Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 9 de 9
Filter
1.
JAMA Netw Open ; 6(1): e2252140, 2023 01 03.
Article in English | MEDLINE | ID: mdl-36662520

ABSTRACT

Importance: Neoadjuvant chemoradiotherapy (CRT) is the standard of care for advanced rectal cancer. Yet, estimating response to CRT remains an unmet clinical challenge. Objective: To investigate and better understand the transcriptomic factors associated with response to neoadjuvant CRT and survival in patients with advanced rectal cancer. Design, Setting, and Participants: A single-center, retrospective, case series was conducted at a comprehensive cancer center. Pretreatment biopsies from 298 patients with rectal cancer who were later treated with neoadjuvant CRT between April 1, 2004, and September 30, 2020, were analyzed by RNA sequencing. Data analysis was performed from July 1, 2021, to May 31, 2022. Exposures: Chemoradiotherapy followed by total mesorectal excision or watch-and-wait management. Main Outcomes and Measures: Transcriptional subtyping was performed by consensus molecular subtype (CMS) classification. Immune cell infiltration was assessed using microenvironment cell populations-counter (MCP-counter) scores and single-sample gene set enrichment analysis (ssGSEA). Patients with surgical specimens of tumor regression grade 3 to 4 or whose care was managed by the watch-and-wait approach for more than 3 years were defined as good responders. Results: Of the 298 patients in the study, 205 patients (68.8%) were men, and the median age was 61 (IQR, 52-67) years. Patients classified as CMS1 (6.4%) had a significantly higher rate of good response, albeit survival was comparable among the 4 subtypes. Good responders exhibited an enrichment in various immune-related pathways, as determined by ssGSEA. Microenvironment cell populations-counter scores for cytotoxic lymphocytes were significantly higher for good responders than nonresponders (median, 0.76 [IQR, 0.53-1.01] vs 0.58 [IQR, 0.43-0.83]; P < .001). Cytotoxic lymphocyte MCP-counter score was independently associated with response to CRT, as determined in the multivariable analysis (odds ratio, 3.81; 95% CI, 1.82-7.97; P < .001). Multivariable Cox proportional hazards regression analysis, including postoperative pathologic factors, revealed the cytotoxic lymphocyte MCP-counter score to be independently associated with recurrence-free survival (hazard ratio [HR], 0.38; 95% CI, 0.16-0.92; P = .03) and overall survival (HR, 0.16; 95% CI, 0.03-0.83; P = .03). Conclusions and Relevance: In this case series of patients with rectal cancer treated with neoadjuvant CRT, the cytotoxic lymphocyte score in pretreatment biopsy samples, as computed by RNA sequencing, was associated with response to CRT and survival. This finding suggests that the cytotoxic lymphocyte score might serve as a biomarker in personalized multimodal rectal cancer treatment.


Subject(s)
Antineoplastic Agents , Rectal Neoplasms , Male , Humans , Middle Aged , Female , Neoadjuvant Therapy , Treatment Outcome , Retrospective Studies , Transcriptome , Rectal Neoplasms/genetics , Rectal Neoplasms/therapy , Rectal Neoplasms/pathology , Biopsy , Tumor Microenvironment/genetics
2.
BMJ Open ; 12(3): e055140, 2022 03 18.
Article in English | MEDLINE | ID: mdl-35304396

