Organ Preservation in Patients with Rectal Cancer Treated with Total Neoadjuvant Therapy.

Background Retrospective studies suggest that watch-and-wait is a safe alternative to total mesorectal excision in selected patients with a clinical complete response after chemoradiotherapy. Objective This study aimed to determine the proportion of patients with rectal cancer who may benefit from watch-and-wait. Design This study is a retrospective analysis of data from prospectively maintained databases. Setting This study was conducted at a comprehensive cancer center. Patients Consecutive patients with stage II or III rectal adenocarcinoma who were treated with total neoadjuvant therapy using induction chemotherapy between 2012 and 2019 under the care of the same surgeon were included. Intervention Induction-type total neoadjuvant therapy consisted of 8 cycles of leucovorin-fluorouracil-oxaliplatin or 5 cycles of capecitabine-oxaliplatin before chemoradiotherapy. Patients with a clinical complete response were offered watch-and-wait, and patients with residual tumor were offered total mesorectal excision. Main outcomes and measures Tumor response was assessed with a digital rectal examination, endoscopy, and MRI. Patient characteristics and recurrence-free survival were compared between the watch-and-wait group and the total mesorectal excision group. Results A total of 88 patients were included in the analysis. One (1%) died during neoadjuvant therapy. Fifty-five patients (62.5%) had an incomplete clinical response and underwent surgery, 10 (18%) of the 55 developed distant metastasis, and 3 (5%) developed local recurrence. The remaining 32 patients (36.3%) had a clinical complete response and underwent watch-and-wait. On average, patients in the watch-and-wait group were older and had smaller, more distal tumors compared with patients in the surgery group. The median radiation dose, number of chemotherapy cycles, rate of adverse events, and length of follow-up did not differ substantively between the total mesorectal excision group and the watch-and-wait group. In the watch-and-wait group, 2 (6%) patients developed tumor regrowth, and one of them had distant metastasis. Recurrence-free survival was significantly higher in the watch-and-wait group. Limitations Generalizability, sample size, and follow-up duration were limitations of this study. Conclusions Approximately one-third of patients with stage II or III rectal cancer can benefit from a watch-and-wait approach with the aim of preserving the rectum if treated with induction-type total neoadjuvant therapy and followed by an experienced multidisciplinary team. See Video Abstract at http://links.lww.com/DCR/B688. Conservacin de rganos en pacientes con cncer de recto tratados con terapia neoadyuvante total ANTECEDENTES:Estudios retrospectivos sugieren que observar y esperar es una alternativa segura a la escision mesorrectal total en pacientes seleccionados con una respuesta clinica completa despues de la quimiorradioterapia.OBJETIVO:Determinar la proporcion de pacientes con cancer de recto que pueden beneficiarse de observar y esperar.DISENO:Analisis retrospectivo de datos de bases de datos mantenidas de forma prospectiva.ESCENARIO:Centro Oncologico Integral.PACIENTES:Pacientes consecutivos con adenocarcinoma de recto en estadio II o III tratados con TNT utilizando quimioterapia de induccion entre 2012 y 2019 bajo el cuidado del mismo cirujano.INTERVENCION:La terapia neoadyuvante total de tipo induccion consistio en ocho ciclos de leucovorin-fluorouracilo-oxaliplatino o cinco ciclos de capecitabina-oxaliplatino antes de la quimiorradioterapia. A los pacientes con una respuesta clinica completa se les ofrecio observar y esperar, y a los pacientes con tumor residual se les ofrecio la escision mesorrectal total.PRINCIPALES RESULTADOS Y MEDIDAS:La respuesta del tumor se evaluo con un tacto rectal, endoscopia y resonancia magnetica. Se compararon las caracteristicas de los pacientes y la supervivencia libre de recurrencia entre el grupo de observacion y espera y el grupo de escision mesorrectal total.RESULTADOS:Se incluyo en el analisis a un total de 88 pacientes. Uno (1%) murio durante la terapia neoadyuvante. Cincuenta y cinco pacientes (62.5%) tuvieron una respuesta clinica incompleta y se sometieron a cirugia; 10 (18%) de los 55 desarrollaron metastasis a distancia y 3 (5%) desarrollaron recidiva local. Los 32 pacientes restantes (36.3%) tuvieron una cCR (respuesta clinica completa) y se sometieron a observar y esperar. En promedio, los pacientes del grupo de observacion y espera eran mayores y tenian tumores mas pequenos y distales en comparacion con el grupo de cirugia. La dosis mediana de radiacion, el numero de ciclos de quimioterapia, la tasa de eventos adversos y la duracion del seguimiento no difirieron sustancialmente entre el grupo de escision mesorrectal total y el grupo de observacion y espera. En el grupo de observacion y espera, 2 (6%) pacientes desarrollaron recrecimiento del tumor y uno de ellos tuvo metastasis a distancia. La supervivencia libre de recurrencia fue significativamente mayor en el grupo de observacion y espera.LIMITACIONES:Generalizabilidad, tamano de la muestra, duracion del seguimiento.CONCLUSIONES:Aproximadamente un tercio de los pacientes con cancer de recto en estadio II o III pueden beneficiarse de un abordaje de observacion y espera con el objetivo de preservar el recto si se tratan con terapia neoadyuvante total de tipo induccion y son seguidos por un equipo multidisciplinario experimentado. Consulte Video Resumen en http://links.lww.com/DCR/B688.