Organ sparing to cure stage IV rectal cancer: A case report and review of literature.

BACKGROUND: Rectal sparing is an option for some rectal cancers with complete or good response after chemoradiotherapy (CRT); however, it has never been evaluated in patients with metastases. We assessed long-term outcomes of a rectal-sparing approach in a liver-first strategy for patients with rectal cancer with resectable liver metastases. CASE SUMMARY: We examined patients who underwent an organ-sparing approach for rectal cancer with synchronous liver metastases using a liver-first strategy during 2010-2015 (n = 8). Patients received primary chemotherapy and pelvic CRT. Liver surgery was performed during the interval between CRT completion and rectal tumor re-evaluation. Clinical and oncological characteristics and long-term outcomes were assessed.All patients underwent liver metastatic resection with curative intent. The R0 rate was 100%. Six and two patients underwent local excision and a watch-and-wait (WW) approach, respectively. All patients had T3N1 tumors at diagnosis and had good clinical response after CRT. The median survival time was 60 (range, 14-127) mo. Three patients were disease free for 5, 8, and 10 years after the procedure. Five patients developed metastatic recurrence in the liver (n = 5) and/or lungs (n = 2). Only one patient developed local recurrence concurrent with metastatic recurrence 24 mo after the WW approach. Two patients died during follow-up. CONCLUSION: The results suggest good local control in patients undergoing organ-sparing strategies for rectal cancer with synchronous liver metastasis. Prospective trials are required to validate these data and identify good candidates for these strategies.

Piecemeal Resection for Large Colorectal Adenomas Remains Essential in 2022: A Single-Center Experience in a Tertiary French Center.

BACKGROUND AND AIMS: Colorectal lesions measuring greater than 20 mm are unsuitable for en bloc endoscopic mucosal resection (EMR): piecemeal EMR (PM-EMR) and endoscopic submucosal dissection (ESD) are needed. The European Society of Gastrointestinal Endoscopy (ESGE) recommends ESD only for microinfiltrative lesions, although Japanese teams perform en bloc ESD for all lesions. We report the outcomes obtained in our endoscopy unit for these lesions and assess the hybrid "knife-assisted piecemeal EMR" (KAPM-EMR) technique. The main aim was to assess the short-term outcomes (C1). The secondary objectives were to evaluate the long-term results (C2), adverse event rate and management of recurrence. METHODS: We retrospectively analyzed data from patients treated by PM-EMR, KAPM-EMR and ESD for a colorectal lesion measuring greater than 20 millimeters using prospective inclusion over four years. RESULTS: Data from 167 patients (median age: 70) with a median follow-up of 15.1 months were analyzed after excluding 95 patients. A total of 131 lesions were removed by PM-EMR, 24 by KAPM-EMR and 12 by ESD; 146/167 (87.4%) patients were considered in remission at C1. Recurrence was treated by endoscopy in 20/21 patients (95%); 86/89 (96.6%) were in remission at C2. A total of 16/167 patients developed adverse events, all of whom except one were endoscopically managed. KAPM-EMR was associated with a higher perforation risk (p=0.037). No differences in postoperative bleeding were found among the three groups (p=0.576). CONCLUSIONS: Piecemeal resection remains an effective and safe technique for large colorectal adenomas. KAPM-EMR may be useful but should be applied with caution due to the risk of perforation.

Intracorporeal Anastomosis and ERAS Program: The Winning Combination of Optimized Postoperative Outcomes After Laparoscopic Right Colectomy.

BACKGROUND: Laparoscopic technique and the enhanced recovery after surgery (ERAS) protocol have become the standard of care in patients undergoing right colon cancer surgery, reducing hospital stay and postoperative morbidity. However, the optimal anastomosis technique [intracorporeal anastomosis (ICA) or extracorporeal anastomosis (ECA)] remains debated. This study aimed to determine the optimal perioperative approach (ICA vs. ECA combined with the ERAS program vs. standard care) for patients undergoing laparoscopic right colectomy for cancer. MATERIALS AND METHODS: This single-center, retrospective study evaluated all consecutive patients who underwent laparoscopic right hemicolectomy for cancer between January 2012 and June 2021. Patient data were analyzed in 4 treatment groups according to the type of anastomosis and the care protocol. The primary endpoint was total postoperative hospital stay (THS). The secondary endpoints were recovery time and overall morbidity rate. RESULTS: The baseline characteristics of the 373 included patients were comparable between the 4 groups. THS was significantly shorter in the ICA/ERAS group than in the ECA/standard and ICA/standard groups ( P <0.01), but there was no significant difference between the ICA/ERAS and ECA/ERAS groups (5.7 vs. 6.4 d; P =0.17). Recovery time was significantly shorter in the ICA/ERAS group ( P <0.01). The overall morbidity rate, including anastomotic morbidity, was comparable among the 4 groups. Regression analysis showed that ICA and the ERAS program were both predictive factors to reduce the THS and recovery time. CONCLUSIONS: ICA combined with the ERAS program achieves the best outcomes and thus seems to be the optimal approach for the management of patients undergoing laparoscopic right colectomy for cancer.

