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2. Final results of DESTINY-CRC01 investigating trastuzumab deruxtecan in patients with HER2-expressing metastatic colorectal cancer.

Author

Yoshino, Takayuki, Di Bartolomeo, Maria, Raghav, Kanwal, Masuishi, Toshiki, Loupakis, Fotios, Kawakami, Hisato, Yamaguchi, Kensei, Nishina, Tomohiro, Wainberg, Zev, Elez, Elena, Rodriguez, Javier, Fakih, Marwan, Ciardiello, Fortunato, Saxena, Kapil, Kobayashi, Kojiro, Bako, Emarjola, Okuda, Yasuyuki, Meinhardt, Gerold, Grothey, Axel, Siena, Salvatore, and DESTINY-CRC01 investigators

Subjects
DESTINY-CRC01 investigators, Humans, Breast Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Camptothecin, Receptor, erbB-2, Immunoconjugates, Female, Antibodies, Monoclonal, Humanized, Trastuzumab, Receptor, ErbB-2, Clinical Research, Clinical Trials and Supportive Activities, Colo-Rectal Cancer, Cancer, Digestive Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals
Abstract

DESTINY-CRC01 (NCT03384940) was a multicenter, open-label, phase 2 trial assessing the efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2-expressing metastatic colorectal cancer (mCRC) that progressed after ≥2 prior regimens; results of the primary analysis are published. Patients received T-DXd 6.4 mg/kg every 3 weeks and were assigned to either: cohort A (HER2-positive, immunohistochemistry [IHC] 3+ or IHC 2+/in situ hybridization [ISH]+), cohort B (IHC 2+/ISH-), or cohort C (IHC 1+). Primary endpoint was objective response rate (ORR) by independent central review in cohort A. Secondary endpoints included ORR (cohorts B and C), duration of response, disease control rate, progression-free survival, overall survival, pharmacokinetics, and safety of T-DXd. 86 patients were enrolled (53 in cohort A, 15 in cohort B, and 18 in cohort C). Results of the primary analysis are published, reporting an ORR of 45.3% in cohort A. Here, we report the final results. No responses occurred in cohorts B or C. Median progression-free survival, overall survival, and duration of response were 6.9, 15.5, and 7.0 months, respectively. Overall serum exposure (cycle 1) of T-DXd, total anti-HER2 antibody, and DXd were similar regardless of HER2 status. Most common grade ≥3 treatment-emergent adverse events were decreased neutrophil count and anemia. Adjudicated drug-related interstitial lung disease/pneumonitis occurred in 8 patients (9.3%). These findings support the continued exploration of T-DXd in HER2-positive mCRC.

Published
2023

3. Survival improvement for patients with metastatic colorectal cancer over twenty years

Author

Zeineddine, Fadl A., Zeineddine, Mohammad A., Yousef, Abdelrahman, Gu, Yue, Chowdhury, Saikat, Dasari, Arvind, Huey, Ryan W., Johnson, Benny, Kee, Bryan, Lee, Michael S., Morelli, Maria Pia, Morris, Van K., Overman, Michael J., Parseghian, Christine, Raghav, Kanwal, Willis, Jason, Wolff, Robert A., Kawaguchi, Yoshikuni, Vauthey, Jean-Nicolas, Sun, Ryan, Kopetz, Scott, and Shen, John Paul

Published
2023
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4. ctDNA applications and integration in colorectal cancer: an NCI Colon and Rectal–Anal Task Forces whitepaper

Author

Dasari, Arvind, Morris, Van K, Allegra, Carmen J, Atreya, Chloe, Benson, Al B, Boland, Patrick, Chung, Ki, Copur, Mehmet S, Corcoran, Ryan B, Deming, Dustin A, Dwyer, Andrea, Diehn, Maximilian, Eng, Cathy, George, Thomas J, Gollub, Marc J, Goodwin, Rachel A, Hamilton, Stanley R, Hechtman, Jaclyn F, Hochster, Howard, Hong, Theodore S, Innocenti, Federico, Iqbal, Atif, Jacobs, Samuel A, Kennecke, Hagen F, Lee, James J, Lieu, Christopher H, Lenz, Heinz-Josef, Lindwasser, O Wolf, Montagut, Clara, Odisio, Bruno, Ou, Fang-Shu, Porter, Laura, Raghav, Kanwal, Schrag, Deborah, Scott, Aaron J, Shi, Qian, Strickler, John H, Venook, Alan, Yaeger, Rona, Yothers, Greg, You, Y Nancy, Zell, Jason A, and Kopetz, Scott

Subjects
Cancer, Clinical Research, Colo-Rectal Cancer, Digestive Diseases, Good Health and Well Being, Biomarkers, Tumor, Circulating Tumor DNA, Colon, Colorectal Neoplasms, Humans, Liquid Biopsy, National Cancer Institute (U.S.), Neoplasm, Residual, Rectal Neoplasms, United States, Oncology and Carcinogenesis
Abstract

An increasing number of studies are describing potential uses of circulating tumour DNA (ctDNA) in the care of patients with colorectal cancer. Owing to this rapidly developing area of research, the Colon and Rectal-Anal Task Forces of the United States National Cancer Institute convened a panel of multidisciplinary experts to summarize current data on the utility of ctDNA in the management of colorectal cancer and to provide guidance in promoting the efficient development and integration of this technology into clinical care. The panel focused on four key areas in which ctDNA has the potential to change clinical practice, including the detection of minimal residual disease, the management of patients with rectal cancer, monitoring responses to therapy, and tracking clonal dynamics in response to targeted therapies and other systemic treatments. The panel also provides general guidelines with relevance for ctDNA-related research efforts, irrespective of indication.

