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Patients with locally advanced rectal cancer who achieve a pathological complete response to neoadjuvant chemoradiation have an improved prognosis. The need for surgery in these patients has been questioned, but the proportion of patients achieving a pathological complete response is small. We aimed to assess whether adding cycles of mFOLFOX6 between chemoradiation and surgery increased the proportion of patients achieving a pathological complete response. We did a phase 2, non-randomised trial consisting of four sequential study groups of patients with stage II–III locally advanced rectal cancer at 17 institutions in the USA and Canada. All patients received chemoradiation (fluorouracil 225 mg/m2 per day by continuous infusion throughout radiotherapy, and 45·0 Gy in 25 fractions, 5 days per week for 5 weeks, followed by a minimum boost of 5·4 Gy). Patients in group 1 had total mesorectal excision 6–8 weeks after chemoradiation. Patients in groups 2–4 received two, four, or six cycles of mFOLFOX6, respectively, between chemoradiation and total mesorectal excision. Each cycle of mFOLFOX6 consisted of racemic leucovorin 200 mg/m2 or 400 mg/m2, according to the discretion of the treating investigator, oxaliplatin 85 mg/m2 in a 2-h infusion, bolus fluorouracil 400 mg/m2 on day 1, and a 46-h infusion of fluorouracil 2400 mg/m2. The primary endpoint was the proportion of patients who achieved a pathological complete response, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00335816. Between March 24, 2004, and Nov 16, 2012, 292 patients were registered, 259 of whom (60 in group 1, 67 in group 2, 67 in group 3, and 65 in group 4) met criteria for analysis. 11 (18%, 95% CI 10–30) of 60 patients in group 1, 17 (25%, 16–37) of 67 in group 2, 20 (30%, 19–42) of 67 in group 3, and 25 (38%, 27–51) of 65 in group 4 achieved a pathological complete response (p=0·0036). Study group was independently associated with pathological complete response (group 4 compared with group 1 odds ratio 3·49, 95% CI 1·39–8·75; p=0·011). In group 2, two (3%) of 67 patients had grade 3 adverse events associated with the neoadjuvant administration of mFOLFOX6 and one (1%) had a grade 4 adverse event; in group 3, 12 (18%) of 67 patients had grade 3 adverse events; in group 4, 18 (28%) of 65 patients had grade 3 adverse events and five (8%) had grade 4 adverse events. The most common grade 3 or higher adverse events associated with the neoadjuvant administration of mFOLFOX6 across groups 2–4 were neutropenia (five in group 3 and six in group 4) and lymphopenia (three in group 3 and four in group 4). Across all study groups, 25 grade 3 or worse surgery-related complications occurred (ten in group 1, five in group 2, three in group 3, and seven in group 4); the most common were pelvic abscesses (seven patients) and anastomotic leaks (seven patients). Delivery of mFOLFOX6 after chemoradiation and before total mesorectal excision has the potential to increase the proportion of patients eligible for less invasive treatment strategies; this strategy is being tested in phase 3 clinical trials. National Institutes of Health National Cancer Institute.

Background Locoregional recurrence (LR) in colon cancer is uncommon but often incurable, while the factors associated with it are unclear. The purpose of this study was to identify patterns and predictors of LR after curative resection for colon cancer. Methods All patients who underwent colon cancer resection with curative intent between 1994 and 2008 at a tertiary referral center were identified from a prospectively maintained institutional database. The association of LR with clinicopathologic and treatment characteristics was determined using univariable and multivariable analyses. Results A total of 1397 patients were included with a median follow-up of 7.8 years; 635 (45%) were female, and the median age was 69 years. LR was detected in 61 (4.4%) patients. Median time to LR was 21 months. On multivariable analysis, the independent predictors of LR were disease stage [hazard ratio (HR) for Stage II 4.6, 95% confidence interval (CI) 1.05–19.9, HR for Stage III 10.8, 95% CI 2.6–45.8], bowel obstruction (HR 3.8, 95% CI 1.9–7.4), margin involvement (HR 4.1, 95% CI 1.9–8.6), lymphovascular invasion (HR 1.9, 95% CI 1.06–3.5), and local tumor invasion (fixation to another structure, perforation, or presence of associated fistula, HR 2.2, 95% CI 1.1–4.5). Adjuvant chemotherapy was not associated with reduced LR in patients with either Stage II or Stage III tumors. Conclusions Adherence to oncologic surgical principles in colon cancer resection results in low rates of LR, which is associated with tumor-dependent factors. Recognition of these factors can help to determine appropriate postoperative surveillance.