The impact of brachytherapy boost for anal canal cancers in the era of de-escalation treatments.

PURPOSE: To analyze clinical outcomes of high-dose-rate (HDR) interstitial brachytherapy boost (ISBT) after external beam radiation therapy (EBRT) or chemoradiotherapy (CRT) for the treatment of anal canal cancers (ACC). METHODS AND MATERIALS: A total of 78 patients with ACC were treated at our institution by ISBT. Local Control (LC), disease-free survival (DFS), overall survival (OS), colostomy-free survival (CFS) and toxicity rates were analyzed. RESULTS: With a median followup (FU) of 59.8 months (95% CI [55.8-64.2]), six (7.7%) local recurrences with 2 patients (2.6%) having persistent disease at 3 months were observed. The 5-year rate of LC for the entire population was 92% [83-96%]. The 5-year DFS rate was 86% [76-93%]. The 5-year OS was 96% [88-99%]. In the univariate analysis, chemotherapy was significantly associated with morbidity grade ≥2. Late digestive toxicity grade ≥3 was reported in 8.9% patients, 1 patient underwent colostomy due to toxicity. The 5-year CFS rate was 88% [79-94%]. CONCLUSIONS: HDR interstitial brachytherapy boost provide excellent rates of tumor control and colostomy-free survival with a favorable profile of GI toxicity. Continence in anal cancer survivors is a challenge and the boost technique must be discussed in a multidisciplinary approach as part of de-escalation treatments.

An optimised liver-first strategy for synchronous metastatic rectal cancer leads to higher protocol completion and lower surgical morbidity.

INTRODUCTION: The optimal management of rectal cancer with synchronous liver metastases remains debatable. Thus, we propose an optimised liver-first (OLF) strategy that combines concomitant pelvic irradiation with hepatic management. This study aimed to evaluate the feasibility and oncological quality of the OLF strategy. MATERIALS AND METHODS: Patients underwent systemic neoadjuvant chemotherapy followed by preoperative radiotherapy. Liver resection was performed in one step (between radiotherapy and rectal surgery) or in two steps (before and after radiotherapy). The data were collected prospectively and analysed retrospectively as intent to treat. RESULTS: Between 2008 and 2018, 24 patients underwent the OLF strategy. The rate of treatment completion was 87.5%. Three patients (12.5%) did not proceed to the planned second-stage liver and rectal surgery because of progressive disease. The postoperative mortality rate was 0%, and the overall morbidity rates after liver and rectal surgeries were 21% and 28.6%, respectively. Only two patients developed severe complications. Liver and rectal complete resection was performed in 100% and 84.6%, respectively. A rectal-sparing strategy was performed in 6 patients who underwent local excision (n = 4) or a watch and wait strategy (n = 2). Among patients who completed treatment, the median overall and disease-free survivals were 60 months (range 12-139 months) and 40 months (range 10-139 months), respectively. Eleven patients (47.6%) developed recurrence, among whom five underwent further treatment with curative intent. CONCLUSION: The OLF approach is feasible, relevant, and safe. Organ preservation was feasible for a quarter of patients and may be associated with reduced morbidity.

Supine bottom-up extralevator abdominoperineal excision for anorectal adenocarcinoma is not inferior to standard approach and may be thus safely performed.

