Status of head and neck brachytherapy in Spain in 2022

Purpose Brachytherapy (BT) has been used for many years for disease control in tumours of the head and neck area (H&N). It is currently performed with high dose rate (HDR) or pulsed dose rate (PDR), but its use has been reduced due to the implementation of new non-invasive external beam radiotherapy techniques such as intensity modulation (IMRT) and volumetric modulated arc therapy (VMAT) and the improvement of surgical techniques. Methods The Spanish Brachytherapy Group (GEB) has carried out a survey to find out the number of centres in Spain that continue to use BT in H&N and its indications and expectations for the future. Results The results were presented at the XX GEB Consensus Meeting held on October 21, 2022, in Valencia (Spain) and it was confirmed that, although there are fewer and fewer centres that use BT in H&N, there are still units with extensive experience in this technique that should be positioned as referral centres. Conclusion It is necessary to carry out continuous work with other specialities involved, such as H&N surgeons, and other radiation oncologists, to improve the training of residents, both oncologists and medical physicists (AU)

Moderate hypofractionated radiation therapy and pathologic response for soft tissue sarcomas (STS) of limbs and trunk: experience from a tertiary cancer center

Background Preoperative radiation therapy following by limb-sparing or conservative surgery is a standard approach for limb and trunk STS. Data supporting hypofractionated radiotherapy schedules are scarce albeit biological sensitivity of STS to radiation would justify it. We sought to evaluate the impact of moderate hypofractionation on pathologic response and its influence on oncologic outcomes. Material and methods From October 2018 to January 2023, 18 patients with limb or trunk STS underwent preoperative radiotherapy at a median dose of 52.5 Gy (range 49.5–60 Gy) in 15 fractions of 3.5 Gy (3.3-4 Gy) with or without neoadjuvant chemotherapy. A favorable pathologic response (fPR) was considered as ≥ 90% tumor necrosis on specimen examination. Results All patients completed planned preoperative radiotherapy. Eleven patients (61.1%) achieved a fPR, and 7 patients (36.8%) a complete pathologic response with total disappearance of tumor cells. Nine patients (47%) developed grade 1–2 acute skin toxicity, and 7 patients (38.8%) had wound complications on follow-up. With a median follow-up of 14 months (range 1–40), no cases of local relapse were observed, and actuarial 3-year overall survival (OS) and distant metastases-free survival (DMFS) are 87% and 76.4%, respectively. In the univariate analysis, the presence of a favorable pathologic response (fPR) was associated with improved 3-year OS (100% vs. 56.03%, p = 0.058) and 3-year DMFS (86.91% vs. 31.46%, p = 0.002). Moreover, both complete or partial RECIST response and radiological stabilization of the tumor lesion showed a significant association with higher rates of 3-year distant metastasis-free survival (DMFS) (83% vs. 83% vs. 56%, p < 0.001) and 3-year overall survival (OS) (100% vs. 80% vs. 0, p = 0.002) (AU)

Radiotherapy-related toxicity for localized prostate cancer: meta-analysis comparing conventional or moderately hypofractionated vs. ultrahypofractionated protocols

BackgroundTo compare toxicities in relation to standard radiation treatments [conventional fractionation RT (CRT) and moderate hypofractionated RT (MRT)] with ultrahypofractionated RT (URT) in the treatment of patients with localized PCa.MethodsA searched was performed in Medline, Embase, Cochrane CENTRAL, and LILACS to January 2020 for studies comparing URT to CRT and/or MRT in relation to genitourinary (GU) and gastrointestinal (GI) toxicity in the treatment of patients with localized PCa. URT, MRT and CRT were defined as protocols delivering a daily dose of ≥5 Gy, 2.4–4.9 Gy, and <2.4 Gy per fractions regardless total dose, respectively.ResultsEight studies with 2929 patients with localized PCa were included in the analysis. These eight studies did not find any difference between URT and MRT/CRT groups in relation to acute GU toxicity (21.0% × 23.8%, RD −0.04; 95% CI −0.13, 0.06; p = 0.46; I2 = 89%) and acute GI toxicity (4.9% × 6.9%, RD −0.03; 95% CI −0.07, 0.01; p = 0.21; I2 = 79%). Six studies did not find any difference between URT and MRT/CRT groups in relation to late GU toxicity (3.9% × 4.7%, RD −0.01; 95% CI −0.03, 0.00; p = 0.16; I2 = 19%) and late GI toxicity (2.1% × 3.5%, RD −0.01; 95% CI −0.03, 0.00; p = 0.05; I2 = 22%).ConclusionThe present study suggests that acute GU/GI and late GU/GI toxicity are similar between URT and standard protocols. More studies with longer follow-ups directed to oncology outcomes are warranted before any recommendation on this topic.

