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2. Blood-based tumor mutational burden impacts clinical outcomes of immune checkpoint inhibitor treated breast and prostate cancers

Author

Barnett, Reagan M., Jang, Albert, Lanka, Sree, Fu, PIngfu, Bucheit, Leslie A., Babiker, Hani, Bryce, Alan, Meyer, Haley M., Choi, Yujin, Moore, Casey, Garje, Rohan, Gao, Xin, Kim, Dae Won, Chang, Richard Y., Gulhati, Pat, Ramaker, Ryne, Bansal, Rani, Zhang, Tian, Oliver Sartor, A., Armstrong, Andrew J., Bilen, Mehmet A., and Barata, Pedro

Published
2024
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3. Transfusion-Transmitted Cache Valley Virus Infection in a Kidney Transplant Recipient With Meningoencephalitis.

Author

Al-Heeti, Omar, Wu, En-Ling, Ison, Michael G, Saluja, Rasleen K, Ramsey, Glenn, Matkovic, Eduard, Ha, Kevin, Hall, Scott, Banach, Bridget, Wilson, Michael R, Miller, Steve, Chiu, Charles Y, McCabe, Muniba, Bari, Chowdhury, Zimler, Rebecca A, Babiker, Hani, Freeman, Debbie, Popovitch, Jonathan, Annambhotla, Pallavi, Lehman, Jennifer A, Fitzpatrick, Kelly, Velez, Jason O, Davis, Emily H, Hughes, Holly R, Panella, Amanda, Brault, Aaron, Staples, J Erin, Gould, Carolyn V, and Tanna, Sajal

Subjects
Hematology, Clinical Research, Organ Transplantation, Biotechnology, Transplantation, Infectious Diseases, Kidney Disease, Aetiology, 2.2 Factors relating to the physical environment, Renal and urogenital, Infection, Good Health and Well Being, Humans, Antibodies, Neutralizing, Blood Transfusion, Bunyamwera virus, Kidney Transplantation, Meningoencephalitis, Cache Valley virus, meningoencephalitis, kidney transplant, blood transfusion, transfusion-transmitted infection, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

BackgroundCache Valley virus (CVV) is a mosquito-borne virus that is a rare cause of disease in humans. In the fall of 2020, a patient developed encephalitis 6 weeks following kidney transplantation and receipt of multiple blood transfusions.MethodsAfter ruling out more common etiologies, metagenomic next-generation sequencing (mNGS) of cerebrospinal fluid (CSF) was performed. We reviewed the medical histories of the index kidney recipient, organ donor, and recipients of other organs from the same donor and conducted a blood traceback investigation to evaluate blood transfusion as a possible source of infection in the kidney recipient. We tested patient specimens using reverse-transcription polymerase chain reaction (RT-PCR), the plaque reduction neutralization test, cell culture, and whole-genome sequencing.ResultsCVV was detected in CSF from the index patient by mNGS, and this result was confirmed by RT-PCR, viral culture, and additional whole-genome sequencing. The organ donor and other organ recipients had no evidence of infection with CVV by molecular or serologic testing. Neutralizing antibodies against CVV were detected in serum from a donor of red blood cells received by the index patient immediately prior to transplant. CVV neutralizing antibodies were also detected in serum from a patient who received the co-component plasma from the same blood donation.ConclusionsOur investigation demonstrates probable CVV transmission through blood transfusion. Clinicians should consider arboviral infections in unexplained meningoencephalitis after blood transfusion or organ transplantation. The use of mNGS might facilitate detection of rare, unexpected infections, particularly in immunocompromised patients.

Published
2023

4. Tilsotolimod Exploits the TLR9 Pathway to Promote Antigen Presentation and Type 1 IFN Signaling in Solid Tumors: A Multicenter International Phase I/II Trial (ILLUMINATE-101).

