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1. Outcomes of Distal Rectal Cancer Patients Who Did Not Qualify for Watch-and-Wait: Comparison of Intersphincteric Resection Versus Abdominoperineal Resection

Author

Feferman, Yael, Verheij, Floris S., Williams, Hannah, Omer, Dana M., Pappou, Emmanouil P., Wei, Iris H., Widmar, Maria, Nash, Garrett M., Paty, Philip B., Smith, J. Joshua, Cercek, Andrea, Yaeger, Rona, Segal, Neil H., Romesser, Paul B., Crane, Christopher, Saltz, Leonard B., Weiser, Martin R., and Garcia-Aguilar, Julio

Published
2024
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3. Long-Term Results of Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy: The Randomized Phase II OPRA Trial

Author

Verheij, Floris S, Omer, Dana M, Williams, Hannah, Lin, Sabrina T, Qin, Li-Xuan, Buckley, James T, Thompson, Hannah M, Yuval, Jonathan B, Kim, Jin K, Dunne, Richard F, Marcet, Jorge, Cataldo, Peter, Polite, Blase, Herzig, Daniel O, Liska, David, Oommen, Samuel, Friel, Charles M, Ternent, Charles, Coveler, Andrew L, Hunt, Steven, Gregory, Anita, Varma, Madhulika G, Bello, Brian L, Carmichael, Joseph C, Krauss, John, Gleisner, Ana, Guillem, José G, Temple, Larissa, Goodman, Karyn A, Segal, Neil H, Cercek, Andrea, Yaeger, Rona, Nash, Garrett M, Widmar, Maria, Wei, Iris H, Pappou, Emmanouil P, Weiser, Martin R, Paty, Philip B, Smith, J Joshua, Wu, Abraham J, Gollub, Marc J, Saltz, Leonard B, and Garcia-Aguilar, Julio

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Rare Diseases, Radiation Oncology, Clinical Trials and Supportive Activities, Clinical Research, Orphan Drug, Patient Safety, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Humans, Adenocarcinoma, Chemoradiotherapy, Neoadjuvant Therapy, Neoplasm Recurrence, Local, Neoplasm Staging, Organ Preservation, Rectal Neoplasms, Treatment Outcome, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.To assess long-term risk of local tumor regrowth, we report updated organ preservation rate and oncologic outcomes of the OPRA trial (ClinicalTrials.gov identifier: NCT02008656). Patients with stage II/III rectal cancer were randomly assigned to receive induction chemotherapy followed by chemoradiation (INCT-CRT) or chemoradiation followed by consolidation chemotherapy (CRT-CNCT). Patients who achieved a complete or near-complete response after finishing treatment were offered watch-and-wait (WW). Total mesorectal excision (TME) was recommended for those who achieved an incomplete response. The primary end point was disease-free survival (DFS). The secondary end point was TME-free survival. In total, 324 patients were randomly assigned (INCT-CRT, n = 158; CRT-CNCT, n = 166). Median follow-up was 5.1 years. The 5-year DFS rates were 71% (95% CI, 64 to 79) and 69% (95% CI, 62 to 77) for INCT-CRT and CRT-CNCT, respectively (P = .68). TME-free survival was 39% (95% CI, 32 to 48) in the INCT-CRT group and 54% (95% CI, 46 to 62) in the CRT-CNCT group (P = .012). Of 81 patients with regrowth, 94% occurred within 2 years and 99% occurred within 3 years. DFS was similar for patients who underwent TME after restaging (64% [95% CI, 53 to 78]) and patients in WW who underwent TME after regrowth (64% [95% CI, 53 to 78]; P = .94). Updated analysis continues to show long-term organ preservation in half of the patients with rectal cancer treated with total neoadjuvant therapy. In patients who enter WW, most cases of tumor regrowth occur in the first 2 years.

Published
2024

8. ASO Visual Abstract: Has Management of Intrahepatic Cholangiocarcinoma Evolved with the Evidence? Trends and Practice Patterns from the National Cancer Database

Author

Schleimer, Lauren E., Kalvin, Hannah L., Ellis, Ryan J., Kingham, T. Peter, Soares, Kevin C., D’Angelica, Michael I., Balachandran, Vinod P., Drebin, Jeffrey, Cercek, Andrea, Abou-Alfa, Ghassan K., O’Reilly, Eileen M., Harding, James J., Gönen, Mithat, Wei, Alice C., and Jarnagin, William R.

Published
2024
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11. Gemcitabine with Cisplatin Versus Hepatic Arterial Infusion Pump Chemotherapy for Liver-Confined Unresectable Intrahepatic Cholangiocarcinoma

Author

Franssen, Stijn, Holster, Jessica J., Jolissaint, Joshua S., Nooijen, Lynn E., Cercek, Andrea, D’Angelica, Michael I., Homs, Marjolein Y. V., Wei, Alice C., Balachandran, Vinod P., Drebin, Jeffrey A., Harding, James J., Kemeny, Nancy E., Kingham, T. Peter, Klümpen, Heinz-Josef, Mostert, Bianca, Swijnenburg, Rutger-Jan, Soares, Kevin C., Jarnagin, William R., and Groot Koerkamp, Bas

Published
2024
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13. Organ Preservation in Patients With Rectal Adenocarcinoma Treated With Total Neoadjuvant Therapy.

Author

Garcia-Aguilar, Julio, Patil, Sujata, Gollub, Marc, Kim, Jin, Yuval, Jonathan, Thompson, Hannah, Verheij, Floris, Omer, Dana, Lee, Meghan, Dunne, Richard, Marcet, Jorge, Cataldo, Peter, Polite, Blase, Herzig, Daniel, Liska, David, Oommen, Samuel, Friel, Charles, Ternent, Charles, Coveler, Andrew, Hunt, Steven, Gregory, Anita, Krauss, John, Gleisner, Ana, Paty, Philip, Weiser, Martin, Nash, Garrett, Pappou, Emmanouil, Guillem, José, Temple, Larissa, Wei, Iris, Widmar, Maria, Lin, Sabrina, Segal, Neil, Cercek, Andrea, Yaeger, Rona, Smith, J, Goodman, Karyn, Wu, Abraham, Saltz, Leonard, Bello, Brian, Varma, Madhulika, and Carmichael, Joseph

Subjects
Adenocarcinoma, Antineoplastic Combined Chemotherapy Protocols, Capecitabine, Chemoradiotherapy, Disease-Free Survival, Fluorouracil, Humans, Neoadjuvant Therapy, Neoplasm Staging, Organ Preservation, Oxaliplatin, Prospective Studies, Rectal Neoplasms
Abstract

PURPOSE: Prospective data on the efficacy of a watch-and-wait strategy to achieve organ preservation in patients with locally advanced rectal cancer treated with total neoadjuvant therapy are limited. METHODS: In this prospective, randomized phase II trial, we assessed the outcomes of 324 patients with stage II or III rectal adenocarcinoma treated with induction chemotherapy followed by chemoradiotherapy (INCT-CRT) or chemoradiotherapy followed by consolidation chemotherapy (CRT-CNCT) and either total mesorectal excision (TME) or watch-and-wait on the basis of tumor response. Patients in both groups received 4 months of infusional fluorouracil-leucovorin-oxaliplatin or capecitabine-oxaliplatin and 5,000 to 5,600 cGy of radiation combined with either continuous infusion fluorouracil or capecitabine during radiotherapy. The trial was designed as two stand-alone studies with disease-free survival (DFS) as the primary end point for both groups, with a comparison to a null hypothesis on the basis of historical data. The secondary end point was TME-free survival. RESULTS: Median follow-up was 3 years. Three-year DFS was 76% (95% CI, 69 to 84) for the INCT-CRT group and 76% (95% CI, 69 to 83) for the CRT-CNCT group, in line with the 3-year DFS rate (75%) observed historically. Three-year TME-free survival was 41% (95% CI, 33 to 50) in the INCT-CRT group and 53% (95% CI, 45 to 62) in the CRT-CNCT group. No differences were found between groups in local recurrence-free survival, distant metastasis-free survival, or overall survival. Patients who underwent TME after restaging and patients who underwent TME after regrowth had similar DFS rates. CONCLUSION: Organ preservation is achievable in half of the patients with rectal cancer treated with total neoadjuvant therapy, without an apparent detriment in survival, compared with historical controls treated with chemoradiotherapy, TME, and postoperative chemotherapy.

