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PubMed1979

Phase II study of Leo 1031 (prednimustine) in advanced ovarian carcinoma.

Thirty-six patients with advanced ovarian carcinoma, 21 who had not responded to conventional surgery and irradiation therapy and 15 who had not responded to conventional surgery, irradiation therapy, and chemotherapy, were treated in a phase II study with Leo 1031. Objective responses were obtained in ten (28%) of the 36 patients (two complete and eight partial responses). An additional 11 (32%) patients had stable disease. The two complete responders were in remission for 4 months. During remission, all of the patients had an improved quality of life. Myelosuppression of varying severity occurred in 11 patients; three of these patients died from their complications. Two patients developed reversible confusion and one patient became psychotic. Eight patients became euphoric during treatment. Leo 1031 might be worthwhile as a palliative chemotherapy for patients with advanced ovarian carcinoma, but the risk of euphoria must always be considered since it can lead to voluntary overdosage.

Adult↗
PubMed1978

Some metabolic aspects of a nitrogen mustard of prednisolone.

Prednimustine (Leo 1031), a conjugate of prednisolone and chlorambucil, was administered to humans and baboons and the metabolic fate of the compound ascertained. Compared to the excretion of prednisolone, prednimustine is excreted more slowly and less quantitatively, with a significant part of the compound being retained in the body. Hydrolysis of the prednimustine molecule appears to take place quantitatively after oral administration, but a substantial part of prednimustine appears to remain intact after its intravenous administration. Fecal excretion of radioactivity was minor compared to the urinary route. The biliary excretion in the baboon was relatively insignificant. Localisation within the lung and spleen of the baboon points to a potential therapeutic use of this drug in neoplastic conditions affecting these organs.

Administration, Oral↗
PubMedDate not supplied

New steroidal alkylating agents in advanced stage D carcinoma of the prostate.

In a previous study, 50 patients with prostatic carcinoma were given continuous oral estramustine phosphate at a dose of 15 mg/kg/day. All patients had progressed on prior standard treatment. The objective and subjective response rates were 19% and 36% respectively. Seven of the 50 patients are still receiving treatment after 1-3 years. One patient who was given estramustine phosphate therapy for 1 year achieved a complete response, which included disappearance of osteoblastic metastasis. He still continues in unmaintained remission despite the fact that estramustine phosphate therapy was stopped because of gastrointestinal toxicity. No serious side effects related to the drug have been seen. Estramustine phosphate may be given safely for a prolonged period and has a place in the treatment of advanced prostatic cancer refractory to hormonal therapy. Twenty-one patients with stage D prostatic adenocarcinoma who failed hormonal therapy were treated with a combination of estramustine phosphate (600 mg/m2/day) plus prednimustine (Leo-1031) (15 mg/m2/day) in daily oral doses. Fifteen patients have been treated with prednimustine alone. The preliminary results of the combination therapy (after 2-9 months) are as follows: five patients (24%) had an objective response and nine patients (44%) had subjective improvement. Only five (24%) did not benefit from the drug and seven (33%) are stable. Of the 16 patients treated with prednimustine alone, one patient has had an unequivocal objective response and one experienced a considerable objective improvement. These preliminary results indicate the possible advantage of adding an alkylating agent (prednimustine) to estramustine phosphate in advanced prostatic carcinoma.

Aged↗
PubMed1991

Feasibility of total body irradiation in chronic lymphocytic leukemia and low-grade non-Hodgkin's lymphomas.

Combined total body irradiation (TBI) and Prednimustine were prospectively evaluated in 30 patients affected either with chronic lymphocytic leukemia (CLL) or with low-grade non-Hodgkin's lymphoma (NHL) eleven patients were previously treated. Between January 1984 and May 1987, 20 evaluable patients with CLL, median age 66 years (range 43-82), classified according to Rai (4 in stage I, 10 in stage II, 4 in stage III, 2 in stage IV) and 10 evaluable patients with NHL low-grade malignancy according to the Working Formulation, Stages III and IV, median age 54 years (range 32-71) were treated using a 6 MeV Linear Accelerator, applying two opposite alternating fields including total body, with a fraction of 15 cGy, 2 fractions weekly (3-day interval) for a total dose of 150 cGy given over 5 weeks. Prednimustine (100 mg/m2, orally, for 5 consecutive days, every 3-4 weeks, for 6-9 courses) was administered 2 months after TBI treatment, as consolidation therapy. By May 1989, a total of 85% hematological responses (defined as normalization of the differential white cell count, of the total blood cell count and of bone marrow infiltration) were obtained after combined treatment in CLL patients; moreover 3 CR (according to the WHO criteria), 75% with splenomegaly reduction and 40% with lymphadenopathy reduction were seen. Ninety percent objective responses (5 CR and 4 PR) were observed in the NHL patients, with 50% having splenomegaly reduction and 67% lymphadenopathy reduction. The median response time in the two groups was, respectively, 14 and 23 months. The overall toxicity (WHO grades 1,2,3,4) after combined treatment was 65% and 70% in the two patient groups. WHO grade III toxicity, completely reversible, was verified in only 16.6% of the cases; all cases, except one, were previously treated. Additionally, 1 toxic death (grade IV thrombocytopenia and leukopenia) was observed in a heavily pretreated patient affected with CLL after TBI alone. Prednimustine regimen was generally well tolerated. The high response rate and acceptable toxicity, confirms the feasibility and the usefulness of TBI in the context of a combined treatment for CLL and low-grade NHL patients. However in order to further reduce the severe toxic side effects, observed in one patient, white blood cells and platelet count should be plotted and monitored carefully, particularly in pretreated patients.

