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3. Population pharmacokinetics of liposomal irinotecan in patients with cancer and exposure–safety analyses in patients with metastatic pancreatic cancer

Author

Brendel, Karl, Bekaii‐Saab, Tanios, Boland, Patrick M, Dayyani, Farshid, Dean, Andrew, Macarulla, Teresa, Maxwell, Fiona, Mody, Kabir, Pedret‐Dunn, Anna, Wainberg, Zev A, and Zhang, Bin

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Rare Diseases, Cancer, Pancreatic Cancer, Clinical Trials and Supportive Activities, Digestive Diseases, Antineoplastic Agents, Carcinoma, Pancreatic Ductal, Diarrhea, Female, Genotype, Glucuronosyltransferase, Humans, Irinotecan, Liposomes, Logistic Models, Male, Metabolic Clearance Rate, Models, Biological, Neoplasm Metastasis, Neutropenia, Pancreatic Neoplasms, Pharmacology and Pharmaceutical Sciences, Medical Physiology, Medical physiology, Pharmacology and pharmaceutical sciences
Abstract

Liposomal irinotecan is a liposomal formulation of irinotecan, which prolongs circulation of irinotecan and its active metabolite SN-38. A population pharmacokinetic (PK) model was developed based on data from seven studies (N = 440). Adequacy of the model was assessed using multiple methods, including visual predictive check. Associations between PK exposure and the incidence of diarrhea (grade ≥3) and neutropenia adverse events (AEs) (grade ≥3) at first event in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) were investigated using logistic regression based on data from two studies (the phase III NAPOLI-1 [N = 260] and phase I/II NCT02551991 [N = 56] trials). The PKs of total irinotecan was described by a two-compartment model with first-order elimination, with SN-38 formed directly by a first-order constant from the central compartment of irinotecan or after using a transit compartment. Clearance was 17.9 L/week (0.107 L/h) and 19,800 L/week (118 L/h) for total irinotecan and SN-38, respectively. The UGT1A1*28 7/7 homozygous genotype had no significant impact on SN-38 clearance. Model evaluation was satisfactory for both irinotecan and SN-38. The incidence of diarrhea (grade ≥3) at first event was significantly higher with increasing average concentrations of total irinotecan and SN-38; there was no significant association between an increased risk of neutropenia AEs (grade ≥3) at first event and average SN-38 concentrations. In summary, the PKs of total irinotecan and SN-38 after administration of liposomal irinotecan were well-described by the model. The UGT1A1*28 status had no significant impact on the PKs of liposomal irinotecan.

Published
2021

4. Pembrolizumab for previously treated, microsatellite instability–high/mismatch repair–deficient advanced colorectal cancer: final analysis of KEYNOTE-164

Author

Le, Dung T., Diaz, Luis A., Jr., Kim, Tae Won, Van Cutsem, Eric, Geva, Ravit, Jäger, Dirk, Hara, Hiroki, Burge, Matthew, O’Neil, Bert H., Kavan, Petr, Yoshino, Takayuki, Guimbaud, Rosine, Taniguchi, Hiroya, Élez, Elena, Al-Batran, Salah-Eddin, Boland, Patrick M., Cui, Yi, Leconte, Pierre, Marinello, Patricia, and André, Thierry

Published
2023
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5. Phase II Open-Label Study of Pembrolizumab in Treatment-Refractory, Microsatellite Instability–High/Mismatch Repair–Deficient Metastatic Colorectal Cancer: KEYNOTE-164

Author

Le, Dung T, Kim, Tae Won, Van Cutsem, Eric, Geva, Ravit, Jäger, Dirk, Hara, Hiroki, Burge, Matthew, O’Neil, Bert, Kavan, Petr, Yoshino, Takayuki, Guimbaud, Rosine, Taniguchi, Hiroya, Elez, Elena, Al-Batran, Salah-Eddin, Boland, Patrick M, Crocenzi, Todd, Atreya, Chloe E, Cui, Yi, Dai, Tong, Marinello, Patricia, Diaz, Luis A, and André, Thierry

