Journal of clinical oncology : official journal of the American Society of Clinical Oncology
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Clinical Trial
Phase I and pharmacologic study of oral topotecan administered twice daily for 21 days to adult patients with solid tumors.
Topotecan is a specific inhibitor of topoisomerase I. Recently bioavailability of an oral formulation of approximately 30% with limited variability was reported. We conducted a phase I and pharmacokinetic study of the oral formulation of topotecan to characterize the maximum-tolerated dose (MTD), toxicities, pharmacokinetics, and antitumor effects in patients with refractory malignancies. ⋯ The DLT in this phase I study for chronic oral topotecan for 21 days was diarrhea. The recommended dose for phase II studies is 0.5 mg/m2 twice daily.
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Randomized Controlled Trial Clinical Trial
Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31.
Although androgen suppression results in a tumor response/remission in the majority of patients with carcinoma of the prostate, its potential value as an adjuvant has not been substantiated. ⋯ Application of androgen suppression as an adjuvant to definitive radiotherapy has been associated with a highly significant improvement in local control and freedom from disease progression. At this point, with a median follow-up time of 4.5 years, a significant improvement in survival has been observed only in patients with centrally reviewed tumors with a Gleason score of 8 to 10.
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To describe the costs and outcomes of palliative chemotherapy in women with recurrent and refractory ovarian cancer from the perspective of a health care provider. ⋯ These data illustrate the cost of palliative management of recurrent and refractory ovarian cancer, which must be considered in the context of quality and duration of survival. They indicate the potential to improve cost efficiency by improving resource management, for example, by shifting from inpatient to outpatient chemotherapy, everything else being equal.
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A prospective study was performed to assess plasma measurement of tumor necrosis factor (TNF), lymphotoxin alpha (LTalpha), and their soluble receptors (p55 and p75) for prognostic risk assignment in patients with malignant lymphomas. ⋯ TNF and its soluble receptors' plasma measurements represent valuable prognostic markers in lymphoma patients.
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Clinical Trial Controlled Clinical Trial
Phase I trial of docetaxel and cisplatin in previously untreated patients with advanced non-small-cell lung cancer.
To determine the maximum-tolerated doses (MTDs), principal toxicities, and pharmacokinetics of the combination of docetaxel and cisplatin administered every 3 weeks to patients with advanced non-small-cell lung cancer (NSCLC) who have not received prior chemotherapy and to recommend a dose for phase II studies. ⋯ Docetaxel 75 mg/m2 over 1 hour followed by cisplatin 75 mg/m2 over 1 hour is recommended for phase II studies. The responses seen in this phase I study suggest a high degree of activity of this combination in previously untreated advanced NSCLC.