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46 results on '"Zemla, Tyler J."'

2. Radiation Therapy Quality Assurance Analysis of Alliance A021501: Preoperative mFOLFIRINOX or mFOLFIRINOX Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Pancreas

Author

Tchelebi, Leila T., Segovia, Diana, Smith, Koren, Shi, Qian, Fitzgerald, T.J., Chuong, Michael D., Zemla, Tyler J., O'Reilly, Eileen M., Meyerhardt, Jeffrey A, Koay, Eugene J., Lowenstein, Jessica, Shergill, Ardaman, Katz, Matthew H.G., and Herman, Joseph M.

Published
2024
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5. Marine omega‐3 fatty acid intake and survival of stage III colon cancer according to tumor molecular markers in NCCTG Phase III trial N0147 (Alliance)

Author

Song, Mingyang, Ou, Fang‐Shu, Zemla, Tyler J, Hull, Mark A, Shi, Qian, Limburg, Paul J, Alberts, Steven R, Sinicrope, Frank A, Giovannucci, Edward L, Van Blarigan, Erin L, Meyerhardt, Jeffrey A, and Chan, Andrew T

Subjects
Genetics, Clinical Trials and Supportive Activities, Colo-Rectal Cancer, Cancer, Clinical Research, Nutrition, Digestive Diseases, Aged, Cetuximab, Colonic Neoplasms, Disease-Free Survival, Fatty Acids, Omega-3, Female, Fish Oils, Fluorouracil, Humans, Male, Microsatellite Instability, Middle Aged, Neoplasm Staging, Proto-Oncogene Proteins B-raf, Proto-Oncogene Proteins p21(ras), Treatment Outcome, colorectal cancer, survivorship care, nutrition, inflammation, tumor microenvironment, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

Marine omega-3 polyunsaturated fatty acids (MO3PUFAs) have anticancer properties and may improve colon cancer survival. However, it remains unknown whether the benefit differs by tumor molecular subtype. We examined data from a phase III randomized trial of FOLFOX or FOLFOX + cetuximab among 1,735 stage III colon cancer patients who completed a dietary questionnaire at enrollment. Multivariable hazard ratios and 95% confidence intervals (CIs) were calculated for the association between MO3PUFA and disease-free survival (DFS) and overall survival according to KRAS and BRAFV600E mutations and DNA mismatch repair (MMR) status. Higher MO3PUFA intake was associated with improved 3-year DFS for KRAS wild-type tumors (77% vs. 73%; HR: 0.84; 95% CI: 0.67-1.05) but not KRAS-mutant tumors (64% vs. 70%; HR: 1.30; 95% CI: 0.97-1.73; Pinteraction = 0.02). Similar heterogeneity was found by MMR (Pinteraction = 0.14): higher MO3PUFA was associated with better 3-year DFS for tumors with deficient MMR (72% vs. 67%) but not proficient MMR (72% vs. 72%). No heterogeneity was found by BRAFV600E mutation. Similar findings were obtained for overall survival. In conclusion, we found a suggestive beneficial association between higher MO3PUFA intake and improved survival among stage III colon cancer patients with wild-type KRAS and deficient MMR. Given the relatively small number of cases with tumor molecular assessments, further studies, preferably through pooled analyses of multiples cohorts, are needed to validate our findings.

Published
2019

7. Immunoscore Is Prognostic in Low-Risk and High-Risk Stage III Colon Carcinomas Treated With Adjuvant Infusional Fluorouracil, Leucovorin, and Oxaliplatin in a Phase III Trial

Author

Sinicrope, Frank A., Shi, Qian, Catteau, Aurelie, Poage, Graham M., Zemla, Tyler J., Mlecnik, Bernhard, Benson, Al B., Gill, Sharlene, Goldberg, Richard M., Kahlenberg, Morton S., Nair, Suresh G., Shields, Anthony F., Smyrk, Thomas C., Galon, Jerome, and Alberts, Steven R.

