Faculty of Medicine

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Prognostic significance of the HPV status in early stage cervical carcinoma
(Macedonian Academy of Sciences and Arts, 2006-09)
Kubelka-Sabit, Katerina
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Prodanova, Irina
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Yashar, Genghis
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Zografski, George
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Aims: In order to evaluate their prognostic significance, the parameters of the human papilloma virus (HPV) status were correlated to the lympho-nodal and tumor status, maximal diameter, minimal thickness of uninvolved stroma, histologic type, grade of differentiation, lympho-vascular space invasion, degree of lymphocytic inflammatory stromal reaction at the invasion front, age and the disease-free survival (DFS) of the patients with early stage invasive cervical carcinomas. Material and methods: 77 cases of cervical carcinomas, limited to the uterus, surgically treated and postoperatively irradiated, were selected for this retrospective study. HPV DNA status (presence and HPV type, type of hybridization signal and number of positive cells per sample) was evaluated using sensitive in situ hybridization detection kit with catalyzed signal amplification with biotinylated probes for types 6/11, 16/18 and 31/33 or 31/33/51. Results: The presence of HPV DNA was detected in 45 (58.4%) cases. Thirty-two (71.1%) showed positivity for HPV type 16/18, 8 (17.8%) for 31/33, whereas multiple infection was detected in (8.9%) 4 cases. Dot hybridization signal was found in 31 (68.9%), diffuse in 2 (4.4%) and mixed in 12 (26.7%) cases. More than five positive nuclei per sample were found in 37 (82.2%) of the cases. Only the presence of HPV was associated with absence of regional lymph node involvement, presence of moderate/abundant lymphocytic infiltration and longer 5 and 10-year DFS. Conclusions: According to our results, more extensive studies are needed to assess the real prognostic influence of the other parameters of HPV status in early stage cervical carcinomas.
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Ki-67 expression in the invasion front as an additional independent significant prognostic factor influencing reccurence in early stage cervical carcinomas.
(Springer, 2005-08)
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Prodanova, Irina
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Kubelka-Sabit, Katerina
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Yashar, Genghis
INTRODUCTION: The attempts to determine the prognostic significance of biological markers and their relation to human papillomavirus (HPV) infection in cervical cancer have yielded controversial results. AIMS: The aims of this retrospective study were to correlate alterations of cell proliferation, growth, differentiation and apoptosis regulatory proteins in early stage cervical carcinomas with HPV infection, histopathological and clinical parameters, and to estimate their prognostic significance. METHODS: Expression of Ki-67, p53, mdm-2, bcl-2, c-erbB-2, EGFR protein, as well as estrogen and progesterone receptors was evaluated by immunohistochemistry in operative specimens of 83 patients with early stage cervical carcinoma. The results were assessed semiquantitatively in the surface area, center and invasion front of each tumor as a percentage of the immunostained cells and/or intensity of immunostaining for each protein. The presence of HPV was assessed by conventional in situ hybridization (ISH) technique and catalyzed reporter deposition signal amplification ISH using mixed biotinylated probes to identify types 6/11, 16/18 and 31/33 or 31/33/51. RESULTS: In our case series 73 patients had a tumor limited to the uterine cervix less than 4 cm in diameter (pT1b1), while 10 patients had larger neoplasms belonging to pT1b2 category. Pelvic lymph node involvement was found in 20 patients. During the follow-up period (range, 65 -181, mean, 121 months) recurrences were observed in 9 patients. The 5, 10 and 15-year disease-free survival rate was 92.7%, 90.8% and 86.6%, respectively. Among the 18 variables pelvic lymph node involvement (P=0.0008), tumor diameter (P=0.035), depth of stromal invasion (P=0.029), histotype (P=0.0009), grade (P=0.056), HPV DNA presence (P=0.056), HPV type (P=0.043), as well as bcl-2 (P=0.035), mdm-2 (P=0.051), EGFR (P<0.0001), and Ki-67 (P=0.031) expression in the tumor’s invasion front were identified as important predictive indicators of recurrence in the univariate analysis. Independent significant prognostic factors for disease-free survival in multivariate analysis were the histotype, HPV DNA presence and Ki-67 expression. CONCLUSIONS: The invasive front of carcinomas proved to be the most important area for tumor prognosis. In addition to the detection of HPV presence and morphological parameters, Ki-67 evaluation could be used in selecting appropriate therapeutical approaches in patients with early stage cervical cancer.
