Neoadjuvant chemotherapy and radiotherapy followed by resection/ablation in stage IV rectal cancer patients with potentially resectable metastases.

BACKGROUND: The optimal treatment of stage IV rectal cancer remains controversial. The purpose of this study was to assess the treatment outcomes and toxicity of neoadjuvant chemotherapy and radiotherapy followed by local treatment of all tumor sites and subsequent adjuvant chemotherapy in stage IV rectal cancer patients with potentially resectable metastases. METHODS: Adult patients diagnosed with locally advanced rectal adenocarcinoma with potentially resectable metastases, who received neoadjuvant chemotherapy and radiotherapy from July 2013 and September 2019 at Sun Yat-sen University cancer center, were included. Completion of the whole treatment schedule, pathological response, treatment-related toxicity and survival were evaluated. RESULTS: A total of 228 patients were analyzed with a median follow-up of 33 (range 3.3 to 93.4) months. Eventually, 112 (49.1%) patients finished the whole treatment schedule, of which complete response of all tumor sites and pathological downstaging of the rectal tumor were observed in three (2.7%) and 90 (80.4%) patients. The three-year overall survival (OS) and progression-free survival (PFS) of all patients were 56.6% (50.2 to 63.9%) and 38.6% (95% CI 32.5 to 45.8%), respectively. For patients who finished the treatment schedule, 3-year OS (74.4% vs 39.2%, P < 0.001) and 3-year PFS (45.5% vs 30.5%, P = 0.004) were significantly improved compared those who did not finish the treatment. Grade 3-4 chem-radiotherapy treatment toxicities were observed in 51 (22.4%) of all patients and surgical complications occurred in 22 (9.6%) of 142 patients who underwent surgery, respectively. CONCLUSIONS: Neoadjuvant chemotherapy and radiotherapy followed by resection/ablation and subsequent adjuvant chemotherapy offered chances of long-term survival with tolerable toxicities for selected patients with potentially resectable stage IV rectal cancer, and could be considered as an option in clinical practice.

Propensity Score-Matched Analysis of Laparoscopic versus Open Surgery for Non-Metastatic Rectal Cancer.

BACKGROUND: Rectal cancer is a pervasive type of malignancy that accounts for one-third of colorectal cancers worldwide. Several studies have assessed the use of laparoscopic surgery as a treatment option. However, there is an ongoing debate regarding its oncological safety. METHODS: This retrospective study included 270 patients with non-metastatic rectal cancer who underwent either laparoscopic resection (LR, n = 93) or open resection (OR, n = 177) in an academic medical center. The primary outcomes were overall survival (OS) and disease-free survival (DFS), whereas the secondary outcome was postoperative complications. We performed propensity score analyses and compared outcomes. Univariate survival analyses using Kaplan-Meier plots and Cox proportional hazard regression models were also conducted. RESULTS: In the propensity score matching analyses, 93 LR- and 93 OR-matched patients were compared. The overall median follow-up time was 3.95 years (range, 1.98‒5.55 years). The 3-year OS was similar between the groups (LR 79.1% vs OR 79.2%, p = 0.82). Meanwhile, the DFS rate was also comparable between the groups (LR 77.8% vs OR 73.2%, p = 0.53). No significant differences in operative blood loss or hospital stay between the groups were observed (150 vs 150 mL, p = 0.74; 9 vs 10 days, p = 0.077, respectively). Also, no difference was found in postoperative complications between the groups (p = 0.23). However, LR was associated with a longer operative time than OR (455 vs 356 min, p < 0.001) and the number of lymph nodes harvested in LR was slightly fewer than OR (10 vs 11, p = 0.045). CONCLUSION: LR of rectal cancer is safe, feasible, and comparable to standard OR in terms of the oncologic outcomes. However, LR required longer operative times. A well-designed prospective study with a large number of participants and long follow-up period is needed to show significant differences between the two groups.
.

Comparison between robotic natural orifice specimen extraction surgery and traditional laparoscopic low anterior resection for middle and low rectal cancer: A propensity score matching analysis.

