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4. A Randomized Trial of Combined PD-L1 and CTLA-4 Inhibition with Targeted Low-Dose or Hypofractionated Radiation for Patients with Metastatic Colorectal CancerPD-L1/CTLA-4 Inhibition with Radiation for Colorectal Cancer

Author

Monjazeb, Arta M, Giobbie-Hurder, Anita, Lako, Ana, Thrash, Emily M, Brennick, Ryan C, Kao, Katrina Z, Manuszak, Claire, Gentzler, Ryan D, Tesfaye, Anteneh, Jabbour, Salma K, Alese, Olatunji B, Rahma, Osama E, Cleary, James M, Sharon, Elad, Mamon, Harvey J, Cho, May, Streicher, Howard, Chen, Helen X, Ahmed, Mansoor M, Mariño-Enríquez, Adrian, Kim-Schulze, Seunghee, Gnjatic, Sacha, Maverakis, Emanual, Marusina, Alina I, Merleev, Alexander A, Severgnini, Mariano, Pfaff, Kathleen L, Lindsay, James, Weirather, Jason L, Ranasinghe, Srinika, Spektor, Alexander, Rodig, Scott J, Hodi, F Stephen, and Schoenfeld, Jonathan D

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Immunology, Immunotherapy, Radiation Oncology, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Digestive Diseases, Colo-Rectal Cancer, Antineoplastic Combined Chemotherapy Protocols, B7-H1 Antigen, Biomarkers, CTLA-4 Antigen, Colorectal Neoplasms, Combined Modality Therapy, Gene Expression Profiling, Humans, Immune Checkpoint Inhibitors, Molecular Targeted Therapy, Neoplasm Metastasis, Neoplasm Staging, Radiation Dose Hypofractionation, Treatment Outcome, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeProspective human data are lacking regarding safety, efficacy, and immunologic impacts of different radiation doses administered with combined PD-L1/CTLA-4 blockade.Patients and methodsWe performed a multicenter phase II study randomly assigning patients with metastatic microsatellite stable colorectal cancer to repeated low-dose fractionated radiation (LDFRT) or hypofractionated radiation (HFRT) with PD-L1/CTLA-4 inhibition. The primary endpoint was response outside the radiation field. Correlative samples were analyzed using multiplex immunofluorescence (IF), IHC, RNA/T-cell receptor (TCR) sequencing, cytometry by time-of-flight (CyTOF), and Olink.ResultsEighteen patients were evaluable for response. Median lines of prior therapy were four (range, 1-7). Sixteen patients demonstrated toxicity potentially related to treatment (84%), and 8 patients had grade 3-4 toxicity (42%). Best response was stable disease in 1 patient with out-of-field tumor shrinkage. Median overall survival was 3.8 months (90% confidence interval, 2.3-5.7 months). Correlative IF and RNA sequencing (RNA-seq) revealed increased infiltration of CD8+ and CD8+/PD-1+/Ki-67+ T cells in the radiation field after HFRT. LDFRT increased foci of micronuclei/primary nuclear rupture in two subjects. CyTOF and RNA-seq demonstrated significant declines in multiple circulating immune populations, particularly in patients receiving HFRT. TCR sequencing revealed treatment-associated changes in T-cell repertoire in the tumor and peripheral blood.ConclusionsWe demonstrate the feasibility and safety of adding LDFRT and HFRT to PD-L1/CTLA-4 blockade. Although the best response of stable disease does not support the use of concurrent PD-L1/CTLA-4 inhibition with HFRT or LDFRT in this population, biomarkers provide support that both LDFRT and HFRT impact the local immune microenvironment and systemic immunogenicity that can help guide future studies.