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Blood vessel invasion and inflammatory stromal reaction at the invasion front as additional significant prognostic factors in surgically treated patients with cervical carcinoma.
(Springer, 2001-09)
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Yashar, Genghis
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Veljanoska, Slavica
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Kubelka, Katerina
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Prodanova, Irina
Introduction: The objective of this study was to evaluate the prognostic significance of 23 clinical and histopathological variables in relation to disease-free (DFS) and overall survival (OS) in patients with early stage cervical carcinomas. Methods: A retrospective analysis of 237 patients with cervical carcinoma, undergoing radical hysterectomy and postoperative irradiation between 1988 and 1997 was conducted. The operative specimens were subjected to detailed and uniform histopathological work-up. The patients were staged according to the postoperative TNM classification of UICC (1997) guidelines. Mean follow-up time was 57 (18-124) months. Results: The 5 and 10-year OS rate was 80.8%, while DFS rates at 5 and 10 years were 76.8% and 75.5%, respectively. In multivariate analysis, blood vessel invasion, pelvic lymph node metastases, tumor diameter, inflammatory stromal reaction at the invasion front, and minimum thickness of uninvolved cervical stroma/parametrial extension, were independent and significant variables. The prognostic index, as an indicator of the patient's place in the prognostic spectrum, defined by the Cox regression model, was able to categorize the patients into three distinct risk groups. The 5-year DFS and OS rates of the low-, intermediate-, and high-risk groups were 97.5%, 86.3%, and 43.8%, vs. 98.8%, 84.5%, and 45.3%, respectively (P<0.0001). Conclusions: The prognostic index could be a sound basis for an appropriate planning of the following therapeutical strategy for the surgically treated patients with cervical carcinoma. The postoperative TNM classification should be modified, incorporating the blood vessel invasion and the inflammatory stromal reaction at the invasion front, as additional significant prognostic factors.
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Prognostic value of cell proliferation, growth and differentiation regulatory proteins in early stage cervical carcinoma
(Springer, 2006-05)
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Yashar, Genghis
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Kubelka-Sabit, Katerina
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Prodanova, Irina
Objectives: The aim of this study was to evaluate the immunohistochemical expression of cell proliferation, growth, and differentiation regulatory proteins in early stage cervical carcinoma and to assess their prognostic value by exploring their relationships to various clinicopathological characteristics (age, lymph node involvement, tumor diameter, depth of invasion, thickness of uninvolved cervical stroma, histotype, grade, lymphvascular space invasion, inflammatory infiltrate), human papillomavirus (HPV) status and influence on disease-free survival. Methods: This retrospective study comprised 83 patients, all subjected to radical hysterectomy with bilateral pelvic lymphadenectomy for early stage cervical carcinoma and postoperative irradiation therapy. Expression of Ki-67, c-erbB-2, EGFR protein, as well as estrogen and progesterone receptors was evaluated by immunohistochemistry using avidinbiotin-peroxidase complex method. The results were assessed semiquantitatively in the surface area, center and invasive front of each tumor as the percentage of the immunostained cells and/or intensity of immunostaining for each protein. The presence of HPV was assessed by conventional in situ hybridization (ISH) technique and catalyzed reporter deposition signal amplification ISH using mixed biotinylated probes to identify types 6/11, 16/18 and 31/33 or 31/33/51. RESULTS: In our case series, 73 (88%) patients had a tumor limited to the uterine cervix less than 4 cm in diameter (pT1b1), while 10 (12%) patients had larger neoplasms belonging to pT1b2 category. Pelvic lymph node involvement was found in 20 (24%) patients. During the follow-up period (range, 65-181, mean, 121 months) recurrences were observed in 9 patients. The 5-, 10- and 15-year disease-free survival rate was 92.7%, 90.8% and 86.6%, respectively. Important predictive indicators of recurrence in the univariate analysis were pelvic lymph node involvement (P=0.0008), tumor diameter (P=0.035), depth of stromal invasion (P=0.029), histological type (P=0.0009), grade of differentiation (P=0.056), HPV DNA presence (P=0.056), HPV type (P=0.043), as well as Ki-67 (P=0.031), and EGFR protein (P=0.0066) expression in the tumor’s invasive front. Among these variables, however, the histological type, HPV DNA presence, Ki-67 and EGFR protein expression were identified as independent significant prognostic factors for disease-free survival in multivariate analysis using Cox regression model. Conclusions: The invasive front of carcinomas proved to be the most important area for the evaluation of prognostic significance of the expression of cell proliferation, growth, and differentiation regulatory proteins. In addition to the detection of HPV presence and morphological parameters, the evaluation of Ki-67 and EGFR protein expression may provide additional prognostic information in patients with early stage cervical carcinomas.
