Radiothérapie adjuvante pour le traitement du cancer du sein de stade précoce: efficacité et innocuité d'une irradiation complète du sein en 5 fractions (ultrahypofractionnement) / Adjuvant radiation therapy for treatment early-stage breast cancer: efficacy and safety of whole breast irradiation in 5 fractions (ultrahypofractionation)

CONTEXTE: Le présent document ainsi que les constats qu'il énonce ont été rédigés par l'INESSS en concertation avec le Comité de l'évolution des pratiques en oncologie (CEPO) dans une volonté d'évaluer les plus récentes données publiées en lien avec les pratiques de la radiothérapie pour le traitement du cancer du sein de stade précoce. L'objectif est de réaliser une recension des données publiées et de mobiliser les savoirs clés afin d'informer les décideurs publics et les professionnels de la santé et des services sociaux. Depuis quelques années, le traitement standard du cancer du sein de stade précoce repose sur la chirurgie conservatrice suivie d'une radiothérapie hypofractionnée en 15 ou 16 fractions (40 - 42,5 Gy) et d'un traitement systémique au besoin. L'administration d'un traitement à fractionnement réduit (15 - 16 fractions) a permis de diminuer le nombre de visites en milieu de soins, l'utilisation des équipements d'irradiation et des ressources humaines par patient, ainsi que les coûts associés au traitement d'irradiation, sans que l'efficacité clinique et l'innocuité ne soient compromises comparativement au fractionnement de 50 Gy en 25 fractions. Une réduction supplémentaire du fractionnement (ultra-hypofractionnement en 5 fractions) pourrait accroitre ces bénéfices si l'efficacité clinique et l'innocuité ne sont pas compromises. PRÉSENTATION DE LA DEMANDE: Au Canada, le cancer du sein est la néoplasie la plus fréquente et la deuxième plus importante cause de décès par cancer chez la femme. Il représente 25 % de tous les

Effectiveness of rectal displacement devices during prostate external-beam radiation therapy: A review.

Dose-escalated prostate radiotherapy (RT) can improve treatment outcomes, but rectal toxicity is the main limiting factor for introducing dose-escalated RT. Pushing rectal wall away from the prostate reduces the volume of the rectum in high-dose region, which can decrease both short- and long-term rectal toxicities after RT. This review focuses on the literature using different rectal displacement devices such as endorectal balloons, tissue spacers, rectal retractor, and ProSpare during prostate External beam radiotherapy, with regard to dosimetric effects, clinical benefits, prostate motion, and postoperative RT setting.

Safety and efficacy of INTRABEAM intraoperative radiotherapy for invasive thymoma.

Intraoperative radiotherapy (IORT) has been used to treat different residual solid tumors after tumor removal and has shown many advantages over other treatment methods. However, the use of IORT for invasive thymoma has not been reported. Therefore, in this study, we tried to determine the safety and efficacy of INTRABEAM IORT for the treatment of invasive thymoma.Among the patients admitted to our hospital from September to December 2016 who were diagnosed with invasive thymoma, 14 were selected as study subjects. With medical histories taken beforehand, 8 of these patients were diagnosed with Masaoka stage IIA and 6 with Masaoka stage IIB; furthermore, 5 of the patients were diagnosed with myasthenia gravis (MG). INTRABEAM radiation (8-10 Gy, low energy) was delivered to the postoperative tumor bed of each patient during surgery. The intra- and postoperative complications were observed and evaluated, and the improvement in symptoms was assessed. An additional 23 patients with stage II thymoma undergoing radical surgery from April to August 2016 were chosen as the control group.One month after the operation, only 1 patient in the IORT group had cough, increased levels of leucocytes and neutrophils, and pulmonary inflammation on chest computed tomography. Reactive inflammation and pleural effusion in the 2 groups were similar (P > .05). There was no significant difference between the 2 groups in the improvement of myasthenia gravis (P > .05). Postoperative chest computed tomography and routine blood examination at 3 and 12 months showed that all the patients recovered, with normal hemogram levels and no pulmonary fibrosis around the radiation field. In addition, ultrasonic cardiography and electrocardiography demonstrated no significant difference before or after surgery within the IORT group. At the end of the follow-up, all the patients were alive, no relapse or remote metastasis was observed in the IORT group, and 2 inpatients in the control group had experienced relapse at 24 and 26 months. There was a significant difference in disease-free survival between the 2 groups (P = .00).It is safe to administer low-energy INTRABEAM IORT at a dose of approximately 10 Gy in patients with stage II invasive thymoma. INTRABEAM IORT does not significantly increase operation- or radiation-related complications and has no significant effect on vital organs such as the lungs and heart. Its long-term efficacy is worth expecting.

