[RADIATION ONCOLOGY: CONTEXT IN CANCER MEDICINE AND CLINICAL TRASLATIONAL RESEARCH MODELS]. / ONCOLOGÍA RADIOTERÁPICA TRASLACIONAL: MODELOS CLÍNICOS.

Radiation Oncology is a clinical speciality supported by technological development including biomedical imaging, ionizing radiation generators and radiobiology of cancer and normal tissues. Translational research and development opportunities incorporate clinical models available in hospital practice with academic interest in health care innovative approaches. Examples of mature research projects in translational radiation oncology are described: a) molecular imaging and expression for radioresponse assessment; b) oligorecurrent cancer results after rescue surgery and intensified radiotherapy; c) stereotactic surgical navigation for intraoperative radiotherapy.

Clinical feasibility of combining intraoperative electron radiation therapy with minimally invasive surgery: a potential for electron-FLASH clinical development.

BACKGROUND: Local cancer therapy by combining real-time surgical exploration and resection with delivery of a single dose of high-energy electron irradiation entails a very precise and effective local therapeutic approach. Integrating the benefits from minimally invasive surgical techniques with the very precise delivery of intraoperative electron irradiation results in an efficient combined modality therapy. METHODS: Patients with locally advanced disease, who are candidates for laparoscopic and/or thoracoscopic surgery, received an integrated multimodal management. Preoperative treatment included induction chemotherapy and/or chemoradiation, followed by laparoscopic surgery and intraoperative electron radiation therapy. RESULTS: In a period of 5 consecutive years, 125 rectal cancer patients were treated, of which 35% underwent a laparoscopic approach. We found no differences in cancer outcomes and tolerance between the open and laparoscopic groups. Two esophageal cancer patients were treated with IOeRT during thoracoscopic resection, with the resection specimens showing intense downstaging effects. Two oligo-recurrent prostatic cancer patients (isolated nodal progression) had a robotic-assisted surgical resection and post-lymphadenectomy electron boost on the vascular and lateral pelvic wall. CONCLUSIONS: Minimally invasive and robotic-assisted surgery is feasible to combine with intraoperative electron radiation therapy and offers a new model explored with electron-FLASH beams.

Point-of-care manufacturing: a single university hospital's initial experience.

BACKGROUND: The integration of 3D printing technology in hospitals is evolving toward production models such as point-of-care manufacturing. This study aims to present the results of the integration of 3D printing technology in a manufacturing university hospital. METHODS: Observational, descriptive, retrospective, and monocentric study of 907 instances of 3D printing from November 2015 to March 2020. Variables such as product type, utility, time, or manufacturing materials were analyzed. RESULTS: Orthopedic Surgery and Traumatology, Oral and Maxillofacial Surgery, and Gynecology and Obstetrics are the medical specialties that have manufactured the largest number of processes. Working and printing time, as well as the amount of printing material, is different for different types of products and input data. The most common printing material was polylactic acid, although biocompatible resin was introduced to produce surgical guides. In addition, the hospital has worked on the co-design of custom-made implants with manufacturing companies and has also participated in tissue bio-printing projects. CONCLUSIONS: The integration of 3D printing in a university hospital allows identifying the conceptual evolution to "point-of-care manufacturing."

Clinical feasibility of combining intraoperative electron radiation therapy with minimally invasive surgery: a potential for electron-FLASH clinical development

Background Local cancer therapy by combining real-time surgical exploration and resection with delivery of a single dose of high-energy electron irradiation entails a very precise and effective local therapeutic approach. Integrating the benefits from minimally invasive surgical techniques with the very precise delivery of intraoperative electron irradiation results in an efficient combined modality therapy. Methods Patients with locally advanced disease, who are candidates for laparoscopic and/or thoracoscopic surgery, received an integrated multimodal management. Preoperative treatment included induction chemotherapy and/or chemoradiation, followed by laparoscopic surgery and intraoperative electron radiation therapy. Results In a period of 5 consecutive years, 125 rectal cancer patients were treated, of which 35% underwent a laparoscopic approach. We found no differences in cancer outcomes and tolerance between the open and laparoscopic groups. Two esophageal cancer patients were treated with IOeRT during thoracoscopic resection, with the resection specimens showing intense downstaging effects. Two oligo-recurrent prostatic cancer patients (isolated nodal progression) had a robotic-assisted surgical resection and post-lymphadenectomy electron boost on the vascular and lateral pelvic wall. Conclusions Minimally invasive and robotic-assisted surgery is feasible to combine with intraoperative electron radiation therapy and offers a new model explored with electron-FLASH beams (AU)

[Delays and treatment interruptions: difficulties in administering radiotherapy in an ideal time-period]. / Retrasos e interrupciones: la dificultad para irradiar en el tiempo ideal.