Published
2022

14. Neoplasia risk in patients with Lynch syndrome treated with immune checkpoint blockade

Author

Harrold, Emily C., Foote, Michael B., Rousseau, Benoit, Walch, Henry, Kemel, Yelena, Richards, Allison L., Keane, Fergus, Cercek, Andrea, Yaeger, Rona, Rathkopf, Dana, Segal, Neil H., Patel, Zalak, Maio, Anna, Borio, Matilde, O’Reilly, Eileen M., Reidy, Diane, Desai, Avni, Janjigian, Yelena Y., Murciano-Goroff, Yonina R., Carlo, Maria I., Latham, Alicia, Liu, Ying L., Walsh, Michael F., Ilson, David, Rosenberg, Jonathan E., Markowitz, Arnold J., Weiser, Martin R., Rossi, Anthony M., Vanderbilt, Chad, Mandelker, Diana, Bandlamudi, Chaitanya, Offit, Kenneth, Berger, Michael F., Solit, David B., Saltz, Leonard, Shia, Jinru, Diaz, Jr., Luis A., and Stadler, Zsofia K.

Published
2023
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15. ASO Visual Abstract: Gemcitabine with Cisplatin Versus Hepatic Arterial Infusion Pump Chemotherapy for Liver-Confined Unresectable Intrahepatic Cholangiocarcinoma

Author

Franssen, Stijn, Holster, Jessica J., Jolissaint, Joshua S., Nooijen, Lynn E., Cercek, Andrea, D’Angelica, Michael I., Homs, Marjolein Y. V., Wei, Alice C., Balachandran, Vinod P., Drebin, Jeffrey A., Harding, James J., Kemeny, Nancy E., Kingham, T. Peter, Klümpen, Heinz-Josef, Mostert, Bianca, Swijnenburg, Rutger-Jan, Soares, Kevin C., Jarnagin, William R., and Groot Koerkamp, Bas

Published
2024
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16. Immune checkpoint inhibitors for POLE or POLD1 proofreading-deficient metastatic colorectal cancer

Author

Ambrosini, M., Rousseau, B., Manca, P., Artz, O., Marabelle, A., André, T., Maddalena, G., Mazzoli, G., Intini, R., Cohen, R., Cercek, A., Segal, N.H., Saltz, L., Varghese, A.M., Yaeger, R., Nusrat, M., Goldberg, Z., Ku, G.Y., El Dika, I., Margalit, O., Grinshpun, A., Kasi, P.M., Schilsky, R., Lutfi, A., Shacham-Shmueli, E., Khan Afghan, M., Weiss, L., Westphalen, C.B., Conca, V., Decker, B., Randon, G., Elez, E., Fakih, M., Schrock, A.B., Cremolini, C., Jayachandran, P., Overman, M.J., Lonardi, S., and Pietrantonio, F.

Published
2024
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17. Extrahepatic perfusion and incomplete hepatic perfusion after hepatic arterial infusion pump implantation: incidence and clinical implications

Author

Filipe, Wills F., Buisman, Florian Buismanz, Koerkamp, Bas Groot, Grunhagen, Dirk J., Homs, Marjolein Y.V., Verhoef, Cornelis, Moelker, Adriaan, Graven, Laura, Franssen, Stijn, Gobardhan, Paul D., Loosveld, Olaf J.L., Pool, Stefan, Mieog, J. Sven D., Speetjens, Frank M., Rietbergen, Daphne D.D., Burgmans, Mark C., Doornesbosch, Pascal G., Patijn, Gijs A., de Groot, Jan Willem B., Meier, Mark A.J., Oostdijk, Ad H.J., Boluis, Karen, Grootscholten, Cecile, klompenhouwer, Elizabeth G., Kok, Niels F.M., kuhlmann, Koert, F.D., Krul, Myrtle F., Versleijen, Michelle W.J., Bruijnen, Rutger C.G., Hagendoorn, Jroen, Lam, Marnix G.E.H., Roodhart, Jeanine M.L., Bennink, Roel J., van Delden, Otto M., Swijnenburg, Rutger-Jan, Buffart, Tineke E., Borel Rinkes, Inne H.M., Cercek, Andrea, Kemeny, Nancy E., Peter Kingham, T., D’Angelica, Michael, van Bommel, Christian P.H., van Doorn, Leni, Ayez, Ninos, Vermaas, Maarten, Nieuwenhuijse, Vincent B., Buisman, Florian E., Grünhagen, Dirk J., Bolhuis, Karen, Doornebosch, Pascal G., Hagendoorn, Jeroen, Harmsen, Paul, Klompenhouwer, Elizabeth G., Outmani, Loubna, Swijnenburg, Rutger Jan, Kuhlmann, Koert F.D., and Groot Koerkamp, Bas

Published
2024
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18. LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial

Author

Siqueira, Dimytri, Pinto, Ibraim, Cervone, Alberto, Assef, Jorge, Vilela, Andrea, Paladino, Antonio, Ramos, Auristela, Rezende, Mariana, Ghorayeb, Samira, Braga Silva, Tacianne Rolemberg, Gjorgjievska, Savica, Hadzibegovic, Irzal, Jurin, Ivana, Sipic, Tomislav, Pavlovic, Nikola, Rudez, Igor, Manola, Sime, GALLET DE SAINT-AURIN, Romain, BOUKANTAR, Madjid, NICOLAS, Eroan, ENNEZAT, Pierre Valdimir, URIEN, Jean Marie, Vincent, Flavien, Delhaye, Cedric, Denimal, Tom, Cosenza, Alessandro, Pamart, Thibault, Porouchani, Sina, Pontana, Francois, Montaigne, David, Balmette, Vincent, Bechiri, Mohamed, Chen, Elisabeth, Janah, Dany, Renker, Matthias, Westermann, Dirk, Valina, Christian, Ferenc, Miroslaw, Löffelhardt, Nikolaus, Rahimi, Faridun, Breitbart, Philipp, Franke, Kilian, Czerny, Martin, Diab, Nawras, Sick, Peter, Adeishvili, Medea, Mangner, Norman, Haussig, Stephan, Sveric, Krunuslav, Crusius, Lisa, Roehlig, Marie, Koliastasis, Leonidas, Drakopoulou, Maria, Katsaros, Odysseas, Ktenopoulos, Nikolaos, Ioanniadis, Andreas, Evangelou, Sotirios, Ninios, Ilias, Molnar, Levente, Papp, Roland, Arnold-Béla, Ferencz, Demeterné Kiss, Orsolya, Nagy, Andrea, Czimbalmos, Csilla, Pellegrinni, Dario, Montonati, Carolina, Pellicano, Mariano, Guagliumi, Giulio, Tespili, Maurizio, Barbara, Bellini, Filippo, Russo, Marco, Ancona, Ciro, Vella, Luca, Ferri, Eustachio, Agricola, Giacomo, Ingallina, Cannone, Gaspare, Brambilla, Nedy, Testa, Luca, Avondo, Stefano, Valvo, Roberto, Clarke, Robin, Fish, Mandy, Kosowski, Michal, Krawczyk, Magdalena, Kubler, Piotr, Kotwica, Tomasz, Teles, Rui, Gonçalves, Pedro, Raposo, Luis, Brito, Joã, Leal, Silvio, Freitas, Pedro, Ribeiras, Regina, Poliacikova, Petra, Mihailovic, Peter Marko, Terseglav, Simon, Steblovnik, Klemen, Cercek, Miha, Vitez, Luka, Sustersic, Miha, Kovac, Ana, Kogoj, Polonca, Dimitrovska, Ljupka, Arana, J.Raul Delgado, Martinez, Sandra Santos, Dieguez, Alfredo Redondo, Barrero, Alejandro, Gonzalez-Bartol, Esther, Aristizabal, Cristhian, Frutos, Ana Serrador, Luna, Juan Pablo Sanchez, Gomez, Mario Garcia, Gabella, Tania Rodriguez, Nelson, Verónica Quevedo, Medina, Jose Novoa, Ojeda, Soledad, de Lezo, Javier Suarez, Romero, Miguel, Gonzalez-Manzanares, Rafael, Alvarado, Marco, Mesa, Dolores, Perea, Jorge, Petursson, Petur, Alchay, Monér, Andréen, Sofie, Gameren, Menno Van, Heijer, Peter den, Meuwissen, Martijn, CHENG, JIN M., Vos, Jeroen, Schölzel, B.E., Simsek, C, Hubbers, S, Van den Branden, Ben J.L., Stens, NA, Versteeg, GAA, Rooijakkers, MJP, Gehlmann, HR, Verkroost, MWA, Geuzebroek, GSC, Van Wely, MH, Van Geuns, RJ, van Nunen, LX, van Garsse, LAFM, Timmers, L, ten Berg, Jurrien, Kraaijeveld, A.O., Dickinson, M.G., Dessing, T.C., Mokhles, M.M., Baumbach, Andreas, van Royen, Niels, Amat-Santos, Ignacio J, Hudec, Martin, Bunc, Matjaz, Ijsselmuiden, Alexander, Laanmets, Peep, Unic, Daniel, Merkely, Bela, Hermanides, Renicus S, Ninios, Vlasis, Protasiewicz, Marcin, Rensing, Benno J W M, Martin, Pedro L, Feres, Fausto, De Sousa Almeida, Manuel, van Belle, Eric, Linke, Axel, Ielasi, Alfonso, Montorfano, Matteo, Webster, Mark, Toutouzas, Konstantinos, Teiger, Emmanuel, Bedogni, Francesco, Voskuil, Michiel, Pan, Manuel, Angerås, Oskar, Kim, Won-Keun, Rothe, Jürgen, Kristić, Ivica, Peral, Vicente, Garg, Scot, Elzomor, Hesham, Tobe, Akihiro, Morice, Marie-Claude, Onuma, Yoshinobu, Soliman, Osama, and Serruys, Patrick W