Using the new INTRABEAM mobile intraoperative radiotherapy system during surgery for pancreatic cancer: a case report.

BACKGROUND: Pancreatic cancer is one of the most common fatal malignancies and has a poor prognosis. Surgical treatment is the most important treatment method, but there is a low rate of radical excision; moreover, the postoperative recurrence rate is high, with a local recurrence rate greater than 50%. The usefulness of intraoperative radiotherapy for pancreatic cancer has previously been examined. However, prior research was based on the traditional high-energy electron beam, which causes serious radiation toxicity. Therefore, the tumor radiation dose was limited, subsequently limiting the effect. In contrast, there is also a low-energy X-ray radiation system called INTRABEAM®. Use of INTRABEAM has been applied clinically, but the treatment effect of INTRABEAM in pancreatic cancer has not been reported. CASE PRESENTATION: We present a case of a 56-year-old Chinese man with local advanced pancreatic cancer with invasion of the coeliac trunk artery and origin of the portal vein. He underwent distal pancreatectomy and splenectomy along with intraoperative radiotherapy using a portable INTRABEAM radiation system. The radiotherapy dose was 10 Gy and irradiation time was 27.4 minutes. There were no obvious postoperative complications. His abdominal pain was alleviated after surgery, and no obvious tumor recurrence has been observed in short-term follow-up. CONCLUSIONS: We believe that it is safe to apply intraoperative radiotherapy using the INTRABEAM radiation system in pancreatic cancer. This approach appears promising for further future development.

Improvement of consistency in delineating breast lumpectomy cavity using surgical clips.

BACKGROUND: Delineation of lumpectomy cavity for whole breast radiation therapy after breast conserving surgery can be challenging because of poor visualization of the cavity. The use of surgical clips on lumpectomy cavity walls has been suggested as an effective and low-cost method to improve the accuracy and consistency of lumpectomy cavity delineation. MATERIALS AND METHODS: Twenty-three eligible female breast cancer patients who were treated with lumpectomy and adjuvant radiation therapy were recruited for this study. During breast conserving surgery, four surgical clips were placed on the superior, inferior, lateral, and medial walls of the lumpectomy cavity. Patients were imaged prior and during radiation treatment. Software was developed to anonymize the image sets and digitally remove the clips from the computed tomography images. Three radiation oncologists contoured the lumpectomy cavity volume, with and without presence of clips. Contoured image sets were analyzed with regard to cavity volume, dimensions, and concordance index. Statistical analysis was performed using a paired t-test. RESULTS: The presence of clips significantly increased the average lumpectomy cavity volumes from 23.50 cc to 26.42 cc (P < 0.0001). The presence of clips also significantly increased the mean craniocaudal, anteroposterior, and mediolateral dimensions by 6.8, 2.3, and 2.9 mm, respectively (all P < 0.01). In addition, the presence of surgical clips improved the consistency in delineation in CC dimension by significantly decreasing the standard deviation (P < 0.006). CONCLUSIONS: The presence of surgical clips improves the accuracy of lumpectomy cavity delineation. However, consistency is only improved in CC dimension.

Impact of vaginal cylinder diameter on outcomes following brachytherapy for early stage endometrial cancer.