BACKGROUND AND OBJECTIVES: This study aimed to find the advantages of robotic natural orifice specimen extraction surgery (NOSES) for middle and low rectal cancer, compared with traditional laparoscopic low anterior resection (LAR). METHODS: Patients receiving robotic NOSES or traditional laparoscopic LAR were retrospectively enrolled from 2013-10 to 2019-06, with middle and low rectal cancer, maximum diameter ≤ 5 cm, pT1-3 or ypT1-3 stage, no distant metastases. The baseline of the two groups was balanced using the propensity score matching method. Surgical quality, postoperative recovery, and long-term oncological outcomes were compared. RESULTS: Totally 137 eligible patients with robotic NOSES and 137 matched patients with traditional laparoscopic LAR were enrolled. Robotic NOSES had a significantly lower open conversion rate (0 vs. 4.4%, p = .030), less intraoperative hemorrhage (50 ml vs. 80 ml, p < .001) and longer distance from distal resection margin of low rectal cancer (1.5 cm vs. 1.0 cm, p = .030). Robotic NOSES significantly reduced the 30-day postoperative complication rate of Clavien-Dindo grade II or higher (17.5% vs. 31.4%, p = .008), promoted gastrointestinal and urinary function recovery, reduced postoperative pain and hospital stay (6.0 vs. 7.0 d, p = .022). The two groups were similar in long-term survival. CONCLUSIONS: Compared with traditional laparoscopic LAR, robotic NOSES had significant advantages in improving surgical quality and promoting postoperative recovery.

Long-term oncological outcomes of low anterior resection for rectal cancer with and without preservation of the left colic artery: a retrospective cohort study.

BACKGROUND: There is uncertainty in the literature about preserving the left colic artery (LCA) during low anterior resection for rectal cancer. We analyzed the effect of preserving the LCA on long-term oncological outcomes. METHODS: We retrospectively collected clinicopathological and follow-up details of patients who underwent low anterior resection for rectal cancer in the General Surgery Department of Guangdong Provincial People's Hospital, from January 2014 to December 2015. Cases were divided into low ligation (LL), LCA preserved, or high ligation (HL), LCA not preserved, of the inferior mesenteric artery. The 5-year overall survival (OS) and disease-free survival (DFS) rates were compared between the two groups. RESULTS: Altogether, there were 221 and 295 cases in the LL group and HL groups, respectively. Operating time in the LL group was significantly longer than in the HL group (224.7 vs. 211.7 min, p = 0.039). Postoperative 30-day mortality, early complications including anastomotic leakage showed no significant differences between the LL and HL groups (postoperative 30-day mortality, 0.9% LL, 1.4% HL, p = 0.884; early complications, 41.2% LL, 38.3% HL, p = 0.509; anastomotic leakage 8.6% LL, 13.2% HL, p = 0.100). The median follow-up periods were 51.4 (7-61) months in the LL group and 51.2 (8-61) months in the HL group. During follow-up, the percentages of patients who died, had local recurrence, or had metastases were 39.8, 7.7, and 38.5%, respectively, in the LL group and 39, 8.5, and 40%, respectively, in the HL group; these differences were not significant (all p > 0.05). The 5-year OS and DFS were 69.6 and 59.6% in the LL group, respectively, and 69.1 and 56.2% in the HL group, respectively; these differences were not significant (all p > 0.05). After stratification by tumor-node-metastasis stage, the difference between the 5-year OS and DFS for stages I, II, and III cancer were not significant (all p > 0.05). CONCLUSIONS: The long-term oncological outcomes of LL group are comparable with HL group. LL cannot be supported due to the absence of lower complication rates and the longer operating times.

No benefit after neoadjuvant chemoradiation in stage IV rectal cancer: A propensity score-matched analysis on a real-world population.

BACKGROUND: Stage IV rectal cancer occurs in 25% of patients and locoregional control of primary tumor is usually poorly considered, since priority is the treatment of metastatic disease. AIMS: This study evaluates impact of neoadjuvant chemoradiation followed by surgery (nCHRTS) vs. upfront surgery on locoregional control and overall survival in stage IV rectal cancer. METHODS: All patients diagnosed with stage IV rectal carcinoma between 2009 and 2019, undergone elective surgery at the National Cancer Institute of Milan (Italy), were included. Propensity score-based matching was performed between the two study groups. Loco-regional recurrence-free survival (LRRFS) and overall survival (OS) were analysed using Kaplan-Meyer method. RESULTS: A total of 139 patients were analyzed. After propensity score matching, 88 patients were included in the final analysis. The 3-yr LRRFS rates were 80.3% for nCHRTS vs. 90.4% for upfront surgery patients (p = 0.35). The 3-yr OS rates were respectively 81.8% vs. 58% (p = 0.36). KRAS mutation (HR 2.506, p = 0.038) and extra-liver metastases (HR 4.308, p = 0.003) were both predictive of worse OS in univariate analysis. CONCLUSION: The present study failed to demonstrate a significant impact of nCHRTS on LRRFS or OS in stage IV rectal cancer.