5-year results of accelerated partial breast irradiation (APBI) with SBRT (stereotactic body radiation therapy) and exactrac adaptive gating (Novalis®) for very early breast cancer patients: was it all worth it?

Purpose To explore the feasibility of image-guided and respiratory-gated Stereotactic Body Radiation Therapy (SBRT) for Accelerated Partial Breast Irradiation (APBI) in patients with very early breast cancer. Material and methods Selected patients with early breast carcinoma after breast-conserving surgery were enrolled in this phase II trial. A fiducial marker was percutaneously placed close to surgical bed and five external fiducials were set on the skin. A CT scan for planning was acquired at free breathing. The treatment was planned and DVH were assessed according to international recommendations. Prescription dose was 30 Gy in five consecutive fractions of 6 Gy. A 6MV monoenergetic LINAC (linear accelerator) that combines stereoscopic X-ray imaging system and ExacTrac Adaptive Gating technique was used. PTV (planning target volume) intrafraction motion was controlled and PTV was irradiated in a selected gated area of the respiratory cycle. Shifts for a correct, gated set-up were calculated and automatically applied. Results Between April 2013 and October 2015, a total of 23 patients were included. The median tumor size was 12 mm. The mean PTV volume was 114 cc. The mean ipsilateral lung V9 Gy was 2.2% and for left-sided breast cancers, the volume of the heart receiving 1.5 Gy was 11.5%. Maximum skin dose was 30.8 Gy. Acute toxicity was grade1 in all the patients and 100% experienced excellent/good breast cosmesis outcomes. With a median follow-up of 66 months (range 8–99 months) local-relapse-free-survival reaches 100%. One patient developed a second breast cancer outside the treated quadrant after 25.1 months. Conclusion APBI with SBRT and ExacTrac Adaptive Gating System was feasible. The acute and late toxicities were almost null and cosmesis was excellent. We also found that the margins of 5 mm applied from CTV to PTV were sufficient to compensate for geometric uncertainties (AU)

Surface-guided radiation therapy for breast cancer: more precise positioning

Introduction Hypofractionated radiation therapy for breast cancer requires highly precise delivery through the use of image-guided radiotherapy (IGRT). Surface-guided radiation therapy (SGRT) is being increasingly used for patient positioning in breast radiotherapy. We aimed to assess the role of SGRT for verification of breast radiotherapy and the tumour bed. Materials and method Prospective study of 252 patients with early stage breast cancer. A total of 1170 determinations of daily positioning were performed. Breast surface positioning was determined with SGRT (AlignRT) and correlated with the surgical clips in the tumour bed, verified by IGRT (ExacTrac). Results SGRT improved surface matching by a mean of 5.3 points compared to conventional skin markers (98.0 vs. 92.7), a statistically significant difference (p < 0.01, Wilcoxon Test). For surface matching values > 95%, ≥ 3 clips coincided in 99.7% of the determinations and all markers coincided in 92.5%. For surface matching rates > 90%, the location of ≥ 3 clips coincided in 99.55% of determinations. Conclusions SGRT improves patient positioning accuracy compared to skin markers. Optimal breast SGRT can accurately verify the localisation of the tumour bed, ensuring matching with ≥ 3 surgical clips. SGRT can eliminate unwanted radiation from IGRT verification systems (AU)

Long-term results of a randomized partial irradiation trial compared to whole breast irradiation in the early stage and low-risk breast cancer patients after conservative surgery