OBJECTIVE: To examine the outcomes (tolerability, toxicity, and recurrence) of vaginal brachytherapy (VBT) among endometrial cancer (EC) patients treated with small cylinder size. METHODS: Patients with EC who received adjuvant VBT between September 2011 and December 2015 were reviewed. Patients were fitted with the largest vaginal cylinder they could comfortably accommodate, from 2.0-3.0 cm diameter. Small cylinders were defined as size 2.3 cm or less. Patient, tumor, or treatment characteristics were correlated with need for small cylinders. Treatment tolerability, measures of gastrointestinal (GI), genitourinary (GU), and vaginal toxicity, and rates of recurrence were analyzed. RESULTS: Three hundred four patients were included. Small cylinders were used in 51 patients (17%). Normal body mass index (BMI; p<0.001), nulligravidity (p<0.001), and shorter vaginal length (p<0.001) were associated with small cylinder size. There was no acute or late grade 3 toxicity. Rates of acute (grade 1-2) GI, GU, or vaginal symptoms were low (10%, 11%, and 19%, respectively). Small cylinder size was associated with increased likelihood of reporting acute GI (p<0.05) but not GU or vaginal symptoms. Small cylinder size was associated with higher risk of grade 1-2 vaginal stenosis (odds ratio [OR]=4.7; 95% confidence interval [CI]=1.5-14.7; p=0.007). There was no association between cylinder size and recurrence rate (p=0.55). CONCLUSION: VBT is generally very well tolerated, however, patients fitted with smaller cylinders (commonly nulligravid and low BMI) may have increased side effects. Further study to improve the dosimetry of VBT for patients requiring small cylinders may be worthwhile.

Cosmetic Outcome and Chronic Breast Toxicity After Intraoperative Radiation Therapy (IORT) as a Single Modality or as a Boost Using the Intrabeam® Device: A Prospective Study.

PURPOSE: We aim to report our results in terms of chronic toxicities and cosmetic outcomes after intraoperative radiotherapy (IORT) using kV X-rays in women treated for early breast cancer at our institution. METHODS: Patients with early breast carcinoma were recruited between April 2011 and November 2014. After breast-conserving surgery, patients were treated with IORT using the Intrabeam® device. IORT was completed by whole-breast radiotherapy (WBRT) at a dose of 46-50.4 Gy in 23-28 fractions in case of adverse pathologic criteria on the final specimen examination. Skin toxicity was graded using the Late Effects in Normal Tissues-Subjective, Objective, Management and Analytic (LENT-SOMA) scale every 6 months, and cosmetic outcomes were evaluated at 36 months by patient self-evaluation and by two radiation oncologists, on a 1-10 scale. RESULTS: Forty-one women received IORT only and 30 patients received IORT followed by WBRT (IORT + WBRT group). After a median follow-up of 38.9 months, no locoregional or distant recurrence occurred. After IORT only, 2.4% of grade 2 or higher breast fibrosis, and no other grade 2 or higher disease, was observed. In the IORT + WBRT group, grade 2 or higher fibrosis and grade 2 or higher breast retraction were observed in 43.3 and 23.3% of patients, respectively. Objective cosmetic outcomes were very good and significantly better in the IORT-only group compared with the IORT + WBRT group (8.87 vs. 6.96) (p < 0.001). CONCLUSION: IORT using the Intrabeam® is well-tolerated, with very little chronic toxicity and good cosmetic outcome. However, a high rate of grade 2 or higher chronic breast toxicity was observed when IORT had to be completed by WBRT.

Clinical target volume in postoperative radiotherapy for gastric cancer: identification of major difficulties and controversies

Purpose: To identify the main difficulties in postoperative clinical target volume (CTV) delineation in gastric cancer (GC). Methods: Before and after a training course, 20 radiation oncology residents were asked to delineate the CTV for the postoperative GC case on four computed tomography scans: dome of the diaphragm, anterior abdominal wall, duodenal stump and porta hepatis level, and to determine the lower CTV border. CTV volume was reconstructed from requested planar contours. Area of intersection (AI) for each requested scan and volume of intersection (VI), defined as the overlap of delineated area/volume with respective reference area (RA)/reference volume (RV) proposed by the senior radiation oncologist, were computed. The degree of agreement between the reference and participants’ contours was quantified using the Concordance Index (CI): AI/RA 9 100 % or VI/RV 9 100 %. The lower CTV border was analyzed separately. Pre- and post-training CIs were compared. A questionnaire investigated the difficulties with contouring. Results: Mean CI value was the lowest for the dome of the diaphragm (24 % pre-training, 35 % post-training) and for the duodenal stump (49 % pre-training, 61 % post-training). Mean CI for the CTV volume was 49 % pre-training and 59 % post-training, p = 0.39. Mean distance from the reference to the participants’ lower CTV borders was 2.73 cm pre-training and 2.0 cm post-training, p = 0.71. In a questionnaire, 75 % of respondents indicated the elective nodal area as the main difficulty. Conclusions: Delineation of the dome of the diaphragm and the duodenal stump, as yet not recognized as the source of variation, should be addressed in the international consensus guidelines and clarified (AU)