A comparison of oncological outcomes after abdominoperineal excision before and after the implementation of a selective perineal flap closure program.

BACKGROUND AND OBJECTIVES: Abdominoperineal excision (APE) is the operation chosen when a patient has low rectal cancer unamenable to sphincter preserving surgery. Perineal flap reconstruction is associated with less wound morbidity but little is known about oncological outcomes. The objective was to compare outcomes in patients undergoing APE before and after the introduction of a program that utilized flap reconstruction of the perineum. METHODS: A retrospective review of a prospectively maintained database was performed. Patients who underwent APE followed by primary closure or flap reconstruction between 1998 and 2018 were selected. The cohorts were divided according to the implementation of the flap reconstruction program in July 2009. Clinicopathological data, recurrence and survival were compared between the cohorts. RESULTS: One hundred and forty nine patients underwent APE for rectal adenocarcinoma between 1998 and 2018. There were 57 patients in the pre-flap era and 92 in the post-flap era. Forty-six patients underwent flap reconstruction in the latter cohort (50%). More patients in the post-flap era underwent neoadjuvant chemoradiotherapy (85.9% vs. 63.2%; p < .01). Margin positivity rates decreased from 21.1% in the pre-flap era to 10.9% in the post-flap era (p = .10) and there was an associated improvement in incidence and time to local recurrence (p = .03). CONCLUSION: The use of perineal flap reconstruction is associated with a longer median time to local recurrence. Perineal flap reconstruction may contribute to reduced margin positivity.

[Comparison of clinical efficacy among different surgical methods for presacral recurrent rectal cancer].

Objective: To investigate the efficacy and prognosis of three surgical methods for presacral recurrent rectal cancer (PRRC). Methods: A retrospective cohort study was carried out. Case inclusion criteria: (1) primary rectal cancer without distant metastasis and undergoing radical surgery; (2) patients undergoing radical surgery after the diagnosis of PRRC; (3) complete inpatient, outpatient and follow-up data. Clinical data of 47 patients meeting the above criteria who underwent operation at the Department of Gastrointestinal Surgery, The Peking University People's Hospital from January 2008 to December 2017 were reviewed and analyzed retrospectively. Of the 47 patients, 31 were male and 16 were female; the mean age was 57 years old; 9 (19.1%) were low differentiation or signet ring cell carcinoma, 38 (80.9%) were medium differentiation; 19 (40.4%) received neoadjuvant therapy. According to operative procedure, 22 patients were in the abdominal/abdominoperineal resection group, 15 in the sacrectomy group and 10 in the abdominosacral resection group. The operative data, postoperative data and prognosis were compared among the three groups. Survival curve was conducted using the Kaplan-Meier method, and log-rank test was used to compare survival difference among three groups. Results: There were no significant differences in baseline data among three groups (all P>0.05). All the 47 patients completed the radical resection successfully. The mean operation time was (4.7±2.1) hours, the median intraoperative blood loss was 600 ml, and the median postoperative hospitalization time was 17 days. Fifteen cases (31.9%) had perioperative complications, of which 3 cases were grade III-IV. There was no perioperative death. The mean operative time was (7.4±1.6) hours in the abdominosacral resection group, (4.9±1.6) hours in the abdominal/abdominoperineal resection group, and (3.0±1.1) hours in the sacroectomy group, with a significant difference (F=25.071, P<0.001). There were no significant differences in intraoperative blood loss, postoperative hospitalization days and perioperative complications among the three groups (all P>0.05). The median follow-up period of all the patients was 24 months, 12 cases (25.5%) developed postoperative dysfunction. The incidence of postoperative dysfunction in the abdominosacral resection group was 5/10, which was higher than 4/15 in the sacrectomy group and 3/22 (13.6%) in the abdominoperineal resection group with statistically significant difference (χ(2)=9.307, P=0.010). The 1-year and 3-year overall survival rates were 86.1% and 40.2% respectively. The 1-year overall survival rates were 86.0%, 86.7% and 83.3%, and the 3-year overall survival rates were 33.2%, 40.0% and 62.5% in the abdominal/abdominoperineal resection group, sacrectomy group and abdominosacral resection group, respectively, whose difference was not statistically significant (χ(2)=0.222, P=0.895). Conclusions: Abdominal/abdominoperineal resection, sacrectomy and abdominosacral resection are all effective for PRRC. Intraoperative function protection should be concerned for patients undergoing abdominosacral resection.

