IMPACT OF PROTRACTED VENOUS INFUSION FLUOROURACIL WITH OR WITHOUT INTERFERON ALFA-2B ON TUMOR RESPONSE, SURVIVAL, AND QUALITY-OF-LIFE IN ADVANCED COLORECTAL-CANCER

Purpose: The aim of this study was to investigate the effects of addin g interferon alfa-2b (IFN) to protracted venous infusion fluorouracil (PVI 5-FU) from the start of treatment in patients with advanced color ectal cancer. Patients and Methods: Patients who attended our unit wit h histologically confirmed advanced colorectal cancer were randomized to receive either PVI 5-FU 300 mg/m(2)/ d via Hickman line, and IFN 5 MU subcutaneously three times weekly, or PVI 5-FU alone. Treatment was given for a maximum of two 10-week blocks, with a 2-week gap for reas sessment of all parameters. Quality of life (QL) wets measured by the European Organization for Research and Treatment of Cancer (EORTC) Qua lity of Life Questionnaire Core 30 (QLQ-C30) pretreatment and every 6 weeks thereafter. Results: A total of 160 patients were randomized, wi th 155 eligible for assessment. Radiologic response was observed in 43 patients (28%): 17 of 77 (22%) in the 5-FU-plus-IFN arm (all partial responses [PRs]) and 26 of 78 (33%) in the 5-FU-alone group (complete re sponses [CRs] and 22 PRs) (difference not significant). Symptomatic improvement occurred in the majority of patients, and equally in both arms: 61% to 80% depending on the symptom. There was no significant d ifference between the two groups in failure-free survival (median, 161 v 193 days) or overall survival (median, 328 v 357 days). However, pa tients who received IFN did experience significantly more toxicity in the form of leukopenia (P = .001), neutropenia (P = .04), mucositis (P = .008), and alopecia (P = .0002). There were no toxic deaths and few notable differences in QL between the two arms. Conclusion: This stud y confirms that PVI 5-FU is effective in treating the symptoms associa ted with metastatic colorectal carcinoma, with only mild to moderate t oxicity and maintenance of QL. IFN 5 MU three times weekly does not en hance these palliative benefits. (C) 1995 by American Society of Clini cal Oncology.