BACKGROUND: Extralevator abdominoperineal excision (APE) for rectal carcinoma has been described in order to improve pathological and oncological results compared to standard APE. To obtain the same oncological advantages as extralevator APE, we have previously described a new procedure starting by a perineal approach: the supine bottom-up APE. Our objective is to compare oncological and surgical outcomes between the supine bottom-up APE and the standard APE. METHODS: All patients with low rectal adenocarcinoma requiring APE were retrospectively included and divided into 2 groups: supine bottom-up APE (Group A) and standard APE (Group B). RESULTS: From 2008 to 2016, 61 patients were divided into Groups A (n = 30) and B (n = 31). Postoperative outcomes and median length of stay were similar between groups. Patients from Group A had a significantly longer distal margin (30 [8-120] vs. 20 [1.5-60] mm, p = 0.04) and higher number of harvested lymph nodes (14.5 [0-33] vs. 11 [5-25], p = 0.03) than those from Group B. Circumferential resection margin involvement was similar between groups (28 vs. 22%, p = 0.6), whereas tumors from Group A were significantly larger and more frequently classified as T4 than those from Group B. Operative time was significantly shorter in Group A (437.5 [285-655] minutes) than in Group B (537.5 [361-721] minutes, p = 0.0009). At the end of follow-up, local recurrence occurred in 7 and 16% of patients from Groups A and B (p = 0.68). Three-year overall and disease-free survival rates were similar between groups (87 vs. 90%, p = 0.62 and 61 vs. 63%, p = 0.88, respectively). CONCLUSION: Our findings suggest that supine bottom-up APE doesn't impair surgical outcomes, pathological results, overall and disease-free survivals in comparison with standard APE. This new procedure may be thus safely performed and decrease the operative time. Further randomized multicentric studies are required to confirm these results.

Nomogram to predict disease recurrence in patients with locally advanced rectal cancer undergoing rectal surgery after neoadjuvant therapy: retrospective cohort study.

INTRODUCTION: Prognostic models can be used for predicting survival outcomes and guiding patient management. TNM staging alone is insufficient for predicting recurrence after chemoradiotherapy (CRT) and surgery for locally advanced rectal cancer. This study aimed to develop a nomogram to better predict cancer recurrence after CRT followed by total mesorectal excision (TME) and tailor postoperative management and follow-up. MATERIALS AND METHODS: Between 2002 and 2019, data were retrospectively collected on patients with rectal adenocarcinoma. Data on sex, age, carcinoembryonic antigen (CEA) level, tumour location, induction chemotherapy, adjuvant chemotherapy, tumour downsizing, perineural invasion, lymphovascular invasion, pathological stage, resection margins (R0 versus R1), and pelvic septic complications were analysed. The variables significantly associated with cancer recurrence were used to build a nomogram that was validated in both the training and validation cohorts. Model performance was evaluated by receiver operating characteristic curve and area under the curve (AUC) analyses. RESULTS: After applying exclusion criteria, 634 patients with rectal adenocarcinoma were included in this study. Eight factors (CEA level, adjuvant chemotherapy, tumour downsizing, perineural invasion, lymphovascular invasion, pathological stage, resection margins (R0 versus R1), and pelvic septic complications) were identified as nomogram variables. Our nomogram showed good performance with an AUC of 0.74 and 0.75 in the training and validation cohorts respectively. CONCLUSION: Our nomogram is a simple tool for predicting cancer recurrence in patients with locally advanced rectal cancer after neoadjuvant CRT followed by TME. It provides an individual risk prediction of recurrence to tailor surveillance.

Case-Matched Comparison of Functional and Quality of Life Outcomes of Local Excision and Total Mesorectal Excision Following Chemoradiotherapy for Rectal Cancer.

