title: Observational study of adjuvant therapy with capecitabine in colon cancer.
abstract: OBJECTIVE
  This observational study was conducted to document the safety of capecitabine-based adjuvant therapy in patients with resected colon cancer under routine clinical conditions.
  
  
  METHODS
  ML20431 was a prospective, multicenter, non-interventional, observational study. It was designed to answer five research questions relating to safety, dosage and administration, and discontinuation from capecitabine-based adjuvant therapy. Patients were required to have R0 resected stage III colon cancer and have started treatment with capecitabine-based adjuvant therapy based on a decision by the investigator. Patients were followed over an observation period of ≤6 months after initiation of therapy. Investigators were required to complete the study case report form at study entry, each treatment cycle, and at the final examination.
  
  
  METHODS
  A total of 1485 patients were included in the study, and 1481 patients were treated with capecitabine and formed the analysis population. Most patients had colon cancer (78.3%), followed by rectal cancer (16.4%). Most patients had stage III disease (69.3%); the remaining patients had stage II disease (30.7%). The most common all-grade adverse reactions were hand-foot syndrome (46.9%), diarrhea (34.4%), and hemoglobin decreases (31.5%). Grade 3/4 adverse reactions were infrequent (<4%). Serious adverse events were reported in 96 patients (6.5%). Six or more cycles of treatment were completed by 77.9% of patients. Approximately two-thirds of patients (67.3%) received capecitabine monotherapy and the remainder (32.7%) received capecitabine in combination with ≥1 drugs, most commonly oxaliplatin (460 cases). Discontinuation of capecitabine was documented in 344 patients (23.2%).
  
  
  CONCLUSIONS
  no efficacy data were collected; the questionnaires for patients' expectations and satisfaction were not formally validated; and a few patients (<1.5%) had some retrospective data.
  
  
  CONCLUSIONS
  The safety profile of capecitabine-based adjuvant therapy in a broad patient population with colon cancer is similar to that previously documented in phase III clinical trials.
authors: MVZ Hämatologie/Onkologie Klinik Dr. Hancken , Stade , Germany.
authors: Claus-Christoph
authors: CC
authors: Steffens
authors: Barbara
authors: B
authors: Tschechne
authors: Christof
authors: C
authors: Schardt
authors: Georg
authors: G
authors: Jacobs
authors: Annette-Rosel
authors: AR
authors: Valdix
authors: Peter
authors: P
authors: Schmidt
authors: Richard
authors: R
authors: Hansen
authors: Hendrik
authors: H
authors: Kröning
authors: Tim
authors: T
authors: Wohlfarth
authors: Dorothee
authors: D
authors: Guggenberger
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant / Q000379:methods; D003110:Colonic Neoplasms / Q000188:drug therapy*; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011446:Prospective Studies; D012004:Rectal Neoplasms / Q000188:drug therapy; D012189:Retrospective Studies
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil
keywords: Adjuvant chemotherapy; Administration and dosage; Capecitabine; Colonic neoplasms; Oxaliplatin; Patient satisfaction; Safety