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Biomedical subjects

I Elomaa

Publications and source records attributed to I Elomaa.

At least 109 records · Page 6Linked to original sources

FEC (5-fluorouracil-epirubicin-cyclophosphamide) monthly versus FEC weekly in metastatic breast cancer. First results of a randomized trial.

Patients (n = 174) with metastatic breast cancer previously untreated with anthracycline cytotoxic agents were randomized into two groups: Group 1 received FEC (5-fluorouracil 500 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 500 mg/m2) once every fourth week and group 2 received the treatment once weekly in the same monthly dosage. Treatment was recommended to continue until disease progression or to a cumulative epirubicin dose of 1,000 mg/m2, but could be discontinued at any time at the patient's request or at the treating physician's judgement. An interim analysis was made when 131 patients were evaluable for response, and 128 patients for toxicity. Hematological toxicity was significantly more severe in the monthly group, as was nausea and vomiting. Of the monthly treated patients 76% had total alopecia compared to 14% in the weekly group. There were no statistically significant differences in the occurrence of mucositis. Monthly FEC gave significantly higher response rate than weekly treatment (52 vs 34%, p = 0.01). Time to progression was significantly (p = 0.004) longer with monthly FEC. Patients in the monthly treated group lived significantly (p = 0.02) longer than patients in the weekly group. These results indicate that both toxicity and efficacy of epirubicin-containing combination therapy in breast cancer is dependent on the treatment schedule, not merely on dosage. Both efficacy and toxicity increased when the treatment was given once monthly compared to the weekly schedule.

Antineoplastic Combined Chemotherapy Protocols↗

Adjuvant hormone therapy in breast cancer.

Recent results from controlled trials of adjuvant tamoxifen and oophorectomy in early breast cancer are reviewed. The results of the statistical overview performed by the Early Breast Cancer Trialists Collaborative Group are summarised, and some important questions left open by this overview are discussed. These include the choice of patients for adjuvant endocrine treatment, long term results of tamoxifen, interaction with postoperative radiotherapy, the effect of tamoxifen on non-cancer deaths, and interaction of the adjuvant effect of tamoxifen with concentrations of oestrogen receptor levels in the tumour.

Breast Neoplasms↗

Postirradiation sarcoma. Analysis of a nationwide cancer registry material.

Thirty-three cases of postirradiation sarcoma (PIS) from the files of the Finnish Cancer Registry were analyzed. The most frequent first primary tumors were cancers of the breast (seven cases) and female reproductive organs (13 cases). Five patients had a childhood cancer. The median total radiation dose at the site of the PIS was 3600 cGy (1600 cGy to 11200 cGy). The median interval from start of radiation therapy to detection of PIS was 13.2 years (3.4 to 22.8 years). The PIS was of soft tissue origin in 25 of 33 cases. The most frequent histologic types were osteosarcoma (ten cases, including four extraskeletal tumors), malignant fibrous histiocytoma (ten cases), and fibrosarcoma (six cases). The overall crude 5-year survival rate was 29% (calculated from the start of treatment for PIS), and for patients initially treated with either radical surgery or combined marginal surgery and postoperative irradiation it was 67%. The authors conclude that there is a chance for cure for radically treated patients with postirradiation sarcoma that emphasizes the importance of regular long-term follow-up of cancer patients.

Adolescent↗

Treatment of osteosarcoma of the extremities with the T-10 protocol, with emphasis on the effects of preoperative chemotherapy with single-agent high-dose methotrexate: a Scandinavian Sarcoma Group study.

From 1982 to 1989, 97 patients with extremity-localized, high-grade osteosarcoma were treated according to the T-10 protocol. Two thirds of the patients consisted of the near-complete national patient materials from Norway and Finland. Eighty patients (82%) received four courses of high-dose methotrexate (HD MTX, 8 to 12 g/m2) at weekly intervals as their only preoperative treatment, and 77 patients (79%) were assessable for histologic response grading according to Rosen et al (Cancer 49:1221-1230, 1991). Observed histologic response was no certain chemotherapy effect (grade I) in 21%, grade II effect in 62%, and grade III or IV effect in 17%. Nonresponders had significantly lower serum MTX concentrations after 24 and 48 hours than responders; the significance of the difference at 48 hours was maintained in a multivariate analysis. After a median follow-up of 45 months, projected 5-year overall and relapse-free survival for all patients were 64% and 54%, respectively. Patients with a good response to preoperative chemotherapy (grade III/IV) had a significantly better survival than grade I/II responders, despite a switch to postoperative cisplatin/doxorubicin chemotherapy in the latter group. These results were obtained in a largely nonselected group of patients. We conclude that a good initial chemotherapy effect is important for the final outcome in osteosarcoma, and that HD MTX alone is insufficient preoperative treatment for the majority of patients. The individual MTX excretion rate is of importance for tumor response, suggesting a dose-response relationship for HD MTX treatment.