Background The aim of this study was to evaluate the clinical implications of pathologic complete response (pCR) (i.e., T0N0M0) after neoadjuvant chemoradiation and radical surgery in patients with locally advanced rectal cancer. Materials and Methods A single-center, prospectively maintained colorectal cancer database was queried for patients with primary cII and cIII rectal cancer staged by CT and ERUS/MRI undergoing long-course neoadjuvant chemoradiation followed by proctectomy with curative intent between 1997 and 2007. Patients were stratified into pCR and no-pCR groups and compared with respect to demographics, tumor and treatment characteristics, and oncologic outcomes. Outcomes evaluated were 5-year overall survival, disease-free survival, disease-specific mortality, local recurrence, and distant recurrence. Results The query returned 238 patients (73% male), with a median age of 57 years and median follow-up of 54 months. Of these, 58 patients achieved pCR. Patients with pCR vs no-pCR were statistically comparable with respect to demographics, chemoradiation regimens, tumor distance from anal verge, clinical stage, surgical procedures performed, and follow-up time. No patient with pCR had local recurrence. Overall survival and distant recurrence were also significantly improved for patients achieving pCR. Conclusions Achievement of pCR after neoadjuvant chemoradiation is associated with greatly improved cancer outcomes in locally advanced rectal cancer. Future studies should evaluate the relationship between increases in pCR rates and improvements in cancer outcomes in this population.

Background Disparity exists in outcomes for rectal cancer patients in the US. Similar problems in several European countries have been addressed by the creation of national networks of rectal cancer centers of excellence (CoEs) that follow evidence-based care pathways and specified protocols of care and process and are certified by regular external validation. Aim This paper reviews the current status of rectal cancer care in the US and examines the evidence for multidisciplinary rectal cancer management. A US rectal cancer CoE system based on the existing UK model is proposed. Methods A literature search was performed for publications related to US rectal cancer outcomes, multidisciplinary management of rectal cancer, and European rectal cancer programs. Results US rectal cancer outcomes are highly variable. The majority of US rectal cancer patients are treated by generalists in low-volume hospitals. Current evidence supports five main principles of rectal cancer care that have been incorporated into European rectal cancer CoE programs. These programs have dramatically improved rectal cancer outcomes in Scandanavian countries and the UK. Conclusions A similar CoE program should be established in the US to improve the outcomes of rectal cancer patients.

Background National data indicate that patients with T4N0 colon carcinoma have worse oncologic outcomes than other stage II cases. Our hypothesis was that optimized surgical resection and lymph node staging in a specialized center could eliminate discrepancies in oncologic outcomes within stage II colon carcinomas. Methods Patient characteristics and outcomes after oncologically radical colectomy for pT4N0 were compared to control groups of T1–2N1, T3N1, and T3N0 cases. Group comparisons were adjusted for age, American Society of Anesthesiologists score, tumor location, year of surgery, and duration of follow-up. Cases with at least 12 collected lymph nodes and uninvolved resection margins (R0) were analyzed separately. In addition, the T4a subgroup was compared to both T4b cases with involvement of bowel loops and with infiltration of other organs or structures. Results T4N0 patients had worse oncologic outcomes than T1–2N1 patients and were comparable to T3N1 patients, regardless of margins status or lymph node collection. When a T4b tumor infiltrated bowel, survival and recurrence rates were similar to T4a cases, while T4b tumors involving other organs were associated with increased recurrence rate and reduced survival. Conclusions T4N0 colon carcinoma remains associated with poor oncologic outcomes, regardless of treatment in a specialized center. The biologic aggressiveness of T4N0 colon cancers and the different oncologic outcomes according to specific organ infiltration should be taken into consideration in the choice of adjuvant therapies.