Published
2024
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19. Therapeutic targeting of SLC6A8 creatine transporter suppresses colon cancer progression and modulates human creatine levels

Author

Kurth, Isabel, Yamaguchi, Norihiro, Andreu-Agullo, Celia, Tian, Helen S, Sridhar, Subhasree, Takeda, Shugaku, Gonsalves, Foster C, Loo, Jia Min, Barlas, Afsar, Manova-Todorova, Katia, Busby, Robert, Bendell, Johanna C, Strauss, James, Fakih, Marwan, McRee, Autumn J, Hendifar, Andrew E, Rosen, Lee S, Cercek, Andrea, Wasserman, Robert, Szarek, Michael, Spector, Scott L, Raza, Syed, Tavazoie, Masoud F, and Tavazoie, Sohail F

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Digestive Diseases, Cancer, Colo-Rectal Cancer, Development of treatments and therapeutic interventions, 5.1 Pharmaceuticals, Animals, Antineoplastic Agents, Cell Line, Tumor, Cell Proliferation, Colonic Neoplasms, Colorectal Neoplasms, Creatine, Humans, Membrane Transport Proteins, Mice, Mice, Nude, Mutation, Nerve Tissue Proteins, Plasma Membrane Neurotransmitter Transport Proteins, Proto-Oncogene Proteins p21(ras)
Abstract

Colorectal cancer (CRC) is a leading cause of cancer mortality. Creatine metabolism was previously shown to critically regulate colon cancer progression. We report that RGX-202, an oral small-molecule SLC6A8 transporter inhibitor, robustly inhibits creatine import in vitro and in vivo, reduces intracellular phosphocreatine and ATP levels, and induces tumor apoptosis. RGX-202 suppressed CRC growth across KRAS wild-type and KRAS mutant xenograft, syngeneic, and patient-derived xenograft (PDX) tumors. Antitumor efficacy correlated with tumoral expression of creatine kinase B. Combining RGX-202 with 5-fluorouracil or the DHODH inhibitor leflunomide caused regressions of multiple colorectal xenograft and PDX tumors of distinct mutational backgrounds. RGX-202 also perturbed creatine metabolism in patients with metastatic CRC in a phase 1 trial, mirroring pharmacodynamic effects on creatine metabolism observed in mice. This is, to our knowledge, the first demonstration of preclinical and human pharmacodynamic activity for creatine metabolism targeting in oncology, thus revealing a critical therapeutic target.

Published
2021

20. Organ preservation after neoadjuvant long-course chemoradiotherapy versus short-course radiotherapy

Author

Bercz, A., Park, B.K., Pappou, E., Nemirovsky, D., Sarkar, R., Yamner, M., Omer, D., Verheij, F.S., Alvarez, J., Atri, P., Reyngold, M., Yaeger, R., Wei, I.H., Wu, A., Raj, N., Widmar, M., Hajj, C., Kim, M.J., Rao, D., Nash, G.M., Williams, V., Shia, J., Segal, N.H., Diaz, L., Ganesh, K., Weiser, M.R., Gollub, M.J., Paty, P.B., Horvat, N., Zinovoy, M., Roth O’Brien, D., Sanchez-Vega, F., Saltz, L.B., Crane, C.H., Cercek, A., Gonen, M., Garcia-Aguilar, J., Smith, J.J., and Romesser, P.B.

Published
2024
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22. ASO Visual Abstract: Combined Hepatic Artery Infusion Pump and Systemic Chemotherapy in the Modern Era for Chemotherapy-Naive Patients with Unresectable Colorectal Liver Metastases

Author

Verheij, Floris S., Kuhlmann, Koert F. D., Silliman, Danielle R., Soares, Kevin C., Kingham, T. Peter, Balachandran, Vinod P., Drebin, Jeffrey A., Wei, Alice C., Jarnagin, William R., Cercek, Andrea, Kok, Niels F. M., Kemeny, Nancy E., and D’Angelica, Michael I.

Published
2023
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23. Hepatic disease control in patients with intrahepatic cholangiocarcinoma correlates with overall survival

Author

Kevin C. Soares, Joshua S. Jolissaint, Sarah M. McIntyre, Kenneth P. Seier, Mithat Gönen, Carlie Sigel, Naaz Nasar, Andrea Cercek, James J. Harding, Nancy E. Kemeny, Louise C. Connell, Bas Groot Koerkamp, Vinod P. Balachandran, Michael I. D'Angelica, Jeffrey A. Drebin, T. Peter Kingham, Alice C. Wei, and William R. Jarnagin

Subjects
bile duct cancer, biliary neoplasm, cholangiocarcinoma, hepatic artery pump, locoregional therapy, regional chemotherapy, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Purpose The role of locoregional therapy compared to systemic chemotherapy (SYS) for unresectable intrahepatic cholangiocarcinoma (IHC) remains controversial. The importance of hepatic disease control, either as initial or salvage therapy, is also unclear. We compared overall survival (OS) in patients treated with resection, hepatic arterial infusion pump (HAIP) chemotherapy, or SYS as it relates to hepatic recurrence or progression. We also evaluated recurrence after resection to determine the efficacy of locoregional salvage therapy. Patients and Methods In this single‐institution retrospective analysis, patients with biopsy‐proven IHC treated with either curative‐intent resection, HAIP (with or without SYS), or SYS alone were analyzed. Propensity score matching (PSM) was used to compare patients with liver‐limited, advanced disease treated with HAIP versus SYS. The impact of locoregional salvage therapies in patients with liver‐limited recurrence was analyzed in the resection cohort. Results From 2000 to 2017, 714 patients with IHC were treated, 219 (30.7%) with resectable disease, 316 (44.3%) with locally advanced disease, and 179 (25.1%) with metastatic disease. Resected patients were less likely to recur or progress in the liver (hazard ratio [HR] 0.41, 95% CI 0.34–0.45) versus those that received HAIP or SYS (HR 0.58, 95% CI 0.50–0.65 vs. HR 0.63, 95% CI 0.57–0.69, respectively). In resected patients, 161 (64.4%) recurred, with 65 liver‐only recurrences. Thirty of these patients received subsequent locoregional therapy. On multivariable analysis, locoregional therapy was associated with improved OS after isolated liver recurrence (HR 0.46, 95% CI 0.29–0.75; p = 0.002). In patients with locally advanced unresectable or multifocal liver disease (with or without distant organ metastases), PSM demonstrated improved hepatic progression‐free survival in patients treated with HAIP versus SYS (HR 0.65; 95% CI 0.46–0.91; p = 0.01), which correlated with improved OS (HR 0.59, 95% CI 0.43–0.80; p