Author

Babiker, Hani, Borazanci, Erkut, Subbiah, Vivek, Agarwala, Sanjiv, Algazi, Alain, Schachter, Jacob, Lotem, Michael, Maurice-Dror, Corinne, Hendler, Daniel, Rahimian, Shah, Minderman, Hans, Haymaker, Cara, Mahadevan, Daruka, Bernatchez, Chantale, Murthy, Ravi, Hultsch, Rolf, Kaplan, Nadia, Woodhead, Gregory, Hennemeyer, Charles, Chunduru, Srinivas, Anderson, Peter, Diab, Adi, and Puzanov, Igor

Subjects
Humans, Toll-Like Receptor 9, Antigen Presentation, Neoplasms, Melanoma, Cohort Studies, Skin Neoplasms, Tumor Microenvironment
Abstract

PURPOSE: Tilsotolimod is an investigational synthetic Toll-like receptor 9 (TLR9) agonist that has demonstrated antitumor activity in preclinical models. The ILLUMINATE-101 phase I study explored the safety, dose, efficacy, and immune effects of intratumoral (it) tilsotolimod monotherapy in multiple solid tumors. PATIENTS AND METHODS: Patients with a diagnosis of refractory cancer not amenable to curative therapies received tilsotolimod in doses escalating from 8 to 32 mg into a single lesion at weeks 1, 2, 3, 5, 8, and 11. Additional patients with advanced malignant melanoma were enrolled into an expansion cohort at the 8 mg dose. Objectives included characterizing the safety, establishing the dose, efficacy, and immunologic assessment. Blood samples and tumor biopsies of injected and noninjected lesions were obtained at baseline and 24 hours after treatment for immune analyses. RESULTS: Thirty-eight and 16 patients were enrolled into the dose escalation and melanoma expansion cohorts, respectively. Deep visceral injections were conducted in 91% of patients. No dose-limiting toxicities (DLT) or grade 4 treatment-related adverse events were observed. Biopsies 24 hours after treatment demonstrated an increased IFN pathway signature and dendritic cell maturation. Immunologic profiling revealed upregulation of IFN-signaling genes and modulation of genes for checkpoint proteins. In the dose escalation cohort, 12 (34%) of 35 evaluable patients achieved a best overall response rate (ORR) of stable disease (SD), whereas 3 (19%) of 16 evaluable patients in the melanoma cohort achieved stable disease. CONCLUSIONS: Overall, tilsotolimod monotherapy was generally well tolerated and induced rapid, robust alterations in the tumor microenvironment. See related commentary by Punekar and Weber, p. 5007.

Published
2022

9. FGFR2-IIIb Expression by Immunohistochemistry Has High Specificity in Cholangiocarcinoma with FGFR2 Genomic Alterations

Author

Uson Junior, Pedro Luiz Serrano, DeLeon, Thomas T., Bogenberger, James M., Pai, Rish K., Kosiorek, Heidi E., Yin, Jun, Ahn, Daniel H., Sonbol, Mohammad Bassam, Bekaii-Saab, Tanios, Mansfield, Aaron S., Buetow, Kenneth, Gores, Gregory J., Smoot, Rory, Vasmatzis, George, Kipp, Benjamin R., Mahipal, Amit, Baker, Alexander T., Babiker, Hani, Barro, Oumar, Dumbauld, Chelsae, Zhou, Yumei, Aslam, Faaiq N., Barrett, Michael, Jacobs, Bertram, Meurice, Nathalie, Arora, Mansi, Petit, Joachim, Elliott, Natalie, Nagalo, Bolni, Salomao, Marcela A., and Borad, Mitesh J.

Published
2022
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15. Prognostication of ß-catenin (CTNNB1) in patients with HCC treated with first line immunotherapy.

Author

Shah, Priyanshi M., primary, Peersen, Anina, additional, Jatoi, Aminah, additional, McWilliams, Robert R., additional, Jin, Zhaohui, additional, Torbenson, Michael S., additional, Halfdanarson, Thorvardur Ragnar, additional, Babiker, Hani M., additional, Conboy, Caitlin, additional, Kankeu Fonkoua, Lionel Aurelien, additional, Washburn, Leslie, additional, Roberts, Lewis R., additional, Gores, Gregory J., additional, Bekaii-Saab, Tanios S., additional, Borad, Mitesh J., additional, Ou, Fang-Shu, additional, and Tran, Nguyen H., additional

Published
2024
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16. Assessment of blood-based tumor mutational burden on clinical outcomes in advanced breast and prostate cancer treated with immune checkpoint inhibitors