Limited surgery following neoadjuvant treatment among patients with localized rectal cancer; a population-based study.

OBJECTIVE: To evaluate the characteristics and outcomes of patients with localized rectal cancer treated with limited versus radical surgery following neoadjuvant treatment. METHODS: Surveillance, Epidemiology, and End Results (SEER) database has been accessed and patients with localized rectal adenocarcinoma (M0) 2004-2015 who have received neoadjuvant radiation before having some sort of surgery were included. Multivariable Cox regression analysis was then used to assess the impact of the type of resection on overall survival and cancer-specific survival. RESULTS: A total of 19162 individuals who have undergone radical surgery and 450 individuals who have undergone limited surgery were included. Using multivariable logistic regression analysis, the following factors were associated with a higher likelihood of radical surgery: younger age (OR for age ≥65 years versus 17-64 years: 0.430; 95% CI: 0.355-0.520) and clinically node-positive stage (OR: 2.442; 95% CI: 1.858-3.211). Within multivariable Cox regression analysis, limited surgery was associated with worse overall survival (HR: 1.276; 95% CI: 1.092-1.491) but no difference in cancer-specific survival (HR: 0.980; 95% CI: 0.728-1.318). CONCLUSION: Among patients with localized rectal cancer treated with neoadjuvant radiation, there does not seem to be a difference in cancer-specific survival according to the type of surgery (limited versus radical surgery).

Long-term oncological outcomes in robotic versus laparoscopic approach for rectal cancer: A systematic review and meta-analysis.

BACKGROUND: Short-term outcomes of robotic mesorectal excision for rectal cancer resection seem comparable to those of conventional laparoscopic mesorectal excision. However, the long-term oncological outcomes of robot mesorectal excision require further investigation. MATERIALS AND METHODS: The PubMed, EMBASE, Medline, and Cochrane Library databases were searched from the date of database inception to March 31, 2019 for all available trials; the results of robotic and laparoscopic mesorectal excision for rectal cancer surgery were compared. Survival parameters, including overall survival (OS) and disease-free survival (DFS), were independently extracted by two investigators. Hazard ratios (HRs) were calculated using random- or fixed-effects models. The presence of heterogeneity was assessed using Q test, and the extent of heterogeneity was quantified by I2 index. The meta-analysis was performed using Review Manager software, version 5.3. RESULTS: A total of seven studies including 2593 patients (1362 treated by robotic mesorectal excision and 1231 by laparoscopic mesorectal excision) were included. Pooled analyses showed no significant difference in OS (HR = 0.94, 95% confidence interval [CI]: 0.63 to 1.39, P = 0.75) or DFS (HR = 0.93, 95% CI: 0.79 to 1.10, P = 0.85) between the robotic and laparoscopic mesorectal excision for treatment of rectal cancer. CONCLUSION: Regarding long-term survival, robotic mesorectal excision for rectal cancer is comparable to laparoscopic mesorectal excision. More prospective, multicenter randomized trials with longer follow-up periods are needed to determine the long-term outcomes of patients undergoing robotic mesorectal excision.

Modified Frailty Index Predicts Postoperative Outcomes in Patients Undergoing Radical Pelvic Surgery.

