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PubMed1992

Prednimustine and mitoxantrone (PmM) in patients with low-grade malignant non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), and prolymphocytic leukemia (PLL).

Thirty-five patients with a mean age of 60.6 years (44-78 years, 22 male, 13 female) with advanced low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), or prolymphocytic leukemia (PLL) were treated every 4 weeks with prednimustine 100 mg/m2 p.o. d 1-d 5 and mitoxantrone 8 mg/m2 i.v. d 1 and d 2. Seven patients had CLL, one lymphocytic NHL, two PLL, 13 immunocytoma, nine centroblastic/centrocytic NHL, and three centrocytic NHL. Twenty-five patients were pretreated. The subjective toxicity of the treatment was mild, with no WHO grade-3 alopecia, polyneuropathy, cardiotoxicity, mucositis, nausea, or vomiting. Hematologic side effects with WHO grade-4 granulopenia and thrombopenia were experienced by 26% and 23% of the patients, respectively. The overall response rate (CR+PR) was 72% for lymphoma patients and 37% for CLL patients, with a median remission duration of 14.6 months. The maximum response was achieved after a median of two treatment courses. Prednimustine with mitoxantrone is a subjectively well tolerated treatment for low-grade malignant NHL, to be further evaluated in phase-III studies. The regimen may shorten the duration of treatment, saving time-consuming out-patient visits and costs.

Adult↗
PubMed1991

alpha Interferon maintenance therapy in patients with low-grade non-Hodgkin's lymphomas after cytoreductive chemotherapy with prednimustine and mitoxantrone.

A combination of prednimustine 100 mg/m2/day orally, days 1-5, and mitoxantrone 8 mg/m2/day intravenously, days 1 and 2, was administered to 19 patients with advanced low-grade non-Hodgkin's lymphoma after failure on or relapse after standard chemotherapy. The prednimustine and mitoxantrone (PmM) regimen was repeated every 4-6 weeks to a maximum of six cycles. Thirteen patients, achieving a complete (4) or partial (9) remission (CR or PR), received two additional courses for consolidation followed by interferon alfa-2b 5 million units (MU) subcutaneously (s.c.) three times weekly until progression or relapse. At the present time, remission duration ranges from 4.5+ to 17.5+ months, with a median of 14.5 months. In a historical comparison to unmaintained first remission preceding the PmM/interferon trial, a tendency towards a longer period of freedom from progression was apparent in the 13 patients receiving interferon maintenance treatment during their second PR or CR. These data provided the basis for a currently ongoing multicentre study randomly comparing initial chemotherapy with PmM versus cyclophosphamide/vincristine (Oncovin)/prednisone (COP) in patients with advanced centroblastic-centrocytic and centrocytic non-Hodgkin's lymphomas, followed by a second randomization in CR and PR patients for maintenance with alpha interferon versus observation only.

Adult↗
PubMedDate not supplied

Cisplatinum and prednimustine, an active regimen for advanced epithelial ovarian cancer.

80 patients with advanced epithelial ovarian carcinoma were treated for 6 months with cisplatinum and prednimustine following initial surgery. Response to treatment was assessed by second-look surgery. The objective response rate was 69% with 38% achieving a complete response for up to 55 months. The toxicity of this regimen was acceptable. Statistically, de-bulking or partial de-bulking had a significant beneficial effect on the likelihood of a complete response. The best survival figures were associated with maximum de-bulking. The combination of cisplatinum and prednimustine is a new and active regimen for operable advanced epithelial ovarian carcinoma.

Adult↗
PubMed1979

Phase II trial of Prednimustine. Leo-1031 (NSC-134087) in acute non-lymphocytic leukemia.

18 patients with acute non-lymphocytic leukaemia were treated with Prednimustine, a chlorambucil ester of prednisolone, as a single drug. 5 patients responded with falling blast counts in peripheral blood, but only 1 obtained a complete remission of 3 months' duration. Since the activity of Prednimustine is lower than that of other commonly used drugs in acute non-lymphocytic leukaemia, future studies should concentrate on other aspects, such as treatment of patients with steroid receptor-positive blast cells or other types of leukaemia.

Adult↗
PubMed1988

Prednimustine, methotrexate, 5-fluorouracil, mitoxantrone and tamoxifen for advanced breast cancer in postmenopausal women. A phase II trial.