Author

Barata, Pedro, primary, Barnett, Reagan, additional, Jang, Albert, additional, Lanka, Sree, additional, Fu, Pingfu, additional, Bucheit, Leslie, additional, Babiker, Hani, additional, Bryce, Alan, additional, Meyer, Haley, additional, Choi, Yujin, additional, Moore, Casey, additional, Garje, Rohan, additional, Gao, Xin, additional, Kim, Dae, additional, Chang, Richard, additional, Gulhati, Pat, additional, Ramaker, Ryne, additional, Bansal, Rani, additional, Zhang, Tian, additional, Armstrong, Andrew, additional, Bilen, Mehmet, additional, and Sartor, Alton Oliver, additional

Published
2024
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17. Molecular Characterization and Therapeutic Opportunities in KRAS Wildtype Pancreatic Ductal Adenocarcinoma

Author

Desai, Aakash, primary, Xiao, Alexander H., additional, Choi, Daheui, additional, Toruner, Merih D., additional, Walden, Daniel, additional, Halfdanarson, Thorvardur R., additional, Alberts, Steven, additional, McWilliams, Robert R., additional, Mahipal, Amit, additional, Ahn, Daniel, additional, Babiker, Hani, additional, Stybayeva, Gulnaz, additional, Revzin, Alexander, additional, Kizilbash, Sani, additional, Adjei, Alex, additional, Bekaii-Saab, Tanios, additional, Mansfield, Aaron S., additional, Carr, Ryan M., additional, and Ma, Wen Wee, additional

Published
2024
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19. Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial

Author

Cascallar, Diana Vera, Varela, Mirta, Lazzaro, Mauricio Fernandez, Kaen, Diego Lucas, Gatica, Gabriela, Flores, David Hugo, Falco, Agustin, Molina, Matias, Van Aelst, Filip, Vulsteke, Christof, Sautois, Brieuc, Machiels, Jean-Pascal, Schallier, Denis, Brust, Leandro, Rapatoni, Liane, Azevedo, Sergio J, Marinho, Gisele, Soares, Joao Paulo Holanda, Dzik, Carlos, Almeida Silva, Jamile, Fay, Andre Poisl, Gingerich, Joel, Fradet, Yves, Ferrario, Cristiano, Potvin, Kylea, Vanhuyse, Marie, Abdelsalam, Mahmoud, Cheng, Susanna, Caglevic, Christian, Reyes, Felipe, Leal, Jose Luis, Francisco, Francisco, Ibanez, Carolina, Joly, Florence, Laguerre, Brigitte, Ladoire, Sylvain, Flechon, Aude, Topart, Delphine, Huillard, Olivier, Oudard, Stéphane, Gross-Goupil, Marine, Culine, Stephane, Loriot, Yohann, Gravis, Gwenaelle, Reichardt, Peter, Retz, Margitta, Herden, Jan, Pfister, David, Ohlman, Carsten, Stoeckle, Michael, Wirth, Manfred, Lorch, Anja, Niegisch, Guenter, Goebell, Peter J, Boegemann, Martin, Merseburger, Axel, Gakis, Georgios, Bedke, Jens, Neisius, Andreas, Thomas, Christian, Hoefner, Thomas, Telekes, Andras, Kosa, Judit Erzsebet, Revesz, Janos, Bodoky, Gyorgy, Csoszi, Tibor, Csejtei, Andras, Geczi, Lajos, Ruzsa, Agnes, Kolonics, Zsuzsanna, Erfan, Jozsef, McDermott, Ray, Bambury, Richard, Sella, Avishay, Frank, Stephen Jay, Kejzman, Daniel, Goldman, Olesya, Rosenbaum, Eli, Peer, Avivit, Berger, Raanan, Rouvinov, Keren, Sarid, David, Fukasawa, Satoshi, Arai, Gaku, Yamaguchi, Akito, Yokomizo, Akira, Takayama, Tatsuya, Kinoshita, Hidefumi, Kikuchi, Eiji, Mizuno, Ryuichi, Fujii, Yasuhisa, Sassa, Naoto, Matsukawa, Yoshihisa, Fujimoto, Kiyohide, Matsubara, Nobuaki, Tanikawa, Toshiki, Tomita, Yoshihiko, Nishimura, Kazuo, Tsujihata, Masao, Oyama, Masafumi, Masumori, Naoya, Kanayama, Hiroomi, Takano, Toshimi, Miura, Yuji, Miyazaki, Jun, Joraku, Akira, Kimura, Tomokazu, Yamamoto, Yoshiaki, Kobayashi, Kazuki, De Wit, Ronald, Aarts, Maureen, Gerritsen, Winald, Los, Maartje, Beerepoot, Laurens, Izmailov, Adel, Gorelov, Sergey Igorevich, Alekseev, Boris Yakovlevich, Semenov, Andrey, Kostorov, Vladimir Anatolyevich, Alekseev, Sergey M, Zyryanov, Alexander, Oschepkov, Vasiliy Nikolaevich, Shidin, Vladimir Aleksandrovich, Vladimirov, Vladimir Ivanovich, Gafanov, Rustem Airatovich, Karlov, Petr Alexandrovich, Anderson, David Brian, Shepherd, Lucinda, Cohen, Graham Lawrence, Rapoport, Bernardo Louis, Ruff, Paul, Lee, Nari, Bae, Woo Kyun, Lee, Hyo Jin, Herranz, Urbano Anido, Rodriguez-Vida, Alejo, Morales Barrera, Rafael, Grande, Enrique, Alonso Gordoa, Teresa, Guma Padro, Josep, Gauna, Daniel Castellano, Arranz, Jose Angel, Munoz Langa, Jose, Sarrio, Regina Girones, Montesa Pino, Alvaro, Juan Fita, Maria Jose, Su, Yu-Li, Lin, Yung-Chang, Su, Wen-Pin, Shen, Ying-Chun, Chang, Yen-Hwa, Huang, Yi-Hsiu, Sriuranpong, Virote, Chansriwong, Phichai, Srimuninnimit, Vichien, Danchaivijitr, Pongwut, Abali, Huseyin, Yavuz, Sinan, Ozyilkan, Ozgur, Sendur, Mehmet Ali Nahit, Ekenel, Meltem, Ozguroglu, Mustafa, Arslan, Cagatay, Gunduz, Seyda, Ozdogan, Mustafa, Birtle, Alison, Powles, Thomas, Huddart, Robert, de Santis, Maria, Zarkar, Anjali, Evans, Linda, Hussain, Syed, DiSimone, Christopher, Muina, Antonio F, Schlegel, Peter, Jhangiani, Haresh S, Harrison, Michael, Slater, Dennis E, Wright, David, Percent, Ivor J, Lin, Jianqing, Hwang, Clara, Mamtani, Ronac, Gupta, Sumati, Bajaj, Madhuri, Galamaga, Robert, Eklund, John, Wallace, James, Shtivelband, Mikhail, Suh, Jason Jung-Gon, Burhani, Nafisa, Eadens, Matthew, Gunturu, Krishna, Burgess, Earle, Wong, John, Chaudhry, Arvind, Van Veldhuizen, Peter, Graff, Stephanie, Thomas, Christian A, Schnadig, Ian D, Carneiro, Benedito, Hussain, Maha, Morgans, Alicia, Fitzharris, John T, Oliff, Ira A, Vuky, Jacqueline, Hauke, Ralph, Baron, Ari, Joshi, Monika, Bolemon, Britt H, Jiang, Peter, Mega, Anthony E, Markus, Maurice, Pfanzelter, Nicklas, Lawler, William Eyre, Cobb, Patrick Wayne, Courtright, Jay G, Jain, Sharad, Doshi, Gurjyot, Gunuganti, Vijay K, Sartor, Oliver Alton, Cole, Scott W, Babiker, Hani, Uchio, Edward M, Drakaki, Alexandra, Mannuel, Heather D, Alva, Ajjai, Guancial, Elizabeth, Fung, Chunkit, Charles, Anthony, Amato, Robert J, Arriaga, Yull, Bowman, Isaac, Ades, Steven, Dreicer, Robert, Yu, Evan, Quinn, David I, Fleming, Mark, Csőszi, Tibor, Özgüroğlu, Mustafa, Géczi, Lajos, Cheng, Susanna Y-S, Oudard, Stephane, Fléchon, Aude, Yu, Evan Y, Nam, Kijoeng, Imai, Kentaro, and Homet Moreno, Blanca

Published
2021
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21. Cell-Free Tumor DNA Dominant Clone Allele Frequency Is Associated With Poor Outcomes in Advanced Biliary Cancers Treated With Platinum-Based Chemotherapy

