Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0015672 (fatigue)
 51,768 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Natural interferon-alpha preparation "Sumiferon" was recently developed in Japan. This is a human lymphoblastoid interferon (HLBI) preparation. Like other interferon preparations, this preparation showed both direct and indirect antitumor effect and the toxicities were moderate. The phase I-II studies were carried out in 38 major institutions in Japan. In the phase I study in 5 patients with advanced breast cancer, the maximum tolerated dose (MTD) was found to be 12 X 10(6) units/day given for 1 month. In the phase II study, HLBI was given in at 3 approximately 6 X 10(6) units/day. Out of 391 cases, 280 were evaluable. Complete and partial responses (CR and PR) were observed in 40 (14.3%) out of 280 evaluable cases, including 11 (19.6%) out of 56 renal cell cancer, 14 (19.2%) out of 73 multiple myeloma, and 9 (17.3) out of 52 malignant lymphoma among others. Major side effects observed were: fever (69.8%), gastrointestinal disturbances (31.4%), leukopenia (30.7%), thrombocytopenia (27.8%), hepatotoxicities (23.6%) and general fatigue (22.1%). Sumiferon seemed to be one of useful antitumor drugs effective against renal cancer.
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PMID:[Introduction of natural interferon-alpha "Sumiferon"]. 363 77

Since interferon alfa-2b (Intron A) is useful as a single agent, it is important to determine if interferon can be combined with standard chemotherapy to improve both response and survival in patients with cancer. Using clonogenic assays, interferon was tested alone and in combination with cyclophosphamide (Cytoxan) or melphalan (Alkeran) using several dose and exposure schedules to evaluate cytotoxicity. In vitro, continuous-exposure interferon produced optimal cell kill. Maximum enhancement of cytotoxicity occurred with cyclophosphamide or melphalan pretreatment (1 hour) and/or simultaneous interferon treatment. Based upon these data, a phase I-II study was designed to determine the tolerance of cancer patients to a fixed dose of cyclophosphamide (150 mg/m2 p.o. daily X 4 days [days 2 to 5]) combined with increasing doses of interferon. Interferon was administered subcutaneously on treatment cycle days 1 to 5, plus days 8, 10, 12, 15, 17, and 19 of the 21-day regimen. Three patients had partial responses: one breast cancer, one angiosarcoma, and one myeloma (mixed). All patients reported mild flu-like symptoms, fatigue, and anorexia. Leukopenia occurred in all patients; three required treatment interruption to allow recovery. Eight patients had a fall in hemoglobin (mean decrease 1.4 g/dL). The combination of cyclophosphamide and interferon was safe and deserves further trial in cancer treatment. However, using this combination schedule, interferon doses greater than or equal to 5 X 10(6) IU were poorly tolerated and compromised administration of full-dose cyclophosphamide.
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PMID:Interferon alfa-2b-cyclophosphamide combination studies: in vitro and phase I-II clinical results. 376 44

Effectiveness of recombinant DNA (rDNA) human interferon alpha 2 (IFN alpha 2) in advanced breast cancer was evaluated in 14 patients who had received prior endocrine and/or cytotoxic therapy. After randomization, 7 patients received IFN alpha 2 two million IU m-2 day-1, s.c., 3 times a week (schedule 1) and 7 patients received 50 million IU m-2 day-1, i.v., for 5 consecutive days, every 3 weeks (schedule 2). Treatment duration was 4-21 weeks in schedule 1 and 6-24 weeks (2-8 courses) in schedule 2. Regressions were not achieved with either schedule. Treatment was associated with significant toxicity and was more severe in schedule 2. Dose limiting toxicities were leukopenia, elevation of liver enzymes, hyperglycemia and fatigue. Serum IFN activity was low or undetectable in patients on schedule 1 and high in patients on schedule 2. At 24 h, serum IFN activity was detectable in only 1/6 patients on schedule 1 as compared to 3/7 patients on schedule 2. IFN neutralizing factors were detected in the serum of only 1 patient prior to treatment but none were detected in any of the patients during or after discontinuation of treatment (4-24 weeks). IFN alpha 2 increased the expression of both HLA class 1 antigens and beta 2 microglobulin in peripheral blood lymphocytes in vivo. This effect was dose related.
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PMID:Recombinant DNA human interferon alpha 2 in advanced breast cancer: a phase 2 trial. 391 78