Subjects
Digestive Diseases, Colo-Rectal Cancer, Cancer, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Antineoplastic Agents, Immunological, Cohort Studies, Colorectal Neoplasms, DNA Mismatch Repair, Drug Administration Schedule, Female, Humans, Infusions, Intravenous, Male, Microsatellite Instability, Middle Aged, Treatment Outcome, Young Adult, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeKEYNOTE-164 (NCT02460198) evaluated the antitumor activity of pembrolizumab in previously treated, metastatic, microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) colorectal cancer (CRC).MethodsThis phase II open-label study involved 128 centers worldwide. Eligible patients were age ≥ 18 years and had metastatic MSI-H/dMMR CRC treated with ≥ 2 prior lines of standard therapy, including fluoropyrimidine, oxaliplatin, and irinotecan with or without anti-vascular endothelial growth factor/epidermal growth factor receptor monoclonal antibody (cohort A) or ≥ 1 prior line of therapy (cohort B). MSI-H/dMMR status was assessed locally. Patients received pembrolizumab 200 mg every 3 weeks for up to 2 years until progression, unacceptable toxicity, or withdrawal. The primary end point was objective response rate by RECIST version 1.1 by independent central review. Secondary end points were duration of response, progression-free survival (PFS), overall survival, safety, and tolerability.ResultsA total of 124 patients with MSI-H/dMMR CRC (61 in cohort A, 63 in cohort B) enrolled. At data cutoff, median follow-up was 31.3 months (range, 0.2-35.6 months) for cohort A and 24.2 months (range, 0.1-27.1 months) for cohort B. Objective response rate was 33% (95% CI, 21% to 46%) and 33% (95% CI, 22% to 46%), respectively, with median duration of response not reached in either cohort. Median PFS was 2.3 months (95% CI, 2.1 to 8.1 months) and 4.1 months (95% CI, 2.1 to 18.9 months). Median overall survival was 31.4 months (95% CI, 21.4 months to not reached) and not reached (95% CI, 19.2 months to not reached). Treatment-related grade 3-4 adverse events occurred in 10 patients (16%) in cohort A and 8 (13%) in cohort B, with the most common occurring in ≥ 2 patients being pancreatitis, fatigue, increased alanine aminotransferase, and increased lipase (2 patients each; 3%) in cohort A.ConclusionPembrolizumab is effective with a manageable safety profile in patients with MSI-H/dMMR CRC.

Published
2020

10. A phase I/II study of nintedanib and capecitabine for refractory metastatic colorectal cancer.

Author

Boland, Patrick M, Ebos, John M L, Attwood, Kristopher, Mastri, Michalis, Fountzilas, Christos, Iyer, Renuka V, Banker, Christopher, Goey, Andrew K L, Bies, Robert, Ma, Wen Wee, and Fakih, Marwan

Subjects
KINASE inhibitors, COLORECTAL cancer, METASTASIS
Abstract

Background Nintedanib is a tyrosine kinase inhibitor with efficacy in bevacizumab-resistant colorectal cancer models. This phase I/II study evaluated the recommended phase II dose and efficacy of nintedanib and capecitabine in refractory metastatic colorectal cancer. Methods Key eligibility criteria included refractory metastatic colorectal cancer and ECOG performance status of 1 or lower. The primary endpoint was 18-week progression-free survival (PFS). A 1-sided binomial test (at α = .1) compared the observed 18-week PFS with a historic control of.25. Results Forty-two patients were enrolled, including 39 at the recommended phase II dose. The recommended phase II dose was established to be nintedanib 200 mg by mouth twice daily and capecitabine 1000 mg/m2 by mouth twice daily. The protocol was evaluated for efficacy in 36 patients. The 18-week PFS was 42% (15/36 patients; P  = .0209). Median PFS was 3.4 mo. Median overall survival was 8.9 mo. Sixteen (44%) patients experienced a grade 3/4 adverse event, most commonly fatigue (8%), palmoplantar erythrodysesthesia (8%), aspartate aminotransferase elevation (6%), asthenia (6%), pulmonary embolus (6%), and dehydration (6%). Osteopontin levels at cycle 1, day 1 and cycle 3, day 1 as well as ΔCCL2 levels correlated to disease control at 18 weeks. Conclusions The combination of nintedanib and capecitabine is well tolerated. Clinical efficacy appears to be superior to regorafenib or tipiracil hydrochloride monotherapy. Further investigation of similar combinations is warranted. ClinicalTrials.gov identifier NCT02393755 [ABSTRACT FROM AUTHOR]

Published
2024
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11. Phase II results of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA) phase II/III study.