Published
2023
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24. Pharmaceutical Agents as Potential Drivers in the Development of Early-Onset Colorectal Cancer: Case-Control Study

Author

Irit Ben-Aharon, Ran Rotem, Cheli Melzer-Cohen, Gilad Twig, Andrea Cercek, Elizabeth Half, Tal Goshen-Lago, Gabriel Chodik, and David Kelsen

Subjects
Public aspects of medicine, RA1-1270
Abstract

BackgroundThe incidence of early-onset colorectal cancer (EOCRC) rose abruptly in the mid 1990s, is continuing to increase, and has now been noted in many countries. By 2030, 25% of American patients diagnosed with rectal cancer will be 49 years or younger. The large majority of EOCRC cases are not found in patients with germline cancer susceptibility mutations (eg, Lynch syndrome) or inflammatory bowel disease. Thus, environmental or lifestyle factors are suspected drivers. Obesity, sedentary lifestyle, diabetes mellitus, smoking, alcohol, or antibiotics affecting the gut microbiome have been proposed. However, these factors, which have been present since the 1950s, have not yet been conclusively linked to the abrupt increase in EOCRC. The sharp increase suggests the introduction of a new risk factor for young people. We hypothesized that the driver may be an off-target effect of a pharmaceutical agent (ie, one requiring regulatory approval before its use in the general population or an off-label use of a previously approved agent) in a genetically susceptible subgroup of young adults. If a pharmaceutical agent is an EOCRC driving factor, regulatory risk mitigation strategies could be used. ObjectiveWe aimed to evaluate the possibility that pharmaceutical agents serve as risk factors for EOCRC. MethodsWe conducted a case-control study. Data including demographics, comorbidities, and complete medication dispensing history were obtained from the electronic medical records database of Maccabi Healthcare Services, a state-mandated health provider covering 26% of the Israeli population. The participants included 941 patients with EOCRC (≤50 years of age) diagnosed during 2001-2019 who were density matched at a ratio of 1:10 with 9410 control patients. Patients with inflammatory bowel disease and those with a known inherited cancer susceptibility syndrome were excluded. An advanced machine learning algorithm based on gradient boosted decision trees coupled with Bayesian model optimization and repeated data sampling was used to sort through the very high-dimensional drug dispensing data to identify specific medication groups that were consistently linked with EOCRC while allowing for synergistic or antagonistic interactions between medications. Odds ratios for the identified medication classes were obtained from a conditional logistic regression model. ResultsOut of more than 800 medication classes, we identified several classes that were consistently associated with EOCRC risk across independently trained models. Interactions between medication groups did not seem to substantially affect the risk. In our analysis, drug groups that were consistently positively associated with EOCRC included beta blockers and valerian (Valeriana officinalis). Antibiotics were not consistently associated with EOCRC risk. ConclusionsOur analysis suggests that the development of EOCRC may be correlated with prior use of specific medications. Additional analyses should be used to validate the results. The mechanism of action inducing EOCRC by candidate pharmaceutical agents will then need to be determined.

Published
2023
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25. Impact of Primary Tumor Laterality on Adjuvant Hepatic Artery Infusion Pump Chemotherapy in Resected Colon Cancer Liver Metastases: Analysis of 487 Patients

Author

Gholami, Sepideh, Stewart, Susan, Kemeny, Nancy, Gönen, Mithat, Groot Koerkamp, Bas, Cercek, Andrea, Kingham, Peter, Balachandran, Vinod, Allen, Peter, DeMatteo, Ronald, Wei, Alice, Connell, Louise, Drebin, Jeffrey, Jarnagin, William, and D’Angelica, Michael

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Colo-Rectal Cancer, Clinical Research, Digestive Diseases, Chemotherapy, Adjuvant, Colonic Neoplasms, Colorectal Neoplasms, Hepatectomy, Hepatic Artery, Humans, Infusions, Intra-Arterial, Liver Neoplasms, Prospective Studies, Survival Rate, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundHepatic artery infusion (HAI) chemotherapy is associated with overall survival (OS) in patients with resected colon cancer liver metastases (CLM). The prognostic impact of primary tumor location in CLM following hepatic resection in patients receiving regional HAI is unknown. This study seeks to investigate the prognostic impact of HAI in relation to laterality in this patient population.MethodsConsecutive patients with resected CLM, with known primary tumor site treated with and without HAI, were reviewed from a prospective institutional database. Correlations between HAI, laterality, other clinicopathological factors, and survival were analyzed, and Cox proportional hazard regression was used to determine whether laterality was an independent prognostic factor.ResultsFrom 1993 to 2012, 487 patients [182 with right colon cancer (RCC), 305 with left colon cancer (LCC)] were evaluated with a median follow-up of 6.5 years. Fifty-seven percent (n = 275) received adjuvant HAI. Patients with RCC had inferior 5-year OS compared with LCC (56% vs. 67%, P = 0.01). HAI was associated with improved 5-year OS in both RCC (68% vs. 45%; P

Published
2021

29. Tucatinib plus trastuzumab for chemotherapy-refractory, HER2-positive, RAS wild-type unresectable or metastatic colorectal cancer (MOUNTAINEER): a multicentre, open-label, phase 2 study

Author

Van Cutsem, Eric, Peeters, Marc, Van den Evnde, Marc, André, Thierry, Borg, Christophe, Sarabi, Matthieu, Ghiringhelli, Francois, Chibaudel, Benoist, Siena, Salvatore, Cremolini, Chiara, Zampino, Maria G., Elez, Elena, Keranen, Susana R., Salazar, Ramon, Alfonso, Pilar, Strickler, John H., Cercek, Andrea, Ng, Kimmie, Wu, Christina, Paulson, Andrew S., Hubbard, Joleen M., Coveler, Andrew L., Fountzilas, Christos, Kardosh, Adel, Kasi, Pashtoon M., Lenz, Heinz-Josef, Ciombor, Kristen K., Bajor, David L., Bekaii-Saab, Tanios S., Gbolahan, Olumide, Boland, Patrick, Berg, Daniel, Sanchez, Federico, Goggins, Timothy, Saeed, Anwar, Burris, Howard, Bendell, Johanna, Outlaw, Darryl, Tafur, Isaac, Shergill, Ardaman, Catenacci, Daniel, Gong, Jun, Garrido-Laguna, Ignacio, Finley, Gene, Weinberg, Benjamin, Shields, Anthony, Philip, Philip, Turk, Anita, Nguyen, Anthony, Braiteh, Fadi, Patel, Vijay, Harwin, William, Anderson, Ian, Kundra, Ajay, Chen, Christopher, Ford, James, Kundranda, Madappa, Nguyen, Danny, Ratnam, Suresh, Richards, Donald, Nallapareddy, Sujatha, Beeram, Sridhar, McKenney, Scott, Shao, Spencer, Strickler, John H, Paulson, Andrew S, Hubbard, Joleen M, Coveler, Andrew L, Kasi, Pashtoon M, Ciombor, Kristen K, Bajor, David L, Stecher, Michael, Feng, Wentao, and Bekaii-Saab, Tanios S

Published
2023
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30. Delphi Initiative for Early-Onset Colorectal Cancer (DIRECt) International Management Guidelines

Author

Cavestro, Giulia Martina, Mannucci, Alessandro, Balaguer, Francesc, Hampel, Heather, Kupfer, Sonia S., Repici, Alessandro, Sartore-Bianchi, Andrea, Seppälä, Toni T., Valentini, Vincenzo, Boland, Clement Richard, Brand, Randall E., Buffart, Tineke E., Burke, Carol A., Caccialanza, Riccardo, Cannizzaro, Renato, Cascinu, Stefano, Cercek, Andrea, Crosbie, Emma J., Danese, Silvio, Dekker, Evelien, Daca-Alvarez, Maria, Deni, Francesco, Dominguez-Valentin, Mev, Eng, Cathy, Goel, Ajay, Guillem, Josè G., Houwen, Britt B.S.L., Kahi, Charles, Kalady, Matthew F., Kastrinos, Fay, Kühn, Florian, Laghi, Luigi, Latchford, Andrew, Liska, David, Lynch, Patrick, Malesci, Alberto, Mauri, Gianluca, Meldolesi, Elisa, Møller, Pål, Monahan, Kevin J., Möslein, Gabriela, Murphy, Caitlin C., Nass, Karlijn, Ng, Kimmie, Oliani, Cristina, Papaleo, Enrico, Patel, Swati G., Puzzono, Marta, Remo, Andrea, Ricciardiello, Luigi, Ripamonti, Carla Ida, Siena, Salvatore, Singh, Satish K., Stadler, Zsofia K., Stanich, Peter P., Syngal, Sapna, Turi, Stefano, Urso, Emanuele Damiano, Valle, Laura, Vanni, Valeria Stella, Vilar, Eduardo, Vitellaro, Marco, You, Yi-Qian Nancy, Yurgelun, Matthew B., Zuppardo, Raffaella Alessia, and Stoffel, Elena M.