BACKGROUND: Neoadjuvant chemoradiotherapy followed by radical surgery is the standard curative treatment for mid- to low-rectal cancer. However, the combination of these treatments may affect patients' GI and genitourinary functions and their quality of life. In the cases of good clinical response to neoadjuvant treatment, local excision is a rectal sparing strategy that would limit these side effects. OBJECTIVE: The aim of this study is to compare the effects of local excision or conventional laparoscopic total mesorectal excision after chemoradiotherapy in patients with rectal cancer. DESIGN: The design is a retrospective study. SETTING: The setting used is a single tertiary center. PATIENTS: Patients with mid- to low-rectal cancer treated with chemoradiotherapy and accessible via conservative surgery at our hospital between January 2010 and December 2018 were included. Patients undergoing local excision were matched 1 to 1 with the patients undergoing total mesorectal excision by age, sex, body mass index, tumor height, and year of surgery. MAIN OUTCOME MEASURES: Quality of life and digestive and genitourinary functions were measured using validated questionnaires. The socioeconomic impact was also assessed. RESULTS: Forty-four patients undergoing local excision agreed to participate and were matched with 44 patients undergoing total mesorectal excision. Patients who underwent local excision reported a more favorable global health status ( p < 0.01), emotional function ( p = 0.035), social function ( p = 0.04), and body image ( p = 0.04). The low anterior resection syndrome score (rate of major syndrome, 23.8% vs 54.5%; p < 0.01) and the specific fecal incontinence subscale score ( p < 0.01) were more favorable in the local excision group. Sexual and urinary outcomes were comparable between the 2 groups. Local excision had a lower impact on the professional status (35.7% vs 76.5%; p = 0.03). LIMITATIONS: The study limitations include its retrospective design and small sample size. CONCLUSIONS: When indicated, local excision improves the bowel function and quality of life of patients undergoing surgery for rectal cancer after chemoradiotherapy compared with total mesorectal excision. See Video Abstract at http://links.lww.com/DCR/B997 . COMPARACIN DE CASOS EMPAREJADOS DE LOS RESULTADOS FUNCIONALES Y DE CALIDAD DE VIDA DE LA ESCISIN LOCAL Y LA ESCISIN TOTAL DE MESORECTO DESPUS DE QUIMIORRADIOTERAPIA EN CNCER DE RECTO: ANTECEDENTES:La quimiorradioterapia neoadyuvante seguida de cirugía radical es el tratamiento curativo estándar para el cáncer de recto medio-bajo. Sin embargo, la combinación de estos tratamientos puede afectar las funciones gastrointestinales y genitourinarias de los pacientes y su calidad de vida. En casos de buena respuesta clínica al tratamiento neoadyuvante, la escisión local es una estrategia conservadora del recto que limitaría estos efectos secundarios.OBJETIVO:Este estudio comparó los efectos de la escisión local o escisión total de mesorecto laparoscópica convencional después de quimiorradioterapia en pacientes con cáncer de recto.DISEÑO:Estudio retrospectivo.ENTORNO CLINICO:Centro terciario único.PACIENTES:Se incluyeron pacientes con cáncer de recto medio-bajo tratados con quimiorradioterapia y accesibles mediante cirugía conservadora en nuestro hospital entre enero del 2010 y diciembre del 2018. Los pacientes sometidos a escisión local se emparejaron uno a uno con los sometidos a escisión total de mesorecto por edad, sexo, índice de masa corporal, altura del tumor y año de cirugía.PRINCIPALES MEDIDAS DE RESULTADO:La calidad de vida, las funciones digestivas y genitourinarias se midieron mediante cuestionarios validados. También se evaluó el impacto socioeconómico.RESULTADOS:Cuarenta y cuatro pacientes sometidos a escisión local aceptaron participar y fueron emparejados con 44 pacientes sometidos a escisión mesorrectal total. Los pacientes que se sometieron a escisión local informaron un estado de salud global más favorable ( p <0,01), función emocional ( p = 0,035), función social ( p = 0,04) e imagen corporal ( p = 0,04). La puntuación baja del síndrome de resección anterior (tasa de síndrome mayor: 23,8 % frente a 54,5 %; p <0,01) y la puntuación de la subescala de incontinencia fecal específica ( p <0,01) fueron más favorables en el grupo de escisión local. Los resultados sexuales y urinarios fueron comparables entre los dos grupos. La escisión local tuvo un menor impacto en el estatus profesional (35,7% vs 76,5%; p = 0,03).LIMITACIONES:Diseño retrospectivo, tamaño de muestra pequeño.CONCLUSIONES:Cuando está indicada, la escisión local mejora la función intestinal y la calidad de vida de los pacientes sometidos a cirugía por cáncer de recto después de quimiorradioterapia en comparación con escisión total de mesorecto. Consulte Video Resumen en http://links.lww.com/DCR/B997 . (Traducción-Dr. Francisco M. Abarca-Rendon ).

Impact of fast-track care program in laparoscopic rectal cancer surgery: a cohort-comparative study.

