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Volum 04 Numarul 3-4, 1998

101 Editorial

The professionalism of an institution or a medical team reflects itself in the quantity and quality of medical research, meaning results, published in notorious Journals, applied in daily medical praxis or in industry (drugs, radiotherapy equipment etc.). This process implies considerably time, human and financial efforts.

The common interest of Oncology researchers and pharmaceutical companies is promotion of drugs or therapy protocols more efficient and! or less toxic then current ones. The main subject of the symposium that took place in May 1998 in the Cancer Institute of Cluj was to precise the actual domains of investigation and investment in Oncology, in order to increase the link between the drug Industry and the medical community.

The paper of N. Ghilezan syntheses the idea of team work in oncology research, all participants (patients, physicians, sponsors, monitors and the social community members of the ethic committee) having equal impor- tance, in order to maintain a safe scientific, economic and ethic level of any clinical research and to avoid conflict of interests.

The next two articles are enhancing the strictly objective, scientific and ethic character of studies on human subjects, following international laws on human rights such Helsinki Statement (D. Uta) or good clinical practice rules approved in Romania by the Ministry of Health (Cristina Vitoc).

The principles of design, flow and evaluation of clinical trials are presented by Viorica Nagy and T. Ciuleanu. S. Donea dissects the current state of romanian oncology research, identifying its deficiencies as well as solu-

tions to improve it, such as a more responsible but also properly rewarded human resources involvement. The latest idea is focused also by A. Eniu, from the young researchers point of view.

Where, when and by whom can scientific work be valued are questions answered by Gh. Benga. The quality, importance and impact of a publication are the most sensitive markers of its value. The „peer review” editing system warrants a level compatible with the international journals’ standards. Order and number of the authors should reflect individual intellectual contribution and not merely executive activity. Usually the first author is the one who has obtained the clinical/ experimental data while the scientific responsibility of the final results belongs to the leader of the research program, and his name will appear last among authors.

The paper of N. Todor reflects the tremendous importance of accuracy and detail in every clinical trial. Starting with the data collection, through the quality and strictness of treatment prescription, all the way to the monitoring and rigorous results’ evaluation, they are all written evidence of the conclusion veridicity.

Beside the theme of the symposium ” Clinical research – industry relationship”, this number presents also a

general paper signed by N. Manolescu and all. regarding the importance of developing comparative oncology studies, and several clinical papers.

Considering a case report A. Cucuianu and all discusses ethiopathogenetic and therapeutic implications of C virus hepatitis association with mixte cryoglobulinemia and NHL.

  1. Rădulescu et all review the literature of cardiac complication secondary to thoracic radiotherapy, side effect that must be actively evaluated and treated since many thoracic irradiated patients are long time survivors.

Doina Piciu and all, reporting five cases of medullary thyroid carcinoma emphasize the clues in diagnosis, treatment and follow-up of this familial disease.

Maria Retegan- Thrdean and all studying the role of the complement system in the biology of breast carci- noma note that the C5b-9 complex deposits are located on the cancer cell membrane and in necrotic areas; the latest topography may be a reason for the 25% overexpression of C5b-9 after radio and! or chemotherapy for breast cancer.

The report of the annual meeting of SRRO and the multiple choice EMC questions conclude the 3-4 /1998 number of our „blue” Journal. I invite you to return the reply forms and your suggestions, proving your interest for the presented issues.

  1. Kacso

103 The ethic of the clinical research

  1. Ghilezan

Oncological Institute „Prof I. Chiricuţă”, U. M. Ph. „Iuliu Haţieganu” Cluj-Napoca

The modem clinical research is a team activity with a clear regulation of the relations between clinical investigator, patient, sponsor, monitor and community. The community through the Ethic Committee, which asks the investigator and the sponsor to obtain an informed consent from the patient and as well to declare any possible conflict of interest, defends the interests and the liberty of the patient to accept a clinical experiment. The scientific and economic implications of the medical research impose the use of a very rigorous methodology able to permit the reproduction of the results and an extension of the end point criteria to some other aspects than survival as quality of life, a reduced toxicity and medico- economical elements. The problem of the future sponsorship for the clinical research underlines the need for a dialogue between the organizations capable to provide financial support and the professional bodies, the partnership investigator- industry being essential for a further development of the clinical research and progress medicine.

Radioterapie & Oncologie Medicală, 1998, 3-4: 103-105

106 Clinical research and the pharmaceutical industry

109 Good Clinical Practice

Cristina Vitoc

Oncological Institute „Prof I. Chiricuţă” Cluj- Napoca

It was presented: the definition, the objective and the principles regarding „The Good Clinical Practice”, an international standard imposed in the good development of the clinical studies. As it has been recently introduced in our country too, recalling these rules will contribuate to a better approach of the clinical research in our country and abroad.

Key words: good clinical practice, clinical studies, quality standard.

