Incidencia y factores pronósticos de recidiva bioquímica después de radioterapia radical. Experiencia del Gregorio Marañón / Incidence and prognostic factors for biochemical recurrence after radical radiotherapy

OBJETIVO: El objetivo del estudio es analizar los resultados obtenidos por la radioterapia externa conformada tridimensionalmente (RTE3D), en pacientes diagnosticados de cáncer de próstata, estudiando los factores predictivos de recidiva bioquímica (RB). MÉTODOS: El estudio incluye 503 pacientes (p), diagnosticados en el Hospital General Universitario Gregorio Marañón de Madrid entre 2000-2007, con cáncer de próstata de riesgos bajo, intermedio y alto (grupos de riesgo de D’Amico), tratados con RTE3D. El fracaso bioquímico se definió como nadir+2 siguiendo el criterio de Phoenix. La mediana de seguimiento fue de 59 meses (rango 3.4-104.2). RESULTADOS: A los 5 y 8 años, la supervivencia libre de recidiva bioquímica (SLRB) fue del 88±2% y 76±3%, respectivamente. En el análisis multivariante, el PSA inicial (p<0.02), la invasión perineural en la biopsia (p<0.00), la dosis de RTE (p=0.01) y la asociación de hormonoterapia (p=0.00) fueron factores independientes de fracaso bioquímico. Un nadir de PSA<0.3 ng/ml se asoció con las mejores cifras de SLRB (96.6% versus 56.5% si el nadir de PSA tras RTE3D fue >1.3 ng/ml).La toxicidad tardía ≥3, rectal y urinaria, fue menor del 5%. En 52 pacientes (75%) se indicó tratamiento de rescate tras el fracaso bioquímico. Sólo 10 pacientes fallecieron de cáncer de próstata. CONCLUSIÓN: El riesgo de fracaso bioquímico depende de las variables clásicas pretratamiento (nivel de PSA inicial, grupo de riesgo e invasión perineural) y, en los pacientes tratados con RTE3D, de la dosis (≤72 Gy), del valor del nadir de PSA y de la adición de HT en los grupos de riesgo intermedio y alto(AU)

OBJECTIVES: The aim of this study is to analyze the outcomes obtained after External-Beam Radiotherapy (3D EBRT) in patients with prostate cancer. METHODS: The study includes 503 patients (p) treated at the Hospital General Universitario Gregorio Marañón in Madrid, diagnosed between 2000-2007, with low, intermediate or high risk prostate cancer (D’Amico risk groups), treated with 3D EBRT. Biochemical recurrence (BR) was defined as nadir +2 following Phoenix’s criterion. The median follow-up was 59 months (range 3.4-104.2). RESULTS: Biochemical relapse-free survival (bRFS) rates at 5 and 8 years were 88±2% and 76±3%, respectively. Multivariate analysis indicated initial PSA (p <0.02), perineural invasion in biopsy specimen (p <0.00), EBRT dose (p = 0.01) and the use of androgen deprivation therapy (ADT) (p = 0.00) to be independent predictors of relapse. Nadir PSA value <0.3 ng/ml was associated with the best 5-year bRFS (96.6% versus 56.5% if nadir PSA > 1.3 ng/ml).Late urinary and rectal toxicity ≥ 3 was lower than 5%. Active rescue treatment was indicated in 85% of patients. Only 10 patients died of prostate cancer. CONCLUSION: The biochemical failure rate is determined by classical pre-treatment features (initial PSA level, risk group, perineural invasion) and low- dose EBRT (≤ 72 Gy), nadir PSA value and the use of ADT in intermediate and high risk groups(AU)

Radical prostatectomy versus external-beam radiotherapy for localized prostate cancer: long-term effect on biochemical control-in search of the optimal treatment.

BACKGROUND: The optimal management of patients with clinically localized prostate carcinoma remains undefined due in part to the absence of well-designed, randomized trials. METHODS: This retrospective study comprised 505 patients diagnosed with low- or intermediate- risk prostate cancer in 1998-2005 and treated at Hospital Gregorio Marañón (Spain) with radical prostatectomy (RP) or external-beam radiotherapy (EBRT). No adjuvant therapy was administered. Biochemical relapse was defined as a prostate-specific antigen (PSA) level ≥0.4 ng/ml for RP cases and nadir + 2 for EBRT cases. RP was performed in 271 patients (53.6%) and EBRT in 234 patients (46.4%). The median follow-up was 60 months. The analysis end point was to compare the biochemical recurrence-free survival (bRFS) between the two groups. RESULTS: The 5-year bRFS rates for RP and EBRT were 79 ± 2% and 86 ± 2%, respectively (P = 0.48). Multivariate analysis indicated that initial PSA (P = 0.00), perineural invasion in the biopsy specimen (P = 0.00), Gleason score (P = 0.04), EBRT dose (P = 0.02), and positive margins (P = 0.00) were independent predictors of relapse. A decision tree model was constructed with these variables. In the EBRT cohort, a nadir PSA of <0.3 ng/ml was associated with the best 5-year bRFS (96.6 vs. 56.5% if nadir PSA > 1.3 ng/ml). Late biochemical failure (>5 years) was more frequent in the RT group and with low-dose EBRT (≤72 Gy). CONCLUSIONS: The biochemical failure rates were similar between PR and EBRT in low- and intermediate-risk subgroups. Outcome was determined by classic pre-treatment features, perineural invasion, low-dose EBRT (≤72 Gy), and nadir PSA value in the RT cohort.

[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)

Informed consent in radiation oncology: is consenting easier than informing?

The patient's right to be informed has been universally recognized and reflected in the legal system of many countries. This right to correct and complete information on behalf of the patient and his admission to proceed with the recommended diagnostic or therapeutic procedure is formalized in the document commonly known as informed consent. Although the legal and bioethical considerations regarding this document have been exhaustively discussed and consensuated, its content continues to create certain doubts and uncertainties. The formal content and the manner in which the consent is obtained are the most difficult aspects. In this article, we analyze what should be included in the written informed consent, with regard to the totality of the information which the patient receives, who should inform, and how the consent should be obtained, as well as how to reflect the different aspects of the variety of radiotherapeutic procedures in the informed consent.

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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