Published
2023
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31. Genomic and transcriptomic determinants of response to neoadjuvant therapy in rectal cancer

Author

Chatila, Walid K., Kim, Jin K., Walch, Henry, Marco, Michael R., Chen, Chin-Tung, Wu, Fan, Omer, Dana M., Khalil, Danny N., Ganesh, Karuna, Qu, Xuan, Luthra, Anisha, Choi, Seo-Hyun, Ho, Yu-Jui, Kundra, Ritika, Groves, Katharine I., Chow, Oliver S., Cercek, Andrea, Weiser, Martin R., Widmar, Maria, Wei, Iris H., Pappou, Emmanouil P., Nash, Garrett M., Paty, Philip B., Shi, Qian, Vakiani, Efsevia, Duygu Selcuklu, S., Donoghue, Mark T. A., Solit, David B., Berger, Michael F., Shia, Jinru, Pelossof, Raphael, Romesser, Paul B., Yaeger, Rona, Smith, J. Joshua, Schultz, Nikolaus, Sanchez-Vega, Francisco, and Garcia-Aguilar, Julio

Published
2022
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32. Impact of chronic obstructive pulmonary disease on short-term outcome in patients with ST-elevation myocardial infarction during COVID-19 pandemic: insights from the international multicenter ISACS-STEMI registry

Author

Giuseppe De Luca, Matteo Nardin, Magdy Algowhary, Berat Uguz, Dinaldo C. Oliveira, Vladimir Ganyukov, Zan Zimbakov, Miha Cercek, Lisette Okkels Jensen, Poay Huan Loh, Lucian Calmac, Gerard Roura Ferrer, Alexandre Quadros, Marek Milewski, Fortunato Scotto di Uccio, Clemens von Birgelen, Francesco Versaci, Jurrien Ten Berg, Gianni Casella, Aaron Wong Sung Lung, Petr Kala, José Luis Díez Gil, Xavier Carrillo, Maurits Dirksen, Victor M. Becerra-Munoz, Michael Kang-yin Lee, Dafsah Arifa Juzar, Rodrigo de Moura Joaquim, Roberto Paladino, Davor Milicic, Periklis Davlouros, Nikola Bakraceski, Filippo Zilio, Luca Donazzan, Adriaan Kraaijeveld, Gennaro Galasso, Arpad Lux, Lucia Marinucci, Vincenzo Guiducci, Maurizio Menichelli, Alessandra Scoccia, Aylin Hatice Yamac, Kadir Ugur Mert, Xacobe Flores Rios, Tomas Kovarnik, Michal Kidawa, Josè Moreu, Vincent Flavien, Enrico Fabris, Iñigo Lozano Martínez-Luengas, Marco Boccalatte, Francisco Bosa Ojeda, Carlos Arellano-Serrano, Gianluca Caiazzo, Giuseppe Cirrincione, Hsien-Li Kao, Juan Sanchis Forés, Luigi Vignali, Helder Pereira, Stephane Manzo, Santiago Ordoñez, Alev Arat Özkan, Bruno Scheller, Heidi Lehtola, Rui Teles, Christos Mantis, Ylitalo Antti, João A. Brum Silveira, Rodrigo Zoni, Ivan Bessonov, Stefano Savonitto, George Kochiadakis, Dimitrios Alexopoulos, Carlos E. Uribe, John Kanakakis, Benjamin Faurie, Gabriele Gabrielli, Alejandro Gutierrez Barrios, Juan Pablo Bachini, Alex Rocha, Frankie Chor-Cheung Tam, Alfredo Rodriguez, Antonia Anna Lukito, Veauthyelau Saint-Joy, Gustavo Pessah, Andrea Tuccillo, Giuliana Cortese, Guido Parodi, Mohamed Abed Bouraghda, Elvin Kedhi, Pablo Lamelas, Harry Suryapranata, and Monica Verdoia

Subjects
STEMI, COPD, Mortality, Diseases of the respiratory system, RC705-779
Abstract

Abstract Background Chronic obstructive pulmonary disease (COPD) is projected to become the third cause of mortality worldwide. COPD shares several pathophysiological mechanisms with cardiovascular disease, especially atherosclerosis. However, no definite answers are available on the prognostic role of COPD in the setting of ST elevation myocardial infarction (STEMI), especially during COVID-19 pandemic, among patients undergoing primary angioplasty, that is therefore the aim of the current study. Methods In the ISACS-STEMI COVID-19 registry we included retrospectively patients with STEMI treated with primary percutaneous coronary intervention (PCI) between March and June of 2019 and 2020 from 109 high-volume primary PCI centers in 4 continents. Results A total of 15,686 patients were included in this analysis. Of them, 810 (5.2%) subjects had a COPD diagnosis. They were more often elderly and with a more pronounced cardiovascular risk profile. No preminent procedural dissimilarities were noticed except for a lower proportion of dual antiplatelet therapy at discharge among COPD patients (98.9% vs. 98.1%, P = 0.038). With regards to short-term fatal outcomes, both in-hospital and 30-days mortality occurred more frequently among COPD patients, similarly in pre-COVID-19 and COVID-19 era. However, after adjustment for main baseline differences, COPD did not result as independent predictor for in-hospital death (adjusted OR [95% CI] = 0.913[0.658–1.266], P = 0.585) nor for 30-days mortality (adjusted OR [95% CI] = 0.850 [0.620–1.164], P = 0.310). No significant differences were detected in terms of SARS-CoV-2 positivity between the two groups. Conclusion This is one of the largest studies investigating characteristics and outcome of COPD patients with STEMI undergoing primary angioplasty, especially during COVID pandemic. COPD was associated with significantly higher rates of in-hospital and 30-days mortality. However, this association disappeared after adjustment for baseline characteristics. Furthermore, COPD did not significantly affect SARS-CoV-2 positivity. Trial registration number: NCT 04412655 (2nd June 2020).

Published
2022
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33. A Novel Approach to Quantify Heterogeneity of Intrahepatic Cholangiocarcinoma: the Hidden-Genome Classifier

Author

Song, Yi, primary, Boerner, Thomas, additional, Drill, Esther, additional, Shin, Paul, additional, Kumar, Sandeep, additional, Sigel, Carlie, additional, Cercek, Andrea, additional, Kemeny, Nancy, additional, Abou-Alfa, Ghassan, additional, Iacobuzio-Donahue, Christine, additional, Cowzer, Darren, additional, Schultz, Nikolaus, additional, Walch, Henry, additional, Balachandran, Vinod, additional, Groot Koerkamp, Bas, additional, Kingham, T. Peter., additional, Soares, Kevin, additional, Wei, Alice, additional, D'Angelica, Michael, additional, Drebin, Jeffrey, additional, Chandwani, Rohit, additional, Harding, James, additional, and Jarnagin, William R., additional

Published
2024
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34. Durable complete responses to PD-1 blockade alone in mismatch repair deficient locally advanced rectal cancer.

