Erlotinib Plus Gemcitabine Compared With Gemcitabine Alone in Patients With Advanced Pancreatic Cancer: A Phase III Trial of the National Cancer Institute of Canada Clinical Trials Group.

PURPOSE: Patients with advanced pancreatic cancer have a poor prognosis and there have been no improvements in survival since the introduction of gemcitabine in 1996. Pancreatic tumors often overexpress human epidermal growth factor receptor type 1 (HER1/EGFR) and this is associated with a worse prognosis. We studied the effects of adding the HER1/EGFR-targeted agent erlotinib to gemcitabine in patients with unresectable, locally advanced, or metastatic pancreatic cancer. PATIENTS AND METHODS: Patients were randomly assigned 1:1 to receive standard gemcitabine plus erlotinib (100 or 150 mg/d orally) or gemcitabine plus placebo in a double-blind, international phase III trial. The primary end point was overall survival. RESULTS: A total of 569 patients were randomly assigned. Overall survival based on an intent-to-treat analysis was significantly prolonged on the erlotinib/gemcitabine arm with a hazard ratio (HR) of 0.82 (95% CI, 0.69 to 0.99; P = .038, adjusted for stratification factors; median 6.24 months v 5.91 months). One-year survival was also greater with erlotinib plus gemcitabine (23% v 17%; P = .023). Progression-free survival was significantly longer with erlotinib plus gemcitabine with an estimated HR of 0.77 (95% CI, 0.64 to 0.92; P = .004). Objective response rates were not significantly different between the arms, although more patients on erlotinib had disease stabilization. There was a higher incidence of some adverse events with erlotinib plus gemcitabine, but most were grade 1 or 2. CONCLUSION: To our knowledge, this randomized phase III trial is the first to demonstrate statistically significantly improved survival in advanced pancreatic cancer by adding any agent to gemcitabine. The recommended dose of erlotinib with gemcitabine for this indication is 100 mg/d.

Use of GLP-1 agonists in high risk patients prior to bariatric surgery: a cohort study.

INTRODUCTION: Body mass index (BMI) > 50 kg/m2 is associated with relatively increased morbidity and mortality with bariatric surgery (BS). There is reluctance to consider these patients operative candidates without preoperative weight loss. Glucagon-like peptide-1 (GLP-1) agonists have demonstrated effective weight loss in the post-BS setting. This study aims to determine the safety and efficacy of GLP-1 agonists in the pre-habilitation of patients with BMI > 50 kg/m2. METHODS: This is a retrospective review of bariatric surgery patients with BMI > 50 kg/m2 from a single bariatric center. Patients were compared by preoperative GLP-1 therapy status. All patients received medical, surgical, psychiatric, and nutritional evaluation and counseling. Preoperative BMI, change in weight from program intake until surgery, time to surgery, and perioperative complications were evaluated. RESULTS: 31 patients were included in the analysis. 18 (58%) received a GLP-1 agonist preoperatively. GLP-1 agonist use was associated with a 5.5 ± 3.2-point reduction in BMI compared to 2.9 ± 2.4 amongst controls (p = 0.026). There was no difference in the mean length of time in the bariatric program prior to surgery between groups (p = 0.332). There were no reported complications related to GLP-1 use in the preoperative setting and no difference in perioperative complications between groups (p = 0.245). DISCUSSION: GLP-1 agonist use in patients with a BMI > 50 kg/m2 results in significantly more weight loss prior to bariatric surgery, without increased time to surgery or complication rate. Further study is required to evaluate the long-term impact of preoperative GLP-1 agonist use prior to bariatric surgery. This therapy may improve perioperative and long-term outcomes in the very high-risk BMI population.

National usage of bariatric surgery for class I obesity: an analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program.

