Recombinant human C1 inhibitor for the prophylaxis of hereditary angioedema attacks: a pilot study.

BACKGROUND: Hereditary angioedema (HAE) is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study evaluated the safety and prophylactic effect of weekly administrations of recombinant C1INH (rhC1INH). METHODS: Patients with a history of HAE attacks occurring ≥every 2 weeks received a once weekly administration of 50 U/kg rhC1INH. Hereditary angioedema attack history was collected at screening. Breakthrough attacks during the study were recorded at each visit. Following a 2-week run-in period, HAE patients received 8 weekly rhC1INH administrations and were followed-up for an additional 6 weeks. Efficacy was evaluated by comparing the HAE attack incidence during the treatment period to the historical attacks over the previous 2 years. Safety evaluation was based on clinical laboratory and adverse events (AEs) reports. RESULTS: The 25 participants reported a mean of 0.9 attacks/week over the past 2 years. The mean breakthrough attack rate during the treatment period was 0.4 attacks/week (95% CI 0.28-0.56). A total of 30 treatment-emergent-AEs were reported in 13 patients, all mild to moderate. One patient died from a laryngeal attack 25 days after last study drug administration. The only possible drug related AEs reported were dry mouth, dizziness and anxiety in one patient and hypotension in another. There were no allergic AEs and no neutralizing antibodies observed. CONCLUSIONS: Weekly administrations of 50 U/kg rhC1INH appeared to reduce the frequency of HAE attacks and were generally safe and well tolerated.

[Breast cancer in combination with other malignant tumors]. / Rak molochnoi zhelezy v sochetanii s drugimi zlokachestvennymi opukholiami.

Since 1950 to 1968 in the Nikolaevsk Province Oncological dispensary 1006 breast cancer patients were radically operated upon. 943 patients were followed up, primary multiple tumors being observed in 52 of them (5.5%). Primary multiple tumors in stage I were noted in 2.3% of cases, in stage II--in 7.7%, in stage III--in 4.2%. A second tumor appeared in different terms following the cure of mammary gland cancer: in the other gland--in 28 cases, in the uterus--in 7, in the stomach--in 4, in ovaries--in 1, 7 patients developed skin cancer, 1--cancer of the lower lip and 2--lymphogranulomatosis.

Localized renal cell carcinoma treated by radical nephrectomy. Influence of pathologic data and the importance of DNA ploidy pattern on disease outcome.

BACKGROUND: The course of patients with renal cell carcinoma may be considerably different. Approximately 50% with presumed localized disease have metastases after nephrectomy. Pathologic stage at diagnosis, histologic grade, and histologic type have been considered the most important predictors of prognosis. Nevertheless, subsets of patients within a specified stage and grade may have considerable differences in disease progression and survival. METHODS: Flow cytometric nuclear DNA analysis was used to study pathologic Stage I or II renal cell carcinoma in 54 patients who underwent radical nephrectomy between 1974 and 1983. RESULTS: Sixty-three percent of the tumors were diploid, and 37% aneuploid. A DNA diploid pattern was more common among Stage I tumors than Stage II tumors (69% versus 33%; P < 0.04). Progression occurred in 31% of the diploid tumors, whereas among the aneuploid group the progression rate reached 59% (P < 0.06). Considered as a single indicator, DNA ploidy pattern was strongly associated with patient survival. Ten years after surgery 79% of the patients who had diploid tumors and 50% of those with aneuploid tumors were alive (P < 0.02). CONCLUSIONS: Nuclear DNA ploidy may serve as an important prognostic variable for patients with early stage renal cell carcinoma.

Testicular seminoma: clinical significance of nuclear deoxyribonucleic acid ploidy pattern as studied by flow cytometry.

PURPOSE: We evaluated the clinical significance of deoxyribonucleic acid (DNA) ploidy pattern as a predictor of prognosis in patients with testicular seminoma. MATERIALS AND METHODS: Flow cytometric nuclear DNA analysis was performed on archival specimens from 65 patients with pure seminoma who underwent radical orchiectomy between 1970 and 1992. RESULTS: A total of 42 specimens (65%) exhibited a DNA diploid pattern, while 23 (35%) were DNA aneuploid. Diploidy was manifested in 73% of the stage I tumors versus 31% of stage II cancers (p = 0.004). No correlation was found between ploidy and histological type, size or local extension of the tumor. Tumor progression was observed in 5 patients, exclusively displaying aneuploid histograms (p = 0.0017), and 3 of them subsequently died of the disease. CONCLUSIONS: DNA ploidy pattern may provide important prognostic information for patients with testicular seminoma.

Radical retropubic prostatectomy in the treatment of localized prostate cancer: experience with 100 consecutive cases.

In recent years radical retropubic prostatectomy is used with increasing frequency to treat localized cancer of the prostate. We report our experience with 100 consecutive cases of prostate cancer that underwent this operation; there were no cases of mortality and a 7% rate of postoperative complications. More than 90% of the patients are socially continent postoperatively and 20% have retained sexual potency. Ninety-four percent of the patients are free of disease (mean follow-up period 18 months). In our opinion, such results support the use of radical retropubic prostatectomy for the treatment of localized prostate cancer in well-selected patients.