Author

Uson Junior, Pedro Luiz Serrano, Majeed, Umair, Yin, Jun, Botrus, Gehan, Sonbol, Mohamad Bassam, Ahn, Daniel H., Starr, Jason S., Jones, Jeremy C., Babiker, Hani, Inabinett, Samantha R., Wylie, Natasha, Boyle, Ashton W.R., Bekaii-Saab, Tanios S., Gores, Gregory J., Smoot, Rory, Barrett, Michael, Nagalo, Bolni, Meurice, Nathalie, Elliott, Natalie, Petit, Joachim, Zhou, Yumei, Arora, Mansi, Dumbauld, Chelsae, Barro, Oumar, Baker, Alexander, Bogenberger, James, Buetow, Kenneth, Mansfield, Aaron, Mody, Kabir, and Borad, Mitesh J.

Published
2022
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22. Second-Line Treatment of Pancreatic Adenocarcinoma: Shedding Light on New Opportunities and Key Talking Points from Clinical Trials

Author

Imperial,Robin, Mosalem,Osama, Majeed,Umair, Tran,Nguyen, Borad,Mitesh, Babiker,Hani, Imperial,Robin, Mosalem,Osama, Majeed,Umair, Tran,Nguyen, Borad,Mitesh, and Babiker,Hani

Abstract

Robin Imperial,1 Osama Mosalem,1 Umair Majeed,1 Nguyen H Tran,2 Mitesh J Borad,3 Hani Babiker1 1Division of Hematology and Oncology, Department of Medicine, Mayo Clinic, Jacksonville, FL, USA; 2Department of Medical Oncology, Rochester, MN, USA; 3Division of Hematology and Oncology, Department of Medicine, Mayo Clinic, Phoenix, AZ, USACorrespondence: Hani Babiker, Division of Hematology and Oncology, Department of Medicine, Mayo Clinic, 4500 San Pablo Rd S, Jacksonville, FL, 32224, USA, Tel +904 953 2000, Fax +904-953-2315, Email babiker.hani@mayo.eduAbstract: Despite improvements in overall cancer mortality, deaths related to pancreatic cancer continue to rise. Following first-line treatment, second-line options are significantly limited. Classically, first-line treatment consisted of either gemcitabine or 5-fluorouracil based systemic chemotherapy. Upon progression of disease or recurrence, subsequent second-line treatment is still gemcitabine or 5-fluorouracil based chemotherapy, depending on what was used in the first line and the timing of progression or recurrence. A better understanding of the molecular underpinnings of pancreatic adenocarcinoma (PDAC) has led to new treatment strategies including specifically targeting the desmoplastic stroma, cytokine signaling and actionable mutations. Furthermore, efforts are also directed to enhance the immunogenicity profile of PDAC’s well-established immunologically “cold” tumor microenvironment. More recently, the outstanding response rates of chimeric antigen receptor T (CAR-T) cells in hematologic malignancies, have led to clinical trials to evaluate the treatment modality in PDAC. In this review, we summarize recently presented clinical trials for metastatic pancreatic adenocarcinoma with novel treatment approaches in the second line and beyond.Keywords: pancreatic adenocarcinoma, immunotherapy, CAR-T, KRAS

Published
2024

30. E6201, an intravenous MEK1 inhibitor, achieves an exceptional response in BRAF V600E-mutated metastatic malignant melanoma with brain metastases

Author

Babiker, Hani M., Byron, Sara A., Hendricks, William P. D., Elmquist, William F., Gampa, Gautham, Vondrak, Jessica, Aldrich, Jessica, Cuyugan, Lori, Adkins, Jonathan, De Luca, Valerie, Tibes, Raoul, Borad, Mitesh J., Marceau, Katie, Myers, Thomas J., Paradiso, Linda J., Liang, Winnie S., Korn, Ronald L., Cridebring, Derek, Von Hoff, Daniel D., Carpten, John D., Craig, David W., Trent, Jeffrey M., and Gordon, Michael S.