Published
2020

5. Regorafenib plus nivolumab in patients with mismatch repair-proficient/microsatellite stable metastatic colorectal cancer: a single-arm, open-label, multicentre phase 2 study

Author

Fakih, Marwan, Raghav, Kanwal Pratap Singh, Chang, David Z., Larson, Tim, Cohn, Allen L., Huyck, Timothy K., Cosgrove, David, Fiorillo, Joseph A., Tam, Rachel, D'Adamo, David, Sharma, Neelesh, Brennan, Barbara J., Wang, Ying A., Coppieters, Sabine, Zebger-Gong, Hong, Weispfenning, Anke, Seidel, Henrik, Ploeger, Bart A., Mueller, Udo, Oliveira, Carolina Soares Viana de, and Paulson, Andrew Scott

Published
2023
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6. Molecular Profiling of Hepatocellular Carcinoma Using Circulating Cell-Free DNA

Author

Kaseb, Ahmed O, Sánchez, Nora S, Sen, Shiraj, Kelley, Robin K, Tan, Benjamin, Bocobo, Andrea G, Lim, Kian H, Abdel-Wahab, Reham, Uemura, Marc, Pestana, Roberto Carmagnani, Qiao, Wei, Xiao, Lianchun, Morris, Jeffrey, Amin, Hesham M, Hassan, Manal M, Rashid, Asif, Banks, Kimberly C, Lanman, Richard B, Talasaz, AmirAli, Mills-Shaw, Kenna R, George, Bhawana, Haque, Abedul, Raghav, Kanwal PS, Wolff, Robert A, Yao, James C, Meric-Bernstam, Funda, Ikeda, Sadakatsu, and Kurzrock, Razelle

Subjects
Liver Disease, Genetics, Digestive Diseases, Genetic Testing, Human Genome, Hepatitis - B, Clinical Research, Liver Cancer, Rare Diseases, Hepatitis, Biotechnology, Cancer, Detection, screening and diagnosis, 4.1 Discovery and preclinical testing of markers and technologies, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Biomarkers, Tumor, Carcinoma, Hepatocellular, Circulating Tumor DNA, Clinical Decision-Making, Cohort Studies, DNA Mutational Analysis, Female, Gene Frequency, High-Throughput Nucleotide Sequencing, Humans, Liver Neoplasms, Male, Middle Aged, Mutation, Patient Selection, Prognosis, United States, Young Adult, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeMolecular profiling has been used to select patients for targeted therapy and determine prognosis. Noninvasive strategies are critical to hepatocellular carcinoma (HCC) given the challenge of obtaining liver tissue biopsies.Experimental designWe analyzed blood samples from 206 patients with HCC using comprehensive genomic testing (Guardant Health) of circulating tumor DNA (ctDNA).ResultsA total of 153/206 (74.3%) were men; median age, 62 years (range, 18-91 years). A total of 181/206 patients had ≥1 alteration. The total number of alterations was 680 (nonunique); median number of alterations/patient was three (range, 1-13); median mutant allele frequency (% cfDNA), 0.49% (range, 0.06%-55.03%). TP53 was the common altered gene [>120 alterations (non-unique)] followed by EGFR, MET, ARID1A, MYC, NF1, BRAF, and ERBB2 [20-38 alterations (nonunique)/gene]. Of the patients with alterations, 56.9% (103/181) had ≥1 actionable alterations, most commonly in MYC, EGFR, ERBB2, BRAF, CCNE1, MET, PIK3CA, ARID1A, CDK6, and KRAS. In these genes, amplifications occurred more frequently than mutations. Hepatitis B (HBV)-positive patients were more likely to have ERBB2 alterations, 35.7% (5/14) versus 8.8% HBV-negative (P = 0.04).ConclusionsThis study represents the first large-scale analysis of blood-derived ctDNA in HCC in United States. The genomic distinction based on HCC risk factors and the high percentage of potentially actionable genomic alterations suggests potential clinical utility for this technology.

Published
2019

8. Serum Tumor Markers and Outcomes in Patients With Appendiceal Adenocarcinoma

Author

Yousef, Abdelrahman, primary, Yousef, Mahmoud, additional, Zeineddine, Mohammad A., additional, More, Aditya, additional, Fanaeian, Mohammad, additional, Chowdhury, Saikat, additional, Knafl, Mark, additional, Edelkamp, Paul, additional, Ito, Ichiaki, additional, Gu, Yue, additional, Pattalachinti, Vinay, additional, Naini, Zahra Alavi, additional, Zeineddine, Fadl A., additional, Peterson, Jennifer, additional, Alfaro, Kristin, additional, Foo, Wai Chin, additional, Jin, Jeff, additional, Bhutiani, Neal, additional, Higbie, Victoria, additional, Scally, Christopher P., additional, Kee, Bryan, additional, Kopetz, Scott, additional, Goldstein, Drew, additional, Strach, Madeleine, additional, Williamson, Andrew, additional, Aziz, Omer, additional, Barriuso, Jorge, additional, Uppal, Abhineet, additional, White, Michael G., additional, Helmink, Beth, additional, Fournier, Keith F., additional, Raghav, Kanwal P., additional, Taggart, Melissa W., additional, Overman, Michael J., additional, and Shen, John Paul, additional

Published
2024
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9. Comprehensive Landscape of BRAF Variant Classes, Clonalities, and Co-Mutations in Metastatic Colorectal Cancer Using ctDNA Profiling

Author

Johnson, Benny, primary, Morris, Van, additional, Wang, Xuemei, additional, Dasari, Arvind, additional, Raghav, Kanwal, additional, Shen, John Paul, additional, Lee, Michael S., additional, Huey, Ryan, additional, Parseghian, Christine, additional, Willis, Jason, additional, Wolff, Robert, additional, Drusbosky, Leylah M., additional, Overman, Michael J., additional, and Kopetz, Scott, additional

