Cost drivers of locally advanced rectal cancer treatment-An analysis of a leading healthcare insurer.

To evaluate the economic burden of locally advanced rectal cancer (LARC) treatment from a society perspective through analysis of health insurance-derived data of commercially insured and Medicare Advantage (MA) patients. Retrospective cost analysis of patients undergoing rectal resection within a multimodal (neoadjuvant chemoradiation + adjuvant chemotherapy) treatment strategy between January 1, 2010 and October 31, 2018, using the claims OptumLabs Data Warehouse database. In total, 1738 (935 commercial and 803 MA) patients were included. Overall treatment costs totaled $230,881,746 (on average$183 653 ± 82 384 per commercially insured and $73 681 ± 32 917 per MA patient). Cost distribution according to category (commercially insured patients) was: 29.92% related to outpatient care (follow-up visits/diagnostics), radiotherapy: 21.83%, index resection: 20.62%, chemotherapy: 17.44%, surgical inpatient: 6.32%, medical inpatient: 3.28%, emergency room: 0.58%. Relative cost distribution of the index resection itself differed marginally between the three approaches and was 21.49% for open, 19.30% for laparoscopic, and 20.93% for robotic surgery. Relative cost distributions of neoadjuvant, adjuvant, and outpatient treatments remained unchanged, independently of the surgical approach. This representation was similar in MA patients. Index-surgery related costs were outweighed by costs related to oncological and outpatient workup/follow-up treatments independently of both surgical approach and insurance type

Contemporary Management of Locally Advanced and Recurrent Rectal Cancer: Views from the PelvEx Collaborative

Pelvic exenteration is a complex operation performed for locally advanced and recurrent pelvic cancers. The goal of surgery is to achieve clear margins, therefore identifying adjacent or involved organs, bone, muscle, nerves and/or vascular structures that may need resection. While these extensive resections are potentially curative, they can be associated with substantial morbidity. Recently, there has been a move to centralize care to specialized units, as this facilitates better multi-disciplinary care input. Advancements in pelvic oncology and surgical innovation have redefined the boundaries of pelvic exenterative surgery. Combined with improved neoadjuvant therapies, advances in diagnostics, and better reconstructive techniques have provided quicker recovery and better quality of life outcomes, with improved survival This article provides highlights of the current management of advanced pelvic cancers in terms of surgical strategy and potential future developments

Induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer: Study protocol of a multicentre, open-label, parallel-arms, randomized controlled study (PelvEx II)

Background: A resection with clear margins (R0 resection) is the most important prognostic factor in patients with locally recurrent rectal cancer (LRRC). However, this is achieved in only 60 per cent of patients. The aim of this study is to investigate whether the addition of induction chemotherapy to neoadjuvant chemo(re)irradiation improves the R0 resection rate in LRRC. Methods: Thismulticentre, international, open-label, phase III, parallel-arms study will enrol 364 patients with resectable LRRC after previous partial or total mesorectal resection without synchronous distant metastases or recent chemo- and/or radiotherapy treatment. Patients will be randomized to receive either induction chemotherapy (three 3-week cycles of CAPOX (capecitabine, oxaliplatin), four 2- week cycles of FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) or FOLFORI (5-fluorouracil, leucovorin, irinotecan)) followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm). Tumours will be restaged usingMRI and, in the experimental arm, a further cycle of CAPOX or two cycles of FOLFOX/FOLFIRI will be administered before chemoradiotherapy in case of stable or responsive disease. The radiotherapy dose will be 25 × 2.0 Gy or 28 × 1.8Gy in radiotherapy-naive patients, and 15 × 2.0Gy in previously irradiated patients. The concomitant chemotherapy agent will be capecitabine administered twice daily at a dose of 825mg/m2 on radiotherapy days. The primary endpoint of the study is the R0 resection rate. Secondary endpoints are long-termoncological outcomes, radiological and pathological response, toxicity, postoperative complications, costs, and quality of life. Discussion: This trial protocol describes the PelvEx II study. PelvEx II, designed as a multicentre, open-label, phase III, parallel-arms study, is the first randomized study to compare induction chemotherapy followed by neoadjuvant chemo(re)irradiation and surgery with neoadjuvant chemo(re)irradiation and surgery alone in patients with locally recurrent rectal cancer, with the aim of improving the number of R0 resections

Induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer: study protocol of a multicentre, open-label, parallel-arms, randomized controlled study (PelvEx II)