Published
2019
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31. Targeting KRAS in pancreatic adenocarcinoma: Progress in demystifying the holy grail

Author

Elhariri, Ahmed, primary, Alhaj, Ahmed, additional, Ahn, Daniel, additional, Sonbol, Mohamad Bassam, additional, Bekaii-Saab, Tanios, additional, Wu, Christina, additional, Rutenberg, Michael Scott, additional, Stauffer, John, additional, Starr, Jason, additional, Majeed, Umair, additional, Jones, Jeremy, additional, Borad, Mitesh, additional, and Babiker, Hani, additional

Published
2023
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33. Second-Line Treatment of Pancreatic Adenocarcinoma: Shedding Light on New Opportunities and Key Talking Points from Clinical Trials.

Author

Imperial, Robin, Mosalem, Osama, Majeed, Umair, Tran, Nguyen H, Borad, Mitesh J, and Babiker, Hani

Subjects
CANCER chemotherapy, CLINICAL trials, CHIMERIC antigen receptors, ADENOCARCINOMA, HEMATOLOGIC malignancies, PANCREATIC tumors
Abstract

Despite improvements in overall cancer mortality, deaths related to pancreatic cancer continue to rise. Following first-line treatment, second-line options are significantly limited. Classically, first-line treatment consisted of either gemcitabine or 5-fluorouracil based systemic chemotherapy. Upon progression of disease or recurrence, subsequent second-line treatment is still gemcitabine or 5-fluorouracil based chemotherapy, depending on what was used in the first line and the timing of progression or recurrence. A better understanding of the molecular underpinnings of pancreatic adenocarcinoma (PDAC) has led to new treatment strategies including specifically targeting the desmoplastic stroma, cytokine signaling and actionable mutations. Furthermore, efforts are also directed to enhance the immunogenicity profile of PDAC's well-established immunologically "cold" tumor microenvironment. More recently, the outstanding response rates of chimeric antigen receptor T (CAR-T) cells in hematologic malignancies, have led to clinical trials to evaluate the treatment modality in PDAC. In this review, we summarize recently presented clinical trials for metastatic pancreatic adenocarcinoma with novel treatment approaches in the second line and beyond. [ABSTRACT FROM AUTHOR]

Published
2024
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36. APRI score is not predictive of post-surgical outcomes in cholangiocarcinoma patients.

Author

Aslam, Faaiq N., Loveday, Tristan A., Uson Junior, Pedro Luiz Serrano, Truty, Mark, Smoot, Rory, Bekaii-Saab, Tanios, Stucky, Chee-Chee, Babiker, Hani, and Borad, Mitesh J.

Subjects
BILIARY tract cancer, TREATMENT effectiveness, BILIARY tract, ALANINE aminotransferase, HEPATIC fibrosis, LIVER histology
Abstract

Background Cholangiocarcinoma is an epithelial malignancy of the intrahepatic or extrahepatic biliary tree, primarily driven by chronic inflammation and fibrosis. Fibrosis has been shown to correlate with malignancy, and the aminotransferase-platelet ratio index (APRI) score, a marker for hepatic fibrosis, has proved useful in prognosticating hepatocellular carcinoma. This study aimed to assess the utility of APRI score in predicting post-surgical outcomes in cholangiocarcinoma patients. Methods Clinical data from a total of 152 cholangiocarcinoma patients who underwent surgical resection at the Mayo Clinic were collected. The data were subsequently analyzed to determine if there was a relationship between APRI score and the demographic, laboratory, pathologic and outcome data, including overall survival. To determine the relationship between quantitative and qualitative data and the APRI score, a P-value <0.05 was considered as statistically significant. Results No relationship between APRI score and demographic factors was identified. There were correlations between APRI score and alanine transaminase, albumin and bilirubin, but the remaining laboratory parameters showed no correlation. APRI score did not prove to be useful as a prognostic tool, as it did not correlate with tumor pathology features (tumor grade t-test P=0.86, N stage ANOVA P=0.94, vascular invasion t-test P=0.59, and perineural invasion t-test P=0.14), or with post-surgical recurrence (t-test P=0.22) and mortality (t-test P=0.39). Conclusion APRI score is not a prognostic tool for post-surgical outcomes in patients with cholangiocarcinoma. [ABSTRACT FROM AUTHOR]

Published
2024
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37. A Pilot Study of F-18 Fluciclovine-PET/CT as a Diagnostic Tool for Bone Metastases in Patients With Castrate Resistant Prostate Adenocarcinoma and Correlative Analysis of Blood and Bone Molecular Testing (The FACT Study).