Purpose To report long-term results of a randomized trial comparing accelerated partial breast irradiation (APBI) to whole-breast irradiation (WBI) in terms of efficacy, toxicity, and cosmesis. Methods and materials WBI group was treated with 3D conformal external irradiation, 2 Gy daily/fraction, 5 fractions/week, to a total dose of 50 Gy. APBI group was treated with 3D conformal external irradiation 3.75 Gy/fraction, twice a day, 5 fractions/week, to a total dose of 37.5 Gy in the APBI group. Patients were followed up every 6 months up to 5 years and yearly thereafter. During follow-up visits, the clinician evaluated chronic toxicity and scored cosmetic results with a four-scale system. Results After a median follow-up of 10.3 years, 43 patients in each group (84%) are alive without disease. One patient died after disease progression in the APBI arm, and there was no death in the WBI arm. The rest of the patients died from another disease different than breast cancer, similarly between groups. There was greater fibrosis in the APBI group (9 patients grade 1 and one grade 2) compared to WBI (3 patients grade 1 and one grade 2); p = 0.18. Regarding cosmesis, in APBI group, 19 and 21 (43.2 and 47%) patients had excellent or good results, similar to the WBI group with 18 patients (40.9%) in each cosmesis outcome. The WBI group did not have any patient with poor cosmesis but the APBI had 3 (6.8%; p = 0.24). Conclusion After a follow-up of 10 years, there were no differences in efficacy between the 2 treatment arms. Despite slight greater toxicity in the APBI group, the cosmesis was similar and satisfactory in both groups (AU)

A multi-institutional analysis of fractionated versus single-fraction stereotactic body radiotherapy (SBRT) in the treatment of primary lung tumors: a comparison between two antipodal fractionations

Objectives Stereotactic body radiotherapy (SBRT) is a consolidate treatment for inoperable early-stage lung tumors, usually delivered in single or multi-fraction regimens. We aimed to compare these two approaches in terms of local effectiveness, safety and survival. Materials and methods Patients affected by medically inoperable early-stage lung tumor were treated at two Institutions with two different schedules: 70 Gy in ten fractions (TF) (BED10: 119 Gy) or 30 Gy in single fraction (SF) (BED10: 120 Gy). Results 73 patients were treated with SBRT delivered with two biological equivalent schedules: SF (44) and TF (29). The median follow-up was 34 months (range 3–81 months). Three-year Overall survival (OS) was 57.9%, 3-year cancer-specific survival (CSS) was 77.2%, with no difference between treatment groups. Three-year progression-free survival (LPFS) was 88.9% and did not differs between SF and TF. Overall, four cases (5.4%) of acute grade ≥ 3 pneumonitis occurred. No differences in acute and late toxicity between the two groups were detected. Conclusion SF and TF seems to be equally safe and effective in the treatment of primary inoperable lung tumors especially for smaller lesion. The SF may be preferentially offered to reduce patient access to hospital with no negative impact on tumor control and survival (AU)

Pattern of care in radiotherapy at a University Hospital in Spain: the RENORT project

Purpose RENORT is a novel data mining application developed to extract relevant clinical data from oncology information systems (OIS; ARIA and Mosaiq) used in radiation oncology (RO). Methods/patients We used RENORT to extract demographic and clinical data from the OIS of all patients treated at the RO Department at the General Hospital of Valencia during the year 2019. Results A total of 1158 treatments were performed. The female/male ratio was 39.3%/60.7%, with a mean age of 66 years. The mean waiting time between the treatment decision/proposal to the first visit was 10.1 days. Mean duration of the treatment preparation process was 21 days. Most patients (90.4%) completed treatment within the prescribed time ± 7 days. The most common sites/treatment types were: metastatic/palliative treatments (n = 300; 25.9%), breast (209; 18.0%), genitourinary (195; 16.8%), digestive (116; 10.0%), thoracic (104; 9.0%), head and neck (62; 5.4%), and skin cancer (51; 4.4%). The distribution according to treatment intent was as follows: palliative (n = 266; 23.0%), adjuvant curative (335; 28.9%), radical without adjuvant treatment (229; 19.8%), radical with concomitant treatment (188; 16.2%), curative neoadjuvant (70; 6.0%), salvage radiotherapy (61; 5.3%); and reirradiation (9; 0.8%). The most common treatment techniques were IMRT/VMAT with IGRT (n = 468; 40.4%), 3D-CRT with IGRT (421; 36.4%), SBRT (127; 11.0%), 2DRT (57; 4.9%), and SFRT (56; 4.8%). A mean of 15.9 fractions were administered per treatment. Hypofractionated schemes were used in 100% of radical intent breast and prostate cancer treatments. Conclusions The RENORT application facilitates data retrieval from oncology information systems to allow for a comprehensive determination of the real role of radiotherapy in the treatment of cancer patients. This application is valuable to identify patterns of care and to assess treatment efficacy (AU)

