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עמוד בית
Fri, 05.12.25

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April 2017
March 2017
Noémi Gyarmati MD, Ágota Kulisch MD PhD, András Németh MD, Annamária Bergmann MD, József Horváth MD, Zsuzsanna Mándó MD, Ágnes Matán MD, Erika Szakál MD, Tímea Sasné Péter, Dóra Szántó and Tamás Bender MD PhD DSc
January 2017
Benjamin Spieler BA, Jeffrey Goldstein MD, Yaacov R. Lawrence MD, Akram Saad MD, Raanan Berger MD PhD, Jacob Ramon MD, Zohar Dotan MD, Menachem Laufer MD, Ilana Weiss MA, Lev Tzvang MS, Philip Poortmans MD PhD and Zvi Symon MD

Background: Radiotherapy to the prostate bed is used to eradicate residual microscopic disease following radical prostatectomy for prostate cancer. Recommendations are based on historical series. 

Objectives: To determine outcomes and toxicity of contemporary salvage radiation therapy (SRT) to the prostate bed. 

Methods: We reviewed a prospective ethics committee-approved database of 229 patients referred for SRT. Median pre-radiation prostate-specific antigen (PSA) was 0.5 ng/ml and median follow-up was 50.4 months (range 13.7–128). Treatment was planned and delivered using modern three-dimensional radiation techniques. Mean bioequivalent dose was 71 Gy (range 64–83 Gy). Progression was defined as two consecutive increases in PSA level > 0.2 ng/ml, metastases on follow-up imaging, commencement of anti-androgen treatment for any reason, or death from prostate cancer. Kaplan-Meier survival estimates and multivariate analysis was performed using STATA. 

Results: Five year progression-free survival was 68% (95%CI 59.8–74.8%), and stratified by PSA was 87%, 70% and 47% for PSA < 0.3, 0.3–0.7, and > 0.7 ng/ml (P < 0.001). Metastasis-free survival was 92.5%, prostate cancer-specific survival 96.4%, and overall survival 94.9%. Low pre-radiation PSA value was the most important predictor of progression-free survival (HR 2.76, P < 0.001). Daily image guidance was associated with reduced risk of gastrointestinal and genitourinary toxicity (P < 0.005). 

Conclusions: Contemporary SRT is associated with favorable outcomes. Early initiation of SRT at PSA < 0.3 ng/ml improves progression-free survival. Daily image guidance with online correction is associated with a decreased incidence of late toxicity.

 

Sarit Appel MD, Yaacov R. Lawrence MRCP, Jeffery Goldstein MD, Raphael M. Pfeffer MD, Ilana Weiss MA, Tatiana Rabin MD, Shira Felder MD, Maoz Ben-Ayun PhD, Lev Tzvang MSc, Dror Alezra PhD, David Simansky MD, Alon Ben-Nun MD PhD, Jair Bar MD PhD and Zvi Symon MD

Background: Stereotactic ablative radiation therapy (SABR) is the application of a very high radiation dose to a small treatment volume. It is the new standard of care in medically inoperable early-stage lung cancer. 

Objectives: To report the outcomes of SABR in stage I lung cancer at Sheba Medical Center since its introduction in 2009.

Methods: We conducted a retrospective chart review of patients with stage I lung cancer treated during the period 2009–2015. Survival status was retrieved from the electronic medical records and confirmed with the national registry. Local failure was defined as increased FDG uptake on PETCT scan within a 2 cm radius of the treated region. Toxicity was estimated from medical records and graded according to common toxicity criteria for adverse events (CTCAE) version 4.03. Overall survival and local control were estimated by the Kaplan-Meier method.