Background Patients with locally advanced or recurrent rectal cancer often require multimodality treatment. Intraoperative radiation therapy (IORT) is a focal approach which aims to improve local control. Methods We retrospectively reviewed 42 patients treated with IORT following definitive resection of a locally advanced or recurrent rectal cancer from 2000–2009. All patients were treated with the Intrabeam® Photon Radiosurgery System (PRS). A dose of 5 Gy was prescribed to a depth of 1 cm (surface dose range: 13.4-23.1, median: 14.4 Gy). Median survival times were calculated using Kaplan-Meier analysis. Results Of 42 patients, 32 had recurrent disease (76%) while 10 had locally advanced disease (24%). Eighteen patients (43%) had tumors fixed to the sidewall. Margins were positive in 19 patients (45%). Median follow-up after IORT was 22 months (range 0.2-101). Median survival time after IORT was 34 months. The 3-year overall survival rate was 49% (43% for recurrent and 65% for locally advanced patients). Local recurrence was evaluable in 34 patients, of whom 32% failed. The 1-year local recurrence rate was 16%. Distant metastasis was evaluable in 30 patients, of whom 60% failed. The 1-year distant metastasis rate was 32%. No intraoperative complications were attributed to IORT. Median duration of IORT was 35 minutes (range: 14–39). Median discharge time after surgery was 7 days (range: 2–59). Hydronephrosis after IORT occurred in 10 patients (24%), 7 of whom had documented concomitant disease recurrence. Conclusions The Intrabeam® PRS appears to be a safe technique for delivering IORT in rectal cancer patients. IORT with PRS marginally increased operative time, and did not appear to prolong hospitalization. Our rates of long-term toxicity, local recurrence, and survival rates compare favorably with published reports of IORT delivery with other methods.

Immunosuppressed patients have an increased risk of developing anal cancer, but little data exists regarding outcomes of this population. A retrospective review of anal cancer patients at a single academic institution from 2006 to 2017 was performed. 19 (14%) of 136 anal cancer patients were immunosuppressed. Immunosuppressed patients were more likely to be hypoalbuminemic (21% vs. 6%, p = 0.025), less likely to complete chemotherapy (58% vs. 80%, p = 0.031) or exhibit a complete response to chemoradiation (57% vs. 82%, p = 0.037), and more likely to experience recurrence (53% vs. 25%, p = 0.013). Hypoalbuminemia was significantly associated with worse overall (HR 6.4, CI 2.2–19.2, p < 0.001) and progression-free (HR 4.4, CI 1.8–10.4, p < 0.001) survival. Immunosuppressed patients have poor tolerance of chemotherapy and response to chemoradiation, and an increased rate of recurrence. This finding is possibly due to the relationship between immunosuppression and hypoalbuminemia, which was associated with worse overall and progression-free survival. •Immunosuppression is a known risk factor for the development of anal cancer.•Immunosuppressed patients have higher rates of anal cancer recurrence.•Malnutrition, common in immunosuppressed patients, is associated with worse survival.

