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Volum 09 Numarul 1, 2003

3 Editorial

From the series of the useful and popular Therapeutic guidelines, the first 2003 issue of the journal is dealing with Ovarian cancer under the authorship of Prof. dr. N. Ghilezan.

This issue is mostly dedicated to the 11th. Annual Conference of the Romanian Society of Radiotherapy and

Medical Oncology (SRRO), held in Cluj between the 9th-12th October 2002. This year, the SRRO Conference was part of the Days of Oncology in Cluj, together with the manifestations of two other scientific societies (Surgical Oncology and Medical Oncology). The subject for SRRO 2002 was Combined Radiochemotherapy, which was debated from a preclinical point of vue (experimental tumor models), as well as the clinical applica- tions in various tumor types. The papers published in this issue are presenting the state of the art and the experience of the Cancer Institute of Cluj with the radiochemo association in lung, cervical, brain and pediatric soft tissue tumors.

The role of the adjuvant chemoradiation in localized non-small cell lung cancer is the subject of a general article by T.E. Ciuleanu, who is reviewing the controversies resulting from the published randomized studies and meta-analyses and is making some recommendations for the management of these patients which were previously considered surgical candidates alone. Petronela Rusu is presenting a phase II study of Concurrent chemoradiotherapy with Navelbine and Cisplatin for unresectable stage III NSCLC which could represent a model for the implementation of the combined strategy in other cancer centers in our country. due to its efficacy and mild toxicity. Viorica Nagy is presenting a large phase III trial (600 patients) which illustrates the Changes in natural history of cervical cancer through concomitant radio-chemotherapy and thus is defining a new standard of treatment, due to a survival gain. Dana Cernea is presenting the experience accumulated between 1995-200 I with the Radiochemotherapy in high gra gliomas. iscussing the ways of improving the results, by increasing the delivered dose of radiation or by associating new drugs temozolomide. Ştefania Neamţu analyzed retrospectively (1987-2000) The results of multimodal treatment in childhood soft tissue sarcomas. found survival curves comparable with the literature data and identified prognostic factors that could recommend the use of chemotherapy and radiotherapy.

Two papers are dedicated to brachytherapy – a general article by G. Kacso which is dealing with the complex domain of the Radiobiology of Interstitial Brachytherapy and an original article of O. Coza, comparing Two types of cervico-uterine applicator.

In Actualities, Cristina Vitoc makes a very useful presentation of the criteria of the new TNM classification for breast carcinomas and T.E. Ciuleanu selects some new topics on lung cancer presented at ASCO and ECCO 2002 meetings. The digestive tumors make the subject of a rare case presentation by Liliana Resiga, a Gastric undifferentiated carcinoma with lymphoid stroma. The literature review done by Daniela Martin concludes the journal.

This issue, dedicated mainly to the combined chemoradiotherapy, is also proposing a trip through most of the tumor types and treatment modalities, offering, I think, some good food for thought to the oncology tans.

T.E. Ciuleanu

5 Radiobiology of Interstitial Brachytherapy

  1. Kacso

UMPh “Iuliu Haţieganu” , Cluj-Napoca, Cancer Institute .”Prof I. Chiricuţă”

Fascinating and extremely complex brachytherapy’s radiobiology is still waiting several answers in order to fully understand it. Mathematical models presented in this material are imperfect but very useful tools for equating, from radiobiological point of view, various regimen of external beam radiotherapy, high or low dose brachytherapy. Their appliance in daily practice must be always subordinated to the clinical judgement and own medical experience.

Key words: Radiobiology, brachytherapy, LDR, HDR.