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Immunohistochemical expression and prognostic significance of the biological markers bcl-2, p53, mdm-2 and ki-67 in early stages of invasive cervical carcinomas
(Springer, 2006-05)
Prodanova, Irina
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Kubelka-Sabit, Katerina
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Yashar, Genghis
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Objectives: The objectives of this study were the evaluation of the immunohistochemical expression of apoptosis regulating proteins (bcl-2, mdm-2 and p53 protein) in correlation with proliferation (Ki-67), human papillomavirus (HPV) infection and other histopathological and clinical parameters in early stage cervical carcinomas and estimation of their prognostic significance. Methods: The subject of this study was a series of 83 surgically treated patients with cervical carcinoma confined to the uterine cervix, who subsequently received complete radiotherapy. The presence of HPV DNA in the neoplasm was determined by the conventional method of in situ hybridization (ISH) and catalyzed reporter deposition signal amplification ISH using mixed biotinylated probes to identify types 6/11, 16/18 and 31/33 or 31/33/51. The immunohistochemical expression of the biological markers was semiquantitatively evaluated as the percentage of immunostained cells in the three compartments of the neoplasm: the surface, the middle layer and the invasive front. Results: 73 patients had a tumor confined to the uterine cervix less than 4 cm in diameter (pT1b1) and the other 10 had larger neoplasms that belong to the pT1b2 category. Regional lymph node involvement was found in 20 (24%) of the patients. During the clinical follow-up (mean, 120.7, range 4.4-181 months) a relapse was diagnosed in 9 (10.8%) patients, 6 of which (7.2%) died of the disease. The expected 5-, 10- and 15- year overall survival was 94.4%, 92.7% and 92.7%, and disease-free survival was 92.7%, 90.8% and 86.6%, respectively. The results of the univariate analysis indicate that significant predictive indicators for recurrence are: lymphonodal status, maximal tumor diameter, depth of stromal invasion, histological type, HPV DNA presence and type, and the immunohistochemical expression of bcl-2, mdm-2 and Ki-67 in the invasive front of the neoplasm. In the multivariate analysis, histological type, HPV DNA presence and the expression of Ki-67 in the invasive front have been selected as the most significant independent prognostic parameters (P=0.0024). The value of the prognostic index (PI), calculated using the Cox regression model, provided the basis on which the patients were classified into two distinct risk groups with significantly different disease-free survival period (P=0.0009). Conclusions: The results indicate that the invasive front of the neoplasms proved to be the most important area for the evaluation of immunohistochemical expression of biological markers. The prognostic index as an indicator of the patient’s place in the prognostic spectrum enables the identification of the risk group of patients in whom, due to a higher risk of relapse, better results are to be expected with the application of more aggressive therapy.
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The implementation of prognostic index and risk grouping in surgically treated cervical carcinoma patients: A prospective validation study
(Македонско лекарско друштво = Macedonian medical association, 2013)
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Veljanoska-Petreska, Slavica
Introduction. The objective of this prospective study was to validate the prognostic criteria defined by the results of our previous study in an independent population of surgically treated cervical carcinoma patients. Methods. The study group consisted of 340 patients who underwent abdominal hysterectomy with pelvic lymphadenectomy as primary therapy. Based on the scores of the variables (blood vessel invasion, lymph node metastases, tumor diameter, degree of inflammatory reaction at the invasive front, and minimum thickness of uninvolved cervical stroma/parametrial extension) and calculated prognostic index (PI) values, the patients were divided into three prognostic groups. Results. The 5-year disease-free survival (DFS) rates of the low, intermediate, and high-risk groups were 98,82%, 84,57%, and 74,01%, respectively. The differences in DFS rates were statistically significant (P<0,00001). In order to validate the model from our previous study, we have compared DFS rates between the groups. There was no difference in DFS rate between low-risk groups, although the majority of the patients in this study were not irradiated, while radiotherapy was administrated invariably to all the original study patients. Similarly, DFS did not differ significantly between the intermediate-risk groups, which could be expected since radiotherapy was administrated to majority of the patients in this study. In contrast, the high-risk group patients in this study had significantly higher DFS rate (74,01% vs. 44,24%, P=0,0010), probably as the result of the adjuvant chemotherapy administrated to 69% of them. Conclusions. PI could be a sound and reliable basis for appropriate planning of the following therapeutical strategy of the surgically treated cervical carcinoma patients.
