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Biomedical subjects

N Niederle

Publications and source records attributed to N Niederle.

At least 109 records · Page 6Linked to original sources
PubMed1987

Two randomised phase II trials of intermittent intravenous versus subcutaneous alpha-2 interferon alone (trial 1) and in combination with 5-fluorouracil (trial 2) in advanced colorectal cancer.

Sixty-five patients with advanced colorectal cancer were randomised to one of two schedules of recombinant alpha-2 interferon (IFN). In the first study, 36 patients received single-agent IFN, either 50 X 10(6) U/m2 intravenously on 5 consecutive days every 4 weeks, or 20 X 10(6) U/m2 subcutaneously three times per week. No tumour responses were seen and toxicity was unacceptable. In the second study, 29 patients received IFN in two similar schedules, but the dose of IFN was reduced to 20 X 10(6) U/m2 per day in the intravenous arm and to 5 X 10(6) U/m2 per day in the subcutaneous arm. In addition these patients were administered intravenous 5-Fluorouracil (5-FU), 250-500 mg/m2 per day on the first 5 days of each 4-weekly cycle. Although the toxicity of this second study was tolerable, only one short-lived partial remission was observed. Alpha-2 interferon, alone or in combination with 5-FU, is ineffective in advanced colorectal cancer.

Adenocarcinoma↗
PubMed1987

[Treatment of metastasized carcinoid tumor of the ileum and cecum with recombinant alpha-2b interferon].

Seven patients with progressive ileal or caecal carcinoid tumors and liver metastases were treated with human recombinant alpha-interferon (IFN alfa-2b) at a dosage of 2-4 x 10(6) U daily or every other day subcutaneously. Six patients had symptoms of the carcinoid syndrome. No change of tumor size lasting 4 to 40+ months (median, 18 months) was noted in 6 patients, and 1 patient had hepatic tumor progression. A decrease in urinary excretion of 5-hydroxyindoleacetic acid by more than 50% lasting 2-11 months (median, 4) was observed in 5 patients. Four patients were completely or partially relieved of flushing, diarrhea, obstruction or abdominal pain. The side-effects were negligible with the exception of mild fever, headache and confusion only during the first days of therapy. Treatment with IFN alfa-2b offers good palliation to patients with disseminated ileal or caecal carcinoid tumor and carcinoid syndrome.

Adult↗
PubMed1987

Interferon alfa-2b in the treatment of chronic myelogenous leukemia.

Thirty-six patients with Philadelphia chromosome-positive CML were treated with interferon alfa-2b for at least 3 months. Thirty-two of the patients had chronic phase disease and four had acute phase disease, one in blast crisis. Patients initially received a daily dose of 4 megaunits/m2 administered subcutaneously; outpatient self administration followed at a dosage decreased in accordance with serially determined blood cell counts. Treatment was continued for 0.5 to 15 months, with a median duration of 7 months. No complete remission was achieved, but hematologic remission occurred in 21 (58%) patients, with partial hematologic remission in an additional 12 (33%). All four patients with acute phase disease failed to respond. Adverse reactions were only significant during the first days of treatment and did not interfere with self administration of the drug. Interferon alfa-2b may prove to be an important alternative therapeutic modality in chronic phase CML.

Adolescent↗
PubMed1986

[Therapy of primary resistant or recurrent small cell bronchial carcinoma with vindesine and ifosfamide].

A combination of vindesine (3 mg/m2, day 1) and ifosfamide (60 mg/kg, days 1-5 + Mesna) was administered every three weeks to 11 patients with primary resistant and 23 with recurrent small-cell bronchial carcinoma. All patients had been pre-treated with chemotherapy, 16 in addition with radiotherapy. At the onset of the vindesine-ifosfamide treatment the cancer was in a localized regional stage in ten patients, while in 24 it was in a more widely spread stage. In 29 patients whose treatment results could be evaluated the remission rate was 38%, with two complete and nine partial remissions. In a further eight patients the cancer was arrested. The patients with complete remission (for 46 and 53 weeks, respectively), those with partial remission (median of 39 weeks) and those with stationary disease (median of 31 weeks) survived significantly longer than those with progressing disease (13 weeks). There was no correlation between treatment result and pre-treatment. On recurrence after complete remission or in the localized regional stage the remission rate was 70% and 60%, respectively, and the survival time was extended in 90% of cases. In addition to nausea, alopecia and myelosuppression, side-effects included vomiting, reversible CNS symptoms, polyneuropathy and urotoxicity. On the basis of acceptable toxicity, combined vindesine and ifosfamide constitute an effective treatment of otherwise treatment-refractory cases of small-cell bronchial carcinoma.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1986

[alpha 2-interferon: preliminary treatment results in chronic myeloid leukemia].

