A Pilot Study of Interferon α-2a, Fluorouracil, and Leucovorin Given with Granulocyte-Macrophage Colony Stimulating Factor in Advanced Gastrointestinal Adenocarcinoma

摘要: We reported previously that the addition of recombinant Escherichia coli human granulocyte-macrophage colony stimulating factor (GM-CSF) to a 5-fluorouracil (5-FU) and leucovorin (LV) regimen seemed ameliorate diarrhea permit increased 5-FU dose intensity (J. L. Grem et al. , J. Clin. Oncol., 12: 560–568, 1994). then tested effect GM-CSF given with more toxic 5-FU/LV/IFN-α (IFN α-2a). Thirty-one patients good performance status no prior chemotherapy for systemic disease received IFN α-2a (5 MU/m 2 s.c., days 1–7), (370 mg/m i.v., 2–6), LV (500 ( Saccharomyces cerevisiae 250 μg/m 7–18) every 3 weeks. Toxicities were compared observed in our Phase II trial 5-FU/LV/IFN 11: 1737–1745, 1993). In comparison study, WBC granulocyte nadirs present significantly higher. When trends toxicity grades all cycles compared, stratifying dose, incidence severity mucositis, skin rash, toxicity, lower trial, whereas nausea/vomiting fatigue worse. The delivered therapy appeared be higher trial. Six 28 evaluable had partial response (21.4%), 13 (46%) stable ≥12 Despite treatment-related patient quality life did not worsen during study. No correlation was between thymidylate synthase content primary tumor specimens response, time treatment failure, or survival. decrease leukopenia, granulocytopenia, rash when experience this α-2a, at cost greater fatigue. potential impact on clinical however, remains determined.