Background A resection with clear margins (R0 resection) is the most important prognostic factor in patients with locally recurrent rectal cancer (LRRC). However, this is achieved in only 60 per cent of patients. The aim of this study is to investigate whether the addition of induction chemotherapy to neoadjuvant chemo(re)irradiation improves the R0 resection rate in LRRC. Methods This multicentre, international, open-label, phase III, parallel-arms study will enrol 364 patients with resectable LRRC after previous partial or total mesorectal resection without synchronous distant metastases or recent chemo- and/or radiotherapy treatment. Patients will be randomized to receive either induction chemotherapy (three 3-week cycles of CAPOX (capecitabine, oxaliplatin), four 2-week cycles of FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) or FOLFORI (5-fluorouracil, leucovorin, irinotecan)) followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm). Tumours will be restaged using MRI and, in the experimental arm, a further cycle of CAPOX or two cycles of FOLFOX/FOLFIRI will be administered before chemoradiotherapy in case of stable or responsive disease. The radiotherapy dose will be 25 × 2.0 Gy or 28 × 1.8 Gy in radiotherapy-naive patients, and 15 × 2.0 Gy in previously irradiated patients. The concomitant chemotherapy agent will be capecitabine administered twice daily at a dose of 825 mg/m2 on radiotherapy days. The primary endpoint of the study is the R0 resection rate. Secondary endpoints are long-term oncological outcomes, radiological and pathological response, toxicity, postoperative complications, costs, and quality of life. Discussion This trial protocol describes the PelvEx II study. PelvEx II, designed as a multicentre, open-label, phase III, parallel-arms study, is the first randomized study to compare induction chemotherapy followed by neoadjuvant chemo(re)irradiation and surgery with neoadjuvant chemo(re)irradiation and surgery alone in patients with locally recurrent rectal cancer, with the aim of improving the number of R0 resections

Surgical Management of Dysplasia and Cancer in Inflammatory Bowel Disease.

Patients with inflammatory bowel disease are at an increased risk of cancer secondary to long-standing intestinal inflammation. Surgical options must take into account the significant risk of synchronous disease at other colonic sites. Ileal pouch anal anastomosis is a viable option for patients with ulcerative colitis, but this should be restricted to early cancers that are unlikely to require preoperative or postoperative radiation treatment

Risk factors for conversion in laparoscopic and robotic rectal cancer surgery.

The aim of this study was to review risk factors for conversion in a cohort of patients with rectal cancer undergoing minimally invasive abdominal surgery. A retrospective analysis was performed of consecutive patients operated on from February 2005 to April 2018. Adult patients undergoing low anterior resection or abdominoperineal resection for primary rectal adenocarcinoma by a minimally invasive approach were included. Exclusion criteria were lack of research authorization, stage IV or recurrent rectal cancer, and emergency surgery. Risk factors for conversion were investigated using logistic regression. A subgroup analysis of obese patients (BMI 30 kg/m <sup>2</sup> or more) was performed. A total of 600 patients were included in the analysis. The overall conversion rate was 9·2 per cent. Multivariable analysis showed a 72 per cent lower risk of conversion when patients had robotic surgery (odds ratio (OR) 0·28, 95 per cent c.i. 0·15 to 0·52). Obese patients experienced a threefold higher risk of conversion compared with non-obese patients (47 versus 24·4 per cent respectively; P < 0·001). Robotic surgery was associated with a reduced risk of conversion in obese patients (OR 0·22, 0·07 to 0·71). Robotic surgery was associated with a lower risk of conversion in patients undergoing minimally invasive rectal cancer surgery, in both obese and non-obese patients

Short-term postoperative outcomes following robotic versus laparoscopic ileal pouch-anal anastomosis are equivalent.

Minimally invasive approaches have become the standard of care for ileal pouch-anal anastomoses (IPAA). There are few reports comparing outcomes following a laparoscopic versus robotic approach. Our aim was to determine if there were any differences in the 30-day postoperative outcomes following IPAA performed laparoscopically versus robotically. A retrospective chart review of all laparoscopic and robotic IPAA performed between January 1, 2015 and June 30, 2018 was carried out. Patients included were adult patients who underwent a proctectomy and IPAA utilizing either a laparoscopic or robotic approach. Data collected included patient demographics, operative variables, and 30-day postoperative outcomes. A total of 132 patients had a minimally invasive IPAA; 58 were performed laparoscopically and 74 robotically. Less than half the patients were female (n = 55; 41.7%) with a median age of 37 years (range 18-68 years). The majority of patients had a diagnosis of ulcerative colitis (n = 103; 78.0%) with medically refractory disease (n = 87; 65.9%). A greater proportion of patients in the laparoscopic cohort had a prolonged length of stay (n = 27; 46.6% versus n = 18; 24.3%; p < 0.001) and a two-stage approach (n = 56; 96.6% versus n = 37; 50%; p < 0.001), but there were no differences in the rates between the laparoscopic versus robotic cohorts of superficial surgical site infection (6.9% versus 6.8%; p = 0.99), peripouch abscess (15.5% versus 6.8%; p = 0.11), anastomotic leak (6.9% versus 2.7%; p = 0.21), pelvic abscess (15.5% versus 6.8%; p = 0.11), and pelvic sepsis (15.5% versus 6.8%; p = 0.11), readmission (24.1% versus 17.6%; p = 0.35) or reoperation (6.9% versus 5.4%; p = 0.72). On multivariable analysis, only male sex remained predictive of prolonged length of stay, and a robotic approach trended toward a decreased rate of prolonged length of stay. Laparoscopic and robotic IPAA have equivalent postoperative morbidity underscoring the safety of the continued expansion of the robotic platform for pouch surgery

Robotic Surgery for Rectal Cancer Provides Advantageous Outcomes Over Laparoscopic Approach: Results From a Large Retrospective Cohort.