Author

Morris, Van K., primary, Yothers, Greg, additional, Kopetz, Scott, additional, Puhalla, Shannon L., additional, Lucas, Peter C., additional, Iqbal, Atif, additional, Boland, Patrick M, additional, Deming, Dustin A., additional, Scott, Aaron J., additional, Lim, Howard J, additional, Jacobs, Samuel A., additional, Hong, Theodore S., additional, Wolmark, Norman, additional, and George, Thomas J., additional

Published
2024
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12. The impact of Wnt pathway alterations including RNF43, GNAS, CTNNB1, and APC on prognosis and potential therapeutic vulnerability in pancreatic adenocarcinoma (PDAC).

Author

Takebe, Naoko, primary, Blais, Edik Matthew, additional, Huynh, Jasmine, additional, Thach, Dzung, additional, de Arbeloa, Patricia Miren, additional, Matrisian, Lynn McCormick, additional, Petricoin, Emanuel, additional, Pishvaian, Michael J., additional, Chung, Vincent, additional, Boland, Patrick M, additional, Yaeger, Rona, additional, Wadlow, Raymond Couric, additional, Hendifar, Andrew Eugene, additional, Nevler, Avinoam, additional, and Cannon, Timothy Lewis, additional

Published
2024
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13. A phase 1b study of the OxPhos inhibitor ME-344 in combination with bevacizumab in refractory metastatic colorectal cancer.

Author

Boland, Patrick M, primary, Lenz, Heinz-Josef, additional, Cusnir, Mike, additional, Florou, Vaia, additional, Pishvaian, Michael J., additional, Cohen, Deirdre J., additional, Ciombor, Kristen Keon, additional, Winer, Arthur, additional, Guo, Jessie Yanxiang, additional, Algaze, Sandra, additional, Wiley, Sandra E, additional, Ghalie, Richard, additional, and Hochster, Howard S., additional

Published
2024
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14. Tumor genomics and sidedness to predict outcomes in metastatic colorectal cancer (mCRC).

Author

Boland, Patrick M, primary, Quintanilha, Julia, additional, Li, Gerald, additional, Clark, Allison, additional, Carlson, Erik, additional, Morley, Samantha, additional, Aboosaiedi, Ali, additional, Mitchell, Jerry W., additional, Ross, Jeffrey S., additional, Graf, Ryon, additional, Deming, Dustin A., additional, and Lieu, Christopher Hanyoung, additional

Published
2024
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15. Recurrence‐free survival dynamics following adjuvant chemotherapy for resected colorectal cancer: A systematic review of randomized controlled trials

Author

Vail, Emma, primary, Choubey, Ankur P., additional, Alexander, H. Richard, additional, August, David A., additional, Berry, Abril, additional, Boland, Patrick M., additional, Eskander, Mariam F., additional, Grandhi, Miral S., additional, Haliani, Brittany, additional, In, Haejin, additional, Kennedy, Timothy J., additional, Langan, Russell C., additional, Maggi, Jason C., additional, Pitt, Henry A., additional, Ganesan, Shridar, additional, and Ecker, Brett L., additional

Published
2024
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17. Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study

Author

Bekaii-Saab, Tanios S, Ou, Fang-Shu, Ahn, Daniel H, Boland, Patrick M, Ciombor, Kristen K, Heying, Erica N, Dockter, Travis J, Jacobs, Nisha L, Pasche, Boris C, Cleary, James M, Meyers, Jeffrey P, Desnoyers, Rodwige J, McCune, Jeannine S, Pedersen, Katrina, Barzi, Afsaneh, Chiorean, E Gabriela, Sloan, Jeffrey, Lacouture, Mario E, Lenz, Heinz-Josef, and Grothey, Axel