BACKGROUND: National and international consensus statements, as well as the National Institutes of Health (NIH), support the use of bariatric surgery for the treatment of class I obesity. Despite this, most payors within the United States limit reimbursement to the outdated 1991 NIH guidelines or a similar adaptation. OBJECTIVES: This study aimed to determine the safety of bariatric surgery in patients with lower BMI compared with standard patients, as well as determine U.S. utilization of bariatric surgery in class I obesity in 2015-2019. SETTING: A retrospective analysis was performed of the 2015-2019 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database. METHODS: Laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass patients were divided into body mass index cohorts: class I obesity (<35 kg/m2) and severe obesity (≥35 kg/m2). Differences in preoperative patient selection and postoperative outcomes were established, and frequency trends were delineated. RESULTS: Analysis included 760,192 surgeries with 8129 (1%) for patients with class I obesity. The patients with class I obesity were older, more commonly female, and with lower American Society of Anesthesiologists (ASA) class, but with higher rates of type 2 diabetes, hyperlipidemia, and gastroesophageal reflux disease (P < .05). Variation was found for operative time, length of stay, 30-day readmission, and composite morbidity. Minimal annual variation was found for bariatric surgeries performed for patients with class I obesity. CONCLUSIONS: The short-term safety of bariatric surgery in patients with class I obesity was corroborated by this study. Despite consensus statements and robust support, rates of bariatric surgery in patients with class I obesity have failed to increase and remain limited to 1%. This demonstrates the impact of the outdated 1991 NIH guidelines regarding access to care for these potentially life-saving surgeries.

Putting Medical Boots on the Ground: Lessons from the War in Ukraine and Applications for Future Conflict with Near-Peer Adversaries.

In the past 20 years of the Global War on Terror, the US has seen substantial improvements in its system of medical delivery in combat. However, throughout that conflict, enemy forces did not have parity with the weaponry, capability, or personnel of the US and allied forces. War against countries like China and Russia, who are considered near-peer adversaries in terms of capabilities, will challenge battlefield medical care in many different ways. This article reviews the experience of a medical team, Global Surgical and Medical Support Group, that has been providing assistance, training, medical support, and surgical support to Ukraine since the Russian invasion began in February 2022. The team has extensive experience in medicine, surgery, austere environments, conflict zones, and building partner nation capacities. This article compares and contrasts the healthcare systems of this war against the systems used during the Global War on Terror. The lessons learned here could help the US anticipate challenges and successfully plan for the provision of medical care in a future conflict against an adversary with capabilities close to its own.

Why the military committee is important to SAGES?

BACKGROUND: SAGES established a military committee in 2009 and since that time. It may not be readily clear why a traditionally laparoscopic and endoscopic surgical society should have a military committee whose members' primary mission is combat surgery. Military surgeons have a second mission, though, which is to provide care for all its beneficiaries in all the surgical subspecialties. They also have a third mission, which is to train the next generation of military surgeons. The aim of this paper is to discuss the relationship with SAGES that enables the military to succeed in these missions and the benefits it provides to SAGES. METHODS: A historical review of the military committee and its activities since its inception in 2009. RESULTS: Through SAGES, military surgeons have a cost-effective means of developing professionally and receiving education in surgical areas outside of the battlefield arena, which the DOD does not provide. For 13 years, SAGES has also provided an academic venue for research in these specialties. With the addition of military members, SAGES can access more surgeons and surgical innovation like surgery in space and worldwide telemedicine. The military committee also gives SAGES an opportunity to directly contribute to the care of military service members, retirees, and VA beneficiaries, which benefits the United States as a whole. CONCLUSIONS: SAGES and the military have enjoyed a mutually beneficial relationship. The contributions of SAGES have undoubtedly saved and improved US service member and beneficiary lives. It has also improved the education and academic advancements of the military surgeons. SAGES also reaches more surgeons and has another platform for surgical innovation. The relationship should continue and be allowed to grow.

Effect of obesity on outcomes after breast reconstruction surgery, an analysis of national surgical quality improvement program.

BACKGROUND: Obesity is a risk factor for breast cancer and may affect the incidence, and outcomes of surgical treatment for breast cancer, including breast reconstruction. OBJECTIVE: This study aimed to evaluate outcomes of breast reconstruction in patients with obesity. METHODS: In a retrospective review of the NSQIP 2013-2018, adult patients who underwent breast reconstruction were included. Procedures were categorized to with or without an implant. Obesity was considered as body mass index(BMI)≥30 kg/m2. We made composite variables for 30-day any complication, wound complications, and major complications. Regression analysis was used to identify the independent effect of obesity on outcomes. RESULTS: A total of 46,042 patients were included(mean age 51.4 ± 11.1 years, 99.8% female). There were 3134(6.8%) patients with any complication, 2429(5.3%) with major, and 2772(6%) with wound complications, 2795 patients(6.1%) with unplanned re-operation, and 3 deaths. Obesity was an independent predictor of any complication, major complications, and wound complications(OR:1.83-1.87), and unplanned re-operation(OR:1.52). Wound complication was lower in the implant group(3.7% vs 10.9%) but obesity had a higher odds of wound complications in the implant group(2 vs 1.4). There was an increase in the odds of complications as BMI rises. CONCLUSION: Patients with a BMI>30 kg/m2 have a significantly higher risk of developing surgical complications following breast reconstruction with both implant and tissue reconstruction. Weight loss strategies should be considered in patients who need breast reconstruction surgeries and this may decrease the risk of postoperative wound complication and the need for reoperation.