Radioterapie & Oncologie Medicală, 2003,1:5-13

14 Localised Non-small Cell Lung Cancer. Role of the Adjuvant Chemoradiation

T.E. Ciuleanu

UMPh.”Iuliu Haţieganu”. Cancer Institute .”Prof I. Chiricufii” Cluj– Napoca

The standard treatment of the patients with a localised (stage I-II) non-small cell lung cancer is radical surgery (lobectomy. pneumonectomy with mediastinal lymphadenectomy or sampling). This paper illustrates the actual status of the adjuvant treatments (chemotherapy and radiotherapy) in this setting. Our conclusion is that neither adjuvant chemotherapy, nor adjuvant radiotherapy or combined chemoradiation can be routinely recommended in radically resected patients. The publication, later this year, of the results of IALT trial and a new metaanalysis in 2006 could eventually modify this conclusion.

Increasing evidence suggests that neoadjuvant chemotl1erapy or chemoradiation could improve survival in subsets of patients with initially resectable or marginally resectable (stage I-IlIA) tumors. None of these approaches is considered standard. The results of the ongoing trials with new generation agents are eagerly awaited.

Key words: ASCO, ESMO. trial.

Radioterapie & Oncologie Medicaăi. 2003. 1:14-20

21 Changes in Natural History of Cervical Cancer through Concomitant Radio-Chemotherapy

Viorica Nagy

UMPh.”Iuliu Haţieganu„, Cancer Institute „Prof I.Chiricuţă” Cluj-Napoca

The treatment of uterine cervix carcinoma is based on surgery and radiation therapy with local evolution or recurrence (17-45%) the most important causes of failure and for the locally controlled cases, the distant metastasis still having an important contribution (15-30%). This lack in improving of the therapeutic results has led to an association of irradiation with chemotherapy in the treatment of the advanced stages of the cancer of cervix as an attempt to increase the local and distal control in this setting. From the different modalities of association, the concurrent radio-chemotherapy gave the best results published in the late 1990. Several clinical trials and meta-analyses have demonstrated the potential of the combined radio-chemotherapy based on cisplatin to improve the overall and disease free survivals (net benefit of 12% respectively 16%, p<0.0001), and to decrease local and distant failures rate and the risk of death. The long time experience of the Cancer Institute Cluj, published in the last 20 years, is in concordance with this trend and a recently closed randomized clinical trial with 600 patients demonstrates a gain of 15% in survival for the concurrent radio-chemotherapy vs radiotherapy alone (75% vs 60%).

Key words: cervical cancer, concomitant radio-chemotherapy.

Radioterapie & O cologie Medicală, 2003, 1:21-26

27 Endocavitary MDR-Brachytherapy in the Treatment of Uterine Cervix Carcinoma: Two Types of Utero-Vaginal Applicators

  1. Cozal,2, Claudia Ordeanul, S. Gavrişl, Daniela Suciul

1 Cancer Institute „Prof I. Chiricuţă „.

2UMPh „Iuliu Hatieganu” Cluj-Napoca

The main purpose of this study is a retrospective comparison between two types of vaginal applicators utilized in the MDR-endocavitary brachytherapy of the uterine cervix carcinoma: the vaginal ovoids from of the Manchester system (a first group of 28 patients) vs. the ring-type vaginal applicator (a second group of 29 patients). A 20% reduction in the volume of tissue irradiated by using the ring-type applicator was obtained compared to the classical vaginal ovoids, at the same length of the uterine applicator. This has not influenced the local control, evaluated as the histological sterilization of the surgica~ specimens in the two groups of patients. Furthermore, the ring-type vaginal applicator confers an advantage in lowering the dose delivered to the urinary bladder. These results must to be confirmed by the further evaluation of the recurrences and late complications.

Key words: endocavitary brachytherapy, ring-type vaginal applicator, vaginal ovoids.