Visiting a physician for evaluation of a breast problem which could be cancer is often assumed to be a highly stressful experience. This study evaluates the degree of emotional distress in women about to undergo examination for signs or symptoms of breast disease. Three hundred twenty-two women who attended the Breast Problem Clinic of the Wisconsin Clinical Cancer Center were studied. Each patient completed standard self-administered psychologic tests to evaluate mood disturbance (Profile of Mood States [POMS]) and responsibility taken for overall health care (Health Locus of Control [HLCS]). Results of these tests were compared to control populations of normal college women and female psychiatric outpatients. The women seen in the Breast Problem Clinic were significantly less distressed on POMS subscales which measure depression, anger, fatigue, and confusion than both psychiatric outpatients and normal college women (P less than 0.001). A second group of 17 women who were seen in the hospital 24 to 48 hours before definitive breast cancer surgery were also studied. Women evaluated as inpatients before breast cancer surgery were more distressed than the women attending the outpatient clinic on most POMS subscales, but were not clearly different from normal college women. No differences between the groups were seen for the HLCS. These data indicate that emotional distress among women attending a breast problem clinic is not extraordinary, but that emotional distress heightens when the diagnosis of breast cancer is known.
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PMID:Psychological distress among women with breast problems. 394 21

Eighteen patients with advanced breast cancer refractory to first-line chemotherapy and hormonal therapy (or estrogen receptor-negative) were treated with human alpha-lymphoblastoid interferon (Wellferon) in a dose of 30 X 10(6) U/m2 im weekly. None of 15 patients receiving three or more doses achieved a partial or complete response. Toxicity was substantial and included fatigue, malaise, fever, hematologic suppression, nausea/vomiting, and diarrhea.
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PMID:Phase II trial of alpha-lymphoblastoid interferon given weekly as treatment of advanced breast cancer. 400 77

Forty-five women with far-advanced metastatic breast cancer were treated with a combination of aminoglutethimide (AG), 1000 mg p.o. daily, and medroxyprogesterone acetate (MPA), 1500 mg p.o. daily. Of 41 patients evaluable for treatment response, there were two complete responses, five partial remissions, 26 patients with minor tumor responses or no change, and eight nonresponders. Major side effects included those known for AG and MPA, i.e., impairment of mental functions, depressive syndromes, fatigue, ataxia, skin rash, changes in body weight, and transient increase of gamma-glutamyl-transferase. Most side effects disappeared spontaneously after 4 to 6 weeks of treatment. Plasma hormone measurements in 28 patients revealed no impairment of adrenocorticotropic hormone and cortisol levels. In conclusion, in the AG combination, it is feasible and safe to replace cortisol by MPA. Treatment results warrant further investigation of AG-MPA in patients with breast cancer of a more favorable prognosis.
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PMID:Phase II study of aminoglutethimide and medroxyprogesterone acetate in the treatment of patients with advanced breast cancer. 612 83

Thirty-eight patients with advanced breast cancer, multiple myeloma, and malignant lymphoma were treated with partially purified (about 0.1%) leukocyte interferon. Patients were treated with a remission-induction schedule of 3 million to 9 million antiviral units daily intramuscularly for 4 to 26 weeks. Responding patients were maintained on a schedule of 3 million U three times weekly. Tumor regression was observed in seven of 17 patients with breast cancer. Six of 10 patients with multiple myeloma responded with a decrease of at least 50% in serum myeloma protein levels or Bence Jones protein excretion. Six of the 11 lymphoma patients achieved tumor regression. Complete remissions occurred in two patients. Of the 19 responding patients, five remain on study for 52 to 63 weeks. Toxicity included low-grade fever, fatigue, anorexia, and partial alopecia. Myelosuppression (lowest median leukocyte count, 2500/mm3; granulocytes, 1300/mm3) occurred in most patients. On the basis of this pilot study, we conclude that leukocyte interferon can induce tumor regression in patients with advanced cancer.
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PMID:Leukocyte interferon-induced tumor regression in human metastatic breast cancer, multiple myeloma, and malignant lymphoma. 615 12

