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FDA warnings for existing drugs dominate pharmaceutical news this month.
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Two recent reports provide information regarding durability of complete remission for those treated for acute myeloid leukemia. The rapidity with which blasts are cleared from the peripheral blood turns out to be an excellent predictor of relapse free survival. For those who remain in complete remission at 3 years, cytogenetic features and patient age remain predictors of relapse.
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Rather than infusional 5 fluorouracil, the use of capecitabine in combination with irinotecan and oxaliplatin (COI) was explored to establish appropriate dose (of irinotecan) and efficacy in terms of response rate and progression-free survival. Toxicity was primarily gastrointestinal and was manageable with no episodes of severe neutropenia or neutropenic fever and response rates were comparable to published phase II reports of FOLFOXIRI.
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Recent studies have shown that thrombopoiesis stimulating molecules improve platelet counts in chronic refractory idiopathic thrombocytopenic purpura (ITP). Busser and colleagues performed a randomized dose escalating trial of eltrombopag, an oral thrombopoietin stimulating agent, vs placebo for chronic ITP. The three doses of 30 mg, 50 mg, and 75 mg daily that were investigated led to platelet counts above 50,000 per uL in 28%, 70% and 81% respectively. Toxicities were similar to placebo. Eltrombopag is an oral thrombomimetic with considerable activity in chronic ITP that warrants further clinical study.
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In a review of a large, multicenter trial of radiation and androgen deprivation therapy for men with locally advanced prostate cancer, patients with BMI of >25 but < than 30, or >30 were found to have a higher rate of prostate-cancer specific mortality. This prospective data is in agreement with previously published population studies indicating a higher death rate from prostate cancer in obese individuals.
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In an analysis of benign breast disease evaluated and treated within the Henry Ford Health system over a thirteen year period, the question of breast cancer risk was determined in the context of the number of benign breast lesions. Patient age and the histologic presence of "atypia" conferred increased risk of later breast cancer, as did the presence of multiple lesions, with or without histological "atypia" and when adjusted for age.
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In this issue: FDA warnings for existing drugs dominate pharmaceutical news this month.