Radioterapie & Oncologie Medicala, 2003, 1:27-32

33 Radiochemotherapy in High Grade Gliomas. The Experience of Cancer Institute Cluj 1995-2001

Dana Cernea1, G. Kacso1.2, Andrada Stan1

1Cancer Institute „Prof I. Chiricuta„,

2UMPh „luliu Hatieganu” Cluj-Napoca

Purpose: To present the results obtained in treatment of high-grade gliomas in adults with surgery and radiotherapy, a retrospective study between 1995-2001. The role of chemotherapy in patients with relapse or as adjuvant treatment is evaluated. Clinical prognostic factors were identified. Patients and Methods: The study presents 120 patients with primary brain tumors (101 patients with high-grade gliomas and 19 patients with oligodendrogliomas) treated between 1995-2001. The standard treatment was surgery followed by radiotherapy. Forty-seven patients (39%) had radical surgery and 73 patients (61 %) had suboptimal surgery. Radiotherapy with currative intent and conventional fractionation was applied in 78 patients and 42 patients were irradiated with palliative intent and modified fractionation. Twenty patients with local relapse whose tumours were resectable underwent surgery and 60 patients underwent chemotherapy. Results: The radiotherapy with curative intent was followed by 82% stable diseases, 8% complete remissions and 10% partial and progressive disease. The global survival at one year, was 49% for patients with glioblastoma multiforme and 32% for patients with anaplastic astrocy- toma (p=0.096). The improvement of neurological status was seen at patients treated with chemotherapy but without benefit in survival. The best results were obtained at patients treated with Temodal concomitent with radiotherapy than followed by adjuvantcllemotllerapy, 15-18 months progression-free survival. Patients under 45 years, a good neurological status, and low grad of differentiation are associated with good survival. Conclusion: Despite aggressive treatment. the high-grade malignant gliomas have a poor prognosis with current methods. Relapse is nearly universal, responses in recurrent disease are not enduring, and quality of life because of tumour growth is poor. New treatment strategies that address symptom control and quality of life as well as progression-free and overall survival are needed.

Keywords: glioblastoma multi forme, anaplastic astrocytoma, radiotherapy, chemotherapy. prognostic factors.

Radioterapie & Oncologie Medicală, 2003, 1:33-40

41 Concurrent Chemoradiotherapy with N avelbine and Cisplatin for U nresectable stage III NSCLC. A Phase II Study

Petronela Rusu1,2, T.E. Ciuleanu1,2, Dana Cemea 1, Doris Pelau1, Viola Gaall, Cristina Cebotaru1, Dana Iancul, T. Guttmanl, N.Todorl, N.Ghilezanl,2

1Cancer Institute „Prof Ion ChiricuţăCluj-Napoca

2UMPh „Iuliu Haţieganu” Cluj-Napoca

Purpose: There has been conducted a prospective phase II study to determine the response rate (RR), toxicity and survival (S) of concurrent Navelbine and Cisplatin (2 cycles), with radiotherapy, followed by 2 more cycles of consolidation chemo- therapy with the same drugs. for locally advanced stage III NSCLC, In order to decrease toxicity the role of protectors like amifostine has been evaluated. Materials and methods: Thirty patients with histologically proven NSCLC, un resectable stage IlIA and IIIB, performance status (PS)=1-2, entered the study from the 16.11.2000 to 24.06.2002. The treatment consisted of 2 cycles of chemotherapy with Navelbine and Cisplatin, given concurrently with radiotherapy, followed by 2 more cycles of consolidation chemotherapy with the same drugs. The doses were lower, when given concurrently with the radiotherapy: (Navelbine 15 mg/sqm, d 1,8, Cisplatin 80 mg/sqm, d 1, q 21) and were the standard ones, when given as consolidation chemotherapy: (navelbine: 25 mg/sqm d 1,8, cisplatin 100 mg/sqm, d 1, q 21). Fifteen patients received amifostine (Ethyol WR-272) 740 mg/sqm, d 1, 8, q 21, which is an organic thiophosphate. found to have radio and chemoprotective effect. Results: Thirty patients were evaluable for toxicity. Grade 3 or 4 neutropenia occured in 7 patients (23°10), esophagitis in 6 patients (20%), digestive toxicities in 4 patients (13%). There was a trend of lower severe toxicities when amifostine was administrated. Of the 28 patients evaluable for response, 4 patients achieved a complete response (CR=14%), 12 patients achieved a partial response (PR= 43%) for an overall response rate (RR) of 57%. Ten patients had stable disease ( SD=35%), and 2 patients had progressive disease (PD=7%). As pointed out in the Kaplan Meiers survival curve, the 1-year survival rate was 55%, the median survival (mS) was 13 months, at a median follow up of 8 months. Conclusions: Preliminary analyses indicate that concurrent Navelbine and Cisplatin (2 cycles) with radiotherapy followed by 2 more cycles of the same drugs given as consolidation chemo.herapy for advanced stage III NSCLC is feasible and well tolerated and has a positive effect on the .response rate and survival.