El ocaso del modelo lineal sin umbral / The downfall of the linear non-threshold model

El modelo lineal sin umbral (MLSU) es una función dosis-respuesta teórica obtenida de extrapolar los efectos tardíos debidos a la exposición a altas dosis de radiación ionizante al rango de las bajas dosis, pero existen grandes incertidumbres respecto a su validez. La aceptación del MLSU como modelo probabilístico preponderante ha sobrevivido hasta nuestros días y constituye la piedra angular que sostiene las políticas actuales de protección radiológica. En las últimas décadas, los avances en biología molecular y evolutiva, en la inmunología del cáncer, así como los resultados obtenidos de los estudios epidemiológicos y en modelos animales, han puesto en entredicho la fiabilidad del MLSU en favor de otras alternativas, como la teoría hormética. A la vista de las evidencias, se hace necesario un debate entre las sociedades científicas implicadas y los organismos reguladores que aborde una redefinición de las bases de la protección radiológica, cuya importancia sería capital en el ámbito médico

The linear non-threshold model (LNTM) is a theoretical dose-response function as a result of extrapolating the late effects of high-dose exposure to ionizing radiation to the low-dose range, but there is great uncertainty about its validity. The acceptance of LNTM as the dominant probabilistic model have survived to the present day and it is actually the cornerstone of current radiation protection policies. In the last decades, advances in molecular and evolutive biology, cancer immunology, and many epidemiological and animal studies have cast serious doubts about the reliability of the NLTM, as well as suggesting alternative models, like the hormetic theory. Considering the given evidences, a discussion between the involved scientific societies and the regulatory commissions is promtly required in order to to reach a redefiniton of theradiation protection basis, as it would be specially crucial in the medical field

Are endometrial cancer radiotherapy results age related?

Objective: To analyze the impact of age on radiotherapy results based on cancer-specific survival (CSS), vaginal-cuff relapses (VCR) and complications analysis in 438 patients with endometrial carcinoma (EC) receiving postoperative radiotherapy (PRT) divided into three age groups for analysis. Materials and methods: From 2003 to 2015, 438 patients with EC were treated with PRT and divided into three age groups: Group-1: 202 patients < 65 years; Group-2: 210 patients ≥ 65 and < 80 years; Group-3: 26 patients ≥ 80 years. Vaginal toxicity was assessed using the objective LENT-SOMA criteria and RTOG scores were recorded for the rectum, bladder, and small bowel. Statistics: Chi square and Student’s t tests, Kaplan-Meier survival study for analysis of CSS. Results: The mean follow-up was 5.6 years in Group-1, 5.6 years in Group-2 and 6.3 years in Group-3 (p = 0.38). No differences were found among the groups in distribution of stage, grade, myometrial invasion, Type 1 vs. 2 EC and VLSI (p = 0.97, p = 0.52, p = 0.35, p = 0.48, p = 0.76, respectively). There were no differences in rectal, bladder and vagina late toxicity (p = 0.46, p = 0.17, p = 0.75, respectively). A better CSS at 5 years was found in Group-1 (p = 0.006), and significant differences were found in late severe small bowel toxicity in Group-3 (p = 0.005). VCR was increased in Group-3 (p = 0.017). Conclusions: Patients ≥ 65 years had a worse outcome in comparison to younger patients. Late vaginal, rectal and bladder toxicities were similar in the three groups, although an increase of severe late small bowel toxicity led to IMRT in patients ≥ 80 years. Further larger studies are needed including quality of life analysis in patients ≥ 80 years

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Comparative analysis of the effect of different radiotherapy regimes on lymphocyte and its subpopulations in breast cancer patients

Purpose: The aim of this study was to determine whether different radiotherapy (RT) fractionation schemes induce disparate effects on lymphocyte and its subsets in breast cancer patients. Methods: 60 female patients diagnosed with breast cancer were recruited in this study after receiving modified radical mastectomy and were randomly divided into two groups. One group received irradiation at a standard dose of 50 Gy in 25 fractions and the other at a dose of 40.3 Gy in 13 fractions. Both total lymphocyte count and its composition were recorded at three timepoints: right before the radiation treatment (T0), immediately after the last fraction of radiotherapy (T1) and 6 months after irradiation therapy ended (T2). Results: Both groups experienced temporal lymphopenia after finishing local radiation (T1) (13F T0 vs. T1 1570.6 ± 243.9 vs. 940.6 ± 141.8, **p < 0.01; 25F T0 vs. T1 1620.5 ± 280.2 vs. 948.5 ± 274.6, **p < 0.01), while the lymphocyte count recovered at follow-up time (T2), and the cell count in the hypofractionation group (13F) was higher than the standard fraction group (25F) (13F vs. 25F 1725.6 ± 225.6 vs. 1657.5 ± 242.4, *p < 0.05). With respect to the composition of lymphocyte, we found T cell, B cell, and NK cell reacted differently to different radiotherapy protocols. Conclusions: Different RT protocols impose different impacts on immunity, leading us to further explore the optimal radiotherapy regimes to synergy with immunotherapy