Prescribed total radiation dose should be administered within in a specific time-frame and delays in commencing treatment and/or unplanned interruptions in radiation delivery are unacceptable because, in certain cancer sites, treatment-time prolongation can have a deleterious effect on local tumour control, and on patient outcomes. The present review evaluated the causes of initial treatment delays as well as interruptions in the scheduled radiotherapy. The literature search highlighted a significant concern in avoiding treatment-time prolongation in head and neck, cervix, breast and lung cancer. Among the causes involved in delay in radiotherapy commencement factors such as waiting lists, lack of material and human resources, and an increase complexity in planning, simulation and verification are highlighted. Most authors recommend radiotherapy commencement as soon as possible in radical (exclusive irradiation with active tumour present) and palliative situations with a maximum delay of no more than 6 to 8 weeks in the case of adjuvant radiotherapy (post-resection) programs. Interruptions during the course of treatment include: planned unit maintenance and servicing, acute patient toxicity or unexpected malfunction of linear accelerators; this last feature has the most deleterious effect on patients as well as radiotherapy practitioners. Interruptions that impact on the programmed time-course for radiotherapy needs to be compensated-for so as assure the biological equivalence in treatment efficacy with respect to cancer site and stage.

Erythropoietin in cancer treatment: considerations about Henke's article.

The concurrent use of erythropoietin beta (EPO)and radiotherapy in head and neck cancer patients has been reported by Henke et al (Lancet 2003;362:1255-60) to correct anemia and impair cancer control. Due to the potential impact in daily clinical practice of this information a systematic critical review of the mentioned article was performed. Authors selected 10 arguments to question the contents regarding methodological and statistical aspects of the trial, and added 14 comments of controversy in more basic scientific concepts mentioned in the text as published. The panel including epidemiologist and radiation oncologists with expertise in clinical research concluded with 5 additional remarks recommending caution in interpretation of these results in terms of changes in daily practice of anemic patients support, and advising not to use EPO at experimental doses or after reaching physiological concentrations of hemoglobin.

[Radiotherapy after radical prostatectomy: description, outcome and prognostic factors in and emerging practice]. / Radioterapia tras prostatectomía radical: factores descriptivos, evolutivos y de pronóstico en una práctica asistencial emergente.

OBJECTIVES: Recently it has been reported in the EORTC (European Organisation for Research and Treatment of Cancer) trial 22911 and the SWOG (Southwest Oncology Group) 8794, the evidence that radiotherapy (RT) is an effective treatment after the prostatectomy in patients with high risk of biochemical failure. We analyze predictor factors of biochemical relapse and the potential benefits induced by rescue treatment are the main purposes of our study. METHODS: From 1993 to 2003, 597 prostatectomy were followed at Hospital Universitario Gregorio Marañón de Madrid, identifying 166 patients (p) (28%) of biochemical failure (defined as PSA > or = 0'5 ng/ml, including post-surgical persistent values). 42 p received RT (78% due to delayed PSA relapse). The median total dose was 66 Gy [60-74]. RESULTS: Clinical variables: Median age: 68 years [49-80], median PSA at diagnosis: 29,8 ng/ml [2,6475]; presurgical Gleason > or = 7: 65%. Histological variables: Prostatectomy induces stage migration to superior T (pT3-T4: 95%) and Gleason categories (> or =7: 81%). 83% of relapsed p had positive margins and 90% had pT3-pT4. OUTCOME VARIABLES: median time to biochemical recurrence was 22,2 months. Median time interval between biochemical failure and RT was 10,5 months. Overall survival (5 years) was 86 +/- 6%. Freedom-from-biochemical failure at 5 years was 76 +/- 4%. RT had poor survival in p with PSA > 2 ng/ml pre-RT (p = 0.03), post-prostatectomy persistant disease (p = 0.05) and Gleason score > or = 7 (p = 0.01). No increased grade 3-4 uro-rectal toxicity was observed. CONCLUSIONS: RT after prostatectomy improves freedom-from-biochemical failure in p with PSA values below 2 ng/ml. In our experience, Gleason score > or = 7 is a negative predictor of response. There is no severe toxicity in our series. Improvement of the staging presurgery, the role of the adjuvant androgen deprivation and selection of patients for adjuvant RT focus current studies on treatment after prostatectomy.

