Definitive Chemoradiation for Rectal Cancer: Is There a Role for Dose Escalation? A National Cancer Database Study.

Background Surgery remains the standard of care in rectal cancer. Select patients will not undergo surgery for reasons such as medical inoperability or a watch-and-wait approach and instead are managed with definitive chemoradiation. Objective We used the National Cancer Database to identify overall survival and predictors thereof in the nonoperative management of patients with rectal cancer. Design This was a retrospective review. Settings This study used deidentified data from the National Cancer Database. Patients We queried the national cancer database from 2004 to 2014 for stage 1 to 3 rectal adenocarcinoma treated with only chemotherapy and radiation to definitive doses. Dose escalated therapy was defined as >54 Gy. Main outcome measures Univariable and multivariable analyses were performed to identify sociodemographic, treatment, and tumor characteristics predictive of dose escalation and overall survival. Propensity-adjusted Cox proportional hazard ratios for survival were used to account for indication bias. Results Among the 6311 patients eligible for the study, 11% were treated with doses >54 Gy. Earlier stage and increased age/comorbidity patients were more likely to receive dose escalation, and patients with more recent treatment and treatment at an academic facility were less likely. The median follow-up time was 31 months (range, 2-154 mo). Three- and 5-year overall survival rates for all patients were 60% and 46%. Patients treated with dose escalation had a median survival of 33 months compared with 56 months for those treated with ≤54 Gy (p Limitations The main limitation is the inherent selection bias present in National Cancer Database studies. Important treatment details and outcomes as they relate to a definitive chemoradiation approach in rectal cancer are lacking. Salvage therapy was also not recorded, which in this population could be surgery. Conclusions In this analysis, dose escalation in the nonoperative management of rectal cancer was associated with a lower overall survival compared with more conventional doses. Careful patient selection and enrollment on appropriate clinical trials may be warranted in the nonoperative setting. See Video Abstract at http://links.lww.com/DCR/B15. LA QUIMIORRADIACION DEFINITIVA PARA EL CANCER RECTAL: ?HAY LUGAR PARA EL AUMENTO DE LA DOSIS? UN ESTUDIO DE BASE DE DATOS NACIONAL DEL CANCER:: La cirugia sigue siendo el estandar en el tratamiento del cancer rectal. Algunos pacientes no son quirurgicos por razones como, no ser operables o con el enfoque de ver y esperar, y en su lugar son tratados con la quimiorradiacion definitiva.Utilizamos la base de datos nacional del cancer para identificar la supervivencia general y los factores predictivos de la misma, en el tratamiento no quirurgico de pacientes con cancer rectal.Esta fue una revision retrospectiva.Utilizamos los datos identificados en la base de datos nacional del cancer.Se consulto la base de datos nacional del cancer del 2004-2014, para adenocarcinoma rectal en estadio 1-3, tratada unicamente con quimioterapia y radiacion hasta la dosis definitiva. La terapia de aumento de la dosis se definio como >54 Gy.Se realizaron analisis univariables y multivariables para identificar caracteristicas sociodemograficas, de tratamiento y predictivas del aumento de la dosis y supervivencia en general. Los indices de riesgo proporcionales de Cox ajustados a la propension para la supervivencia, se utilizaron para tener en cuenta el sesgo de indicacion.Entre los 6311 pacientes elegibles para el estudio, el 11% fue tratado con dosis >54 Gy. Los pacientes en estadios tempranos y con mayor edad/comorbilidad, tenian mas probabilidades de recibir aumento de la dosis, y menos propensos los pacientes con tratamientos recientes y de centros academicos. El tiempo medio de seguimiento fue de 31 meses (2-154 meses). Las tasas de supervivencia global de tres y cinco anos para todos los pacientes, fueron respectivamente del 60% y 46%. Los pacientes tratados con aumento de la dosis, tuvieron una supervivencia media de 33 meses, en comparacion con los 56 meses para los pacientes tratados con ≤54 Gy (p