Published
2019
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20. Combination of Immunotherapy and Radiation Therapy in Gastrointestinal Cancers: An Appraisal of the Current Literature and Ongoing Research

Author

Kumar, Ritesh, primary, Kim, Jongmyung, additional, Deek, Matthew P., additional, Eskander, Mariam F., additional, Gulhati, Prateek, additional, In, Haejin, additional, Kennedy, Timothy, additional, Shah, Mihir M., additional, Grandhi, Miral S., additional, Berim, Lyudmyla, additional, Spencer, Kristen R., additional, Langan, Russell C., additional, Hochster, Howard S., additional, Boland, Patrick M., additional, and Jabbour, Salma K., additional

Published
2023
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22. List of Contributors

Author

Abraham, Jame, primary, Advani, Anjali, additional, Basse, Per, additional, Bhatia, Shailender, additional, Boland, Patrick M., additional, Chen, Hongbin, additional, Dy, Grace K., additional, Ernstoff, Marc S., additional, Fountzilas, Christos, additional, Friedman, Gregory K., additional, Gillespie, G. Yancey, additional, Hanif, Ahmad, additional, Harrison, Michael R., additional, Inman, Brant A., additional, Ito, Fumito, additional, Iyer, Renuka V., additional, Kalinski, Pawel, additional, Khan, Sumera, additional, Kruse, Megan, additional, Lee, Sunyoung S., additional, Lee, Sylvia, additional, Loecher, Matthew, additional, Maawy, Ali A., additional, Mayor, Paul, additional, McNamara, Megan A., additional, Puzanov, Igor, additional, Ring, Eric K., additional, Sawalha, Yazeed, additional, Starbuck, Kristen, additional, Zhang, Tian, additional, and Zsiros, Emese, additional

Published
2019
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24. Supplementary Figure 1 from Phase Ib/II Study of Cetuximab plus Pembrolizumab in Patients with Advanced RAS Wild-Type Colorectal Cancer

Author

Fountzilas, Christos, primary, Bajor, David L., primary, Mukherjee, Sarbajit, primary, Saltzman, Joel, primary, Witkiewicz, Agnieszka K., primary, Maguire, Orla, primary, Minderman, Hans, primary, Nambiar, Ram, primary, Rosenheck, Hanna R., primary, Knudsen, Erik S., primary, Muhitch, Jason B., primary, Abrams, Scott I., primary, Wang, Chong, primary, Hutson, Alan D., primary, Attwood, Kristopher, primary, Hicks, Karen A., primary, Jurcevic, Jennifer A., primary, Kalinski, Pawel, primary, Iyer, Renuka, primary, and Boland, Patrick M., primary

Published
2023
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25. Supplementary Figure 2 from Phase Ib/II Study of Cetuximab plus Pembrolizumab in Patients with Advanced RAS Wild-Type Colorectal Cancer

Author

Fountzilas, Christos, primary, Bajor, David L., primary, Mukherjee, Sarbajit, primary, Saltzman, Joel, primary, Witkiewicz, Agnieszka K., primary, Maguire, Orla, primary, Minderman, Hans, primary, Nambiar, Ram, primary, Rosenheck, Hanna R., primary, Knudsen, Erik S., primary, Muhitch, Jason B., primary, Abrams, Scott I., primary, Wang, Chong, primary, Hutson, Alan D., primary, Attwood, Kristopher, primary, Hicks, Karen A., primary, Jurcevic, Jennifer A., primary, Kalinski, Pawel, primary, Iyer, Renuka, primary, and Boland, Patrick M., primary

Published
2023
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26. Supplementary Figure 3 from Phase Ib/II Study of Cetuximab plus Pembrolizumab in Patients with Advanced RAS Wild-Type Colorectal Cancer

Author

Fountzilas, Christos, primary, Bajor, David L., primary, Mukherjee, Sarbajit, primary, Saltzman, Joel, primary, Witkiewicz, Agnieszka K., primary, Maguire, Orla, primary, Minderman, Hans, primary, Nambiar, Ram, primary, Rosenheck, Hanna R., primary, Knudsen, Erik S., primary, Muhitch, Jason B., primary, Abrams, Scott I., primary, Wang, Chong, primary, Hutson, Alan D., primary, Attwood, Kristopher, primary, Hicks, Karen A., primary, Jurcevic, Jennifer A., primary, Kalinski, Pawel, primary, Iyer, Renuka, primary, and Boland, Patrick M., primary