Published
2022
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11. SerpinB3/4 Expression Is Associated with Poor Prognosis in Patients with Cholangiocarcinoma

Author

Martini, Andrea, primary, Prasai, Kritika, additional, Zemla, Tyler J., additional, Ahmed, Fowsiyo Y., additional, Elnagar, Mamoun B., additional, Giama, Nasra H., additional, Guzzardo, Vincenza, additional, Biasiolo, Alessandra, additional, Fassan, Matteo, additional, Yin, Jun, additional, Pontisso, Patrizia, additional, and Roberts, Lewis R., additional

Published
2024
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14. Phase Ib open-label study to evaluate safety, tolerability, immunogenicity, and efficacy of multiple subcutaneous injections of PolyPEPI1018 vaccine as an add-on immunotherapy to TAS-102 in participants with late-stage microsatellite-stable metastatic colorectal cancer (MSS mCRC; OBERTO-201).

Author

Hubbard, Joleen M., primary, Zemla, Tyler J., additional, Graham, Rondell P., additional, Jin, Zhaohui, additional, Zhu, Mojun, additional, Mitchell, Jessica L., additional, Novo, Elise, additional, Vegh, Eva, additional, Lorincz, Orsolya, additional, Kremlitzka, Mariann, additional, Somogyi, Eszter, additional, Molnar, Levente, additional, Tóth, József, additional, and Toke, Eniko Rita, additional

Published
2023
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16. A phase II single-arm study of the FGFR inhibitor pemigatinib in patients with metastatic colorectal cancer (mCRC) harboring FGF/FGFR alterations.

Author

Ciombor, Kristen Keon, primary, Zemla, Tyler J., additional, Hubbard, Joleen M., additional, Jia, Jingquan, additional, Gbolahan, Olumide B., additional, Sousa, Andrea, additional, Wilson, Luke, additional, Waechter, Blake, additional, Ou, Fang-Shu, additional, Nixon, Andrew B., additional, and Bekaii-Saab, Tanios S., additional

Published
2023
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19. Gene expression of vitamin D (VitD) pathway markers and survival in patients (Pts) with metastatic colorectal cancer (mCRC): CALGB/SWOG 80405 (Alliance).

Author

Kohn, Christine G, primary, Ou, Fang-Shu, additional, Ma, Chao, additional, Larson, Nicholas B, additional, Zemla, Tyler J., additional, Yuan, Chen, additional, Niedzwiecki, Donna, additional, Hollis, Bruce W., additional, Nixon, Andrew B., additional, Lenz, Heinz-Josef, additional, Blanke, Charles David, additional, Goldberg, Richard M., additional, Mayer, Robert J., additional, Venook, Alan P., additional, O'Reilly, Eileen Mary, additional, Meyerhardt, Jeffrey A., additional, and Ng, Kimmie, additional

Published
2022
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20. Evaluation of methylated DCR1 as a biomarker for response to adjuvant irinotecan-based therapy in stage III colon cancer: cancer and leukaemia Group B 89803 (Alliance)

Author

Symonds, Lynn, primary, Yu, Ming, additional, Zhang, YuHong, additional, Ou, Fang-Shu, additional, Zemla, Tyler J., additional, Carter, Kelly, additional, Bertagnolli, Monica, additional, Innocenti, Federico, additional, Bosch, Linda JW, additional, Meijer, Gerrit A, additional, Carvalho, Beatriz, additional, Grady, William M., additional, and Cohen, Stacey A., additional

Published
2022
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21. 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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22. A randomized phase II trial of MEK and CDK4/6 inhibitors vesus tipiracil/trifluridine (TAS-102) in metastatic KRAS/NRAS mutant (mut) colorectal cancer (CRC).

Author

Lee, Michael Sangmin, primary, Zemla, Tyler J., additional, Ciombor, Kristen Keon, additional, McRee, Autumn Jackson, additional, Akce, Mehmet, additional, Dakhil, Shaker R., additional, Jaszewski, Brandy L., additional, Ou, Fang-Shu, additional, Bekaii-Saab, Tanios S., additional, and Kopetz, Scott, additional

Published
2022
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23. A phase I study of pharmacokinetic (PK)-driven sequential dosing of rucaparib (RUB) with irinotecan liposome (nal-IRI) and fluorouracil (5FU) in metastatic gastrointestinal (mGI) and pancreas (PANC) cancers.

