A double-blind trial of tamoxifen plus prednisolone versus tamoxifen plus placebo in postmenopausal women with metastatic breast cancer: a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic

Article Abstract:

Treatment of breast cancer in women is predicated upon menopausal status. For postmenopausal women with advanced breast cancer, the most appropriate starting therapy is hormonal therapy, most commonly the anti-estrogen drug tamoxifen. This treatment is not appropriate for all postmenopausal patients, of course, and would be inappropriate for women whose cancers do not express estrogen receptors. Many studies have attempted to improve on the success rate of tamoxifen by combining it with other agents, but only one study indicated that some improvement had been achieved in this way. A study was undertaken, therefore, to investigate whether the addition of the steroid hormone prednisolone improves the results achieved with tamoxifen in the treatment of advanced breast cancer. A total of 320 postmenopausal patients were treated; 159 were randomly assigned to receive tamoxifen (plus a placebo, which has no physiological effect) and 161 received both tamoxifen and prednisolone. Of the 320 patients, only 256 had tumors which could be objectively assessed. Of these, a complete response was seen in 48 patients (38 percent) treated with only tamoxifen and in 61 patients (47 percent) treated with both drugs. This difference was not statistically significant. When the survival data were tabulated, the median survival time was 35 months for the tamoxifen-only group and 32 months for the group treated with tamoxifen and prednisolone. The three-year survival was just over 40 percent for both groups. Incidental to the outcome of the study was the finding of better survival for the patients with greater amounts of estrogen receptors on their tumor cells. The patients who received prednisolone in addition to the tamoxifen experienced greater weight gain and edema (fluid retention) as side effects. There seems to be no justification for the inclusion of prednisolone in the treatment of postmenopausal women with advanced breast cancer. (Consumer Summary produced by Reliance Medical Information, Inc.)

Case studies, Postmenopausal women, Tamoxifen, Prednisolone, Combined modality therapy

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A controlled trial of cyproheptadine in cancer patients with anorexia and/or cachexia

Article Abstract:

Eighty-seven percent of cancer patients are affected by anorexia and cachexia. The anorectic loss of appetite and the metabolic deficits of cachexia (ill health, malnutrition and wasting) both contribute to the wasting away which is so often observed among cancer patients. Unfortunately, these problems are complex, and many factors all contribute to the wasting effect. There is no effective treatment for these conditions, but some scientific evidence suggests that cyproheptadine might be helpful as a weight-enhancing treatment for cancerous cachexia (cachexia caused by cancer) and anorexia. Cyproheptadine acts as an antagonist of the brain's transmitter substance, serotonin. In a randomized placebo-controlled study of cyproheptadine in 295 patients with advanced cancer, the patients receiving the drug had significantly less nausea and vomiting, and reported better appetites. The patients treated with cyproheptadine were also dizzier and felt more sedated. Unfortunately, the beneficial effect of cyproheptadine on the stomach and its apparent effect on the appetite did not result in arresting weight loss. The weight loss experienced by the patients treated with cyproheptadine was not significantly different from the patients treated only with placebo. The authors report that after this study was complete, they acquired some data indicating that high doses of megestrol acetate has beneficial effects on cancer cachexia, but these data are not yet published. (Consumer Summary produced by Reliance Medical Information, Inc.)

Complications and side effects, Anorexia nervosa, Cancer, Cancer treatment, Cachexia, Appetite disorders, Cyproheptadine

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Evaluation of the continuous infusion of etoposide plus cisplatin in metastatic breast cancer: a collaborative North Central Cancer Treatment Group/Mayo Clinic phase II study

Article Abstract:

Although cisplatin has substantial antitumor activity in metastatic breast cancer patients who have not yet failed to respond to chemotherapy, it has a poor record when used alone to fight breast cancers in women who have already shown resistance to another regimen. Even though etoposide, also called VP-16, is ineffective when used alone, it shows a synergy with cisplatin. In a study of 44 women with metastatic breast cancer, 43 of whom had received previous chemotherapy, cisplatin and etoposide were delivered by continuous infusion. Etoposide was given at a rate of 130 mg per meter squared per day over a three-day period. For the second two days, cisplatin was added at a rate of 45 mg per meter squared per day. Treatment cycles were repeated every four weeks, and dose adjustments were made for toxicity. The toxicity reactions were not mild; two treatment-related deaths occurred, and patients experienced kidney failure and pancytopenia, a deficiency of all types of blood cells. Partial response occurred in 11 of the 44 patients, and the median time to tumor progression in these patients was 4 months, as opposed to 3 months for the entire group. The median survival time for all patients was 7 months. The treatment protocol achieved modest survival rates at the price of marked toxicity. (Consumer Summary produced by Reliance Medical Information, Inc.)

Evaluation, Chemotherapy, Cisplatin, Etoposide

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