Published
2023
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27. Supplementary Data from ZEBRA: A Multicenter Phase II Study of Pembrolizumab in Patients with Advanced Small-Bowel Adenocarcinoma

Author

Pedersen, Katrina S., primary, Foster, Nathan R., primary, Overman, Michael J., primary, Boland, Patrick M., primary, Kim, Sunnie S., primary, Arrambide, Kathryn A., primary, Jaszewski, Brandy L., primary, Bekaii-Saab, Tanios, primary, Graham, Rondell P., primary, Welch, Jack, primary, Wilson, Richard H., primary, and McWilliams, Robert R., primary

Published
2023
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28. Supplementary Figure 4 from Phase Ib/II Study of Cetuximab plus Pembrolizumab in Patients with Advanced RAS Wild-Type Colorectal Cancer

Author

Fountzilas, Christos, primary, Bajor, David L., primary, Mukherjee, Sarbajit, primary, Saltzman, Joel, primary, Witkiewicz, Agnieszka K., primary, Maguire, Orla, primary, Minderman, Hans, primary, Nambiar, Ram, primary, Rosenheck, Hanna R., primary, Knudsen, Erik S., primary, Muhitch, Jason B., primary, Abrams, Scott I., primary, Wang, Chong, primary, Hutson, Alan D., primary, Attwood, Kristopher, primary, Hicks, Karen A., primary, Jurcevic, Jennifer A., primary, Kalinski, Pawel, primary, Iyer, Renuka, primary, and Boland, Patrick M., primary

Published
2023
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29. Supplementary Figure 5 from Phase Ib/II Study of Cetuximab plus Pembrolizumab in Patients with Advanced RAS Wild-Type Colorectal Cancer

Author

Fountzilas, Christos, primary, Bajor, David L., primary, Mukherjee, Sarbajit, primary, Saltzman, Joel, primary, Witkiewicz, Agnieszka K., primary, Maguire, Orla, primary, Minderman, Hans, primary, Nambiar, Ram, primary, Rosenheck, Hanna R., primary, Knudsen, Erik S., primary, Muhitch, Jason B., primary, Abrams, Scott I., primary, Wang, Chong, primary, Hutson, Alan D., primary, Attwood, Kristopher, primary, Hicks, Karen A., primary, Jurcevic, Jennifer A., primary, Kalinski, Pawel, primary, Iyer, Renuka, primary, and Boland, Patrick M., primary

Published
2023
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30. Supplementary Table 1 from Phase Ib/II Study of Cetuximab plus Pembrolizumab in Patients with Advanced RAS Wild-Type Colorectal Cancer

Author

Fountzilas, Christos, primary, Bajor, David L., primary, Mukherjee, Sarbajit, primary, Saltzman, Joel, primary, Witkiewicz, Agnieszka K., primary, Maguire, Orla, primary, Minderman, Hans, primary, Nambiar, Ram, primary, Rosenheck, Hanna R., primary, Knudsen, Erik S., primary, Muhitch, Jason B., primary, Abrams, Scott I., primary, Wang, Chong, primary, Hutson, Alan D., primary, Attwood, Kristopher, primary, Hicks, Karen A., primary, Jurcevic, Jennifer A., primary, Kalinski, Pawel, primary, Iyer, Renuka, primary, and Boland, Patrick M., primary

Published
2023
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31. Supplementary Table 3 from Phase Ib/II Study of Cetuximab plus Pembrolizumab in Patients with Advanced RAS Wild-Type Colorectal Cancer

