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1. Personalized matched targeted therapy in advanced pancreatic cancer: a pilot cohort analysis

Author

Shaya, Justin, Kato, Shumei, Adashek, Jacob J, Patel, Hitendra, Fanta, Paul T, Botta, Gregory P, Sicklick, Jason K, and Kurzrock, Razelle

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Rare Diseases, Digestive Diseases, Pancreatic Cancer, Clinical Research, Good Health and Well Being, Genetics, Medical biotechnology
Abstract

Despite progress, 2-year pancreatic cancer survival remains dismal. We evaluated a biomarker-driven, combination/N-of-one strategy in 18 patients (advanced/metastatic pancreatic cancer) (from Molecular Tumor Board). Targeted agents administered/patient = 2.5 (median) (range, 1-4); first-line therapy (N = 5); second line, (N = 13). Comparing patients (high versus low degrees of matching) (matching score ≥50% versus

Published
2023

2. Disparities in germline testing among racial minorities with prostate cancer

Author

Weise, Nicole, Shaya, Justin, Javier-Desloges, Juan, Cheng, Heather H, Madlensky, Lisa, and McKay, Rana R

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Aging, Clinical Research, Genetics, Prevention, Cancer, Urologic Diseases, Prostate Cancer, 4.4 Population screening, Detection, screening and diagnosis, 4.1 Discovery and preclinical testing of markers and technologies, Early Detection of Cancer, Ethnic and Racial Minorities, Germ Cells, Germ-Line Mutation, Humans, Male, Prostatic Neoplasms, United States, Urology & Nephrology, Clinical sciences, Oncology and carcinogenesis
Abstract

Germline testing is becoming increasingly relevant in prostate cancer (PCa) screening, prognosis, and management. A subset of patients with PCa harbor pathogenic/likely pathogenic variants (P/LPVs) in genes mediating DNA-repair processes, and these P/LPVs have implications for cancer screening, treatment, and cascade testing. As a result, it is recommended that all men with high-risk localized and metastatic PCa undergo routine germline testing. As more PCa patients undergo germline testing, it is important that clinicians and genetics experts recognize current disparities in germline testing rates among racial/ethnic minorities in the United States. The reasons for these disparities are multiple and require similarly manifold consideration to close the germline testing gap and reduce inequities in PCa screening, management, and treatment.

Published
2022

3. Geriatric risk factors for serious COVID-19 outcomes among older adults with cancer: a cohort study from the COVID-19 and Cancer Consortium

Author

Elkrief, Arielle, Hennessy, Cassandra, Kuderer, Nicole M, Rubinstein, Samuel M, Wulff-Burchfield, Elizabeth, Rosovsky, Rachel P, Vega-Luna, Karen, Thompson, Michael A, Panagiotou, Orestis A, Desai, Aakash, Rivera, Donna R, Khaki, Ali Raza, Tachiki, Lisa, Lynch, Ryan C, Stratton, Catherine, Elias, Rawad, Batist, Gerald, Kasi, Anup, Shah, Dimpy P, Bakouny, Ziad, Cabal, Angelo, Clement, Jessica, Crowell, Jennifer, Dixon, Becky, Friese, Christopher R, Fry, Stacy L, Grover, Punita, Gulati, Shuchi, Gupta, Shilpa, Hwang, Clara, Khan, Hina, Kim, Soo Jung, Klein, Elizabeth J, Labaki, Chris, McKay, Rana R, Nizam, Amanda, Pennell, Nathan A, Puc, Matthew, Schmidt, Andrew L, Shahrokni, Armin, Shaya, Justin A, Su, Christopher T, Wall, Sarah, Williams, Nicole, Wise-Draper, Trisha M, Mishra, Sanjay, Grivas, Petros, French, Benjamin, Warner, Jeremy L, Wildes, Tanya M, and Consortium, COVID-19 and Cancer

Subjects
Epidemiology, Public Health, Health Sciences, Clinical Research, Aging, Cancer, Prevention, Good Health and Well Being, Aged, COVID-19, COVID-19 Testing, Cohort Studies, Humans, Middle Aged, Neoplasms, Risk Factors, SARS-CoV-2, COVID-19 and Cancer Consortium, Public health
Abstract

BackgroundOlder age is associated with poorer outcomes of SARS-CoV-2 infection, although the heterogeneity of ageing results in some older adults being at greater risk than others. The objective of this study was to quantify the association of a novel geriatric risk index, comprising age, modified Charlson comorbidity index, and Eastern Cooperative Oncology Group performance status, with COVID-19 severity and 30-day mortality among older adults with cancer.MethodsIn this cohort study, we enrolled patients aged 60 years and older with a current or previous cancer diagnosis (excluding those with non-invasive cancers and premalignant or non-malignant conditions) and a current or previous laboratory-confirmed COVID-19 diagnosis who reported to the COVID-19 and Cancer Consortium (CCC19) multinational, multicentre, registry between March 17, 2020, and June 6, 2021. Patients were also excluded for unknown age, missing data resulting in unknown geriatric risk measure, inadequate data quality, or incomplete follow-up resulting in unknown COVID-19 severity. The exposure of interest was the CCC19 geriatric risk index. The primary outcome was COVID-19 severity and the secondary outcome was 30-day all-cause mortality; both were assessed in the full dataset. Adjusted odds ratios (ORs) and 95% CIs were estimated from ordinal and binary logistic regression models.Findings5671 patients with cancer and COVID-19 were included in the analysis. Median follow-up time was 56 days (IQR 22-120), and median age was 72 years (IQR 66-79). The CCC19 geriatric risk index identified 2365 (41·7%) patients as standard risk, 2217 (39·1%) patients as intermediate risk, and 1089 (19·2%) as high risk. 36 (0·6%) patients were excluded due to non-calculable geriatric risk index. Compared with standard-risk patients, high-risk patients had significantly higher COVID-19 severity (adjusted OR 7·24; 95% CI 6·20-8·45). 920 (16·2%) of 5671 patients died within 30 days of a COVID-19 diagnosis, including 161 (6·8%) of 2365 standard-risk patients, 409 (18·5%) of 2217 intermediate-risk patients, and 350 (32·1%) of 1089 high-risk patients. High-risk patients had higher adjusted odds of 30-day mortality (adjusted OR 10·7; 95% CI 8·54-13·5) than standard-risk patients.InterpretationThe CCC19 geriatric risk index was strongly associated with COVID-19 severity and 30-day mortality. Our CCC19 geriatric risk index, based on readily available clinical factors, might provide clinicians with an easy-to-use risk stratification method to identify older adults most at risk for severe COVID-19 as well as mortality.FundingUS National Institutes of Health National Cancer Institute Cancer Center.