Published
2024
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10. First-In-Human Phase I Study of Tinengotinib (TT-00420), a Multiple Kinase Inhibitor, as a Single Agent in Patients With Advanced Solid Tumors

Author

Piha-Paul, Sarina A, primary, Xu, Binghe, additional, Dumbrava, Ecaterina E, additional, Fu, Siqing, additional, Karp, Daniel D, additional, Meric-Bernstam, Funda, additional, Hong, David S, additional, Rodon, Jordi A, additional, Tsimberidou, Apostolia M, additional, Raghav, Kanwal, additional, Ajani, Jaffer A, additional, Conley, Anthony P, additional, Mott, Frank, additional, Fan, Ying, additional, Fan, Jean, additional, Peng, Peng, additional, Wang, Hui, additional, Ni, Shumao, additional, Sun, Caixia, additional, Qiang, Xiaoyan, additional, Levin, Wendy J, additional, Ngo, Brenda, additional, Ru, Qinhua Cindy, additional, Wu, Frank, additional, and Javle, Milind M, additional

Published
2024
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11. Sustained Disease Control in Immune Checkpoint Blockade Responders with Microsatellite Instability-high Colorectal Cancer after Treatment Termination

Author

Simmons, Kristen, primary, Thomas, Jane V., additional, Ludford, Kaysia, additional, Willis, Jason A., additional, Higbie, Victoria S., additional, Raghav, Kanwal P.S., additional, Johnson, Benny, additional, Dasari, Arvind, additional, Kee, Bryan K., additional, Parseghian, Christine M., additional, Lee, Michael S., additional, Le, Phat H., additional, Morelli, Maria P., additional, Shen, John Paul, additional, Bent, Alisha, additional, Vilar, Eduardo, additional, Wolff, Robert A., additional, Kopetz, Scott, additional, Overman, Michael J., additional, and Morris, Van Karlyle, additional

Published
2023
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15. Efficacy of Systemic Chemotherapy in Patients With Low-grade Mucinous Appendiceal Adenocarcinoma

Author

Shen, John Paul, primary, Yousef, Abdelrahman M., additional, Zeineddine, Fadl A., additional, Zeineddine, Mohammad A., additional, Tidwell, Rebecca S., additional, Beaty, Karen A., additional, Scofield, Lisa C., additional, Rafeeq, Safia, additional, Hornstein, Nicholas, additional, Lano, Elizabeth, additional, Eng, Cathy, additional, Matamoros, Aurelio, additional, Foo, Wai Chin, additional, Uppal, Abhineet, additional, Scally, Christopher, additional, Mansfield, Paul, additional, Taggart, Melissa, additional, Raghav, Kanwal P., additional, Overman, Michael J., additional, and Fournier, Keith, additional

Published
2023
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17. Feasibility and Value of Genomic-Profiling in Cancer of Unknown Primary: Real-World Evidence from Prospective Profiling Study

Author

Huey, Ryan W, primary, Shah, Aakash Tushar, additional, Reddi, Honey V, additional, Dasari, Priyadarsini, additional, Topham, James T, additional, Hwang, Hyunsoo, additional, Dhillon, Nishat, additional, Willett, Anneleis, additional, Smaglo, Brandon, additional, Estrella, Jeannelyn S, additional, Rashid, Asif, additional, Matamoros, Aurelio, additional, Overman, Michael J, additional, Choquette, Linda, additional, Omerza, Greg, additional, Kelly, Kevin, additional, Wang, Xuemei, additional, Loree, Jonathan M, additional, Rueter, Jens, additional, Varadhachary, Gauri R, additional, and Raghav, Kanwal, additional

Published
2023
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18. Incidence of Primary End Point Changes Among Active Cancer Phase 3 Randomized Clinical Trials

Author

Florez, Marcus A., primary, Jaoude, Joseph Abi, additional, Patel, Roshal R., additional, Kouzy, Ramez, additional, Lin, Timothy A., additional, De, Brian, additional, Beck, Esther J., additional, Taniguchi, Cullen M., additional, Minsky, Bruce D., additional, Fuller, Clifton D., additional, Lee, J. Jack, additional, Kupferman, Michael, additional, Raghav, Kanwal P., additional, Overman, Michael J., additional, Thomas, Charles R., additional, and Ludmir, Ethan B., additional

Published
2023
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19. Abstract CT107: Phase Ib Study of Pembrolizumab in Combination with Intratumoral Injection of Clostridium novyi-NT in Patients with Advanced Solid Tumors

Author

Nelson, Blessie Elizabeth, primary, Janku, Filip, additional, Fu, Siqing, additional, Dumbrava, Ecaterina I., additional, Hong, David S., additional, Karp, Daniel, additional, Naing, Aung, additional, Rodon, Jordi, additional, Tsimberidou, Apostolia, additional, Amaria, Rodabe N., additional, Conley, Anthony, additional, Damodaran, Senthil, additional, Raghav, Kanwal P., additional, Kreider, Brent L., additional, Tung, David, additional, Varterasian, Mary, additional, Khazaie, Khashayarsha, additional, and Piha-Paul, Sarina, additional

Published
2023
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20. Abstract CT118: A phase I/II trial of a CXCR1/2 inhibitor in combination with anti-PD-1 for circulating tumor DNA (ctDNA) positive & refractoryRAS-mutated microsatellite stable (MSS) colorectal cancer

Author

Johnson, Benny, primary, Haymaker, Cara, additional, Morris, Van K., additional, Dasari, Arvind, additional, Higbie, Victoria Serpas, additional, Shen, John Paul, additional, Parseghian, Christine, additional, Morelli, Maria Pia, additional, Huey, Ryan, additional, Lee, Michael S., additional, Willis, Jason, additional, Raghav, Kanwal P., additional, Yuan, Ying, additional, Zebala, John, additional, DePinho, Ronald A., additional, Kopetz, Scott, additional, and Overman, Michael, additional