Adolescent↗

Hormone-resistant metastatic prostate cancer. Comparisons between estramustine phosphate and low-dose epirubicin treatments.

We compared the effect and toxicity of estramustine phosphate and weekly low-dose epirubicin in a prospective randomized trial in 41 patients with metastatic prostate cancer refractory to hormonal manipulation. No significant difference between treatment modalities was seen. Palliation was reached in over 60% of patients. The median survival was 15 months in both groups. Toxicity was mild. Further, we investigated the effect of epirubicin after the failure of preceding estramustine phosphate therapy in additional 20 patients. Pain relief was achieved in 50% of these patients. The median survival was 10 months. Toxicity was acceptable.

Aged↗

Testicular function after chemotherapy for osteosarcoma.

Testicular volume, sperm count and four hormones were measured in 18 patients 1-13 years after chemotherapy for osteosarcoma. The testicles were small in 13 patients. 17 patients gave semen samples: 10 were azoospermic and 2 were oligozoospermic. Testicular volume and sperm count were possibly associated with the type of chemotherapy. Of the 7 patients who had received cisplatin-containing chemotherapy, 6 had small testes and azoospermia; 1 was oligozoospermic with normal-sized testes. In 3 of the 11 patients whose chemotherapy had not included cisplatin, testicular size and sperm count were normal.

Adolescent↗

Ten years' experience in patients with osteogenic sarcoma in Finland.

Ten years' results of 56 patients with high grade osteogenic sarcoma are reported. Fifty-two patients had M0 disease. Immediately after open biopsy the patients were treated with chemotherapy using modified Rosen's protocols T4, T7 and T10. The primary tumor was adequately removed in most patients. Six children were treated with limb saving. The actuarial and disease-free survival was 80% after 1 year, and 73% to 8 years. Two patients died because of toxic side effects of chemotherapy, one of septicemia, the other of late cardiac failure secondary to doxorubicin.

Actuarial Analysis↗

Experiences of clodronate treatment of multifocal eosinophilic granuloma of bone.

Clodronate, an inhibitor of osteoclast function, reduces bone resorption in osteolytic metastases and in multiple myeloma. We have evaluated its ability to decrease bone destruction in patients with multifocal eosinophilic granuloma of the skeleton. Two patients, whose multifocal bone granulomas appeared with a frequency of about 6 months, received 1.6 g day-1 oral clodronate for 6 months. Both patients had a reduction in serum calcium level which was accompanied by a decline in the fasting urinary hydroxyproline/creatinine and calcium/creatinine ratios and a slight increase in parathyroid hormone (PTH) level. Pain relief was observed in both patients. No new bone lesions were seen during the treatment and the old lesions healed. After discontinuing the therapy, however, new painful lesions appeared after 5 years in patient 1 and after 3, 4 and 5 years in patient 2. We suppose that clodronate delayed the appearance of new granulomas.

Adult↗

Pharmacokinetics of clodronate in patients with metastatic breast cancer.

Pharmacokinetics of clodronate was studied in six breast cancer patients with only bone metastases. 14C-clodronate was administered intravenously (10 muCi/200 mg) and orally (20 muCi/400 mg) on separate occasions. Vc of clodronate averaged 6.3 +/- 3.0 (SD) 1 and Vdss 16.3 +/- 3.81 corresponding to the extracellular water volume. Distribution and elimination were fast with t1/2 alpha of 0.22 +/- 0.22 h and t1/2 beta of 2.3 +/- 0.9 h. The elimination occurred mainly by renal excretion of the unchanged drug CLP averaging 107 +/- 27 ml/min and CLR 80 +/- 18 ml/min. The protein unbound, free fraction in plasma was 64%. On the basis of urinary excretion data, there was a slow terminal elimination phase with a half-life of 12.8 +/- 6.9 h. Thus about 20% of the intravenous dose was retained in the body, most likely in the bones, 3 days after drug administration. About 75% of the intravenous dose was recovered in urine and 5% in feces. Based on cumulative excretion data into urine after both routes of administration, the bioavailability of oral clodronate was 1.9 +/- 0.4%. These findings correspond closely to those obtained in healthy volunteers in previous studies.

Administration, Oral↗

Pharmacokinetics of disodium clodronate after daily intravenous infusions during five consecutive days.