Published
2022

4. Analysis of CDK12 alterations in a pan‐cancer database

Author

Pan, Elizabeth, Cabal, Angelo, Javier‐DesLoges, Juan, Patel, Devin, Panian, Justine, Lee, Suzanna, Shaya, Justin, Nonato, Taylor, Xu, Xiaojun, Stewart, Tyler, Rose, Brent, Shabaik, Ahmed, Cohen, Ezra, Kurzrock, Razelle, Tamayo, Pablo, and McKay, Rana R

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Immunology, Clinical Research, Colo-Rectal Cancer, Cancer, Human Genome, Genetics, Digestive Diseases, Rare Diseases, 2.1 Biological and endogenous factors, Aetiology, Good Health and Well Being, Cyclin-Dependent Kinases, Data Management, Humans, Male, Neoplasms, Prostate, Retrospective Studies, biomarkers, cancer genetics, clinical cancer research, genomics, Biochemistry and Cell Biology, Oncology and carcinogenesis
Abstract

BackgroundCDK12 inactivation leading to increased neoantigen burden has been hypothesized to sensitize tumors to immune checkpoint inhibition. Pan-cancer data regarding the frequency of CDK12 alterations are limited. We aimed to characterize CDK12 alterations across all cancer types through real-world clinical-grade sequencing.MethodsThis was a single-center retrospective analysis of 4994 cancer patients who underwent tissue or blood genomic profiling, including CDK12 assessment, conducted as part of routine care from December 2012 to January 2020. Prevalence, clinical characteristics, and treatment outcomes of patients with tumors with pathogenic CDK12 alterations were described.ResultsIn all, 39 (0.78%, n = 39/4994) patients had pathogenic CDK12 alterations. Among CDK12-altered tumors, the most common organ site was prostate (n = 9, 23.1%) followed by colorectal (n = 5, 12.8%). Adenocarcinoma was the most common histology (n = 26, 66.7%). Median follow-up from time of diagnosis was 4.02 years. Median overall survival from time of metastasis was 4.43 years (95% CI: 3.11-5.74). Ten patients with CDK12-altered tumors received at least one immune checkpoint inhibitor-containing regimen. The majority of patients (n = 6/10, 60%) experienced an objective response. Progression-free survival for patients who had metastatic disease and received a checkpoint inhibitor-containing regimen was 1.16 years (95% CI: 0.32-2.00).ConclusionCDK12 alterations are rare events across hematologic and solid tumor malignancies. They represent a clinically distinct molecular cancer subtype which may have increased responsiveness to checkpoint inhibition. Prospective studies are warranted to investigate checkpoint inhibition in CDK12-altered tumors.

Published
2022

5. Asymptomatic detection of SARS‐CoV‐2 among cancer patients receiving infusional anti‐cancer therapy

Author

Shaya, Justin, Cabal, Angelo, Nonato, Taylor, Torriani, Francesca, Califano, Joseph, Lippman, Scott, Sacco, Assuntina, and McKay, Rana R

Subjects
Prevention, Biodefense, Lung, Cancer, Emerging Infectious Diseases, Vaccine Related, Clinical Research, Infectious Diseases, Good Health and Well Being, Adult, Aged, Aged, 80 and over, Asymptomatic Infections, COVID-19, California, Female, Hospitalization, Humans, Male, Mass Screening, Middle Aged, Neoplasms, Retrospective Studies, SARS-CoV-2, Young Adult, asymptomatic, cancer, Covid-19, PCR testing, screening, Biochemistry and Cell Biology, Oncology and Carcinogenesis
Abstract

BackgroundLittle is known regarding the rate and clinical outcomes of asymptomatic carriers of SARS-CoV-2 among patients with cancer. Detection of asymptomatic carriers is important in this population given the use of myelosuppressive and immunomodulating therapies. Understanding the asymptomatic carrier rate will help to develop mitigation strategies in this high-risk cohort.MethodsRetrospective cohort analysis of an asymptomatic screening protocol which required patients receiving infusional anti-cancer therapy to undergo a symptom/exposure screen and SARS-CoV-2 PCR testing 24-96 h prior to their infusion. The primary outcome of this analysis was the rate of asymptomatic SARS-CoV-2 infection. Secondary outcomes included the rate of COVID-19-related hospitalization and mortality and delays in oncologic therapy.ResultsAmong a cohort of 2691 cancer patients who underwent asymptomatic screening, 1.6% (N = 43/2691) of patients were found to be SARS-CoV-2 positive on asymptomatic screening. 11.6% (N = 5/43) of the cohort ultimately developed COVID-19-related symptoms. Four patients required hospitalization for complications of COVID-19 infection. No patient died from COVID-related complications. 97.7% (N = 42/43) had their anti-cancer therapy delayed or deferred with a median delay of 21 days (range: 7-77 days).ConclusionsOverall, among a cohort of active cancer patients receiving anti-cancer therapy, an asymptomatic SARS-CoV2 PCR-based screening protocol detected a small cohort of asymptomatic carriers. The majority of these patients remained asymptomatic on long-term follow-up and outcomes were much more favorable compared to previously described outcomes of cancer patients with symptomatic COVID-19 infection.