Published
2023
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21. Abstract CT148: Efficacy, safety, and biomarker analysis of combined MEK (Cobimetinib) and PD-L1 (Atezolizumab) inhibition (COTEZO) in advanced small bowel adenocarcinoma (SBA)

Author

Hornstein, Nicholas, primary, Shen, John P., additional, Pellatt, Andrew J., additional, Liu, Suyu, additional, Knafl, Mark, additional, Willett, Anneleis F., additional, Zhu, Haifeng, additional, Maru, Dipen M., additional, Darbonne, Walter, additional, Wistuba, Ignacio I., additional, Futreal, Andy, additional, Yao, James C., additional, Woodman, Scott E., additional, Overman, Michael J., additional, and Raghav, Kanwal P., additional

Published
2023
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22. Definitive liver radiotherapy for intrahepatic cholangiocarcinoma with extrahepatic metastases

Author

De, Brian, primary, Upadhyay, Rituraj, additional, Liao, Kaiping, additional, Kumala, Tiffany, additional, Shi, Christopher, additional, Dodoo, Grace, additional, Abi Jaoude, Joseph, additional, Corrigan, Kelsey L., additional, Manzar, Gohar S., additional, Marqueen, Kathryn E., additional, Bernard, Vincent, additional, Lee, Sunyoung S, additional, Raghav, Kanwal P.S., additional, Vauthey, Jean-Nicolas, additional, Tzeng, Ching-Wei, additional, Tran Cao, Hop S., additional, Lee, Grace, additional, Wo, Jennifer, additional, Hong, Theodore S, additional, Crane, Christopher H, additional, Minsky, Bruce D., additional, Smith, Grace L., additional, Holliday, Emma B., additional, Taniguchi, Cullen M., additional, Koong, Albert C., additional, Das, Prajnan, additional, Javle, Milind, additional, Ludmir, Ethan B., additional, and Koay, Eugene, additional

Published
2023
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26. Abstract B028: Changes in exosomal RNA expression associate with treatment response to BRAF + EGFR + PD-1 blockade in MSS, BRAFV600E colorectal cancer: A liquid biopsy approach

Author

Morris, Van Karlyle, primary, Rajapakshe, Kimal I., additional, Bahrambeigi, Vahid, additional, Parsehgian, Christine M., additional, Johnson, Benny, additional, Raghav, Kanwal P., additional, Dasari, Arvind, additional, Huey, Ryan W., additional, Overman, Michael J., additional, Willis, Jason, additional, Lee, Michael S., additional, Wolff, Robert A., additional, Kee, Bryan K., additional, Le, Phat, additional, Guerrero, Paola A., additional, Kopetz, Scott, additional, and Maitra, Anirban, additional

Published
2022
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27. Abstract A023: Influence of pre-diagnosis obesity and post-diagnosis aspirin use on survival from stage IV colorectal cancer

Author

Davis, Jennifer S., primary, Chavez, Janelle C., additional, Kok, Melissa, additional, Miguel, Yazmin San, additional, Lee, Hwa Young, additional, Henderson, Henry, additional, Overman, Michael J., additional, Morris, Van Karlyle, additional, Kee, Bryan, additional, Fogelman, David, additional, Advani, Shailesh M., additional, Johnson, Benny, additional, Parseghian, Christine, additional, Shen, John Paul, additional, Dasari, Arvind, additional, Shaw, Kenna R., additional, Vilar, Eduardo, additional, Raghav, Kanwal P., additional, Shureiqi, Imad, additional, Wolff, Robert A., additional, Meric-Bernstam, Funda, additional, Maru, Dipen, additional, Menter, David G., additional, Kopetz, Scott, additional, and Chang, Shine, additional

Published
2022
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28. Abstract PR005: Outcomes in colitis-associated metastatic colorectal cancer and intersection with early-onset and signet ring cell carcinoma

Author

Villarreal, Oscar E., primary, Zeineddine, Fadl, additional, Chacko, Ray, additional, Parseghian, Christine, additional, Johnson, Benny, additional, Willis, Jason, additional, Lee, Michael, additional, Morris, Van Karlyle, additional, Dasari, Arvind, additional, Raghav, Kanwal, additional, Overman, Michael, additional, You, Y. Nancy, additional, Wang, Yinghong, additional, Maru, Dipen, additional, Shen, John Paul, additional, and Kopetz, Scott, additional

Published
2022
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29. Association of Prediagnosis Obesity and Postdiagnosis Aspirin With Survival From Stage IV Colorectal Cancer

Author

Davis, Jennifer S., primary, Chavez, Janelle C., additional, Kok, Melissa, additional, San Miguel, Yazmin, additional, Lee, Hwa Young, additional, Henderson, Henry, additional, Overman, Michael J., additional, Morris, Van, additional, Kee, Bryan, additional, Fogelman, David, additional, Advani, Shailesh M., additional, Johnson, Benny, additional, Parseghian, Christine, additional, Shen, John Paul, additional, Dasari, Arvind, additional, Shaw, Kenna R., additional, Vilar, Eduardo, additional, Raghav, Kanwal P., additional, Shureiqi, Imad, additional, Wolff, Robert A., additional, Meric-Bernstam, Funda, additional, Maru, Dipen, additional, Menter, David G., additional, Kopetz, Scott, additional, and Chang, Shine, additional

Published
2022
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30. Bintrafusp Alfa, an Anti-PD-L1:TGFβ Trap Fusion Protein, in Patients with ctDNA-positive, Liver-limited Metastatic Colorectal Cancer

