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Background When the conservative treatment is not recommended, Nipple Sparing Mastectomy (NSM) is proposed more and more frequently for the surgical treatment of breast cancer. The risk of local recurrence behind the nipple areolar complex (NAC) is the main limiting factor of the NSM procedure. To minimize such risk, we proposed in 2002 a intraoperative radiotherapy of the preserved NAC. Patients and methods From March 2002 to November 2006, 579 cases (in 570 patients) of NSM were performed for carcinoma. The median follow up time was 19 months (Range: 1-60). The subcutaneous mastectomy was performed through an incision removing a portion of the skin overlying the tumour. An extemporaneous histological examination was performed on the retroareolar glandular tissue. If the histology was positive the patient was not considered eligible. Then an intraoperative radiotherapy with electrons (ELIOT) of 16 Gy in one shot was delivered on the NAC area. An immediate breast reconstruction was done using implants in most cases and in several cases a musculocutaneous flaps, usually in large breast. The number of local recurrences was recorded and the correlation between their occurrence and the clinical and histological criteria were analysed using the Gray test statistical method in a competing framework. Results In 516 cases the negative retroareolar frozen section biopsy was confirmed by the final histology, while in 63 cases, the final histology showed foci of carcinoma. Seven out of these 63 cases underwent a secondary NAC removal. In the 56 cases which preserved areolas we did not observe any local recurrence after 19 months follow up. The probability of retro areola positive histology increases with the tumour size. and was not related to the nodal status. The rate of local relapses was 0.9% per year. We didn't find any significant difference in the local relapse rate according to different patient's and tumour's features. Most relapses were located close to the tumour bed but never in the NAC area. Conclusion Our study confirms that the local recurrence rate in the NSM completed with local radiotherapy on the NAC is not higher than the usual rate observed in the literature and the preservation of the NAC does not increase the risk. The absence of local recurrence in the region where a portion of glandular tissue has been purposely preserved is a good argument in favour of ELIOT.

In order to reduce mutilation, nipple-areola complex (NAC) conservation can be proposed for the treatment of breast cancer when mastectomy is indicated. To reduce the risk of retro areolar recurrence, a novel radiosurgical treatment combining subcutaneous mastectomy with intraoperative radiotherapy (ELIOT) is proposed. One thousand and one nipple sparing mastectomies (NSM) were performed from March 2002 to November 2007 at the European institute of oncology (EIO), for invasive carcinoma in 82% of the patients and in situ carcinoma in 18%. Clinical complications, aesthetic results, oncological and psychological results were recorded. A comparison was performed between the 800 patients who received ELIOT and the 201 who underwent delayed one-shot radiotherapy on the days following the operation. The median follow up time was 20 months (range 1-69) for a follow up performed in 83% of the patients. The NAC necrosed totally in 35 cases (3.5%) and partially in 55 (5.5%) and was removed in 50 (5%). Twenty infections (2%) were observed and 43 (4.3%) prostheses removed. The median rate of the patients for global cosmetic result on a scale ranging from 0 (worst) to 10 (excellent) was 8. Evaluation by the surgeon in charge of the follow-up gave a similar result. Only 15% of the patients reported a partial sensitivity of the NAC. Of the fourteen (1.4%) local recurrences, ten occurred close to the tumour site, all far from the NAC corresponding to the field of radiation. No recurrences were observed in the NAC. In a group of patients characterized by a very close free margin under the areola, no local recurrence was observed. Overall, 36 cases of metastases and 4 deaths were observed. No significant outcome difference was observed between the 800 patients receiving intraoperative radiotherapy (ELIOT) and the 201 patients receiving delayed irradiation.