Author

Ma, Wen Wee, primary, Zemla, Tyler J., additional, Walden, Daniel, additional, McWilliams, Robert R., additional, Shaib, Walid Labib, additional, Ahn, Daniel H., additional, El-Rayes, Bassel F., additional, Halfdanarson, Thorvardur Ragnar, additional, Hobday, Timothy J., additional, Bruggeman, Sarah, additional, Jaszewski, Brandy L., additional, Ou, Fang-Shu, additional, Wu, Christina, additional, and Bekaii-Saab, Tanios S., additional

Published
2022
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24. Racial differences in survival and response to therapy in patients with metastatic colorectal cancer: A secondary analysis of CALGB/SWOG 80405 (Alliance A151931)

Author

Snyder, Rebecca A., primary, He, Jun, additional, Le‐Rademacher, Jennifer, additional, Ou, Fang‐Shu, additional, Dodge, Andrew B., additional, Zemla, Tyler J., additional, Paskett, Electra D., additional, Chang, George J., additional, Innocenti, Federico, additional, Blanke, Charles, additional, Lenz, Heinz‐Josef, additional, Polite, Blasé N., additional, and Venook, Alan P., additional

Published
2021
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25. A011801 (CompassHER2 RD): Postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer.

Author

O'Sullivan, Ciara Catherine Maria, primary, Ballman, Karla V., additional, McCall, Linda Mackie, additional, Zemla, Tyler J., additional, Weiss, Anna, additional, Mitchell, Melissa, additional, Blinder, Victoria Susana, additional, Tung, Nadine M., additional, Irvin, William Johnson, additional, Lee, Myounghee, additional, Goetz, Matthew P., additional, Symmans, William Fraser, additional, Borges, Virginia F., additional, Krop, Ian E., additional, Partridge, Ann H., additional, and Carey, Lisa A., additional

Published
2021
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26. A randomized trial of radium-223 (Ra-223) dichloride and cabozantinib in patients (pts) with advanced renal cell carcinoma (RCC) with bone metastases (RADICAL/Alliance A031801).

Author

McKay, Rana R., primary, Jacene, Heather, additional, Atherton, Pamela J., additional, Perez Burbano, Gabriela, additional, Ajmera, Archana, additional, Baghaie, Shiva, additional, Koball, Janet, additional, Zemla, Tyler J., additional, Chen, Ronald C., additional, Choudhury, Atish Dipankar, additional, Lang, Joshua Michael, additional, Cole, Suzanne, additional, Al Baghdadi, Tareq, additional, Kwok, Young, additional, Beltran, Himisha, additional, George, Daniel J., additional, Morris, Michael J., additional, and Choueiri, Toni K., additional

Published
2021
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27. Preemptive Versus Reactive Topical Clobetasol for Regorafenib‐Induced Hand‐Foot Reactions: A Preplanned Analysis of the ReDOS Trial

Author

Jatoi, Aminah, primary, Ou, Fang‐Shu, additional, Ahn, Daniel H., additional, Zemla, Tyler J., additional, Le‐Rademacher, Jennifer G., additional, Boland, Patrick, additional, Ciombor, Kristen K., additional, Jacobs, Nisha L., additional, Pasche, Boris, additional, Cleary, James M., additional, McCune, Jeannine S., additional, Pedersen, Katrina S., additional, Barzi, Afsaneh, additional, Chiorean, E. Gabriela, additional, Heying, Erica N., additional, Lenz, Heinz‐Josef, additional, Sloan, Jeff A., additional, Grothey, Axel, additional, Lacouture, Mario E., additional, and Bekaii‐Saab, Tanios, additional

Published
2021
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28. PDIGREE: An adaptive phase III trial of PD-inhibitor nivolumab and ipilimumab (IPI-NIVO) with VEGF TKI cabozantinib (CABO) in metastatic untreated renal cell cancer (Alliance A031704).

Author

Zhang, Tian, primary, Ballman, Karla V., additional, Choudhury, Atish Dipankar, additional, Chen, Ronald C., additional, Watt, Colleen, additional, Wen, Yujia, additional, Shergill, Ardaman, additional, Zemla, Tyler J., additional, Emamekhoo, Hamid, additional, Vaishampayan, Ulka N., additional, Morris, Michael J., additional, George, Daniel J., additional, and Choueiri, Toni K., additional

Published
2021
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29. Cetuximab and Irinotecan With or Without Bevacizumab in Refractory Metastatic Colorectal Cancer: BOND-3, an ACCRU Network Randomized Clinical Trial.