Published
2021

6. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study

Author

Kuderer, Nicole M, Choueiri, Toni K, Shah, Dimpy P, Shyr, Yu, Rubinstein, Samuel M, Rivera, Donna R, Shete, Sanjay, Hsu, Chih-Yuan, Desai, Aakash, de Lima Lopes, Gilberto, Grivas, Petros, Painter, Corrie A, Peters, Solange, Thompson, Michael A, Bakouny, Ziad, Batist, Gerald, Bekaii-Saab, Tanios, Bilen, Mehmet A, Bouganim, Nathaniel, Larroya, Mateo Bover, Castellano, Daniel, Del Prete, Salvatore A, Doroshow, Deborah B, Egan, Pamela C, Elkrief, Arielle, Farmakiotis, Dimitrios, Flora, Daniel, Galsky, Matthew D, Glover, Michael J, Griffiths, Elizabeth A, Gulati, Anthony P, Gupta, Shilpa, Hafez, Navid, Halfdanarson, Thorvardur R, Hawley, Jessica E, Hsu, Emily, Kasi, Anup, Khaki, Ali R, Lemmon, Christopher A, Lewis, Colleen, Logan, Barbara, Masters, Tyler, McKay, Rana R, Mesa, Ruben A, Morgans, Alicia K, Mulcahy, Mary F, Panagiotou, Orestis A, Peddi, Prakash, Pennell, Nathan A, Reynolds, Kerry, Rosen, Lane R, Rosovsky, Rachel, Salazar, Mary, Schmidt, Andrew, Shah, Sumit A, Shaya, Justin A, Steinharter, John, Stockerl-Goldstein, Keith E, Subbiah, Suki, Vinh, Donald C, Wehbe, Firas H, Weissmann, Lisa B, Wu, Julie Tsu-Yu, Wulff-Burchfield, Elizabeth, Xie, Zhuoer, Yeh, Albert, Yu, Peter P, Zhou, Alice Y, Zubiri, Leyre, Mishra, Sanjay, Lyman, Gary H, Rini, Brian I, Warner, Jeremy L, Consortium, COVID-19 and Cancer, Abidi, Maheen, Acoba, Jared D, Agarwal, Neeraj, Ahmad, Syed, Ajmera, Archana, Altman, Jessica, Angevine, Anne H, Azad, Nilo, Bar, Michael H, Bardia, Aditya, Barnholtz-Sloan, Jill, Barrow, Briana, Bashir, Babar, Belenkaya, Rimma, Berg, Stephanie, Bernicker, Eric H, Bestvina, Christine, Bishnoi, Rohit, Boland, Genevieve, Bonnen, Mark, Bouchard, Gabrielle, Bowles, Daniel W, Busser, Fiona, Cabal, Angelo, Caimi, Paolo, and Carducci, Theresa

Subjects
Biomedical and Clinical Sciences, Health Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Aging, Prevention, Cancer, Lung, Good Health and Well Being, Aged, Antiviral Agents, Azithromycin, Betacoronavirus, COVID-19, Cause of Death, Comorbidity, Coronavirus Infections, Databases, Factual, Female, Humans, Hydroxychloroquine, Male, Middle Aged, Neoplasms, Pandemics, Pneumonia, Viral, Prognosis, Risk Factors, SARS-CoV-2, COVID-19 Drug Treatment, COVID-19 and Cancer Consortium, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundData on patients with COVID-19 who have cancer are lacking. Here we characterise the outcomes of a cohort of patients with cancer and COVID-19 and identify potential prognostic factors for mortality and severe illness.MethodsIn this cohort study, we collected de-identified data on patients with active or previous malignancy, aged 18 years and older, with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection from the USA, Canada, and Spain from the COVID-19 and Cancer Consortium (CCC19) database for whom baseline data were added between March 17 and April 16, 2020. We collected data on baseline clinical conditions, medications, cancer diagnosis and treatment, and COVID-19 disease course. The primary endpoint was all-cause mortality within 30 days of diagnosis of COVID-19. We assessed the association between the outcome and potential prognostic variables using logistic regression analyses, partially adjusted for age, sex, smoking status, and obesity. This study is registered with ClinicalTrials.gov, NCT04354701, and is ongoing.FindingsOf 1035 records entered into the CCC19 database during the study period, 928 patients met inclusion criteria for our analysis. Median age was 66 years (IQR 57-76), 279 (30%) were aged 75 years or older, and 468 (50%) patients were male. The most prevalent malignancies were breast (191 [21%]) and prostate (152 [16%]). 366 (39%) patients were on active anticancer treatment, and 396 (43%) had active (measurable) cancer. At analysis (May 7, 2020), 121 (13%) patients had died. In logistic regression analysis, independent factors associated with increased 30-day mortality, after partial adjustment, were: increased age (per 10 years; partially adjusted odds ratio 1·84, 95% CI 1·53-2·21), male sex (1·63, 1·07-2·48), smoking status (former smoker vs never smoked: 1·60, 1·03-2·47), number of comorbidities (two vs none: 4·50, 1·33-15·28), Eastern Cooperative Oncology Group performance status of 2 or higher (status of 2 vs 0 or 1: 3·89, 2·11-7·18), active cancer (progressing vs remission: 5·20, 2·77-9·77), and receipt of azithromycin plus hydroxychloroquine (vs treatment with neither: 2·93, 1·79-4·79; confounding by indication cannot be excluded). Compared with residence in the US-Northeast, residence in Canada (0·24, 0·07-0·84) or the US-Midwest (0·50, 0·28-0·90) were associated with decreased 30-day all-cause mortality. Race and ethnicity, obesity status, cancer type, type of anticancer therapy, and recent surgery were not associated with mortality.InterpretationAmong patients with cancer and COVID-19, 30-day all-cause mortality was high and associated with general risk factors and risk factors unique to patients with cancer. Longer follow-up is needed to better understand the effect of COVID-19 on outcomes in patients with cancer, including the ability to continue specific cancer treatments.FundingAmerican Cancer Society, National Institutes of Health, and Hope Foundation for Cancer Research.