ABSTRACT

INTRODUCTION: Total mesorectal excision (TME) and postoperative adjuvant chemotherapy following neoadjuvant chemoradiotherapy (CRT) is the standard treatment for locally advanced rectal cancer (LARC). However, neoadjuvant CRT has no recognised impact on reducing distant recurrence, and patients suffer from a long-lasting impairment in quality of life (QOL) associated with TME. Total neoadjuvant therapy (TNT) is an alternative approach that could reduce distant metastases and increase the proportion of patients who could safely undergo non-operative management (NOM). This study is designed to compare two TNT regimens in the context of NOM for selecting a more optimal regimen for patients with LARC. METHODS AND ANALYSIS: NOMINATE trial is a prospective, multicentre, randomised phase II selection design study. Patients must have clinical stage II or III (T3-T4Nany) LARC with distal location (≤5 cm from the anal verge or for those who are candidates for abdominoperineal resection or intersphincteric resection). Patients will be randomised to either arm A consisting of CRT (50.4 Gy with capecitabine) followed by consolidation chemotherapy (six cycles of CapeOx), or arm B consisting of induction chemotherapy (three cycles of CapeOx plus bevacizumab) followed by CRT and consolidation chemotherapy (three cycles of CapeOx). In the case of clinical complete response (cCR) or near cCR, patients will progress to NOM. Response assessment involves a combination of digital rectal examination, endoscopy and MRI. The primary endpoint is the proportion of patients achieving pathological CR or cCR≥2 years, defined as the absence of local regrowth within 2 years after the start of NOM among eligible patients. Secondary endpoints include the cCR rate, near cCR rate, rate of NOM, overall survival, distant metastasis-free survival, locoregional failure-free survival, time to disease-related treatment failure, TME-free survival, permanent stoma-free survival, safety of the treatment, completion rate of the treatment and QOL. Allowing for a drop-out rate of 10%, 66 patients (33 per arm) from five institutions will be accrued. ETHICS AND DISSEMINATION: The study protocol was approved by Wakayama Medical University Certified Review Board in December 2020. Trial results will be published in peer-reviewed international journals and on the jRCT website. TRIAL REGISTRATION NUMBER: jRCTs051200121.


Subject(s)
Quality of Life , Rectal Neoplasms , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Bevacizumab/therapeutic use , Chemoradiotherapy/methods , Consolidation Chemotherapy/methods , Humans , Neoadjuvant Therapy/methods , Neoplasm Staging , Prospective Studies , Rectal Neoplasms/pathology , Rectal Neoplasms/therapy , Treatment Outcome
3.
Dis Colon Rectum ; 65(7): 894-900, 2022 07 01.
Article in English | MEDLINE | ID: mdl-34775412

ABSTRACT

BACKGROUND: Lavage cytology is a method to detect cancer cells released within the abdominal cavity. It has been widely utilized, in particular, for gastric cancer. However, its clinical significance has not yet been determined in colorectal cancer. OBJECTIVE: This study aimed to investigate the frequency of lavage cytology positivity and its influence on the prognosis of patients with colorectal cancer. DESIGN: This is a single-institution retrospective observational study. SETTING: This study was conducted at a comprehensive cancer center. PATIENTS: We retrospectively analyzed 3135 colorectal cancer cases from 2007 to 2013 at our institution. Intraoperative peritoneal washing cytology was performed just after the start of the operation. Fluids were centrifuged for 5 minutes at 2500 rotations per minute, cell