Phase II trial of prednimustine, L-1031, (NSC-134087) in advanced breast cancer

Mouridsen, Henning T.; Kristensen, Dan; Nielsen, Jacqueline; Dombernowsky, P

doi:10.1002/1097-0142(19800715)46:2<253::aid-cncr2820460205>3.0.co;2-1

Cancer

1980

DOI: 10.1002/1097-0142(19800715)46:2<253::aid-cncr2820460205>3.0.co;2-1

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Phase II trial of prednimustine, L-1031, (NSC-134087) in advanced breast cancer

Henning T. Mouridsen¹,

Dan Kristensen²,

Jacqueline Nielsen³

et al.

Abstract: The therapeutic effect of prednimustine was studied in 35 patients with advanced breast cancer resistant to previous cytotoxic and/or endocrine therapy. Response (PR + CR) was obtained in 14 patients (40%) of a median duration of five months. Among the 14 responding patients, 10 were resistant to previous endocrine therapy and chemotherapy, in all cases including alkylating agents, and 4 were resistant to previous endocrine therapy. Hematologic toxicity was rather pronounced, but other toxicities were only mod… Show more

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1980

1983

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Cited by 17 publications

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“…8. 13,14) and breast cancer (11,15). Activity has also been demonstrated in a smaller number of patients with acute myelocytic leukaemia (1, 2) and ovarian carcinoma (12).…”

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confidence: 97%

Clinical Trial of Prednimustine, Leo‐1031 (NSC‐134087), in Patients with Non‐Hodgkin Lymphomata and Chronic Lymphocytic Leukaemia Previously Treated with Steroids and Alkylating Agents

Pedersen‐Bjergaard¹,

Hansen²,

Geisler³

et al. 1980

Journal of Internal Medicine

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Prednimustine, a chlorambucil ester of prednisolone, was administered to 16 patients with non-Hodgkin lymphomata (NHL) and 14 patients with chronic lymphocytic leukaemia (CLL), all previously treated with steroids and alkylating agents. Response was obtained in 8 patients with NHL and 11 patients with CLL. Two NHL patients had long-lasting complete remissions. Median duration of response for lymphomata was 12 weeks, for CLL more than 15 weeks. Delayed reversible and rather pronounced myelosuppression was the major side-effect observed in median 6 weeks from the start of Prednimustine with a median duration of 4 weeks.

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“…8. 13,14) and breast cancer (11,15). Activity has also been demonstrated in a smaller number of patients with acute myelocytic leukaemia (1, 2) and ovarian carcinoma (12).…”

mentioning

confidence: 97%

Clinical Trial of Prednimustine, Leo‐1031 (NSC‐134087), in Patients with Non‐Hodgkin Lymphomata and Chronic Lymphocytic Leukaemia Previously Treated with Steroids and Alkylating Agents

Pedersen‐Bjergaard¹,

Hansen²,

Geisler³

et al. 1980

Journal of Internal Medicine

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A phase III trial comparing prednimustine (LEO 1031) to chlorambucil plus prednisolone in advanced breast cancer

Løber¹,

Mouridsen²,

Christiansen³

et al. 1983

Cancer

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Prednimustine is an ester of chlorambucil and prednisolone. The drug has had some activity in experimental as well as in human tumors, including breast cancer. The objective of the current study is to compare the clinical effectiveness and toxicity of prednimustine with its components of chlorambucil plus prednisolone, and to compare the clinical effectiveness and toxicity of a continuous treatment with an intermittent one. Two hundred and one patients with advanced breast cancer were randomized to the following treatments: I: prednimustine continuously; 40 mg/m2 d; II: prednimustine intermittently, 160 mg/m2 d 1 to 5, repeated every three weeks; and III: chlorambucil 8 mg/m2 d plus prednisolone 8 mg/m2 d, both given continuously. All treatments were given orally. One hundred and ninety five patients were evaluable for assessment of response to the treatments. The response rates were 21% in both of the prednimustine‐treated groups, whereas only 11% of the patients treated with chlorambucil and prednisolone responded. The duration of remission with continuous prednimustine was longer than with the other two treatment groups, but not significantly so. One hundred and ninety five patients were evaluable for assessment of hematologic toxicity. No differences were observed between the two prednimustine‐treated groups, whereas the group treated with chlorambucil plus prednisolone experienced a significantly higher degree of leukopenia and/or thrombopenia. Subjective toxicities, nausea, vomiting and psychical symptoms were only moderate in the three treatment groups, but significantly more pronounced in the group treated with intermittent prednimustine. Because of these promising results, prednimustine should be compared to other alkylating agents in patients with advanced breast cancer in randomized trials.

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Disposition of orally administered 14C-prednimustine in cancer patients

Gaver¹,

Deeb²,

Pittman³

et al. 1983

Cancer Chemother. Pharmacol.

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A single oral solution dose (40 mg/m2) of 14C-prednimustine was administered to each of four cancer patients. Plasma, urine, and feces were collected at appropriate times and analyzed for total radioactivity. Plasma samples were analyzed for prednimustine. Peak plasma levels of radioactivity (1-3 micrograms 14C-prednimustine equivalents) occurred at 1.5-3 h in three patients and at 5-6 h in one patient. No intact prednimustine was detected in the plasma; this means that if present, it would be at a concentration of 0.02 micrograms/ml or less and would account for less than 1% of the total drug-related material at the time of peak plasma levels. Solvent-extractable metabolites had a plasma half-life of about 8 h or less. By 24 h essentially all the plasma radioactivity appeared to be covalently bound, and it was eliminated slowly with an estimated terminal elimination half-life of about 10 days. Rapid urinary excretion occurred in the first 24 h, and 40%-60% of the dose was recovered in the urine in 72 h. Although prednimustine was well absorbed, the ester was subject to extensive presystemic metabolism and was not present in the systemic circulation after oral administration.

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Phase II trial of prednimustine, L-1031, (NSC-134087) in advanced breast cancer

Cited by 17 publications

References 14 publications

Clinical Trial of Prednimustine, Leo‐1031 (NSC‐134087), in Patients with Non‐Hodgkin Lymphomata and Chronic Lymphocytic Leukaemia Previously Treated with Steroids and Alkylating Agents

Clinical Trial of Prednimustine, Leo‐1031 (NSC‐134087), in Patients with Non‐Hodgkin Lymphomata and Chronic Lymphocytic Leukaemia Previously Treated with Steroids and Alkylating Agents

A phase III trial comparing prednimustine (LEO 1031) to chlorambucil plus prednisolone in advanced breast cancer

Disposition of orally administered 14C-prednimustine in cancer patients

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