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The implementation of prognostic index and risk grouping in surgically treated cervical carcinoma patients: A prospective validation study.
(Springer, 2008-05)
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Prodanova, Irina
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Kubelka-Sabit, Katerina
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Veljanovska, Slavica
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Arsovski, Oliver
BACKGROUND: The objective of this prospective study was to validate the prognostic criteria defined by the results of our previous study in an independent population of surgically treated cervical carcinoma patients. METHOD: The study group consisted of 340 patients who underwent abdominal hysterectomy with pelvic lymphadenectomy as primary therapy between 2000 and 2005. Based on the scores of the variables (blood vessel invasion, lymph node metastases, tumor diameter, degree of inflammatory reaction at the invasive front, and minimum thickness of uninvolved cervical stroma/parametrial extension) and calculated prognostic index (PI) values, the patients were divided into three prognostic groups. RESULTS: During the follow-up period (range, 1.6–89.7, mean, 39.7±22.2 months) recurrences were observed in 1% (1/97), 12.2% (16/131) and 23.2% (26/112) of the low-, intermediate-, or high-risk group patients, respectively. The 5-year disease-free survival (DFS) rates of the low, intermediate, and high-risk groups were 98.82%, 84.57%, and 74.01%, respectively. The differences in DFS rates were statistically significant (P<0.0001). In order to validate the model from our previous study, we have compared DFS rates between the groups. There was no difference in DFS rate between low-risk groups, in spite of the fact that majority of the patients in this study were not irradiated, while radiotherapy was administrated invariably to all the patients included in the original study. Similarly, DFS did not differ significantly between the intermediate-risk groups from both studies, which could be expected since radiotherapy was administrated to majority of the patients (125/131) in this study. In contrast, the high-risk group patients in this study had significantly higher DFS rate (74.01% vs. 44.24, P=0.0010), probably as the result of the adjuvant chemotherapy administrated to 69% of them. CONCLUSION: PI could be a sound and reliable basis for an appropriate planning of the following therapeutical strategy of the surgically treated cervical cancer patients.
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Adjuvant chemotherapy in patients with stage IIIA endometrial carcinoma with solitary adnexal involvement
(Macedonian Association of Pathology, 2016-09)
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Veljanoska, Slavica
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Objective: The optimal adjuvant therapy in endometrial cancer patients with solitary adnexal involvement is still controversial. The purpose of this study was to evaluate, retrospectively, the outcome and efficacy of adjuvant chemotherapy in these patients. Material and Methods: The medical records of the patients with stage IIIA endometrial cancer with solitary adnexal involvement who were treated with surgical resection and adjuvant chemotherapy between 2005 and 2010, were retrospectively analyzed. A total of 40 patients treated with platinum-based adjuvant chemotherapy were included. Following surgery, all patients received 4 cycles of Carboplatin 300 mg/m2 and Paclitaxel 175 mg/m2 by intravenous injection every 3 weeks. The survival and recurrence rates were evaluated. Results: The median follow-up period was 5 years (60 months). Recurrences occurred in 12.5 % (n=5) of the patients. One local recurrence (1/5, 20%) and 4 distant metastases (4/5, 80%) in liver (n=2, 40%), lung (n=1, 20%) and paraaortal lymph nodes (n=1, 20%) were observed. The 3-year disease-free survival (DFS) and overall survival (OS) rates were 87.5% and 92.3%, respectively. Conclusions: In conclusion, platinum-based adjuvant chemotherapy may improve prognosis and survival in stage IIIA endometrial cancer patients with solitary adnexal involvement and could be considered as a potential adjuvant treatment. Although adjuvant chemotherapy has demonstrated improved both disease-fee and overall survival compared to radiotherapy (DFS 87.5% vs 69%; OS 92.3% vs 78%), further studies are needed to define the optimal treatment strategy.

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