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Recommendations of the Spanish brachytherapy group (GEB) of Spanish Society of Radiation Oncology (SEOR) and the Spanish Society of Medical Physics (SEFM) for high-dose rate (HDR) non melanoma skin cancer brachytherapy

Clinical indications of brachytherapy in non-melanoma skin cancers, description of applicators and dosimetry recommendations are described based on the literature review, clinical practice and experience of Spanish Group of Brachytherapy and Spanish Society of Medical Physics reported in the XIV Annual Consensus Meeting on Non Melanoma Skin Cancer Brachytherapy held in Benidorm, Alicante (Spain) on October 21st, 2016. All the recommendations for which consensus was achieved are highlighted in blue. Regular and small surfaces may be treated with Leipzig, Valencia, flap applicators or electronic brachytherapy (EBT). For irregular surfaces, customized molds or interstitial implants should be employed. The dose is prescribed at a maximum depth of 3-4 mm of the clinical target volume/planning target volume (CTV/PTV) in all cases except in flaps or molds in which 5 mm is appropriate. Interstitial brachytherapy should be used for CTV/PTV >5 mm. Different total doses and fraction sizes are used with very similar clinical and toxicity results. Hypofractionation is very useful twice or 3 times a week, being comfortable for patients and practical for Radiotherapy Departments. In interstitial brachytherapy 2 fractions twice a day are applied (AU)

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Infrastructure and equipment for radiation oncology in the Spanish National Health System: analysis of external beam radiotherapy 2015-2020

Purpose. Planning for radiation oncology requires reliable estimates of both demand for radiotherapy and availability of technological resources. This study compares radiotherapy resources in the 17 regions of the decentralised Spanish National Health System (SNHS). Materials and methods. The Sociedad Española de Oncología Radioterápica (SEOR) performed a cross-sectional survey of all Spanish radiation oncology services (ROS) in 2015. We collected data on SNHS radiotherapy units, recording the year of installation, specific features of linear accelerators (LINACs) and other treatment units, and radiotherapeutic techniques implemented by region. Any machine over 10 years old or lacking a multileaf collimator or portal imaging system was considered obsolete. We performed a k-means clustering analysis using the Hartigan-Wong method to test associations between the gross domestic regional product (GDRP), the number of LINACs per million population and the percentage of LINACs over 10 years old. Results. The SNHS controls 72 (61%) of the 118 Spanish ROS and has 180 LINACs, or 72.5% of the total public and private resources. The mean rate of LINACs per million population is 3.9 for public ROS, and 42% (n = 75) of the public accelerators were obsolete in 2015: 61 due to age and 14 due to technological capability. There was considerable regional variation in terms of the number and technological capacity of radiotherapy units; correlation between GRDP and resource availability was moderate. Conclusion. Despite improvements, new investments are still needed to replace obsolete units and increase access to modern radiotherapy. Regular analysis of ROS in each Spanish region is the only strategy for monitoring progress in radiotherapy capacity (AU)

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Accelerated hypofractionated radiation therapy (AHRT) for non-small-cell lung cancer: can we leave standard fractionation?

