Quality of life during cytostatic therapy for advanced symptomatic colorectal carcinoma: a randomized comparison of two regimens.

Physician- and patient-rated 'quality of life' was studied in patients receiving chemotherapy for advanced symptomatic colorectal cancer. The patients participated in a Nordic multicentre randomized study comparing single-drug 5-fluorouracil (5-FU) with a combination of sequential methotrexate-5-FU with leucovorin rescue (MFL). Forty-four patients (all patients included at one of the hospitals) entered this associated 'quality of life' study, 22 in each group. In the MFL group, five patients had a partial remission (PR) and seven prolonged stationary disease (SD), whereas in the 5-FU group, only one patient had a PR and two SD. Median survival was longer in the MFL group (9 months) than in the 5-FU group (4 months). According to the physicians' judgement, 12 (55%) of the patients randomized to MFL experienced improved 'quality of life' compared to five (23%) in the 5-FU group. Patients' ratings gave the same figure (55%) in the MFL group, whereas only two (9%) patients in the 5-FU group considered themselves improved. The correlations between physicians' and patients' ratings were good. Adverse effects of treatment were minor and influenced ratings negatively only in one patient (5-FU group). Items that reflected changes in everyday activities discriminated better than other items in the 'quality of life' assessment. Since 'quality of life' measures were better in the MFL group in this associated study, and since objective and subjective responses, changes in Karnofsky performance status (KPS) and in survival also were better in the MFL group, not only in this study but also in the Nordic trial (249 patients randomized), we conclude that MFL is superior to 5-FU as a palliative treatment.

RCT Entities:   Population Interventions Outcomes