Long-Term Results of Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy: The Randomized Phase II OPRA Trial.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.To assess long-term risk of local tumor regrowth, we report updated organ preservation rate and oncologic outcomes of the OPRA trial (ClinicalTrials.gov identifier: NCT02008656). Patients with stage II/III rectal cancer were randomly assigned to receive induction chemotherapy followed by chemoradiation (INCT-CRT) or chemoradiation followed by consolidation chemotherapy (CRT-CNCT). Patients who achieved a complete or near-complete response after finishing treatment were offered watch-and-wait (WW). Total mesorectal excision (TME) was recommended for those who achieved an incomplete response. The primary end point was disease-free survival (DFS). The secondary end point was TME-free survival. In total, 324 patients were randomly assigned (INCT-CRT, n = 158; CRT-CNCT, n = 166). Median follow-up was 5.1 years. The 5-year DFS rates were 71% (95% CI, 64 to 79) and 69% (95% CI, 62 to 77) for INCT-CRT and CRT-CNCT, respectively (P = .68). TME-free survival was 39% (95% CI, 32 to 48) in the INCT-CRT group and 54% (95% CI, 46 to 62) in the CRT-CNCT group (P = .012). Of 81 patients with regrowth, 94% occurred within 2 years and 99% occurred within 3 years. DFS was similar for patients who underwent TME after restaging (64% [95% CI, 53 to 78]) and patients in WW who underwent TME after regrowth (64% [95% CI, 53 to 78]; P = .94). Updated analysis continues to show long-term organ preservation in half of the patients with rectal cancer treated with total neoadjuvant therapy. In patients who enter WW, most cases of tumor regrowth occur in the first 2 years.

Persistent Disparities in Access to Elective Colorectal Cancer Surgery After Medicaid Expansion Under the Affordable Care Act: A Multistate Evaluation.

BACKGROUND: Despite their higher incidence of colorectal cancer, ethnoracial minority and low-income patients have reduced access to elective colorectal cancer surgery. Although the Affordable Care Act's Medicaid expansion increased screening of colonoscopies, its effect on disparities in elective colorectal cancer surgery remains unknown. OBJECTIVE: This study assessed the effects of Medicaid expansion on elective colorectal cancer surgery rates overall and by race-ethnicity and income. DESIGN: Using the 2012 to 2015 State Inpatient Databases, a retrospective cohort study was conducted. SETTINGS: State Inpatient Databases from 3 expansion states (Maryland, New Jersey, and Kentucky) and 2 nonexpansion states (Florida and North Carolina) were used. PATIENTS: This study examined 22,304 adult patients aged 18 to 64 years who underwent colorectal cancer surgery. MAIN OUTCOME MEASURES: Using interrupted time series analysis, the effect of Medicaid expansion on the odds of elective colorectal cancer surgery was assessed. RESULTS: Elective vs nonelective surgery rates remained unchanged overall (70.2% vs 70.7%, p = 0.63) and in ethnoracial minorities in expansion states (whites from 72.8% to 73.8% pre to post, p = 0.40 and non-white from 64.0% to 63.1% pre to post, p = 0.67). There was an instantaneous increase in odds of elective surgery in expansion vs nonexpansion states at policy implementation (adjusted OR 1.37; 95% CI, 1.05-1.79; p = 0.02), but it subsequently decreased (combined adjusted OR 0.95; 95% CI, 0.92-0.99; p = 0.03). Elective surgery rates were also unchanged among ethnoracial minorities (instantaneous changes in expansion states, combined effect 1.06; pre-trend 1.01 vs post-trend 0.98) and low-income persons in expansion states (pre-trend 1.03 vs post-trend 0.97) (for all, p > 0.1). LIMITATIONS: The study was limited to 5 states. Although patients may have increased access to cancer screening services and surgery after expansion, the State Inpatient Databases only provide information on patients who underwent surgery. CONCLUSIONS: Despite gains in screening, Medicaid expansion was not associated with reductions in known ethnoracial or income-based disparities in elective colorectal cancer surgery rates. Expanding access to colorectal cancer surgery for underserved populations likely requires attention to provider and health system factors contributing to persistent disparities. See Video Abstract at http://links.lww.com/DCR/C217 . DISPARIDADES PERSISTENTES EN EL ACCESO A LA CIRUGA ELECTIVA DEL CNCER COLORRECTAL DESPUS DE LA EXPANSIN DE MEDICAID EN VIRTUD DE LA LEY DEL CUIDADO DE SALUD A BAJO PRECIO UNA EVALUACIN MULTIESTATAL: ANTECEDENTES: A pesar de su mayor incidencia de cáncer colorrectal, los pacientes de minorías etnoraciales y de bajos ingresos tienen un acceso reducido a la cirugía electiva de cáncer colorrectal. Aunque la expansión de Medicaid de la Ley del Cuidado de Salud a Bajo Precio aumentó las colonoscopias de detección, aún se desconoce su efecto sobre las disparidades en la cirugía electiva de cáncer colorrectal.OBJETIVO: Este estudio evaluó los efectos de la expansión de Medicaid en las tasas de cirugía electiva de cáncer colorrectal en general y por raza, etnia e ingresos.DISEÑO: Utilizando las bases de datos estatales de pacientes hospitalizados de 2012-2015, se realizó un estudio de cohorte retrospectivo.CONFIGURACIÓN: Se utilizaron bases de datos estatales de pacientes hospitalizados de tres estados en expansión (Maryland, Nueva Jersey, Kentucky) y dos estados sin expansión (Florida, Carolina del Norte).PACIENTES: Este estudio examinó a 22,304 pacientes adultos de 18 a 64 años que se sometieron a cirugía de cáncer colorrectal.RESULTADO PRINCIPAL: Mediante el análisis de series de tiempo interrumpido, se evaluó el efecto de la expansión de Medicaid en las probabilidades de cirugía electiva de cáncer colorrectal.RESULTADOS: Las tasas de cirugía electiva frente a no electiva permanecieron sin cambios en general (70,2% frente a 70,7%, p = 0,63) y en las minorías etnoraciales en los estados de expansión (blancos del 72,8% al 73,8 % antes y después, p = 0,40 y no blancos del 64,0% al 63,1% pre a post, p = 0,67). Hubo un aumento instantáneo en las probabilidades de cirugía electiva en los estados de expansión frente a los de no expansión en la implementación de la política (OR ajustado 1,37, IC del 95%, 1,05-1,79, p = 0,02), pero disminuyó posteriormente (OR ajustado combinado 0,95, 95% IC, 0,92-0,99, p = 0,03). Las tasas de cirugía electiva también se mantuvieron sin cambios entre las minorías etnoraciales (cambios instantáneos en los estados de expansión, efecto combinado 1,06; antes de la tendencia 1,01 frente a la postendencia 0,98) y las personas de bajos ingresos en los estados de expansión (antes de la tendencia 1,03 frente a la postendencia 0,97; para todos, p > 0,1).LIMITACIONES: El estudio se limitó a cinco estados. Si bien los pacientes pueden tener un mayor acceso a los servicios de detección de cáncer y la expansión posterior a la cirugía, la base de datos de pacientes hospitalizados del estado solo brinda información sobre los pacientes que se sometieron a cirugía.CONCLUSIONES: A pesar de los avances en la detección, la expansión de Medicaid no se asoció con reducciones en las disparidades etnoraciales o basadas en los ingresos conocidas en las tasas de cirugía electiva de cáncer colorrectal. Ampliar el acceso a la cirugía del cáncer colorrectal para las poblaciones desatendidas probablemente requiera atención a los factores del proveedor y del sistema de salud que contribuyen a las disparidades persistentes. Consulte el Video Resumen en http://links.lww.com/DCR/C217 . (Traducción-Dr. Yesenia.Rojas-Khalil ).

Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy.

PURPOSE: Prospective data on the efficacy of a watch-and-wait strategy to achieve organ preservation in patients with locally advanced rectal cancer treated with total neoadjuvant therapy are limited. METHODS: In this prospective, randomized phase II trial, we assessed the outcomes of 324 patients with stage II or III rectal adenocarcinoma treated with induction chemotherapy followed by chemoradiotherapy (INCT-CRT) or chemoradiotherapy followed by consolidation chemotherapy (CRT-CNCT) and either total mesorectal excision (TME) or watch-and-wait on the basis of tumor response. Patients in both groups received 4 months of infusional fluorouracil-leucovorin-oxaliplatin or capecitabine-oxaliplatin and 5,000 to 5,600 cGy of radiation combined with either continuous infusion fluorouracil or capecitabine during radiotherapy. The trial was designed as two stand-alone studies with disease-free survival (DFS) as the primary end point for both groups, with a comparison to a null hypothesis on the basis of historical data. The secondary end point was TME-free survival. RESULTS: Median follow-up was 3 years. Three-year DFS was 76% (95% CI, 69 to 84) for the INCT-CRT group and 76% (95% CI, 69 to 83) for the CRT-CNCT group, in line with the 3-year DFS rate (75%) observed historically. Three-year TME-free survival was 41% (95% CI, 33 to 50) in the INCT-CRT group and 53% (95% CI, 45 to 62) in the CRT-CNCT group. No differences were found between groups in local recurrence-free survival, distant metastasis-free survival, or overall survival. Patients who underwent TME after restaging and patients who underwent TME after regrowth had similar DFS rates. CONCLUSION: Organ preservation is achievable in half of the patients with rectal cancer treated with total neoadjuvant therapy, without an apparent detriment in survival, compared with historical controls treated with chemoradiotherapy, TME, and postoperative chemotherapy.

Incidental Polyp on Colectomy Specimen is Linked with Higher Odds of Polyp on Interval Colonoscopy.