Author

Morris, Van K., primary, Overman, Michael J., additional, Lam, Michael, additional, Parseghian, Christine M., additional, Johnson, Benny, additional, Dasari, Arvind, additional, Raghav, Kanwal, additional, Kee, Bryan K., additional, Huey, Ryan, additional, Wolff, Robert A., additional, Shen, John Paul, additional, Li, June, additional, Zorrilla, Isabel, additional, Tzeng, Ching-Wei D., additional, Tran Cao, Hop S., additional, Chun, Yun Shin, additional, Newhook, Timothy E., additional, Vauthey, Nicolas, additional, Duose, Dzifa, additional, Luthra, Raja, additional, Haymaker, Cara, additional, and Kopetz, Scott, additional

Published
2022
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31. Antibiotic Exposure Does Not Impact Immune Checkpoint Blockade Response in MSI-H/dMMR Metastatic Colorectal Cancer: A Single-Center Experience

Author

Serpas Higbie, Victoria, primary, Rogers, Jane, additional, Hwang, Hyunsoo, additional, Qiao, Wei, additional, Xiao, Lianchun, additional, Dasari, Arvind, additional, Mola-Rudd, Kerri, additional, Morris, Van K, additional, Wolff, Robert A, additional, Raghav, Kanwal, additional, Huey, Ryan, additional, Parseghian, Christine, additional, Willis, Jason, additional, Kopetz, Scott, additional, Overman, Michael J, additional, and Johnson, Benny, additional

Published
2022
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32. Phase II study of durvalumab (anti-PD-L1) and trametinib (MEKi) in microsatellite stable (MSS) metastatic colorectal cancer (mCRC)

Author

Johnson, Benny, primary, Haymaker, Cara L, additional, Parra, Edwin R, additional, Soto, Luisa Maren Solis, additional, Wang, Xuemei, additional, Thomas, Jane V, additional, Dasari, Arvind, additional, Morris, Van K, additional, Raghav, Kanwal, additional, Vilar, Eduardo, additional, Kee, Bryan K, additional, Eng, Cathy, additional, Parseghian, Christine M, additional, Wolff, Robert A, additional, Lee, Younghee, additional, Lorenzini, Daniele, additional, Laberiano-Fernandez, Caddie, additional, Verma, Anuj, additional, Lang, Wenhua, additional, Wistuba, Ignacio I, additional, Futreal, Andrew, additional, Kopetz, Scott, additional, and Overman, Michael J, additional

Published
2022
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33. Overall Survival in Phase 3 Clinical Trials and the Surveillance, Epidemiology, and End Results Database in Patients With Metastatic Colorectal Cancer, 1986-2016: A Systematic Review

Author

Chan Shen, Daniel Tannenbaum, Robert Horn, Jane Rogers, Cathy Eng, Shouhao Zhou, Benny Johnson, Scott Kopetz, Van Morris, Michael Overman, Christine Parseghian, George J. Chang, Maria A. Lopez-Olivo, Raghav Kanwal, Lee M. Ellis, and Arvind Dasari

Subjects
Adult, Databases, Factual, Humans, Antineoplastic Agents, General Medicine, Colorectal Neoplasms, Progression-Free Survival
Abstract

Phase 3 trials for patients with metastatic colorectal cancer (mCRC) have been conducted with varying designs and often with surrogate end points for overall survival (OS).To critically examine the factors associated with clinically relevant improvement in OS (defined as ≥2 months) in these trials and to evaluate their association with outcomes reflected in Surveillance, Epidemiology, and End Results (SEER) registry data.Medline, EMBASE, Cochrane, Web of Science, ClinicalTrials.gov, EU Clinical Trials Register, and the International Clinical Trials Registry Platform were searched for phase 3 trials of systemic therapy for patients with mCRC by decade (1986-1996, 1997-2006, and 2007-2016), excluding early or pilot studies, studies that did not involve an anticancer drug, studies on cancer screening and prevention, reports of pooled data from multiple trials, and studies with nonpharmaceutical approaches. The association of drug development with OS outside the clinical trial setting was evaluated using data from the SEER registry, including adult patients with a primary cancer site in the colon or rectum, including adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma; a distant stage; and receipt of chemotherapy as first-line therapy. Kaplan-Meier curves and log-rank tests were used to assess OS.The literature search identified 150 phase III clinical trials with 77 494 total enrollments, and 67 126 patients with mCRC were identified from the SEER database. Significant increases in survival were noted over time, best reflected in the experimental arm of first-line therapy (OS increased by 5.7 months per 10 years; 95% CI, 4.7-6.6 months; progression-free survival increased by 1.4 months per 10 years; 95% CI, 0.7-2.1 months). Although 69 of 148 trials (46.6%) met their predefined primary end point (including 20 of 44 trials [45.5%] with OS as the primary end point), only 35 of 132 trials (26.5%) resulted in improvement in OS by 2 months or more (including 13 of 42 trials [31.0%] with OS as the primary end point). Multivariable logistic regression showed that third-line therapies or later (odds ratio, 0.57; 95% CI, 0.51-0.63) and funding by pharmaceutical companies (odds ratio, 0.57; 95% CI, 0.54-0.60) were less often associated with improvement in OS. Furthermore, there was a decrease in the novelty of targets and agents over time, with trials that evaluated regimens composed entirely of previously approved drugs for mCRC increasing from 28% to 50%. Data from the SEER database showed that median OS increased from 12 months (95% CI, 12-13 months) (1986-1996) to 21 months (95% CI, 21-22 months) (2007-2015) (P .001), but the 5-year OS continued to be low at 12.2% in 2011.In this systematic review, OS for patients with mCRC appeared to improve significantly in trials, translating into meaningful benefits outside the clinical trial setting; however, these advances, although significant cumulatively, are largely incremental individually. These data should be a call to aim for larger gains from future trials with novel drugs, building on the increasing understanding of the biology of mCRC and sophisticated translational research tools.

