Longitudinal quality of life (QoL) and quality adjusted survival (QAS) in a randomised controlled trial (RCT) comparing bolus (24 weeks) vs. protracted venous infusion (PVI 12 weeks) 5-FU as adjuvant chemotherapy for colorectal cancer (CRC)

Abstract

3625 Background: QoL is infrequently assessed in RCTs of adjuvant therapy for CRC. This analysis aims to assess QoL and QAS in patients receiving adjuvant 5-FU for stage II and III CRC according to treatment arm, age, gender and primary tumour location. Methods: We performed a multicentre RCT in which 801 patients were randomised to 6 months of bolus 5-FU/leucovorin (n=404) or 12 weeks of PVI 5-FU (n=397). QoL was assessed by EORTC QoL core 30 questionnaire before randomisation, during treatment and follow-up to a maximum of 5 years. QAS analysis was performed by integrating the product of the grouped QoL and the survival function. P-values <0.01 were considered significant. Results: Between 1993 and 2003, 9,607 questionnaires were returned. There was significant difference in the deterioration of QoL scores at week 2 with bolus 5-FU compared to PVI 5-FU, 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 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. Females and rectal cancer patients had significantly worse baseline QoL scores. QoL improved significantly in patients aged <70 during follow-up whereas patients >= 70 only returned to baseline. The changes from baseline QoL by sex, age and primary tumour locations followed the same general trends as treatment arms. There was no significant differences in QAS between treatment arms, although patients with stage III and performance status 1–2 had significantly worse QAS. Conclusions: 12 weeks of adjuvant PVI 5-FU was associated with significantly better QoL during treatment and faster time to recovery compared to bolus 5-FU. No significant financial relationships to disclose.