Purpose. To report interim results from a single-institution study conducted to assess accelerated hypofractionated radiotherapy (AHRT) delivered with 3D conformal radiotherapy in two groups of patients with non-small cell lung cancer: (1) patients with early stage disease unable to tolerate surgery and ineligible for stereotactic body radiation therapy, and (2) patients with locally advanced disease unsuitable for concurrent chemoradiotherapy. Methods/patients. A total of 83 patients (51 stage I-II, 32 stage III) were included. Radiotherapy targets included the primary tumor and positive mediastinal areas identified on the pre-treatment PET-CT. Mean age was 77.8 ± 7.8 years. ECOG performance status (PS) was ≥2 in 50.6 % of cases. Radiotherapy was delivered in daily fractions of 2.75 Gy to a total dose of 66 Gy (BED10 84 Gy). Acute and late toxicities were evaluated according to NCI CTC criteria. Results. At a median follow-up of 42 months, median overall survival (OS) and cause-specific survival (CSS) were 23 and 36 months, respectively. On the multivariate analysis, PS [HR 4.14, p = 0.0001)], stage [HR 2.51, p = 0.005)], and maximum standardized uptake values (SUVmax) [HR 1.04, p = 0.04)] were independent risk factors for OS. PS [HR 5.2, p = 0.0001)] and stage [HR 6.3, p = 0.0001)] were also associated with CSS. No cases of severe acute or late treatment-related toxicities were observed. Conclusions. OS and CSS rates in patients treated with AHRT for stage I-II and stage III NSCLC were good. Treatment was well tolerated with no grade three or higher treatment-related toxicity. PS, stage, and SUV max were predictive for OS and CSS (AU)

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Modificación de la dosis de terapias biológicas en psoriasis moderada-grave: análisis descriptivo en condiciones de práctica clínica / Dose Modification in Biologic Therapy for Moderate to Severe Psoriasis: A Descriptive Analysis in a Clinical Practice Setting

INTRODUCCIÓN: La modificación de dosis de biológicos en pacientes con psoriasis en remisión adecuadamente seleccionados podría reducir el riesgo de exposición al fármaco y su carga económica. MATERIAL Y MÉTODOS: Estudio observacional, descriptivo y transversal en 112 pacientes con psoriasis moderada-grave tratados con biológicos durante ≥6 meses en enero de 2014. El objetivo consistió en alcanzar y mantener una respuesta PASI 75. Los pacientes iniciaron el tratamiento con la pauta estándar; en aquellos que cumplieron el objetivo se redujo la dosis, y cuando no alcanzaron la respuesta con la pauta estándar esta se intensificó. RESULTADOS: Un 42,9% siguió la pauta estándar, un 50% la reducida y un 7,1% la intensificada. El fármaco con el que más se redujo la dosis fue adalimumab (57,7%) y los que más se intensificaron fueron ustekinumab e infliximab (17,9% y 12,5%). Los pacientes que recibieron dosis reducidas presentaron una psoriasis de más evolución (p = 0,049) y llevaban más tiempo en tratamiento con el mismo biológico (p = 0,009) (diferencias significativas). Hubo una proporción significativamente superior de pacientes con artritis psoriásica entre los no aptos a reducir dosis (p = 0,023). El ahorro del gasto fue del 21,5% con adalimumab, 13,8% con etanercept, 0,9% con ustekinumab y 0,55% con infliximab. CONCLUSIONES: Presentaron una probabilidad de reducción de dosis significativamente mayor aquellos pacientes con más tiempo de evolución y más tiempo bajo el mismo tratamiento biológico. Entre los pacientes sin reducción de dosis hubo mayor proporción con artritis psoriásica. El ahorro global con este algoritmo de modificación de dosis fue del 13%. Se requieren estudios controlados que ayuden a definir el perfil de paciente más adecuado para reducir la dosis sin pérdida de eficacia del tratamiento

INTRODUCTION: In biologic therapy, dose modification in carefully selected patients when psoriasis is in remission could reduce treatment costs and the risks associated with drug exposure. MATERIAL AND METHODS: Observational, descriptive, crosssectional study, performed in January 2014, of 112 patients with moderate to severe psoriasis who had been on biologic therapy for at least 6 months. The therapeutic objective in all cases was to achieve and maintain a 75% reduction in Psoriasis Area and Severity Index (PASI 75). All the patients had started treatment with the standard regimen. During treatment, the dose had been reduced in patients who achieved the therapeutic objective and escalated in those who failed to respond adequately to standard doses. RESULTS: At the time of the study, 42.9% of the patients were receiving the standard dose, 50% were on a reduced dose, and 7.1% were on an escalated regimen. The agent with which the dose was most often reduced was adalimumab (57.7%), and the agents with which therapy was most often escalated were ustekinumab (17.9%) and infliximab (12.5%). Patients who received reduced doses had significantly longer-standing disease (P=.049) and longer treatment duration with the same biologic agent (P=.009). In the group that did not fulfill the criteria for dose reduction, the proportion of patients with psoriatic arthritis was significantly higher (P=.023). Cost savings were as follows: 21.5% with adalimumab, 13.8% with etanercept, .9% with ustekinumab, and .55% with infliximab. CONCLUSIONS: Patients with longer-standing disease and longer treatment duration with the same biologic agent were significantly more likely to be candidates for dose reduction. The proportion of patients with psoriatic arthritis was greater in the group of patients who did not fulfill the conditions for dose reduction. The overall cost saving achieved using the dose modification algorithm described in this study was 13%. Controlled studies are needed to define the profile of the patients best suited for dose reduction strategies without loss of treatment efficacy