Published
2022

34. Perioperative nivolumab monotherapy versus nivolumab plus ipilimumab in resectable hepatocellular carcinoma:a randomised, open-label, phase 2 trial

Author

Kaseb, Ahmed Omar, Hasanov, Elshad, Cao, Hop Sanderson Tran, Xiao, Lianchun, Vauthey, Jean Nicolas, Lee, Sunyoung S., Yavuz, Betul Gok, Mohamed, Yehia I., Qayyum, Aliya, Jindal, Sonali, Duan, Fei, Basu, Sreyashi, Yadav, Shalini S., Nicholas, Courtney, Sun, Jing Jing, Singh Raghav, Kanwal Pratap, Rashid, Asif, Carter, Kristen, Chun, Yun Shin, Tzeng, Ching Wei David, Sakamuri, Divya, Xu, Li, Sun, Ryan, Cristini, Vittorio, Beretta, Laura, Yao, James C., Wolff, Robert A., Allison, James Patrick, Sharma, Padmanee, Kaseb, Ahmed Omar, Hasanov, Elshad, Cao, Hop Sanderson Tran, Xiao, Lianchun, Vauthey, Jean Nicolas, Lee, Sunyoung S., Yavuz, Betul Gok, Mohamed, Yehia I., Qayyum, Aliya, Jindal, Sonali, Duan, Fei, Basu, Sreyashi, Yadav, Shalini S., Nicholas, Courtney, Sun, Jing Jing, Singh Raghav, Kanwal Pratap, Rashid, Asif, Carter, Kristen, Chun, Yun Shin, Tzeng, Ching Wei David, Sakamuri, Divya, Xu, Li, Sun, Ryan, Cristini, Vittorio, Beretta, Laura, Yao, James C., Wolff, Robert A., Allison, James Patrick, and Sharma, Padmanee

Abstract

Background: Hepatocellular carcinoma has high recurrence rates after surgery; however, there are no approved standard-of-care neoadjuvant or adjuvant therapies. Immunotherapy has been shown to improve survival in advanced hepatocellular carcinoma; we therefore aimed to evaluate the safety and tolerability of perioperative immunotherapy in resectable hepatocellular carcinoma. Methods: In this single-centre, randomised, open-label, phase 2 trial, patients with resectable hepatocellular carcinoma were randomly assigned (1:1) to receive 240 mg of nivolumab intravenously every 2 weeks (for up to three doses before surgery at 6 weeks) followed in the adjuvant phase by 480 mg of nivolumab intravenously every 4 weeks for 2 years, or 240 mg of nivolumab intravenously every 2 weeks (for up to three doses before surgery) plus one dose of 1 mg/kg of ipilimumab intravenously concurrently with the first preoperative dose of nivolumab, followed in the adjuvant phase by 480 mg of nivolumab intravenously every 4 weeks for up to 2 years plus 1 mg/kg of ipilimumab intravenously every 6 weeks for up to four cycles. Patients were randomly assigned to the treatment groups by use of block randomisation with a random block size. The primary endpoint was the safety and tolerability of nivolumab with or without ipilimumab. Secondary endpoints were the proportion of patients with an overall response, time to progression, and progression-free survival. This trial is registered with ClinicalTrials.gov (NCT03222076) and is completed. Findings: Between Oct 30, 2017, and Dec 3, 2019, 30 patients were enrolled and 27 were randomly assigned: 13 to nivolumab and 14 to nivolumab plus ipilimumab. Grade 3–4 adverse events were higher with nivolumab plus ipilimumab (six [43%] of 14 patients) than with nivolumab alone (three [23%] of 13). The most common treatment-related adverse events of any grade were increased alanine aminotransferase (three [23%] of 13 patients on nivolumab vs seven [50%] of 14 pa

Published
2022

35. Efficacy of pembrolizumab in patients with advanced cancer of unknown primary (CUP): a phase 2 non-randomized clinical trial

Author

Raghav, Kanwal P, primary, Stephen, Bettzy, additional, Karp, Daniel D, additional, Piha-Paul, Sarina A, additional, Hong, David S, additional, Jain, Dipti, additional, Chudy Onwugaje, Dilichukwu O, additional, Abonofal, Abdulrahman, additional, Willett, Anneleis F, additional, Overman, Michael, additional, Smaglo, Brandon, additional, Huey, Ryan W, additional, Meric-Bernstam, Funda, additional, Varadhachary, Gauri R, additional, and Naing, Aung, additional

Published
2022
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36. Phase II Study of Ramucirumab in Advanced Biliary Tract Cancer Previously Treated By Gemcitabine-Based Chemotherapy

Author

Lee, Sunyoung, primary, Shroff, Rachna T., additional, Makawita, Shalini, additional, Xiao, Lianchun, additional, Danner De Armas, Anaemy, additional, Bhosale, Priya, additional, Reddy, Kavitha, additional, Shalaby, Ahmed, additional, Raghav, Kanwal, additional, Pant, Shubham, additional, Wolff, Robert A., additional, and Javle, Milind, additional

Published
2022
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37. Benchmarking Outcomes after Ablative Radiotherapy for Molecularly Characterized Intrahepatic Cholangiocarcinoma

Author

De, Brian, primary, Abu-Gheida, Ibrahim, additional, Patel, Aashini, additional, Ng, Sylvia, additional, Zaid, Mohamed, additional, Thunshelle, Connor, additional, Elganainy, Dalia, additional, Corrigan, Kelsey, additional, Rooney, Michael, additional, Javle, Milind, additional, Raghav, Kanwal, additional, Lee, Sunyoung, additional, Vauthey, Jean-Nicolas, additional, Tzeng, Ching-Wei, additional, Tran Cao, Hop, additional, Ludmir, Ethan, additional, Minsky, Bruce, additional, Smith, Grace, additional, Holliday, Emma, additional, Taniguchi, Cullen, additional, Koong, Albert, additional, Das, Prajnan, additional, and Koay, Eugene, additional