Published
2020

7. Germline alterations among Hispanic men with prostate cancer

Author

Pan, Elizabeth, Shaya, Justin, Madlensky, Lisa, Randall, J. Michael, Javier-Desloges, Juan, Millard, Frederick E., Rose, Brent, Parsons, J. Kellogg, Nielsen, Sarah M., Hatchell, Kathryn E., Esplin, Edward D., Nussbaum, Robert L., Weise, Nicole, Murphy, James, Martinez, Maria Elena, and McKay, Rana R.

Published
2022
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8. PROMISE: a real-world clinical-genomic database to address knowledge gaps in prostate cancer

Author

Koshkin, Vadim S., Patel, Vaibhav G., Ali, Alicia, Bilen, Mehmet A., Ravindranathan, Deepak, Park, Joseph J., Kellezi, Olesia, Cieslik, Marcin, Shaya, Justin, Cabal, Angelo, Brown, Landon, Labriola, Matthew, Graham, Laura S., Pritchard, Colin, Tripathi, Abhishek, Nusrat, Sanober, Barata, Pedro, Jang, Albert, Chen, Shuang R., Garje, Rohan, Acharya, Luna, Hwang, Clara, Pilling, Amanda, Oh, William, Jun, Tomi, Natesan, Divya, Nguyen, Chris, Kilari, Deepak, Pierro, Michael, Thapa, Bicky, Cackowski, Frank, Mack, Alleda, Heath, Elisabeth, Marshall, Catherine H., Tagawa, Scott T., Halabi, Susan, Schweizer, Michael T., Armstrong, Andrew, Dorff, Tanya, Alva, Ajjai, and McKay, Rana

Published
2022
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14. Assessment of Regional Variability in COVID-19 Outcomes Among Patients With Cancer in the United States.

Author

Hawley, Jessica E, Sun, Tianyi, Chism, David D, Duma, Narjust, Fu, Julie C, Gatson, Na Tosha N, Mishra, Sanjay, Nguyen, Ryan H, Reid, Sonya A, Serrano, Oscar K, Singh, Sunny R K, Venepalli, Neeta K, Bakouny, Ziad, Bashir, Babar, Bilen, Mehmet A, Caimi, Paolo F, Choueiri, Toni K, Dawsey, Scott J, Fecher, Leslie A, Flora, Daniel B, Friese, Christopher R, Glover, Michael J, Gonzalez, Cyndi J, Goyal, Sharad, Halfdanarson, Thorvardur R, Hershman, Dawn L, Khan, Hina, Labaki, Chris, Lewis, Mark A, McKay, Rana R, Messing, Ian, Pennell, Nathan A, Puc, Matthew, Ravindranathan, Deepak, Rhodes, Terence D, Rivera, Andrea V, Roller, John, Schwartz, Gary K, Shah, Sumit A, Shaya, Justin A, Streckfuss, Mitrianna, Thompson, Michael A, Wulff-Burchfield, Elizabeth M, Xie, Zhuoer, Yu, Peter Paul, Warner, Jeremy L, Shah, Dimpy P, French, Benjamin, Hwang, Clara, Hawley, Jessica E, Sun, Tianyi, Chism, David D, Duma, Narjust, Fu, Julie C, Gatson, Na Tosha N, Mishra, Sanjay, Nguyen, Ryan H, Reid, Sonya A, Serrano, Oscar K, Singh, Sunny R K, Venepalli, Neeta K, Bakouny, Ziad, Bashir, Babar, Bilen, Mehmet A, Caimi, Paolo F, Choueiri, Toni K, Dawsey, Scott J, Fecher, Leslie A, Flora, Daniel B, Friese, Christopher R, Glover, Michael J, Gonzalez, Cyndi J, Goyal, Sharad, Halfdanarson, Thorvardur R, Hershman, Dawn L, Khan, Hina, Labaki, Chris, Lewis, Mark A, McKay, Rana R, Messing, Ian, Pennell, Nathan A, Puc, Matthew, Ravindranathan, Deepak, Rhodes, Terence D, Rivera, Andrea V, Roller, John, Schwartz, Gary K, Shah, Sumit A, Shaya, Justin A, Streckfuss, Mitrianna, Thompson, Michael A, Wulff-Burchfield, Elizabeth M, Xie, Zhuoer, Yu, Peter Paul, Warner, Jeremy L, Shah, Dimpy P, French, Benjamin, and Hwang, Clara

