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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.
AuthorsIan Chau, Andrew R Norman, David Cunningham, Tim Iveson, Mark Hill, Tamas Hickish, Fiona Lofts, Duncan Jodrell, Andrew Webb, Diana Tait, Paul J Ross, Pat Shellito, Jacqueline R Oates
JournalEuropean journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 41 Issue 11 Pg. 1551-9 (Jul 2005) ISSN: 0959-8049 [Print] England
PMID16026692 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Leucovorin
  • Fluorouracil
Topics
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
  • Chemotherapy, Adjuvant
  • Colorectal Neoplasms (drug therapy)
  • Female
  • Fluorouracil (administration & dosage)
  • Health Status
  • Humans
  • Infusions, Intravenous
  • Leucovorin (administration & dosage)
  • Male
  • Middle Aged
  • Prospective Studies
  • Quality of Life
  • Survival Analysis

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