Patients undergoing radical pelvic surgery such as proctectomy or radical cystectomy are at risk of experiencing a variety of complications. Frailty renders patients vulnerable to adverse events. We hypothesize that frailty measured preoperatively using a validated scoring system correlates with increased likelihood of experiencing Clavien-Dindo grade IV complications and 30-day mortality and may be used as a predictive model for patients preoperatively. The NSQIP database was queried for patients who underwent proctectomy or radical cystectomy from 2008 to 2012. Preoperative frailty was calculated using the 11-point modified frailty index (MFI). Patients were scored based on the presence of indicators and categorized into two groups (<3 or ≥3). Major postoperative morbidities and mortality were identified and analyzed in each group. 10,048 proctectomy and cystectomy patients were identified. The MFI was found to be predictive of both 30-day mortality (P < 0.0001) and Clavien-Dindo grade IV complications (P < 0.0001). Receiver operating characteristic analysis demonstrated improved discriminative power of the MFI with the addition of American Society of Anesthesiologists class for both prediction of complications and 30-day mortality. An MFI score of ≥3 is predictive of postoperative morbidity and mortality. Providers should be encouraged to calculate frailty preoperatively to predict adverse outcomes.

Surgical treatment of stage IV colorectal cancer with synchronous liver metastases: A systematic review and network meta-analysis.

BACKGROUND: The ideal treatment approach for colorectal cancer (CRC) with synchronous liver metastases (SCRLM) remains debated. We performed a network meta-analysis (NMA) comparing the 'bowel-first' approach (BFA), simultaneous resection (SIM), and the 'liver-first' approach (LFA). METHODS: A systematic search of comparative studies in CRC with SCRLM was undertaken using the Embase, PubMed, Web of Science, and CENTRAL databases. Outcome measures included postoperative complications, 30- and 90-day mortality, chemotherapy use, treatment completion rate, 3- and 5-year recurrence-free survival, and 3- and 5-year overall survival (OS). Pairwise and network meta-analysis were performed to compare strategies. Heterogeneity was assessed using the Higgins I2 statistic. RESULTS: One prospective and 43 retrospective studies reporting on 10 848 patients were included. Patients undergoing the LFA were more likely to have rectal primaries and a higher metastatic load. The SIM approach resulted in a higher risk of major morbidity and 30-day mortality. Compared to the BFA, the LFA more frequently resulted in failure to complete treatment as planned (34% versus 6%). Pairwise and network meta-analysis showed a similar 5-year OS between LFA and BFA and a more favorable 5-year OS after SIM compared to LFA (odds ratio 0.25-0.90, p = 0.02, I2 = 0%), but not compared to BFA. CONCLUSION: Despite a higher tumor load in LFA compared to BFA patients, survival was similar. A lower rate of treatment completion was observed with LFA. Uncertainty remains substantial due to imprecise estimates of treatment effects. In the absence of prospective trials, treatment of stage IV CRC patients should be individually tailored.

Association between surgical approach and survival following resection of abdominopelvic malignancies.

BACKGROUND AND OBJECTIVES: Recent studies demonstrating decreased survival following minimally invasive surgery (MIS) for cervical cancer have generated concern regarding oncologic efficacy of MIS. Our objective was to evaluate the association between surgical approach and 5-year survival following resection of abdominopelvic malignancies. METHODS: Patients with stage I or II adenocarcinoma of the prostate, colon, rectum, and stage IA2 or IB1 cervical cancer from 2010-2015 were identified from the National Cancer Data Base. The association between surgical approach and 5-year survival was assessed using propensity-score-matched cohorts. Distributions were compared using logistic regression. Hazard ratio for death was estimated using Cox proportional-hazard models. RESULTS: The rate of deaths at 5 years was 3.4% following radical prostatectomy, 22.9% following colectomy, 18.6% following proctectomy, and 6.8% following radical hysterectomy. Open surgery was associated with worse survival following radical prostatectomy (HR, 1.18; 95% CI, 1.05-1.33; P = .005), colectomy (HR, 1.45; 95% CI, 1.39-1.51; P < .001), and proctectomy (HR, 1.28; 95% CI, 1.10-1.50; P = .002); however, open surgery was associated with improved survival following radical hysterectomy (HR, 0.61; 95% CI, 0.44-0.82; P = .003). CONCLUSIONS: These results suggest that MIS is an acceptable approach in selected patients with prostate, colon, and rectal cancers, while concerns regarding MIS resection of cervical cancer appear warranted.

Transanal total mesorectal excision for rectal cancer has been suspended in Norway.