Results: During the study period 114 patients were treated for 122 stage I lung cancer lesions. Median follow-up time was 27 months (range 8.2–69.5 months), median age was 76 years. Eighty-two percent of the tumors were stage IA (size ≤ 3 cm). Median survival was 46 months; estimated 3 year overall survival was 59% (95%CI 47–69%) and local control was 88% (95%CI 78–94%). Toxicity included chest wall pain in 8.4% of patients, rib fracture in 0.9%, grade 1–2 pneumonitis in 12%, grade 3 in 12% and grade 5 (death) in 0.9%.

Conclusions: SABR has been successfully implemented at Sheba Medical Center for the treatment of stage I lung cancer in inoperable patients. It is associated with excellent local control, minor toxicity and an acceptable overall survival.

 

December 2016
Claudia Brogna MD, Raffaele Manna MD PhD, Ilaria Contaldo MD, Domenico M. Romeo MD, Maria Chiara Stefanini MD, Antonio Chiaretti MD, Eugenio Mercuri MD PhD and Paolo Mariotti MD
August 2016
Francesca Riboni MD, Stefano Cosma MD PhD, Pino Gino Perini MD and Chiara Benedetto MD PhD
Bernardo Melamud MD, Shikma Keller MD, Mahmud Mahamid MD, Kalman Paz MD and Eran Goldin MD
April 2016
Fabiola Atzeni MD PhD, Alberto Batticciotto MD PhD, Ignazio F. Masala MD, Rossella Talotta MD, Maurizio Benucci MD and Piercarlo Sarzi-Puttini MD

Long-term extension studies and observational drug registers have revealed an increased risk of serious infections in patients treated with anti-tumor necrosis factor agents, particularly infliximab, etanercept and adalimumab. The same may be true for the newer biological drugs rituximab, tocilizumab and abatacept, although this has yet to be confirmed by long-term observational studies. We review the risk of tuberculosis, herpes zoster and other opportunistic infections, and the recommendations for screening for tuberculosis and hepatitis B and C infections in patients affected by rheumatoid arthritis, with the aim of informing patients and encouraging greater awareness among physicians.

Merav A. Ben-David MD, Ruth Elkayam MPA RN, Ilana Gelernter MA and Raphael M. Pfeffer MD

Background: Radiation-induced dermatitis is commonly seen during radiotherapy for breast cancer. Melatonin-based creams have shown a protective effect against ultraviolet-induced erythema and a radioprotective effect in rats.

Objectives: To evaluate the efficacy of melatonin-containing cream in minimizing acute radiation dermatitis. 

Methods: In this phase II, prospective, randomized, placebo-controlled double-blind study, patients who underwent breast-conserving surgery for stage 0-2 breast cancer were randomly allocated to melatonin emulsion (26 women) or placebo (21 women) for twice daily use during radiation treatment and 2 weeks following the end of radiotherapy. All women received 50 Gy whole breast radiation therapy with 2 Gy/fx using computed tomography-based 3D planning. Patients were examined and completed a detailed questionnaire weekly and 2 weeks following the end of treatment.

Results: The occurrence of grade 1/2 acute radiation dermatitis was significantly lower (59% vs. 90%, P = 0.038) in the melatonin group. Women older than 50 had significantly less dermatitis than younger patients (56% vs. 100%, P = 0.021). The maximal radiation dermatitis in the study group was grade 2 in 15% of the treated patients.

Conclusions: Patients treated with melatonin-containing emulsion experienced significantly reduced radiation dermatitis compared to patients receiving placebo.

Nicola A. Pascarelli PhD, Sara Cheleschi PhD, Giovanni Bacaro PhD, Giacomo M. Guidelli MD, Mauro Galeazzi MD and Antonella Fioravanti MD PhD

Background: Balneotherapy is one of the most commonly used non-pharmacological approaches for osteoarthritis (OA). Recent data indicate that some biomarkers could be useful to predict OA progression and to assess therapeutic response.

Objectives: To evaluate the effects of mud-bath therapy on serum biomarkers in patients with knee OA. 

