Klinická onkologie : casopis Ceské a Slovenské onkologické spolecnosti
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Recent guidance from the US Food and Drug Administration supports the conduct of a new type of exploratory clinical trials, commonly called phase 0 clinical trials, on the development of innovative anticancer agents, particularly targeted agents. Phase 0 clinical trials are controversial mainly because of the lack of clinical benefit to the participant patients. However, it was recognized that Phase 0 clinical trials can provide a platform to assessing the biological effects on the targets in tumoral human samples, evaluate biomarkers for drug effects and to generate essential human pharmacokinetics and pharmacodynamics data earlier in the drug development. It is expected that such trials will became a routine part of early-phase oncological drug development in the future.
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Cheaper drug forms have been administered more and more in the last decade in oncology and in other fields of clinical medicine, too. Their production was enabled by the end of patent protection of the original drugs used previously. ⋯ There are still some unresolved problems associated with their administration. The current knowledge concerning the safety of biosimilars and possible risks associated with their use is summarised in this review.
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Lenalidomide is a promising new drug in the treatment of patients with multiple myeloma. The analogue of thalidomide was created with the intention of improving the anticancer activity, its immunomodulatory properties as well as reducing the toxicity of the preparation. The mechanism of antitumor action of the preparation appears to be the effect on cells, tumour microenvironment and in particular the regulation of cytokinine production. ⋯ Patients treated with a combination of lenalidomide and dexamethasone had significantly higher therapeutic response and overall survival than patients treated with dexamethasone alone. Profound toxicity seems to be the myelosuppressive effect of lenalidomide. The work gives a summary of the information available on lenalidomide in the treatment of multiple myeloma.
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Breast cancer patients with a tumor size of < or = 1 cm are still rare but their number is increasing as a consequence of mammary screening. It is logical that the best adjuvant treatment in such cancers is often discussed with respect to the risk of relapse of the disease. The number of patients in clinical trials with very small breast cancer is quite low, and a specific clinical trial for such patients is not planned. ⋯ Indirectly, we can assume the application of adjuvant treatment with trastuzumab in such very small breast cancer. However, the decision should be individual with regards to further risk factors for the disease and risk of the treatment itself. This article is more a contemplation in order to provoke discussion on this provocative subject.
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Newer imaging modalities, such as 18F-FDG PET/CT and 99mTc-MIBI scintigraphy, have been recently introduced to assess the activity and extent of disease in patients with multiple myeloma (MM) and gammopathy of undetermined significance (MGUS). The aim of our study was to compare the impact of these imaging modalities in the evaluation of MM and MGUS patients. ⋯ 18F-FDG PET/CT appeared to be a better imaging technique than 99mTc-MIBI scintigraphy in the detection of focal lesions in patients with symptomatic MM. 99mTc-MIBI was superior in the visualization of diffuse disease. On the other hand, despite its limited capacity in detecting focal lesions, 99mTc-MIBI scintigraphy still remains the most rapid and inexpensive technique for whole-body evaluation and may be an alternative option when a PET/CT facility is not available.