pellets were smeared on microscope glass slides, and Papanicolaou staining was performed. MAIN OUTCOME MEASURES: The primary outcome was the 5-year overall survival rate. The secondary outcome was the 5-year recurrence rate. RESULTS: Lavage cytology positivity was detected in 19 (2.0%) and 86 (16.9%) cases of stage III and IV colorectal cancer; however, no positive cases were found in stage I and II colorectal cancer. Lavage cytology positivity was an independent prognostic factor in stage III and IV colorectal cancer in the multivariate analysis (5-year mortality HR 3.59 [1.69-7.64] in stage III, 2.23 [1.15-4.31] in stage IV). The prognosis of the 5-year survival rate was significantly worse in the lavage cytology-positive group in stages III and IV. In terms of recurrence, the results of the lavage cytology-positive group in stage III were similar to those of the lavage cytology-positive/negative group in stage IV (73.7%, 70.0%, and 75.0%). LIMITATIONS: This study was limited by its retrospective study design. CONCLUSIONS: Lavage cytology positivity is an independent prognostic and regulatory factor of stage IV colorectal cancer. See Video Abstract at http://links.lww.com/DCR/B770.INCIDENCIA Y VALOR PRONÓSTICO EN LA CITOLOGÍA DEL LAVADO PERITONEAL EN CÁNCER COLORECTALANTECEDENTES:La citología del lavado peritoneal es un método para detectar células cancerosas liberadas dentro de la cavidad abdominal. Se ha utilizado ampliamente, en particular para el cáncer gástrico. Sin embargo, aún no se ha determinado su importancia clínica en el cáncer colorrectal.OBJETIVO:Este estudio tuvo como objetivo investigar la frecuencia de positividad de la citología del lavado y su influencia en el pronóstico de los pacientes con cáncer colorrectal.DISEÑO:Este fue un estudio observacional retrospectivo de una sola institución.DISENTORNO CLÍNICO:El estudio se llevó a cabo en un centro oncológico integral.PACIENTES:Analizamos retrospectivamente 3.135 casos de cáncer colorrectal desde 2007 hasta 2013 en nuestra institución. La citología de lavado peritoneal intraoperatorio se realizó inmediatamente después del inicio de la operación. Los fluidos se centrifugaron durante 5 min a 2.500 rpm, los sedimentos celulares se extendieron sobre portaobjetos de vidrio de microscopio y se realizó la tinción con Papanicolaou.DISPRINCIPALES MEDIDAS DE VALORACIÓN:El primer resultado fueron las tasas de supervivencia general a 5 años. El segundo resultado las tasas de recurrencia a los 5 años.RESULTADOS:Se detectó positividad en la citología de lavado en 19 (2,0%) y 86 (16,9%) casos de cáncer colorrectal en estadio III y IV, respectivamente; sin embargo, no se encontraron casos positivos en el cáncer colorrectal en estadio I y II. La positividad de la citología de lavado fue un factor pronóstico independiente en el cáncer colorrectal en estadio III y IV en el análisis multivariado [cociente de riesgo de mortalidad a 5 años 3,59 (1,69-7,64), en estadio III, 2,23 (1,15-4,31), en estadio IV]. El pronóstico de la tasa de supervivencia a 5 años fue significativamente peor en el grupo con citología de lavado positiva en los estadios III y IV. En cuanto a la recurrencia, los resultados del grupo de lavado con citología positiva en el estadio III fueron similares a los del grupo de lavado con citología positiva / negativa en el estadio IV (73,7%, 70,0% y 75,0%).LIMITACIONES:Este estudio estuvo limitado por su diseño de estudio retrospectivo.CONCLUSIONES:La positividad de la citología de lavado es un factor pronóstico y regulador independiente del cáncer colorrectal en estadio IV. Consulte Video Resumen en http://links.lww.com/DCR/B770. (Traducción- Dr. Ingrid Melo).