Radioterapie & Oncologie Medicală. 1998. 3-4: 109-110

111 Clinical protocols

Viorica Nagy

  1. M. Ph. „Iuliu Hţieganu” Cluj-Napoca

Oncological Institute „Prof I. Chiricuţă” Cluj-Napoca

The results of one or more new oncological treatments are evaluated in clinical trials. Every prospective and controlled clinical trial must follow some principles, which materialize in a written protocol. The most important subjects headings of a protocol are: scientific background and objectives, selection of patients and eligibility criteria, design of study, treatment programs, required clinical and laboratory data, criteria for evaluating the effect of treatment, patients randomization, statistical considerations and aspects of management.

Key words: clinical trial, clinical protocol.

Radioterapie & OncologieMedicală, 1998,3-4:111-113

114 Monitoring clinical trials

T.E. Ciuleanu, Elisabeta Ciuleanu, Cristina Cebotaru, Ioana Rădulescu, G. Kacso

Oncological Institute „Prof. I. Chiricuţă” Cluj Napoca

The monitoring of the clinical trials (periodical interim analysis of the data accumulating during the ongoing study) includes clinical and statistical expertise. Monitoring is accomplished in investigators’ quality control meetings and interim analysis of the data by the data monitoring committee. The interim monitoring of the data is providing patients’ safety, a periodical reassessment of the ethical aspects of the study, the decision whether to continue or to prematurely stop the study depending on the interim results, and precludes the publication of immature data. Controversies persist regarding the role of the data monitoring committees (recommendations or decisions ?), as well as on the investigators access to the interim results. External or independent committees offer the greatest credibility to clinical studies.

Key words: monitoring, clinical trials.

Radioterapie & OncologieMedicală, 1998,3-4: 114-117

118 The oncological clinic medical research

122 The research team in the clinical studies. The place and purpose of the resident physicist.

  1. Eniu

Oncological Institute „Prof I. Chiricuţă” Cluj-Napoca

The medical residents in oncological specialities (radiotherapy and medical oncology) are seen as important human resources. Taking active part in the research activity, mainly in the ongoing trials in the institute, they acquire important elements for their professional formation. On the other hand, the institution in which they work can benefit from their activity. The poor outcome quantified by the small number of original papers published by the residents has several reasons. We tried to identify some solutions to increase the motivation of the today residents in order to improve the quality of the future specialists in oncology.

Keywords: residents, research, oncology.

Radioterapie & Oncologie Medicală, 1998,3-4:122-123

124 Turning to good account the scientific research

127 Computer based system for chemotherapy prescription

  1. Todor, T. E. Ciuleanu, Cristina Cebotaru

Oncological Institute „Prof I. Chiricuţă” Cluj-Napoca

The main data structures in computer based chemotherapy prescription are showed: a database (BD) counting chemo- therapy protocols and a BD filled with patients characteristics connected to the previous one by a shortcut of the regimen. Subsequently a File Maker Pro solution is presented together with it’s advantages: data accuracy, easy generalisation for the new regimens, administrative requests updated.

Keywords: chemotherapy, File Maker Pro, database.

Radioterapie & Oncologie Medicală, 1998, 3-4:127-130

131 The precision of the survival’s estimation and the statistical semnification estimate

  1. Todor

Oncological Institute „Prof I. Chiricuţă” Cluj-Napoca

The paper is built on two solid samples of our Institute. The survival time of the patients is evaluated with different precissions: days, two days, …, seven days (a week), … then p value from logrank test is plotted. It can bee seen as one passes from statistical significance to nonsignificance and back. The anexes contains a Mathematica program used to plot the p value for the two samples from fig. I and 5.

Keywords: survival analysis, logrank test, error analysis.

Radioterapie & Oncologie Medicală, 1998, 3-4:131-135

136 The importance of comparative oncology

  1. Manolescu, R. Bengescu, I. Miclăuş, A. I. Baba, S. Bolte, V. Comişel

Comparative Oncology, having a relatively young age as a branch of oncology, needs to be developed, along with her two medical science sisters- human and veterinary oncology, in order to obtain additional data regarding the epidemiology and etiology of cancer.

Key words: oncology, comparative oncology, veterinary oncology, ecosystem, cancer.

