The oncologist
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Clinical Trial
A phase I trial of weekly paclitaxel plus prolonged oral eniluracil/5-fluorouracil in patients with refractory malignancies.
This phase I study was conducted to determine the dose-limiting toxicity (DLT), maximum-tolerated doses, and recommended phase II doses of the combination of weekly intravenous paclitaxel and oral eniluracil/5-fluorouracil (5-FU). ⋯ The combination of paclitaxel and eniluracil/5-FU was generally well tolerated. The recommended doses for further phase II testing are paclitaxel 80 mg/m(2) i.v. weekly for 4 weeks plus eniluracil/ 5-FU 10.0/1.0 mg/m(2) orally twice daily on days 1-28 with cycles repeated every 35 days.
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Despite the advent of cisplatin-based combination chemotherapy for advanced non-small cell lung cancer (NSCLC), the prognosis for this patient population remains poor. Novel biologically targeted agents currently in development have the potential for greater efficacy against NSCLC, and possibly less toxicity than is associated with conventional cytotoxic chemotherapy. The epidermal growth factor receptor (EGFR) is recognized as a potentially useful target, and the small molecule, orally active EGFR-tyrosine kinase inhibitor ZD1839 (Iressa) is currently the furthest along in clinical development of the anti-EGFR agents. This review summarizes the currently available clinical data on the use of ZD1839 in the treatment of NSCLC.
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Although cytotoxic chemotherapy has had a significant impact on the treatment of some malignancies, its impact against most solid tumors is limited. This is especially true in the case of non-small cell lung cancer (NSCLC) in which about 90% of patients ultimately die from metastatic disease. Although chemotherapy has produced modest improvements in response rates and survival in a subset of patients with advanced NSCLC, its primary objective remains to provide palliation of disabling disease-related symptoms. ⋯ ZD1839 also had an acceptable tolerability profile: most drug-related adverse events were mild and reversible and quite different from those typically associated with cytotoxic agents. Some patients also experienced improved quality of life, particularly those with a partial response or stable disease. Thus, ZD1839 offers a new treatment option providing meaningful symptom relief for many patients with advanced NSCLC.
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The optimal treatment approach in metastatic breast cancer is controversial. Until recently, the arguments for administering antitumor agents sequentially in the metastatic setting have traditionally outweighed those for administering agents in combination. Older, often empirically designed drug combinations were no more effective and often more toxic than monotherapy, compromising quality of life for little or no clinical benefit. ⋯ Sequential therapy allows the optimal delivery of single-drug therapy and potentially reduces the risk of toxicity, which may improve quality of life. Sequential therapy may be especially appropriate in frail or elderly patients, who may be unable to tolerate the toxicity of combination therapy, or in patients with slowly growing tumors. This article expands on these issues by reviewing trials comparing combination regimens with sequential approaches.
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As a result of increasing anthracycline use earlier in the course of breast cancer, oncologists are frequently faced with the challenge of treating patients whose disease has progressed during or following anthracycline therapy or who are ineligible for further anthracycline therapy. Many of these women remain candidates for cytotoxic chemotherapy, and several treatment options exist. Until recently, the taxanes, docetaxel in particular, were widely regarded as the most effective therapy for these patients, based on a survival advantage observed with docetaxel. ⋯ Quality of life was maintained with capecitabine/docetaxel combination therapy, which further supports the use of this regimen in patients with anthracycline-pretreated metastatic breast cancer. Pharmacoeconomic modeling using the data from the phase III trial has shown that the capecitabine/docetaxel combination therapy is highly cost effective when compared with other cancer treatments that improve survival. This review describes several treatment options for patients with anthracycline-pretreated breast cancer, including the phase III data (efficacy, tolerability, quality of life, and pharmacoeconomics) for capecitabine plus docetaxel in this setting.