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PubMed1986

CCNU, etoposide, and prednimustine (CEP) in refractory Hodgkin's disease.

Starting in February 1980, 58 patients with Hodgkin's disease refractory to both MOPP and ABVD received as third-line chemotherapy a combination of CCNU or lomustine, etoposide, and prednimustine (CEP). Complete response (CR) was achieved in 40% of cases and partial response (PR) in 14%. The median duration of CR was greater than 15 months, and the median survival of complete responders was longer than 24 months. In addition, CEP alternating with ABVD was given to 21 patients refractory to MOPP chemotherapy. In this series, CR was documented in 67% of patients with a median duration of 24+ months and a median survival of 36+ months. Treatment was generally well tolerated, and all acute side effects were reversible. Present findings indicate that CEP is an effective regimen in patients refractory to MOPP and ABVD.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1989

Advanced mycosis fungoides: chemotherapy with etoposide, methotrexate, bleomycin, and prednimustine.

We assessed the efficacy and toxicity of a chemotherapeutic regimen in patients with stage II-IV mycosis fungoides. Eleven previously treated outpatients received etoposide and methotrexate p.o. and bleomycin i.v. every 3 weeks. There was 1 complete remission for 2 months and 7 partial remissions with a median duration of 6 months (range 2-16 months). Three patients showed stable disease lasting 1-5 months (median 2 months). In 4 patients, remissions were maintained with prednimustine after 10 courses of induction chemotherapy. Mild nausea occurred in all patients and severe leukocytopenia and thrombocytopenia in 1 patient. Toxicity of the treatment regimen was acceptable and response rates comparable to those seen by others with more toxic single-agent or combination chemotherapies.

Adult↗
PubMed1988

Premarin priming before prednimustine, high-dose folinic acid and 5-fluorouracil as salvage chemotherapy for advanced breast cancer.

Thirty patients with advanced and mainly pretreated breast cancer were treated with a combination of premarin, prednimustine, high-dose folinic acid and 5-fluorouracil. Among the 30 evaluable patients, 9 (30%) achieved an objective response (median duration: 9 months). Oral mucositis was the limiting toxicity, while myelosuppression was quite mild. In spite of considerable activity as salvage regimen, these results do not seem better than those achieved in our Institute with high-dose folinic acid and 5-fluorouracil alone.

Breast Neoplasms↗
PubMed1987

Combination chemotherapy with prednimustine, adriamycin, vincristine (VAP) in advanced breast cancer. A phase II study.

The purpose of this study was to evaluate VAP combination chemotherapy in advanced breast cancer: prednimustine 80 mg/m2 p.o. days 1-5, adriamycin 40 mg/m2 and vincristine 1.4 mg/m2 1st day in cycles of 3 weeks. Twenty-one women entered the study and 19 were evaluable. The mean age was 54.5 years (25-69) with an average performance status of 60 according to Karnofsky. Hormonal receptors were unknown in 10, positive in 6 and negative in 3. The dominant site of disease was soft tissues in 11, bones in 1, liver in 3 and lung in 4. Fourteen patients had as prior treatment cyclophosphamide, methotrexate and 5-fluorouracil (CMF), two had tamoxifen and three none. Ten patients (52.6%) had a partial response with a mean survival of 7.8+ months, 5 patients (26.3%) had stable disease with a mean survival 6.6+ months and 4 patients (21.1%) had progressive disease with a mean survival of 3 months. Regarding toxicity all patients had alopecia, most of the patients had nausea grade I, whereas 5 patients developed mild leukopenia. We conclude that VAP is an effective, well tolerated chemotherapy combination in patients with advanced breast cancer which deserves further clinical trials.

Adult↗
PubMed1986

Preliminary analysis of combined treatment with prednimustine and 4'epidoxorubicin in advanced breast cancer.