Published
2021
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39. Clinical and pathologic features correlated with rare favorable survival in patients with

Author

Morris, Van, Kee, Bryan, Overman, Michael, Dasari, Arvind, Raghav, Kanwal, Johnson, Benny, Parseghian, Christine, Wolff, Robert A., Garg, Naveen, Eng, Cathy, and Kopetz, Scott

Subjects
Oncology, Gastroenterology, Original Article, digestive system diseases
Abstract

BACKGROUND: BRAF(V600E) mutations occur in fewer than 10% of all patients with metastatic colorectal cancer (CRC) and arise from sessile serrated adenomas. Despite efficacy with targeted therapies against MAPK signaling and with immunotherapies in this population, survival outcomes for patients with BRAF(V600E) mutated metastatic CRC in general are poor. Characteristics distinguishing patients with BRAF(V600E) mutated metastatic CRC with favorable versus unfavorable outcomes have not been well annotated. METHODS: Records of 187 patients with BRAF(V600E) mutated metastatic CRC evaluated at MD Anderson Cancer Center between 2005–2020 were reviewed. Patients with the shortest and longest metastatic survival (N=25 for each group) were compared. Associations between prognostic group and clinical/pathologic features were measured by odds ratio and for median survival by log-rank testing. RESULTS: Median metastatic survival differed between the 2 BRAF(V600E) mutated metastatic CRC populations (8.6 vs. 83.9 months, hazard ratio 32; P

Published
2021

40. A Prospective Phase II Study of Safety and Efficacy of Sorafenib Followed by 90Y Glass Microspheres for Patients with Advanced or Metastatic Hepatocellular Carcinoma

Author

Kaseb, Ahmed Omar, primary, Kappadath, S Cheenu, additional, Lee, Sunyoung S, additional, Raghav, Kanwal Pratap, additional, Mohamed, Yehia I, additional, Xiao, Lianchun, additional, Morris, Jeffrey S, additional, Ohaji, Chimela, additional, Avritscher, Rony, additional, Odisio, Bruno C, additional, Kuban, Joshua, additional, Abdelsalam, Mohamed E, additional, Chasen, Beth, additional, Elsayes, Khaled M, additional, Elbanan, Mohamed, additional, Wolff, Robert A, additional, Yao, James C, additional, and Mahvash, Armeen, additional

Published
2021
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41. Antibiotic Exposure Does Not Impact Immune Checkpoint Blockade Response in MSI-H/dMMR Metastatic Colorectal Cancer: A Single-Center Experience.

Author

Higbie, Victoria Serpas, Rogers, Jane, Hwang, Hyunsoo, Qiao, Wei, Xiao, Lianchun, Dasari, Arvind, Mola-Rudd, Kerri, Morris, Van K, Wolff, Robert A, Raghav, Kanwal, Huey, Ryan, Parseghian, Christine, Willis, Jason, Kopetz, Scott, Overman, Michael J, and Johnson, Benny

Subjects
THERAPEUTIC use of monoclonal antibodies, PATHOGENESIS, DNA, IMMUNE checkpoint inhibitors, METASTASIS, RETROSPECTIVE studies, COLORECTAL cancer, TREATMENT effectiveness, NIVOLUMAB, DESCRIPTIVE statistics, SURVIVAL analysis (Biometry)
Abstract

Background Immune checkpoint blockade (ICB) has improved outcomes for patients with microsatellite instability high (MSI-H)/deficient mismatch repair (dMMR) tumors. However, not all MSI-H/dMMR patients will exhibit the same ICB efficacy. Previous studies suggest that concomitant antibiotic use while receiving ICB may result in poorer outcomes. We aimed to evaluate this association in patients with MSI-H/dMMR metastatic colorectal cancer (mCRC). Materials and Methods A single-site, retrospective review of 57 patients with MSI-H/dMMR mCRC that received ICB was completed. Data collected included patient demographics, ICB information, and antibiotic use. Antibiotic exposure was considered from 90 days prior to ICB through 6 weeks after initiation. Primary endpoint was overall response rate (ORR). Results The majority of patients received pembrolizumab (27 [47%]) or nivolumab (17 [30%]) monotherapy as their ICB agent. Of the 57 patients, 19 (33.3%) had antibiotic exposure from 90 days prior to ICB initiation through 6 weeks after initiation with most (13 [68%]) having antibiotic use in the 30 days preceding ICB initiation. Similar ORRs were seen in both groups (P -value >.99). No difference was observed in OS (P -value.29) or PFS (P -value.36) between groups. Conclusion Our data show no association of lower response rates or survival in those MSI-H/dMMR patients with mCRC who receive antibiotics around the initiation of ICB. This information needs to be confirmed in a larger prospective cohort. [ABSTRACT FROM AUTHOR]

Published
2022
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43. Development and Validation of Insulin-like Growth Factor-1 Score to Assess Hepatic Reserve in Hepatocellular Carcinoma

Author

Kaseb, Ahmed O., Xiao, Lianchun, Hassan, Manal M., Chae, Young Kwang, Lee, Ju-Seog, Vauthey, Jean-Nicolas, Krishnan, Sunil, Cheung, Sheree, Hassabo, Hesham M., Aloia, Thomas, Conrad, Claudius, Curley, Steven A., Vierling, John M., Jalal, Prasun, Raghav, Kanwal, Wallace, Michael, Rashid, Asif, Abbruzzese, James L., Wolff, Robert A., and Morris, Jeffrey S.