SAGES 2022 guidelines regarding the use of laparoscopy in the era of COVID-19.

BACKGROUND: SARS-CoV-2 has changed global healthcare since the pandemic began in 2020. The safety of minimally invasive surgery (MIS) utilizing insufflation from the standpoint of safety to the operating room personnel is currently being explored. The aims of this guideline are to examine the existing evidence to provide guidance regarding MIS for the patient with, or suspecting of having, the SARS-CoV-2 as well as the healthcare team involved. METHODS: Systematic literature reviews were conducted for 2 key questions (KQ) regarding the safety of MIS in the setting of COVID-19 pandemic. Reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis criteria. Evidence-based recommendations were formulated using a narrative synthesis of the literature by subject experts. Recommendations for future research were also proposed. RESULTS: In KQ1, a total of 1361 articles were reviewed, with 2 articles meeting inclusion. In KQ2, a total of 977 articles were reviewed, with 4 articles met inclusions criteria, of which 2 studies reported on the SARS-CoV2 virus specifically. Despite many publications in the field, very little well-controlled and unbiased data exist to inform the recommendations. Of that which is available, it shows that both laparoscopic and open operations in Covid-positive patients had similar rates of OR staff positivity rates; however, patients who underwent laparoscopic procedures had a lower perioperative mortality than open procedures. Also, SARS-CoV-2 particles have been detected in the surgical plume at laparoscopy. CONCLUSION: With demonstrated equivalence of operating room staff exposure, and noninferiority of laparoscopic access with respect to mortality, either laparoscopic or open approaches to abdominal operations may be used in patients with SARS-CoV-2. Measures should be employed for all laparoscopic or open cases to prevent exposure of operating room staff to the surgical plume, as virus can be present in this plume.

Guidelines for the performance of minimally invasive splenectomy.

BACKGROUND: Minimally invasive splenectomy (MIS) is increasingly favored for the treatment of benign and malignant diseases of the spleen over open access approaches. While many studies cite the superiority of MIS in terms of decreased morbidity and length of stay over a traditional open approach, the comparative effectiveness of specific technical and peri-operative approaches to MIS is unclear. OBJECTIVE: To develop evidence-based guidelines that support clinicians, patients, and others in decisions on the peri-operative performance of MIS. METHODS: A guidelines committee panel of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) including methodologists used the Grading of Recommendations Assessment, Development and Evaluation approach to grade the certainty of evidence and formulate recommendations. RESULTS: Informed by a systematic review of the evidence, the panel agreed on eight recommendations for the peri-operative performance of MIS for adults and children in elective situations addressing six key questions. CONCLUSIONS: Conditional recommendations were made in favor of lateral positioning for non-hematologic disease, intra-operative platelet administration for patients with idiopathic thrombocytopenic purpura instead of preoperative administration, and the use of mechanical devices to control the splenic hilum. Further, a conditional recommendation was made against routine intra-operative drain placement.

Laparoscopic splenectomy as a definitive management option for high-grade traumatic splenic injury when non operative management is not feasible or failed: a 5-year experience from a level one trauma center with minimally invasive surgery expertise.

Technique, indications and outcomes of laparoscopic splenectomy in stable trauma patients have not been well described yet. All hemodynamically non-compromised abdominal trauma patients who underwent splenectomy from 1/2013 to 12/2017 at our Level 1 trauma center were included. Demographic and clinical data were collected and analysed with per-protocol and an intention-to-treat comparison between open vs laparoscopic groups. 49 splenectomies were performed (16 laparoscopic, 33 open). Among the laparoscopic group, 81% were successfully completed laparoscopically. Laparoscopy was associated with a higher incidence of concomitant surgical procedures (p 0.016), longer operative times, but a significantly faster return of bowel function and oral diet without reoperations. No significant differences were demonstrated in morbidity, mortality, length of stay, or long-term complications, although laparoscopic had lower surgical site infection (0 vs 21%).The isolated splenic injury sub-analysis included 25 splenectomies,76% (19) open and 24% (6) laparoscopic and confirmed reduction in post-operative morbidity (40 vs 57%), blood transfusion (0 vs 48%), ICU admission (20 vs 57%) and overall LOS (7 vs 9 days) in the laparoscopic group. Laparoscopic splenectomy is a safe and effective technique for hemodynamically stable patients with splenic trauma and may represent an advantageous alternative to open splenectomy in terms of post-operative recovery and morbidity.

