Quality of life in patients with metastatic colorectal cancer receiving chemotherapy: a randomized, double-blind trial comparing 5-FU versus 5-FU with leucovorin.

We compared health-related quality of life (HQL) measures in 210 patients with metastatic colorectal cancer who were receiving equitoxic regimens of weekly 5-fluorouracil (5-FU) plus leucovorin (LV) or 5-FU alone in a multicenter, placebo-controlled, double-blind, randomized trial. The HQL was assessed during the first 120 days of treatment by the patient-generated functional living index-cancer (FLIC) questionnaire. Also assessed were clinician-generated measures to evaluate physical functioning and suffering: Karnofsky performance status (KPS), body weight, disease symptoms, and hospitalization. No significant difference was detected between treatment groups in HQL or in any measurement of efficacy or toxicity. The number of patients hospitalized was similar in both groups, 35 patients receiving 5-FU-LV, 32 receiving 5-FU-placebo, but those receiving 5-FU-LV were hospitalized longer (450 vs 315 total days). The KPS improved or stabilized in 23% and 37% of patients, respectively. Overall, FLIC scores significantly improved in 27% or remained stable in 62% of all patients; disease symptoms improved in 19-49%; a weight increase of 2 kg or more occurred in 27%. A change in FLIC was not associated with tumor response or improvement in pain, but a decline in FLIC was associated with improved survival. An improvement in KPS or weight was associated with tumor response and strongly correlated with survival. Improvement of pain was associated with a stable or increase in weight, and worsening of pain correlated with lack of tumor response.

RCT Entities:   Population Interventions Outcomes