Phase II evaluation of VP-16-213 in patients with advanced breast cancer: a Southwest Oncology Group Study.
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Biomedical subjects
Publications and source records attributed to R Bottomley.
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A prospective study of tamoxifen therapy in doses of 10 mg twice daily was carried out in 79 patients with advanced renal cell cancer. The objective response rate (complete response plus partial response) was 6.3% (five of 79 patients), while 34.1% (27 of 79 patients) had stable disease. Survival of this group of patients (complete response plus partial response plus stable disease) was significantly longer than that of patients with progressive disease (P less than 0.04). Also, among patients with a good performance status at the beginning of the study, survival was longer than among those with a poor performance status (P less than 0.001). No statistical significance was found in the survival of these patients according to sex (P = 0.55) or whether or not they had received previous systemic therapy (P = 0.97). Toxicity was low and acceptable. We concluded that stratification according to performance status may be used in future randomized systemic therapy protocols for patients with metastatic renal cell cancer. Also, in spite of the low response rate to hormonal therapy including tamoxifen, the use of these agents with combination chemotherapy may enhance the overall response rate without increasing side effects.
The Southwest Oncology Group did a limited institutional pilot study of the combination of doxorubicin and ifosfamide in the treatment of previously treated adult patients with acute leukemia. Thirty-four patients received one or two courses of the combination. All patients had received prior chemotherapy and 32 had received prior anthracycline chemotherapy. Three patients died before their responses could be fully evaluated. Fourteen patients achieved complete remission (41%) and one patient achieved partial remission. The complete remission rate was 27% for patients with acute myeloblastic leukemia (myelomonoblastic leukemia, monoblastic leukemia, and erythroleukemia) and 89% for patients with acute lymphocytic and undifferentiated leukemia (ALL). Toxic effects included severe hematologic reactions in 33 of 34 patients, hematuria in six patients, altered sensorium in one patient, and congestive heart failure in one patient. The safety of the combination was established and toxic side effects of this therapy were tolerable. The 89% complete remission rate for previously treated patients with ALL suggests that the combination of doxorubicin and ifosfamide may be particularly effective in ALL.