Author

Babiker, Hani M, Kay, Matthew D, Stuehm, Carol, Woodhead, Gregory, and Kuo, Phillip H

Subjects
ANALYSIS of bones, TISSUE analysis, ADENOCARCINOMA, PILOT projects, RESEARCH, MOLECULAR diagnosis, ACADEMIC medical centers, SPECIALTY hospitals, PREDICTIVE tests, POSITRON emission tomography computed tomography, CASTRATION-resistant prostate cancer, CANCER treatment, BONE metastasis, RESEARCH funding, RADIOPHARMACEUTICALS, BLOOD testing, STATISTICAL correlation, DEOXY sugars
Abstract

Background: Suspicious F-18 fluciclovine PET/CT findings for osseous metastases from prostate cancer (PC) were targeted for core needle biopsy. We correlated the maximum standardized uptake value (SUVmax) of biopsied lesions, with biopsy results, other diagnostic outcomes, and blood and tissue molecular analysis (TMA). Material and Methods: Patients with castrate resistant prostate cancer (CRPC) were recruited from a university oncology clinic. SUVmax, histology, blood, and TMA were correlated. Results: Fifteen patients were enrolled and 12 underwent bone biopsies. Fifty percent of bone biopsies demonstrated malignancy. Higher SUVmax was associated with positive biopsies for adenocarcinoma (P = .003), and lesions with SUVmax ≥ 5.1 were all positive for malignancy. Significant correlation between blood and somatic TMA (P = .002) was also found. Conclusion: Higher uptake of F-18 fluciclovine was associated with higher predictive value for osseous metastasis on biopsy. There was a significant correlation between blood and TMA. This study provides a valuable model for amino acid PET, as well as important molecular data on tumors. ctDNA correlates with tissue next-generation sequencing in prostate cancer. [ABSTRACT FROM AUTHOR]

Published
2023
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40. Supplementary Data from Tilsotolimod Exploits the TLR9 Pathway to Promote Antigen Presentation and Type 1 IFN Signaling in Solid Tumors: A Multicenter International Phase I/II Trial (ILLUMINATE-101)

Author

Babiker, Hani, primary, Borazanci, Erkut, primary, Subbiah, Vivek, primary, Agarwala, Sanjiv, primary, Algazi, Alain, primary, Schachter, Jacob, primary, Lotem, Michael, primary, Maurice-Dror, Corinne, primary, Hendler, Daniel, primary, Rahimian, Shah, primary, Minderman, Hans, primary, Haymaker, Cara, primary, Mahadevan, Daruka, primary, Bernatchez, Chantale, primary, Murthy, Ravi, primary, Hultsch, Rolf, primary, Kaplan, Nadia, primary, Woodhead, Gregory, primary, Hennemeyer, Charles, primary, Chunduru, Srinivas, primary, Anderson, Peter M., primary, Diab, Adi, primary, and Puzanov, Igor, primary

Published
2023
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41. Safety and efficacy of the tumor-selective adenovirus enadenotucirev, in combination with nivolumab, in patients with advanced/metastatic epithelial cancer: a phase I clinical trial (SPICE)

Author

Fakih, Marwan, primary, Harb, Wael, additional, Mahadevan, Daruka, additional, Babiker, Hani, additional, Berlin, Jordan, additional, Lillie, Tom, additional, Krige, David, additional, Carter, Jo, additional, Cox, Chris, additional, Patel, Minesh, additional, Parfitt, Lola, additional, Powell, Mark, additional, and Rosen, Lee, additional

Published
2023
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42. Abstract OT3-24-01: ReFocus: A Phase 1/2 Study of the Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients with Advanced Solid Tumors Including Breast Cancer

Author

Kamath, Suneel, primary, Tai, David, additional, Moreno, Irene, additional, Babiker, Hani, additional, Jin, Zhaohui, additional, Yoo, Changhoon, additional, Ricard, Fabien, additional, Jen, Kai Yu, additional, Coward, Jim, additional, Liu, Jia, additional, Opdam, Frans, additional, Millward, Michael, additional, Ponz-Sarvise, Mariano, additional, Yachnin, Jeffrey, additional, Kim, Richard, additional, Park, Joon Oh, additional, Subbiah, Vivek, additional, and Schram, Alison M., additional

Published
2023
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43. First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC)