Subject(s)
Colorectal Neoplasms , Peritoneal Neoplasms , Colorectal Neoplasms/pathology , Humans , Incidence , Neoplasm Staging , Prognosis , Retrospective Studies , Therapeutic Irrigation
4.
Dis Colon Rectum ; 64(8): 937-945, 2021 08 01.
Article in English | MEDLINE | ID: mdl-33951685

ABSTRACT

BACKGROUND: Although smaller circular staplers are easier to insert and less likely to involve the vagina and levator ani muscles when performing double stapling technique anastomosis, surgeons often consider that larger circular staplers would be safer in reducing the risk of postoperative anastomotic strictures. OBJECTIVE: This study aimed to investigate the safety of using 25-mm circular staplers compared with 28/29-mm staplers in the double stapling technique anastomosis regarding the development of anastomotic strictures and other complications. DESIGN: This is a retrospective observational study. SETTING: This study was conducted at a single comprehensive cancer center. PATIENTS: Consecutive patients undergoing curative colorectal resection with double stapling technique anastomosis for stage I to III sigmoid colon and rectal cancer between 2013 and 2016 were included. MAIN OUTCOME MEASURES: The incidence of anastomotic complications (strictures, leakage, and bleeding) was compared between the 25- and 28/29-mm circular staplers. Predictors for anastomotic strictures were investigated with multivariable logistic regression. RESULTS: Small (25-mm) staplers were used in 186 (22.8%) of 815 eligible patients. The 25-mm staplers were associated with use in female patients, splenic flexure take down, high tie of the inferior mesenteric artery, and low anastomosis. Overall anastomotic complications (11.8% vs 13.7%, p = 0.51), strictures (5.9% vs 3.3%, p = 0.11), leakage (2.7% vs 3.8%, p = 0.47), and bleeding (4.8% vs 7.6%, p = 0.19) were not different between the 25- and 28/29-mm staplers. From multivariable logistic regression, independent predictors of anastomotic strictures included diverting ostomy and anastomotic leakage, but not small circular stapler use. Most of the 32 anastomotic strictures were successfully treated without surgical intervention (finger dilation, n = 25; endoscopic intervention, n = 5). LIMITATIONS: This was a single-center retrospective study. CONCLUSIONS: Use of 25-mm circular staplers for double stapling technique anastomosis is safe and does not increase the risk of anastomotic strictures and other anastomotic complications in comparison with larger staplers. See Video Abstract at http://links.lww.com/DCR/B576. SEGURIDAD DE ENGRAPADORAS CIRCULARES PEQUEAS EN ANASTOMOSIS, CON TCNICA DE DOBLE ENGRAPADO PARA CNCER DE RECTO Y COLON SIGMOIDE: ANTECEDENTES:Aunque las engrapadoras circulares más pequeñas son más fáciles de insertar y menos probable que involucren a la vagina y los músculos elevadores del ano, cuando se realiza una anastomosis con técnica de doble engrapado, frecuentemente los cirujanos consideran que las engrapadoras circulares más grandes, serían más seguras para disminuir los riesgos de estenosis anastomóticas postoperatorias.OBJETIVO:El estudio se dirigió para investigar la seguridad en el uso de engrapadoras circulares de 25 mm, en comparación con engrapadoras de 28/29 mm, en anastomosis con técnica de doble engrapado, en relación al desarrollo de estenosis anastomóticas y otras complicaciones.DISEÑO:Estudio observacional retrospectivo.AJUSTE:Centro oncológico integral único.PACIENTES:Se incluyeron pacientes consecutivos sometidos a resección colorrectal curativa, con anastomosis y técnica de doble engrapado, para cáncer de recto y colon sigmoide en estadios I-III entre 2013 y 2016.PRINCIPALES MEDIDAS DE RESULTADO:Se compararon las incidencias de complicaciones anastomóticas (estenosis, fugas y sangrados) entre las engrapadoras circulares de 25 y 28/29 mm. Los predictores para estenosis anastomóticas se investigaron con regresión logística multivariable.RESULTADOS:Entre un total de 815 pacientes elegibles, se utilizaron engrapadoras de 25 mm en 186 (22,8%). Las engrapadoras de 25 mm se asociaron con el uso en pacientes femeninas, descenso del ángulo esplénico, ligadura alta de arteria mesentérica inferior y anastomosis baja. Complicaciones anastomóticas generales (11,8% vs. 13,7%, p = 0,51), estenosis (5,9% vs. 3,3%, p = 0,11), fugas (2,7% vs. 3,8%, p = 0,47) y sangrado (4,8% vs. 7,6%, p = 0,19). No hubo diferencia entre las engrapadoras de 25 y 28/29 mm. En la regresión logística multivariable, predictores independientes de estenosis anastomóticas incluyeron ostomía derivativa y fuga anastomótica, pero no incluyeron el uso de engrapadoras circulares pequeñas. La mayoría de las 32 estenosis anastomóticas se trataron con éxito sin intervención quirúrgica (dilatación del dedo, n = 25; intervención endoscópica, n = 5).LIMITACIONES:Fue un estudio retrospectivo de un solo centro.CONCLUSIONES:El uso de engrapadoras circulares de 25 mm para la anastomosis con técnica de doble engrapado, es seguro y no aumenta el riesgo de estenosis anastomóticas y de otras complicaciones anastomóticas, cuando son comparadas con engrapadoras más grandes. Consulte Video Resumen en http://links.lww.com/DCR/B576. (Traducción-Dr. Fidel Ruiz-Healy).


Subject(s)
Anastomosis, Surgical/methods , Colon, Sigmoid/surgery , Colonic Neoplasms/surgery , Rectal Neoplasms/surgery , Surgical Stapling/methods , Sutures , Adult , Aged , Aged, 80 and over , Anastomosis, Surgical/adverse effects , Anastomotic Leak/etiology , Constriction, Pathologic/etiology , Female , Humans , Male , Middle Aged , Retrospective Studies , Surgical Stapling/adverse effects
5.
Discov Oncol ; 12(1): 2, 2021.
Article in English | MEDLINE | ID: mdl-33844707