Author

Lipsyc-Sharf, Marla, Ou, Fang-Shu, Yurgelun, Matthew B, Rubinson, Douglas A, Schrag, Deborah, Dakhil, Shaker R, Stella, Philip J, Weckstein, Douglas J, Wender, Donald B, Faggen, Meredith, Zemla, Tyler J, Heying, Erica N, Schuetz, Samantha R, Noble, Stephanie, Meyerhardt, Jeffrey A, Bekaii-Saab, Tanios, Fuchs, Charles S, and Ng, Kimmie

Subjects
RESEARCH, DISEASE progression, CONFIDENCE intervals, EPIDERMAL growth factor receptors, MONOCLONAL antibodies, IRINOTECAN, ANTINEOPLASTIC agents, METASTASIS, COLORECTAL cancer, RANDOMIZED controlled trials, TREATMENT effectiveness, CANCER patients, BLIND experiment, BEVACIZUMAB, STATISTICAL sampling, PROGRESSION-free survival, DRUG side effects, DRUG toxicity, PHARMACODYNAMICS
Abstract

Background Combination irinotecan and cetuximab is approved for irinotecan-refractory metastatic colorectal cancer (mCRC). It is unknown if adding bevacizumab improves outcomes. Patients and Methods In this multicenter, randomized, double-blind, placebo-controlled phase II trial, patients with irinotecan-refractory RAS- wildtype mCRC and no prior anti-EGFR therapy were randomized to cetuximab 500 mg/m2, bevacizumab 5 mg/kg, and irinotecan 180 mg/m2 (or previously tolerated dose) (CBI) versus cetuximab, irinotecan, and placebo (CI) every 2 weeks until disease progression or intolerable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), and adverse events (AEs). Results The study closed early after the accrual of 36 out of a planned 120 patients due to changes in funding. Nineteen patients were randomized to CBI and 17 to CI. Baseline characteristics were similar between arms. Median PFS was 9.7 versus 5.5 months for CBI and CI, respectively (1-sided log-rank P =.38; adjusted hazard ratio [HR] = 0.64; 95% confidence interval [CI], 0.25-1.66). Median OS was 19.7 versus 10.2 months for CBI and CI (1-sided log-rank P =.02; adjusted HR = 0.41; 95% CI, 0.15-1.09). ORR was 36.8% for CBI versus 11.8% for CI (P =.13). Grade 3 or higher AEs occurred in 47% of patients receiving CBI versus 35% for CI (P =.46). Conclusion In this prematurely discontinued trial, there was no significant difference in the primary endpoint of PFS between CBI and CI. There was a statistically significant improvement in OS in favor of CBI compared with CI. Further investigation of CBI for the treatment of irinotecan-refractory mCRC is warranted. Clinical Trial Registration: NCT02292758 [ABSTRACT FROM AUTHOR]

Published
2022
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30. Direct oral anticoagulants for cancer-associated venous thromboembolism: a systematic review and meta-analysis

Author

Mulder, Frits I., primary, Bosch, Floris T. M., additional, Young, Annie M., additional, Marshall, Andrea, additional, McBane, Robert D., additional, Zemla, Tyler J., additional, Carrier, Marc, additional, Kamphuisen, Pieter Willem, additional, Bossuyt, Patrick M. M., additional, Büller, Harry R., additional, Weitz, Jeffrey I., additional, Middeldorp, Saskia, additional, and van Es, Nick, additional

Published
2020
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31. Celecoxib in addition to standard adjuvant therapy with 5-fluorouracil, leucovorin, oxaliplatin (FOLFOX) in stage III colon cancer: Results from CALGB/SWOG 80702.

Author

Meyerhardt, Jeffrey A., primary, Shi, Qian, additional, Fuchs, Charles S., additional, Niedzwiecki, Donna, additional, Zemla, Tyler J., additional, Kumthekar, Priya, additional, Guthrie, Katherine A, additional, Couture, Felix, additional, Kuebler, J. Phillip, additional, Bendell, Johanna C., additional, Kumar, Pankaj, additional, Lewis, DeQuincy Andrew, additional, Tan, Benjamin R., additional, Bertagnolli, Monica M., additional, Grothey, Axel, additional, Hochster, Howard S., additional, Goldberg, Richard M., additional, Venook, Alan P., additional, Blanke, Charles David, additional, and Shields, Anthony Frank, additional

Published
2020
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32. PDIGREE: An adaptive phase III trial of PD-inhibitor nivolumab and ipilimumab (IPI-NIVO) with VEGF TKI cabozantinib (CABO) in metastatic untreated renal cell cancer (Alliance A031704).

