Oncology Ny
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Randomized Controlled Trial
Romiplostim for the treatment of chronic immune (idiopathic) thrombocytopenic purpura.
On August 22, 2008, Romiplostim (Nplate for Injection) received approval from the US Food and Drug Administration (FDA) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. This report summarizes the FDA analyses of the clinical data supporting this approval. ⋯ The FDA approved romiplostim for use among certain patients with chronic ITP. This approval included a Risk Evaluation and Mitigation Strategy to ensure that the benefits of the drug outweigh its risks.
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Randomized Controlled Trial Comparative Study Clinical Trial
Irinotecan in advanced lung cancer: focus on North American trials.
New agents with improved systemic activity are needed for the treatment of lung cancer. Irinotecan (Camptosar) is a promising agent in advanced non-small-cell (NSCLC) and small-cell lung cancer (SCLC). In a Japanese phase III trial of advanced NSCLC, irinotecan or irinotecan/cisplatin demonstrated a significant survival advantage compared to the standard of vindesine/cisplatin. ⋯ Current and planned trials in NSCLC with irinotecan in combination with gemcitabine (Gemzar), the taxanes, and other new agents, and thoracic radiotherapy should also provide useful clinical data. Moreover, trials in SCLC are investigating the rationale of combining irinotecan with a platinum agent as a component of chemoradiotherapy regimens. Promising data from these and other studies will further elucidate a role for irinotecan in the management of lung cancer.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Docetaxel vs doxorubicin in metastatic breast cancer resistant to alkylating chemotherapy.
Single-agent docetaxel (Taxotere) has been shown to be highly active in metastatic breast cancer, with an overall response rate of 47%, median time to progression of 4 months, and survival of 10 months when administered as second-line therapy. These data compare favorably with those reported for doxorubicin (Adriamycin), which has been considered the most active single agent in this setting. This nonblinded, multicenter, randomized phase III study compared the median time to progression, response rate, quality of life, toxicity, and survival after treatment with docetaxel or doxorubicin in patients with metastatic breast cancer in whom previous alkylating chemotherapy failed. ⋯ In addition, doxorubicin produced a higher incidence of grade 3 to 4 thrombocytopenia. Cardiac toxicity led to discontinuation in 7 patients and death in 2 patients in the doxorubicin group; fluid retention led to discontinuation in 1 patient in the docetaxel group. Based on this preliminary analysis, docetaxel was more active and safer than doxorubicin in patients with metastatic breast cancer in whom previous alkylating chemotherapy failed.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Docetaxel vs mitomycin plus vinblastine in anthracycline-resistant metastatic breast cancer.
This nonblinded, multicenter, randomized phase III study compares the median time to progression (primary endpoint), response rate, and quality of life, safety, and survival of docetaxel (Taxotere) vs mitomycin (Mutamycin) plus vinblastine (Velban) in patients with metastatic breast cancer in whom previous anthracycline-containing chemotherapy has failed. Patients were randomized to receive an intravenous infusion of either 100 mg/m2 of docetaxel for 1 hour every 3 weeks, or 12 mg/m2 of mitomycin every 6 weeks plus 6 mg/m2 of vinblastine every 3 weeks. This preliminary analysis presents data on 200 patients among 392 patients recruited. ⋯ Based on this preliminary analysis, docetaxel appears to be equally as safe as and more active than mitomycin/ vinblastine in patients with metastatic breast cancer in whom previous anthracycline-containing chemotherapy has failed. These results are subject to cautious interpretation because this analysis was conducted on the first 200 patients who finished the study treatments, and these preliminary results may underestimate response and overstate treatment discontinuation rates. Thus, the final analysis on the entire patient population is necessary to confirm these preliminary findings.