BACKGROUND: Incidentally found polyps on surgical pathology after colectomy is an underreported phenomenon, and management guidelines are lacking. Elucidation of the significance of incidental polyps is needed to determine if post-operative endoscopic surveillance modification is warranted. We sought to determine the relationship between incidental polyp on colectomy specimen and findings on post-operative colonoscopy. MATERIALS AND METHODS: A multi-institutional retrospective review was performed on patients that underwent colorectal resection from 2018-2019. Surgical pathology was reviewed for polyps and assigned as expected or incidental based on pre-operative colonoscopy. If performed, post-operative colonoscopy was reviewed for new lesion identification. The odds of detecting new lesion on post-operative colonoscopy was compared between cases with incidental polyp on surgical specimen and patients without incidental findings. RESULTS: In 243 colorectal resections, incidental polyps were identified in 55 cases (22.6%). Post-operative colonoscopy was completed in 65 cases (26.7%) with new polyp detected in 24 cases (9.88%). Of those, 10 had an incidental polyp previously identified on surgical specimen while 14 did not. The presence of incidental surgical specimen polyp was associated with a greater than two-fold higher odds of detecting new polyp on post-operative colonoscopy (odds-ratio 2.76, 95% confidence interval 1.15-6.63;P = 0.023). CONCLUSION: This analysis revealed a high frequency of incidental polyps on surgical specimens with an increased rate of newly found lesions on post-operative colonoscopy. Incidental polyps may be a risk factor for other missed lesions still within the patient. Therefore, providers should consider surveillance interval modification on an individual basis in the setting of incidental surgical specimen polyps.

Port site metastases after minimally invasive resection for colorectal cancer: A retrospective study of 13 patients.

BACKGROUND: Minimally invasive surgeries are increasingly being performed for primary colon cancer resections since laparoscopic and robotic surgeries have less post-operative pain, shorter length of hospitalization, less morbidity, improved patient satisfaction and equivalent R0 resection rates compared to laparotomy. METHODS: To analyze characteristics of patients who developed port site metastases after minimally invasive colectomy, a retrospective case series of a single institution from 2004 to 2017 was performed. The study included patients who had a minimally invasive resection of the primary colon cancer and subsequent cytoreduction and heated intraperitoneal chemotherapy (CRS/HIPEC) for peritoneal metastases. Patient characteristics, histology, pathology, prior treatments, time between surgeries, carcinoembryonic antigen (CEA) levels and survival were reviewed. RESULTS: There were 123 patients who had CRS/HIPEC and 13 of them had a history of laparoscopic or robotic colectomy followed by the development of port site disease. Four were females, nine were males. Median age was 48 years (range, 19-64). Eleven of 13 primary colon cancers were T3 or T4. Ten of 13 patients had no clinical evidence of peritoneal metastases at the time of initial resection. All 13 patients had metastatic deposits at port sites that were confirmed histopathologically at the time of CRS/HIPEC. CONCLUSIONS: Port site metastases were present concomitantly with peritoneal metastases in 13 patients. An advanced T-stage of disease occurred in 85% of patients. Port site metastases do occur after minimally invasive colon resection.

Dynamic Article: Tandem Robotic Technique of Extralevator Abdominoperineal Excision and Rectus Abdominis Muscle Harvest for Immediate Closure of the Pelvic Floor Defect.

BACKGROUND: Extralevator abdominoperineal excision for distal rectal cancers involves cylindrical excision of the mesorectum with wide division of the levator ani muscles. Although this technique has been shown to decrease local cancer recurrence and improve survival, it leaves the patient with a considerable pelvic floor defect that may require reconstruction. OBJECTIVE: We developed an innovative technique of robotic extralevator abdominoperineal excision combined with robotic harvest of the rectus abdominis muscle flap for immediate reconstruction of the pelvic floor defect. DESIGN: This was a retrospective review pilot study. SETTING: This study was conducted at a tertiary care cancer center. PATIENTS: Three patients who underwent robotic extralevator abdominoperineal excision with robotic rectus abdominis flap harvest for distal rectal adenocarcinoma were included. MAIN OUTCOMES MEASURES: Intraoperative and postoperative outcomes included operative time, intraoperative complications, length of hospital stay, wound complications, incidence of perineal hernia, persistent pain, and functional limitations. RESULTS: Three patients underwent this procedure. The median operative time was 522 minutes with median hospital stay of 6 days. One patient experienced perineal wound complication requiring limited incision and drainage followed by complete healing of the wound by secondary intention. The other 2 patients did not experience any wound complications. Longest follow-up was 16 months. None of the patients developed perineal hernias during this time period. LIMITATIONS: The small sample size and retrospective nature were limitations. CONCLUSIONS: This technique confers multiple advantages including improved visualization and dexterity within the pelvis and accurate wide margins at the pelvic floor. An incisionless robotic flap harvest with preservation of the anterior rectus sheath obviates the risk of ventral hernia while providing robust tissue closure of the radiated abdominoperineal excision wound. This technique may result in faster postoperative recovery, decreased morbidity, improved functional outcomes and cosmesis. Further studies are needed to prospectively analyze this approach (Supplemental Digital Content 1, video abstract, http://links.lww.com/DCR/A188).