title: Longitudinal quality of life and quality adjusted survival in a randomised controlled trial comparing six months of bolus fluorouracil/leucovorin vs. twelve weeks of protracted venous infusion fluorouracil as adjuvant chemotherapy for colorectal cancer.
abstract: Longitudinal quality of life (QOL) assessment is infrequently made in adjuvant therapy for colorectal cancer (CRC). This analysis aims to assess QOL and quality adjusted survival (QAS) in patients receiving adjuvant 5-FU for stage II and III CRC. We performed a multicentre study in which 801 patients were randomised to 6 months of bolus 5-FU/leucovorin (LV n = 404) or 12 weeks of protracted venous infusion (PVI) 5-FU (n = 397). There were significant differences in the deterioration of QOL scores at week 2 with bolus 5-FU/LV compared to PVI 5-FU (P < 0.001), coinciding with toxicity peak during the first cycle. Following week 12, global QOL recovered to baseline when PVI 5-FU was stopped but this was delayed with bolus 5-FU/LV until completion at week 24. QOL scores significantly improved in both arms during follow-up (P < 0.001) and reached a plateau by year 1 without incremental improvement between years 2 and 5. There was a trend towards better QAS with PVI 5-FU. Twelve weeks of adjuvant PVI 5-FU was associated with significantly better QOL during treatment and faster time to recovery compared to 6 months of bolus 5-FU/LV.
authors: Department of Medicine, Royal Marsden Hospital, Sutton, Surrey, UK.
authors: Ian
authors: I
authors: Chau
authors: Andrew R
authors: AR
authors: Norman
authors: David
authors: D
authors: Cunningham
authors: Tim
authors: T
authors: Iveson
authors: Mark
authors: M
authors: Hill
authors: Tamas
authors: T
authors: Hickish
authors: Fiona
authors: F
authors: Lofts
authors: Duncan
authors: D
authors: Jodrell
authors: Andrew
authors: A
authors: Webb
authors: Diana
authors: D
authors: Tait
authors: Paul J
authors: PJ
authors: Ross
authors: Pat
authors: P
authors: Shellito
authors: Jacqueline R
authors: JR
authors: Oates
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006304:Health Status; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D016019:Survival Analysis
chemical_list: D002955:Leucovorin; D005472:Fluorouracil