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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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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Magnetic resonance imaging (MRI) is used quite routinely in radiotherapy treatment planning in the primary radiotherapy of prostate cancer as it provides more contrast imaging of soft tissues in the small pelvis than planning CT, thanks to which it allows more exact delineation of target volumes and thus the saving of organs at risk We tried to verify whether it is possible to use MRI by analogy in the planning of prostate bed radiotherapy. ⋯ Preliminary results suggest that clinical target volume defined with the help of MRI is shifted compared with CTV defined on planning CT. The agreement of CTV delineation by one radiation oncologist is moderate to fair and is similar to interobserver variability in the contouring of the prostate bed in the planning CT. MRI provides more contrast imaging of the anterior rectal wall, where we have confirmed the most differences in contouring. Moreover, it provides better imaging of local recurrences and seminal vesicles, where the most differences in our group of patients were seen in comparison with planning CT.
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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.