Radioterapia tras prostatectomía radical: factores descriptivos, evolutivos y de pronóstico en una práctica asistencial emergente / Radiotherapy after radical prostatectomy: description, outcome and prognostic factors in and emerging practice

Objetivo: Recientemente se han comunicado firmes evidencias por la EORTC (European Organisation for Research and Treatment of Cancer -ensayo 22911) y el SWOG (Southwest Oncology Group- ensayo 8794), señalando que la radioterapia (RT) es un tratamiento eficaz tras la prostatectomía en pacientes con alto riesgo de fracaso bioquímico. Definir el momento óptimo para su administración e identificar factores de riesgo predictivos de recidiva, son objetivos transcendentes para guiar la práctica asistencial. Métodos: Desde 1993 hasta 2003, 597 pacientes fueron tratados con prostatectomía radical en el Hospital General Universitario Gregorio Marañón y áreas de referencia asistencial. 166 pacientes (28%) desarrollaron una recidiva bioquímica (definida como PSA ≥0,5 ng/ml e incluyendo aquellos casos con persistencia tumoral). Cuarenta y dos, recibieron tratamiento con RT (78% tras fallo bioquímico). La dosis media de RT fue de 66 Gy [60-74]. Resultados: Variables clínicas: Edad media: 68 años [49-80], media del PSA al diagnóstico: 29,8 ng/ml [2,6-475], Gleason prequirúrgico ≥7: 65%. Variables patológicas: Tras la prostatectomía, los pacientes tenían datos de mayor agresividad histológica que la definida previamente en las biopsias, apareciendo Gleason ≥7 en el 81% de los pacientes. El 83% a su vez tenían borde afecto y en el 90% de los casos el estadio era pT3-pT4. Variables evolutivas: El tiempo medio de aparición de la recidiva bioquímica fue de 22,2 meses, con un intervalo de 10,5 meses desde el diagnóstico hasta el inicio de la RT. La SG fue de 86±6 % a los 5 años y la Supervivencia Libre de Fracaso Bioquímico (SLFB) fue de 76±4% a los 5 años. Los factores predisponentes para la recidiva fueron: PSA >2 ng/ml al inicio de la RT (p=0,03), persistencia tumoral (p=0,05) y Gleason ≥7 tras la prostatectomía (p=0,01). No se observó un aumento de la toxicidad grado 3 y 4 en los pacientes tratados con RT. Conclusiones: La RT tras prostatectomía es un tratamiento eficaz de rescate tras recidiva bioquímica o persistencia cuando el PSA no supera los 2 ng/ml. En nuestra serie, el Gleason ≥7 es un factor adverso de respuesta a la RT de rescate. No existe un aumento de la toxicidad severa. La mejora de las técnicas de estadificación prequirúrgica, el papel de la hormonoterapia adyuvante y la selección de los pacientes para RT adyuvante centran los estudios actuales de los tratamientos tras prostatectomía (AU)

Objectives: Recently it has been reported in the EORTC (European Organisation for Research and Treatment of Cancer) trial 22911 and the SWOG (Southwest Oncology Group) 8794, the evidence that radiotherapy (RT) is an effective treatment after the prostatectomy in patients with high risk of biochemical failure. We analyze predictor factors of biochemical relapse and the potential benefits induced by rescue treatment are the main purposes of our study. Methods: From 1993 to 2003, 597 prostatectomy were followed at Hospital Universitario Gregorio Marañón de Madrid, identifying 166 patients (p) (28%) of biochemical failure (defined as PSA ≥0’5 ng/ml, including post-surgical persistent values). 42 p received RT (78% due to delayed PSA relapse). The median total dose was 66 Gy [60-74]. Results: Clinical variables: Median age: 68 years [49-80], median PSA at diagnosis: 29,8 ng/ml [2,6-475]; presurgical Gleason ≥7: 65%. Histological variables: Prostatectomy induces stage migration to superior T (pT3-T4: 95%) and Gleason categories (≥7: 81%). 83% of relapsed p had positive margins and 90% had pT3-pT4. Outcome variables: median time to biochemical recurrence was 22,2 months. Median time interval between biochemical failure and RT was 10,5 months. Overall survival (5 years) was 86±6%. Freedom-from-biochemical failure at 5 years was 76±4%. RT had poor survival in p with PSA >2 ng/ml pre-RT (p=0,03), post-prostatectomy persistant disease (p=0,05) and Gleason score ≥7 (p=0,01). No increased grade 3-4 uro-rectal toxicity was observed. Conclusions: RT after prostatectomy improves freedom-from-biochemical failure in p with PSA values below 2 ng/ml. In our experience, Gleason score ≥7 is a negative predictor of response. There is no severe toxicity in our series. Improvement of the staging presurgery, the role of the adjuvant androgen deprivation and selection of patients for adjuvant RT focus current studies on treatment after prostatectomy (AU)

