Adriamycin as a Single Agent in Various Forms of Advanced Neoplasia of Adults and Children.

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Abstract
This paper reviews the effects of adriamycin (ADM) observed in a series of 485 patients (419 adults and 66 children) treated at the Istituto Nazionale Tumori, Milan, from September 1968 to December 1973. Nine two patients were insufficiently treated to provide meaningful information on drug effects. The drug was administered by rapid intravenous injection through 6 dose schedules. In the last two schedules ADM was administered every 3 weeks at the dose of 20–25 mg/m2 for 3 consecutive days (schedule E) or of 60–75 mg/m2 in a single injection (schedule F). With schedules E and F there was an appreciable decrease in the incidence of stomatitis and of severe myelosuppression. Thrombocytopenia occurred in about 10 % of patients. The overall incidence of cardiomyopathy was 1.9 %. As observed by American investigators, cardiomyopathy occurred especially after a total dose exceeding 600 mg/m2 (17 %) and 4/9 patients died of irreversible heart failure. Congestive failure occurred in 7/9. In 6/9 patients showing cardiomyopathy ADM was administered through schedules E or F. One patient was a child 3 years old and 8 were adults with a mean age of 39 years. Non specific electrocardiographic abnormalities were present in about 10 % of patients during treatment with ADM but only exceptionally were they able to predict subsequent cardiomyopathy. The therapeutic results were promising in several types of previously treated and untreated neoplastic disease. The best responses (complete plus partial remission greater than 50 %) were observed in the group of malignant lymphomas (44%) especially in histiocytic lymphoma (67 %), in Ewing's sarcoma (41 %), Wilms's tumor (55 %), carcinoma of thyroid (45 %), testicular tumors (39 %), neuroblastoma (38 %), naso-pharyngeal carcinoma (29 %), breast cancer (26 %), as well as in the small series of acute and chronic myeloproliferative disorders. Significant regressions were also obtained in transitional carcinoma of urinary bladder (2/6) ovarian carcinomas (29 %), in soft tissue sarcomas (22 %) and in mesothelioma (25 %). A lower rate of substantial tumor response was seen in bronchogenic (15 %) and gastrointestinal carcinomas (22 %) as well as in epidermoid carcinomas of head and neck (10 %). No significant regression was noted in osteogenic sarcomas, chondrosarcoma, renal carcinoma and malignant melanoma. In responsive patients the mean duration of response was usually short. This could be in part explained by the fact that (41 %) of patients had previously been treated with conventional drugs. Our experience shows that ADM is useful in a number of neoplastic diseases, where it produces a prompt tumor regression in responsive patients. The successful results achieved with ADM as a single agent indicate that the drug should be incorporated in several protocols of combination chemotherapy and of combined treatment modalities provided the total dose does not exceed 550 mg/m2.