ABSTRACT
Twelve patients with advanced colorectal cancer were subjected to alternating cycles of treatment with low immunomodulating doses of recombinant alpha-interferon (alpha IFN) + 5-fluorouracil (5FU) or with 5FU alone. Hematological, biochemical and physical evaluation of the patients showed that alpha IFN + 5FU cycles were well tolerated like 5FU alone, except for modest and transient fever following alpha IFN administration. At hematological nadir (day 15-18 of each cycle) lymphocytopenia and granulocytopenia were more pronounced during alpha IFN + 5FU than 5FU cycles. No difference was found for platelet nadir. At the beginning of each cycle complete leukocyte recovery was observed in all cases. Platelet recovery was also complete, although counts were higher after alpha IFN + 5FU than after 5FU alone. Clinical results showed 1 complete remission, 1 partial remission, 5 stable disease and 5 progressive disease. These data point out that low doses of alpha IFN can be safely associated with 5FU. However further studies are required to establish the possible therapeutic value of alpha IFN-mediated immunomodulation for immunochemotherapy of colorectal cancer.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/adverse effects , Colonic Neoplasms/drug therapy , Fluorouracil/adverse effects , Interferon Type I/adverse effects , Leukopenia/chemically induced , Rectal Neoplasms/drug therapy , Adult , Aged , Female , Humans , Male , Middle AgedABSTRACT
In a randomized, multicenter study, 168 evaluable patients with colorectal adenocarcinoma at B2, C1 or C2 stages of the Dukes, Astler and Coller classification, were treated after radical surgery with BCG and 5-fluorouracil alone (regimen A) or in combination with hydroxyurea, methyl-CCNU and mitomycin C (regimen B). Radiation therapy was mandatory after surgery for rectal cancer. Response to therapy was evaluated for length of disease-free interval after surgery and was analyzed in comparison to the data obtained upon entrance to the study. The results are reported as life curves of the duration of the disease-free interval for treatment in comparison to the presence or absence of various signs or symptoms of disease. Also reported are responses obtained using the Cox method for linear regression analysis on non-parametric data, that gave information on the importance of various prognostic factors.