A phase II trial in postmenopausal women with advanced breast cancer naive to cytotoxic treatment for recurrent disease was performed with a combinated chemo-endocrine regimen of prednimustine, methotrexate, mitoxantrone, 5-fluorouracil, and tamoxifen. Thus we replaced the most toxic agents--cyclophosphamide and doxorubicin often used in combinations--with prednimustine and mitoxantrone respectively, which are supposed to be equally efficient but less toxic. Seventy-seven patients were registered but 6 were ineligible. Complete response was obtained in 11%, partial response in 29%, no change in 29%, and progressive disease in 31%. Median duration of response was 18.5 months, time to disease progression 9.2 months, and survival 16.0 months. Toxicity was modest; 61% had no or only moderate alopecia not necessitating a wig, 59% had no or only moderate, if any, nausea. Bone marrow suppression, especially thrombopenia, was a major dose limiting factor. This regimen seems to be effective and have low toxicity in advanced breast cancer in postmenopausal women.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1986

Treatment of advanced resistant Hodgkin's disease with lomustine, etoposide, and prednimustine.

Fifteen patients with Hodgkin's disease resistant to the chemotherapy combinations of cyclophosphamide, vinblastine, procarbazine and prednisone and doxorubicin, bleomycin, vinblastine, and dacarbazine were treated with lomustine, etoposide, and prednimustine. Four of them achieved complete remission and two achieved partial remission (overall response rate, 40%). The median duration of response was 5.5 months, with two complete responders relapsing at 4 and 17 months and the other two remaining disease-free at 7 and 18 months, whereas disease progression was observed at 2.5 and 6 months in the partial responders. Extrahematological toxicity was scarce. Severe myelosuppression was observed in only three patients. These results indicate that lomustine, etoposide, and prednimustine can play a role in the treatment of advanced resistant Hodgkin's disease.

Adolescent↗
PubMed1977

[Effect of Prednimustine (Leo 1031) in chronic lymphatic leukemia].

46 ambulatory patients with chronic lymphocytic leukemia were treated with Prednimustine either continuously (daily or each other day 20 mg) or intermittently (daily 20 mg for 14 days, followed by a pause of 4 weeks). A good response was seen in 28 patients lasting up to 17 + months (mean 4,5 + months) after terminating therapy. Patients without prior chemotherapy have improved earlier and to a smaller amount of the total dose applicated. Signes of bone marrow toxicity (anaemia, thrombocytopenia) were observed in 8 cases, gastrointestinal side effects in 7 cases, cutaneous exanthema in 3 cases, and one patient exhibited a severe stomatitis after treatment. Prednimustine constitutes an effective drug for chronic lymphatic leukemia.

Adult↗
PubMed1986

A preliminary analysis of combination therapy with vincristine, adriamycin, and prednimustine (VAP) in advanced breast cancer: a phase II study.

Between March 1984 and May 1985, 29 patients with metastatic breast cancer and high-risk prognostic factors were treated with vincristine, 1.4 mg/m2 IV on day 1, Adriamycin, 40 mg/m2 IV on day 1, and prednimustine, 100 mg/m2 PO on days 3 to 7. Courses were repeated every 3 weeks. At the present time, 26 patients are evaluable for tumor response; 29 are evaluable for toxicity. Fourteen of 26 patients (53.8%) achieved a partial response lasting 2 to 9 months (median 5.5+). A complete response was not recorded. Ten of 26 patients (38.5%) had stable disease; two patients (7.7%) showed a primary tumor progression. Most common side effects were nausea, vomiting, and alopecia, all generally mild to moderate. Fourteen of 29 patients developed leukocytopenia, mainly of WHO grade 1; thrombocytopenia was registered in one patient only and a fall of hemoglobin in three patients only. In 15 patients, no hematologic toxicity occurred. These preliminary data suggest good antitumor activity and acceptable toxicity for vincristine-Adriamycin-prednimustine in patients with metastatic breast cancer.

Adult↗
PubMed1988

Mitoxantrone in combination with prednimustine in treatment of unfavorable non-Hodgkin lymphoma.

Mitoxantrone (Novantrone) and prednimustine (Sterecyt) are both active as single agents in the treatment of unfavorable non-Hodgkin lymphoma (UNHL). The efficacy and toxicity of the combination of these agents (NOSTE) was evaluated in 28 patients with advanced histopathologically proven UNHL who were not eligible for aggressive conventional chemotherapy. The median age was 68, range 45-84. Sixteen patients were previously untreated. Eleven patients had received doxorubicin or epidoxorubicin containing regimens and 1 patient had received CVP as first line therapy. MUGA scan was used in monitoring cardiac function in patients with cardiac risk. Novantrone was administered at a dose of 8 mg/m2 IV on days 1 and 2 and Sterecyt as an absolute dose 100 mg/less than or equal to 1.6 m2-150 mg/greater than 1.6 m2 on days 1 through 5. The regimen was repeated every 4th week. The number of courses per patient ranged from 2 to 10. Objective response was obtained in 22 (78%) patients (20 CR and 2 PR). No response occurred in 6 patients (4 SD, 2 PD). Decreased left ventricular ejection fraction was recorded in 1 patient who suffered from asthma and ischemic heart disease. Hematological toxicity was tolerable. Gastrointestinal toxicity was rare. No hair loss was observed. After a median follow-up of 28 months the crude survival was 46%. Twelve of twenty complete responders are still in remission, the median duration of remission is 28.3 months, range 15-37. NOSTE in this pilot study showed a high response rate, good tolerance and mild toxicity.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1991