Canadian Society of Thoracic Radiology/Canadian Association of Radiologists Clinical Practice Guidance for Non-Vascular Thoracic MRI.

Historically thoracic MRI has been limited by the lower proton density of lung parenchyma, cardiac and respiratory motion artifacts and long acquisition times. Recent technological advancements in MR hardware systems and improvement in MR pulse sequences have helped overcome these limitations and expand clinical opportunities for non-vascular thoracic MRI. Non-vascular thoracic MRI has been established as a problem-solving imaging modality for characterization of thymic, mediastinal, pleural chest wall and superior sulcus tumors and for detection of endometriosis. It is increasingly recognized as a powerful imaging tool for detection and characterization of lung nodules and for assessment of lung cancer staging. The lack of ionizing radiation makes thoracic MRI an invaluable imaging modality for young patients, pregnancy and for frequent serial follow-up imaging. Lack of familiarity and exposure to non-vascular thoracic MRI and lack of consistency in existing MRI protocols have called for clinical practice guidance. The purpose of this guide, which was developed by the Canadian Society of Thoracic Radiology and endorsed by the Canadian Association of Radiologists, is to familiarize radiologists, other interested clinicians and MR technologists with common and less common clinical indications for non-vascular thoracic MRI, discuss the fundamental imaging findings and focus on basic and more advanced MRI sequences tailored to specific clinical questions.

Postoperative sepsis after primary bariatric surgery: an analysis of MBSAQIP.

BACKGROUND: Identifying patients at higher risk of postoperative sepsis (PS) may help to prevent this life-threatening complication. OBJECTIVES: This study aimed to identify the rate and predictors of PS after primary bariatric surgery. SETTING: An analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) 2015-2017. METHODS: Patients undergoing elective sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) were included. Exclusion criteria were revisional, endoscopic, and uncommon, or investigational procedures. Patients were stratified by the presence or absence of organ/space surgical site infection (OS-SSI), and patients who developed sepsis were compared with patients who did not develop sepsis in each cohort. Logistic regression was used to identify independent predictors of PS. RESULTS: In total, 438,752 patients were included (79.4% female, mean age 44.6±12 years). Of those, 661 patients (.2%) developed PS of which 245 (37.1%) developed septic shock. Out of 892 patients with organ/space surgical site infections (OS-SSI), 298 (45.1%) developed sepsis (P <.001). Patients who developed PS had higher mortality (8.8% versus .1%, P < .001), and this was highest in patients without OS-SSI (11.8% versus 5%, P = .002). The main infectious complications associated with PS in patients without OS-SSI were pneumonia and urinary tract infection. Independent predictors of PS in OS-SSI included RYGB versus SG (OR, 1.8), and age ≥50 years (OR, 1.4). Independent predictors of PS in patients without OS-SSI were conversion to other approaches (OR, 6), operation length >2 hours (OR, 5.7), preoperative dialysis (OR, 4.1), preoperative therapeutic anticoagulation (OR, 2.8), limited ambulation most or all of the time (OR, 2.4), preoperative venous stasis (OR, 2.4), previous nonbariatric foregut surgery (OR, 2), RYGB versus SG (OR, 2), hypertension on medication (OR, 1.5), body mass index ≥50 kg/m2(OR, 1.4), age ≥50 years (OR, 1.3), obstructive sleep apnea (OR, 1.3). CONCLUSION: Development of OS-SSI after primary bariatric surgery is associated with sepsis and increased 30-day mortality. Patients without OS-SSI who develop PS have a significantly higher mortality rate compared with patients with OS-SSI who develop PS. Early identification and intervention in patients with PS, including those without OS-SSI, may improve survival in this high-risk group.

Phyllodes Tumors-The Predictors and Detection of Recurrence.

BACKGROUND: Phyllodes tumors are rare breast neoplasms and the histopathological grade and surgical margins help guide treatment and follow-up. The traditional surgical teaching is resection with ≥10 mm margins, but are narrower surgical margins acceptable? The purpose of our study was to identify predictors of local recurrence. METHODS: A retrospective analysis was performed to identify patients with phyllodes tumors who underwent surgery between 2002 and 2014 using a regional pathology database. Electronic medical records were used to identify surgical management, pathological characteristics, and follow-up encounters. RESULTS: A total of 150 phyllodes tumors were included: 110 of 150 (73%) benign, 21 of 150 (14%) borderline, and 19 of 150 (13%) malignant. At initial surgery, 29 specimens had a positive margin and 15 (56%) underwent re-excision. Seventy tumors had a surgical margin of ≤1 mm, 40 had a margin of 2 to 9 mm, and 11 had a margin of ≥10 mm. There were 11 of 150 (7.3%) locally recurrent tumors: 5 of 11 (45%) benign, 3 of 11 (27%) borderline, and 3 of 11 (27%) malignant. In total, 10 of 11 locally recurrent tumors had a positive margin or ≤1 mm margin at initial surgery. CONCLUSIONS: Phyllodes tumors can have a personalized treatment approach based on histopathological grade and surgical margins. Borderline and malignant phyllodes tumors with a positive or ≤1 mm surgical margin have an increased risk of recurrence. In benign phyllodes tumors, an optimal narrow negative margin may exist but the traditional ≥10 mm excisional margin is not necessary. Local recurrence rates may be sufficiently low in benign phyllodes tumors that imaging can be performed on the presence of clinical symptoms.

Time to weigh in on obesity and associated comorbidities in combat-wounded amputees.

BACKGROUND: The Joint Trauma System database estimates that about 1,200 individuals have sustained a combat-related amputation during the Global War on Terror. Previous retrospective studies have demonstrated that combat-related amputees develop obesity and cardiovascular disease, but the incidence of obesity and associated comorbidities in this population is unknown. The objectives of this study are to determine the prevalence of obesity in the military amputee population and to compare this with the general population. METHODS: This is a retrospective review of 978 patients who sustained a combat-related amputation from 2003 to 2014. Prevalence of obesity and comorbid conditions were determined. A multivariate logistic regression model was performed to identify risk factors for postamputation obesity. Kaplan-Meier curves were constructed using obesity as the event of interest. RESULTS: A total of 1,233 charts were reviewed with 978 patients included for analysis. The median age of injury was 24 years. Median follow-up time was 8.7 years, ranging from 0.5 years to 16.9 years. The average Injury Severity Score was 23.3. The average body mass index preinjury was 25.6 kg/m2, and the average most recent corrected body mass index was found to be 31.4 kg/m2. Prevalence of comorbidities was higher in the amputee population. Fifty percent of patients who progressed to obesity did so within 1.3 years. CONCLUSION: There is a notable prevalence of obesity that develops in the amputee population that is much higher than the general population. We determined that the amputee population is at risk, and these patients should be closely monitored for 1 to 2.5 years following injury. This study provides a targeted period for which monitoring and intervention can be implemented. LEVEL OF EVIDENCE: Retrospective, basic science, outcomes analysis, level III/IV.

Advancing Therapeutic Development for Pulmonary Morbidities Associated with Preterm Birth.

Chronic pulmonary and respiratory conditions associated with preterm birth are incompletely characterized, complicating long-term treatment and development of more effective therapies. Stakeholders face challenges in the development of validated, clinically meaningful endpoints that adequately measure morbidities and predict or represent health outcomes for preterm neonates. We propose in this paper a research agenda, informed by the input of experts from a 2018 workshop we convened on this topic, to advance endpoint and treatment development. We discuss the necessity of further evaluation of existing endpoints and the improved characterization of disease endotypes. We also discuss key steps to the development of optimized short- and long-term endpoints that can be linked to meaningful health outcomes. Finally, we discuss the importance of limiting variability in data collection and the application of new clinical trial endpoints as well as the critical nature of multi-stakeholder collaboration to advancing therapeutic development for this vulnerable patient population.

Is the minimally invasive trauma surgeon the next (r)evolution of trauma surgery? Indications and outcomes of diagnostic and therapeutic trauma laparoscopy in a level 1 trauma centre.