Abstract

Importance: The COVID-19 pandemic has had a distinct spatiotemporal pattern in the United States. Patients with cancer are at higher risk of severe complications from COVID-19, but it is not well known whether COVID-19 outcomes in this patient population were associated with geography. Objective: To quantify spatiotemporal variation in COVID-19 outcomes among patients with cancer. Design, Setting, and Participants: This registry-based retrospective cohort study included patients with a historical diagnosis of invasive malignant neoplasm and laboratory-confirmed SARS-CoV-2 infection between March and November 2020. Data were collected from cancer care delivery centers in the United States. Exposures: Patient residence was categorized into 9 US census divisions. Cancer center characteristics included academic or community classification, rural-urban continuum code (RUCC), and social vulnerability index. Main Outcomes and Measures: The primary outcome was 30-day all-cause mortality. The secondary composite outcome consisted of receipt of mechanical ventilation, intensive care unit admission, and all-cause death. Multilevel mixed-effects models estimated associations of center-level and census division-level exposures with outcomes after adjustment for patient-level risk factors and quantified variation in adjusted outcomes across centers, census divisions, and calendar time. Results: Data for 4749 patients (median [IQR] age, 66 [56-76] years; 2439 [51.4%] female individuals, 1079 [22.7%] non-Hispanic Black individuals, and 690 [14.5%] Hispanic individuals) were reported from 83 centers in the Northeast (1564 patients [32.9%]), Midwest (1638 [34.5%]), South (894 [18.8%]), and West (653 [13.8%]). After adjustment for patient characteristics, including month of COVID-19 diagnosis, estimated 30-day mortality rates ranged from 5.2% to 26.6% across centers. Patients from centers located in metropolitan areas with population less than 250 000 (RUCC 3) had lower odds of 30-day

Published
2022

15. Analysis of CDK12 alterations in a pan‐cancer database

Author

Pan, Elizabeth, primary, Cabal, Angelo, additional, Javier‐DesLoges, Juan, additional, Patel, Devin, additional, Panian, Justine, additional, Lee, Suzanna, additional, Shaya, Justin, additional, Nonato, Taylor, additional, Xu, Xiaojun, additional, Stewart, Tyler, additional, Rose, Brent, additional, Shabaik, Ahmed, additional, Cohen, Ezra, additional, Kurzrock, Razelle, additional, Tamayo, Pablo, additional, and McKay, Rana R., additional

Published
2021
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17. PROMISE: a real-world clinical-genomic database to address knowledge gaps in prostate cancer

Author

Koshkin, Vadim S., primary, Patel, Vaibhav G., additional, Ali, Alicia, additional, Bilen, Mehmet A., additional, Ravindranathan, Deepak, additional, Park, Joseph J., additional, Kellezi, Olesia, additional, Cieslik, Marcin, additional, Shaya, Justin, additional, Cabal, Angelo, additional, Brown, Landon, additional, Labriola, Matthew, additional, Graham, Laura S., additional, Pritchard, Colin, additional, Tripathi, Abhishek, additional, Nusrat, Sanober, additional, Barata, Pedro, additional, Jang, Albert, additional, Chen, Shuang R., additional, Garje, Rohan, additional, Acharya, Luna, additional, Hwang, Clara, additional, Pilling, Amanda, additional, Oh, William, additional, Jun, Tomi, additional, Natesan, Divya, additional, Nguyen, Chris, additional, Kilari, Deepak, additional, Pierro, Michael, additional, Thapa, Bicky, additional, Cackowski, Frank, additional, Mack, Alleda, additional, Heath, Elisabeth, additional, Marshall, Catherine H., additional, Tagawa, Scott T., additional, Halabi, Susan, additional, Schweizer, Michael T., additional, Armstrong, Andrew, additional, Dorff, Tanya, additional, Alva, Ajjai, additional, and McKay, Rana, additional

Published
2021
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19. Interplay of Immunosuppression and Immunotherapy Among Patients With Cancer and COVID-19

Author

Bakouny, Ziad, Labaki, Chris, Grover, Punita, Awosika, Joy, Gulati, Shuchi, Hsu, Chih-Yuan, Alimohamed, Saif I., Bashir, Babar, Berg, Stephanie, Bilen, Mehmet A., Bowles, Daniel, Castellano, Cecilia, Desai, Aakash, Elkrief, Arielle, Eton, Omar E., Fecher, Leslie A., Flora, Daniel, Galsky, Matthew D., Gatti-Mays, Margaret E., Gesenhues, Alicia, Glover, Michael J., Gopalakrishnan, Dharmesh, Gupta, Shilpa, Halfdanarson, Thorvardur R., Hayes-Lattin, Brandon, Hendawi, Mohamed, Hsu, Emily, Hwang, Clara, Jandarov, Roman, Jani, Chinmay, Johnson, Douglas B., Joshi, Monika, Khan, Hina, Khan, Shaheer A., Knox, Natalie, Koshkin, Vadim S., Kulkarni, Amit A., Kwon, Daniel H., Matar, Sara, McKay, Rana R., Mishra, Sanjay, Moria, Feras A., Nizam, Amanda, Nock, Nora L., Nonato, Taylor K., Panasci, Justin, Pomerantz, Lauren, Portuguese, Andrew J., Provenzano, Destie, Puc, Matthew, Rao, Yuan J., Rhodes, Terence D., Riely, Gregory J., Ripp, Jacob J., Rivera, Andrea V., Ruiz-Garcia, Erika, Schmidt, Andrew L., Schoenfeld, Adam J., Schwartz, Gary K., Shah, Sumit A., Shaya, Justin, Subbiah, Suki, Tachiki, Lisa M., Tucker, Matthew D., Valdez-Reyes, Melissa, Weissmann, Lisa B., Wotman, Michael T., Wulff-Burchfield, Elizabeth M., Xie, Zhuoer, Yang, Yuanchu James, Thompson, Michael A., Shah, Dimpy P., Warner, Jeremy L., Shyr, Yu, Choueiri, Toni K., and Wise-Draper, Trisha M.