Author

Zhang, Tian, primary, Ballman, Karla V., additional, Choudhury, Atish Dipankar, additional, Chen, Ronald C., additional, Watt, Colleen, additional, Wen, Yujia, additional, Shergill, Ardaman, additional, Zemla, Tyler J., additional, Emamekhoo, Hamid, additional, Vaishampayan, Ulka N., additional, Morris, Michael J., additional, George, Daniel J., additional, and Choueiri, Toni K., additional

Published
2020
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33. Predictive and prognostic value of HER2 gene expression and HER2 amplification in patients with metastatic colorectal cancer (mCRC) enrolled in CALGB/SWOG 80405 (Alliance).

Author

Battaglin, Francesca, primary, Ou, Fang-Shu, additional, Qu, Xueping, additional, Bertagnolli, Monica M., additional, Hochster, Howard S., additional, Niedzwiecki, Donna, additional, Goldberg, Richard M., additional, Mayer, Robert J., additional, Zemla, Tyler J., additional, Blanke, Charles David, additional, Venook, Alan P., additional, Kabbarah, Omar, additional, Lenz, Heinz-Josef, additional, and Innocenti, Federico, additional

Published
2020
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34. Alliance A151804: Establishment of a national biorepository to advance studies of immune-related adverse events.

Author

Kozono, David E., primary, Sharon, Elad, additional, Le-Rademacher, Jennifer, additional, Twohy, Erin, additional, Zemla, Tyler J., additional, Wen, Yujia, additional, Watson, Mark, additional, Dib, Elie G., additional, Kirkwood, John M., additional, Lyman, Gary H., additional, Naidoo, Jarushka, additional, Nixon, Andrew B., additional, and Mittendorf, Elizabeth A., additional

Published
2020
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35. Contribution of Immunoscore and Molecular Features to Survival Prediction in Stage III Colon Cancer

Author

Sinicrope, Frank A, primary, Shi, Qian, primary, Hermitte, Fabienne, primary, Zemla, Tyler J, primary, Mlecnik, Bernhard, primary, Benson, Al B, primary, Gill, Sharlene, primary, Goldberg, Richard M, primary, Kahlenberg, Morton S, primary, Nair, Suresh G, primary, Shields, Anthony F, primary, Smyrk, Thomas C, primary, Galon, Jerome, primary, and Alberts, Steven R, primary

Published
2020
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36. Phase II Trial of Trifluridine/Tipiracil in Patients with Advanced, Refractory Biliary Tract Carcinoma

Author

Chakrabarti, Sakti, primary, Zemla, Tyler J., additional, Ahn, Daniel H., additional, Ou, Fang-Shu, additional, Fruth, Briant, additional, Borad, Mitesh J., additional, Hartgers, Mindy L., additional, Wessling, Jaclynn, additional, Walkes, Rachel L., additional, Alberts, Steven R., additional, McWilliams, Robert R., additional, Liu, Minetta C., additional, Durgin, Lori M., additional, Bekaii-Saab, Tanios S., additional, and Mahipal, Amit, additional

Published
2019
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37. Mutational Analysis of Patients With Colorectal Cancer in CALGB/SWOG 80405 Identifies New Roles of Microsatellite Instability and Tumor Mutational Burden for Patient Outcome

Author

Innocenti, Federico, primary, Ou, Fang-Shu, additional, Qu, Xueping, additional, Zemla, Tyler J., additional, Niedzwiecki, Donna, additional, Tam, Rachel, additional, Mahajan, Shilpi, additional, Goldberg, Richard M., additional, Bertagnolli, Monica M., additional, Blanke, Charles D., additional, Sanoff, Hanna, additional, Atkins, James, additional, Polite, Blasé, additional, Venook, Alan P., additional, Lenz, Heinz-Josef, additional, and Kabbarah, Omar, additional

Published
2019
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38. Time-to-Treatment-Failure and Related Outcomes Among 1000+ Advanced Non–Small Cell Lung Cancer Patients: Comparisons Between Older Versus Younger Patients (Alliance A151711)