Methods: The study group comprised 103 patients with primary symptomatic bilateral knee OA who were randomly assigned to receive a cycle of mud-bath therapy over a period of 2 weeks or to continue their standard therapy alone. Clinical and biochemical parameters were assessed at baseline and after 2 weeks. Clinical assessments included global pain score on a Visual Analogue Scale (VAS) and the Western Ontario and McMaster Universities Index (WOMAC) subscores for knee OA. Cartilage oligomeric matrix protein (COMP), C-terminal cross-linked telopeptide type II collagen (CTX-II), myeloperoxidase (MPO) and high sensitivity C-reactive protein (hsCRP) serum levels were assessed by ELISA.

Results: At the end of mud-bath therapy we observed a statistically significant improvement in VAS and WOMAC subscores. Serum levels of COMP, MPO and hsCRP did not show any significant modification in both groups, while a significant increase (P < 0.001) in CTX-II serum levels was observed in the mud-bath group after the treatment.

Conclusions: A cycle of mud-bath therapy added to usual treatment had a beneficial effect on pain and function in patients with knee OA. The evaluation of serum biomarkers showed only a significant increase of CTX-II, perhaps due to an increase of cartilage turnover induced by thermal stress.

January 2016
Tamara Kushnir MA, Ofer N. Gofrit MD, Ruth Elkayam MA, Shani Shimon-Paluch MD, Yaacov R. Lawrence MBBS MRCP, Ilana Weiss MA and Zvi Symon MD

Background: Androgen deprivation therapy (ADT) added to radiation therapy (RT) in intermediate to high risk prostate cancer negatively impacts quality of life. 

Objectives: To compare health-related quality of life (HR-QOL) in patients receiving combined RT with and without ADT 

Methods: The study population comprised patients treated with definitive RT for prostate cancer who completed the Expanded Prostate Cancer Index Composite-26 form between 3 and 24 months after completing RT. Covariance and a stepwise backward logistic regression model was used. 

Results: Data were available for 143 patients who received RT+ADT and 70 who received RT alone. The sexual function and hormonal vitality scores of patients receiving RT+ADT were significantly lower than those receiving RT alone (P < 0.0001). Patients with only compulsory school education had significantly lower sexual function scores than patients with university level education (P ≤ 0.005). Patients with depression had significantly lower hormonal vitality scores than those without depression (P ≤ 0.0001). 

Conclusions: The addition of ADT to RT is responsible for decrements in quality of life in the sexual and hormonal vitality domains, which is further compounded by lack of education and depression. This underlines the need to improve education, identify and treat depression, and develop strategies to improve the quality of life of patients receiving combination therapy. 

 

December 2015
Yuval Konstantino MD, Tali Shafat BSc, Victor Novack MD PhD, Lena Novack PhD and Guy Amit MD MPH
 

Background: Implantable cardioverter defibrillators (ICDs) reduce mortality in patients implanted for primary and secondary prevention of sudden cardiac death. Data on the incidence of appropriate ICD therapies in primary vs. secondary prevention are limited. 


Objectives: To compare ICD therapies and mortality in primary vs. secondary prevention of sudden cardiac death. 


Methods: We conducted a retrospective analysis of 581 consecutive patients receiving an ICD for primary (66%) or secondary (34%) prevention indications. 


Results: During long-term follow-up, 29% of patients implanted for secondary prevention received appropriate ICD therapy vs. 18% implanted for primary prevention. However, the overall 7 year mortality rate was not significantly different between the two groups (26.9%, P = 0.292). Multivariate analysis showed that patients implanted for primary prevention had a significantly lower risk of appropriate ICD therapy even after adjustment for age, left ventricular ejection fraction < 0.35 and chronic renal failure (HR 1.63, 95%CI 1.10–2.41, P = 0.015).


Conclusions: Patients implanted for secondary prevention were more likely to receive appropriate ICD therapy, with a significantly shorter time period from ICD implant to the first therapy. However, all-cause mortality was comparable between primary and secondary prevention groups. 


 

 
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