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Minimally Invasive Proctectomy for Rectal Cancer: A National Perspective on Short-term Outcomes and Morbidity

Taylor, James P; Stem, Miloslawa; Althumairi, Azah A; Gearhart, Susan L; Safar, Bashar; Fang, Sandy H; Efron, Jonathan E
BACKGROUND:Prior randomized trials showed comparable short-term outcomes between open and minimally invasive proctectomy (MIP) for rectal cancer. We hypothesize that short-term outcomes for MIP have improved as surgeons have become more experienced with this technique. METHODS:Rectal cancer patients who underwent elective abdominoperineal resection (APR) or low anterior resection (LAR) were included from the American College of Surgeons National Surgical Quality Improvement Program database (2016-2018). Patients were stratified based on intent-to-treat protocol: open (O-APR/LAR), laparoscopic (L-APR/LAR), robotic (R-APR/LAR), and hybrid (H-APR/LAR). Multivariable logistic regression analysis was used to assess the impact of operative approach on 30-day morbidity. RESULTS:A total of 4471 procedures were performed (43.41% APR and 36.59% LAR); O-APR 42.72%, L-APR 20.99%, R-APR 16.79%, and H-APR 19.51%; O-LAR 31.48%, L-LAR 26.34%, R-LAR 17.48%, and H-LAR 24.69%. Robotic APR and LAR were associated with shortest length of stay and significantly lower conversion rate. After adjusting for other factors, lap, robotic and hybrid APR and LAR were associated with decreased risk of overall morbidity when compared to open approach. R-APR and H-APR were associated with decreased risk of serious morbidity. No difference in the risk of serious morbidity was observed between the four LAR groups. CONCLUSION:Appropriate selection of patients for MIP can result in better short-term outcomes, and consideration for MIP surgery should be made.
PMID: 32383054
ISSN: 1432-2323
CID: 5272492

CRC COVID: Colorectal cancer services during COVID-19 pandemic. Study protocol for service evaluation

Courtney, Alona; Howell, Ann-Marie; Daulatzai, Najib; Savva, Nicos; Warren, Oliver; Mills, Sarah; Rasheed, Shahnawaz; Milind, Goel; Tekkis, Nicholas; Gardiner, Matthew; Dai, Tinglong; Safar, Bashar; Efron, Jonathan E; Darzi, Ara; Tekkis, Paris; Kontovounisios, Christos
INTRODUCTION/BACKGROUND:COVID-19 has had an impact on the provision of colorectal cancer care. The aim of the CRC COVID study is to describe the changes in colorectal cancer services in the UK and USA in response to the pandemic and to understand the long-term impact. METHODS AND ANALYSIS/METHODS:This study comprises 4 phases. Phase 1 is a survey of colorectal units that aims to evaluate adherences and deviations from the best practice guidelines during the COVID-19 pandemic. Phase 2 is a monthly prospective data collection of service provision that aims to determine the impact of the service modifications on the long-term cancer specific outcomes compared to the national standards. Phase 3 aims to predict costs attributable to the modifications of the CRC services and additional resources required to treat patients whose treatment has been affected by the pandemic. Phase 4 aims to compare the impact of COVID-19 on the NHS and USA model of healthcare in terms of service provision and cost, and to propose a standardised model of delivering colorectal cancer services for future outbreaks. ETHICS AND DISSEMINATION/BACKGROUND:This study is a service evaluation and does not require HRA Approval or Ethical Approval in the UK. Local service evaluation registration is required for each participating centre. In the USA, Ethical Approval was granted by the Research and Development Committee. The results of this study will be disseminated to stakeholders, submitted for peer review publications, conference presentations and circulated via social media. REGISTRATION DETAILS/BACKGROUND:Nil.
PMCID:7417919
PMID: 32835148
ISSN: 2468-3574
CID: 5272502

Anal Squamous Cell Carcinoma: Radiation Therapy Alone Must Be Avoided

Almaazmi, Hamda; Taylor, James P; Stem, Miloslawa; Yu, David; Lo, Brian D; Safar, Bashar; Efron, Jonathan E
BACKGROUND:Anal squamous cell carcinoma (ASCC) is the most common histological subtype of anal cancer. Rates have been observed to increase in recent years. Combined chemoradiotherapy (CCRT) is currently the gold standard of treatment. The aim of this study is to assess ASCC prevalence, treatment trends, and overall survival (OS) in the United States. METHODS:Patients diagnosed with stage I-IV ASCC were identified from the National Cancer Database from 2004 to 2015. The primary outcome was 5-year OS, which was analyzed using Kaplan-Meier survival curves, log-rank test, and Cox proportional hazards models. RESULTS:34,613 cases were included (stage I: 21.45%; II: 41.00%; III: 31.62%; IV: 5.94%), with an increasing trend in prevalence. CCRT was the most used treatment. Multimodal treatment, combining surgery with CCRT, offered the best OS rates for stage I, II, and IV cancers (I: 84.87%; II: 75.12%; IV: 33.08%), comparable with survival of stage III patients treated with CCRT (III: 61.14%). Radiation alone had the worse OS rates, and on adjusted analysis, radiation treatment alone had the greatest risk of mortality (I: hazard ratio, 2.01; 95% confidence interval, 1.14-3.54; P = 0.016; II: 2.05, 1.44-2.93, P < 0.001; IV: 1.99, 0.99-4.02, P = 0.054). CONCLUSIONS:ASCC has increased in prevalence, notably in stage III and IV disease. Although CCRT is the most commonly used treatment type for all stages of ASCC, multimodal treatment offers better OS in stages I, II, and IV. Treatment with radiation alone offers the worst OS no matter the stage and should no longer be used as a solitary treatment modality.
PMID: 31648811
ISSN: 1095-8673
CID: 5272462

Comparison of the ViOptix Intra.Ox Near Infrared Tissue Spectrometer and Indocyanine Green Angiography in a Porcine Bowel Model

Khavanin, Nima; Almaazmi, Hamda; Darrach, Halley; Kraenzlin, Franca; Safar, Bashar; Sacks, Justin M
BACKGROUND: This study aims to directly compare measurements of tissue oxygenation obtained using the Intra.Ox (Vioptix Inc., Fremont, CA) near infrared spectrometer with the perfusion assessment of the indocyanine green (ICG)-based SPY Elite imaging system (Stryker Co., Kalamazoo, MI) in a porcine bowel model. METHODS: Two live minipigs underwent laparotomy and isolation of a 30-cm segment of a large bowel. Standardized oximetry measurements were taken along the segment of bowel immediately before, after, and serially for 30 minutes following transection. A 0.5 mg/kg dose of ICG was then injected intravenously and the SPY Elite system was used to visualize and quantify tissue perfusion. Pearson's correlation coefficients were calculated using the outcomes. RESULTS: = 0.645). CONCLUSION/CONCLUSIONS: Both the Intra.Ox and the SPY detected clinically relevant changes in bowel oxygenation following transection and ligation. The use of intravenous ICG dye did not appear to affect measurements of tissue oxygenation obtained using the Intra.Ox.
PMID: 32088921
ISSN: 1098-8947
CID: 5272482

Early Discontinuation of Infliximab in Pregnant Women With Inflammatory Bowel Disease

Truta, Brindusa; Leeds, Ira L; Canner, Joseph K; Efron, Jonathan E; Fang, Sandy H; Althumari, Azah; Safar, Bashar
OBJECTIVES:Early discontinuation of infliximab (IFX) in pregnant women with inflammatory bowel disease (IBD) decreases the intrauterine fetal exposure to the drug but may increase the risk of disease flaring leading to poor pregnancy outcomes. In this study, we assessed the impact of early IFX discontinuation on mother's disease activity and on their at-risk babies. METHODS:In a retrospective study of the Truven Health Analytics MarketScan database from 2011 to 2015, we compared IBD patients who discontinued IFX more than 90 days ("early IFX") with those who discontinue IFX 90 days or less ("late IFX) before delivery. We evaluated the risk of flaring, defined by new steroid prescriptions, visits to emergency room and/or hospital admissions, the pregnancy outcomes, and the at-risk babies. RESULTS:After IFX discontinuation, the early IFX group (68 deliveries) required significantly more steroid prescriptions than the late IFX group (318 deliveries) to control disease activity (P < 001). There were more preterm babies in the early IFX group (P < 049), but no difference within the 2 groups was noticed in the rate of intrauterine growth retardation, small for gestation, and stillborn babies. Similarly, there was no increase in acute respiratory infections, development delays, and congenital malformations in babies of the mothers from the late IFX vs early IFX groups. CONCLUSIONS:Steroid-free remission IBD mothers are at risk for disease flares and preterm babies when IFX is discontinued early in pregnancy. Continuation of IFX seems to be safe at least for the first year of life.
PMID: 31670762
ISSN: 1536-4844
CID: 5272472

Assessing the Effectiveness of External Beam Radiation Therapy when compared to Brachytherapy in Rectal Cancer [Meeting Abstract]

Taylor, James; Eltahir, Ahmed; Stem, Miloslawa; Zhang, George; Narang, Amol; Efron, Jonathan; Safar, Bashar; Atallah, Chady
ISI:000579885400072
ISSN: 0360-3016
CID: 5242172

Local excision for T1 rectal tumours: are we getting better?

Atallah, C; Taylor, J P; Lo, B D; Stem, M; Brocke, T; Efron, J E; Safar, B
AIM:The objective was to assess the effect of three different surgical treatments for T1 rectal tumours, radical resection (RR), open local excision (open LE) and laparoscopic local excision (laparoscopic LE), on overall survival (OS). METHODS:Adults from the National Cancer Database (2008-2016) with a diagnosis of T1 rectal cancer were stratified by treatment type (LE vs RR). We assumed that laparoscopic LE equates to transanal minimally invasive surgery (TAMIS) or transanal endoscopic microsurgery. The primary outcome was 5-year OS. Subgroup analyses of the LE group stratified by time period [2008-2010 (before TAMIS) vs 2011-2016 (after TAMIS)] and approach (laparoscopic vs open) were performed. RESULTS:Among 10 053 patients, 6623 (65.88%) underwent LE (74.33% laparoscopic LE vs 25.67% open LE) and 3430 (34.12%) RR. The use of LE increased from 52.69% in 2008 to 69.47% in 2016, whereas RR decreased (P < 0.001). In unadjusted analysis, there was no significant difference in 5-year OS between the LE and RR groups (P = 0.639) and between the two LE time periods (P = 0.509), which was consistent with the adjusted analysis (LE vs RR, hazard ratio 1.05, 95% CI 0.92-1.20, P = 0.468; 2008-2010 LE vs 2011-2016 LE, hazard ratio 1.09, 95% CI 0.92-1.29, P = 0.321). Laparoscopic LE was associated with improved OS in the unadjusted analysis only (P = 0.006), compared to the open LE group (hazard ratio 0.94, 95% CI 0.78-1.12, P = 0.495). CONCLUSIONS:This study supports the use of a LE approach for T1 rectal tumours as a strategy to reduce surgical morbidity without compromising survival.
PMID: 32886836
ISSN: 1463-1318
CID: 5242142

Aggressive Multimodal Treatment and Metastatic Colorectal Cancer Survival

Zhang, George Q; Taylor, James P; Stem, Miloslawa; Almaazmi, Hamda; Efron, Jonathan E; Atallah, Chady; Safar, Bashar
BACKGROUND:We aimed to assess patient and demographic factors, treatment trends, and survival outcomes of patients with colorectal cancer with metastasis to the liver, lung, or both sites. Differences remain among national guidelines about the optimal management strategy. METHODS:Adults from the National Cancer Database (2010 to 2015) with a primary diagnosis of colorectal liver, lung, or liver and lung metastases were included and stratified by metastasis site. The primary end point was 5-year overall survival, analyzed using Kaplan-Meier survival curves, log-rank test, and the Cox proportional hazards model. RESULTS:Among 82,609 included patients, 70.42% had liver, 8.74% had lung, and 20.85% had simultaneous liver and lung metastases. Treatment with chemotherapy alone was used the most (21.11%), followed by chemotherapy with colorectal radical resection (CRRR) (19.4%), no treatment (14.35%), CRRR alone (9.03%), and chemotherapy with CRRR and liver/lung resection (8.22%). Patients with lung metastasis had significantly better 5-year overall survival rates than the other 2 metastatic groups (15.99%, 16.70%, and 5.51%; p < 0.001), even after stratifying by treatment type and adjusting for other factors. Chemotherapy with CRRR and liver/lung resection was associated with the greatest reduction in mortality risk for all sites in both unadjusted (35.15%, 44.52%, and 20.10%; p < 0.001) and adjusted analyses (hazard ratio 0.42; 95% CI, 0.38 to 0.47; p < 0.001; hazard ratio 0.31; 95% CI, 0.18 to 0.53; p < 0.001; and hazard ratio 0.79; 95% CI, 0.62 to 1.01; p = 0.064 for trend), and forgoing treatment or CRRR alone offered the worst overall survival. CONCLUSIONS:Patients with metastasis to lung had increased overall survival compared with other sites of metastases, regardless of treatment modality. Combined resection of primary tumor, metastasectomy, and chemotherapy appears to offer the greatest chance of survival.
PMID: 32014570
ISSN: 1879-1190
CID: 5239612

Frailer Patients Undergoing Robotic Colectomies for Colon Cancer Experience Increased Complication Rates Compared With Open or Laparoscopic Approaches

Lo, Brian D; Leeds, Ira L; Sundel, Margaret H; Gearhart, Susan; Nisly, Gabriela R C; Safar, Bashar; Atallah, Chady; Fang, Sandy H
BACKGROUND:Minimally invasive surgical techniques are routinely promoted as alternatives to open surgery because of improved outcomes. However, the impact of robotic surgery on certain subsets of the population, such as frail patients, is poorly understood. OBJECTIVE:The purpose of our study was to examine the association between frailty and minimally invasive surgical approaches with colon cancer surgery. DESIGN:This is a retrospective study of prospectively collected outcomes data. Thirty-day surgical outcomes were compared by frailty and surgical approach using doubly robust multivariable logistic regression with propensity score weighting, and testing for interaction effects between frailty and surgical approach. SETTING:Patients undergoing an open, laparoscopic, or robotic colectomy for primary colon cancer, 2012 to 2016, were identified from the American College of Surgeons National Surgical Quality Improvement Program database. PATIENTS:Patients undergoing a colectomy with an operative indication for primary colon cancer were selected. MAIN OUTCOME MEASURES:The primary outcomes measured were 30-day postoperative complications. RESULTS:After propensity score weighting of patients undergoing colectomy, 33.8% (n = 27,649) underwent an open approach versus 34.3% (n = 28,058) underwent laparoscopic surgery versus 31.9% (n = 26,096) underwent robotic surgery. Robotic (OR, 0.53; 95% CI, 0.42-0.69, p < 0.001) and laparoscopic (OR, 0.58; 95% CI, 0.52-0.66, p < 0.001) surgeries were independently associated with decreased rates of major complications. Frailer patients had increased complication rates (OR, 1.56; 95% CI, 1.07-2.25, p = 0.018). When considering the interaction effects between surgical approach and frailty, frailer patients undergoing robotic surgery were more likely to develop a major complication (combined adjusted OR, 3.15; 95% CI, 1.34-7.45, p = 0.009) compared with patients undergoing open surgery. LIMITATIONS:Use of the modified Frailty Index as an associative proxy for frailty was a limitation of this study. CONCLUSIONS:Although minimally invasive surgical approaches have decreased postoperative complications, this effect may be reversed in frail patients. These findings challenge the belief that robotic surgery provides a favorable alternative to open surgery in frail patients. See Video Abstract at http://links.lww.com/DCR/B163. LOS PACIENTES MÁS FRÁGILES SOMETIDOS A COLECTOMÍA ROBÓTICA POR CÁNCER DE COLON EXPERIMENTAN MAYORES TASAS DE COMPLICACIONES EN COMPARACIÓN CON ABORDAJES LAPAROSCÓPICO O ABIERTO: Las técnicas quirúrgicas mínimamente invasivas estan frecuentement promovidas como alternativas a la cirugía abierta debido a sus mejores resultados. Sin embargo, el impacto de la cirugía robótica en ciertos subgrupos de población, como el caso de los pacientes endebles, es poco conocido.El propósito de nuestro estudio fue examinar la asociación entre la fragilidad de los pacientes y el aborgaje quirúrgico mínimamente invasivo para la cirugía de cáncer de colon.Estudio retrospectivo de datos de resultados recolectados prospectivamente. Los resultados quirúrgicos a 30 días se compararon entre fragilidad y abordaje quirúrgico utilizando la regresión logística multivariable doblemente robusta con ponderación de puntaje de propensión y pruebas de efectos de interacción entre fragilidad y abordaje quirúrgico.Los pacientes identificados en la base de datos del Programa Nacional de Mejora de la Calidad Quirúrgica del Colegio Estadounidense de Cirujanos, que fueron sometidos a una colectomía abierta, laparoscópica o robótica por cáncer de colon primario, de 2012 a 2016.Todos aquellos pacientes seleccionados con indicación quirúrgica de cáncer primario de colon que fueron sometidos a una colectomía.Las complicaciones postoperatorias a 30 días.Luego de ponderar el puntaje de propensión de los pacientes colectomizados, el 33.8% (n = 27,649) fué sometido a laparotomía versus el 34.3% (n = 28,058) operados por laparoscopía versus el 31.9% (n = 26,096) operados con tecnica robótica. Las cirugías robóticas (OR 0.53, IC 95% 0.42-0.69, p < 0.001) y laparoscópicas (OR 0.58, IC 95% 0.52-0.66, p < 0.001) se asociaron de forma independiente con una disminución de las tasas de complicaciones mayores. Los pacientes más delicados tenían mayores tasas de complicaciones (OR 1.56, IC 95% 1.07-2.25, p = 0.018). Al considerar los efectos de interacción entre el abordaje quirúrgico y la fragilidad, los pacientes más débiles sometidos a cirugía robótica tenían más probabilidades de desarrollar una complicación mayor (OR ajustado combinado 3.15, IC 95% 1.34-7.45, p = 0.009) en comparación con los pacientes sometidos a cirugía abierta.El uso del índice de fragilidad modificado como apoderado asociativo de la fragilidad.Si bien los abordajes quirúrgicos mínimamente invasivos han disminuido las complicaciones postoperatorias, este efecto puede revertirse en pacientes lábiles. Estos hallazgos desafían la creencia de que la cirugía robótica proporciona una alternativa favorable a la cirugía abierta en pacientes frágiles. Consulte Video Resumen en http://links.lww.com/DCR/B163. (Traducción-Dr. Xavier Delgadillo).
PMID: 32032198
ISSN: 1530-0358
CID: 5239622

The Impact of Imatinib on Survival and Treatment Trends for Small Bowel and Colorectal Gastrointestinal Stromal Tumors

Almaazmi, Hamda; Stem, Miloslawa; Lo, Brian D; Taylor, James P; Fang, Sandy H; Safar, Bashar; Efron, Jonathan E; Atallah, Chady
BACKGROUND:The aim of this study is to assess treatment trends and overall survival (OS) in small bowel (SB) and colorectal (CR) gastrointestinal stromal tumors (GIST) with respect to the introduction of imatinib in 2008. METHODS:Patients diagnosed with SB and CR GIST were identified from the National Cancer Database (2004-2015). The primary outcome was 5- and 10-year OS. Patients were stratified by tumor site, time period (before and after imatinib), and treatment type. OS was analyzed using Kaplan-Meier survival curves, log-rank test, and Cox proportional hazards models. RESULTS:A total of 8441 cases were included (SB 81.66%; CR 18.34%). Radical resection was the most common treatment (SB 42.33%; CR 38.69%). The addition of chemotherapy to radical resection for SB GIST increased between the two time periods (31.76 to 40.43%; p < 0.001), and was associated with improved unadjusted and adjusted OS (2009-2015: adjusted HR [AHR] 0.73, 95% CI 0.59-0.89, p = 0.002). Patients with SB GIST had better 5- and 10-year OS compared with CR (SB 69.83% and 47.68%; CR 61.33% and 45.39%; p < 0.001), even after stratifying by treatment type and tumor size and adjusting for other factors (SB 5-year AHR 1.35, 95% CI 1.19-1.53; 10-year AHR 1.23, 95% CI 1.09-1.38; each p < 0.001). CONCLUSION:CR GIST are associated with lower OS than SB GIST. Radical resection is the most common treatment type for both sites. Chemotherapy with radical resection offers better OS in SB GIST, but not in CR GIST. Further studies are needed to assess the biology of CR GIST to explain the worse OS.
PMID: 31388887
ISSN: 1873-4626
CID: 5239602