ABSTRACT

OBJECTIVES: This prospective observational study aimed to clarify the incidence and independent risk factors of wound infection after laparoscopic surgery for primary colonic and rectal cancer. METHODS: A prospective surveillance of surgical site infection (SSI) was conducted in consecutive patients with primary colorectal cancer, who underwent elective laparoscopic surgery in a single comprehensive cancer center between 2005 and 2014. The outcomes of interest were the incidence and risk factors of wound infection. RESULTS: In total, 3170 patients were enrolled in the study. The overall incidence of wound infection was 3.0%. The incidence of wound infection was significantly higher in rectal surgery than in colonic surgery (4.7 vs. 2.1%, p < 0.001). In rectal surgery, independent risk factors for developing wound infection included abdominoperineal resection (p < 0.001, odds ratio [OR] = 11.4, 95% confidence interval [CI]: 5.04-24.8), body mass index (BMI) ≥ 25 kg/m2 (p = 0.041, OR = 1.97, 95% CI, 1.03-3.76), and chemoradiotherapy (p = 0.032, OR = 2.18, 95% CI, 1.07-4.45). In laparoscopic colonic surgery, no significant risk factors were identified. CONCLUSIONS: Laparoscopic rectal surgery has a higher risk of wound infection than colonic surgery. Laparoscopic rectal surgery involving abdominoperineal resection, patients with higher BMI, and chemoradiotherapy requires careful observation in wound care and countermeasures against wound infection.

6.
Int J Clin Oncol ; 26(5): 893-902, 2021 May.
Article in English | MEDLINE | ID: mdl-33481157

ABSTRACT

BACKGROUND: Laparoscopic modified complete mesocolic excision (mCME) with D3 lymph node dissection has been performed with increasing frequency, but the oncological safety remains unclear. This study investigated the oncological safety of laparoscopic modified CME with D3 dissection for pT3/4a M0 colon cancer. PATIENTS: Consecutive patients with pT3/4a M0 colon cancer undergoing curative colectomy at a comprehensive cancer center between 2004 and 2013 were included. Outcomes were compared between early (2004-2008, n = 450) and late (2009-2014, n = 741) periods. Prognostic factors were investigated by multivariate analysis. RESULTS: A total of 1191 patients were eligible. Median follow-up was 57 months. Laparoscopic surgeries were more common in the late period (early vs late: 53.6% vs. 91.8%, p < 0.01). Patients in the late period showed lower blood loss (20 mL vs. 10 mL, p < 0.01), higher number of harvested lymph nodes (18.1 vs. 21.6, p < 0.01) and fewer patients with < 12 harvested nodes (13.6% vs. 5.8%, p < 0.01). Postoperative complication rates were similar between periods (2.7% vs. 2.7%, p = 0.97). Five-year relapse-free survival rate (RFS) (75.3% vs. 82.7%, p < 0.01) and overall survival rate (OS) (86.9% vs. 91.7%, p = 0.01) were higher in the late period. Multivariate analysis revealed laparoscopic surgery as an independent favorable prognostic factor for both RFS (hazard ratio (HR) = 0.73, 95% confidence interval (CI) 0.54-0.99, p = 0.03) and OS (HR = 0.56, 95% CI 0.37-0.83, p < 0.01). CONCLUSION: Improved oncologic outcomes and more frequent laparoscopic surgery during the 10-year period of the study were demonstrated for modified CME with D3 dissection, suggesting the safety of this procedure performed by experienced surgeons for pT3/4a M0 colon cancer.