Author

Gajra, Ajeet, primary, Zemla, Tyler J., additional, Jatoi, Aminah, additional, Feliciano, Josephine L., additional, Wong, Melisa L., additional, Chen, Hongbin, additional, Maggiore, Ronald, additional, McMurray, Ryan P., additional, Hurria, Arti, additional, Muss, Hyman B., additional, Cohen, Harvey J., additional, Lafky, Jacqueline, additional, Edelman, Martin J., additional, Lilenbaum, Rogerio, additional, and Le-Rademacher, Jennifer G., additional

Published
2018
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39. Physical Activity and Outcomes in Patients with Stage III Colon Cancer: A Correlative Analysis of Phase III Trial NCCTG N0147 (Alliance)

Author

Phipps, Amanda I., primary, Shi, Qian, additional, Zemla, Tyler J., additional, Dotan, Efrat, additional, Gill, Sharlene, additional, Goldberg, Richard M., additional, Hardikar, Sheetal, additional, Jahagirdar, Balkrishna, additional, Limburg, Paul J., additional, Newcomb, Polly A., additional, Shields, Anthony, additional, Sinicrope, Frank A., additional, Sargent, Daniel J., additional, and Alberts, Steven R., additional

Published
2018
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42. PolyPEPI1018 vaccine in combination with TAS-102 in participants with late-stage microsatellite-stable metastatic colorectal cancer (MSS mCRC): A phase Ib study to evaluate safety, tolerability, immunogenicity and efficacy (OBERTO-201).

Author

Hubbard, Joleen M., Zemla, Tyler J., Graham, Rondell P., Jin, Zhaohui, Zhu, Mojun, Mitchell, Jessica L., Novo, Elise, Vegh, Eva, Lorincz, Orsolya, Csiszovszki, Zsolt, Kremlitzka, Mariann, Somogyi, Eszter, Molnar, Levente, Tóth, József, and Toke, Eniko Rita

Published
2023
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44. Phase II Trial of Trifluridine/Tipiracil in Patients with Advanced, Refractory Biliary Tract Carcinoma.

Author

Chakrabarti, Sakti, Zemla, Tyler J., Ahn, Daniel H., Ou, Fang‐Shu, Fruth, Briant, Borad, Mitesh J., Hartgers, Mindy L., Wessling, Jaclynn, Walkes, Rachel L., Alberts, Steven R., McWilliams, Robert R., Liu, Minetta C., Durgin, Lori M., Bekaii‐Saab, Tanios S., and Mahipal, Amit

Subjects
ANTINEOPLASTIC agents, CANCER patients, CLINICAL trials, CONFIDENCE intervals, DRUG side effects, DRUG toxicity, ENZYME inhibitors, SURVIVAL analysis (Biometry), BILE duct tumors, TREATMENT effectiveness, DISEASE progression, DESCRIPTIVE statistics, DEOXYRIBONUCLEOSIDES
Abstract

Lessons Learned: Trifluridine/tipiracil (FTD/TPI) shows promising antitumor activity in heavily pretreated patients with advanced biliary tract carcinoma, including patients with 5‐fluorouracil refractory tumors.FTD/TPI has an acceptable safety profile and should be studied further in patients with advanced biliary tract carcinoma after progression on standard first‐line therapy. Background: Patients with advanced biliary tract carcinoma (BTC) refractory to first‐line therapy lack an established second‐line option. Trifluridine/tipiracil (FTD/TPI) has activity in both fluoropyrimidine‐sensitive and ‐resistant tumors, which led us to conduct a single arm phase II trial to evaluate the safety and efficacy of FTD/TPI for patients previously treated for advanced BTC. Methods: Patients with advanced BTC previously treated with at least one line of chemotherapy were enrolled and treated with FTD/TPI until disease progression or unacceptable toxicity. The primary endpoint target was to have at least 6 patients who were progression free and alive at 16 weeks among 25 evaluable patients. Secondary endpoints included overall survival (OS), overall response rate (ORR), progression‐free survival (PFS), and toxicity. Results: Of 27 evaluable patients, 59.3% received at least three prior lines of therapy, and 81.5% had previous exposure to fluoropyrimidine. Eight (32%, 95% confidence interval [CI], 14.9%–53.5%) patients were progression free at 16 weeks in the primary analysis population (n = 25), which met the predefined efficacy criteria. Median PFS and OS were 3.8 (95% CI, 2–5.8 months) and 6.1 (95% CI, 4.4–11.4 months) months, respectively. No objective responses were seen. There were no unexpected safety signals noted. Conclusion: FTD/TPI demonstrated promising antitumor activity, with acceptable toxicity, in heavily pretreated patients with advanced BTC. [ABSTRACT FROM AUTHOR]

Published
2020
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45. GALAD score for the diagnosis of Hepatocellular Carcinoma in sub-Saharan Africa; a validation study in Ghanaian patients.