The pharmacokinetics of disodium clodronate was studied in six patients, three females and two males with Paget's disease and one male patient with prostatic cancer. The drug was given at a dose of 300 mg/day as a 3-hour infusion for 5 consecutive days. The concentration of the drug in serum and urine was measured by a gas chromatographic method. The peak concentration of disodium clodronate in serum was 5.7 +/- 1.0 micrograms/ml (means +/- SD) for the males and 10.1 +/- 2.8 micrograms/ml for the females. The elimination half-lives of the drug were 0.76 +/- 0.47 h and 1.79 +/- 0.26 h and the total clearances 18.2 +/- 3.3 l/h and 11.5 +/- 1.9 l/h, respectively. During the fifth day both sexes showed similar mean clearances of 11.9 +/- 1.3 l/h and 11.1 +/- 2.5 l/h and half-lives of about 2 h. The renal clearances was 7.3 +/- 0.5 l/h and 5.9 +/- 0.4 l/h for males and females, respectively. The mean urinary excretion of disodium clodronate during the 5-day period was 59.5% in the male patients and 56.0% in the female patients. We concluded that the slow infusion may increase the accumulation of clodronate in the body causing a higher clearance and a lower urine excretion of the drug than seen in earlier studies with faster infusions.

Aged↗

Evaluation of salmon calcitonin treatment in bone metastases from breast cancer--a controlled trial.

Salmon calcitonin 100 MRCU/day or a saline placebo were given in daily injections for at least three months to 49 patients with bone metastases from breast cancer in a randomized double-blind trial. All patients were normocalcemic, and most patients had stable or regressing disease at start of trial. No improvement in general performance or bone pain was detected as measured by a visual analogue scale, the daily duration of pain or consumption of analgetic drugs. Calcitonin had no effect on disease progression as judged by bone scans and radiographs. Calcitonin therapy did not affect serum calcium, alkaline phosphatase, bone gla-protein, or the urinary excretion of calcium and hydroxyproline. Serum phosphate and magnesium decreased significantly during calcitonin treatment (p = 0.01, and 0.00005, respectively). It was concluded that salmon calcitonin in this dosage has no discernible effect on skeletal pain, general performance, bone metabolism or disease progression in patients with breast cancer metastatic to bone. A significant decrease in serum phosphate and magnesium probably indicated an effect of calcitonin on the renal excretion of these ions.

Bone Neoplasms↗

Preservation of intestinal integrity during radiotherapy using live Lactobacillus acidophilus cultures.

Twenty-four female patients suffering from gynaecological malignancies and scheduled for internal and external irradiation of the pelvic area (pelvic dose 5000 cGy) were selected for a study on prevention of intestinal side-effects by live Lactobacillus acidophilus cultures. The patients were randomised into two groups. Both groups received dietary counselling recommending a low-fat and low-residue diet during radiotherapy. The control group received dietary counselling only. The test group received 150 ml of a fermented milk test product supplying them with at least 2 X 10(9) live Lactobacillus acidophilus bacteria daily and 6.5% lactulose as substrate for the bacteria. The results indicated that the test product appeared to prevent radiotherapy-associated diarrhoea. However, flatulence was increased probably due to lactulose ingestion in the test group.

Adult↗

Aminoglutethimide for advanced prostatic cancer resistant to conventional hormonal therapy.

Aminoglutethimide (AG) and hydrocortisone (HC) were given to 20 patients with advanced prostatic cancer resistant to conventional hormonal therapy. Most patients had painful bone metastases and were heavily pretreated. 12 of 16 patients required narcotic analgetics. 8 of 20 were bedridden. AG + HC produced relief of bone pain in 12 patients (75%) and only 4 required narcotics after treatment. The performance status improved in 8 of 20 patients (40%). However, the number of bone metastases seen in bone scans decreased in only 4 patients (22%). The level of serum alkaline phosphatase decreased in 11 of 18 patients and that of acid phosphatase in 8 of 16 patients. The reduction of bone pain lasted approximately 4 months (range 1-15 months). The median lifespan between the start of AG treatment and death was 8 months (range 2-22 months). There was no difference in survival between responders and nonresponders. 3 patients had skin rash, 1 lethargy and 1 thrombocytopenia.

Aged↗

Weekly low-dose doxorubicin as second line therapy in advanced breast cancer.

This is a retrospective analysis of women whose advanced breast cancer was treated with weekly low-dose doxorubicin (12 mg/m2) as second line therapy. The patients received doxorubicin as single agent therapy (group D, n = 47) or combined with various cytotoxic (group D+CT, n = 52) or with hormonal drugs (group D+ET, n = 37). Objective responses were found in 23% in group D, in 33% in group D+CT and in 30% in group D+ET. Mean response duration was 11 months in group D+CT and group D+ET and 6 months in group D (p = 0.007, Student's t-test). Median survival was 17 months in group D+CT and 9 months both in group D and group D+ET (p = 0.01, Mantel-Cox). The toxicity was mild. However, nausea occurred more often in group D+CT than in group D (p = 0.009, chi-square-test).

Adult↗