7.
Dis Colon Rectum ; 64(1): 53-59, 2021 01.
Article in English | MEDLINE | ID: mdl-32639283

ABSTRACT

BACKGROUND: Endoscopic assessment is crucial in diagnosing clinical complete response after neoadjuvant therapy in rectal cancer. OBJECTIVE: The purpose of this research was to evaluate the benefits of adding narrow-band imaging endoscopy to conventional chromoendoscopy in predicting pathologic complete response in the surgical specimen. DESIGN: This was a prospective nonrandomized study. SETTINGS: This was an ad hoc study of a prospective phase II trial at a single comprehensive cancer center that evaluated oncologic outcomes of a neoadjuvant therapy for rectal cancer. PATIENTS: Patients with high-risk stage II to III low rectal cancer who received neoadjuvant modified folinic acid, fluorouracil, and oxaliplatin plus bevacizumab followed by chemoradiotherapy and surgery were included. INTERVENTION: Tumor response after neoadjuvant therapy was evaluated using conventional white light endoscopy plus chromoendoscopy then followed by using narrow-band imaging based on a predefined diagnostic protocol. MAIN OUTCOME MEASURES: Diagnostic accuracy for predicting pathologic complete response and inter-rater agreement between an expert and trainee endoscopists were compared between the assessments using conventional white light endoscopy plus chromoendoscopy and the assessment adding narrow-band imaging. RESULTS: In total, 61 patients were eligible for the study, and 19 had pathologic complete response (31.1%). Although the addition of narrow-band imaging correctly converted the diagnosis in 3 patients, overall diagnostic improvement in predicting pathologic complete response was limited (conventional chromoendoscopy vs adding narrow-band imaging: accuracy, 70.5% vs 75.4%; sensitivity, 63.2% vs 73.7%; specificity, 73.8% vs 76.2%; positive predictive value, 52.2% vs 58.3%; and negative predictive value, 81.6% vs 86.5%). A κ value for the inter-rater agreement improved from 0.599 to 0.756 by adding narrow-band imaging. LIMITATIONS: This was a single-center study with a relatively small sample size. CONCLUSIONS: Despite the limited improvement in diagnostic accuracy, adding narrow-band imaging to chromoendoscopy improved inter-rater agreement between the expert and nonexpert endoscopists. Narrow-band imaging is a reliable and promising modality for universal standardization of the diagnosis of clinical complete response. See Video Abstract at http://links.lww.com/DCR/B275. ADICIÓN DE IMÁGENES DE BANDA ESTRECHA A LA CROMOENDOSCOPÍA PARA LA EVALUACIÓN DE LA RESPUESTA TUMORAL A LA TERAPIA NEOADYUVANTE EN EL CÁNCER DE RECTO: La evaluación endoscópica es fundamental para valorar la respuesta clínica completa después de la terapia neoadyuvante en el cáncer de recto.Evaluar los beneficios de agregar endoscopia de imagen de banda estrecha a la cromoendoscopía convencional para predecir la respuesta patológica completa en la muestra quirúrgica.Estudio prospectivo no aleatorizado.Un estudio ad hoc de un ensayo prospectivo de fase II en un solo centro integral de cáncer que evaluó los resultados oncológicos de una terapia neoadyuvante para el cáncer rectal.Pacientes con cáncer rectal bajo de alto riesgo en estadio II-III que recibieron ácido folínico neoadyuvante modificado, fluorouracilo y oxaliplatino más bevacizumab seguido de quimiorradioterapia y cirugía.La respuesta tumoral después de la terapia neoadyuvante se evaluó mediante endoscopia de luz blanca convencional más cromoendoscopía, seguido de imágenes de banda estrecha basadas en un protocolo de diagnóstico predefinido.La precisión diagnóstica para predecir la respuesta patológica completa y el acuerdo entre evaluadores entre un experto y un endoscopista en entrenamiento se compararon entre las evaluaciones utilizando endoscopia de luz blanca convencional más cromoendoscopía y la evaluación agregando imágenes de banda estrecha.En total, 61 pacientes fueron elegibles para el estudio, y 19 tuvieron una respuesta patológica completa (31.1%). Aunque la adición de imágenes de banda estrecha convirtió correctamente el diagnóstico en 3 pacientes, la mejora diagnóstica general en la predicción de la respuesta patológica completa fue limitada (cromoendoscopía convencional versus adición de imágenes de banda estrecha: precisión, 70.5% versus 75.4%; sensibilidad, 63.2% versus 73.7%; especificidad, 73.8% versus 76.2%; valor predictivo positivo, 52.2% versus 58.3%; y valor predictivo negativo, 81.6% versus 86.5%). Un valor de kappa para el acuerdo entre evaluadores mejoró de 0.599 a 0.756 al agregar imágenes de banda estrecha.Un estudio de centro único con un tamaño de muestra relativamente pequeño.A pesar de la mejora limitada en la precisión diagnóstica, agregar imágenes de banda estrecha a la cromoendoscopía mejoró el acuerdo entre evaluadores entre los endoscopistas expertos y no expertos. La imagenología de banda estrecha es una modalidad confiable y prometedora para la estandarización universal del diagnóstico de respuesta clínica completa. Consulte Video Resumen en http://links.lww.com/DCR/B275.


Subject(s)
Adenocarcinoma/diagnostic imaging , Chemoradiotherapy, Adjuvant , Narrow Band Imaging , Neoadjuvant Therapy , Proctoscopy/methods , Rectal Neoplasms/diagnostic imaging , Adenocarcinoma/pathology , Adenocarcinoma/therapy , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Female , Humans , Male , Middle Aged , Neoplasm Staging , Proctectomy , Prospective Studies , Rectal Neoplasms/pathology , Rectal Neoplasms/therapy , Sensitivity and Specificity , Treatment Outcome
8.
Ann Surg Oncol ; 26(8): 2507-2513, 2019 Aug.
Article in English | MEDLINE | ID: mdl-30963400