BACKGROUND: Fast-track care programs after surgery improve recovery and decrease the length of hospital stay and postoperative morbidity in colonic cancer. However, the true impact of these programs on morbidity rates after rectal cancer surgery remains unclear. We aimed to assess the feasibility and impact of the fast-track program on postoperative outcomes after restorative laparoscopic rectal cancer resection and temporary loop ileostomy. METHODS: This single-center observational study assessed data of patients undergoing elective rectal cancer surgery during a defined period before (standard group) and after the introduction of a fast-track program (fast-track group) from a prospectively maintained database. The primary endpoint was postoperative 90-day morbidity. Secondary endpoints were 30-day morbidity, fast-track program compliance, length of hospital stay, and readmission rate. RESULTS: Overall, 336 patients (n = 176, standard group; n = 160, fast-track group) were assessed; there was no significant between-group difference in the patients' baseline characteristics (age, sex, body mass index, comorbidities, or neoadjuvant treatment). The protocol compliance rate was 91.4% in the fast-track group. The 90-day morbidity and mean total length of hospital stay were significantly lower in the fast-track group than in the standard group (34% vs 49%, respectively, p < 0.01 and 8.96 days vs 10.2 days, p < 0.01, respectively). There was no difference in readmission rates. Multivariate analysis revealed the fast-track program to be the only predictive factor of postoperative morbidity. CONCLUSION: Fast-track programs can be safely implemented following rectal cancer surgery to reduce the overall morbidity rate and length of hospital stay without adversely increasing the readmission rate.

Systematic Early Urinary Catheter Removal Integrated in the Full Enhanced Recovery After Surgery (ERAS) Protocol After Laparoscopic Mid to Lower Rectal Cancer Excision: A Feasibility Study.

PURPOSE: Enhanced Recovery After Surgery (ERAS) programs advocate early urinary catheter removal after rectal cancer surgery; however, the optimal duration remains unclear. This study assessed the feasibility of the early urinary catheter removal protocol after rectal cancer surgery within an ERAS pathway and identified predictive factors for failure of this strategy. METHODS: Between March 2017 and October 2018, all unselected and consecutive patients who underwent rectal cancer resection and benefited from our ERAS program were included. Urinary complications (infection and retention) were prospectively recorded. Success was defined as catheter removal on postoperative day (POD) 3 without urinary complications. RESULTS: Of 135 patients (male, 63.7%; neoadjuvant chemoradiation, 57.0%; urology history, 17.8%), 120 had early urinary catheter removal with no complications (success rate, 88.9%), 8 did not have urinary catheter removal on POD 3 due to clinical judgment or prescription error, 5 experienced a urinary tract infection, and 2 had acute urinary retention. Obesity (odds ratio [OR], 0.16; P = 0.003), American Society of Anesthesiologists physical status classification > II (OR, 0.28; P = 0.048), antiaggregant platelet medication (OR, 0.12; P < 0.001), absence of anastomosis (OR, 0.1; P = 0.003), and prolonged operative time (OR, 0.21; P = 0.020) were predictive factors for failure. Conversely, optimal compliance with the ERAS program (OR, 7.68; P < 0.001), postoperative nonsteroidal anti-inflammatory drug use (OR, 21.71; P < 0.001), and balanced intravenous fluid therapy (OR, 7.87; P = 0.001) were associated with increased strategy success. CONCLUSION: Withdrawal of the urinary catheter on POD 3 was successfully achieved after laparoscopic rectal resection and can be safely implemented in the ERAS program.

Does neoadjuvant FOLFOX chemotherapy improve the prognosis of high-risk Stage II and III colon cancers? Three years' follow-up results of the PRODIGE 22 phase II randomized multicentre trial.

AIM: Neoadjuvant chemotherapy has proven valuable in locally advanced resectable colon cancer (CC) but its effect on oncological outcomes is uncertain. The aim of the present paper was to report 3-year oncological outcomes, representing the secondary endpoints of the PRODIGE 22 trial. METHOD: PRODIGE 22 was a randomized multicentre phase II trial in high-risk T3, T4 and/or N2 CC patients on CT scan. Patients were randomized between 6 months of adjuvant FOLFOX (upfront surgery) or perioperative FOLFOX (four cycles before surgery and eight cycles after; FOLFOX perioperative). In wild-type RAS patients, a third arm testing perioperative FOLFOX-cetuximab was added. The primary endpoint was the tumour regression grade. Secondary endpoints were 3-year overall survival (OS), disease-free survival (DFS), recurrence-free survival (RFS) and time to recurrence (TTR). RESULTS: Overall, 120 patients were enrolled. At interim analysis, the FOLFOX-cetuximab arm was stopped for futility. The remaining 104 patients represented our intention-to-treat population. In the perioperative group, 96% received the scheduled four neoadjuvant cycles and all but one had adjuvant FOLFOX for eight cycles. In the control arm, 38 (73%) patients received adjuvant FOLFOX. The median follow-up was 54.3 months. Three-year OS was 90.4% in both arms [hazard ratio (HR) = 0.85], 3-year DFS, RFS and TTR were, respectively, 76.8% and 69.2% (HR=0.94), 73% and 69.2% (HR = 0.86) and 82% and 72% (HR = 0.67) in the perioperative and control arms, respectively. Forest plots did not show any subgroup with significant difference for survival outcomes. No benefit from adding cetuximab was observed. CONCLUSION: Perioperative FOLFOX has no detrimental effect on long-term oncological outcomes and may be an option for some patients with locally advanced CC.

