Clinical Oncology

[How to evaluate clinical trials?]

TORDAY László, VÉGH Éva

SEPTEMBER 10, 2014

Clinical Oncology - 2014;1(03)

[Data from a clinical study should be always viewed with great care, and is recommended to examine and evaluate the data in-depth. First of all should be determined the evidence level of the trial’s results and what recommendations can be made based on them. The study’s type and the study design, the number of participating patients, statistical power, randomisation, stratifi cation, the balance between study arms, the endpoints and the adequacy of follow-up time should be examined. In addition the importance of the observed statistical signifi cance, the clinical relevance of the data and the real magnitude of the detected differences, and the time-dependent variables are worth to consider because these factors can determine the impact of the given clinical trial on the every-day clinical practice. In the era of the “creative study plans” a critical attitude is necessary to be convinced that the study does not contain any typical bias that could infl uence the real value and actual results of the trial.]

COMMENTS

0 comments

Further articles in this publication

Clinical Oncology

[Targeted therapy: based upon the primary tumor or on its metastases?]

TÍMÁR József

[Most of the primary tumors at various stages are resected or destroied by radiotherapy. Meanwhile, contemporary target therapies are administered in advanced stages, but the required molecular pathologic analysis is performed on the primary tumor supposing stable genetic profi ls durings at different stages of cancer progression. Advanced molecular technologies provided high resolution images on the clonal heterogeneity of the primary tumors and its role in cancer progression. Data indicate that in early and locoregional stages/recurrences the chance for genetic discordance is low while, in late visceral metastases this risk is increasingly higher. The clinical relevance of the genetically discordant metastatic tumors is proven by several retrospective studies. This is the basis of the recommendations that in case of progressing cancer molecular pathologic tests must be performed on metastatic tumors, especially when the primary tumor is resected. On the other hand, it is an unresolved issue what to do in case of discordance between the primary and the metastasis.]

Clinical Oncology

[Treatment of hepatocellular carcinoma - today]

VÉGH Éva, DEMETER Gyula, BODOKY György

[The hepatocellular carcinoma (HCC) is one of the main causes of cancer-related death globally, and at the same time, it is the main event leading to death in cirrhotic patients. In the etiology of HCC, the non-alcoholic liver disease may be an important cause besides the viral cirrhosis. The HCC’s staging systems (Child-Pugh scores, Cancer of the Liver Italian Programme/CLIP, Barcelona Clinic Liver Cancer/ BCLC) play an important role in predicting the prognosis and determining the appropriate therapy. In Europe, the treatment strategy is based on the BCLC staging system. Screening of cirrhotic patient is also important because curative therapy is available only for the early-stage HCC. Several therapeutic options exist in the intermediate stage disease; among them the radiofrequency ablation (RFA), the transarterial chemoembolization (TACE) and the percutan ethanol injection (PEI) are most important. For the advanced disease, the only approved systemic therapy is sorafenib, which has been well-tolerated and yielded a substantially relative improvement in overall survival. For patient in end-stage disease with impaired liver function or a poor performance status, only supportive care is recommended.]

Clinical Oncology

[European examination for clinical oncologists]

HERRMANN Richard

[One of the major tasks of the European Examination Board is to harmonize the knowledge and practice of clinical oncologists throughout the world. The examination consits 100 questions and the positive result is aknowledged by a diploma. More and more countries replace the national exam by ESMO-exam. It is still a challenge how to evaluate the activity of clinical oncologists who are specialized in different area of oncology. The ESMO-exam is available mainly at the ESMO congresses.]

Clinical Oncology

[New aspects in cancer pain relief]

RUZSA Ágnes, HORVÁTH Zsolt

[Authors investigate the new advances in cancer pain relief among the long survival cancer patient, 25-30% of whom suffering from pain. The new molecular targets provide new druggable pain relief options. The changed strategy of pain-killing therapy enhance s the possibility for the long survival cancer patients to decrease problems of the side effects of opiod therapy. The lower doses of opioids in invasive theraputical techniques help patients to live in higher quality of life without the uncomfortable side effects of the drugs.]

Clinical Oncology

[Pharmacological treatment of metastatic melanoma]

OLÁH Judit, GYULAI Rolland

[Malignant melanoma belongs to the group of relatively easily manageable tumors; if detected and removed early, it rarely metastasizes. Although the visible nature of the primary tumor provides opportunity for early diagnosis, there is a signifi cant portion of patients who receive proper management only with substantial delay. The fact that there are annually 300-400 patients with metastatic disease in Hungary, can be mostly attributed to public unawareness about melanoma, and consequent delay in seeking medical treatment. Metastatic melanoma remains - even today - an incurable disease. Molecular genetic research, however, resulted in revolutionary changes in melanoma management. Today, apart from the classic pathological prognostic factors, information regarding specifi c molecular modifi cations (such as in the expression of the BRAF, NRAS, c-KIT genes and proteins) are inevitable for the setting up of a personalized oncological treatment plan. By targeting members of the MAPK signal transmission pathway (using BRAF- and MEK-inhibitors), signifi cant improvement could be achieved in metastatic melanoma. Similarly, new drugs targeting specifi c immune checkpoint regulators (such as CTLA-4 and PD-1/PD-1L) provide previously unprecedented survival benefi t for melanoma patients. In this review the most recent developments in the fi eld of melanoma management are summarized.]