The continent ileostomy (CI) was first described in 1969 as an important advancement in the surgical treatment of patients with ulcerative colitis, providing an option for fecal continence to patients who would otherwise require a conventional ileostomy. The CI enjoyed a brief period of relative popularity during the 1970s before being displaced by today's gold standard for the surgical treatment of ulcerative colitis, the restorative proctocolectomy (ileal pouch–anal anastomosis [IPAA]). Although the CI is only rarely performed today, it still has a role to play in the treatment of patients with inflammatory bowel disease who have failed medical treatment. Current indications are patients with failed IPAAs who are not candidates for redo-IPAA, patients who require total proctocolectomy but cannot be reconstructed with IPAA, and patients with an existing conventional ileostomy that is adversely affecting their quality of life. CI, however, is a complex procedure that carries significant risk of both postoperative complications and the need for reoperation over the long term due to slippage of the nipple valve. Patients being considered for this procedure should undergo extensive preoperative counseling and must have a thorough understanding of the associated risks and a realistic vision of anticipated benefits. In well-selected and properly motivated patients, however, CI can be durable in the majority with long-term pouch survival rates approaching 80%. Published data suggest that these patients enjoy greater quality of life than their counterparts with a conventional ileostomy and that 95% would choose to undergo the procedure again or recommend it to another.

Background Surgical outcome and quality of life (QOL) following perineal proctectomy for rectal prolapse remain poorly documented. Methods From 1994 to 2004, patients with full-thickness rectal prolapse were treated exclusively with perineal proctectomy independent of age or comorbidities. Subjective patient assessments and recurrences were determined retrospectively from hospital and clinic records. Consenting patients completed the gastrointestinal quality of life index (GIQLI). Results Perineal proctectomy was performed in 103 consecutive patients with a median age of 75 years (range 30–94). Most patients underwent concurrent levatorplasty (anterior 85.8%, posterior 67.9%). Durable results were obtained in all patients; the recurrence rate was 8.5% over a mean follow-up of 36 months. Preoperatively, 75.5% of patients reported fecal incontinence, and 32.1% had obstructed defecation. Incontinence significantly improved post-proctectomy (41.5%, p  < 0.001), as did constipation (10.4%, p  < 0.001). GIQLI respondents reported satisfaction following proctectomy with 63% scoring within one standard deviation of healthy controls. Patients with recurrent prolapse reported a lower QOL. Risk factors for recurrence included duration of prolapse, need for posterior levatorplasty, and prior anorectal surgery. Conclusions Perineal proctectomy provides significant relief from fecal incontinence and obstructive symptoms caused by rectal prolapse, with an acceptable recurrence rate and low morbidity.

Background A minimum of 12 examined lymph nodes (LN) is recommended to ensure adequate staging and oncologic resection of patients undergoing proctectomy for rectal adenocarcinoma. However, a decreased number of LN is not unusual in patients receiving neoadjuvant chemoradiation. Purpose We hypothesized that a decreased number of LN in the proctectomy specimen of these patients may be an indicator of tumor response and be associated with improved prognosis. Methods A single-center colorectal cancer database was queried for c-stage II–III rectal cancer patients undergoing neoadjuvant chemoradiation followed by proctectomy between 1997 and 2007. Patients were categorized into two groups according to the number of LN retrieved from the proctectomy specimen: <12 LN versus ≥12 LN. Groups were compared with respect to demographics, tumor and treatment characteristics, and the following oncologic outcomes: overall-survival (OS), cancer-specific-mortality (CSM), cancer-free-survival (CFS), distant (DR), and local recurrences (LR). Results The query returned 237 patients. There were 173 (73 %) males, and the median age was 57 years [interquartile range (IQR) 49–66 years]. The median number of LN retrieved was 15 (IQR 10–23) and 70 (30 %) patients had less than 12 nodes examined. The <12 nodes group was older [60 (IQR 51–71 years) vs. 55 (IQR 48–65 years), p  = 0.009] and had more pathologic complete responders (36 vs. 19 %, p  = 0.01). No <12 nodes patient experienced a LR, whereas the 5-year LR rate was 11 % in the ≥12 nodes group ( p  = 0.004). Other oncologic outcomes were not significantly different. Conclusions Retrieval of less than 12 nodes in the proctectomy specimen of rectal cancer patients treated with neoadjuvant chemoradiation does not affect OS, CSM, CFS, or DR and may be a marker of higher tumor response and, consequently, decreased LR rate.