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Hannoun-Levi J.-M.,Antoine Lacassagne Center | Hannoun-Levi J.-M.,Sophia University | Gourgou-Bourgade S.,Biostatistic Unit | Belkacemi Y.,Henri Mondor Hospital | And 7 more authors.
Brachytherapy | Year: 2013

Purpose: To analyze the feasibility, reproducibility, and impact on functional status of postoperative accelerated and partial breast irradiation (APBI) using interstitial high-dose rate-brachytherapy in women older than 70 years. Methods and Materials: From July 2004 to April 2008, 46 patients were screened for enrollment in a nationwide prospective Phase II trial. A total of 40 patients were eligible according to the inclusion criteria (aged >70 years, T1-2 <30mm, and pN0). The total delivered dose was 34Gy of 10 fractions for 5 days. Feasibility and reproducibility were evaluated using a Quality Index (QI) defined as (V100%-clinical target volume)/V100%. Skin toxicity was reported using Common Terminology Criteria for Adverse Events version 3.0. ABPI impact on functional dependence was evaluated using the Activity of Daily Living and Instrumental Activity of Daily Living scales. Reproducibility and feasibility were assessed with the optimal two-stage design of Simon. Results: Median age was 74 years (70-87 years). All patients were treated according to the protocol. Median Quality Index calculated for the 40 eligible patients was 13.3% (1-70%). It was considered acceptable, partially acceptable, and nonacceptable in 10, 28, and 2 patients, respectively. Within 12 months after APBI, overall rates of toxicity were 59%, 28%, and 2% for Grade 1, 2, and 3 events, respectively. Twelve months after APBI, 35 patients (87%) achieved excellent/good cosmetic result. Compared with baseline values, Activity of Daily Living and Instrumental Activity of Daily Living scores remained unchanged 6 and 12 months after APBI. Conclusions: APBI by means of high-dose rate-brachytherapy is a feasible/reproducible technique without significant impact on functional dependence in the treatment of elderly women with early breast cancer. © 2013 American Brachytherapy Society.

Pivot X.,University Hospital Jean Minjoz | Lortholary A.,Catherine Of Sienne Center | Abadie-Lacourtoisie S.,Paul Papin Center | Mefti-Lacheraf F.,Rene Huguenin Center | And 3 more authors.
Breast | Year: 2011

Purpose: The aim of this study was to demonstrate the renal safety equivalence of ibandronate 6 mg infused over 15 min versus 60 min, in patients with bone metastases of breast cancer. Patients and methods: Patients were females having breast cancer with at least one bone metastasis. Exclusion criteria were renal failure (creatinine clearance < 30 mL/min), tooth/jaw disorder or uncontrolled severe disease. Eligible patients were randomly assigned to receive nine ibandronate 6 mg i.v. infusions over either 15 min or 60 min. The primary outcome was the 95% confidence interval (CI) of the difference in creatinine clearance between groups, 28 days after the last infusion. The equivalence margin was ±8 mL/min. Results: Overall 334 patients were randomized (165-15 min infusions vs. 169 to 60 min infusions, 325 (159 vs. 166) were analyzed by intent-to-treat, and 312 (151 vs. 161) were analyzed per protocol. Per protocol, the 15 min-60 min difference in creatinine clearance [95% CI] was -3.00 [-8.18, 2.18]. By intent-to-treat, this difference was-2.91 [-7.99, 2.16]. Death and serious adverse event rates did not differ between groups. Three serious adverse events were considered related to ibandronate: an osteonecrosis of the jaw (15-min group), a pain in jaw and an enamel cracking (60-min group). Two renal failures, reported in the 60 min group, were not considered related to ibandronate. None occurred in the 15 min group. Conclusion: Ibandronate may be infused over 15 min without clinically significant consequence on renal safety. © 2011 Elsevier Ltd.