Prednimustine combined with mitoxantrone and 5-fluorouracil for first and second-line chemotherapy in advanced breast cancer.

A total of 60 patients with advanced breast cancer were treated with a combination of prednimustine (P: 110 mg/m2, days 1-5), mitoxantrone (M: 12 mg/m2, day 1) and 5-fluorouracil (F: 500 mg/m2, day 1) (PMF). Treatment was repeated every 3 weeks. In all 53 patients were evaluable for response. A total of 12 subjects had failed prior chemotherapy for metastatic disease. In response to PMF treatment we observed 21 partial remissions and 3 complete remissions, amounting to a total response rate of 45%. The median duration of response was 39 weeks, and median survival was 56 weeks. Dose-limiting side effects were leukopenia (40 cases) and thrombocytopenia (11 patients). Nausea and vomiting was experienced by 93% of subjects; in 56% of cases it reached WHO stage II-III. Alopecia occurred in 18% of our patients. Our results suggest that PMF represents an active regimen in the treatment of advanced breast cancer and yields a response rate of 45%. Considering that the majority of our patients had not received prior chemotherapy, the question remains open as to whether a 45% response rate outweighs the observed toxicity.

Adult↗
PubMed1992

Cellular kinetics of prednimustine versus chlorambucil plus prednisolone in vitro.

Intracellular concentrations of prednimustine (PM), chlorambucil (CLB), phenylacetic acid mustard (PAAM) and prednisolone (P) were measured in different experimental tumor cell lines that had been incubated with either PM or CLB + P. For intracellular analytical determination, we modified a high-pressure liquid chromatographic method for the detection of these substances in plasma. Intact PM could be detected in the intracellular compartment of the incubated tumor cells. PM-incubated cells from PM-injected rats exhibited a higher intracellular concentration-time integral (PAAM) and longer concentration-time profiles for drugs with alkylating capacity than did cells exposed to the CLB + P mixture or to CLB. PAAM was not detectable after incubation of cells with PM, whereas in CLB-incubated cells the AUC of PAAM exceeded that of the parent drug CLB. Our in vitro results therefore favour the concept of a facilitated intracellular uptake and an increased antiproliferative effect for PM versus CLB and CLB + P.

Animals↗
PubMed1992

Remission induction with carboplatin-epirubicin-prednimustine followed by consolidation radiotherapy in advanced ovarian cancer.

Adjuvant chemoradiotherapy was administered to 26 patients with stage Ic-IV ovarian cancer after radical cytoreductive surgery. All patients received six cycles of carboplatin, epirubicin, and prednimustine and had no clinical evidence of disease after completion of chemotherapy. They received whole-abdominal radiation and radiation to the retroperitoneal lymph nodes. This protocol was discontinued for five (23%) patients because of myelosuppression, progressive disease, or withdrawal. One patient had a small bowel obstruction due to intraperitoneal adhesions. The survival of ten stage-III ovarian cancer patients, who received chemoradiotherapy and were evaluable for assessment of treatment efficacy, was retrospectively compared with the survival of 11 stage-III patients who received chemotherapy only. At 36 months, a slight advantage of the chemoradiotherapy versus the chemotherapy-only group was observed (p = 0.11). These preliminary results suggest that adjuvant chemoradiotherapy may prolong the "no evidence of disease" interval of radically operated ovarian cancer patients. Toxicity is acceptable when second-look surgery is avoided and when subsequent radiotherapy is limited to patients with no evidence of disease.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1990

[Treatment of aggressive non-Hodgkin's lymphoma in aged patients with a combination of methyl-GAG, etoposide and prednimustine].

The authors report the results of a chemotherapy regimen of methyl-GAG, etoposide and prednimustine in 21 elderly patients (median age = 78 years) with aggressive non-Hodgkin's lymphoma. Sixteen patients responded (11 complete remissions, 5 partial remissions) with minor toxic side-effects. This regimen could be proposed for patients whose age and/or cardiovascular status prohibit treatment with usual anthracycline-containing chemotherapy programs.

Aged↗
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↗