Hellenic Society of Breast Surgeons

Athens, Greece

Hellenic Society of Breast Surgeons

Athens, Greece

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Markopoulos C.,Hellenic Society of Breast Surgeons | Tzoracoleftherakis E.,Hellenic Society of Breast Surgeons | Polychronis A.,Hellenic Society of Breast Surgeons | Venizelos B.,Hellenic Society of Breast Surgeons | And 12 more authors.
Breast Cancer Research | Year: 2010

Introduction: The aim of this multicenter, phase III, prospective open label clinical trial was to investigate the effect of risedronate (R) on bone mineral density (BMD) in postmenopausal, early breast cancer (BC) patients scheduled to receive anastrozole (A).Methods: Pre-treatment BMD of 213 patients with hormone receptor-positive BC was evaluated at lumbar spine (LS) and hip (HP). Patients were categorized according to their baseline BMD T-score as being at low, moderate and high risk of osteoporosis. Low risk patients received anastrozole only (A), moderate risk were randomized to anastrozole +/- risedronate (A+/-R) administration and high risk patients received anastrozole + risedronate (A+R). Anastrozole was given at a dosage of 1 mg/day while oral risedronate was given at 35 mg/week. BMD was then assessed at 12 and 24 months. All patients received daily supplements of calcium (1000 mg/day) and vitamin D (400 IU/day).Results: At 24 months, in the moderate risk group, treatment with A+R resulted in a significant increase in BMD at LS and HP compared to treatment with A only (5.7% v -1.5%, Wilcoxon test P = 0.006, and 1.6% v -3.9% Wilcoxon test P = 0.037, respectively), while no significant difference was found at 12 months; 24.3% of the patients moved to normal BMD region. In the high risk group, a significant increase for LS was detected both at 12 and 24 months (6.3% and 6.6%, P < 0.001) but not for HP; BMD in 14% of patients improved to the osteopenic region. In the low risk group, a significant decrease of BMD was detected at 12 months for LS and HP (-5.3% P < 0.001 and -2.4% P < 0.001, respectively,); at 24 months, a significant decrease of BMD was detected only for LS (-2.5%, P < 0.001). However, 22% of patients became osteopenic and only 4% became osteoporotic.Conclusions: The addition of oral risedronate in post-menopausal breast cancer patients receiving anastrozole has a favorable effect on BMD. Patients with pre-treatment osteopenic to osteoporotic status should be treated with a combination of both therapies in order to avoid bone loss induced by aromatase inhibition. Patients with normal BMD before starting treatment with anastrozole have a very low risk to develop osteoporosis.Trial registration: ClinicalTrials.gov Identifier NCT00809484. © 2010 Markopoulos et al.; licensee BioMed Central Ltd.


Markopoulos C.,Hellenic Society of Breast Surgeons | Xepapadakis Gr.,Hellenic Society of Breast Surgeons | Venizelos V.,Hellenic Society of Breast Surgeons | Tsiftsoglou A.,Hellenic Society of Breast Surgeons | And 6 more authors.
European Journal of Surgical Oncology | Year: 2012

Aims: The objective of this retrospective study was to describe the results from five institutions' experience of using Oncotype DX® to identify patients who need chemotherapy despite the presence of primarily favorable characteristics. Patients and methods: Oncotype DX was performed in 106 pre- and postmenopausal patients with estrogen receptor-positive, HER2-negative, early breast cancer with a combination of favorable prognostic factors or favorable prognostic factors with at least one unfavorable characteristic (tumor size >2 cm, tumor grading of II-III, Ki-67 ≥ 10%, presence of lymph node micrometastases) in which it was unclear whether hormonal therapy only or chemotherapy plus hormonal therapy was the optimal adjuvant treatment. Results: Sixty-four (60.4%) women had Recurrence Score (RS) values <18, 29 (27.4%) intermediate RS values of 18-30, and 13 (12.3%) high RS values of ≥31. Tumor size, grading and presence of micrometastases were not associated with the RS. There was a significant association between Recurrence Score and the number of unfavorable characteristics as a categorical but not as a continuous variable. High Recurrence Scores were predictive of high Ki-67 but the converse was not true. Overall, 29 of 106 (27.4%) patients received chemotherapy because of an intermediate or a high Recurrence Score. Conclusion: The Recurrence Score helped in treatment decision-making for estrogen receptor-positive, HER2-negative patients with favorable characteristics or an intermediate risk of recurrence due to the presence of at least one unfavorable factor. The results of the 21-gene assay increased the likelihood for patients with intermediate clinical and histopathological risk factors receiving chemotherapy. © 2012 Elsevier Ltd. All rights reserved.