Is Piecemeal Endoscopic Resection Acceptable for Early Colorectal Cancers in Certain Situations? A Single-Center French Study.

BACKGROUND AND AIMS: The use of endoscopic treatment for early colorectal cancer (ECC) is increasing. The European guidelines suggest performing piecemeal endoscopic resection (pmR) for benign lesions and en bloc resection for ECC, especially for patients with favorable lymph node involvement risk evaluations. However, en bloc resections for lesions larger than two centimeters require invasive endoscopic techniques. Our retrospective single-center study aimed to determine the clinical impact of performing pmR for ECC rather than traditional en bloc resection. METHODS: A single-center study was performed between January 2012 and September 2017. All ECC patients were included. The main objective was to evaluate the number of patients who potentially underwent unnecessary surgery due to piecemeal resection. The secondary endpoints were as follows: disease-free survival (DFS), defined as the time from pmR to endoscopic failure (local recurrence not treatable by endoscopy), complication rate, number of patients who did not undergo surgery by default, and factors predictive of outcomes and complications. RESULTS: One hundred and forty-six ECC endoscopically treated patients were included. In total, 85 patients were excluded (71 who underwent en bloc resection, 14 with pending follow-up). Data from 61 patients (33 women and 28 men) were analyzed. Two patients underwent potentially unnecessary surgery [3.28% (0.9%- 11.2%)]. The DFS rate was 87% (75%-93%) at 6 months and 85% [72%-92%] at 12 months. The median follow- up time was 16.5 months (12.4-20.9). Three patients (4.9%) had complications. One patient did not undergo surgery by default. A Paris classification of 0-2c (HR=9.3 (2.4-35.9), p<0.001) and Vienna classification of 5 [HR=16.3 (3.3-80.4), p<0.001] were factors associated with poor DFS. CONCLUSION: Performing pmR in place of en bloc resection for ECC had a limited impact on patients. If the pathology (especially deep margins) is analyzable, careful monitoring could be acceptable in ECC patients who undergo pmR.

Organ preservation with chemoradiotherapy plus local excision for rectal cancer: 5-year results of the GRECCAR 2 randomised trial.

BACKGROUND: GRECCAR 2 was the first multicentre, randomised trial to compare local excision with total mesorectal excision in downstaged low rectal cancer. Encouraging oncological results were noted at 3 years' follow-up but needed to be corroborated with longer follow-up. In this study, we aimed to report the 5-year oncological outcomes, including local recurrence, metastatic disease, and survival. METHODS: Patients age 18 years and older with T2T3 low rectal cancer, of maximum size 4 cm, who were clinically good responders after chemoradiotherapy (residual tumour ≤2 cm) were randomly assigned before surgery to either local excision or total mesorectal excision. Randomisation was centralised and not stratified and used permuted blocks of size eight. In the local excision group, a completion total mesorectal excision was performed if pathological tumour stage was ypT2-3. The primary objective of this study was to assess the 5-year oncological outcomes of local recurrence, metastatic disease, disease-free survival, overall survival, and cancer-specific mortality, which were the secondary endpoints of GRECCAR 2. We used Kaplan-Meier estimates and Cox modelling to estimate and compare recurrence and survival in modified intention-to-treat and as-treated populations. This trial was registered with ClinicalTrials.gov, number NCT00427375. FINDINGS: Between March 1, 2007, and Sept 24, 2012, 148 patients who were good clinical responders were randomly assigned to treatment, three patients were excluded after randomisation (because they had metastatic disease, tumour >8 cm from anal verge, or withdrew consent), leaving 145 for analysis: 74 in the local excision group and 71 in the total mesorectal excision group. Median follow-up was 60 months (IQR 58-60) in the local excision group and 60 months (57-60) in the total mesorectal excision group. 23 patients died and five were lost to follow-up. In the local excision group, 26 had a completion total mesorectal excision for ypT2-3 tumour. In the modified intention-to-treat analysis, there was no difference between the local excision and total mesorectal excision groups in 5-year local recurrence (7% [95% CI 3-16] vs 7% [3-16]; adjusted hazard ratio [HR] 0·71 [95% CI 0·19-2·58]; p=0·60), metastatic disease (18% [CI 11-30] vs 19% [11-31]; 0·86 [0·36-2·06]; p=0·73), overall survival (84% [73-91] vs 82% [71-90]; 0·92 [0·38-2·22]; p=0·85), disease-free survival (70% [58-79] vs 72% [60-82]; 0·87 [0·44-1·72]; p=0·68), or cancer-specific mortality (7% [3-17] vs 10% [5-20]; 0·65 [0·17-2·49]; p=0·53). INTERPRETATION: The 5-year results of this multicentre randomised trial corroborate the 3-year results, providing no evidence of difference in oncological outcomes between local excision and total mesorectal excision. Local excision can be proposed in selected patients having a small T2T3 low rectal cancer with a good clinical response after chemoradiotherapy. FUNDING: National Cancer Institute of France.