Author

Cercek, Andrea, primary, Sinopoli, Jenna Cohen, additional, Shia, Jinru, additional, Weiss, Jill A., additional, Temple, Lindsay, additional, Smith, Jesse Joshua, additional, Saltz, Leonard B., additional, Widmar, Maria, additional, Fumo, Gerard, additional, Aparo, Santiago, additional, Romesser, Paul Bernard, additional, Walch, Henry S., additional, Patel, Mitesh, additional, Jayaprakasam, Vetri Sudar, additional, Kim, Tae-Hyung, additional, Paty, Philip, additional, Gonen, Mithat, additional, Garcia-Aguilar, Julio, additional, Weiser, Martin R., additional, and Diaz, Luis A, additional

Published
2024
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36. Final results of a phase 2 study of tucatinib and trastuzumab for HER2-positive mCRC (MOUNTAINEER).

Author

Strickler, John H, primary, Cercek, Andrea, additional, Siena, Salvatore, additional, Andre, Thierry, additional, Ng, Kimmie, additional, Van Cutsem, Eric, additional, Wu, Christina, additional, Paulson, Andrew Scott, additional, Hubbard, Joleen M., additional, Coveler, Andrew L., additional, Fountzilas, Christos, additional, Kardosh, Adel, additional, Kasi, Pashtoon Murtaza, additional, Lenz, Heinz-Josef, additional, Ciombor, Kristen Keon, additional, Elez, Elena, additional, Bajor, David L, additional, Nayeri, Mina, additional, Feng, Wentao, additional, and Bekaii-Saab, Tanios S., additional

Published
2024
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37. LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial

Author

Baumbach, Andreas, primary, van Royen, Niels, additional, Amat-Santos, Ignacio J, additional, Hudec, Martin, additional, Bunc, Matjaz, additional, Ijsselmuiden, Alexander, additional, Laanmets, Peep, additional, Unic, Daniel, additional, Merkely, Bela, additional, Hermanides, Renicus S, additional, Ninios, Vlasis, additional, Protasiewicz, Marcin, additional, Rensing, Benno J W M, additional, Martin, Pedro L, additional, Feres, Fausto, additional, De Sousa Almeida, Manuel, additional, van Belle, Eric, additional, Linke, Axel, additional, Ielasi, Alfonso, additional, Montorfano, Matteo, additional, Webster, Mark, additional, Toutouzas, Konstantinos, additional, Teiger, Emmanuel, additional, Bedogni, Francesco, additional, Voskuil, Michiel, additional, Pan, Manuel, additional, Angerås, Oskar, additional, Kim, Won-Keun, additional, Rothe, Jürgen, additional, Kristić, Ivica, additional, Peral, Vicente, additional, Garg, Scot, additional, Elzomor, Hesham, additional, Tobe, Akihiro, additional, Morice, Marie-Claude, additional, Onuma, Yoshinobu, additional, Soliman, Osama, additional, Serruys, Patrick W, additional, Siqueira, Dimytri, additional, Pinto, Ibraim, additional, Cervone, Alberto, additional, Assef, Jorge, additional, Vilela, Andrea, additional, Paladino, Antonio, additional, Ramos, Auristela, additional, Rezende, Mariana, additional, Ghorayeb, Samira, additional, Braga Silva, Tacianne Rolemberg, additional, Gjorgjievska, Savica, additional, Hadzibegovic, Irzal, additional, Jurin, Ivana, additional, Sipic, Tomislav, additional, Pavlovic, Nikola, additional, Rudez, Igor, additional, Manola, Sime, additional, GALLET DE SAINT-AURIN, Romain, additional, BOUKANTAR, Madjid, additional, NICOLAS, Eroan, additional, ENNEZAT, Pierre Valdimir, additional, URIEN, Jean Marie, additional, Vincent, Flavien, additional, Delhaye, Cedric, additional, Denimal, Tom, additional, Cosenza, Alessandro, additional, Pamart, Thibault, additional, Porouchani, Sina, additional, Pontana, Francois, additional, Montaigne, David, additional, Balmette, Vincent, additional, Bechiri, Mohamed, additional, Chen, Elisabeth, additional, Janah, Dany, additional, Matthias, Renker, additional, Westermann, Dirk, additional, Valina, Christian, additional, Ferenc, Miroslaw, additional, Löffelhardt, Nikolaus, additional, Rahimi, Faridun, additional, Breitbart, Philipp, additional, Franke, Kilian, additional, Czerny, Martin, additional, Diab, Nawras, additional, Sick, Peter, additional, Adeishvili, Medea, additional, Mangner, Norman, additional, Haussig, Stephan, additional, Sveric, Krunuslav, additional, Crusius, Lisa, additional, Roehlig, Marie, additional, Koliastasis, Leonidas, additional, Drakopoulou, Maria, additional, Katsaros, Odysseas, additional, Ktenopoulos, Nikolaos, additional, Ioanniadis, Andreas, additional, Evangelou, Sotirios, additional, Ninios, Ilias, additional, Molnar, Levente, additional, Papp, Roland, additional, Arnold-Béla, Ferencz, additional, Demeterné Kiss, Orsolya, additional, Nagy, Andrea, additional, Czimbalmos, Csilla, additional, Pellegrinni, Dario, additional, Montonati, Carolina, additional, Pellicano, Mariano, additional, Guagliumi, Giulio, additional, Tespili, Maurizio, additional, Barbara, Bellini, additional, Filippo, Russo, additional, Marco, Ancona, additional, Ciro, Vella, additional, Luca, Ferri, additional, Eustachio, Agricola, additional, Giacomo, Ingallina, additional, Cannone, Gaspare, additional, Brambilla, Nedy, additional, Testa, Luca, additional, Avondo, Stefano, additional, Valvo, Roberto, additional, Clarke, Robin, additional, Fish, Mandy, additional, Kosowski, Michal, additional, Krawczyk, Magdalena, additional, Kubler, Piotr, additional, Kotwica, Tomasz, additional, Teles, Rui, additional, Gonçalves, Pedro, additional, Raposo, Luis, additional, Brito, João, additional, Leal, Silvio, additional, Freitas, Pedro, additional, Ribeiras, Regina, additional, Poliacikova, Petra, additional, Mihaolovic, Peter Marko, additional, Terseglav, Simon, additional, Steblovnik, Klemen, additional, Cercek, Miha, additional, Vitez, Luka, additional, Sustersic, Miha, additional, Kovac, Ana, additional, Kogoj, Polonca, additional, Dimitrovska, Ljupka, additional, Arana, J.Raul Delgado, additional, Martinez, Sandra Santos, additional, Dieguez, Alfredo Redondo, additional, Barrero, Alejandro, additional, Gonzalez-Bartol, Esther, additional, Aristizabal, Cristhian, additional, Frutos, Ana Serrador, additional, Luna, Juan Pablo Sanchez, additional, Gomez, Mario Garcia, additional, Gabella, Tania Rodriguez, additional, Nelson, Verónica Quevedo, additional, Medina, Jose Novoa, additional, Ojeda, Soledad, additional, de Lezo, Javier Suarez, additional, Romero, Miguel, additional, Gonzalez-Manzanares, Rafael, additional, Alvarado, Marco, additional, Mesa, Dolores, additional, Perea, Jorge, additional, Petursson, Petur, additional, Alchay, Monér, additional, Andréen, Sofie, additional, Van Gameren, Menno, additional, den Heijer, Peter, additional, Meuwissen, Martijn, additional, CHENG, JIN M., additional, Vos, Jeroen, additional, Schölzel, B.E., additional, Simsek, C, additional, Hubbers, S, additional, Stens, NA, additional, Versteeg, GAA, additional, Rooijakkers, MJP, additional, Gehlmann, HR, additional, Verkroost, MWA, additional, Geuzebroek, GSC, additional, Van Wely, MH, additional, Van Geuns, RJ, additional, van Nunen, LX, additional, van Garsse, LAFM, additional, Timmers, L, additional, ten Berg, Jurrien, additional, Kraaijeveld, A.O., additional, Dickinson, M.G., additional, Dessing, T.C., additional, and Mokhles, M.M., additional

Published
2024
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38. The Influence of Late Gadolinium Enhancement Cardiac Magnetic Resonance Image Analysis Imprecision on Myocardial Damage Quantification in Patients with Myocarditis: A Pilot Study