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A retrospective analysis of lung metastasis in 64 patients with alveolar soft part sarcoma

Objectives. To analyse the lung metastasis and possible factors influencing lung metastasis in alveolar soft part sarcoma (ASPS) patients. Methods. The medical records of 64 consecutive ASPS patients were reviewed to analyse their treatments, features of lung metastasis, and possible factors influencing lung metastasis. Results. Thirty-six females and 28 males with a median age of 27 years were included. The primary disease sites were the extremities in 51 patients and other locations in 13 patients. The median primary tumour size was 5 cm. Wide local excision of the primary tumour was performed on 56 patients (87.5 %). Thirteen patients (20.3 %) received postoperative adjuvant radiotherapy, and nine patients (14.1 %) underwent adjuvant chemotherapy. Twelve patients (18.8 %) presented with metastatic lung disease. Twenty-nine patients (45.3 %) developed metastatic lung disease during follow-up. Lung metastasis occurred in 64.1 % of the patients. Lung metastasis was detected at a median interval of 20 months after primary ASPS diagnosis. Being male, >20 years of age, having a primary tumour size ≥5 cm, and local recurrence were associated with a greater rate of lung metastasis. Median survival after the diagnosis of lung metastasis was 34 months. The 5-year survival rates were 64.1 and 95.2 % for patients with and without lung metastasis (P < 0.001). Thirty-seven patients with metastatic lung disease received anthracycline- and ifosfamide-based chemotherapy. One patient experienced a partial remission. Conclusions. ASPS patients have a high prevalence of lung metastasis. Sex, age, primary tumour size, and local recurrence are major factors influencing lung metastasis. Chemotherapy is not efficacious in ASPS patients with lung metastasis (AU)

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Locoregional recurrence after curative intent resection for intrahepatic cholangiocarcinoma: implications for adjuvant radiotherapy

Backgrounds. As for intrahepatic cholangiocarcinoma, the most frequent site of failure after curative intent resection is the liver. We identified the risk factors for locoregional recurrence after curative intent resection for intrahepatic cholangiocarcinoma. Methods. Medical records of 115 patients treated with surgical resection alone for intrahepatic cholangiocarcinoma from November 2000 to December 2010 were retrospectively reviewed. Locoregional failure was defined as recurrence within 20 mm from resection margin or regional lymph node. Overall survival and locoregional recurrence rates were analyzed using Kaplan–Meier methods, and the prognostic factors were analyzed using Cox proportional hazards model. Results. Median follow-up duration of surviving patients was 61 months (range 8–139). Sixty-six patients had recurrence, and 45 of 66 patients (68 %) had locoregional recurrence. The 5-year overall survival and locoregional control rates were 49.1 and 51.6 %, respectively. ≥T2b disease and R1 resection were associated with locoregional recurrence in multivariate analysis. Patients were divided into two groups whether these risk factors exist or not. The 5-year locoregional control rates of low (no risk factor n = 64) and high (1 or 2 risk factors n = 51) risk groups were 62.5 and 34.7 %, respectively (P = 0.001). Conclusions. After curative intent resection, locoregional control and survival of patients with intrahepatic cholangiocarcinoma were far from satisfactory. Further studies are needed to evaluate the potential benefit of adjuvant locoregional treatment such as radiotherapy for patients with high-risk factors (≥T2b disease or R1 resection) (AU)

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Efectos adversos a largo plazo de la fase de llenado vesical en varones tratados con radioterapia pélvica / Long-term adverse effects on bladder filling phase in males submitted to the pelvic radiotherapy