Author

Autio, Karen A, primary, Higano, Celestia S, additional, Nordquist, Luke, additional, Appleman, Leonard J, additional, Zhang, Tian, additional, Zhu, Xin-Hua, additional, Babiker, Hani, additional, Vogelzang, Nicholas J, additional, Prasad, Sandip M, additional, Schweizer, Michael T, additional, Madan, Ravi A, additional, Billotte, Stephane, additional, Cavazos, Nora, additional, Bogg, Orlaith, additional, Li, Ray, additional, Chan, Kam, additional, Cho, Helen, additional, Kaneda, Megan, additional, Wang, I-Ming, additional, Zheng, Jenny, additional, Tang, Szu-Yu, additional, Hollingsworth, Robert, additional, Kern, Kenneth A, additional, and Petrylak, Daniel P, additional

Published
2023
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44. APRI score is not predictive of post-surgical outcomes in cholangiocarcinoma patients

Author

Aslam, Faaiq N, primary, Loveday, Tristan A, additional, Uson Junior, Pedro Luiz Serrano, additional, Truty, Mark, additional, Smoot, Rory, additional, Bekaii-Saab, Tanios, additional, Ahn, Daniel, additional, Sonbol, Mohamad Bassam, additional, Wu, Christina, additional, Stucky, Chee-Chee, additional, Babiker, Hani, additional, and Borad, Mitesh J, additional

Published
2023
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45. Trial in progress: Phase II study of niraparib and dostarlimab for the treatment of germline or somatic homologous recombination repair mutated metastatic pancreatic cancer.

Author

McWilliams, Robert R., primary, Kasi, Pashtoon Murtaza, additional, Foster, Nathan R., additional, Zhu, Mojun, additional, Carr, Ryan Michael, additional, Ma, Wen Wee, additional, Hartgers, Mindy L., additional, Jones, Kayla M., additional, Bartusiewicz, Jacqueline M., additional, Dong, Haidong, additional, Markovic, Svetomir, additional, Alberts, Steven R, additional, Ahn, Daniel H., additional, Babiker, Hani M., additional, Bekaii-Saab, Tanios S., additional, and Couch, Fergus, additional

Published
2023
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47. Proton Therapy With Concurrent Chemotherapy for Thoracic Esophageal Cancer: Toxicity, Disease Control, and Survival Outcomes

Author

Rutenberg, Michael S., primary, Hoppe, Bradford S., additional, Starr, Jason S., additional, Awad, Ziad, additional, Thomas, Mathew, additional, Morris, Christopher G., additional, Johnson, Perry, additional, Henderson, Randal H., additional, Jones, Jeremy C., additional, MBBS, Bharatsinh Gharia, additional, Bowers, Steven, additional, Wolfsen, Herbert C., additional, Krishnan, Sunil, additional, Ko, Stephen J., additional, Babiker, Hani M., additional, and Nichols, Romaine C., additional

Published
2022
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48. Pharmacotherapeutic options for pancreatic ductal adenocarcinoma

Author

Sardar, Muhammad, primary, Recio-Boiles, Alejandro, additional, Mody, Kabir, additional, Karime, Christian, additional, Chandana, Sreenivasa R, additional, Mahadevan, Daruka, additional, Starr, Jason, additional, Jones, Jeremy, additional, Borad, Mitesh, additional, and Babiker, Hani, additional

Published
2022
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49. Genomic landscape of advanced prostate cancer patients with BRCA1 versus BRCA2 mutations as detected by comprehensive genomic profiling of cell-free DNA

Author

Swami, Umang, primary, Zimmerman, Raquel Mae, additional, Nussenzveig, Roberto H., additional, Hernandez, Edgar Javier, additional, Jo, Yeonjung, additional, Sayegh, Nicolas, additional, Wesolowski, Sergiusz, additional, Kiedrowski, Lesli A., additional, Barata, Pedro C., additional, Lemmon, Gordon Howard, additional, Bilen, Mehmet A., additional, Heath, Elisabeth I., additional, Nandagopal, Lakshminarayan, additional, Babiker, Hani M., additional, Pal, Sumanta K., additional, Lilly, Michael, additional, Maughan, Benjamin L., additional, Haaland, Benjamin, additional, Yandell, Mark, additional, Sartor, Oliver, additional, and Agarwal, Neeraj, additional

Published
2022
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