Interferon (IFN-alpha 2 B) was administered to 21 patients with chronic myeloid leukaemia (CML), at an initial dose of 4 X 10(6) IU/m2 daily subcutaneously, adapted to changes in leukocyte count in the course of treatment. Of 16 patients that could be fully evaluated (12 males, 4 females; aged 21-64 years), 15 were in the chronic phase, one had a blast crisis. "Haematological remission" was achieved in nine of the 16 patients, while in the remainder, with one exception, transitory reduction in leukocyte count was obtained. With pretreatment counts of 18-151 X 10(9)/l, normalization to 2.7-6.9 X 10(9)/l was achieved in 13 patients after 3-40 weeks. In parallel to these effects there was a decrease in platelet count (before treatment 86-1550 X 10(9)/l to 30-279 X 10(9)/l after an average of six weeks) and in lactate dehydrogenase (initially 220-958 U/l to 87-232 U/l after 3-33 weeks). A reduction in Philadelphia chromosome-positive metaphases by as much as 50% was observed in four of eight patients. Administration of IFN-alpha 2 B achieved a relatively rapid cell reduction in the chronic phase of CML. The long-term effect on the course of the disease and the place of IFN in the overall concept of CML treatment remains unanswered.

Adult↗
PubMed1986

Crossover comparison of the antiemetic efficacy of nabilone and alizapride in patients with nonseminomatous testicular cancer receiving cisplatin therapy.

Twenty nonseminomatous testicular cancer patients not pretreated with emetogenic chemotherapy were included in a crossover study of antiemetic therapy. Patients were randomly assigned to receive either nabilone (2 X 2 mg/day) or alizapride (3 X 150 mg/day) prior to beginning low-dose cisplatin chemotherapy. Patients on nabilone had significantly fewer episodes of emesis than those on alizapride (medians, 1.1 vs 2.9; p less than 0.01). Nabilone was superior to alizapride in giving complete relief from nausea (medians, 65% vs 30%; p less than 0.01), and was more effective in shortening the duration of nausea (medians, 1.3 h vs 5.1 h; p less than 0.01); however, it caused more adverse effects. It is concluded that nabilone has greater antiemetic activity than alizapride in young patients receiving low-dose cisplatin chemotherapy. Nabilone dosage should be reduced to decrease the incidence and degree of adverse reactions while leaving the definite antiemetic activity unchanged.

Administration, Oral↗
PubMed1985

Chemotherapy of metastatic seminoma.

Response to chemotherapy and survival was retrospectively analyzed in 28 patients with bulky retroperitoneal and disseminated seminoma treated between 1977 and 1983. The median age was 41 years (range: 23-52). All patients had histological evidence of pure testicular seminoma, however, 14 patients revealed moderate increases of human beta-chorionic gonadotropin levels. Prior radiotherapy had been given to 9/28 (32%) patients. Treatment consisted of at least four courses of simultaneous or sequentially alternating therapy with cisplatin, vinblastine, bleomycin plus/minus adriamycin (PVB +/- A), administration of ifosfamide or combination therapy with ifosfamide/cisplatin (IFS/DDP) or ifosfamide/etoposide (IFS/ETP). Twenty-five of 28 patients (89%) achieved a complete (CR), and 3/28 patients a partial remission. Relapse occurred in 1/8 CR patients after adjuvant postchemotherapeutic irradiation, and in 1/11 patients without any further radiotherapy. So far, 23/28 patients (82%) are free of disease after a median follow-up of 28+ (14+----82+) months. Marked myelosuppression was observed in previously irradiated patients, mainly after PVB +/- A therapy. In two patients, transient nephrotoxicity developed after PVB and IFS/DDP, respectively. After PVB +/- A chemotherapy, three patients revealed polyneuropathy, paralytic subileus and bleomycin-induced pneumonitis, respectively. In conclusion, the present series suggests a high probability of continuous CR in even bulky retroperitoneal and widespread metastatic seminoma. So far, no definite conclusions can be made on the therapeutic superiority of one of the different chemotherapeutic regimens used. However, this preliminary experience suggests that the combination of ifosfamide and etoposide or cisplatin may prove less toxic than sequentially alternating or simultaneous PVB +/- A chemotherapy.