Mosbah R.,Institute Curie Rene Huguenin | Rouzier R.,Institute Curie Rene Huguenin | Rouzier R.,University of Versailles | Guinebretiere J.-M.,Rene Huguenin Center | And 3 more authors.
Anticancer Research | Year: 2015

Aim: The objective of the present study was to describe the biological characteristics of each lesion in patients with bifocal/bicentric (BF/BC) breast cancer. Patients and Methods: We retrospectively reviewed the charts of 205 patients diagnosed with BF/BC cancer. The degree of concordance between the two lesions was assessed using Pearson product-moment correlation coefficients. Results: A total of 205 patients were included. Both tumors displayed the same histological type in 182 patients (89%). The same grade was found for both tumors in 178 of the cases (96.7% and 100% for grade 3 lesions). Immunohistochemical concordance between the two tumors was excellent, with correlation coefficients of 0.98, 0.96 and 0.99 for estrogen receptors (ER), progesterone receptors (PR) and Ki67, respectively. Human Epidermal growth factor Receptor 2 (HER2) status was available for both tumors in 177 cases (86%), with a perfect concordance. We did not find any differences in molecular sub-type between tumor foci. Conclusion: Immunohistochemistry should be performed only on the main tumor in cases of BF/BC cancer.

Zwahlen D.R.,Kantonsspital Graubuenden | Zwahlen D.R.,William Buckland Radiotherapy Center | Schick U.,University of Geneva | Bolukbasi Y.,Ege University | And 9 more authors.
Rare Tumors | Year: 2016

Uterine carcinosarcomas (UCS) are rare tumors. Consensus regarding therapeutic management in non-metastatic disease is lacking. This study reports on outcome and predictive factors when using postoperative radiotherapy. We analyzed a retrospective analysis in 124 women treated between 1987- 2007 in the framework of the Rare-Cancer- Network. Median follow-up was 27 months. Postoperative pelvic EBRT was administered in 105 women (85%) and 92 patients (74%) received exclusive or additional vaginal brachytherapy. Five-year overall survival (OS), disease-free survival (DFS), cancer specific survival (CSS) and locoregional control (LRC) were 51.6% (95% CI 35-73%), 53.7% (39-71%), 58.6% (38-74%) and 48% (38-67%). Multivariate analysis showed that external beam radiation therapy (EBRT) >50Gy was an independent prognostic factor for better OS (P=0.03), CSS (P=0.02) and LRC (P=0.01). Relative risks (RR) for better OS (P=0.02), DFS (P=0.04) and LRC (P=0.01) were significantly associated with younger age (≤60 years). Higher brachytherapy (BT)-dose (>9Gy) improved DFS (P=0.04) and LRC (P=0.008). We concluded that UCS has high systemic failure rate. Local relapse was reduced by a relative risk factor of over three in all stages of diseases when using higher doses for EBRT and brachytherapy. Postoperative RT was most effective in UCS stage I/II-diseases. © D.R. Zwahlen et al., 2016.

Schick U.,University of Geneva | Bolukbasi Y.,Ege University | Thariat J.,Antoine Lacassagne Center | Abdah-Bortnyak R.,Rambam Medical Center | And 9 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2012

Purpose: To provide further understanding regarding outcome and prognostic factors of endometrial stromal tumors (EST). Methods and Materials: A retrospective analysis was performed on the records of 59 women diagnosed with EST and treated with curative intent between 1983 and 2007 in the framework of the Rare Cancer Network. Results: Endometrial stromal sarcomas (ESS) were found in 44% and undifferentiated ESS (UES) in 49% of the cases. In 7% the grading was unclear. Of the total number of patients, 33 had Stage I, 4 Stage II, 20 Stage III, and 1 presented with Stage IVB disease. Adjuvant chemotherapy was administered to 12 patients, all with UES. External-beam radiotherapy (RT) was administered postoperatively to 48 women. The median follow-up was 41.4 months. The 5-year overall survival (OS) rate was 96.2% and 64.8% for ESS and UES, respectively, with a corresponding 5-year disease-free survival (DFS) rate of 49.4% and 43.4%, respectively. On multivariate analysis, adjuvant RT was an independent prognostic factor for OS (p = 0.007) and DFS (p = 0.013). Locoregional control, DFS, and OS were significantly associated with age (≤60 vs. >60 years), grade (ESS vs. UES), and International Federation of Gynecology and Obstetrics stage (I-II vs. III-IV). Positive lymph node staging had an impact on OS (p < 0.001). Conclusion: The prognosis of ESS differed from that of UES. Endometrial stromal sarcomas had an excellent 5-year OS, whereas the OS in UES was rather low. However, half of ESS patients had a relapse. For this reason, adjuvant treatment such as RT should be considered even in low-grade tumors. Multicenter randomized studies are still warranted to establish clear guidelines. © 2012 Elsevier Inc.

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