Radioterapia hipofraccionada versus radioterapia convencional en cáncer de próstata: una revisión sistemática sobre eficacia y seguridad / Hypofractionated radiation therapy versus conventional radiation therapy in prostate cancer: A systematic review of its safety and efficacy

Contexto: Nuevas alternativas terapéuticas pueden mejorar la eficacia y seguridad del tratamiento del cáncer de próstata. Objetivo. Evaluar si la radioterapia hipofraccionada conlleva mejor eficacia y seguridad en el tratamiento del cáncer de próstata. Adquisición de la evidencia Revisión sistemática de la literatura con búsqueda en Pubmed, Cochrane Libarry, CRD, ClinicalTrials y Euroscan, recogiéndose indicadores de efectividad y seguridad. Síntesis de la evidencia: Se incluyeron 2 revisiones sistemáticas y un ensayo clínico. En relación con la eficacia existe una gran heterogeneidad entre los estudios, y no se encuentran resultados concluyentes de la superioridad de la opción hipofraccionada sobre la normofraccionada. En relación con la seguridad no se encuentran diferencias significativas en la aparición de complicaciones genitourinarias agudas entre ambos tratamientos. Sin embargo, una de las revisiones encuentra más complicaciones gastrointestinales agudas en los pacientes tratados con radioterapia hipofraccionada. En las complicaciones a largo plazo no se encuentran diferencias significativas según el tipo de radioterapia utilizada, aunque los estudios presentan limitaciones. Conclusiones: Hasta el momento no existen resultados concluyentes que demuestren que la radioterapia hipofraccionada es más eficaz o segura que la normofraccionada en el tratamiento del cáncer de próstata localizado

Context: New therapeutic alternatives can improve the safety and efficacy of prostate cancer treatment. Objectives: To assess whether hypofractionated radiation therapy results in better safety and efficacy in the treatment of prostate cancer. Acquisition of evidence: Systematic review of the literature through searches on PubMed, Cochrane Library, CRD, ClinicalTrials and EuroScan, collecting indicators of safety and efficacy. Synthesis of the evidence: We included 2 systematic reviews and a clinical trial. In terms of efficacy, there is considerable heterogeneity among the studies, and no conclusive results were found concerning the superiority of the hypofractionated option over the normal fractionated option. In terms of safety, there were no significant differences in the onset of acute genitourinary complications between the 2 treatments. However, one of the reviews found more acute gastrointestinal complications in patients treated with hypofractionated radiation therapy. There were no significant differences in long-term complications based on the type of radiation therapy used, although the studies did have limitations. Conclusions: To date, there are no conclusive results that show that hypofractionated radiation therapy is more effective or safer than normal fractionated radiation therapy in the treatment of localized prostate cancer

Clinical radiobiology of head and neck cancer: the hypothesis of stem cell activation

Purpose To estimate and reduce uncertainties of a selfconsistent set of radiobiological parameters based on the outcome of head and neck cancer (HNC) patients treated with radiotherapy (RT). Methods Published studies comparing at least two RT schedules for HNC patients were selected. The method used to estimate the radiobiological parameters consists of three sequential steps that allow a significant reduction of uncertainties: the first, in which the intrinsic (a) and the repair (b) radio-sensitivities were estimated together with the doubling time (Td) by an analytical/graphical method; the second, in which the kick-off time for accelerated proliferation (Tk) was estimated applying the hypothesis of activation for sub-populations of stem cells during the RT; the third, in which the number of clonogens (N) was obtained by the Tumor Control Probability (TCP) model. Independent clinical data were used to validate results. Results The best estimate and the 95 % confidence intervals (95 % CIs) were: a = 0.24 Gy-1 (0.23–0.26), b = 0.023 Gy-2 (0.021–0.025), a/b = 10.6 Gy (8.4–12.6), Td = 3.5 days (3.1–3.9), Tk = 19.2 days (15.1–23.3), N = 7 9 107 (4 9 107 –1 9 108 ). From these data, the dose required to offset repopulation occurring in 1 day (Dprolif) and starting after Tk was also estimated as 0.69 Gy/day (0.52–0.86). Conclusions The estimation of all the radiobiological parameters of HNC was obtained based on the hypothesis of activation for specifically tumorigenic sub-populations of stem cells. The similarity of results to those from other studies strengthens such a hypothesis that could be very useful for the predictivity of the TCP model and to design new treatment strategies for HNC (AU)