Author

Fountzilas, Christos, primary, Bajor, David L., primary, Mukherjee, Sarbajit, primary, Saltzman, Joel, primary, Witkiewicz, Agnieszka K., primary, Maguire, Orla, primary, Minderman, Hans, primary, Nambiar, Ram, primary, Rosenheck, Hanna R., primary, Knudsen, Erik S., primary, Muhitch, Jason B., primary, Abrams, Scott I., primary, Wang, Chong, primary, Hutson, Alan D., primary, Attwood, Kristopher, primary, Hicks, Karen A., primary, Jurcevic, Jennifer A., primary, Kalinski, Pawel, primary, Iyer, Renuka, primary, and Boland, Patrick M., primary

Published
2023
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32. Supplementary Table 2 from Phase Ib/II Study of Cetuximab plus Pembrolizumab in Patients with Advanced RAS Wild-Type Colorectal Cancer

Author

Fountzilas, Christos, primary, Bajor, David L., primary, Mukherjee, Sarbajit, primary, Saltzman, Joel, primary, Witkiewicz, Agnieszka K., primary, Maguire, Orla, primary, Minderman, Hans, primary, Nambiar, Ram, primary, Rosenheck, Hanna R., primary, Knudsen, Erik S., primary, Muhitch, Jason B., primary, Abrams, Scott I., primary, Wang, Chong, primary, Hutson, Alan D., primary, Attwood, Kristopher, primary, Hicks, Karen A., primary, Jurcevic, Jennifer A., primary, Kalinski, Pawel, primary, Iyer, Renuka, primary, and Boland, Patrick M., primary

Published
2023
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33. Trial in progress: A phase II study (with safety run-in) of evorpacept (ALX148), cetuximab, and pembrolizumab in patients with refractory microsatellite-stable metastatic colorectal cancer (AGICC-ALX148 21CRC01).

Author

Lentz, Robert William, primary, Hu, Junxiao, additional, Blatchford, Patrick Jud, additional, Pitts, Todd, additional, Leal, Alexis Diane, additional, Kim, Sunnie S., additional, Davis, S. Lindsey, additional, Lieu, Christopher Hanyoung, additional, Scott, Aaron James, additional, Boland, Patrick M, additional, Hochster, Howard S., additional, and Messersmith, Wells A., additional

Published
2023
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34. Molecular characterization of metastatic colorectal cancer (mCRC) in patients (pts) treated with cetuximab and pembrolizumab.

Author

Fountzilas, Christos, primary, Rosario, Spencer, additional, Withers, Henry G., additional, Mukherjee, Sarbajit, additional, Bajor, David L, additional, Saltzman, Joel N., additional, Wang, Chong, additional, Attwood, Kristopher, additional, Knudsen, Erik S., additional, Witkiewicz, Agnieszka K, additional, Iyer, Renuka V., additional, and Boland, Patrick M, additional

Published
2023
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35. HCRN GI16-288: A phase II trial of perioperative CV301 vaccination in combination with nivolumab and systemic chemotherapy for resectable hepatic-limited metastatic colorectal cancer—Preliminary efficacy and correlative results.

Author

Spencer, Kristen Renee, primary, Hochster, Howard S., additional, Boland, Patrick M, additional, Berim, Lyudmyla Derby, additional, Kennedy, Timothy, additional, Grandhi, Miral, additional, Langan, Russell C, additional, Moore, Dirk F., additional, Kane, Michael P., additional, Krishnamurthi, Smitha S., additional, Mayo, Skye C., additional, Kasi, Anup, additional, Pimentel, Agustin, additional, and Carpizo, Darren R., additional

Published
2023
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36. Phase II/III study of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA).

Author

Morris, Van K., primary, Yothers, Greg, additional, Kopetz, Scott, additional, Jacobs, Samuel A., additional, Lucas, Peter C., additional, Iqbal, Atif, additional, Boland, Patrick M, additional, Deming, Dustin A., additional, Scott, Aaron James, additional, Lim, Howard John, additional, Hong, Theodore S., additional, Wolmark, Norman, additional, and George, Thomas J., additional

Published
2023
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37. Phase II study of TAS-OX (TAS-102 and oxaliplatin) plus bevacizumab for late-line colorectal cancer.