Abstract

IMPORTANCE: Cytokine storm due to COVID-19 can cause high morbidity and mortality and may be more common in patients with cancer treated with immunotherapy (IO) due to immune system activation. OBJECTIVE: To determine the association of baseline immunosuppression and/or IO-based therapies with COVID-19 severity and cytokine storm in patients with cancer. DESIGN, SETTING, AND PARTICIPANTS: This registry-based retrospective cohort study included 12 046 patients reported to the COVID-19 and Cancer Consortium (CCC19) registry from March 2020 to May 2022. The CCC19 registry is a centralized international multi-institutional registry of patients with COVID-19 with a current or past diagnosis of cancer. Records analyzed included patients with active or previous cancer who had a laboratory-confirmed infection with SARS-CoV-2 by polymerase chain reaction and/or serologic findings. EXPOSURES: Immunosuppression due to therapy; systemic anticancer therapy (IO or non-IO). MAIN OUTCOMES AND MEASURES: The primary outcome was a 5-level ordinal scale of COVID-19 severity: no complications; hospitalized without requiring oxygen; hospitalized and required oxygen; intensive care unit admission and/or mechanical ventilation; death. The secondary outcome was the occurrence of cytokine storm. RESULTS: The median age of the entire cohort was 65 years (interquartile range [IQR], 54-74) years and 6359 patients were female (52.8%) and 6598 (54.8%) were non-Hispanic White. A total of 599 (5.0%) patients received IO, whereas 4327 (35.9%) received non-IO systemic anticancer therapies, and 7120 (59.1%) did not receive any antineoplastic regimen within 3 months prior to COVID-19 diagnosis. Although no difference in COVID-19 severity and cytokine storm was found in the IO group compared with the untreated group in the total cohort (adjusted odds ratio [aOR], 0.80; 95% CI, 0.56-1.13, and aOR, 0.89; 95% CI, 0.41-1.93, respectively), patients with baseline immunosuppression treated with IO (vs untreated) had worse COVID-19 severity and cytokine storm (aOR, 3.33; 95% CI, 1.38-8.01, and aOR, 4.41; 95% CI, 1.71-11.38, respectively). Patients with immunosuppression receiving non-IO therapies (vs untreated) also had worse COVID-19 severity (aOR, 1.79; 95% CI, 1.36-2.35) and cytokine storm (aOR, 2.32; 95% CI, 1.42-3.79). CONCLUSIONS AND RELEVANCE: This cohort study found that in patients with cancer and COVID-19, administration of systemic anticancer therapies, especially IO, in the context of baseline immunosuppression was associated with severe clinical outcomes and the development of cytokine storm. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04354701

Published
2023
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20. Germline alterations among Hispanic men with prostate cancer.

Author

Shaya, Justin, primary, Nielsen, Sarah M., additional, Hatchell, Kathryn E., additional, Esplin, Edward D., additional, Nussbaum, Robert Luke, additional, Weise, Nicole, additional, Madlensky, Lisa, additional, Murphy, James Don, additional, Martinez, Elena, additional, and McKay, Rana R., additional

Published
2021
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25. A phase I/II study of combination olaparib and radium-223 in men with metastatic castration-resistant prostate cancer with bone metastases (COMRADE): A trial in progress.

Author

Shaya, Justin, primary, Xie, Wanling, additional, Saraiya, Biren, additional, Parikh, Mamta, additional, Folefac, Edmund, additional, Olson, Adam C., additional, Choudhury, Atish Dipankar, additional, Einstein, David Johnson, additional, Heath, Elisabeth I., additional, Parikh, Rahul Atul, additional, Kunos, Charles, additional, Ivy, S. Percy, additional, LoRusso, Patricia, additional, Kurzrock, Razelle, additional, Shapiro, Geoffrey, additional, and McKay, Rana R., additional

Published
2021
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28. A Systematic Framework to Rapidly Obtain Data on Patients with Cancer and COVID-19: CCC19 Governance, Protocol, and Quality Assurance