Author

Nartey YA, Yang JD, Zemla TJ, Ayawin J, Asibey SO, El-Kassas M, Bampoh SA, Duah A, Agyei-Nkansah A, Awuku YA, Afihene MY, Yamada H, Yin J, Plymoth A, and Roberts LR

Abstract

Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide including sub-Saharan Africa. The GALAD score, derived from Gender, Age, Lens culinaris agglutinin-reactive fraction of alpha fetoprotein (AFP-L3%), AFP and Des-carboxy-prothrombin (DCP) has high accuracy in diagnosing HCC in Asia, Europe, and North America, however, it has not been validated in an African cohort. The aim of this study was to assess the performance of the GALAD score in the diagnosis of HCC in sub-Saharan Africa. Clinical data from patients with cirrhosis (n=93) or HCC (n=78) from outpatient hepatology clinics at three teaching hospitals in Ghana were abstracted, and serum samples were analyzed. A logistic regression model predicting HCC status based on GALAD score was constructed to obtain the Receiver Operating Characteristics (ROC) curve for GALAD. The area under the curve (AUC) with 95% confidence interval (CI) was calculated. The median GALAD score was higher among HCC patients vs. cirrhosis controls (8.0 vs. -4.1, p<0.01). The AUC of the GALAD score for HCC detection was 0.86 (95% CI 0.79 - 0.92). At a cut-off value of -0.37, the GALAD score had a sensitivity of 0.81 and a specificity of 0.86. The AUC (95% CI) was 0.87 (0.80 - 0.95) and 0.81 (0.67 - 0.94) in HBV positive and HBV negative patients, respectively. The GALAD score has a high accuracy for HCC detection. It has great potential to improve HCC surveillance in sub-Saharan Africa where imaging resources are limited.

Published
2024
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46. Atezolizumab plus bevacizumab as first-line systemic therapy for hepatocellular carcinoma: a multi-institutional cohort study.

Author

Storandt MH, Zemla TJ MS, Patell K, Naleid N, Gile JJ, Tran NH, Chakrabarti S, Jin Z, Borad M, and Mahipal A

Abstract

Background: Atezolizumab plus bevacizumab is the standard of care for advanced hepatocellular carcinoma (HCC) in the first-line setting, although was only evaluated in patients with Child-Pugh (CP) A liver function in the IMbrave150 trial. We sought to determine the outcomes of these patients based on CP score and ALBI grade in the US population., Methods: This multicenter cohort study included patients with HCC who received atezolizumab with bevacizumab as first-line systemic therapy between March 2018 and November 2023. Overall survival (OS) was determined using the Kaplan-Meier method and multivariate analyses were performed using Cox proportional hazard regression method., Results: Among 322 patients, 226, 86, and 10 patients had CP-A, CP-B, and CP-C liver function, respectively. Median age was 66.5 years, 78.6% were male, and 82.6% were White. Median OS (mOS) was 21.6 months for those with CP-A, 9.1 months for those with CP-B7, and 4.7 months for those with CP-B8-C12 (P < .0001). Among patients with CP-A, those with ALBI grade 1 had an mOS of 34.9 months versus 14.2 months in those with grade 2. In multivariate analyses, CP score, ALBI grade, hepatitis B, performance status, and macrovascular invasion were significantly associated with survival., Conclusions: CP score is an important prognostic tool for patients with HCC receiving atezolizumab plus bevacizumab, and this regimen remains a viable option for patients with CP-B7 with no additional safety concern, although the benefit is significantly less than those with CP-A. ALBI score has independent predictive value in patients with CP-A liver function., (© The Author(s) 2024. Published by Oxford University Press.)

Published
2024
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