Published
2021

6. Trastuzumab with trimodality treatment for oesophageal adenocarcinoma with HER2 overexpression (NRG Oncology/RTOG 1010): a multicentre, randomised, phase 3 trial

Author

Safran, Howard P, Winter, Kathryn, Ilson, David H, Wigle, Dennis, DiPetrillo, Thomas, Haddock, Michael G, Hong, Theodore S, Leichman, Lawrence P, Rajdev, Lakshmi, Resnick, Murray, Kachnic, Lisa A, Seaward, Samantha, Mamon, Harvey, Diaz Pardo, Dayssy Alexandra, Anderson, Carryn M, Shen, Xinglei, Sharma, Anand K, Katz, Alan W, Salo, Jonathan, Leonard, Kara L, Moughan, Jennifer, and Crane, Christopher H

Published
2022
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7. Highly Sensitive Circulating Tumor DNA Assay Aids Clinical Management of Radiographically Occult Isolated Peritoneal Metastases in Patients With GI Cancer

Author

Singh, Harshabad, Klempner, Samuel J., Melnitchouk, Nelya, Chander, Deepak P., Negrea, Ovidiu George, Patel, Anuj K., Schlechter, Benjamin L., Rubinson, Douglas A., Huffman, Brandon M., Nambiar, Chetan, Remland, Joshua, Andrews, Elizabeth, Leahy, Megan E., Brais, Lauren K., Enzinger, Peter C., Mamon, Harvey J., Giannakis, Marios, Meyerhardt, Jeffrey A., Ng, Kimmie, Perez, Kimberly J., Aguirre, Andrew J., Clark, Jeffrey W., Cleary, James M., and Wolpin, Brian M.

Published
2023
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9. Adjuvant Chemoradiotherapy With Epirubicin, Cisplatin, and Fluorouracil Compared With Adjuvant Chemoradiotherapy With Fluorouracil and Leucovorin After Curative Resection of Gastric Cancer: Results From CALGB 80101 (Alliance)

Author

Fuchs, Charles S, Niedzwiecki, Donna, Mamon, Harvey J, Tepper, Joel E, Ye, Xing, Swanson, Richard S, Enzinger, Peter C, Haller, Daniel G, Dragovich, Tomislav, Alberts, Steven R, Bjarnason, Georg A, Willett, Christopher G, Gunderson, Leonard L, Goldberg, Richard M, Venook, Alan P, Ilson, David, O'Reilly, Eileen, Ciombor, Kristen, Berg, David J, Meyerhardt, Jeffrey, and Mayer, Robert J

Subjects
Clinical Trials and Supportive Activities, Cancer, Clinical Research, Patient Safety, Digestive Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adenocarcinoma, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Chemoradiotherapy, Adjuvant, Cisplatin, Combined Modality Therapy, Epirubicin, Esophagogastric Junction, Female, Fluorouracil, Humans, Leucovorin, Male, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Risk Factors, Stomach Neoplasms, Survival Rate, Treatment Outcome, United States, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

Purpose After curative resection of gastric or gastroesophageal junction adenocarcinoma, Intergroup Trial 0116 (Phase III trial of postoperative adjuvant radiochemotherapy for high risk gastric and gastroesophageal junction adenocarcinoma: Demonstrated superior survival for patients who received postoperative chemoradiotherapy with bolus fluorouracil (FU) and leucovorin (LV) compared with surgery alone. CALGB 80101 (Alliance; Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma) assessed whether a postoperative chemoradiotherapy regimen that replaced FU plus LV with a potentially more active systemic therapy could further improve overall survival. Patients and Methods Between April 2002 and May 2009, 546 patients who had undergone a curative resection of stage IB through IV (M0) gastric or gastroesophageal junction adenocarcinoma were randomly assigned to receive either postoperative FU plus LV before and after combined FU and radiotherapy (FU plus LV arm) or postoperative epirubicin, cisplatin, and infusional FU (ECF) before and after combined FU and radiotherapy (ECF arm). Results With a median follow-up duration of 6.5 years, 5-year overall survival rates were 44% in the FU plus LV arm and 44% in the ECF arm ( Plogrank = .69; multivariable hazard ratio, 0.98; 95% CI, 0.78 to 1.24 comparing ECF with FU plus LV). Five-year disease-free survival rates were 39% in the FU plus LV arm and 37% in the ECF arm ( Plogrank = .94; multivariable hazard ratio, 0.96; 95% CI, 0.77 to 1.20). In post hoc analyses, the effect of treatment seemed to be similar across all examined patient subgroups. Conclusion After a curative resection of gastric or gastroesophageal junction adenocarcinoma, postoperative chemoradiotherapy using a multiagent regimen of ECF before and after radiotherapy does not improve survival compared with standard FU and LV before and after radiotherapy.