Problemática asistencial del tratamiento combinado en los pacientes con tumores de cabeza y cuello localmente avanzados (contrarréplica) / Health-care issues of combination treatment in patients with locally advanced head and neck tumors (riposte)

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Retrasos e interrupciones: la dificultad para irradiar en el tiempo ideal / Delays and treatment interruptions: difficulties in administering radiotherapy in an ideal time-period

Administrar la dosis prescrita en el tiempo programado, sin retrasos en el inicio ni interrupciones en su ejecución, es un objetivo fundamental en los tratamientos con radioterapia (RT). En algunas localizaciones tumorales, se ha objetivado su influencia pronóstica en el control local y en la evolución de los pacientes. El presente estudio analiza las causas de los retrasos en el inicio de la RT así como, una vez iniciado el tratamiento, los principales motivos que prolongan la irradiación. En la revisión de la literatura realizada, los cánceres de cabeza y cuello, cérvix, mama y pulmón, parecen ser los más "perjudicados" por las interrupciones o demoras en la administración de la dosis total programada. En el caso del retraso en el inicio, se mencionan como las principales causas de demora: las listas de espera, la falta de recursos y la complejidad de los tratamientos actuales de RT. El inicio tan precoz como sea posible, en los tratamientos radicales y paliativos, y el intervalo de 6-8 semanas, en los tratamientos complementarios, son las recomendaciones recogidas en la mayoría de los estudios. Las interrupciones durante el tratamiento incluyen las paradas técnicas previstas para el mantenimiento programado de las unidades, que suponen el 60%, así como las producidas por toxicidad y averías. La influencia de las mismas, según el momento y la localización tumoral, así como los mecanismos para compensar la prolongación del tiempo total de tratamiento, completan la revisión bibliográfica llevada a cabo en este trabajo

Prescribed total radiation dose should be administered within in a specific time-frame and delays in commencing treatment and/or unplanned interruptions in radiation delivery are unacceptable because, in certain cancer sites, treatment-time prolongation can have a deleterious effect on local tumour control, and on patient outcomes. The present review evaluated the causes of initial treatment delays as well as interruptions in the scheduled radiotherapy. The literature search highlighted a significant concern in avoiding treatment-time prolongation in head and neck, cervix, breast and lung cancer. Among the causes involved in delay in radiotherapy commencement factors such as waiting lists, lack of material and human resources, and an increase complexity in planning, simulation and verification are highlighted. Most authors recommend radiotherapy commencement as soon as possible in radical (exclusive irradiation with active tumour present) and palliative situations with a maximum delay of no more than 6 to 8 weeks in the case of adjuvant radiotherapy (post-resection) programs. Interruptions during the course of treatment include: planned unit maintenance and servicing, acute patient toxicity or unexpected malfunction of linear accelerators; this last feature has the most deleterious effect on patients as well as radiotherapy practitioners. Interruptions that impact on the programmed time-course for radiotherapy needs to be compensated-for so as assure the biological equivalence in treatment efficacy with respect to cancer site and stage

Erythropoietin in cancer treatment: considerations about Henke's article

The concurrent use of erythropoietin beta (EPO) and radiotherapy in head and neck cancer patients has been reported by Henke et al (Lancet 2003; 362:1255-60) to correct anemia and impair cancer control. Due to the potential impact in daily clinical practice of this information a systematic critical review of the mentioned article was performed. Authors selected 10 arguments to question the contents regarding methodological and statistical aspects of the trial, and added 14 comments of controversy in more basic scientific concepts mentioned in the text as published. The panel including epidemiologist and radiation oncologists with expertise in clinical research concluded with 5 additional remarks recommending caution in interpretation of these results in terms of changes in daily practice of anemic patients support and advising not to use EPO at experimental doses or after reaching physiological concentrations of hemoglobin

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