BACKGROUND: Transanal total mesorectal excision (TaTME) for rectal cancer has emerged as an alternative to the traditional abdominal approach. However, concerns have been raised about local recurrence. The aim of this study was to evaluate local recurrence after TaTME. Secondary aims included postoperative mortality, anastomotic leak and stoma rates. METHODS: Data on all patients who underwent TaTME were recorded and compared with those from national cohorts in the Norwegian Colorectal Cancer Registry (NCCR) and the Norwegian Registry for Gastrointestinal Surgery (NoRGast). Kaplan-Meier estimates were used to compare local recurrence. RESULTS: In Norway, 157 patients underwent TaTME for rectal cancer between October 2014 and October 2018. Three of seven hospitals abandoned TaTME after a total of five procedures. The local recurrence rate was 12 of 157 (7·6 per cent); eight local recurrences were multifocal or extensive. The estimated local recurrence rate at 2·4 years was 11·6 (95 per cent c.i. 6·6 to 19·9) per cent after TaTME compared with 2·4 (1·4 to 4·3) per cent in the NCCR (P < 0·001). The adjusted hazard ratio was 6·71 (95 per cent c.i. 2·94 to 15·32). Anastomotic leaks resulting in reoperation occurred in 8·4 per cent of patients in the TaTME cohort compared with 4·5 per cent in NoRGast (P = 0·047). Fifty-six patients (35·7 per cent) had a stoma at latest follow-up; 39 (24·8 per cent) were permanent. CONCLUSION: Anastomotic leak rates after TaTME were higher than national rates; local recurrence rates and growth patterns were unfavourable.

ANTECEDENTES: La resección total del mesorrecto transanal (transanal total mesorectal excision, TaTME) para el cáncer de recto se ha propuesto como una alternativa al abordaje abdominal tradicional. Sin embargo, la recidiva local (local recurrence, LR) después de este procedimiento es motivo de preocupación. El objetivo de este estudio fue evaluar la LR en pacientes operados mediante TaTME. Los objetivos secundarios incluyeron la mortalidad postoperatoria, las fugas anastomóticas y el porcentaje de estomas. MÉTODOS: Se registraron los datos de todos los pacientes operados mediante TaTME y se compararon con las cohortes nacionales del Registro Noruego de Cáncer Colorrectal (Norwegian Colorectal Cancer Registry, NCCR) y del Registro Noruego de Cirugía Gastrointestinal (Norwegian Registry for Gastrointestinal Surgery, NoRGast) utilizando estimaciones de Kaplan-Meier y la prueba de log-rank para comparar curvas de LR. RESULTADOS: En Noruega, 157 pacientes se sometieron a TaTME por cáncer de recto entre octubre de 2014 y octubre de 2018. Tres de siete hospitales abandonaron el TaTME después de un total de cinco procedimientos. La LR observada fue 12/157 (7,6%), siendo ocho de ellas multifocales o extensas. La tasa estimada de LR a 2,4 años fue de 11,6 % (i.c. del 95% 6,6 a 19,9) versus 2,4 % (1,4 a 4,3) en el NCCR (log rank P < 0,001). El cociente de riesgos instantáneos (hazard ratio, HR) ajustado fue 6,7 (i.c. del 95% 2,9 a 15,3). Las fugas anastomóticas que precisaron una reintervención después de TaTME ocurrieron en un 8,4% versus 4,5% en el registro NoRGast (P = 0,047). Cincuenta y seis pacientes (35,7%) tenían un estoma en el último seguimiento; 39 (24,8%) eran permanentes. CONCLUSIÓN: Las tasas de fuga anastomótica tras una TaTME fueron más altas que los datos nacionales con tasas de LR y patrones de crecimiento desfavorables.

An Analysis of Long-Term Outcomes in Patients Treated by Extensive Bowel Resection Due to Advanced Ovarian Cancer Relative to the Effectiveness of Surgery.

INTRODUCTION: Surgery for advanced ovarian cancer (AOC) often requires bowel resections. However, the impact of bowel surgery on patient overall survival (OS) has not yet been precisely determined. OBJECTIVE: The aim of the study was to analyze the OS rates in a group of AOC patients undergoing bowel resection. METHODS: We carried out a retrospective analysis of patients who had undergone low anterior resection of the rectum (LAR) during primary or interval debulking surgery for AOC. We divided the patients into 2 groups: Group 1 included 69 patients who underwent only LAR; Group 2 included 66 patients who underwent LAR and additional bowel resection. The control group included 71 AOC patients who did not required bowel resection. RESULTS: In the subgroup of patients with no gross residual disease (NGR), there were no differences in OS between Groups 1 and 2. In the subgroup of "optimally" (tumors <1 cm) debulked patients, Group 1 patients had a higher median OS than Group 2 patients. Additionally, there was no difference between Groups 1 and 2 as far as the number of severe adverse events. CONCLUSIONS: Multiple bowel resections seem to improve OS in patients when NGR is achieved but should be avoided when complete resection is not possible.