Author

Hochster, Howard S., primary, Liu, Hao, additional, Berim, Lyudmyla Derby, additional, Spencer, Kristen Renee, additional, Gulhati, Pat, additional, DiRubbo, Manda, additional, Cohen, Seth D., additional, Lee, Patrick, additional, Leitner, Stuart P., additional, Radovich, Delia, additional, Misdary, Christian, additional, Perez, Christian, additional, Datta, Sutirtha, additional, Gonzalez, Andrea, additional, Saunders, Tracie, additional, and Boland, Patrick M, additional

Published
2023
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40. High-risk MSI-H stage II colon cancer: Treatment patterns and outcomes.

Author

Fleming, Patrick, primary, Chen, Chunxia, additional, Moore, Dirk F., additional, Hochster, Howard S., additional, Jabbour, Salma K., additional, Berim, Lyudmyla Derby, additional, Spencer, Kristen Renee, additional, Gulhati, Pat, additional, Donohue, Kristen, additional, Maloney Patel, Nell, additional, and Boland, Patrick M, additional

Published
2022
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41. Understanding Suboptimal Response to Immune Checkpoint Inhibitors.

Author

Zhu, Mojun, Zhang, Henan, Pedersen, Katrina S., Foster, Nathan R., Jaszewski, Brandy L., Liu, Xin, Hirdler, Jacob B., An, Zesheng, Bekaii‐Saab, Tanios S., Halfdanarson, Thorvardur R., Boland, Patrick M., Yan, Yiyi, Hubbard, Joleen H., Ma, Wen Wee, Yoon, Harry H., Revzin, Alexander, Fernandez‐Zapico, Martin E., Overman, Michael J., McWilliams, Robert R., and Dong, Haidong

Subjects
IMMUNE checkpoint inhibitors, SMALL intestine cancer, PROGRAMMED cell death 1 receptors, IMMUNE response, CLINICAL indications, TREATMENT effectiveness
Abstract

Immune checkpoint inhibitors (ICIs), as a novel class of anticancer therapy, can be more efficacious and less toxic than chemotherapy, but their clinical success is confined to certain tumor types. Elucidating their targets, mechanisms and scope of action, and potential synergism with chemotherapy and/or targeted therapies are critical to widen their clinical indications. Treatment response to an ICI targeting programmed death‐1 (anti‐PD‐1) is sought to be understood here by conducting a preplanned correlative analysis of a phase II clinical trial in patients with small bowel adenocarcinoma (SBA). The cytolytic capacity of circulating immune cells in cancer patients using a novel ex vivo cytotoxicity assay is evaluated, and the utility of circulating biomarkers is investigated to predict and monitor the treatment effect of anti‐PD‐1. Baseline expression of Bim and NKG7 and upregulation of CX3CR1 in circulating T cells are associated with the clinical benefit of anti‐PD‐1 in patients with SBA. Overall, these findings suggest that the frequency and cytolytic capacity of circulating, effector immune cells may differentiate clinical response to ICIs, providing a strong rationale to support immune monitoring using patient peripheral blood. [ABSTRACT FROM AUTHOR]

Published
2023
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42. FL118, acting as a ‘molecular glue degrader’, binds to, dephosphorylates and degrades the oncoprotein DDX5 (p68) to control c‐Myc, survivin and mutant Kras against colorectal and pancreatic cancer with high efficacy

Author

Ling, Xiang, primary, Wu, Wenjie, additional, Aljahdali, Ieman A. M., additional, Liao, Jianqun, additional, Santha, Sreevidya, additional, Fountzilas, Christos, additional, Boland, Patrick M., additional, and Li, Fengzhi, additional

Published
2022
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43. Understanding Suboptimal Response to Immune Checkpoint Inhibitors

Author

Zhu, Mojun, primary, Zhang, Henan, additional, Pedersen, Katrina S., additional, Foster, Nathan R., additional, Jaszewski, Brandy L., additional, Liu, Xin, additional, Hirdler, Jacob B., additional, An, Zesheng, additional, Bekaii‐Saab, Tanios S., additional, Halfdanarson, Thorvardur R., additional, Boland, Patrick M., additional, Yan, Yiyi, additional, Hubbard, Joleen H., additional, Ma, Wen Wee, additional, Yoon, Harry H., additional, Revzin, Alexander, additional, Fernandez‐Zapico, Martin E., additional, Overman, Michael J., additional, McWilliams, Robert R., additional, and Dong, Haidong, additional

