arm B, but grade ≥3 toxicities were not different. Patients in arm A tended to present more favorable preservation of QoL in global health status, physical and role functioning, fatigue, and appetite loss.
  
  
  CONCLUSIONS
  Initial aggressive treatment strategy would not be recommended for this patient population because QoL appeared more preserved, treatments were better tolerated, and survivals did not differ in patients treated with initial capecitabine monotherapy.
authors.affiliation: *Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang †Department of Clinical Epidemiology and Biostatistics ‡Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul §Department of Internal Medicine, St. Vincent's Hospital, Catholic University College of Medicine, Suwon ∥Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang ¶Department of Internal Medicine, Division of Hematology and Medical Oncology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam #Department of Internal Medicine, Cancer Metastasis Research Center, Yonsei Cancer Center, Yonsei University College of Medicine **Department of Internal Medicine, Samsung Medical Center, Division of Hematology-Oncology, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Yong Sang
authors.initials: YS
authors.lastname: Hong
authors.forename: Kyung Hae
authors.initials: KH
authors.lastname: Jung
authors.forename: Hwa Jung
authors.initials: HJ
authors.lastname: Kim
authors.forename: Kyu-Pyo
authors.initials: KP
authors.lastname: Kim
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Kim
authors.forename: Jae-Lyun
authors.initials: JL
authors.lastname: Lee
authors.forename: Byoung Yong
authors.initials: BY
authors.lastname: Shim
authors.forename: Dae Young
authors.initials: DY
authors.lastname: Zang
authors.forename: Jee Hyun
authors.initials: JH
authors.lastname: Kim
authors.forename: Joong Bae
authors.initials: JB
authors.lastname: Ahn
authors.forename: Young Suk
authors.initials: YS
authors.lastname: Park
authors.forename: Tae Won
authors.initials: TW
authors.lastname: Kim
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D044466:Asian People; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077150:Oxaliplatin; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil