Publications

2021

Vajravelu, Ravy K, Lawrence Copelovitch, and Michelle R Denburg. (2021) 2021. “Reply.”. Clinical Gastroenterology and Hepatology : The Official Clinical Practice Journal of the American Gastroenterological Association 19 (9): 1994. https://doi.org/10.1016/j.cgh.2020.11.031.
Han, Samuel, Jennifer M Kolb, Patrick Hosokawa, Chloe Friedman, Charlie Fox, Frank I Scott, Christopher H Lieu, et al. (2021) 2021. “The Volume-Outcome Effect Calls for Centralization of Care in Esophageal Adenocarcinoma: Results From a Large National Cancer Registry.”. The American Journal of Gastroenterology 116 (4): 811-15. https://doi.org/10.14309/ajg.0000000000001046.

INTRODUCTION: Using the National Cancer Database, we assessed the relationship between facility overall esophageal adenocarcinoma (EAC) case volume and survival.

METHODS: We categorized facilities into volume quintiles based on annual EAC patient volume and performed a multivariable Cox proportional hazards regression between facility patient volume and survival.

RESULTS: In a cohort of 116,675 patients, facilities with higher vs lower (≥25 vs 1-4 cases) annual EAC patient volume demonstrated improved survival (adjusted hazard ratio: 0.80. 95% confidence interval: 0.70-0.91).

DISCUSSION: This robust volume-outcome effect calls for centralization of care for EAC patients at high annual case volume facilities.

Vajravelu, Ravy K, Lawrence Copelovitch, and Michelle R Denburg. (2021) 2021. “Reply.”. Clinical Gastroenterology and Hepatology : The Official Clinical Practice Journal of the American Gastroenterological Association 19 (9): 1994. https://doi.org/10.1016/j.cgh.2020.11.031.
Han, Samuel, Jennifer M Kolb, Patrick Hosokawa, Chloe Friedman, Charlie Fox, Frank I Scott, Christopher H Lieu, et al. (2021) 2021. “The Volume-Outcome Effect Calls for Centralization of Care in Esophageal Adenocarcinoma: Results From a Large National Cancer Registry.”. The American Journal of Gastroenterology 116 (4): 811-15. https://doi.org/10.14309/ajg.0000000000001046.

INTRODUCTION: Using the National Cancer Database, we assessed the relationship between facility overall esophageal adenocarcinoma (EAC) case volume and survival.

METHODS: We categorized facilities into volume quintiles based on annual EAC patient volume and performed a multivariable Cox proportional hazards regression between facility patient volume and survival.

RESULTS: In a cohort of 116,675 patients, facilities with higher vs lower (≥25 vs 1-4 cases) annual EAC patient volume demonstrated improved survival (adjusted hazard ratio: 0.80. 95% confidence interval: 0.70-0.91).

DISCUSSION: This robust volume-outcome effect calls for centralization of care for EAC patients at high annual case volume facilities.

Vajravelu, Ravy K, Lawrence Copelovitch, and Michelle R Denburg. (2021) 2021. “Reply.”. Clinical Gastroenterology and Hepatology : The Official Clinical Practice Journal of the American Gastroenterological Association 19 (9): 1994. https://doi.org/10.1016/j.cgh.2020.11.031.
Han, Samuel, Jennifer M Kolb, Patrick Hosokawa, Chloe Friedman, Charlie Fox, Frank I Scott, Christopher H Lieu, et al. (2021) 2021. “The Volume-Outcome Effect Calls for Centralization of Care in Esophageal Adenocarcinoma: Results From a Large National Cancer Registry.”. The American Journal of Gastroenterology 116 (4): 811-15. https://doi.org/10.14309/ajg.0000000000001046.

INTRODUCTION: Using the National Cancer Database, we assessed the relationship between facility overall esophageal adenocarcinoma (EAC) case volume and survival.

METHODS: We categorized facilities into volume quintiles based on annual EAC patient volume and performed a multivariable Cox proportional hazards regression between facility patient volume and survival.

RESULTS: In a cohort of 116,675 patients, facilities with higher vs lower (≥25 vs 1-4 cases) annual EAC patient volume demonstrated improved survival (adjusted hazard ratio: 0.80. 95% confidence interval: 0.70-0.91).

DISCUSSION: This robust volume-outcome effect calls for centralization of care for EAC patients at high annual case volume facilities.

Scott, Frank I, Amneet K Hans, Mark E Gerich, Blair Fennimore, Ronac Mamtani, Ravy K Vajravelu, and James D Lewis. (2021) 2021. “Identification of the Most Effective Position for Ustekinumab in Treatment Algorithms for Crohn’s Disease.”. Clinical Gastroenterology and Hepatology : The Official Clinical Practice Journal of the American Gastroenterological Association 19 (10): 2082-2092.e10. https://doi.org/10.1016/j.cgh.2020.08.021.

BACKGROUND & AIMS: Ustekinumab is a monoclonal antibody against interleukin 12 and interleukin 23 that has been approved by the Food and Drug Administration for treatment of Crohn's disease (CD). We sought to identify the ideal position for ustekinumab in treatment algorithms for CD.

METHODS: We constructed a Markov model to identify an optimal treatment sequence for CD that included ustekinumab for 1 year or more. The base case was a 35-year old male with moderate to severe CD who had not previously received biologic or immunomodulator therapy. The standard of care treatment algorithm was defined as initial therapy with infliximab and azathioprine, followed by adalimumab and azathioprine, vedolizumab, and lastly surgical resection. The model assessed positions for ustekinumab before standard of care, ustekinumab after infliximab and azathioprine but before the remaining treatments, after infliximab, azathioprine, and adalimumab but before vedolizumab and surgery, or after the other biologics but before surgery. We derived transition probabilities and quality adjusted life years (QALYs) from relevant trials, observational studies, and time trade-off analyses. Primary analyses consisted of first order Monte Carlo simulation of 100 trials of cohorts of 100,000 individuals.

RESULTS: Ustekinumab as first-line therapy yielded the greatest QALYs (incremental effectiveness, 0.016-0.020 QALYs), resulting in 10% more patients in remission or response, and 2% fewer surgeries at 1 year, compared with other algorithms. The model was not sensitive to 25% variation in transition probabilities.

CONCLUSIONS: In a simulation based on a 35-year old male patient with moderate to severe CD, we found that ustekinumab as the first-line biologic therapy yields greater QALYs at the end of 1 year than compared with use later in the CD treatment algorithm.

DeJesse, Jeshua, Ravy K Vajravelu, Christina Dudzik, Gillain Constantino, Jessica M Long, Kirk J Wangensteen, Kathleen D Valverde, and Bryson W Katona. (2021) 2021. “Uptake and Outcomes of Small Intestinal and Urinary Tract Cancer Surveillance in Lynch Syndrome.”. World Journal of Clinical Oncology 12 (11): 1023-36. https://doi.org/10.5306/wjco.v12.i11.1023.

BACKGROUND: Lynch syndrome (LS) is a hereditary cancer predisposition syndrome associated with increased risk of multiple cancers. While colorectal cancer surveillance decreases mortality in LS and is recommended by guidelines, there is lack of evidence for the efficacy of surveillance for extra-colonic cancers associated with LS, including small intestinal cancer (SIC) and urinary tract cancer (UTC). Given the limited evidence, guidelines do not consistently recommend surveillance for SIC and UTC, and it remains unclear how often individuals will choose to undergo and follow through with extra-colonic surveillance recommendations.

AIM: To study factors associated with SIC and UTC surveillance uptake and outcomes in LS.

METHODS: This is an IRB-approved retrospective analysis of individuals with LS seen at a tertiary care referral center. Included individuals had a pathogenic or likely pathogenic variant in MLH1, MSH2, MSH6, PMS2, or EPCAM, or were a confirmed obligate carrier, and had at least one documented visit to our center. Information regarding SIC and UTC surveillance was captured for each individual, and detailed personal and family history was obtained for individuals who had an initial LS management visit in our center's dedicated high-risk LS clinic between January 1, 2017 and October 29, 2020. During these initial management visits, all patients had in-depth discussions of SIC and UTC surveillance with 1 of 3 providers experienced in LS management to promote informed decision-making about whether to pursue SIC and/or UTC surveillance. Statistical analysis using Pearson's chi-squared test and Wilcoxon rank-sum test was completed to understand the factors associated with pursuit and completion of SIC and UTC surveillance, and a P value below 0.05 was deemed statistically significant.

RESULTS: Of 317 individuals with LS, 86 (27%) underwent a total of 105 SIC surveillance examinations, with 5 leading to additional work-up and no SICs diagnosed. Additionally, 99 (31%) patients underwent a total of 303 UTC surveillance examinations, with 19 requiring further evaluation and 1 UTC identified. Of 155 individuals who had an initial LS management visit between January 1, 2017 and October 29, 2020, 63 (41%) chose to undergo SIC surveillance and 58 (37%) chose to undergo UTC surveillance. However, only 26 (41%) and 32 (55%) of those who initially chose to undergo SIC or UTC surveillance, respectively, successfully completed their surveillance examinations. Individuals with a pathogenic variant in MSH2 or EPCAM were more likely to initially choose to undergo SIC surveillance (P = 0.034), and older individuals were more likely to complete SIC surveillance (P = 0.007). Choosing to pursue UTC surveillance was more frequent among older individuals (P = 0.018), and females more frequently completed UTC surveillance (P = 0.002). Personal history of cancer and family history of SIC or UTC were not significantly associated with electing nor completing surveillance. Lastly, the provider discussing SIC/UTC surveillance was significantly associated with subsequent surveillance choices.

CONCLUSION: Pursuing and completing SIC/UTC surveillance in LS is influenced by several factors, however broad incorporation in LS management is likely unhelpful due to low yield and frequent false positive results.

Vajravelu, Ravy K, Lawrence Copelovitch, and Michelle R Denburg. (2021) 2021. “Reply.”. Clinical Gastroenterology and Hepatology : The Official Clinical Practice Journal of the American Gastroenterological Association 19 (9): 1994. https://doi.org/10.1016/j.cgh.2020.11.031.
Han, Samuel, Jennifer M Kolb, Patrick Hosokawa, Chloe Friedman, Charlie Fox, Frank I Scott, Christopher H Lieu, et al. (2021) 2021. “The Volume-Outcome Effect Calls for Centralization of Care in Esophageal Adenocarcinoma: Results From a Large National Cancer Registry.”. The American Journal of Gastroenterology 116 (4): 811-15. https://doi.org/10.14309/ajg.0000000000001046.

INTRODUCTION: Using the National Cancer Database, we assessed the relationship between facility overall esophageal adenocarcinoma (EAC) case volume and survival.

METHODS: We categorized facilities into volume quintiles based on annual EAC patient volume and performed a multivariable Cox proportional hazards regression between facility patient volume and survival.

RESULTS: In a cohort of 116,675 patients, facilities with higher vs lower (≥25 vs 1-4 cases) annual EAC patient volume demonstrated improved survival (adjusted hazard ratio: 0.80. 95% confidence interval: 0.70-0.91).

DISCUSSION: This robust volume-outcome effect calls for centralization of care for EAC patients at high annual case volume facilities.