The aim of this study was to evaluate the trend in use, feasibility and safety of laparoscopy in a single level 1 European trauma centre. Laparoscopy in abdominal trauma is gaining acceptance as a diagnostic and a therapeutic tool as it reduces surgical invasiveness and may reduce post-operative morbidity. All trauma patients who underwent a laparoscopic procedure between January 2013 and December 2017 were retrospectively analysed. A sub-analysis of isolated abdominal trauma was also performed. There has been a significant increase in the use of this technique in the considered time period. A total of 40 patients were included in the study: 17 diagnostic laparoscopies and overall 32 therapeutic laparoscopies. Conversion rate was 15%. All patients were hemodynamically stable. The majority of patients were younger than 60 years, with an ASA score of I-II and sustained a blunt trauma. Mean ISS score was 17. Colon and diaphragm were the most commonly laparoscopically diagnosed injuries, while splenectomy was the most common operation. The average operating time was 106 min. There were no missed injuries, no SSI, no re-interventions and no mortality related to the surgical procedure. The average length of stay was 14 days. No significant difference was found in the isolated abdominal trauma group. Laparoscopy is an emergent safe and effective technique for both diagnostic and therapeutic purposes in selected stable abdominal penetrating or blunt trauma patients. However, these results need to be put in relation with the level of the centre and the expertise of the surgeon.

Safe surgery in the elderly: A review of outcomes following robotic proctectomy from the Nationwide Inpatient Sample in a cross-sectional study.

BACKGROUND: As our nation's population ages, operating on older and sicker patients occurs more frequently. Robotic operations have been thought to bridge the gap between a laparoscopic and an open approach, especially in more complex cases like proctectomy. METHODS: Our objective was to evaluate the use and outcomes of robotic proctectomy compared to open and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed. All cases were restricted to age 70 years old or greater. RESULTS: We identified 6740 admissions for rectal cancer including: 5879 open, 666 laparoscopic, and 195 robotic procedures. The median age was 77 years old. The incidence of a robotic proctectomy increased by 39%, while the open approach declined by 6% over the time period studied. Median (interquartile range) length of stay was shorter for robotic procedures at 4.3 (3-7) days, compared to laparoscopic 5.8 (4-8) and open at 6.7 (5-10) days (p < 0.01), while median total hospital charges were greater in the robotic group compared to laparoscopic and open cases ($64,743 vs. $55,813 vs. $50,355, respectively, p < 0.01). There was no significant difference in the risk of total complications between the different approaches following multivariate analysis. CONCLUSION: Robotic proctectomy was associated with a shorter LOS, and this may act as a surrogate marker for an overall improvement in adverse events. These results demonstrate that a robotic approach is a safe and feasible option, and should not be discounted solely based on age or comorbidities.

Phase II APEC trial: The impact of primary tumor side on outcomes of first-line cetuximab plus FOLFOX or FOLFIRI in patients with RAS wild-type metastatic colorectal cancer.

AIM: The open-label, nonrandomized, phase II APEC study enrolled 167 patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) to investigate the safety and efficacy of first-line, every-2-weeks cetuximab plus investigator's choice of FOLFIRI or FOLFOX in this patient population. METHODS: A subgroup analysis of the APEC study population by primary tumor location was performed. RESULTS: A total of 130 patients (81.8%) had left-sided and 29 (18.2%) had right-sided mCRC. Median progression-free survival (PFS), overall survival (OS) and overall response rate (ORR) were 14.0 months, 30.6 months and 68.5% for patients with left-sided tumors and 8.9 months, 24.6 months and 51.7% for patients with right-sided mCRC, concurring with pivotal phase III trial results. In patients with right-sided tumors, median PFS was 15.4 months vs 8.3 months with cetuximab plus FOLFIRI vs cetuximab plus FOLFOX, respectively; median OS was 32.1 months vs 21.8 months with cetuximab plus FOLFIRI vs cetuximab plus FOLFOX, respectively. CONCLUSION: The APEC tumor-location subgroup analysis results were largely consistent with available literature regarding the equivalent efficacy of cetuximab plus FOLFIRI/FOLFOX in patients with left-sided RAS wt mCRC. A trend toward improved efficacy with cetuximab plus FOLFIRI compared with cetuximab plus FOLFOX was observed in patients with right-sided tumors; however, a direct comparison between groups cannot be made due to the nonrandomized study design. Nevertheless, the similar ORR observed with either chemotherapy backbone in patients with right-sided RAS wt mCRC suggests a potential role for both regimens in this patient population when cytoreduction is a treatment goal.