ABSTRACT

PURPOSE: The aim of this study is to evaluate the safety and efficacy of induction modified 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus bevacizumab followed by S- 1-based chemoradiotherapy in magnetic resonance imaging (MRI)-defined poor-risk locally advanced low rectal cancer. PATIENTS AND METHODS: This was a prospective phase II trial at a single comprehensive cancer center. The primary endpoint was the pathological complete response (pCR) rate. Eligible patients had clinical stage II-III low rectal adenocarcinoma with any of the following MRI-defined poor-risk features: circumferential resection margin (CRM) ≤ 1 mm, cT4, positive lateral nodes, mesorectal N2 disease, and/or requiring abdominoperineal resection. Patients received six cycles of mFOLFOX6 with 5 mg/kg bevacizumab followed by oral S-1 (80 mg/m2/day on days 1-14 and 22-35) plus radiotherapy (50.4 Gy). Surgery was conducted through a laparoscopic approach. Lateral node dissection was selectively added when the patient had enlarged lateral nodes. RESULTS: A total of 43 patients were enrolled. Grade 3-4 adverse events occurred in nine patients during induction chemotherapy and in five patients during chemoradiotherapy. One patient declined surgery with a clinical complete response. Forty-two patients underwent surgery, and 16 had pCR [37.2%, 95% confidence interval (CI) 24.4-52.1%]. All underwent R0 resection without conversion, including combined resection of adjacent structures (n = 14) and lateral node dissection (n = 30). Clavien-Dindo grade 3-4 complications occurred in six patients (14.3%). With median follow-up of 52 months, six developed recurrences (lung n = 5, local n = 1; 3-year relapse-free survival 86.0%). CONCLUSIONS: This study achieved a high pCR rate with favorable toxicity and postoperative complications in poor-risk locally advanced low rectal cancer. Multicenter study is warranted to evaluate this regimen.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Chemoradiotherapy, Adjuvant/mortality , Laparoscopy/mortality , Lymph Node Excision/mortality , Neoadjuvant Therapy/mortality , Neoplasm Recurrence, Local/therapy , Rectal Neoplasms/therapy , Adult , Aged , Bevacizumab/administration & dosage , Capecitabine/administration & dosage , Combined Modality Therapy , Female , Fluorouracil/administration & dosage , Follow-Up Studies , Humans , Leucovorin/administration & dosage , Male , Middle Aged , Neoplasm Recurrence, Local/pathology , Oxaliplatin/administration & dosage , Prognosis , Prospective Studies , Rectal Neoplasms/pathology , Survival Rate
9.
Asian J Endosc Surg ; 7(1): 52-5, 2014 Jan.
Article in English | MEDLINE | ID: mdl-24450344

ABSTRACT

Abdominosacral resection may be the only curative procedure for locally advanced rectal cancer involving the presacral fascia or sacrum. Multimodal therapy might be necessary to prevent local and distant recurrence for such tumors. A 67-year-old man was diagnosed with locally advanced rectal cancer widely involving the right pelvic sidewall and presacral fascia near the S4/5 junction on the right posterolateral side. We performed laparoscopic abdominosacral resection (S4/5) with en bloc right lateral lymph node dissection and seminal vesicle resection to obtain a clear resection margin after systemic chemotherapy with mFOLFOX6 (oxaliplatin, leucovorin, and 5-fluorouracil) plus bevacizumab, followed by preoperative chemoradiotherapy. The total operative time was 660 min, and the estimated blood loss was 550 mL. The final pathological findings revealed no residual cancer cells (pathological complete response). Laparoscopic abdominosacral resection appears to be safe and feasible in selected patients.


Subject(s)
Abdomen/surgery , Adenocarcinoma/surgery , Laparoscopy/methods , Rectal Neoplasms/surgery , Rectum/surgery , Sacrum/surgery , Adenocarcinoma/therapy , Aged , Antibodies, Monoclonal, Humanized/administration & dosage , Antineoplastic Agents/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Bevacizumab , Chemoradiotherapy, Adjuvant , Chemotherapy, Adjuvant , Fluorouracil/therapeutic use , Humans , Leucovorin/therapeutic use , Male , Neoadjuvant Therapy , Organoplatinum Compounds/therapeutic use , Rectal Neoplasms/therapy
SELECTION OF CITATIONS
SEARCH DETAIL