Published
2022
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44. Assessment of Capecitabine and Bevacizumab With or Without Atezolizumab for the Treatment of Refractory Metastatic Colorectal Cancer

Author

Mettu, Niharika B., primary, Ou, Fang-Shu, additional, Zemla, Tyler J., additional, Halfdanarson, Thorvardur R., additional, Lenz, Heinz-Josef, additional, Breakstone, Rimini A., additional, Boland, Patrick M., additional, Crysler, Oxana V., additional, Wu, Christina, additional, Nixon, Andrew B., additional, Bolch, Emily, additional, Niedzwiecki, Donna, additional, Elsing, Alicia, additional, Hurwitz, Herbert I., additional, Fakih, Marwan G., additional, and Bekaii-Saab, Tanios, additional

Published
2022
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45. Phase II/III study of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA).

Author

Morris, Van K., primary, Yothers, Greg, additional, Kopetz, Scott, additional, Jacobs, Samuel A., additional, Lucas, Peter C., additional, Iqbal, Atif, additional, Boland, Patrick M, additional, Deming, Dustin A., additional, Scott, Aaron James, additional, Lim, Howard John, additional, Hong, Theodore S., additional, Wolmark, Norman, additional, and George, Thomas J., additional

Published
2022
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46. Phase Ib/II Study of Cetuximab plus Pembrolizumab in Patients with Advanced RAS Wild-Type Colorectal Cancer

Author

Fountzilas, Christos, primary, Bajor, David L., additional, Mukherjee, Sarbajit, additional, Saltzman, Joel, additional, Witkiewicz, Agnieszka K., additional, Maguire, Orla, additional, Minderman, Hans, additional, Nambiar, Ram, additional, Rosenheck, Hanna R., additional, Knudsen, Erik S., additional, Muhitch, Jason B., additional, Abrams, Scott I., additional, Wang, Chong, additional, Hutson, Alan D., additional, Attwood, Kristopher, additional, Hicks, Karen A., additional, Jurcevic, Jennifer A., additional, Kalinski, Pawel, additional, Iyer, Renuka, additional, and Boland, Patrick M., additional

Published
2021
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47. First-line liposomal irinotecan with oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) in pancreatic ductal adenocarcinoma: A phase I/II study

Author

Wainberg, Zev A., primary, Bekaii-Saab, Tanios, additional, Boland, Patrick M., additional, Dayyani, Farshid, additional, Macarulla, Teresa, additional, Mody, Kabir, additional, Belanger, Bruce, additional, Maxwell, Fiona, additional, Moore, Yan, additional, Thiagalingam, Arunthathi, additional, Wang, Tiffany, additional, Zhang, Bin, additional, and Dean, Andrew, additional

Published
2021
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49. Phase II/III study of Circulating tumOr DNA as a predictive BiomaRker in Adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA).

Author

Morris, Van K., primary, Yothers, Greg, additional, Kopetz, Scott, additional, Jacobs, Samuel A., additional, Lucas, Peter C., additional, Iqbal, Atif, additional, Boland, Patrick M, additional, Deming, Dustin A., additional, Scott, Aaron James, additional, Lim, Howard John, additional, Wolmark, Norman, additional, and George, Thomas J., additional

Published
2021
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50. Blood-based tumor mutational burden from circulating tumor DNA (ctDNA) across advanced solid malignancies using a commercially available liquid biopsy assay.

Author

Drusbosky, Leylah, primary, Bilen, Mehmet Asim, additional, Azzi, Georges, additional, Barata, Pedro C., additional, Boland, Patrick M, additional, Bryce, Alan Haruo, additional, Chae, Young Kwang, additional, Force, Jeremy Meyer, additional, Gutierrez, Martin, additional, Kasi, Pashtoon Murtaza, additional, Dada, Hiba I., additional, Weipert, Caroline, additional, Hensel, Chuck, additional, Kiedrowski, Lesli A., additional, Lee, Che-Yu, additional, Lefterova, Martina, additional, and Gandara, David R., additional

Published
2021
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