INTRODUCCIÓN: Los efectos adversos de la radioterapia externa RT sobre la función del tracto urinario inferior de los varones están pobremente estudiados. OBJETIVO: Estudiar y cuantificar los efectos a largo plazo sobre la fase de llenado en varones tratados con radioterapia. MÉTODOS: Estudio comparativo retrospectivo de una cohorte de 99 varones tratados con radioterapia externa, realizada con una media de 4,7 años antes del inicio del estudio. Los pacientes estudiados fueron sometidos a radioterapia como tratamiento del cáncer de próstata localizado, tumor de colon y tumor de recto. Se utilizó como grupo control una cohorte de 97 hombres mayores de 50 años que no habían sido sometidos a tratamiento radioterápico. RESULTADOS: La capacidad vesical cistomanométrica y en el momento del primer deseo miccional fueron significativamente menores en el grupo tratado con radioterapia. El análisis univariante mostró una disminución de la acomodación vesical 3,5 veces mayor en el grupo tratado con radioterapia y un aumento del riesgo para desarrollar incontinencia de esfuerzo de 9,3 veces. No se encontraron diferencias en el riesgo de hiperactividad del detrusor. En el análisis multivariante la existencia de antecedentes de cirugía radical pelviana fue un factor de confusión para el desarrollo de incontinencia urinaria de esfuerzo, no siéndolo para la disminución de la acomodación vesical. CONCLUSIONES: El principal efecto adverso que se produce a largo plazo después del tratamiento con radioterapia pélvica es la disminución de la acomodación vesical durante la fase de llenado. El tratamiento con RT adyuvante produce alteraciones urinarias a largo plazo

OBJECTIVE: To describe and quantify the long-term adverse effects on filling phase of lower urinary tract function in males submitted to radiotherapy. METHODS: We performed a retrospective comparative study on a cohort of 99 men undergoing EBRT a mean of 4.7 years before for clinically localized prostate, rectum or colon neoplasia, and another cohort formed by 97 men over 50 years who did not undergo radiotherapy. RESULTS: Cystometric bladder capacity and bladder capacity at first voiding desire were significantly lower in the radiotherapy group. Univariate analysis showed that the radiotherapy group evinced a risk to present a diminished compliance of 3.5 times more and 9.3 times more to find stress urinary incontinence, but we did not found increased risk for detrusor overactivity. In multivariate analysis the history of radical surgery acted as a confounding factor in the risk of stress urinary incontinence, but not to suffer diminished bladder compliance. CONCLUSIONS: The main long-term adverse effect of pelvic radiotherapy on male bladder function during filling is the increased risk of low bladder compliance

Comparative dosimetric findings using accelerated partial breast irradiation across five catheter subtypes.

PURPOSE: Accelerated partial breast irradiation (APBI) with balloon and strut adjusted volume implants (SAVI) show promising results with excellent tumor control and minimal toxicity. Knowing the factors that contribute to a high skin dose, rib dose, and D95 coverage may reduce toxicity, improve tumor control, and help properly predict patient outcomes following APBI. METHODS AND MATERIALS: A retrospective analysis of 594 patients treated with brachytherapy based APBI at a single institution from May 2008 to September 2014 was grouped by applicator subtype. Patients were treated to a total of 34 Gy (3.4 Gy x 10 fractions over 5 days delivered BID) targeting a planning target volume (PTV) 1.0 cm beyond the lumpectomy cavity using a high dose rate source. RESULTS: SAVI devices had the lowest statistically significant values of DmaxSkin (81.00 ± 29.83), highest values of D90 (101.50 ± 3.66), and D95 (96.09 ± 4.55). SAVI-mini devices had the lowest statistically significant values of DmaxRib (77.66 ± 32.92) and smallest V150 (18.01 ± 3.39). Multi-lumen balloons were able to obtain the smallest V200 (5.89 ± 2.21). Strut-based applicators were more likely to achieve a DmaxSkin and a DmaxRib less than or equal to 100 %. The effect of PTV on V150 showed a strong positive relationship (p < .001). PTV and DmaxSkin showed a weak negative relationship in multi-lumen applicators (p = .016) and SAVI-mini devices (p < .001). PTV and DmaxRib showed a weak negative relationship in multi-lumen applicators (p = .009), SAVI devices (p < .001), and SAVI-mini devices (p < .001). CONCLUSION: PTV volume is strongly correlated with V150 in all devices and V200 in strut based devices. Larger PTV volumes result in greater V150 and V200, which could help predict potential risks for hotspots and resulting toxicities in these devices. PTV volume is also weakly negatively correlated with max skin dose and max rib dose, meaning that as the PTV volumes increase one can expect slightly smaller max skin and rib doses. Strut based applicators are significantly more effective in keeping skin and rib dose constraints under 125 and 100 % when compared to any balloon based applicator.