Adult↗
PubMed1992

A prospective study of a new combination chemotherapy regimen in patients older than 70 years with unfavorable non-Hodgkin's lymphoma.

PURPOSE: A prospective trial with a new combination of etoposide, mitoxantrone, and prednimustine (VMP), specifically devised for elderly patients with non-Hodgkin's lymphoma (NHL), was undertaken. PATIENTS AND METHODS: Between January 1987 and April 1990, 52 consecutive unselected patients older than 70 years (median age, 75.6 years) with stage I to IV intermediate- and high-grade NHL, or with stage III to IV low-grade malignancy with symptomatic disease received etoposide and prednimustine 80 mg/m2 orally for 5 days and mitoxantrone 8 to 10 mg/m2 day 1 intravenously (IV), every 21 days. Fourteen patients were previously treated. RESULTS: Among the 48 assessable patients, the objective response rate was 81%; 46% of the patients achieved a complete response (CR). The overall toxicity seemed to be acceptable, with 15 (7%) episodes of grade 4 leukopenia and 41 (18%) episodes of grade 3, over a total of 226 administered cycles. The median survival was 12 months. The patients who obtained CR have a longer survival than those who did not (34 v 8 months; P less than .001). Fifty-eight percent of patients achieving CR were free from relapse at 24 months; up to 36 months from the start of therapy, 25% were free from relapse. As far as patients affected by diffuse histiocytic lymphoma, 66% of previously untreated patients obtained a CR, and 55% of them were still disease-free at 24 months from the start of therapy. CONCLUSION: We conclude that VMP is effective, well tolerated, and feasible on an outpatient basis in an unselected, elderly population affected by unfavorable NHL.

Age Factors↗
PubMed1990

Treatment of low-grade non-Hodgkin's lymphoma by cytoreductive chemotherapy with prednimustine/mitoxantrone followed by interferon alpha-2b maintenance: results of a clinical phase II study.

In a clinical phase II study, the antitumor activity of the recently introduced combination of prednimustine and mitoxantrone (PmM) was evaluated in 17 patients with advanced low-grade non-Hodgkin's lymphoma after failure with or relapse after standard chemotherapy. The PmM regimen consisted of prednimustine 100 mg/m2/d orally on days 1 to 5, and mitoxantrone 8 mg/m2/d intravenously on days 1 and 2, giving a total dose of 16 mg/m2. Treatment was repeated every 4 to 6 weeks to a maximum of 6 cycles. Patients achieving complete remission (CR) or partial remission (PR) received two additional courses for consolidation, followed by interferon (IFN) alpha-2b 5 x 10(6) U subcutaneously three times a week until progression or relapse. Twelve of the 17 patients (71%) responded (CR, 4 and PR, 8). Side effects consisted mainly of neutropenia, which required dose reduction in 48% of treatment cycles. All 12 responders subsequently received IFN alpha-2b maintenance treatment. At present, remission duration ranges from 4.5+ to 17.5+ months (median 14.5 months). In comparison to unmaintained first remission prior to receiving PmM/IFN alpha-2b, a clear tendency towards a longer period of freedom from progression emerged in the 12 patients receiving IFN alpha-2b maintenance treatment during a second PR or CR. These data indicate a high antitumor activity of PmM in low-grade non-Hodgkin's lymphoma and suggest a beneficial effect of IFN alpha-2b maintenance. Present findings, however, will require confirmation in future investigations.

Adult↗
PubMed1994

Risk of leukemia following treatment for non-Hodgkin's lymphoma.