Published
2014
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44. Definitive Liver Radiotherapy for Intrahepatic Cholangiocarcinoma with Extrahepatic Metastases

Author

De, Brian, Upadhyay, Rituraj, Liao, Kaiping, Kumala, Tiffany, Shi, Christopher, Dodoo, Grace, Abi Jaoude, Joseph, Corrigan, Kelsey L., Manzar, Gohar S., Marqueen, Kathryn E., Bernard, Vincent, Lee, Sunyoung S, Raghav, Kanwal P.S., Vauthey, Jean-Nicolas, Tzeng, Ching-Wei, Tran Cao, Hop S., Lee, Grace, Wo, Jennifer, Hong, Theodore S, Crane, Christopher H, Minsky, Bruce D., Smith, Grace L., Holliday, Emma B., Taniguchi, Cullen M., Koong, Albert C., Das, Prajnan, Javle, Milind, Ludmir, Ethan B., and Koay, Eugene

Abstract

Introduction:Tumor-related liver failure (TRLF) is the most common cause of death in patients with intrahepatic cholangiocarcinoma (ICC). Though we previously showed that liver radiotherapy (L-RT) for locally advanced ICC is associated with less frequent TRLF and longer overall survival (OS), the role of L-RT for patients with extrahepatic metastatic disease (M1) remains undefined. We sought to compare outcomes for M1 ICC patients treated with and without L-RT. Methods:We reviewed ICC patients that found to have M1 disease at initial diagnosis at a single institution between 2010 and 2021 who received L-RT, matching them with an institutional cohort by propensity score and a National Cancer Database (NCDB) cohort by frequency technique. The median biologically effective dose was 97.5 Gy (interquartile range 80.5–97.9 Gy) for L-RT. Patients treated with other local therapies or supportive care alone were excluded. We analyzed survival with Cox proportional hazard modeling. Results:We identified 61 patients who received L-RT and 220 who received chemotherapy alone. At median follow-up of 11 months after diagnosis, median OS was 9 months (95% confidence interval [CI] 8–11) and 21 months (CI: 17–26) for patients receiving chemotherapy alone and L-RT, respectively. TRLF was the cause of death more often in the patients who received chemotherapy alone compared to those who received L-RT (82% vs. 47%; p= 0.001). On multivariable propensity score-matched analysis, associations with lower risk of death included duration of upfront chemotherapy (hazard ratio [HR] 0.82; p= 0.005) and receipt of L-RT (HR: 0.40; p= 0.002). The median OS from diagnosis for NCDB chemotherapy alone cohort was shorter than that of the institutional L-RT cohort (9 vs. 22 months; p< 0.001). Conclusion:For M1 ICC, L-RT associated with a lower rate of death due to TRLF and longer OS versus those treated with chemotherapy alone. Prospective studies of L-RT in this setting are warranted.

Published
2022
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45. Development and Validation of a Novel Nomogram for Individualized Prediction of Survival in Cancer of Unknown Primary

Author

Raghav, Kanwal, primary, Hwang, Hyunsoo, additional, Jácome, Alexandre A., additional, Bhang, Eric, additional, Willett, Anneleis, additional, Huey, Ryan W., additional, Dhillon, Nishat P., additional, Modha, Jignesh, additional, Smaglo, Brandon, additional, Matamoros, Aurelio, additional, Estrella, Jeannelyn S., additional, Jao, Justin, additional, Overman, Michael J., additional, Wang, Xuemei, additional, Greco, F. Anthony, additional, Loree, Jonathan M., additional, and Varadhachary, Gauri R., additional

Published
2021
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46. Pilot Clinical Trial of Perioperative Durvalumab and Tremelimumab in the Treatment of Resectable Colorectal Cancer Liver Metastases

Author

Kanikarla Marie, Preeti, primary, Haymaker, Cara, additional, Parra, Edwin Roger, additional, Kim, Young Uk, additional, Lazcano, Rossana, additional, Gite, Swati, additional, Lorenzini, Daniele, additional, Wistuba, Ignacio I., additional, Tidwell, Rebecca S. Slack, additional, Song, Xiaofei, additional, Foo, Wai Chin, additional, Maru, Dipen M., additional, Chun, Yun Shin, additional, Futreal, Andy, additional, Kee, Bryan, additional, Menter, David, additional, Solis, Luisa, additional, Tzeng, Ching-Wei, additional, Parseghian, Christine, additional, Raghav, Kanwal, additional, Morris, Van, additional, Chang, Chia-Chi, additional, Jenq, Robert, additional, Tam, Alda, additional, Bernatchez, Chantale, additional, Kopetz, Scott, additional, Vauthey, Jean-Nicolas, additional, and Overman, Michael J., additional

Published
2021
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47. Radiation-Associated Lymphopenia and Outcomes of Patients with Unresectable Hepatocellular Carcinoma Treated with Radiotherapy

Author

De, Brian, primary, Ng, Sweet Ping, additional, Liu, Amy Y, additional, Avila, Santiago, additional, Tao, Randa, additional, Holliday, Emma B, additional, Brownlee, Zachary, additional, Kaseb, Ahmed, additional, Lee, Sunyoung, additional, Raghav, Kanwal, additional, Vauthey, Jean-Nicolas, additional, Minsky, Bruce D, additional, Herman, Joseph M, additional, Das, Prajnan, additional, Smith, Grace, additional, Taniguchi, Cullen, additional, Krishnan, Sunil, additional, Crane, Christopher H, additional, Grassberger, Clemens, additional, Hong, Theodore, additional, Lin, Steven H, additional, Koong, Albert C, additional, Mohan, Radhe, additional, and Koay, Eugene J, additional

Published
2021
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