Annals of oncology : official journal of the European Society for Medical Oncology
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The conventional phase I clinical trial stands as a bridge between the laboratory and the clinic in the development of novel anticancer agents. The purpose of the phase I study is primarily to determine toxicity and to define the maximum tolerated dose of the drug in man. It is assumed for this purpose that dose-response curves for toxicity and efficacy are parallel or, simply expressed, the more pain, the more gain. Novel antineoplastic drugs are being developed that are mechanistically remote from conventional cytotoxic drugs, which have DNA as their predominant target; some of these new agents have, at least in vitro, bell-shaped dose-response curves. ⋯ It is essential that flexible clinical trial methodologies are developed to accommodate new drugs and that attempts are made, when possible, to incorporate pharmacodynamic endpoints in addition to toxicological endpoints.
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Comparative Study
Hodgkin's disease with a mediastinal mass greater than 10 cm: results of four different treatment approaches.
Management of Hodgkin's disease (HD) and large mediastinal adenopathy (LMA) usually includes intensive chemotherapy (CT) with or without radiation therapy (XT) regardless of stage. ⋯ Results of this study suggest that patients with stage I-III Hodgkin's disease and LMA greater than 10 cm treated with 3 NOVP and XT have results similar to those obtained for a similar group of patients treated with 2 to 6 MOPP or 6 CVPP/ABDIC and XT. NOVP has also been reported to produce limited toxicity in this trial and should be considered as an alternative to MOPP or doxorubicin-containing regimens in treatment of patients with early-staged disease and LMA greater than 10 cm.
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Oncologists, health care workers and health organizations consider well-performed teaching programs in clinical oncology a fundamental step in cancer control. The aim of our study was to assess the views of teachers and students on the present status of oncology teaching in Italian medical schools and on the most common shortcomings in cancer education. ⋯ This survey emphasizes the dualism between students' expectations and teachers' ideas about cancer teaching. Doctor/patient relationships and poor attention to practical clinical problems seem the most critical issues for clinical oncology training in Italian medical schools.
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In phase II studies of the EORTC-ECTG, acute hypersensitivity reaction, edema and skin toxicity were important side effects of docetaxel (TaxotereTM). ⋯ The acute hypersensitivity reaction could be completely blocked in all but in 1 of 14 patients, and this pretreatment schedule had an important prophylactic effect on edema formation. Skin toxicity was successfully treated with an ointment of glycerin and chlorhexidine.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Tropisetron in the prevention of chemotherapy-induced nausea and vomiting in patients responding poorly to previous conventional antiemetic therapy.
An open, two-armed, multicentre trial was conducted in 231 patients with malignant disease who had previously failed to respond to conventional antiemetic treatment for the prevention of chemotherapy-induced nausea and vomiting. Patients were randomized to receive either tropisetron (5 mg/day; n = 115) or a standard antiemetic therapy, which was considered optimal for each individual but did not include a 5-HT3 receptor antagonist (n = 116). Acute vomiting on Day 1 was controlled in 60 (52%) tropisetron patients, compared with only 29 (25%) patients receiving optimal standard therapy (p < 0.001). ⋯ In conclusion, in cases of acute nausea and vomiting it is more effective to switch refractory patients to tropisetron rather than attempt to optimize the dose of standard antiemetic therapy. For delayed nausea and vomiting, combination antiemetic therapy, with differing types of receptor antagonism and corticosteroids may provide the best way forward. Such studies are in progress.