Author

Abidi, Maheen, primary, Aboulafia, David M., additional, Accordino, Melissa K., additional, Acoba, Jared D., additional, Ahluwalia, Manmeet S., additional, Ahmad, Syed A., additional, Ajmera, Archana, additional, Alimohamed, Saif I., additional, Altman, Jessica, additional, Angevine, Anne H., additional, Bakouny, Ziad, additional, Bar, Michael H., additional, Bardia, Aditya, additional, Barnholtz-Sloan, Jill S., additional, Barrow McCollough, Briana, additional, Bashir, Babar, additional, Batist, Gerald, additional, Bekaii-Saab, Tanios S., additional, Berg, Stephanie, additional, Bernicker, Eric H., additional, Bhutani, Divaya, additional, Bilen, Mehmet A., additional, Bindal, Poorva, additional, Bishnoi, Rohit, additional, Blau, Sibel, additional, Bohachek, Pamela, additional, Boland, Genevieve, additional, Bonnen, Mark, additional, Bouchard, Gabrielle, additional, Bouganim, Nathaniel, additional, Bowles, Daniel W., additional, Busser, Fiona J., additional, Butt, Omar, additional, Cabal, Angelo, additional, Cabalona, Wilhelmina D., additional, Cabebe, Elwyn C., additional, Caimi, Paolo, additional, Campian, Jian L., additional, Carducci, Theresa M., additional, Chen, James L., additional, Cheng, Alex, additional, Chism, David D., additional, Choueiri, Toni K., additional, Clark, Melanie J., additional, Clement, Jessica M., additional, Connors, Jean M., additional, Cook, Erin, additional, Curran, Catherine R., additional, Daher, Ahmad, additional, Dailey, Mark E., additional, Davis, Elizabeth J., additional, Dawsey, Scott J., additional, Deeken, John F., additional, Del Prete, Salvatore A., additional, Demetri, George D., additional, Desai, Aakash, additional, Doroshow, Deborah B., additional, Durbin, Eric B., additional, Egan, Pamela C., additional, Elias, Rawad, additional, Elkrief, Arielle, additional, Elms, Destry J., additional, Elshoury, Amro, additional, Faller, Bryan, additional, Farmakiotis, Dimitrios, additional, Fecher, Leslie A., additional, Feldman, Lawrence E., additional, Ferrario, Cristiano, additional, Fiala, Mark A., additional, Flora, Daniel B., additional, French, Benjamin, additional, Friese, Christopher R., additional, Fu, Julie C., additional, Gadgeel, Shirish M., additional, Gainor, Justin, additional, Galsky, Matthew D., additional, Gantt, Gerald, additional, Garcia, Jorge A., additional, Gartrell, Benjamin A., additional, Gatti-Mays, Margaret E., additional, Gill, David M., additional, Gillaspie, Erin A., additional, Giordano, Antonio, additional, Glace, (Mary) Grace, additional, Glover, Michael J., additional, Goel, Sanjay, additional, Graber, Jerome J., additional, Griffiths, Elizabeth A., additional, Grivas, Petros, additional, Grover, Punita, additional, Gulati, Anthony P., additional, Gulati, Shuchi, additional, Gupta, Shilpa, additional, Gurley, Michael, additional, Hafez, Navid, additional, Halabi, Susan, additional, Halfdanarson, Thorvardur R., additional, Halmos, Balazs, additional, Hausrath, Daniel J., additional, Hawley, Jessica E., additional, Hennessy, Cassandra, additional, Herbst, Roy S., additional, Hershman, Dawn L., additional, Hoppenot, Claire, additional, Hoskins, Kent F., additional, Hoyo-Ulloa, Irma, additional, Hsu, Emily, additional, Hsu, Chih-Yuan, additional, Hwang, Clara, additional, Islam, Jessica Yasmine, additional, Jabbour, Salma K., additional, Jani, Chinmay, additional, Jha, Alokkumar, additional, Jhawar, Sachin R., additional, Johnson, Douglas B., additional, Joshi, Monika, additional, Kasi, Anup, additional, Kelleher, Kaitlin, additional, Kennecke, Hagen F., additional, Khaki, Ali Raza, additional, Khan, Hina, additional, Khan, Mahir, additional, Kharofa, Jordan, additional, Kloecker, Goetz, additional, Knoble, Jeanna L., additional, Kulkarni, Amit A., additional, Kumar, Vaibhav, additional, Lammers, Philip E., additional, Leighton, John C., additional, Lemmon, Christopher A., additional, Lewis, Mark A., additional, Li, Ang, additional, Li, Xuanyi, additional, Liu, Stephen V., additional, Lo, K.M., additional, Loaiza-Bonilla, Arturo, additional, Logan, Barbara B., additional, Loggers, Elizabeth T., additional, de Lima Lopes, Gilberto, additional, Loree, Jonathan M., additional, LoRusso, Patricia, additional, Low, Clarke A., additional, Lustberg, Maryam B., additional, Lyman, Gary H., additional, Lynch, Ryan C., additional, Madhavan, Subha, additional, Mahadevan, Daruka, additional, Mahmood, Sana Z., additional, Mansoor, Abdul-Hai, additional, Marcum, Michelle, additional, Markham, Merry-Jennifer, additional, Mashru, Sandeep H., additional, Masters, Tyler, additional, Mavromatis, Blanche H., additional, McKay, Rana R., additional, McNair, Christopher, additional, McWeeney, Shannon, additional, Menendez, Alvaro G., additional, Menon, Harry, additional, Mesa, Ruben A., additional, Mico, Vasil, additional, Miller, Chaim, additional, Mishra, Sanjay, additional, Monahan, Ryan S., additional, Morgans, Alicia K., additional, Mulcahy, Mary F., additional, Mundt, Daniel, additional, Mushtaq, Sarah, additional, Nagaraj, Gayathri, additional, Nagle, Sarah, additional, Nakasone, Elizabeth S., additional, Nakayama, John M., additional, Nelson, Heather H., additional, Nemecek, Eneida R., additional, Nguyen, Ryan H., additional, Nizam, Amanda, additional, Nohria, Anju, additional, Nuzzo, Pier Vitale, additional, Ohri, Nitin, additional, Olszewski, Adam J., additional, Owenby, Susie, additional, Painter, Corrie A., additional, Palmer, Joshua D., additional, Panagiotou, Orestis A., additional, Park, Cathleen, additional, Pasquinelli, Mary M., additional, Patel, Jaymin M., additional, Patel, Kanishka G., additional, Peddi, Prakash, additional, Pennell, Nathan A., additional, Peters, Solange, additional, Pilar, Christine, additional, Pillainayagam, Clement, additional, Puc, Matthew, additional, Ramirez, Amelie G., additional, Rathmann, Joerg, additional, Ravindranathan, Deepak, additional, Reid, Sonya A., additional, Reuben, Daniel Y., additional, Revankar, Sanjay G., additional, Reynolds, Kerry L., additional, Rho, Young Soo, additional, Rhodes, Terence D., additional, Rice, Robert L., additional, Riess, Jonathan, additional, Rini, Brian I., additional, Rink, Cameron, additional, Rosen, Lane R., additional, Rosenstein, Lori J., additional, Rosovsky, Rachel P., additional, Routy, Bertrand, additional, Rovito, Marc A., additional, Rubinstein, Samuel M., additional, Saif, M. Wasif, additional, Salazar, Mary, additional, Santos Dutra, Miriam, additional, Schapira, Lidia, additional, Schmidt, Andrew L., additional, Schroeder, Brett A., additional, Schwartz, Gary K., additional, Schwartz, Candice, additional, Schweizer, Michael T., additional, Serrano, Oscar K., additional, Shafer, Danielle A., additional, Shah, Pankil K., additional, Shah, Dimpy, additional, Shah, Mansi R., additional, Shah, Sumit A., additional, Shah, Chintan, additional, Shaw, Grace, additional, Shaya, Justin A., additional, Shyr, Yu, additional, Slosky, David A., additional, Smits, Melissa, additional, Solorzano, Carmen C., additional, Stauffer, Karen, additional, Stockerl-Goldstein, Keith E., additional, Stover, Daniel G., additional, Stratton, Jamie, additional, Stratton, Catherine, additional, Streckfuss, Mitrianna, additional, Subbiah, Suki, additional, Tachiki, Lisa, additional, Tadesse, Eyob, additional, Thompson, Michael A., additional, Topaloglu, Umit, additional, Tucker, Matthew D., additional, Van Allen, Eliezer M., additional, Van Loon, Susan, additional, Vega-Luna, Karen, additional, Venepalli, Neeta K., additional, Verma, Amit, additional, Vikas, Praveen, additional, Vinayak, Shaveta, additional, Vinh, Donald C., additional, Wagner, Michael J., additional, Wall, Sarah, additional, Wang, Lucy L., additional, Warner, Jeremy L., additional, Wehbe, Firas H., additional, Weinstein, Paul L., additional, Weiss, Matthias, additional, Weissmann, Lisa B., additional, Wildes, Tanya M., additional, Williams, Nicole, additional, Wise-Draper, Trisha M., additional, Wood, William A., additional, Wu, Julie Tsu-Yu, additional, Wulff-Burchfield, Elizabeth M., additional, Xie, Zhuoer, additional, Xu, Wenxin, additional, Yeh, Albert C., additional, Yu, Irene S., additional, Yu, Peter Paul, additional, Zacks, Rosemary, additional, Zaman, Qamar Ul, additional, Zaren, Howard, additional, Zhang, Tian, additional, Zhou, Alice Y., additional, Zhu, Huili, additional, Zon, Rebecca L., additional, and Zubiri, Leyre, additional

