mitolactol and Soft-Tissue-Neoplasms

The aim of this study was to compare the treatment efficacy of mitomycin-C plus tamoxifen (MT) to adriamycin, dibromodulcitol and tamoxifen (DAT) in previously treated patients with metastatic breast cancer. Thirty-two patients with measurable or evaluable disease were entered on the study. Twenty-three were prospectively randomized to receive DAT (Group 1) or MT (Group 2). Nine patients with prior exposure to adriamycin were directly assigned to receive MT (Group 3). Thirty-one patients were evaluable for response and toxicity. The hematological toxicities were comparable among the three treatment groups. DAT gave more nausea and vomiting than MT. One patient developed irreversible fatal congestive heart failure while receiving DAT. The response for Group 1 was 5/11, Group 2, 3/12, and Group 3, 3/8. The duration of response for patients in Group 1 was 455+, 315, 251, 239, 231 days, in Group 2 it was 328+, 144+, 119, and in Group 3 it was 35+, 84, and 112 days. The median time to treatment failure did not differ significantly between Group 1 (114 days), 2 (83 days) and 3 (61 days) (p = 0.24). The median survival time was similar among the three groups (p = 0.41). This pilot study suggests that MT and DAT are both effective treatment programs in patients with metastatic breast cancer who have failed prior chemotherapy regimens.

Topics: Antibiotics, Antineoplastic; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; Breast Neoplasms; Doxorubicin; Drug Therapy, Combination; Female; Humans; Mitolactol; Mitomycin; Mitomycins; Pilot Projects; Random Allocation; Soft Tissue Neoplasms; Tamoxifen

Twenty-six evaluable patients with metastatic breast carcinoma previously treated with a combination of cyclophosphamide, methotrexate, 5-fluorouracil, vincristine, and prednisone (CMFVP) were treated with a combination of doxorubicin (Adriamycin), dibromodulcitol, and mitomycin (ADM). Four patients (15%) achieved complete remission, and 10 patients (39%) had a partial response. Five patients (19%) had stable disease, and seven patients (27%) experienced disease progression. The median time to disease progression was 10 months for responding patients (range, 4-44 months) and 5 months (range, 2-13 months) for patients with stable disease. The median survival duration was 15 months (range, 6-44+ months) for responders, 11 months (range, 2-27 months) for patients with stable disease, and 4 months (range, 2-41 months) for nonresponders. Two of the four patients with complete remission are alive and in continued remission at a follow-up of 44 and 40 months. Seventy-one patients with greater than or equal to two sites of metastasis responded, whereas 23% of patients with greater than or equal to three metastatic sites responded. Although higher responses were seen with soft tissue and osseous metastasis, responses were observed in all three sites of metastasis. This combination chemotherapy regimen with ADM is an effective second-line program for patients who have previously received CMFVP chemotherapy.

Topics: Adult; Aged; Alopecia; Antineoplastic Combined Chemotherapy Protocols; Bone Neoplasms; Breast Neoplasms; Cyclophosphamide; Doxorubicin; Female; Fluorouracil; Humans; Leukopenia; Methotrexate; Middle Aged; Mitolactol; Mitomycins; Nausea; Prednisone; Soft Tissue Neoplasms; Thrombocytopenia; Time Factors; Vincristine; Vomiting

Patients with objectively measurable soft tissue sarcomas, osteosarcomas, chondrosarcomas, and mesotheliomas were treated with dibromodulcitol (DBD) (180 mg/m2 p.o. days 1-10 q4 wks.). ICRF-159 (300 mg/m2 p.o. tid days 1-3 q4 wks), or maytansine (MAYT) (1.5 mg/m2 I.V. q3 wks.). Forty-five evaluable patients received DBD, 47 MAYT, and 37 ICRF-159. Only patients who had had their histopathologic diagnoses confirmed by a pathology reference panel were included in the final analysis. Two patients had objective partial responses: a patient with osteosarcoma who responded to DBD and a patient with fibrosarcoma who had a partial response of brief duration to ICRF-159. Approximately 70% of the patients treated with each drug were of ECOG performance status 0 or 1, and over half had moderate or worse toxicity. It seems unlikely that these drugs have significant therapeutic activity for common mesenchymal malignancies.

Topics: Adolescent; Adult; Aged; Bone Neoplasms; Drug Evaluation; Female; Humans; Male; Maytansine; Mesothelioma; Middle Aged; Mitolactol; Osteosarcoma; Oxazines; Piperazines; Prognosis; Random Allocation; Razoxane; Sarcoma; Soft Tissue Neoplasms