Superior target volume and organ stability with the use of endorectal balloons in post-prostatectomy radiotherapy.

INTRODUCTION: We investigated the endorectal balloon (ERB) as a method to improve post-prostatectomy clinical target volume (CTV) stability. METHODS: Seventy cone-beam CT (CBCT) obtained during radiotherapy treatment from seven patients treated with an ERB and 68 CBCT from seven patients treated without an ERB were contoured according to published guidelines. CTV was subdivided into superior and inferior CTV; whole rectal volume was subdivided into superior and inferior rectum and anal volume. Concordance index (CI) of CBCT treatment volumes compared with planning volumes was calculated and displacements were measured. RESULTS: Whole rectal, superior and inferior rectum and anal CI were significantly improved with the ERB by 21%, 17%, 26% and 17% respectively (P < 0.0001). Overall CTV and inferior CTV CI was improved by 4% with the ERB (overall CTV P = 0.021; Inferior CTV P < 0.0001). In the ERB cohort, average displacement for superior CTV was 0.37 cm anterior-posterior (AP) and 0.10 cm left-right (LR). Average standard deviation was 0.27 cm AP and 0.11 cm LR. Inferior CTV average displacement was 0.11 cm AP and 0.02 cm LR. Average standard deviation was 0.11 cm AP and 0.02 cm LR. In the non-ERB cohort, average displacement for superior CTV was 0.43 cm AP and 0.10 mm left-right (LR). Average standard deviation was 0.45 cm AP and 0.13 cm LR. Inferior CTV average displacement was 0.16 cm AP and 0.01 cm LR. Average standard deviation was 0.17 cm AP and 0.03 cm LR. There was no statistically significant impact of bladder filling on CTV CI in ERB patients (P = 0.551) as opposed to non-ERB patients (P = 0.0421). CONCLUSION: ERBs in the post-prostatectomy setting resulted in increased rectal and CTV stability while negating the effects of bladder filling on CTV stability.

Adjuvant brachytherapy for endometrial cancer: advantages of the vaginal mold technique.

PURPOSE: Treatment of endometrial carcinoma in the adjuvant setting includes in most cases vaginal brachytherapy. In our institution, we use the customized vaginal mold technique. Herein, we report the advantages of this personalized applicator in terms of target coverage, normal tissue preservation, the incidence of air pockets, and its potential impact on dosimetry. METHODS AND MATERIALS: A total of 15 patients receiving postoperative vaginal cuff high-dose-rate brachytherapy with the mold applicator technique were enrolled in this prospective data collection study. Patients were treated with either two or four fractions of 5 Gy prescribed to the clinical target volume, which consisted of an irradiation of the vaginal cuff and the upper third of the vagina. Target coverage; dose to organs at risk, in addition to the volume; and the dosimetric impact of air pockets surrounding the mold were evaluated. RESULTS: In 15 patients, a total of 27 air pockets were identified. The average number of air pockets per patient was 1.8 (range, 0-4), with the average total air pocket volume being 0.1 cc (range, 0.01-0.54). The average dose reduction at 5mm from the air pocket was 26% (range, 6-45%). The minimal clinical target volume coverage reported was 95% and the maximal dose received by 2 cc of the bladder, rectum, and sigmoid never exceeded 110% of the prescribed dose. CONCLUSIONS: Vaginal cuff high-dose-rate brachytherapy using the molded applicator provides personalized tailored treatment in terms of anatomical conformity. This translates into a dosimetrical advantage with smaller and fewer air pockets than reported in the literature with the use of cylinders.

Application of a hydrogel spacer for postoperative salvage radiotherapy of prostate cancer.