Published
2017

14. A single-institution experience of acute toxicities in patients treated with short course hypofractionated radiotherapy in locally advanced rectal cancer.

Author

Lee, Katie Nadine, primary, Neibart, Shane, additional, Droznin, Alexander D., additional, Huynh, Mai Anh, additional, Guthier, Christian V., additional, Turner, Brandon E., additional, Martin, Neil E., additional, Lam, Miranda B., additional, Peng, Luke, additional, Enzinger, Peter C., additional, Meyerhardt, Jeffrey A., additional, and Mamon, Harvey J., additional

Published
2024
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15. Pharmacogenetic study in gastric cancer patients treated with adjuvant fluorouracil/leucovorin or epirubicin/cisplatin/fluorouracil before and after chemoradiation on CALGB 80101 (Alliance)

Author

Patel, Jai N., Jiang, Chen, Owzar, Kouros, Mulkey, Flora, Luzum, Jasmine A., Mamon, Harvey J., Haller, Daniel G., Dragovich, Tomislav, Alberts, Steven R., Bjarnason, Georg, Willet, Christopher G., Niedzwiecki, Donna, Enzinger, Peter, Ratain, Mark J., Fuchs, Charles, and McLeod, Howard L.

Published
2021
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19. Neoadjuvant short-course radiotherapy or chemoradiation plus consolidative chemotherapy followed by radical operation for locally advanced rectal cancer.

Author

Shing Fung Lee, Pui Lam Yip, Barry Wo, Sean-Man Wong, Natalie, Vellayappan, Balamurugan A., Mamon, Harvey J., and Shing Lee, Francis Ann

Subjects
RECTAL cancer, ABDOMINOPERINEAL resection, CHEMORADIOTHERAPY, TUMOR classification, RADIOTHERAPY, CANCER chemotherapy, TREATMENT failure
Abstract

Introduction: Limited evidence compares short-course radiotherapy (SCRT) and long-course chemoradiotherapy (LCCRT), both of which are followed by consolidative chemotherapy before radical rectal surgery. We conducted a retrospective cohort study to assess treatment response, survival outcomes, and toxicity in patients with locally advanced rectal cancer. Materials and methods: Patients (cT3-4 and/or N+) treated with SCRT or LCCRT, consolidative chemotherapy, or total mesorectal excision between 2013 and 2021 were identified. the cause-specific cumulative incidence of disease-related treatment failure, locoregional recurrence, distant metastases, and overall survival were evaluated using flexible parametric competing risk analysis and Kaplan-Meier methods, adjusted for treatment regimens and clinicopathological factors. A pathological complete response (pCR), tumor downstaging, and toxicity have been reported. Results: Among the 144 patients, 115 (80%) underwent curative rectal surgery. The LCCRT and SCRT groups achieved pCR in 10 (18%) and seven (12%) patients, respectively (odds ratio, 1.68; 95% confidence interval [CI], 0.59-4.78). The adjusted cause-specific hazard ratio for disease-related treatment failure with LCCRT versus SCRT was 0.26 (95% CI, 0.08-0.87). Three-year cumulative probability of disease-related treatment failure was 10.0% and 25.6% for LCCRT and SCRT, respectively. No significant differences in T-downstaging, Ndownstaging, significant pathologic downstaging (ypT0-2N0), locoregional failure, distant metastasis, or overall survival were found. Late rectal toxicity occurred in 10 (15%) LCCRT and two (3%) SCRT patients, respectively. Conclusion: LCCRT with consolidative chemotherapy demonstrated improved disease-related treatment failure compared with SCRT, despite higher late rectal toxicity. Further research is needed to assess the long-term oncologic outcomes and toxicity. [ABSTRACT FROM AUTHOR]

Published
2024
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22. Preoperative Treatment of Locally Advanced Rectal Cancer