Adult↗
PubMed1984

Vindesine/cisplatin chemotherapy in relapsed or primarily resistant small-cell carcinoma of the lung.

Thirty-eight pretreated patients with primarily resistant [6] or relapsed [32] small-cell lung cancer were treated with a combination of vindesine (3-4 mg/m2) and cisplatin (60-100 mg/m2). Eight patients responded to this therapy with three (8%) complete and five (13%) partial remissions. Minor responses were noted in 12 (32%) additional patients. Chemotherapeutic response was rare in regions of prior irradiation. In the complete remission group survival from start of vindesine/cisplatin therapy lasted 61, 48 and 38 weeks, respectively. In the "less-than-complete-remission" group median survival was 12 weeks. Nausea and vomiting were the prominent side-effects, while only mild to moderate myelosuppression was noticed in most cases. The vindesine/cisplatin combination showed significant activity in heavily pretreated small-cell lung carcinoma. However, the remission rates remain low in this unfavourable condition, which might be due to pronounced chemotherapeutic resistance in previously irradiated areas.

Adult↗
PubMed1984

[Biological effect of recombined leukocyte alpha-2-interferon in metastasizing colorectal cancers].

High-dosage recombinant alpha 2 interferon ( rIFN -alpha 2) was used for treatment of 12 patients with metastatic adenocarcinoma of the colon or rectum. In a prospective randomised fashion either 50 X 10(6) E/m2 as 30-minute infusion on 5 consecutive days four-weekly or 20 X 10(6) E/m2 subcutaneously thrice weekly were administered. No significant regression of the tumour could be observed. Treatment side-effects such as fever, shivering and fatigue were so pronounced particularly after subcutaneous administration that no patient could be treated for longer than 8 weeks. According to these findings single use of rIFN -alpha 2 does not seem to be of use for treatment of metastatic colorectal carcinomas. Subcutaneous administration is associated with considerable side-effects which subjectively in the majority of patients were considered intolerable.

Adenocarcinoma↗
PubMed1984

4'-Epi-Doxorubicin -- a clinical phase-II trial in solid tumors.

4'-Epi-doxorubicin is a new anthracycline analog with reduced cardiac toxicity in animal studies. A phase-II study was performed in 17 patients predominantly with non-small-cell lung cancer. All suffered from recurrent or advanced tumors and 7 of 16 evaluable patients had been pretreated with an alternative chemotherapy. 4'-Epi-doxorubicin was applied at a dose of 75 mg/m2 every 3-4 weeks. The median total dose was 280 mg (range: 130-250 mg). Only one patient with epidermoid lung cancer (overall response rate: 6%) showed a minor response and stable disease was observed in six other patients with bronchogenic carcinoma. Myelosuppression was rare and moderate: leukocytopenia of less than 2,000/mm3 occurred in 25% of patients and thrombocytopenia of less than 100,000/mm3 in 8% of patients. The frequency of alopecia and gastrointestinal side effects was 88% and 80%, respectively. Persistent electrocardiographic alterations were recorded in 2 of 14 (14%) patients. One of four patients revealed a marked reduction of left ventricular ejection fraction in radionuclide cardiography. It is concluded that 4'-epi-doxorubicin is not superior to adriamycin in this low-prospect treatment area, but studies with increased doses appear necessary in adriamycin-sensitive tumors because of recent reports from phase-III trials showing reduced cardiac and gastrointestinal toxicity with 4'-epi-doxorubicin in comparison with adriamycin.

Adult↗
PubMed1984

Phase II evaluation of fractionated low and single high dose cisplatin in various tumors.