Long Term Results of Modified Intersphincteric Resections for Low Rectal Cancer: A Single Center Experience.

BACKGROUND AND OBJECTIVES: The objective of this article is to evaluate the long-term oncological and functional outcomes following modified intersphincteric resections (ISR) for low rectal cancer. The modified technique consisted of the abandonment of colonic J-pouches, transverse coloplasty, or defunctioning temporary stoma in favor of a direct handsewn coloanal anastomosis (CAA). MATERIAL AND METHODS: Sixty consecutive patients with type II and III (juxta-anal or intra-anal) low rectal tumors underwent modified ISR by the same surgical team and were followed for a period of five years. Functional outcomes using the Wexner Score, postoperative complications, recurrence rates, morbidity, and mortality rates were assessed. RESULTS: The five-year survival rate was 93.3% with a disease-free interval at three years of 98%. Morbidity was 15% (n = 9) consisting of intestinal wall necrosis (n = 6), stenosis (n = 2), and sacral metastasis (n = 1). The Wexner score values were, at 1 year, 8.5 (range, 4-13); at three years 7.2 (range, 2-11); and at 5 years 6.7 (range, 2-12). A second surgery was needed in only one case that showed postoperative transmural necrosis of the colonic wall. CONCLUSIONS: In highly selected patients with type II or III low rectal tumors and proper preoperative imaging staging, ISR might be a viable alternative to other techniques such as abdominoperineal resection and low anterior resection, both from a functional and an oncological perspective.

State-wide outcomes in elective rectal cancer resection: is there a case for centralization in Victoria?

BACKGROUND: The role of service centralization in rectal cancer surgery is controversial. Recent studies suggest centralization to high-volume centres may improve postoperative mortality. We used a state-wide administrative data set to determine the inpatient mortality for patients undergoing elective rectal cancer surgery and to compare individual hospital volumes. METHODS: The Victorian Admitted Episodes Dataset was explored using the Dr Foster Quality Investigator tool. The inpatient mortality rate, 30-day readmission rate and the proportion of patients with increased length of stay were measured for all elective admissions for rectal cancer resections between 2012 and 2016. A peer group of 14 hospitals were studied using funnel plots to determine inter-hospital variation in mortality. Procedure types were compared between the groups. RESULTS: There were 2241 elective resections performed for rectal cancer in Victoria over 4 years. The crude inpatient mortality rate was 1.1%. There were no significant differences in mortality among 14 hospitals within the peer group. The number of elective resections over 4 years ranged from 14 to 136 (median 65) within these institutions. Ultralow anterior resection was the commonest procedure performed. CONCLUSION: Inpatient mortality after elective rectal cancer surgery in Victoria is rare and compares favourably internationally. Based on inpatient mortality alone, there is no compelling evidence to further centralize elective rectal cancer surgery in Victoria. More work is needed to develop data sets with oncological information capable of providing accurate complete state-wide data which will be essential for future service planning, training and innovation.

"Watch and wait" approach in rectal cancer patients following complete clinical response to neoadjuvant chemoradiotherapy does not compromise oncologic outcomes.

BACKGROUND/AIMS: Although standart treatment for non-metastatic locally advanced rectal cancer includes neoadjuvant chemoradiation followed by surgical resection, patients who have achieved complete clinical response can be followed up without surgery. MATERIALS AND METHODS: Between 2010 and 2016, 61 patients received neoadjuvant chemoradiotherapy for low rectal cancer. Those patients who achieved clinical complete response were included in the "watch and wait" protocol and did not receive surgery. The remaining patients underwent radical surgery and some of these were diagnosed as having complete response pathologically. This study compared the oncological results of clinically complete responders with those patients defined as pathologically tumor-free. RESULTS: Seven patients who received neoadjuvant chemoradiotherapy were re-staged as having complete clinical response and included in the "watch and wait" approach protocol. The 5-year disease free survival was 100%. Mean follow-up was 63 months and the mean age was 57.3. Fifty-four patients underwent radical surgery and 7 of them were diagnosed as having pathological complete response. The 5-year survival was 100%. Mean follow-up was 56 months and the mean age was 50.6. All patients except one are alive without tumor recurrence in the surgery group. However, those who received surgery experienced significant morbidities due to their surgery. CONCLUSION: The oncological results of the "watch and wait" approach patients were no different from the patients who received radical surgery and were diagnosed as having pathological complete response. Those patients in particular who required abdomino-perineal resection before chemoradiation should be informed about this approach if they have achieved complete response clinically.