Radioterapie & OncologieMedicală, 1998,3-4:136-138

139 Low-grade non-Hodgkin’s lymphoma in a patient with chronic viral hepatitis C and mixed cryoglobulinemia

  1. Cucuianu1, Monica Acalovschi2, Gabriela Fogaş2, Milena Duma1, Mariana Patiu1, Olga Soriţău1, L. Petrov1

1 Oncological Institute „Prof L Chiricuţă” Cluj-Napoca

2 Trd. Medical Clinic, Cluj-Napoca

We present the clinical observation of a 47 year old woman, diagnosed in 1984 with chronic liver disease, subsequently found to be hepatitis C virus (HCV) antibody positive, in which splenectomy was performed in 1996 because of hyper- splenism. Soon afterwards, abdominal ultrasonography revealed multiple intraabdomina11ymphadenopathy, which increased in size during 1997 up to a 4-5 cm diameter, the patient meanwhile complaining of fatigue, weight loss, night sweats and fever. Hematological findings consisted of lymphocytosis with mature B cell phenotype, type II cryoglobulinemia, with a major lymphoid bone marrow infiltrate. The final diagnosis was low-grade non-Hodgkin’s lymphoma stage IV B, mixed cryoglobulinemia, chronic active viral hepatitis C. After chlorambucil treatment, associated with alpha-interferon (indicated for chronic viral hepatitis), a partial response was achieved. The possible role of HCV infection in the pathogenesis of non-Hodgkin’s lymphoma, as well as the prognostic and therapeutic implications are hereby discussed.

Key words: non-Hodgkin’s lymphoma, hepatitis C virus, mixed cryoglobulinemia.

Radioterapie & Oncologie Medicală, 1998, 3-4: 139-144

145 Cardiovascular sequelae of therapeutic thoracic radiation

  1. Radulescu1, Elisabeta Ciuleanu2, C. Duncea1

1 Fifth Medical Clinic,

2 Oncological Institute „Prof I. Chiricuţă” Cluj-Napoca

All the cardiac structures are involved secondary to the oncological radiotherapy. – , In this study the main cardiac complications secondary to therapeutic thoracic radiation are presented: cardiomyopa- thies, coronary heart disease, valvular lesions, cardiac arrhythmias.

Key words: oncological radiotherapy, cardiomyopathies, coronary heart disease, valvular lesions

Radioterapie & On cologie Medicală, 1998,3-4:145-147

148 Medullary thyroid carcinoma in family form – case reports

Doina Piciu1, Adriana Porutiu1, D. Eniu2

1 Oncological Institute „Prof I. Chiricuta” Cluj-Napoca

2 U. M. Ph. „Iuliu Haţieganu” Cluj-Napoca

Five cases of familial medullary thyroid carcinoma (MTC) which were studied at Oncological Institute in 1998 were examined to correlate the clinical, hystologic and immunologic findings. All patients were women, with the mean age of 25.2 years, two patients being adults and three with the cancer occurring in childhood. One single patient had hiperparathyroidism associated to MTC, the other four had familial MTC unallocated with other endocrinopathies. The mean follow- up was 14.2 months. Two patients were alive without disease, one alive with regional metastases and two of them undergo in treatment.

In three cases the diagnosis was suspected only regarding the family history and the values of serum CEA, without any other clinical signs. In the other cases this two features were related with the presence of a cervicalnodul. Serum calcitonine (Ct) levels were not measured. All of them underwent total thyroidectomia and occasionally radioiodine therapy +/- cobaltotherapy.

Despite of the number of MTC, the prognosis and the presence in the familial form request a special attention among the other thyroid cancers.

Key words: medullary thyroid carcinoma, family form, CEA (Carcinoembryonic antigen).

Radioterapie & Oncologie Medicală, 1998, 3-4:148-152

153 C5b-9 complex in breast cancer

Maria Retegan-Turdeanu1, F. Niculescu2, H. Rus2

1 Radiology Clinic, Cluj-Napoca, Romania

2 Department of Pathology, University of Maryland, School of Medicine, Baltimore, USA

Complement activation either by classical or alternative pathways lead to formation of C5b-9 complexes. Assembly of C5b-9 channels occurs stepwise manner, by forming membrane-associated C5b- 7, C5b-8 and C5b-9 complexes, collec- tively called as terminal complement complexes (TCC). These complexes expose neoantigenic determinants allowing them to differentiate the individual C5 to the C9 components. Complement activation is presented on breast cancer cells. This study presents the localization and semiquantitative evaluation of the C5b-9 complexes on breast cancer cells, using indirect peroxidases technique. In our study C5b-9 complexes were found on the membrane of cells and in the necrotic areas in the all breast cancer samples. C5b-9 deposits were more intense and extended on treated breast cancer samples. They were strongly exposed in 89,181 on the treated breast cancer and in 64,701 on the untreated breast cancer. In conclusion, the complement activation is presented on breast cancer and it is more intense in treated ones. This suggest that complement system is involved in breast cancer biology.

Key words: breast cancer, C5b-9, complement.

Radioterapie & Oncologie Medicală, 1998, 3-4:153-159

160 Annual’s Conference Report of the Roumanian Society of Oncological Radiotherapy (SRRO)

G. Kacso

163 ORL Cancers, Romania 1990-1994. The experience of 6 Radiotherapy Centres afiliated to SRRO.

V. Cernea

164 Questionnair EMC

167 Author’s index