TY - JOUR
T1 - Fluorouracil and recombinant alfa-2a-interferon
T2 - an active regimen against advanced colorectal carcinoma
AU - Wadler, S.
AU - Schwartz, E. L.
AU - Goldman, M.
AU - Lyver, A.
AU - Rader, M.
AU - Zimmerman, M.
AU - Itri, L.
AU - Weinberg, V.
AU - Wiernik, P. H.
PY - 1989
Y1 - 1989
N2 - Based on in vitro studies that have demonstrated synergy between recombinant alfa-2a-interferon (rIFNα-2a) and the fluoropyrimidine, fluorouracil (5FU), against two human colon cancer cell lines, a pilot clinical trial was initiated to determine the effects of the combination of 5FU and rIFNα-2a in patients with advanced, unresectable colorectal carcinoma. A total of 30 patients were enrolled; all were evaluable. 5FU was administered as a loading course, 750 mg/m2 daily for 5 days by continuous infusion followed by weekly bolus therapy. rIFNα-2a, 9 MU, was administered subcutaneously three times per week. Of 17 previously untreated patients evaluable for response, 13 achieved a response. Three patients had disease progression. No previously treated patients had a major response. There was one death clearly related to therapy, an event preceded by watery diarrhea and neutropenic sepsis. Other toxicities were reversible and responded to dose reduction. With a median follow-up of 16+ months, median survival has not been reached among the previously untreated patient cohort. We conclude that the combination of 5FU and rIFNα-2a is an active regimen against disseminated colorectal cancer in previously untreated patients.
AB - Based on in vitro studies that have demonstrated synergy between recombinant alfa-2a-interferon (rIFNα-2a) and the fluoropyrimidine, fluorouracil (5FU), against two human colon cancer cell lines, a pilot clinical trial was initiated to determine the effects of the combination of 5FU and rIFNα-2a in patients with advanced, unresectable colorectal carcinoma. A total of 30 patients were enrolled; all were evaluable. 5FU was administered as a loading course, 750 mg/m2 daily for 5 days by continuous infusion followed by weekly bolus therapy. rIFNα-2a, 9 MU, was administered subcutaneously three times per week. Of 17 previously untreated patients evaluable for response, 13 achieved a response. Three patients had disease progression. No previously treated patients had a major response. There was one death clearly related to therapy, an event preceded by watery diarrhea and neutropenic sepsis. Other toxicities were reversible and responded to dose reduction. With a median follow-up of 16+ months, median survival has not been reached among the previously untreated patient cohort. We conclude that the combination of 5FU and rIFNα-2a is an active regimen against disseminated colorectal cancer in previously untreated patients.
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U2 - 10.1200/JCO.1989.7.12.1769
DO - 10.1200/JCO.1989.7.12.1769
M3 - Article
C2 - 2585018
AN - SCOPUS:0024834136
SN - 0732-183X
VL - 7
SP - 1769
EP - 1775
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 12
ER -