To compare short term outcomes of patients undergoing laparoscopic or robotic rectal cancer surgery. Significant benefits of robotic rectal cancer surgery over laparoscopy have yet to be demonstrated. Operative time and direct institutional cost seem in favor of the laparoscopic approach. We performed a retrospective review of consecutive patients operated on for rectal cancer with a mini-invasive approach at Mayo Clinic from 2005 to 2018. The primary aim of this study was to investigate the difference in postoperative morbidity between the laparoscopic and robotic approach. Multivariable models for odds to complications and prolonged (≥6 days) length of stay were built. A total of 600 patients were included in the analysis. The number of patients undergoing robotic surgery was 317 (52.8%). The 2 groups were similar in respect to age, sex, and body mass index. Laparoscopic surgery was correlated to shorter operative time (214 vs 324 minutes; P < 0.001). Patients undergoing robotic surgery had a lower overall complications rate (37.2% vs 51.2%; P < 0.001). Robotic surgery was found to be the most protective factor [odds ratio (OR) 0.485; P = 0.006] for odds to complications. The event of a complication (OR 9.33; P < 0.001) and conversion to open surgery (OR 3.095; P = 0.002) were identified as risk factors for prolonged length of stay whereas robotic surgery (OR 0.62; P = 0.027) was the only independent protective factor. Robotic rectal cancer surgery is strongly associated with better short-term outcomes over laparoscopic surgery

Impact of enhanced recovery on oncological outcomes following minimally invasive surgery for rectal cancer.

Oncological outcomes of locally advanced rectal cancer depend on the quality of surgical and oncological management. Enhanced recovery pathways (ERPs) have yet to be assessed for their oncological impact when used in combination with minimally invasive surgery. This study assessed outcomes with or without an ERP in patients with rectal cancer. This was a retrospective analysis of all consecutive adult patients who underwent elective minimally invasive surgery for primary rectal adenocarcinoma with curative intent between February 2005 and April 2018. Both laparoscopic and robotic procedures were included. Short-term morbidity and overall survival were compared between patients treated according to the institutional ERP and those who received conventional care. A total of 600 patients underwent minimally invasive surgery, of whom 320 (53·3 per cent) were treated according to the ERP and 280 (46·7 per cent) received conventional care. ERP was associated with less overall morbidity (34·7 versus 54·3 per cent; P < 0·001). Patients in the ERP group had improved overall survival on univariable (91·4 versus 81·7 per cent at 5 years; hazard ratio (HR) 0·53, 95 per cent c.i. 0·28 to 0·99) but not multivariable (HR 0·78, 0·41 to 1·50) analysis. Multivariable analysis revealed age (HR 1·46, 1·17 to 1·82), male sex (HR 1·98, 1·05 to 3·70) and complications (HR 2·23, 1·30 to 3·83) as independent risk factors for compromised overall survival. Disease-free survival was comparable for patients who had ERP or conventional treatment (80·5 versus 84·6 per cent at 5 years respectively; P = 0·272). Treatment within an ERP was associated with a lower morbidity risk that may have had a subtle impact on overall but not disease-specific survival

The extent of colorectal resection and short-term outcomes in patients with ulcerative colitis.

There is limited literature on the impact of the extent of resection on short-term outcomes in patients with ulcerative colitis (UC) in an elective setting. The aim of this study was to better understand the impact of approach and extent of resection on short-term outcomes for patients undergoing total proctocolectomy (TPC) and subtotal colectomy (STC) for UC. Patients with UC who underwent elective TPC or STC were captured from the ACS-NSQIP® 2011-2018 database and divided into four cohorts: Open TPC (O-TPC), Laparoscopic TPC (L-STC), Open STC (O-STC), and Laparoscopic STC (L-STC). Baseline and perioperative variables were compared between the four groups alongside 30-day mortality and 30-day complication rates. Of 3387 patients, 368 (10.9%) underwent O-STC, 406 (12%) underwent O-TPC, 1958 (58%) underwent L-STC, and 655 (19%) underwent L-TPC. Overall rate of prolonged length of stay (LOS) was 27% and 9% needed a blood transfusion. There was no difference in the risk of complications between open TPC and open STC. Those who had open surgery had a higher risk of complications and prolonged LOS. Patients who had L-TPC had prolonged LOS compared to patients who had L-STC, but less compared to those who had O-STC. Elective surgery for UC is associated with high rates of prolonged LOS and blood transfusion despite MIS approaches. Short-term outcomes and LOS are more impacted by the operative approach than the extent of resection. Despite this laparoscopic TPC has higher rates of prolonged LOS when compared to laparoscopic STC