To evaluate the local control (LC), progression free survival (PFS), out-field PFS, overall survival (OS), toxicity and failure predictors of SRT in a series of various sites oligometastatic CRC patients. Patients with oligometastatic CRC disease were analyzed retrospectively. The SRT prescribed dose was dependent on the lesion volume and its location. 102 consecutive oligometastatic CRC patients (150 lesions) were included. They underwent SRT between 2012 and 2015. Median prescription dose was 45 Gy (median dose/fraction was 15 Gy/3 fractions biological equivalent dose (BED10) 112.5 Gy). Median follow-up was 11.4 months. No patients experienced G3 and G4 toxicity. No progression was found in 82% (radiological response at 3 months) and 85% (best radiological response) out of 150 evaluable lesions. At 1 and 2 years: LC was 70% and 55%; OS was 90% and 90%; PFS was 37% and 27%; out-field PFS was 37% and 23% respectively. Progressive disease was correlated with BED10 (better LC when BED10 was ≥ 75 Gy (p < 0.0001)). In multivariate analysis, LC was higher in lesions with a Plpnning target volume (PTV) volume < 42 cm3 and BED10 ≥ 75 Gy. Patients with Karnofsky performance status < 90 showed higher out-field progression. SRT is an effective treatment for patients with oligometastases from CRC. Its low treatment-associated morbidity and acceptable LC make of SRT an option not only in selected cases. Further studies should be focused to clarify which patient subgroup will benefit most from this treatment modality and to define the optimal dose to improve LC while maintaining low toxicity profile.

BackgroundVentricular tachycardia (VT) is a life-threatening condition, which usually implies the need of an implantable cardioverter defibrillator in combination with antiarrhythmic drugs and catheter ablation. Stereotactic body radiotherapy (SBRT) represents a common form of therapy in oncology, which has emerged as a well-tolerated and promising alternative option for the treatment of refractory VT in patients with structural heart disease.ObjectiveIn the STRA-MI-VT trial, we will investigate as primary endpoints safety and efficacy of SBRT for the treatment of recurrent VT in patients not eligible for catheter ablation. Secondary aim will be to evaluate SBRT effects on global mortality, changes in heart function, and in the quality of life during follow-up.MethodsThis is a spontaneous, prospective, experimental (phase Ib/II), open-label study (NCT04066517); 15 patients with structural heart disease and intractable VT will be enrolled within a 2-year period. Advanced multimodal cardiac imaging preceding chest CT-simulation will serve to elaborate the treatment plan on different linear accelerators with target and organs-at-risk definition. SBRT will consist in a single radioablation session of 25 Gy. Follow-up will last up to 12 months.ConclusionsWe test the hypothesis that SBRT reduces the VT burden in a safe and effective way, leading to an improvement in quality of life and survival. If the results will be favorable, radioablation will turn into a potential alternative option for selected patients with an indication to VT ablation, based on the opportunity to treat ventricular arrhythmogenic substrates in a convenient and less-invasive manner.

Purpose Acute toxicity in head and neck (H&N) cancer patients treated with definitive radiotherapy (RT) has a crucial role in compliance to treatments. The aim of this study was to correlate doses to swallowing-associated structures and acute dysphagia. Methods We prospectively analyzed 42 H&N cancer patients treated with RT. Dysphagia (grade ≥ 3) and indication for percutaneous endoscopic gastrostomy (PEG) insertion were classified as acute toxicity. Ten swallowing-related structures were considered for the dosimetric analysis. The correlation between clinical information and the dose absorbed by the contoured structures was analyzed. Multivariate logistic regression method using resampling methods (bootstrapping) was applied to select model order and parameters for normal tissue complication probability (NTCP) modelling. Results A strong multiple correlation between dosimetric parameters was found. A two-variable model was suggested as the optimal order by bootstrap method. The optimal model (Rs = 0.452, p  < 0.001) includes V 45 of the cervical esophagus (odds ratio [OR] = 1.016) and D mean of the cricopharyngeal muscle (OR = 1.057). The model area under the curve was 0.82 (95% confidence interval 0.69–0.95). Conclusion Our results suggested that the absorbed dose to the cricopharyngeal muscle and cervical esophagus might play a relevant role in the development of acute RT-related dysphagia.