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Three or four fractions per week in postoperative high-dose-rate brachytherapy for endometrial carcinoma. The long-term results on vaginal relapses and toxicity

BACKGROUND: High-dose-rate brachytherapy (HDR-BT) is an accepted part of treatment for endometrial carcinoma and is usually performed in 1-2 fractions per week using different total doses and doses per fraction. To reduce the overall treatment time, HDR-BT was administered with a 3-4 days/week schedule. PATIENTS AND METHODS: From June 2003 to December 2008, 164 patients with stage I-IIIc endometrial carcinoma were treated with HDR-BT (4-5 Gy per fraction). The patients were divided into two groups; Group 1 (40/164 patients) was treated with HDR-BT alone (6 fractions; 4 fractions/week) and Group 2 (124/164 patients) was treated with both (External Beam Radiotherapy [EBRT] + HDR-BT: 3 fractions/week). Complications were analyzed using RTOG scores for rectum and bladder and the objective scores of LENT-SOMA for vaginal complications. RESULTS: The mean followup was 48 months. In Group 1, 35 % of patients underwent treatment in ≤10 days and 65 % in >10 days. In Group 2, 53.2 % received treatment in ≤5 days and in 46.8 % in >5 days. Vaginal relapse was observed in only two patients (1.2 %), both having received adjuvant EBRT + HDR-BT. Acute vaginal toxicity appeared in 8.5 % and late vaginal toxicity in 20.7 % of patients with 13.4 % being G1, 6.7 % G2 and only 0.6 % being G4. No statistically significant differences were found in complications in either brachytherapy group regardless of the overall time. CONCLUSION: In our series, three fractions given in 3-5/days after EBRT or six fractions in 10 days, is a safe regimen in terms of complications and local control (AU)

Daily schedule for high-dose-rate brachytherapy in postoperative treatment of endometrial carcinoma

PURPOSE: To analyze the results of daily high-dose-rate brachytherapy (HDRBT) on local control and toxicity in the postoperative treatment of endometrial carcinoma (EC). MATERIALS AND METHODS: From January 2007 to September 2010, 112 patients were treated with HDRBT after surgery for EC. FIGO staging: 24-IA, 48-IB, 14-II, 12-IIIA, 2-IIIB, 8-IIIC1 and 4-IIIC2. Pathology 99/112 endometrioid and 23/112 other types. Radiotherapy patients were divided into two groups-Group 1 (70/112) consists of external beam irradiation (EBI) plus HDRBT (2 fractions of 5-6 Gy) and Group 2 (42/112) consists of HDRBT alone (4 fractions of 5-6 Gy). Toxicity evaluation RTOG scores for bladder and rectum, and the objective criteria of LENT-SOMA for vagina. Statistics bivariate analysis of Chi-square and Fisher exact tests. RESULTS: With a mean follow-up of 29.52 months (range 9.60-53.57) no patient developed vaginal-cuff relapse. In Group 1 early toxicity appeared in 9 % in rectum, 8.5 % in bladder (G1-G2) and 1.4 % in vagina (G1); late toxicity was present in 8.5 % in rectum (all G1-G2 but 1 G3) and in 25 % in vagina (all G1-G2 but one G4). In Group 2, 9.4 % developed G1-G2 bladder and 6.9 % acute vagina (G1-G2) toxicity. Only 2.3 % had a G1 rectal score and 6.9 % had G1-G2 as vaginal scores for late problems. CONCLUSIONS: (1) Daily HDRBT using two fractions of 5-6 Gy after EBI and four fractions of 5-6 Gy as exclusive treatment was a safe regime. (2) Group 1 showed a higher incidence of late vaginal toxicity (AU)