Doxorubicin versus mitomycin versus doxorubicin plus mitomycin in advanced breast cancer: a randomized study. 1986

M Andersson, and S Daugaard, and H von der Maase, and H T Mouridsen

In a randomized trial the antineoplastic and toxic effects of doxorubicin (ADR), mitomycin (MMC), and the combination of the two were evaluated in postmenopausal patients with advanced breast cancer using the following treatment regimens: ADR (75 mg/m2 by iv bolus every 3 weeks); MMC (20 mg/m2 by iv bolus every 6 weeks); and ADR (45 mg/m2 by iv bolus every 3 weeks) and MMC (10 mg/m2 by iv bolus every 6 weeks). One hundred one patients were entered in the study. Entrance to single-agent MMC therapy was stopped after allocation of 12 patients because of unacceptable side effects, especially nausea and vomiting, and the suggestion of minor efficacy. One of these patients had partial response, eight had no change, and three had progressive disease. The patients in the ADR and ADR plus MMC group were similar as to the following: age (median, 60 years); menopausal age; disease-free interval; performance status, extent of previous cytotoxic therapy (approximately 90% were pretreated) and radiation therapy; and dominant site of disease but with significantly more involved organ sites in the ADR plus MMC group. Among evaluable patients (42 in the ADR group and 39 in the ADR plus MMC group), response rates were as follows: complete response--21 versus five; partial response--26 versus 44; no change--40 versus 38; and progressive disease--12 versus 13 (P greater than 0.10). Median times to disease progression were 5.2 and 7.8 months, respectively (log-rank test, P = 0.03), but survival times were similar, 9.3 and 10.2 months, respectively (log-rank test, P greater than 0.40). For the two treatment groups suppression of wbc count was similar, while anemia, thrombopenia, and nausea and vomiting were significantly more common among the ADR plus MMC-treated group. Five treatment-induced deaths were observed in the ADR plus MMC group (one from sepsis; two from diffuse hemorrhage; and two from cardiomyopathy), compared to none in the ADR group. In conclusion, this study disclosed no major advantage of the combination of ADR plus MMC compared to ADR alone as second-line treatment of advanced breast cancer, but results from other studies may imply a possible role of MMC as part of second-line combination chemotherapy regimens.

UI MeSH Term Description Entries
D008593 Menopause The last menstrual period. Permanent cessation of menses (MENSTRUATION) is usually defined after 6 to 12 months of AMENORRHEA in a woman over 45 years of age. In the United States, menopause generally occurs in women between 48 and 55 years of age. Change of Life, Female
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D008937 Mitomycins A group of methylazirinopyrroloindolediones obtained from certain Streptomyces strains. They are very toxic antibiotics used as ANTINEOPLASTIC AGENTS in some solid tumors. PORFIROMYCIN and MITOMYCIN are the most useful members of the group.
D009362 Neoplasm Metastasis The transfer of a neoplasm from one organ or part of the body to another remote from the primary site. Metastase,Metastasis,Metastases, Neoplasm,Metastasis, Neoplasm,Neoplasm Metastases,Metastases
D009364 Neoplasm Recurrence, Local The local recurrence of a neoplasm following treatment. It arises from microscopic cells of the original neoplasm that have escaped therapeutic intervention and later become clinically visible at the original site. Local Neoplasm Recurrence,Local Neoplasm Recurrences,Locoregional Neoplasm Recurrence,Neoplasm Recurrence, Locoregional,Neoplasm Recurrences, Local,Recurrence, Local Neoplasm,Recurrence, Locoregional Neoplasm,Recurrences, Local Neoplasm,Locoregional Neoplasm Recurrences,Neoplasm Recurrences, Locoregional,Recurrences, Locoregional Neoplasm
D011897 Random Allocation A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects. Randomization,Allocation, Random
D001943 Breast Neoplasms Tumors or cancer of the human BREAST. Breast Cancer,Breast Tumors,Cancer of Breast,Breast Carcinoma,Cancer of the Breast,Human Mammary Carcinoma,Malignant Neoplasm of Breast,Malignant Tumor of Breast,Mammary Cancer,Mammary Carcinoma, Human,Mammary Neoplasm, Human,Mammary Neoplasms, Human,Neoplasms, Breast,Tumors, Breast,Breast Carcinomas,Breast Malignant Neoplasm,Breast Malignant Neoplasms,Breast Malignant Tumor,Breast Malignant Tumors,Breast Neoplasm,Breast Tumor,Cancer, Breast,Cancer, Mammary,Cancers, Mammary,Carcinoma, Breast,Carcinoma, Human Mammary,Carcinomas, Breast,Carcinomas, Human Mammary,Human Mammary Carcinomas,Human Mammary Neoplasm,Human Mammary Neoplasms,Mammary Cancers,Mammary Carcinomas, Human,Neoplasm, Breast,Neoplasm, Human Mammary,Neoplasms, Human Mammary,Tumor, Breast
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D004317 Doxorubicin Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of DAUNORUBICIN. Adriamycin,Adriablastin,Adriablastine,Adriblastin,Adriblastina,Adriblastine,Adrimedac,DOXO-cell,Doxolem,Doxorubicin Hexal,Doxorubicin Hydrochloride,Doxorubicin NC,Doxorubicina Ferrer Farm,Doxorubicina Funk,Doxorubicina Tedec,Doxorubicine Baxter,Doxotec,Farmiblastina,Myocet,Onkodox,Ribodoxo,Rubex,Urokit Doxo-cell,DOXO cell,Hydrochloride, Doxorubicin,Urokit Doxo cell
D005260 Female Females

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