Author

Schrag, Deborah, primary, Shi, Qian, additional, Weiser, Martin R., additional, Gollub, Marc J., additional, Saltz, Leonard B., additional, Musher, Benjamin L., additional, Goldberg, Joel, additional, Al Baghdadi, Tareq, additional, Goodman, Karyn A., additional, McWilliams, Robert R., additional, Farma, Jeffrey M., additional, George, Thomas J., additional, Kennecke, Hagen F., additional, Shergill, Ardaman, additional, Montemurro, Michael, additional, Nelson, Garth D., additional, Colgrove, Brian, additional, Gordon, Vallerie, additional, Venook, Alan P., additional, O’Reilly, Eileen M., additional, Meyerhardt, Jeffrey A., additional, Dueck, Amylou C., additional, Basch, Ethan, additional, Chang, George J., additional, and Mamon, Harvey J., additional

Published
2023
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23. Patient-Reported Outcomes During and After Treatment for Locally Advanced Rectal Cancer in the PROSPECT Trial (Alliance N1048)

Author

Basch, Ethan, primary, Dueck, Amylou C., additional, Mitchell, Sandra A., additional, Mamon, Harvey, additional, Weiser, Martin, additional, Saltz, Leonard, additional, Gollub, Marc, additional, Rogak, Lauren, additional, Ginos, Brenda, additional, Mazza, Gina L., additional, Colgrove, Brian, additional, Chang, George, additional, Minasian, Lori, additional, Denicoff, Andrea, additional, Thanarajasingam, Gita, additional, Musher, Benjamin, additional, George, Thomas, additional, Venook, Alan, additional, Farma, Jeffrey, additional, O'Reilly, Eileen, additional, Meyerhardt, Jeffrey A., additional, Shi, Qian, additional, and Schrag, Deborah, additional

Published
2023
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24. Supplementary Data from A Randomized Trial of Combined PD-L1 and CTLA-4 Inhibition with Targeted Low-Dose or Hypofractionated Radiation for Patients with Metastatic Colorectal Cancer

Author

Monjazeb, Arta M., primary, Giobbie-Hurder, Anita, primary, Lako, Ana, primary, Thrash, Emily M., primary, Brennick, Ryan C., primary, Kao, Katrina Z., primary, Manuszak, Claire, primary, Gentzler, Ryan D., primary, Tesfaye, Anteneh, primary, Jabbour, Salma K., primary, Alese, Olatunji B., primary, Rahma, Osama E., primary, Cleary, James M., primary, Sharon, Elad, primary, Mamon, Harvey J., primary, Cho, May, primary, Streicher, Howard, primary, Chen, Helen X., primary, Ahmed, Mansoor M., primary, Mariño-Enríquez, Adrian, primary, Kim-Schulze, Seunghee, primary, Gnjatic, Sacha, primary, Maverakis, Emanual, primary, Marusina, Alina I., primary, Merleev, Alexander A., primary, Severgnini, Mariano, primary, Pfaff, Kathleen L., primary, Lindsay, James, primary, Weirather, Jason L., primary, Ranasinghe, Srinika, primary, Spektor, Alexander, primary, Rodig, Scott J., primary, Hodi, F. Stephen, primary, and Schoenfeld, Jonathan D., primary

Published
2023
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25. Supplementary Information from Genomic Evolution after Chemoradiotherapy in Anal Squamous Cell Carcinoma

Author

Mouw, Kent W., primary, Cleary, James M., primary, Reardon, Brendan, primary, Pike, Jonathan, primary, Braunstein, Lior Z., primary, Kim, Jaegil, primary, Amin-Mansour, Ali, primary, Miao, Diana, primary, Damish, Alexis, primary, Chin, Joanna, primary, Ott, Patrick A., primary, Fuchs, Charles S., primary, Martin, Neil E., primary, Getz, Gad, primary, Carter, Scott, primary, Mamon, Harvey J., primary, Hornick, Jason L., primary, Van Allen, Eliezer M., primary, and D'Andrea, Alan D., primary

Published
2023
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26. Comparison of MR‐soft tissue based versus biliary stent based alignment for image guidance in pancreatic SBRT