Surgical Quality Assurance in COLOR III: Standardization and Competency Assessment in a Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to develop an objective and reliable surgical quality assurance system (SQA) for COLOR III, an international multicenter randomized controlled trial (RCT) comparing transanal total mesorectal excision (TaTME) with laparoscopic approach for rectal cancer. BACKGROUND OF SUMMARY DATA: SQA influences outcome measures in RCTs such as lymph nodes harvest, in-hospital mortality, and locoregional cancer recurrence. However, levels of SQA are variable. METHOD: Hierarchical task analysis of TaTME was performed. A 4-round Delphi methodology was applied for standardization of TaTME steps. Semistructured interviews were conducted in round 1 to identify key steps and tasks, which were rated as mandatory, optional, or prohibited in rounds 2 to 4 using questionnaires. Competency assessment tool (CAT) was developed and its content validity was examined by expert surgeons. Twenty unedited videos were assessed to test reliability using generalizability theory. RESULTS: Eighty-three of 101 surgical tasks identified reached 70% agreement (26 mandatory, 56 optional, and 1 prohibited). An operative guide of standardized TaTME was created. CAT is matrix of 9 steps and 4 performance qualities: exposure, execution, adverse event, and end-product. The overall G-coefficient was 0.883. Inter-rater and interitem reliability were 0.883 and 0.986. To enter COLOR III, 2 unedited TaTME and 1 laparoscopic TME videos were submitted and assessed by 2 independent assessors using CAT. CONCLUSION: We described an iterative approach to develop an objective SQA within multicenter RCT. This approach provided standardization, the development of reliable and valid CAT, and the criteria for trial entry and monitoring surgical performance during the trial.

Excluding the ischiorectal fossa irradiation during neoadjuvant chemoradiotherapy with intensity-modulated radiotherapy followed by abdominoperineal resection decreases perineal complications in patients with lower rectal cancer.

BACKGROUND: The aim of this study was to explore the impact of including or excluding the ischiorectal fossa (IRF) within the clinical target volume during neoadjuvant chemoradiotherapy (NCRT) using intensity modulated radiotherapy, in locally advanced lower rectal cancer (LALRC). METHODS: We retrospectively analysed the data of 220 LALRC patients who received NCRT followed by abdominoperineal resection between January 2009 and January 2015. Six patients were excluded because of loss to follow-up, 90 patients received IRF irradiation (IRF group) while 124 patients did not (NIRF group). Survival, patterns of recurrence, and treatment toxicities were compared between the two groups. RESULTS: Overall, patient/treatment variables were well balanced except for surgical technique. Perineal wound complications in the IRF and NIRF groups, were 40.0 and 24.2%, respectively (p = 0.010); corresponding 3-year perineal recurrence rates, local recurrence free survival, overall survival, and distant relapse free survival were 4.4% vs. 2.4% (p = 0.670), 88.1% vs. 95.0% (p = 0.079), 82.6% vs. 88.4% (p = 0.087), and 61.9% vs. 81.0% (p = 0.026), respectively. Multivariate analyses demonstrated the following factors to be significantly related to perineal wound complications: irradiation of the IRF (odds ratio [OR] 2.892, p = 0.002), anaemia (OR 3.776, p = 0.010), operation duration > 180 min (OR 2.486, p = 0.007), and interval between radiotherapy and surgery > 8 weeks (OR 2.400, p = 0.010). CONCLUSIONS: Exclusion of the IRF from the clinical target volume during NCRT using intensity-modulated radiotherapy in LALRC could lower the incidence of perineal wound complications after abdominoperineal resection, without compromising oncological outcomes.