Published
2020
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38. Assessment of Regional Variability in COVID-19 Outcomes Among Patients With Cancer in the United States.

Author

Hawley JE, Sun T, Chism DD, Duma N, Fu JC, Gatson NTN, Mishra S, Nguyen RH, Reid SA, Serrano OK, Singh SRK, Venepalli NK, Bakouny Z, Bashir B, Bilen MA, Caimi PF, Choueiri TK, Dawsey SJ, Fecher LA, Flora DB, Friese CR, Glover MJ, Gonzalez CJ, Goyal S, Halfdanarson TR, Hershman DL, Khan H, Labaki C, Lewis MA, McKay RR, Messing I, Pennell NA, Puc M, Ravindranathan D, Rhodes TD, Rivera AV, Roller J, Schwartz GK, Shah SA, Shaya JA, Streckfuss M, Thompson MA, Wulff-Burchfield EM, Xie Z, Yu PP, Warner JL, Shah DP, French B, and Hwang C

Subjects
Aged, Cause of Death, Censuses, Female, Health Facilities, Humans, Intensive Care Units, Male, Middle Aged, Odds Ratio, Registries, Respiration, Artificial, Retrospective Studies, Risk Factors, SARS-CoV-2, Severity of Illness Index, Spatial Analysis, United States epidemiology, COVID-19 epidemiology, Neoplasms epidemiology, Pandemics, Rural Population, Social Vulnerability, Urban Population
Abstract

Importance: The COVID-19 pandemic has had a distinct spatiotemporal pattern in the United States. Patients with cancer are at higher risk of severe complications from COVID-19, but it is not well known whether COVID-19 outcomes in this patient population were associated with geography., Objective: To quantify spatiotemporal variation in COVID-19 outcomes among patients with cancer., Design, Setting, and Participants: This registry-based retrospective cohort study included patients with a historical diagnosis of invasive malignant neoplasm and laboratory-confirmed SARS-CoV-2 infection between March and November 2020. Data were collected from cancer care delivery centers in the United States., Exposures: Patient residence was categorized into 9 US census divisions. Cancer center characteristics included academic or community classification, rural-urban continuum code (RUCC), and social vulnerability index., Main Outcomes and Measures: The primary outcome was 30-day all-cause mortality. The secondary composite outcome consisted of receipt of mechanical ventilation, intensive care unit admission, and all-cause death. Multilevel mixed-effects models estimated associations of center-level and census division-level exposures with outcomes after adjustment for patient-level risk factors and quantified variation in adjusted outcomes across centers, census divisions, and calendar time., Results: Data for 4749 patients (median [IQR] age, 66 [56-76] years; 2439 [51.4%] female individuals, 1079 [22.7%] non-Hispanic Black individuals, and 690 [14.5%] Hispanic individuals) were reported from 83 centers in the Northeast (1564 patients [32.9%]), Midwest (1638 [34.5%]), South (894 [18.8%]), and West (653 [13.8%]). After adjustment for patient characteristics, including month of COVID-19 diagnosis, estimated 30-day mortality rates ranged from 5.2% to 26.6% across centers. Patients from centers located in metropolitan areas with population less than 250 000 (RUCC 3) had lower odds of 30-day mortality compared with patients from centers in metropolitan areas with population at least 1 million (RUCC 1) (adjusted odds ratio [aOR], 0.31; 95% CI, 0.11-0.84). The type of center was not significantly associated with primary or secondary outcomes. There were no statistically significant differences in outcome rates across the 9 census divisions, but adjusted mortality rates significantly improved over time (eg, September to November vs March to May: aOR, 0.32; 95% CI, 0.17-0.58)., Conclusions and Relevance: In this registry-based cohort study, significant differences in COVID-19 outcomes across US census divisions were not observed. However, substantial heterogeneity in COVID-19 outcomes across cancer care delivery centers was found. Attention to implementing standardized guidelines for the care of patients with cancer and COVID-19 could improve outcomes for these vulnerable patients.

Published
2022
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