Laparoscopy is not enough: full ERAS compliance is the key to improvement of short-term outcomes after colectomy for cancer.

BACKGROUND: The enhanced recovery after surgery (ERAS) programs and laparoscopic techniques both reduce hospital stay and postoperative morbidity in patients undergoing colorectal cancer surgery. Laparoscopic techniques are an integral part of the ERAS program. However, evidence showing that the implementation of a multimodal rehabilitation program in addition to laparoscopy for colonic cancer would improve postoperative outcomes is still lacking. This study aimed to evaluate the impact of ERAS program on postoperative outcomes after elective laparoscopic colonic cancer resection. METHODS: This is a single-center observational study from a prospectively maintained database. Two groups were formed from all patients undergoing laparoscopic colonic surgery for neoplasm during a defined period before (standard group) and after introduction of an ERAS program (ERAS group). The primary endpoint was postoperative 90-day morbidity. Secondary endpoints were the total length of hospital stay, readmission rate, and compliance with ERAS protocol. RESULTS: A total of 320 patients were included in the analyses, with 160 patients in the standard group and 160 in the ERAS group. There were no differences in the baseline characteristics between the two groups. Overall morbidity was significantly lower in the ERAS group (21.25%) than that in the standard group (34.4%; OR = 0.52 [0.31-0.85], p < 0.01). This difference was not due to the reduction in major complications. Mean total hospital stay was significantly lower in the ERAS group (5.8 days) than that in the standard group (8.2 days, p < 0.01). There were no differences in readmission rates and anastomotic complications. CONCLUSIONS: The ERAS pathway reduced the overall morbidity rates and shortened the length of hospital stay, without increasing the readmission rates. A significant reduction in nonsurgical complications was evident, whereas no significant reduction was found for surgical complications.

Does A Longer Waiting Period After Neoadjuvant Radio-chemotherapy Improve the Oncological Prognosis of Rectal Cancer?: Three Years' Follow-up Results of the Greccar-6 Randomized Multicenter Trial.

OBJECTIVE: The aim of this study was to report the 3-year survival results of the GRECCAR-6 trial. SUMMARY BACKGROUND DATA: Current data on the effect of an extended interval between radiochemotherapy (RCT) and resection for rectal cancer on the rate of complete pathological response (pCR = ypT0N0) is controversial. Furthermore, its effect on oncological outcomes is unknown. METHODS: The GRECCAR-6 trial was a phase III, multicenter, randomized, open-label, parallel-group, controlled trial. Patients with cT3/T4 or TxN+ tumors of the mid or lower rectum who had received RCT (45-50 Gy with 5-fluorouracil or capecitabine) were included and randomized into a 7- or 11-week waiting period. Primary endpoint was the pCR rate. Secondary endpoints were 3-year overall (OS), disease-free survival (DFS), and recurrence rates. RESULTS: A total of 265 patients from 24 participating centers were enrolled. A total of 253 patients underwent a mesorectal excision. Overall pCR rate was 17% (43/253). Mean follow-up from surgical resection was 32 ±â€Š8 months. Twenty-four deaths occurred with an 89% OS at 3 years. DFS was 68.7% at 3 years (75 recurrences). Three-year local and distant recurrences were 7.9% and 23.8%, respectively. The randomization group had no impact on the 3-year OS (P = 0.8868) or DFS (P = 0.9409). Distant (P = 0.7432) and local (P = 0.3944) recurrences were also not influenced by the waiting period. DFS was independently influenced by 3 factors: circumferential radial margin (CRM) ≤1 mm [hazard ratio (HR) = 2.03; 95% confidence interval (CI), 1.17-3.51], ypT3-T4 (HR = 2.69; 95% CI, 1.19-6.08) and positive lymph nodes (HR = 3.62; 95% CI, 1.89-6.91). CONCLUSION: Extending the waiting period by 4 weeks following RCT has no influence on the oncological outcomes of T3/T4 rectal cancers.

