Abstract
The combination of 5-fluorouracil (5-FU) and interferon-alpha (IFN-alpha) has reported activity in the treatment of advanced colorectal carcinoma. Laboratory studies of IFN-beta suggest that this agent may offer theoretical advantages over IFN-alpha in combination with 5-FU. A total of 27 patients with advanced or recurrent colorectal carcinoma were treated in a non-randomized open phase II study with a combination of 5-fluorouracil (750 mg m(-1) daily for 5 days as a continuous intravenous (i.v.) infusion followed, from day 15, by i.v. bolus 750 mg m(-2) every 7 days) and recombinant interferon-beta [r-hIFN-beta-1a; 9 MIU (total dose) by subcutaneous injection from day 1 on every Monday, Wednesday and Friday throughout the treatment period]. Toxicity was less than that seen with this schedule of 5-FU in combination with IFN-alpha. Among 21 evaluable patients, four objective responses were seen. Recombinant human interferon-beta-1a in combination with 5-FU is an acceptable regimen in terms of toxicity. However, the study did not demonstrate a superior response rate when compared with previous reports of treatment with 5-FU alone or in combination with IFN-alpha.
Highlights
Responses reflect World Health Organization (WHO) definitions: partial remission (PR) was defined as a decrease of evaluable tumour size of 2 50% maintained for 4 weeks; complete remission (CR) as complete disappearance of all known disease for at least 4 weeks; progressive disease (PD) as a 25% or greater increase in the size of one or more measurable lesions or the appearance of one or more new lesions; and stable disease (SD) as failure to establish a 50% decrease or 25% increase in tumour volume
Three patients died as a result of colorectal carcinoma within 30 days of starting treatment; none of the deaths were thought to be related to treatment and progression was not documented after entrance to the study: one patient suffered a haematemesis at day 12; one progressed rapidly between agreeing to take part in the study and commencing treatment and would not have been treated had he declined to withdraw; one patient was admitted to his local hospice on day 30 where he died without full evaluation of the cause
Three further patients are not evaluable for response: one patient withdrew early owing to leucopenia with infection on day 32 and declined further treatment; one patient, aged 82, withdrew because of grade II nausea in week 3; one patient was withdrawn following a carotid thrombosis, thought to be unrelated to the treatment regimen
Summary
The aims of the study were to explore the efficacy of the combination of 5-FU with r-hIFN-p-la in patients with advanced colorectal carcinoma and to evaluate the safety and tolerability of the regimen in this patient group
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