BACKGROUND: In contrast to primary radiotherapy, no reports are available for a hydrogel spacer application in postoperative salvage radiotherapy for prostate cancer. CASE REPORT: A 77-year-old patient presented 20 years after radical prostatectomy with a digitally palpable local recurrence at the urethrovesical anastomosis (PSA 5.5 ng/ml). The hydrogel spacer (10 ml, SpaceOAR™) was injected between the local recurrence and rectal wall under transrectal ultrasound guidance. Treatment planning was performed with an intensity-modulated technique up to a total dose of 76 Gy in 2-Gy fractions. The same planning was performed based on computed tomography before spacer injection for comparison. RESULTS: The local recurrence, initially directly on the rectal wall, could be displaced more than 1 cm from the rectal wall after hydrogel injection. With a mean total dose of 76 Gy to the planning target volume, rectal wall volumes included in the 70 Gy, 60 Gy, 50 Gy isodoses were 0 cm(3), 0 cm(3), and 0.4 cm(3) with a spacer and 2.9 cm(3), 4.5 cm(3), and 6.2 cm(3) without a spacer, respectively. The patient reported rectal urgency during radiotherapy, completely resolving after the end of treatment. The PSA level was 5.4 ng/ml a week before the end of radiotherapy and dropped to 0.9 ng/ml 5 months after radiotherapy. CONCLUSION: A hydrogel spacer was successfully applied for dose-escalated radiotherapy in a patient with macroscopic local prostate cancer recurrence at the urethrovesical anastomosis to decrease the dose at the rectal wall. This option can be considered in specifically selected patients.

Intraoperative radiotherapy-containing multidisciplinary management of trunk-wall soft-tissue sarcomas

PURPOSE: A joint analysis of data from centers within the intraoperative radiotherapy (IORT)-Spanish cooperative initiative was performed to investigate the main contributions of IORT to the multidisciplinary treatment of trunk-wall soft-tissue sarcoma (TW-STS). MATERIALS AND METHODS: Patients with a histologic diagnosis of TW-STS (primary tumor 53 %; locally recurrent 47 %) with absence of distant metastases, undergoing surgery with radical intent and IORT (median dose 12.5 Gy) were considered eligible for participation in this study. In addition, all primary tumors received external-beam radiotherapy (median dose 50 Gy). RESULTS: From 1986 to 2012, a total of 68 patients were analyzed in the study from three Spanish institutions. With a median follow-up time of 53 months (range 4-316), 5-year local control (LC) was 58 %. Five-year IORT in-field control, disease-free survival (DFS) and overall survival were 70, 45 and 51 %, respectively. On multivariate analysis, only microscopically involved margin (R1) resection status retained significance in relation to LC (HR 3.97, p < 0.001). In regard to IORT in field control, incomplete resection (HR 3.23, p = 0.008) and recurrent disease status (HR 2.52, p = 0.04) retained a significant association in multivariate analysis. CONCLUSION: From this joint analysis emerges the fact that margin and disease status influences local and central control, but DFS remains modest, given the high risk of distant metastases. Intensified local treatment needs to be tested in the context of more efficient concurrent, neo-, and adjuvant systemic therapy (AU)

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Intraoperative radiation therapy in early breast cancer using a linear accelerator outside of the operative suite: an "image-guided" approach.

PURPOSE: To present local control, complications, and cosmetic outcomes of intraoperative radiation therapy (IORT) for early breast cancer, as well as technical aspects related to the use of a nondedicated linear accelerator. METHODS AND MATERIALS: This prospective trial began in May of 2004. Eligibility criteria were biopsy-proven breast-infiltrating ductal carcinoma, age >40 years, tumor <3 cm, and cN0. Exclusion criteria were in situ or lobular types, multicentricity, skin invasion, any contraindication for surgery and/or radiation therapy, sentinel lymph node involvement, metastasis, or another malignancy. Patients underwent classic quadrantectomy with intraoperative sentinel lymph node and margins evaluation. If both free, the patient was transferred from operative suite to linear accelerator room, and IORT was delivered (21 Gy). Primary endpoint: local recurrence (LR); secondary endpoints: toxicities and aesthetics. Quality assurance involved using a customized shield for chest wall protection, applying procedures to minimize infection caused by patient transportation, and using portal films to check collimator-shield alignment. RESULTS: A total of 152 patients were included, with at least 1 year follow-up. Median age (range) was 58.3 (40-85.4) years, and median follow-up time was 50.7 (12-110.5) months. The likelihood of 5-year local recurrence was 3.7%. There were 3 deaths, 2 of which were cancer related. The Kaplan-Meier 5-year actuarial estimates of overall, disease-free, and local recurrence-free survivals were 97.8%, 92.5%, and 96.3%, respectively. The overall incidences of acute and late toxicities were 12.5% and 29.6%, respectively. Excellent, good, fair, and bad cosmetic results were observed in 76.9%, 15.8%, 4.3%, and 2.8% of patients, respectively. Most treatments were performed with a 5-cm collimator, and in 39.8% of the patients the electron-beam energy used was ≥12 MeV. All patients underwent portal film evaluation, and the shielding was repositioned in 39.9% of cases. No infection or anesthesia complications were observed. CONCLUSIONS: Local control with IORT was adequate, with low complication rates and good cosmetic outcomes. More than one-third of patients benefited from the "image-guidance" approach, and almost 40% benefited from the option of higher electron beam energies.