High-dose-rate vs. low-dose-rate interstitial brachytherapy boost for anal canal cancers.

PURPOSE: The purpose of this study was to analyze and compare clinical outcomes of low-dose-rate (LDR) and high-dose-rate (HDR) interstitial brachytherapy boost (ISBT) after EBRT or radio chemotherapy for the treatment of anal canal cancers. METHODS AND MATERIALS: One hundred patients with anal canal cancers were treated at our institution by ISBT [LDR (n = 50); HDR (n = 50)]. Chronic toxicity rates, local control, disease-free survival, overall survival, and colostomy-free survival of the two different dose-rate brachytherapy modalities were analyzed and compared. RESULTS: With a median followup of 42.2 months (95% CI, [34.5-48.8]), 9 (9% [4.8-16.2%]) local recurrences were observed, 4 (8% [3.2-18.8%]) in LDR vs. 5 (10% [4.4-21.4%]) in HDR group (odds ratio [OR] = 1.28 [0.32-5.07], p = 0.73). The 5-year rate of local control for the entire population was 90% [81-95%], 93% [79-98%] vs. 86% [69-94%] for LDR and HDR, respectively (p = 0.38). The 5-year disease-free survival rate for all patients was 82% [71-90%], 88% [73-95%] vs. 72% [44-88%] for LDR and HDR, respectively (p = 0.21). The 5-year overall survival rate for global population was 94% [84-98%], with no significant differences between LDR (97% [79-100%]) and HDR (93% [80-98%]) (p = 0.27). The 5-year colostomy-free survival rate was 92% [83-96%], respectively, 95% [83-99%] vs. 86% [69-94%] for LDR and HDR (p = 0.21). Significant differences were found in terms of chronic toxicity rates, with 28 (56% [42.3-68.8%]) patients concerned in low-dose-rate brachytherapy vs. 17 (34% [22.4-47.9%]) in high-dose-rate brachytherapy (OR = 0.40 [0.18-0.91], p = 0.03). CONCLUSIONS: Local recurrence rates were comparable between both groups; HDR brachytherapy seem to have a better toxicity profile. Our data confirmed the finding that HDR can be used to safely administer ISBT without increasing chronic toxicity.

Well-Differentiated Papillary Mesothelioma of the Peritoneum: A Retrospective Study from the RENAPE Observational Registry.

BACKGROUND: Well-differentiated papillary mesothelioma of the peritoneum (WDPMP) is a rare entity. Questions regarding management are still being debated as no more than 50 cases have been reported in the literature. OBJECTIVE: We aimed to analyze the clinical, therapeutic, and prognostic data of patients with WDPMP from the RENAPE observational registry. PATIENTS AND METHODS: All patients diagnosed with WDPMP and prospectively included in the RENAPE national registry between 2010 and 2018 were also included in our study. Expert pathologists from the RENA-PATH group confirmed all cases. All clinical, therapeutic, postoperative, and prognostic data were extracted and analyzed. RESULTS: We report on 56 patients with a mean age of 52 years (range 21-74). WDPMP was incidentally diagnosed during imaging or surgery in 16% and 36% of patients, respectively, and an association with synchronous malignancy was found in 18% of patients. Nine lesions showed discrete signs of fatty invasion. The median Peritoneal Cancer Index was 11 (range 0-33). Eleven patients were treated with definitive excision, 4 were treated with cytoreductive surgery (CRS) only, 37 were treated with CRS and hyperthermic intraperitoneal chemotherapy (HIPEC), and 2 were treated with CRS plus HIPEC plus early postoperative intraperitoneal chemotherapy. CRS was considered to be complete in 90% of cases. One patient died postoperatively and 16 patients (31%) faced postoperative complications. The median disease-free survival was 144 months; Four patients relapsed, with a median period of 27 months. No prognostic factors could be identified. CONCLUSIONS: Our analysis confirms the favorable prognosis of WDPMP. CRS and HIPEC could be a therapeutic option for diffuse, symptomatic, and/or recurrent disease.