Nichols Wc

Randomized Clinical Trial of Diethylstilbestrol versus Tamoxifen in Postmenopausal Women with Advanced Breast Cancer

Before the introduction of tamoxifen, diethylstilbestrol (DES) was widely considered to be the hormonal treatment of choice in postmenopausal women with advanced breast cancer. We performed a randomized clinical trial of these two agents to determine their relative efficacy and toxicity. The trial involved 143 evaluable patients, of whom 99 had received no prior systemic therapy and 44 had received previous chemotherapy. The regression rates (complete plus partial) were higher in patients receiving DES (41 per cent) than in those receiving tamoxifen (33 per cent), but not significantly so (P = 0.37). In patients who had had no prior systemic therapy, the rates were 44 per cent and 38 per cent, respectively (P = 0.55), and in those who had had previous chemotherapy, 32 per cent vs. 23 per cent (P = 0.50). Analysis of the time until treatment failure for the two treatment groups showed no significant difference (medians: DES, 142 days; tamoxifen, 171 days). Toxicity was greater in patients receiving DES; nine of 74 patients (12 per cent) discontinued therapy solely because of adverse reactions. Since there was no statistically significant difference in efficacy and since tamoxifen was less toxic, tamoxifen appears to be the preferred agent.

Malignant, predominantly lymphocytic thymoma with central and peripheral nervous system metastases.

Histologic features of an invasive mediastinal tumor found in a 25‐year‐old woman fulfilled the accepted criteria for diagnosis of predominantly lymphocytic thymoma. Histochemical and cell marker studies indicated that the neoplasm contained a preponderance of T lymphocytes.

Cis-diamminedichloroplatinum (II) administered by 24-hour infusion in the treatment of patients with advanced upper aerodigestive cancer

A regression rate of 12% (4/33) among patients with advanced upper aerodigestive carcinomas who received an intravenous regimen of cis‐diamminedichloroplatinum, 90 mg/m2/24 hours each three weeks was achieved. The response rate was 13% (3/23) among patients with typical squamous cell carcinoma. Most individuals had received extensive prior surgery and/or radiation therapy. Nineteen patients had ECOG performance score 0, 1. A median time to progression and survival of 1.6 months and 6.7 months, respectively, were associated with moderate to severe nausea and vomiting in virtually all patients. These results differ from previous reports of single agent platinum regimens which have achieved regression rates of approximately 40% among apparently comparable patients. Subtle clinically inapparent differences between study populations and the influence of yet unrecognized covariates may have impacted on the response discrepancy. Innovative studies of the high‐dose, infusion platinum therapy may clarify the efficacy of the program in patients with advanced head and neck cancer.

Phase II study of the three-drug combination of mitomycin C, CCNU, and methotrexate (MCM) in advanced non-small cell lung cancer

Ninety-two patients with advanced non-small cell lung cancer, 51 without prior chemotherapy exposure, were treated with the combination of mitomycin C, lomustine (CCNU), and methotrexate (MCM). Overall, the regression rate was 33%, the median regression duration 4.9 months, and the median survival 4.9 months. Patients with ECOG performance scores (PSs) of 0–1 had a statistically significant higher regression rate than did patients with ECOG PSs of 2–3 (43% versus 15%; p = 0.005) as did patients without prior chemotherapy (41% versus 22%; p = 0.05). Cell type and prior chemotherapy exposure did not affect regression duration, time to progression, nor survival. Subjective toxicity was quite acceptable. Cumulative myelosuppression was the most significant objective toxicity. MCM is a relatively effective combination chemotherapy regimen, even in patients with prior chemotherapy exposure (predominantly doxorubicin and cisplatin-based chemotherapy).