All articles in the issue

Related contents

Clinical Neuroscience

[Decisional collisions between evidence and experience based medicine in care of people with epilepsy]

RAJNA Péter

[Background – Based on the literature and his long-term clinical practice the author stresses the main collisions of evidence and experience based medicine in the care of people with epilepsy. Purpose – To see, what are the professional decisions of high responsibility in the epilepsy-care, in whose the relevant clinical research is still lacking or does not give a satisfactory basis. Methods – Following the structure of the Hungarian Guideline the author points the critical situations and decisions. He explains also the causes of the dilemmas: the lack or uncertainty of evidences or the difficulty of scientific investigation of the situation. Results – There are some priorities of experience based medicine in the following areas: definition of epilepsy, classification of seizures, etiology – including genetic background –, role of precipitating and provoking factors. These are able to influence the complex diagnosis. In the pharmacotherapy the choice of the first drug and the optimal algorithm as well as the tasks during the care are also depends on personal experiences sometimes contradictory to the official recommendations. Same can occur in the choice of the non-pharmacological treatments and rehabilitation. Discussion and conclusion – Personal professional experiences (and interests of patients) must be obligatory accessories of evidence based attitude, but for achieving the optimal results, in some situations they replace the official recommendations. Therefore it is very important that the problematic patients do meet experts having necessary experiences and also professional responsibility to help in these decisions. ]

Clinical Neuroscience

[Guidelines for the treatment of traumatic brain injury - 2017]

BÜKI András, BARZÓ Pál, DEMETER Béla, KANIZSAI Péter, EZER Erzsébet, TÓTH Péter, HORVÁTH Péter, VARGA Csaba

[Traumatic brain injury (TBI) is recognized to be the main cause of death and disability in the first four decades representing a major socio-economical problem worldwide. Recent communications revealed a particularly worrying image about the quality of care for TBI in Hungary. For any improvement a systematic approach characterized by utilization of scientific evidence based guidelines forming the basis for close monitoring of the actual care are considered a prerequisite. In Hungary the first evidence based guidelines in the field of TBI have been issued by the National Society for Anesthesiology and Intensive Care more than two decades ago followed by joint guidelines of the Hungarian Neurosurgical Society and the Hungarian College of Neurosurgeons. These publications were primarily based on the work of the European Brain Injury Consortium as well as guidelines issued by the Brain Trauma Foundation. Recent renewal of the latter and a need to refresh the outdated national guidelines was met by a call from regulatory authorities to issue the updated version of the Hungarian TBI-guidelines. The present review is aimed to briefly summarize the most fundamental elements of the national head injury guidelines that would hopefully be officially issued in a far more detailed format soon.]

Lege Artis Medicinae

[Bayesian and frequentist T-test and ANOVA]

MOLNÁR D. László

[T-test and ANOVA are just special cases of linear models. With these models measured values of a continuous variable (e.g. blood pressure) can be compared in two or more groups (e.g. treatment groups). In real life medical application of the frequentist linear models the data often fail the assumptions (e.g. normality and equal variances) originally needed to derive the mathematical equations and distributions for these models. Bayesian linear models are robust, flexible and transparent analogues and alternatives of the frequentist models. Bayesian statistical models can also be useful, when the data do comply with the prescribed conditions for the t-test or ANOVA. An advantage of the bayesian method is the possible incorporation of any prior knowledge into the models. It must be borne in mind, however, that there are many frequentist methods that can be used even if the distributions are not normal, or in the case of heteroscedasciticy or other model inadequacy as well. It is worth mentioning that even the frequentist Lasso (least absolute shrinkage and selection operator) is in near relationship with the Bayesian method, since it is a linear regression method, where the traditional fitting algorithm is modified with a constraint, and some information will be discarded in order to focus on the most relevant coefficients and make the model interpretation easy. Cal­culations were performed in R, primarily with the BayesFactor package developed by Morey and Rouder in 2015. ]

Lege Artis Medicinae

[Bayesian statistical methods in medicine]

MOLNÁR D. László

[Frequentist statistical methods are wide-spread and their use is easy due to the many statistical softwares and books available for the researchers. Despite the growing interest in Bayesian statistical methods teaching statistics is still mainly based on the frequentist theory. Frequentist statistics is based on the definition of probability as a relative frequency, while the Bayesian probability is a quantity that represents a state of knowledge or belief. Bayesian statistics is, in essence, a learning process. In certain situations the bayesian methods are the only possibility for data analysis. Bayesian statistical methods can be applied well in health data analysis. Every re- searcher is, to a certain extent, a Bayesian. The article discusses the application of Bayesian statistical methods in medicine. ]

Lege Artis Medicinae

[Cardiovascular prevention - Opportunities of risk reduction, 2010]

NAGY András Csaba

[10 years of experience following the millennium has confirmed again that data on long term cardiovascular morbidity and mortality can be influenced by effective prevention most substantially. Growing body of knowledge and experience in the field of modern cardiovascular prevention is available, but novel and novel milestone studies have been published leading to updating of guidelines, however, we cannot be satisfied with the results. Evidence suggest that despite recent efforts, Hungarian cardiovascular morbidity and mortality has not been reduced significantly and except for some success - acute ST elevation myocardial infarction care in accordance with the European standard - we are behind the other EU countries in cardiovascular mortality of the active (age 30-65 years) age group. Recently several interesting contradiction has been published in the field of prevention, like the effectiveness of aspirin as primer prevention, which changes our common prevention conception. Data have to be also addressed, which can explain the controversial results from a different point of view. Now we are talking about the results of REALITY study, which highlight not only the noncompliance of the patient but that of the physician as well.]