Author

Han, Zhaohui, primary, Sudhyadhom, Atchar, additional, Hsu, Shu‐Hui, additional, Hu, Yue‐Houng, additional, Mak, Raymond H., additional, Huynh, Mai Anh, additional, van Dams, Ritchell R., additional, Tanguturi, Shyam, additional, Venkatachalam, Veena, additional, Mancias, Joseph D., additional, Mamon, Harvey J., additional, Martin, Neil E., additional, Lam, Miranda B., additional, and Leeman, Jonathan E., additional

Published
2023
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30. Use of the Toxicity Index in Evaluating Adverse Events in Anal Cancer Trials

Author

Kharofa, Jordan R., primary, Yothers, Greg, additional, Kachnic, Lisa A., additional, Ajani, Jaffer, additional, Meyer, Joshua E., additional, Augspurger, Mark E., additional, Okawara, Gordon S., additional, Garg, Madhur K., additional, Schefter, Tracey E., additional, Swanson, Todd A., additional, Doncals, Desiree E., additional, Kim, Hyun, additional, Zaki, Bassem I., additional, Narayan, Samir, additional, Lee, R. Jeffery, additional, Mamon, Harvey J., additional, Schwartz, Michael A., additional, Moughan, Jennifer, additional, and Crane, Christopher H., additional

Published
2022
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31. Retrospective Review of Outcomes After Radiation Therapy for Oligoprogressive Disease on Immune Checkpoint Blockade

Author

Mahmood, Umair, primary, Huynh, Mai Anh, additional, Killoran, Joseph H., additional, Qian, Jack M., additional, Bent, Eric H., additional, Aizer, Ayal A., additional, Mak, Raymond H., additional, Mamon, Harvey J., additional, Balboni, Tracy A., additional, Gunasti, Lauren, additional, Ott, Patrick A., additional, Awad, Mark M., additional, and Schoenfeld, Jonathan D., additional

Published
2022
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36. Phase II Study of Proton-Based Stereotactic Body Radiation Therapy for Liver Metastases: Importance of Tumor Genotype

Author

Hong, Theodore S., Wo, Jennifer Y., Borger, Darrell R., Yeap, Beow Y., McDonnell, Erin I., Willers, Henning, Blaszkowsky, Lawrence S., Kwak, Eunice L., Allen, Jill N., Clark, Jeffrey W., Tanguturi, Shyam, Goyal, Lipika, Murphy, Janet E., Wolfgang, John A., Drapek, Lorraine C., Arellano, Ronald S., Mamon, Harvey J., Mullen, John T., Tanabe, Kenneth K., Ferrone, Cristina R., and Zhu, Andrew X.

Published
2017
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50. Correction: A Randomized Trial of Combined PD-L1 and CTLA-4 Inhibition with Targeted Low-dose or Hypofractionated Radiation for Patients with Metastatic Colorectal Cancer

Author

Monjazeb, Arta M., primary, Giobbie-Hurder, Anita, additional, Lako, Ana, additional, Thrash, Emily M., additional, Brennick, Ryan C., additional, Kao, Katrina Z., additional, Manuszak, Claire, additional, Gentzler, Ryan D., additional, Tesfaye, Anteneh, additional, Jabbour, Salma K., additional, Alese, Olatunji B., additional, Rahma, Osama E., additional, Cleary, James M., additional, Sharon, Elad, additional, Mamon, Harvey J., additional, Cho, May, additional, Streicher, Howard, additional, Chen, Helen X., additional, Ahmed, Mansoor M., additional, Mariño-Enríquez, Adrian, additional, Kim-Schulze, Seunghee, additional, Gnjatic, Sacha, additional, Maverakis, Emanual, additional, Marusina, Alina I., additional, Merleev, Alexander A., additional, Severgnini, Mariano, additional, Pfaff, Kathleen L., additional, Lindsay, James, additional, Weirather, Jason L., additional, Ranasinghe, Srinika, additional, Spektor, Alexander, additional, Rodig, Scott J., additional, Hodi, F. Stephen, additional, and Schoenfeld, Jonathan D., additional

Published
2021
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