Key word: Navelbine, Cisplatin, thoracic radiation therapy,

Radioterapie & Oncologie Medicală, 2003, 1:41-46

47 The Results of Multimodal Treatment in Childhood Soft Tissue Sarcomas

Ştefania Neamţu, Emilia Mihuţ, Rodica Cosnarovici, Dana Cernea, Milena Duma, V. Popiţa, T. Guttman, N. Todor

Cancer Institute „Prof I. Chiricuta”, Cluj-Napoca

Purpose: to evaluate the results of multimodal therapy in childhood soft tissue sarcomas and to identify clinical factors predicting response. Patients and methods: between 1987 to 2000, at the Oncopediatric Department of the Cancer Institute „I.Chiricuta” Cluj-Napoca were treated 56 patients with soft tissue sarcomas. The most common sarcomas were rhabdomyosarcoma, followed by liposarcoma and fibrosarcoma. The primary sites were extremity (34%), head/neck (23%), genitourinary tract (16%), trunk (14%), orbit (7%), retroperitoneum and mediastinum (6%). All the patients received surgical treatment, followed by chemotherapy and/or radiotherapy. Results: with a median follow-up of 20 months. the overall 2-year survival was 51 % and event free-survival 48%. There was a significant difference of survival rates related to the tumor invasiveness, the involvement of regional lymph nodes, the response of the first treatment. Conclusions: the retrospective study done on an unselected group of children with soft tissue sarcomas presents a global survival rate under the values reported in literature. In perspective, the results can be ameliorated using aggressive chemotherapy protocols, hyperfractionated radiotherapy.

Key words: soft tissue sarcomas, children, surgery, chemotherapy, radiotherapy.

Radiaterapie & O cologie Medicală, 2003, 1:47-52

53 Undifferentiated Gastric Carcinoma with Lymphoid Stroma. Case Report and Review of the Literature

Liliana Resiga1, G. Kacso1, C.D. Olinicil,2

1Cancer Institute „Prof I. Chiricuţă”;

2Dept, of Pathology, UMPh „Iuliu Haţieganu” Cluj-Napoca

The authors report the case of a 48 year-old male who showed an undifferentiated gastric carcinoma with lymphoid stroma confirmed immunohistochemically, The clinical, histological and pathogenetic features as well as the differential diagnosis of the entity are briefly discussed.

Key words: undifferentiated gastric carcinoma with lymphoid stroma, histology, clinical features, pathogenesis.

Radioterapie & Oncologie Medicală,2003, 1:53-56

57 Epithelial Ovarian Cancer. Therapeutic Guidelines

  1. Ghilezan, G. Peltecu, I. Munteanu

66 „American Joint Committee on Cancer”. Revision the Staging System for Breast Cancer

Cristina Vitoc, N. Ghilezan

71 New Developments in Lung Cancer (Report on ASCO- Orlando, FL, USA and ESMO, Nice, France 2002 Meetings)

  1. E. Ciuleanu

75 REVIEW OF LITERATURE

77 CME QUESTIONNAIRE

79 GUIDELINES FOR AUTHORS