Seventy-three evaluable patients with advanced measurable solid tumors were given cisdichlorodiammineplatinum (II) (DDP) at a dose of 20 mg/M2 IV for 1-5 days every 3 weeks, and 19 patients who failed on this low dose DDP protocol received a single high dose of 100 mg/M2 IV once every 3 weeks. Forty-six patients had received prior chemotherapy, and 29 patients were untreated. Results included four complete responses (5.5%) in malignant melanoma, spindle-cell sarcoma, adrenal carcinoma, and bladder carcinoma lasting 2 to 4 months. In 21 patients (28.8%), partial responses were achieved. Twenty-two patients (30.1%) showed stable disease and 26 (35.6%) had tumor progression. A response rate of 25% (4/16 patients) was found for malignant melanoma, 45.5% (5/11) for nonsmall-cell lung cancer, and 35.3% (6/17) for sarcomas of various types. One patient with teratocarcinoma, who relapsed on low-dose DDP, had another partial remission for 4 months after high-dose therapy. Toxicity was most commonly seen with gastrointestinal side effects and myelosuppression. Cumulative nephrotoxicity was prevented by prehydration and/or treatment with furosemide or mannitol.

Adult↗
PubMed1984

Treatment of recurrent small cell lung carcinoma with vindesine and cisplatin.

Thirty-two males with recurrent small cell lung cancer after previous remission were treated with vindesine (3-4 mg/m2) plus cisplatin (60-100 mg/m2). Six patients (19%) responded to this therapy with two complete (CR) and four partial remissions. Minor responses were seen in another ten patients (32%). In patients with CR survival from start of treatment lasted 61 and 38 weeks; in patients who did not achieve CR median survival was 12 weeks. Nausea and vomiting were the predominant side effects, while only mild to moderate myelosuppression was noted. The vindesine and cisplatin regimen demonstrated significant activity against heavily pretreated small cell lung cancer, although chemotherapeutic response was poor in regions of prior irradiation.

Adult↗
PubMed1983

[Angiotensin-converting enzyme activity during cytostatic therapy in patients with primary inoperable bronchial carcinoma].

In 43 patients with inoperable bronchogenic carcinoma--32 small cell and 11 squamous or large cell--Angiotensin-Converting-Enzyme (ACE) activity in serum was determined before and every 3-5 weeks during cytotoxic chemotherapy. ACE-activity prior to therapy was 10.7 U +/- 1.17 SE as compared to the normal values 20.4 U +/- 1.8 SE which was statistically significant (p less than 0.01). There was no significant difference between the basal values of patients with small cell and not small cell-carcinoma of the lung. Only for patients with small cell-carcinoma of the lung a significant rise in ACE-activity could be obtained. Mean values of these patients reached normal levels in case they had complete remission, which was achieved in the limited disease group in 82% of patients. The present data suggest, that ACE-activities in serum correspond well to the clinical course in patients with small cell carcinoma of the lung. The decision on the individual mode of therapy may thus become more substantiated by serial determinations of ACE in the course of treatment.

Adult↗
PubMed1983

Phase II trial of aclacinomycin A in acute leukemia and various solid tumors.

Aclacinomycin A (ACM) is a new anthracycline antibiotic with a reduced cardiac toxicity in animal models. A phase II study was performed in a total of 25 patients, 23 of whom are evaluable for response. All suffered from recurrent and advanced tumors. Pretreatment consisted of at least four different chemotherapeutic agents (range: 4-9). Lung cancer patients (3/9) were irradiated to the mediastinum. Eighteen patients were pretreated with doxo- or daunomycin. The dose for solid tumors was 2-3 mg/kg given on 3 consecutive days every 3 weeks. Leukemia patients received a daily dose of 20 mg/m2, and standard response criteria were used. Marked reductions of leukocyte counts were achieved in leukemia patients. The overall response rate was about 15% in solid tumors, but major objective responses (CR + PR) have not been observed. Myelosuppression was commonly moderate in solid tumor patients, nausea and vomiting were rare, and alopecia was not induced. Cumulative cardiotoxicity was not evaluated in this trial. Treatment with ACM requires further investigation in acute leukemias and solid tumors, not pretreated with anthracycline antibiotics.

Aclarubicin↗