Markopoulos C.,Hellenic Society of Breast Surgeons | Koukouras D.,Hellenic Society of Breast Surgeons | Venizelos V.,Hellenic Society of Breast Surgeons | Karyda I.,Hellenic Society of Breast Surgeons | And 9 more authors.
Breast | Year: 2016

Introduction: The aim of this observational study was to assess the combined impact of chemotherapy (CT) and aromatase inhibitors (AI) therapy on bone mineral density (BMD) in postmenopausal women with estrogen receptor (ER)-positive early breast cancer. Methods: Patients were treated with a third generation AI, either as adjuvant therapy (HT cohort, n = 166) or as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort, n = 124), and were followed up for a 12-month period. BMD was evaluated at lumbar spine (LS) and total hip (HP) before CT, before AI therapy and after 12 months of AI therapy. The primary study objective was changes in LS BMD between pre CT treatment and post 12 months AI therapy in the CT cohort. Results: There were no statistically significant changes in LS BMD, either within CT or HT cohort. In the CT cohort, the mean LS BMD change was -0.72% (95% CI: -2.97%, +1.53%, p = 0.5526) between CT start and month 12 of AI therapy, while it was -0.19% (95% CI: -2.12%, +1.74%, p = 0.8309) and -0.59% (95% CI: -3.18%, +2.00%, p = 0.4759) between CT start and AI start and AI start and month 12 of AI therapy respectively. The mean change in LS BMD in the HT cohort (i.e. after 12 months of AI treatment) was +1.51% (95% CI: -0.96%, +3.98%, p = 0.7420). Conclusions: The results of this study indicate that, under routine clinical practice, most postmenopausal patients who receive CT before AI therapy do not experience debilitating BMD consequences during the first year of AI treatment.Trial registration: ClinicalTrials.gov Identifier NCT01298362. © 2016 Elsevier Ltd.


Markopoulos C.,Hellenic Society of Breast Surgeons | Tzoracoleftherakis E.,Hellenic Society of Breast Surgeons | Koukouras D.,Hellenic Society of Breast Surgeons | Venizelos B.,Hellenic Society of Breast Surgeons | And 4 more authors.
Journal of Cancer Research and Clinical Oncology | Year: 2012

Purpose: We investigated whether age at anastrozole (A) initiation influences the effect of treatment on bone mineral density (BMD). We conducted a post hoc analysis of the dataset of Arimidex Bone Mass Index Oral Bis-phosphonates prospective trial, studying the effect of risedronate (R) on BMD of postmenopausal, early breast cancer patients receiving A. Methods: Patients were stratified into those with normal BMD or mild osteopenia (T>-2) receiving A-only and patients with mild or severe osteopenia (T ≤ -2) or osteoporosis (T<-2.5) receiving A and per os R (A + R). Depending on age on treatment initiation, patients were grouped into two age cohorts, above and below 65 years. BMD change in lumbar spine (LS) and hip (HP) was evaluated at 12 months. An analysis of patients with normal BMD at baseline was additionally performed. Results: Among patients receiving A-only, women ≤65 years were more likely to have a decrease in LS-BMD than older (p = 0.034). HP-BMD decrease at 12 months was not related to age (p = 0.182). In patients with mild or severe osteopenia or osteoporosis, treated with A + R, no age effect was observed for LS or HP (p = 0.099 and p = 0.939, respectively). Among patients with normal BMD at baseline, the age effect on LS-BMD change was more profound (p = 0.026). Conclusions: Our study suggests that younger postmeno-pausal women with normal BMD or mild osteopenia receiving A-only face an increased risk of bone loss in LS. Among patients with mild or severe osteopenia or osteoporosis treated with A + R, 12 months LS or HP BMD variations were configured regardless of age group. © Springer-Verlag 2012.


PubMed | Hellenic Society of Breast Surgeons
Type: Journal Article | Journal: European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology | Year: 2012

The objective of this retrospective study was to describe the results from five institutions experience of using Oncotype DX() to identify patients who need chemotherapy despite the presence of primarily favorable characteristics.Oncotype DX was performed in 106 pre- and postmenopausal patients with estrogen receptor-positive, HER2-negative, early breast cancer with a combination of favorable prognostic factors or favorable prognostic factors with at least one unfavorable characteristic (tumor size >2 cm, tumor grading of II-III, Ki-67 10%, presence of lymph node micrometastases) in which it was unclear whether hormonal therapy only or chemotherapy plus hormonal therapy was the optimal adjuvant treatment.Sixty-four (60.4%) women had Recurrence Score (RS) values <18, 29 (27.4%) intermediate RS values of 18-30, and 13 (12.3%) high RS values of 31. Tumor size, grading and presence of micrometastases were not associated with the RS. There was a significant association between Recurrence Score and the number of unfavorable characteristics as a categorical but not as a continuous variable. High Recurrence Scores were predictive of high Ki-67 but the converse was not true. Overall, 29 of 106 (27.4%) patients received chemotherapy because of an intermediate or a high Recurrence Score.The Recurrence Score helped in treatment decision-making for estrogen receptor-positive, HER2-negative patients with favorable characteristics or an intermediate risk of recurrence due to the presence of at least one unfavorable factor. The results of the 21-gene assay increased the likelihood for patients with intermediate clinical and histopathological risk factors receiving chemotherapy.