A cooperative phase I-II study of HLBI (human lymphoblastoid interferon), natural interferon-alpha, was carried out in 38 major institutions in Japan. The eligibility of patients and evaluation of tumor response were based on the 'Criteria for the Evaluation of Clinical Effects of Cancer Chemotherapy on Solid Tumor' by Koyama and Saito, and on Blood Cancer by Kimura. Major objectives of the phase I study were pharmacokinetics and toxicity of HLBI . Based on the toxicity observed in 5 patients with advanced breast cancer, the maximum tolerated dose (MTD) was determined to be 12 X 10(6) unit/day for 1 month. In phase II study, HLBI was administered by i.m. injection at a dose of 3-6 X 10(6) unit/day. Out of 391 patients entered into this study, 280 patients were evaluable. Complete and partial responses were observed in 40 (14.3%) out of 280 evaluable patients, including 11 (19.6%) out of 56 renal cell cancers, 14 (19.2%) out of 73 multiple myelomas, and 9 (17.3%) out of 52 malignant lymphomas among others. Major side effects were fever (69.8%), gastrointestinal disturbances (31.4%), leukopenia (30.7%), thrombocytopenia (27.8%), hepatotoxicities (23.6%) and general fatigue (22.1%).
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PMID:[A cooperative phase I-II study of HLBI in patients with malignant tumors]. 632 4

Nineteen patients with advanced refractory metastatic breast cancer no longer responsive to chemotherapy were treated in the first phase II efficacy trial of recombinant leukocyte A interferon (IFL-rA), a highly purified single molecular species of alpha interferon prepared by recombinant DNA methods. Patients received a previously determined maximum tolerated dose for this agent (50 X 10(6) U/m2 body surface area) by intramuscular injection three times weekly for up to 3 months. The symptoms of toxicity observed in this trial resemble those previously reported for alpha interferons and include fever, chills, fatigue, anorexia, and leukopenia. All patients required dose reductions, most often for reasons of severe fatigue. Of the 17 patients evaluable for tumor response, one patient had stable disease and 16 had evidence of tumor progression. We conclude that IFL-rA is not an active agent in the treatment of advanced, refractory breast cancer when used at a maximum tolerated dose on this treatment schedule.
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PMID:Recombinant leukocyte A interferon in advanced breast cancer. Results of a phase II efficacy trial. 634 90

A randomized trial began in 1980 comparing the efficacy and toxicity of mitoxantrone and doxorubicin. Patients with metastatic breast cancer unresponsive to cyclophosphamide-methotrexate-5-fluorouracil with or without tamoxifen were randomized to either mitoxantrone, 12 mg/m2, or doxorubicin, 60 mg/m2, every 3 weeks. Patients were crossed over to the alternative treatment if they progressed after two courses or fail to respond after four courses. Fifty-nine patients have been randomized at the present time, and most of these have a performance status near to normal. During initial therapy, partial responses were obtained in 10 of 25 patients receiving doxorubicin, and a further 12 showed stable disease; 3 showed progressive disease. Of the 26 patients who received mitoxantrone as initial therapy, 7 achieved a partial response, 14 had stable disease, and 5 progressive disease. Twenty-seven patients received doxorubicin or mitoxantrone as secondary therapy; two patients each responded to these drugs, suggesting a lack of cross-resistance. The median time to response was 48 days for doxorubicin and 57 days for mitoxantrone. The duration of partial responses measured from the onset of response was similar for both drugs, being 84 days for doxorubicin and 96 days for mitoxantrone. Hematologic toxicity, vomiting, alopecia, and fatigue tended to be less frequent and less severe with mitoxantrone than with doxorubicin. Mitoxantrone appears to be an effective and well-tolerated agent for breast cancer. Definitive comparisons will be available at the completion of this study.
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PMID:A comparative trial of mitoxantrone and doxorubicin in patients with minimally pretreated breast cancer. 638 59


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