Clinical Results of Leukocyte Interferon-Induced Tumor Regression in Resistant Human Metastatic Cancer Resistant to Chemotherapy and/or Radiotherapy-Pulse Therapy Schedule

Abstract

The efficacy of Human 6 IFN (HLIFN) given in a pulse fashion was determined in a phase II study. Ninety-one cancer patients were evaluated (9 myeloma, 12 breast, 14 prostate, 9 melanoma, 4 renal, 6 astrocytoma, 7 ovarian, 9 large bowel, 7 gastric, 14 head and neck). They all had advanced progressive cancer that was resistant to chemotherapy and/or radiotherapy. Patients were treated by intramuscular injection of 6 X 10(2) I.U./m2 for three consecutive days every four weeks. 84 patients were evaluable. Complete clinical response was obtained in 23 patients (4 myeloma, 2 breast, 5 prostate, 1 melanoma, 1 renal, 2 astrocytoma, 2 ovarian, 2 large bowel, 1 gastric, 3 head and neck). Partial responses were observed in 35 patients (3 myeloma, 7 breast, 6 prostate, 4 melanoma, 1 renal, 2 astrocytoma, 3 ovarian, 4 head and neck). Objective responses were related (P less than 0.01) to serum IFN level, with complete and partial responses (P less than 0.01) more commonly seen in those patients whose serum IFN levels at two hours were in the range of 1000 to 1650 I.U./ml. Side effects resulting from pulse IFN were acceptable for this group of patients and consisted of fever, transient chills, malaise and asthenia, and transient thrombocytopenia and leukocytopenia. The extent of fever was directly related (P less than 0.01) to response, and was most elevated in patients who achieved objective responses. IFN administered in a pulse fashion appears to be more effective than daily IFN and merits further evaluation.

Interferon-alfa corrects thrombocytosis in patients with myeloproliferative disorders

“…Only after prolonged IFN treatment did a significant decline emerge in these bone marrow compartments (unpublished observation). This finding is in accordance with the experience of clinical [22] and in vitro studies [12,25], where exposure to IFN inhibited the proliferation of erythroid and myeloid precursor cells. It is noteworthy that the frequently observed decrease in leukocyte counts correlated significantly with the degree of response in the platelet population.…”

Human leukocyte interferon alpha: Structure, pharmacology, and therapeutic applications

“…262 In another study on carcinomas, responses of around 47% were obtained,1*4 with the dose of 3-6 MU/day.…”

Chemohormonal and Immunohormonal Approaches in Advanced Prostatic Carcinoma

“…First, interferons exert a di rect regulatory effect on tumor cells, modulating growth, differentiation, response to growth-stimulating factors and the expression of surface antigens. Second, as immu-exception of one single paper [16] reporting an objective response rate of as high as 84% by employing a pulse ther apy schedule for more than 1 year, the results are general ly disappointing. Responses occur infrequently, and tox icity is substantial in most cases.…”