In an effort to define a well-tolerated therapeutic regimen for advanced breast cancer, we have studied a combination of 4'epidoxorubicin, 50 mg/m2 IV on day 1, and prednimustine, 100 mg/m2 PO on days 3 to 7 given every 3 weeks. Twenty-nine patients have been entered, and 22 are presently evaluable for response. Median age of the evaluable patients is 62 (range, 36 to 77), and median performance status (SAKK) is 2. Five patients had received chemotherapy, 16 hormonal therapy, five radiation therapy, and five no prior therapy for advanced disease. Most patients were in a high-risk group, with dominant visceral metastatic sites in 19 out of 22 cases. We have observed eight partial responses, nine no changes, and five progressions. Median response duration is 6 months. It is too early to discuss median overall survival. Toxicity is evaluable in 27 patients who received at least one course with a full dose of chemotherapy. Hematologic toxicity has been low, with only four patients having leukocyte nadirs below 2000/mm3 and three patients with thrombocyte nadirs below 100,000/mm3. Major alopecia (requiring a wig) was observed in eight patients. Emesis (controlled by minor antiemetics) was reported in six cases. This well-tolerated regimen is active in advanced high-risk elderly breast cancer patients, but dosage might be too low for younger patients and nonpretreated patients.

Adult↗
PubMed1986

A randomized comparative study of prednimustine and doxorubicin in patients with metastatic breast cancer.

A clinical protocol outline of a study randomizing prednimustine v doxorubicin in patients with metastatic breast cancer is presented. The study has just been initiated, and no results are available at the present time. Unique features of this clinical trial are discussed, including the correlation of objective parameters of tumor response with symptomatic improvement as measured by quality of life, performance status, and pain indices as well as alterations in body weight.

Breast Neoplasms↗
PubMed1987

[Phase II study of prednimustine in follicular lymphoma and chronic lymphocytic leukemia].

A phase II study of Prednimustine (PMN) was conducted for follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL). PMN at a dose of 40-60 mg/body, p.o. every day, was administered to 17 patients with FL and 4 with CLL. The dose and schedule of PMN was modified according to hematological toxicity. Among the 17 patients with FL, there were 6 (35.3%) CRs and 7 (41.2%) PRs, with a high response rate of 76.5%. Among the 4 patients with CLL, there were 2 PRs and one case which showed clinical improvement. PMN was effective for cases of FL and CLL refractory to alkylating agents, and therefore the result suggested a lack of clinical cross-resistance to these agents. As to the side effects observed in patients with FL, mild leukopenia (median of lowest count 3,150/mm3) occurred. One case experienced anorexia, while increased appetite was observed in 4 cases. We conclude that PMN is effective for FL and CLL, and that in addition, it has an advantage in that its mild side effects allow long-term administration through outpatient clinics, so that the quality of life for patients is not impaired.

Administration, Oral↗
PubMed1986

Prednimustine v cyclophosphamide-vincristine-prednisolone in the treatment of non-Hodgkin's lymphoma with favorable histopathology: results of a national cancer care program in Sweden.

In a nationwide multicenter study, single-agent treatment with prednimustine (PM) was compared with combination chemotherapy with CVP (cyclophosphamide, vincristine, and prednisolone) in patients with stage III-IV non-Hodgkin's lymphoma (NHL) with favorable histology (Rappaport groups nodular lymphocytic poorly differentiated, nodular mixed, and diffuse lymphocytic poorly and well-differentiated). From January 1979 to May 1982, 217 evaluable patients were randomized, and at present analysis, the median follow-up time is 42 months. Overall response rate in the PM group was 63% (complete, 40%; partial, 23%) compared with 66% in the CVP group (complete, 32%; partial, 34%). There was no significant difference in relapse-free survival (RFS) or survival between the two groups, median RFS being 30 months and median survival being 42 months, respectively. Reclassification of the lymphomas according to the Kiel system (possible in 80%) revealed high-grade malignant NHL in 22 patients (12 in PM group, 10 in CVP group). Within this small group, there was a marked difference in survival in favor of CVP-treated patients. However, treatment with PM was less toxic and better tolerated than the CVP regimen. It was concluded that for patients with low-grade malignant NHL treatment with PM is equally effective and less toxic than the CVP regimen.