Author

Lana Kralj, Andreja Cerne Cercek, Alja Gomišček Novak, and Borut Kirn

Subjects
myocarditis, cardiac magnetic resonance, variability, full width at half maximum, thresholding methods, segmentation, Technology, Engineering (General). Civil engineering (General), TA1-2040, Biology (General), QH301-705.5, Physics, QC1-999, Chemistry, QD1-999
Abstract

Background: Myocardial damage in myocarditis is assessed through late gadolinium enhancement (LGE) cardiac magnetic resonance (CMR). Variability in quantifying myocarditis extent results from imprecise image segmentation and inconclusive data on quantification method selection. To improve analysis precision, segmentation steps are systematically ranked based on their inherent risks of error. Additionally, data on two distinct quantification methods are presented. Methods: Using newly developed software, four experts analyzed five LGE-CMR left ventricular (LV) short-axis (SAx) images of myocarditis patients in three sessions. Regions of interest (ROIs) (myocardial (ROImyoc), reference (ROIref), and exclusion region (ROIexcl)) were identified and used to calculate LGE extent with 3σ (intensity above three standard deviations (σ) in reference) and the full width at half maximum (FWHM) method (intensity above 50% of maximum signal in reference). The reference LGE extent was calculated and the influence of the ROIs on LGE extent variability was determined. Interobserver and intraobserver variability were evaluated as 1-intraclass correlation coefficient (ICC). Results: LGE extent variability was 6.2 ± 0.6% for 3σ and 4.0 ± 0.6% for FWHM. The contributions of ROImyoc, ROIref, and ROIexcl were 1.5 ± 0.2%, 2.7 ± 0.4%, and 2 ± 0.3%, respectively, for 3σ, and 1.1 ± 0.1%, 1.6 ± 0.4%, and 1.3 ± 0.3%, respectively, for FWHM. LGE extent was lower in FWHM. Interobserver variability was 0.56 for 3σ and 0.43 for FWHM. The intraobserver variability was higher for the 3σ method in all four observers. Conclusion: ROIref selection contributed most to LGE extent variability. FWHM yielded lower LGE extent and lower inter- and intraobserver variability. Due to low statistical significance, the findings are only partially confirmed.

Published
2023
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39. Considerations and barriers to starting a new HAI pump program: an international survey of the HAI Consortium Research Network

Author

Cavnar, Michael, Ghalambor, Tara, Lidsky, Michael E., Dominguez-Rosado, Ismael, Cho, May, Karanicolas, Paul, Merkow, Ryan, Mayo, Skye C., Rocha, Flavio G., Fields, Ryan C., Koerkamp, Bas G., Yopp, Adam, Petrowsky, Hendrik, Cercek, Andrea, Kemeny, Nancy, Kingham, Peter, Jarnagin, William, Allen, Peter, D'Angelica, Michael, and Gholami, Sepideh

Published
2022
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40. Impaired tolerance to the autoantigen LL-37 in acute coronary syndrome

Author

Fernando Chernomordik, Bojan Cercek, Jianchang Zhou, Xiaoning Zhao, Nicole Wai Man Lio, Kuang-Yuh Chyu, Prediman K. Shah, and Paul C. Dimayuga

Subjects
acute coronary syndrome, LL-37, T cells, immune checkpoint, self-antigen, platelets, Immunologic diseases. Allergy, RC581-607
Abstract

BackgroundLL-37 is the only member of the cathelicidin family of antimicrobial peptides in humans and is an autoantigen in several autoimmune diseases and in acute coronary syndrome (ACS). In this report, we profiled the specific T cell response to the autoimmune self-antigen LL-37 and investigated the factors modulating the response in peripheral blood mononuclear cells (PBMCs) of healthy subjects and ACS patients.Methods and resultsThe activation induced marker (AIM) assay demonstrated differential T cell profiles characterized by the persistence of CD134 and CD137, markers that impair tolerance and promote immune effector and memory response, in ACS compared to Controls. Specifically, CD8+CD69+CD137+ T cells were significantly increased by LL-37 stimulation in ACS PBMCs. T effector cell response to LL-37 were either HLA dependent or independent as determined by blocking with monoclonal antibody to either Class-I HLA or Class-II HLA. Blocking of immune checkpoints PD-1 and CTLA-4 demonstrated the control of self-reactive T cell response to LL-37 was modulated predominantly by CTLA-4. Platelets from healthy controls down-modulated CD8+CD69+CD137+ T cell response to LL-37 in autologous PBMCs. CD8+CD69+CD137+ T cell AIM profile negatively correlated with platelet count in ACS patients.ConclusionsOur report demonstrates that the immune response to the autoantigen LL-37 in ACS patients is characterized specifically by CD8+CD69+CD137+ T cell AIM profile with persistent T cell activation and the generation of immunologic memory. The results provide potentially novel insight into mechanistic pathways of antigen-specific immune signaling in ACS.

Published
2023
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41. Predicting 10-year survival after resection of colorectal liver metastases; an international study including biomarkers and perioperative treatment

Author

Buisman, Florian E., Giardiello, Daniele, Kemeny, Nancy E., Steyerberg, Ewout W., Höppener, Diederik J., Galjart, Boris, Nierop, Pieter M.H., Balachandran, Vinod P., Cercek, Andrea, Drebin, Jeffrey A., Gönen, Mithat, Jarnagin, William R., Kingham, T.P., Vermeulen, Peter B., Wei, Alice C., Grünhagen, Dirk J., Verhoef, Cornelis, D'Angelica, Micheal I., and Koerkamp, Bas Groot

Published
2022
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44. Impact of chronic obstructive pulmonary disease on short-term outcome in patients with ST-elevation myocardial infarction during COVID-19 pandemic: insights from the international multicenter ISACS-STEMI registry

Author

De Luca, Giuseppe, Nardin, Matteo, Algowhary, Magdy, Uguz, Berat, Oliveira, Dinaldo C., Ganyukov, Vladimir, Zimbakov, Zan, Cercek, Miha, Okkels Jensen, Lisette, Loh, Poay Huan, Calmac, Lucian, Roura Ferrer, Gerard, Quadros, Alexandre, Milewski, Marek, Scotto di Uccio, Fortunato, von Birgelen, Clemens, Versaci, Francesco, Ten Berg, Jurrien, Casella, Gianni, Wong Sung Lung, Aaron, Kala, Petr, Díez Gil, José Luis, Carrillo, Xavier, Dirksen, Maurits, Becerra-Munoz, Victor M., Lee, Michael Kang-yin, Arifa Juzar, Dafsah, de Moura Joaquim, Rodrigo, Paladino, Roberto, Milicic, Davor, Davlouros, Periklis, Bakraceski, Nikola, Zilio, Filippo, Donazzan, Luca, Kraaijeveld, Adriaan, Galasso, Gennaro, Lux, Arpad, Marinucci, Lucia, Guiducci, Vincenzo, Menichelli, Maurizio, Scoccia, Alessandra, Yamac, Aylin Hatice, Ugur Mert, Kadir, Flores Rios, Xacobe, Kovarnik, Tomas, Kidawa, Michal, Moreu, Josè, Flavien, Vincent, Fabris, Enrico, Martínez-Luengas, Iñigo Lozano, Boccalatte, Marco, Bosa Ojeda, Francisco, Arellano-Serrano, Carlos, Caiazzo, Gianluca, Cirrincione, Giuseppe, Kao, Hsien-Li, Sanchis Forés, Juan, Vignali, Luigi, Pereira, Helder, Manzo, Stephane, Ordoñez, Santiago, Özkan, Alev Arat, Scheller, Bruno, Lehtola, Heidi, Teles, Rui, Mantis, Christos, Antti, Ylitalo, Brum Silveira, João A., Zoni, Rodrigo, Bessonov, Ivan, Savonitto, Stefano, Kochiadakis, George, Alexopoulos, Dimitrios, Uribe, Carlos E., Kanakakis, John, Faurie, Benjamin, Gabrielli, Gabriele, Gutierrez Barrios, Alejandro, Bachini, Juan Pablo, Rocha, Alex, Tam, Frankie Chor-Cheung, Rodriguez, Alfredo, Lukito, Antonia Anna, Saint-Joy, Veauthyelau, Pessah, Gustavo, Tuccillo, Andrea, Cortese, Giuliana, Parodi, Guido, Bouraghda, Mohamed Abed, Kedhi, Elvin, Lamelas, Pablo, Suryapranata, Harry, and Verdoia, Monica

Published
2022
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46. Clinical Calculator for Predicting Freedom From Recurrence After Resection of Stage I-III Colon Cancer in Patients With Microsatellite Instability.