BACKGROUND: There have been few evaluations of the risk of acute nonlymphocytic leukemia (ANLL) following therapy for non-Hodgkin's lymphoma (NHL). Further, the relationship between cumulative dose of cytotoxic drug, radiation dose to active bone marrow, and the risk of ANLL following NHL have not been well described. PURPOSE: Our purpose was to examine the risk of ANLL in relationship to all prior treatment for NHL. METHODS: Within a cohort study of 11,386 2-year survivors of NHL, 35 case patients with secondary ANLL were identified and matched to 140 controls with NHL who did not develop ANLL. The primary eligibility criteria for the cohort included a diagnosis of NHL as a first primary cancer from January 1, 1965, through December 31, 1989; age 18 through 70 years at the time of initial diagnosis; and survival for 2 or more years without the development of a second invasive primary malignancy. Detailed information on chemotherapeutic drugs and radiotherapy was collected for all patients. Standard conditional logistic regression programs were used to estimate the relative risk (RR) of ANLL associated with specific therapies by comparing the exposure histories of case patients with individually matched controls. RESULTS: Significant excesses of ANLL followed therapy with either prednimustine (RR = 13.4; 95% confidence interval [CI] = 1.1-156; P trend for dose < .05) or regimens containing mechlorethamine and procarbazine (RR = 12.6; 95% CI = 2.0-79; P < .05). Elevated risks of leukemia following therapy with chlorambucil were restricted to patients given cumulative doses of 1300 mg or more (RR = 6.5; 95% CI = 1.6-26; P < .05). Cyclophosphamide regimens were associated with a small, nonsignificant increased risk of ANLL (RR = 1.8;95% CI = 0.7-4.9), with most patients receiving relatively low cumulative doses (< 20,000 mg). Radiotherapy given at higher doses without alkylating agents was linked to a nonsignificant threefold risk of ANLL compared with lower dose radiation or no radiotherapy. CONCLUSIONS: Our results suggest that prednimustine may be a human carcinogen, with a positive dose-response gradient evident for ANLL risk. The low, nonsignificant risk of leukemia associated with cyclophosphamide was reassuring because this drug is commonly used today. Despite the excesses of ANLL associated with specific therapies, secondary leukemia remains a rare occurrence following NHL. Of 10,000 NHL patients treated for 6 months with selected regimens including low cumulative doses of cyclophosphamide and followed for 10 years, an excess of four leukemias might be expected.

Aged↗
PubMed1991

Lymphomas in the elderly.

The elderly patients with lymphoma suffer from a relevant excess mortality, both during treatment and in the course of follow-up: various causes contribute, including: 1) "generational" mortality; 2) iatrogenic mortality due to unexpected organ/system fragility; 3) low remission rates, due to low tolerated doses and, 4) a high prevalence of second tumors. The difficulty in achieving high cure rates begins after age 50 and steadily increases for patients over 60, 70 and 80. Less aggressive staging procedures are justified, and the modern visualizing techniques provide alternatives to lymphangiography and laparosplenectomy. In HD, local radiation instead of Total Nodal Irradiation, and doses of 30 or even 20 Gy may be administered for stages I and II; for stages III and IV the ChlVPP and the NOVP or the "ABVD without D" regimens may be adopted. After chronological and/or biological age 80, sequentially administered single agents produce an effective palliation, allowing for a good quality of life during treatment, and often obtain a reasonable prolongation of survival. Many NHL of elderly patients are indolent in their course, and a "watch and wait" policy is often in the true interest of the patient; when local aggressiveness only is apparent, a local low dose radiation may be considered. For advanced stage, treatment-requiring low-grade-NHL, oral chlorambucil plus or minus low dose steroids (or prednimustine) should be considered in alternative to watch and wait. For high grade, aggressive NHL, chemotherapy with short, non-Methotrexate-containing programs like POCE, NOSTE, P-VABEC, or other variations of MACOP-B are acceptable. Beyond age 80, or when other factors deteriorate the chances for survival, single agents like VM 26, or simple combinations of VP 16 + Prednimustine or VP 16 and Mitoxantrone may be adopted.

Adult↗
PubMed1978

Sister chromatid exchanges in lymphocyte cultures of patients receiving chemotherapy for malignant disorders.

The frequency of sister chromatid exchange (SCE) was studied in peripheral lymphocytes of patients receiving chemotherapy for various malignant disorders. Significantly increased SCE frequencies were recorded in six patients 2-7 weeks after CCNU treatment and in one patient 2 weeks after melphalan treatment. One patient treated with prednimustine and one treated with DTIC had SCE frequencies just within the upper limit of the control range 1-2 weeks after therapy. Normal SCE frequencies were recorded in nine patients studied at times varying from 3 days to several weeks after administration of cytostatic courses involving 5-fluorouracil, vincristine, adriamycin, cyclophosphamide, bleomycin, thioTEPA, methotrexate, and prednimustine. Radiotherapy could not be causally related to increased SCE frequencies in any of the patients. The results indicate that CCNU and melphalan, in contrast to several other chemotherapeutic agents, induce very long-lived DNA lesions, which may be of crucial importance for the development of secondary neoplasms.

Adolescent↗
PubMed1987

Protective function of metallothionein against certain anticancer agents.

The possible role of metallothioneins (MT) in the cellular protection against ionizing radiation and alkylating agent cytotoxicity has been investigated by the use of cultured cells with either low or high levels of MT. The cytotoxic activity of the drugs cis-dichlorodiammineplatinum (cis-DDP), chlorambucil and prednimustine was reduced 1,5-3 fold in cells containing high levels of MT, and furthermore about 70% of platinum and 30% chlorambucil was shown to be associated with the protein. Increased resistance was also demonstrated in MT-rich cells during exposure to ionizing radiation. Evidence that MT also may play a role in vivo as a resistance mechanism, was provided in studies of tumors derived from either the MT-rich or MT-poor cells which had been inoculated in nude mice. During treatment of the animals with cis-DDP, the MT-rich tumors exhibited a significant degree of resistance. These results indicate that MT may play an important role in the intrinsic protection of cells against these agents, and raises the question whether it also may be a factor in the acquired resistance of tumors against chemotherapy.

Animals↗