Adolescent↗
PubMed1986

Combined cytotoxic and endocrine treatment of postmenopausal patients with advanced breast cancer: preliminary results of a phase II study of the combination of prednimustine, novantrone, methotrexate, 5-fluorouracil, and tamoxifen.

Postmenopausal patients with advanced measurable and/or evaluable breast cancer entered a phase II trial of multiple agent cytotoxic therapy combined with endocrine therapy. Cycles of PNMF (prednimustine, novantrone, methotrexate, and 5-fluorouracil) were repeated every 4 weeks as follows: P, 100 mg/m2 PO on days 1 to 5; M, 40 mg/m2 IV on day 1; F, 600 mg/m2 IV on day 1, and N, 14 mg/m2 IV on day 8. The endocrine therapy was tamoxifen given continuously, 10 mg three times daily. As of May 1985, 32 eligible patients had entered the study, 20 of whom had been treated for a sufficient time to enable evaluation of response. Ten patients responded (one complete, nine partial), five experienced no change, and five patients experienced progressive disease. The treatment regimen was fairly well tolerated, the dose-limiting factor being the hematologic toxicity. Conclusions from the trial must await the inclusion of more patients and longer time of follow-up.

Adult↗
PubMed1978

Prednimustine (NSC-134087, Leo 1031) treatment of lymphocytic and lymphocytic-histiocytic lymphomas.

Nineteen patients with advanced lymphocytic or lymphocytic-histiocytic lymphomas were treated with Prednimustine (NSC-134087, Leo 1031). The median induction dose was 25 mg/m2 a day by mouth (range 11-42). Ten patients had previously received radiation or chemotherapy, or both. Four patients had a complete remission and eleven a partial remission. The median duration of remission was 12.5+ months for complete responders and 5 months for partial responders. Thirteen patients had a moderate myelosuppression. One patient had urticaria and pruritus and refused further treatment.

Bone Marrow↗
PubMed1978

Prednimustine therapy for advanced prostatic cancer.

23 patients with advanced, hormonal-resistant, prostatic cancer were treated with daily oral prednimustine--a combination of prednisolone and chlorambucil. 8 patients (35%) subjectively responded with disappearance of skeletal pain and improvement in appetite, weight and sense of well being. 3 patients had objective evidence of tumour regression. Clinical toxicity was moderate, and only occasional myelosuppression was encountered. The ease of administration and predictable toxicity of prenimustine make it a potentially useful agent, alone or in combination, for advanced prostatic cancer.

Adrenal Glands↗
PubMed1978

Continuous treatment of non-Hodgkin's malignant lymphoma with prednimustine (Leo 1031).

The effect of Prednimustine was evaluated in 37 patients with generalised non-Hodgkin's lymphomas. The patients were divided into three groups according to dosage and previous treatment. Totally, in all three groups, 22 complete and 10 partial remissions were observed. During follow-up, five of the complete responders and all partial responders have relapsed. Leucopenia and thrombocytopenia were induced in several patients, but were always moderate and reversible after withdrawal of the drug. In some patients with a history of peptic ulcer or diabetes mellitus, these conditions were aggravated.

Adult↗
PubMed1991

Treatment of resistant Hodgkin's disease with CCNU, etoposide and prednimustine (CEP).

Starting in January 1984, 63 patients with resistant Hodgkin's disease received CEP as salvage-usually third-line-chemotherapy. Complete response (CR) was achieved in 3%, partial response (PR) in 51%. The median duration of remission (CR + PR) was greater than 15 months. Treatment was generally well tolerated. Our results confirm that CEP is an effective therapeutic regimen in resistant Hodgkin's disease.

Adolescent↗
PubMed1990

Prednimustine.

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Animals↗