A novel approach of INTRABEAM intraoperative radiotherapy for nipple-sparing mastectomy with breast reconstruction.

BACKGROUND: Despite the advancement and increasing use of breast-conserving surgery, mastectomies, including nipple-sparing mastectomy (NSM), are still carried out in a portion of breast cancer patients. However, the role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC). INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This pilot study aims to broaden the application of the INTRABEAM system for breast cancer, investigating the feasibility of INTRABEAM IORT in NSM with breast reconstruction. PATIENTS AND METHODS: From December 2012 to June 2013, 7 female patients with breast cancer were enrolled in the study. NSM with or without axillary dissection was performed first. After confirming negative retroareolar frozen section results and no poor local bleeding in the NAC, INTRABEAM IORT was carried out with a single dose of 16 Gy, followed by breast reconstruction. The complications and short-term outcomes were assessed. RESULTS: The median radiation time was 13 minutes 14 seconds in the 7 cases. One patient complained of mild pain in the radiation field on the skin in the first 2 weeks. All 7 patients were followed for a median of 7 months. No acute radiation injury with symptoms (heart, lung, or hematologic system), NAC necrosis, local recurrence, or metastasis was observed. Although every patient had reduction in NAC sensitivity, the contours of the breasts (including the NAC) were satisfactory. CONCLUSIONS: INTRABEAM IORT may be a feasible and convenient approach for NSM with breast reconstruction in patients with breast cancer.

In vivo dosimetry in intraoperative electron radiotherapy: microMOSFETs, radiochromic films and a general-purpose linac.

INTRODUCTION: In vivo dosimetry is desirable for the verification, recording, and eventual correction of treatment in intraoperative electron radiotherapy (IOERT). Our aim is to share our experience of metal oxide semiconductor field-effect transistors (MOSFETs) and radiochromic films with patients undergoing IOERT using a general-purpose linac. MATERIALS AND METHODS: We used MOSFETs inserted into sterile bronchus catheters and radiochromic films that were cut, digitized, and sterilized by means of gas plasma. In all, 59 measurements were taken from 27 patients involving 15 primary tumors (seven breast and eight non-breast tumors) and 12 relapses. Data were subjected to an outliers' analysis and classified according to their compatibility with the relevant doses. Associations were sought regarding the type of detector, breast and non-breast irradiation, and the radiation oncologist's assessment of the difficulty of detector placement. At the same time, 19 measurements were carried out at the tumor bed with both detectors. RESULTS: MOSFET measurements ([Formula: see text] = 93.5 %, sD = 6.5 %) were not significantly shifted from film measurements ([Formula: see text] = 96.0 %, sD = 5.5 %; p = 0.109), and no associations were found (p = 0.526, p = 0.295, and p = 0.501, respectively). As regards measurements performed at the tumor bed with both detectors, MOSFET measurements ([Formula: see text] = 95.0 %, sD = 5.4 % were not significantly shifted from film measurements ([Formula: see text] = 96.4 %, sD = 5.0 %; p = 0.363). CONCLUSION: In vivo dosimetry can produce satisfactory results at every studied location with a general-purpose linac. Detector choice should depend on user factors, not on the detector performance itself. Surgical team collaboration is crucial to success.