Author

Bektas, Ayyuce Begum, Hakki, Lynn, Khan, Asama, Widmar, Maria, Wei, Iris H., Pappou, Emmanouil, Smith, J. Joshua, Nash, Garrett M., Paty, Philip B., Garcia-Aguilar, Julio, Cercek, Andrea, Stadler, Zsofia, Segal, Neil H., Shia, Jinru, Gonen, Mithat, and Weiser, Martin R.

Subjects
COLON cancer, IRRITABLE colon, NOMOGRAPHY (Mathematics), LYMPH nodes, TUMOR classification, DISEASE risk factors
Abstract

PURPOSE: Outcome for patients with nonmetastatic, microsatellite instability (MSI) colon cancer is favorable: however, high-risk cohorts exist. This study was aimed at developing and validating a nomogram model to predict freedom from recurrence (FFR) for patients with resected MSI colon cancer. PATIENTS AND METHODS: Data from patients who underwent curative resection of stage I, II, or III MSI colon cancer in 2014-2021 (model training cohort, 384 patients, 33 events; median follow-up, 38.8 months) were retrospectively collected from institutional databases. Variables associated with recurrence in multivariable analysis were selected for inclusion in the clinical calculator. The calculator's predictive accuracy was measured with the concordance index and validated using data from patients who underwent treatment for MSI colon cancer in 2007-2013 (validation cohort, 164 patients, eight events; median follow-up, 84.8 months). RESULTS: T category and number of positive lymph nodes were significantly associated with recurrence in multivariable analysis and were selected for inclusion in the clinical calculator. The calculator's concordance index for FFR in the model training cohort was 0.812 (95% CI, 0.742 to 0.873), compared with 0.759 (95% CI, 0.683 to 0.840) for the staging schema of the eighth edition of the American Joint Committee on Cancer Staging Manual. The concordance index for the validation cohort was 0.744 (95% CI, 0.666 to 0.822), confirming robust predictive accuracy. CONCLUSION: Although in general patients with nonmetastatic MSI colon cancer had favorable outcome, patients with advanced T category and multiple metastatic lymph nodes had higher risk of recurrence. The clinical calculator identified patients with MSI colon cancer at high risk for recurrence, and this could inform surveillance strategies. In addition, the model could be used in trial design to identify patients suitable for novel adjuvant therapy. Clinical calculator predicts freedom from recurrence of microsatellite unstable colon cancer. [ABSTRACT FROM AUTHOR]

Published
2024
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47. Colonic Adenosquamous Carcinoma: A Single-Center Review of Patient Clinicopathologic Characteristics, Genetics, and Clinical Outcomes.

Author

Lieb II, David A., M. Thompson, Hannah, Verheij, Floris S., Shia, Jinru, Sanchez-Vega, Francisco, Karagkounis, Georgios, Widmar, Maria, Wei, Iris H., Smith, J. Joshua, Nash, Garrett M., Weiser, Martin R., Paty, Philip B., Cercek, Andrea, Saltz, Leonard B., Garcia-Aguilar, Julio, and Pappou, Emmanouil

Subjects
SQUAMOUS cell carcinoma, ADENOCARCINOMA, RESEARCH funding, TREATMENT effectiveness, SYMPTOMS, RETROSPECTIVE studies, DESCRIPTIVE statistics, COLON tumors, MEDICAL records, ACQUISITION of data, GENETICS
Abstract

Simple Summary: Colonic adenosquamous carcinoma is an extremely rare subtype of colon cancer, making its study and characterization challenging. Here, we demonstrate the clinical properties of a cohort of patients with this rare subtype, characterized by a relatively young age at the time of diagnosis, right-sided predominance, an advanced stage at the time of diagnosis, frequent recurrence, and poor overall survival. All of these add further to the limited body of literature highlighting the more aggressive nature of colonic adenosquamous carcinoma, particularly when compared to adenocarcinoma. (1) Background: Adenosquamous carcinoma (ASC) is a rare subtype of colon cancer. Its rarity makes characterization challenging, although colonic ASC is believed to present at more advanced stages and have worse outcomes versus adenocarcinoma. This study aims to characterize the clinicopathological characteristics and clinical outcomes of colonic ASC. (2) Methods: This is a single-center, retrospective review of patients diagnosed with colonic ASC from 2000 to 2020. Data extracted included patient demographics, staging at diagnosis, tumor clinicopathologic and genetic characteristics, and clinical outcomes. (3) Results: Among 61,126 patients with colorectal cancer, 13 (0.02%) had colonic ASC, with a mean age at diagnosis of 48.7 years. The cecum/ascending colon was the most common primary site (6/13, 46.2%), and all except one patient was diagnosed with Stage III or IV disease. Among the eight patients with mismatch repair genetics available, only one was mismatch repair deficient. Eleven patients (84.6%) underwent surgery, and 11 likewise received some form of chemotherapy. Recurrence occurred in 7 of 13 patients (53.8%), and the overall five-year survival rate was 38.5%. The median survival rate was 39.4 months overall (30.5 months for Stage III, 23.7 months for Stage IV). (4) Conclusions: Overall, colonic ASC is rare, and this cohort of colonic ASC patients demonstrated advanced stage at diagnosis, frequent recurrence, and poor overall survival. Additional research remains to compare these characteristics with those of comparably staged adenocarcinoma and to develop specific management recommendations. [ABSTRACT FROM AUTHOR]

Published
2024
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48. Type of recurrence is associated with disease-free survival after salvage surgery for locally recurrent rectal cancer

Author

Jimenez-Rodriguez, Rosa M., Yuval, Jonathan B., Sauve, Charles-Etienne Gabriel, Wasserman, Isaac, Aggarwal, Piyush, Romesser, Paul B., Crane, Christopher H., Yaeger, Rona, Cercek, Andrea, Guillem, Jose G., Weiser, Martin R., Wei, Iris H., Widmar, Maria, Nash, Garrett M., Pappou, Emmanouil P., Garcia-Aguilar, Julio, Gollub, Marc J., Paty, Philip B., and Smith, J. Joshua

Published
2021
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49. Oncologic Outcomes of Salvage Abdominoperineal Resection for Anal Squamous Cell Carcinoma Initially Managed with Chemoradiation

Author

Rosen, Roni, primary, Quezada-Diaz, Felipe F., additional, Gönen, Mithat, additional, Karagkounis, Georgios, additional, Widmar, Maria, additional, Wei, Iris H., additional, Smith, J. Joshua, additional, Nash, Garrett M., additional, Weiser, Martin R., additional, Paty, Philip B., additional, Cercek, Andrea, additional, Romesser, Paul B., additional, Sanchez-Vega, Francisco, additional, Adileh, Mohammad, additional, Roth O’Brien, Diana, additional, Hajj, Carla, additional, Williams, Vonetta M., additional, Shcherba, Marina, additional, Gu, Ping, additional, Crane, Christopher, additional, Saltz, Leonard B., additional, Garcia Aguilar, Julio, additional, and Pappou, Emmanouil, additional

Published
2024
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50. A phase II study of guadecitabine combined with irinotecan vs regorafenib or TAS‐102 in irinotecan‐refractory metastatic colorectal cancer patients

Author

Lee, Valerie, primary, Parkinson, Rose, additional, Zahurak, Marianna, additional, Cope, Leslie, additional, Cercek, Andrea, additional, Verheul, Henk, additional, Gootjes, Elske, additional, Lenz, Heinz Josef, additional, Iqbal, Syma, additional, Jones, Peter, additional, Baylin, Stephen, additional, Rami, Vandna, additional, Ahuja, Nita, additional, El Khoueiry, Anthony, additional, and Azad, Nilofer S., additional

Published
2024
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