PubMed | Hellenic Society of Breast Surgeons
Type: Journal Article | Journal: Journal of cancer research and clinical oncology | Year: 2012

We investigated whether age at anastrozole (A) initiation influences the effect of treatment on bone mineral density (BMD). We conducted a post hoc analysis of the dataset of Arimidex Bone Mass Index Oral Bisphosphonates prospective trial, studying the effect of risedronate (R) on BMD of postmenopausal, early breast cancer patients receiving A.Patients were stratified into those with normal BMD or mild osteopenia (T>-2) receiving A-only and patients with mild or severe osteopenia (T-2) or osteoporosis (T<-2.5) receiving A and per os R (A+R). Depending on age on treatment initiation, patients were grouped into two age cohorts, above and below 65years. BMD change in lumbar spine (LS) and hip (HP) was evaluated at 12months. An analysis of patients with normal BMD at baseline was additionally performed.Among patients receiving A-only, women 65years were more likely to have a decrease in LS-BMD than older (p=0.034). HP-BMD decrease at 12months was not related to age (p=0.182). In patients with mild or severe osteopenia or osteoporosis, treated with A+R, no age effect was observed for LS or HP (p=0.099 and p=0.939, respectively). Among patients with normal BMD at baseline, the age effect on LS-BMD change was more profound (p=0.026).Our study suggests that younger postmenopausal women with normal BMD or mild osteopenia receiving A-only face an increased risk of bone loss in LS. Among patients with mild or severe osteopenia or osteoporosis treated with A+R, 12months LS or HP BMD variations were configured regardless of age group.


The aim of this observational study was to assess the combined impact of chemotherapy (CT) and aromatase inhibitors (AI) therapy on bone mineral density (BMD) in postmenopausal women with estrogen receptor (ER)-positive early breast cancer.Patients were treated with a third generation AI, either as adjuvant therapy (HT cohort, n=166) or as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort, n=124), and were followed up for a 12-month period. BMD was evaluated at lumbar spine (LS) and total hip (HP) before CT, before AI therapy and after 12 months of AI therapy. The primary study objective was changes in LS BMD between pre CT treatment and post 12 months AI therapy in the CT cohort.There were no statistically significant changes in LS BMD, either within CT or HT cohort. In the CT cohort, the mean LS BMD change was-0.72% (95% CI:-2.97%,+1.53%, p=0.5526) between CT start and month 12 of AI therapy, while it was-0.19% (95% CI:-2.12%,+1.74%, p=0.8309) and-0.59% (95% CI:-3.18%,+2.00%, p=0.4759) between CT start and AI start and AI start and month 12 of AI therapy respectively. The mean change in LS BMD in the HT cohort (i.e. after 12 months of AI treatment) was+1.51% (95% CI:-0.96%,+3.98%, p=0.7420).The results of this study indicate that, under routine clinical practice, most postmenopausal patients who receive CT before AI therapy do not experience debilitating BMD consequences during the first year of AI treatment.ClinicalTrials.gov Identifier NCT01298362.


PubMed | Hellenic Society of Breast Surgeons
Type: Clinical Trial, Phase III | Journal: Breast cancer research : BCR | Year: 2010

The aim of this multicenter, phase III, prospective open label clinical trial was to investigate the effect of risedronate (R) on bone mineral density (BMD) in postmenopausal, early breast cancer (BC) patients scheduled to receive anastrozole (A).Pre-treatment BMD of 213 patients with hormone receptor-positive BC was evaluated at lumbar spine (LS) and hip (HP). Patients were categorized according to their baseline BMD T-score as being at low, moderate and high risk of osteoporosis. Low risk patients received anastrozole only (A), moderate risk were randomized to anastrozole +/- risedronate (A+/-R) administration and high risk patients received anastrozole + risedronate (A+R). Anastrozole was given at a dosage of 1 mg/day while oral risedronate was given at 35 mg/week. BMD was then assessed at 12 and 24 months. All patients received daily supplements of calcium (1000 mg/day) and vitamin D (400 IU/day).At 24 months, in the moderate risk group, treatment with A+R resulted in a significant increase in BMD at LS and HP compared to treatment with A only (5.7% v -1.5%, Wilcoxon test P = 0.006, and 1.6% v -3.9% Wilcoxon test P = 0.037, respectively), while no significant difference was found at 12 months; 24.3% of the patients moved to normal BMD region. In the high risk group, a significant increase for LS was detected both at 12 and 24 months (6.3% and 6.6%, P < 0.001) but not for HP; BMD in 14% of patients improved to the osteopenic region. In the low risk group, a significant decrease of BMD was detected at 12 months for LS and HP (-5.3% P < 0.001 and -2.4% P < 0.001, respectively,); at 24 months, a significant decrease of BMD was detected only for LS (-2.5%, P < 0.001). However, 22% of patients became osteopenic and only 4% became osteoporotic.The addition of oral risedronate in post-menopausal breast cancer patients receiving anastrozole has a favorable effect on BMD. Patients with pre-treatment osteopenic to osteoporotic status should be treated with a combination of both therapies in order to avoid bone loss induced by aromatase inhibition. Patients with normal BMD before starting treatment with anastrozole have a very low risk to develop osteoporosis.

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