Introduction/BackgroundRe-irradiation of local recurrences of gynaecological cancer pose a difficult challenge to Oncologist. For their biological and physical characteristics particle therapy (PT) could be an interesting treatment.MethodologyThe aim of the study was to evaluate the feasibility and early clinical outcome in patients (pts) with gynaecological pelvic sidewall recurrence (PSWr). Between May 2014 to December 2018, 10 patients (median age 56) with PSWr within or at the edge of the previously irradiated field were treated using PT. They had recurrence of: cervical (5), endometrial (3), uterine (1) and ovarian (1) cancer. Previous radiotherapy prescription dose ranged from 46 to 59.4 Gy and 5 patients underwent brachytherapy (range: 7–28 Gy).Two patients, with marginal lymph node recurrence, were irradiated with protons with up to a total dose of 25 GyRBE and 51 GyRBE, respectively. The remaining women underwent carbon-ion radiotherapy (median total dose 50.4 GyRBE; range: 36–57) administered in a median number of 12 fractions. Six patients with PSWr received surgical spacer placement by open surgery to keep intestinal tracts apart from the tumour as the distance between tumour and nearest intestinal tracts was not sufficient. No pts received concurrent chemotherapy. Preliminary local control (LC) and toxicity profile (according to CTCAE V4.03 scale) were evaluated.ResultsAll patients completed the planned treatment and no acute toxicities G>2 were observed. For the evaluable patients, 1 case of intermediate G≥3 toxicity was reported in women received sequential Bevacizumab (BV). For pts with a follow-up ≥3 months, median LC was 7 months (range: 3–14), median MFS was 4.5 months (range: 3–14,5) and median OS was 7 months (range: 3–14,5). 1 pt experienced local progression and 4 pts died for systemic progression. Data are still ongoing.ConclusionFor pts with PSWr a PT approach seems to be feasible and our results showed a promising short-term outcome and limited radiation-related side effects. Longer follow-up and large patient accrual are required.DisclosureNothing to disclose.

Introduction: Health-related quality of life (HQL) parameters have never been tested in patients having chondromas/chondrosarcomas who are being treated with protons. The aim of this study was to document changes in HQL of chordoma/chondrosarcoma patients treated with proton beam radiotherapy. Treatments commenced in September 2011 at CNAO, and HQL studies were initiated in January 2012 for all patients undergoing treatment. Methods: The validated Italian translation of the EORTC QLQ-C30 version 3.0 was used for HQL evaluation. The HQL assessments were made prior to starting radiation and at completion of treatment. Scoring was as per the EORTC manual. As per standard norms, a difference of >10 points in the mean scores was taken to be clinically meaningful. Results: Between January and September 2012, 17 patients diagnosed with chordoma or chondrosarcoma, with a mean ± SD age of 49.5 ± 16.4 years, had completed treatment. The involved sites were skull base (n = 12) and sacral/paraspinal (n = 5). The prescribed dose was 70–74 GyE at 2 GyE per fraction, 5 days/week. When comparing pre- and post-treatment scores, neither a clinically meaningful nor a statistically significant change was documented. Conclusions: During treatment, HQL is not adversely affected by protons, allowing normal life despite the long course of treatment. This is an ongoing study and more long-term assessment will help evaluate the actual impact of proton therapy on HQL for these slow-responding tumours.

Introduction/BackgroundWe analyzed early clinical outcomes of carbon ion radiotherapy (CIRT) in the first patients with gynecological malignant mucosal melanoma(g-MMM) treated at CNAO.MethodologyBetween 2016 and 2018, 9 patients(pts) with g-MMM were treated with CIRT after surgery or in exclusive settings (table 1) . They had 7 vaginal(VaM),1 cervical(CM) and 1 vulvar(VuM)MMM. One pt with VaM had been previously irradiated with photons;8 pts are considered inoperable and 1 pt underwent adjuvant CIRT on the small pelvic space after radical surgery without lymphadenectomy. Two pts underwent neoadjuvant and sequential anti-PD-1 immunotherapy. Because of the large volume of macroscopic disease,CM and VuM patients were irradiated with up to a total dose of 28 GyRBE(3 fractions) and 68.8 GyRBE(16 fractions), respectively, to the Clinical Target Volume (CTV) defined as the Gross Tumor Volume (GTV)+uterine cervix and corpus for the CM and GTV+vulva for the VuM. For inoperable VaM, small pelvic space including GTV was irradiated with up to a total dose of 38.7-43 GyRBE followed by a GTV boost of up to a total dose of 68.8 GyRBE in 16 fractions (figure 1). All patients were treated with synchrotron-based scanning carbon ion beams. Early clinical and toxicity profile(according to CTCAE V4.03) were evaluated.ResultsTreatment was well tolerated and no interruption was needed. For the evaluable pts, toxicity profile was favorable and no G≥2 acute/late toxicities were observed. Overall,for pts with a follow-up≥3 months,median LC ranged from 3 to 13 months(

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