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1. Managing hyperglycemia and rash associated with alpelisib: expert consensus recommendations using the Delphi technique.

Author

Gallagher, Emily, Moore, Heather, Lacouture, Mario, Dent, Susan, Farooki, Azeez, Goncalves, Marcus, Isaacs, Claudine, Johnston, Abigail, Juric, Dejan, Quandt, Zoe, Spring, Laura, Berman, Brian, Decker, Melanie, Hortobagyi, Gabriel, Kaffenberger, Benjamin, Kwong, Bernice, Pluard, Timothy, Rao, Ruta, Schwartzberg, Lee, and Broder, Michael

Abstract

Hyperglycemia and rash are expected but challenging adverse events of phosphatidylinositol-3-kinase inhibition (such as with alpelisib). Two modified Delphi panels were conducted to provide consensus recommendations for managing hyperglycemia and rash in patients taking alpelisib. Experts rated the appropriateness of interventions on a 1-to-9 scale; median scores and dispersion were used to classify the levels of agreement. Per the hyperglycemia panel, it is appropriate to start alpelisib in patients with HbA1c 6.5% (diabetes) to

Published
2024

7. Activity and safety of enobosarm, a novel, oral, selective androgen receptor modulator, in androgen receptor-positive, oestrogen receptor-positive, and HER2-negative advanced breast cancer (Study G200802): a randomised, open-label, multicentre, multinational, parallel design, phase 2 trial

Author

Palmieri, Carlo, Linden, Hannah, Birrell, Stephen N, Wheelwright, Sally, Lim, Elgene, Schwartzberg, Lee S, Dwyer, Amy R, Hickey, Theresa E, Rugo, Hope S, Cobb, Patrick, O'Shaughnessy, Joyce A, Johnston, Stephen, Brufsky, Adam, Tilley, Wayne D, and Overmoyer, Beth

Published
2024
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10. Pan-cancer analysis of RNA expression of ANGIOTENSIN-I-CONVERTING ENZYME 2 reveals high variability and possible impact on COVID-19 clinical outcomes.

Author

Elliott, Andrew, Saul, Michelle, Zeng, Jia, Marshall, John, Kim, Edward, Nagasaka, Misako, Lenz, Heinz-Josef, Schwartzberg, Lee, Spetzler, David, Abraham, Jim, Xiu, Joanne, Stafford, Phillip, and Michael Korn, W

Subjects
Aged, Angiotensin-Converting Enzyme 2, COVID-19, Case-Control Studies, Female, Humans, Male, Middle Aged, Neoplasms, RNA, Serine Endopeptidases, Tumor Microenvironment, Exome Sequencing
Abstract

Patients with cancer demonstrate particularly poor outcomes from COVID-19. To provide information essential for understanding the biologic underpinnings of this association, we analyzed whole-transcriptome RNA expression data obtained from a large cohort of cancer patients to characterize expression of ACE2, TMPRSS2, and other proteases that are involved in viral attachment to and entry into target cells. We find substantial variability of expression of these factors across tumor types and identify subpopulations expressing ACE2 at very high levels. In some tumor types, especially in gastrointestinal cancers, expression of ACE2 and TMPRSS2 is highly correlated. Furthermore, we found infiltration with T-cell and natural killer (NK) cell infiltration to be particularly pronounced in ACE2-high tumors. These findings suggest that subsets of cancer patients exist with gene expression profiles that may be associated with heightened susceptibility to SARS-CoV-2 infection, in whom malignant tumors function as viral reservoir and possibly promote the frequently detrimental hyper-immune response in patients infected with this virus.

Published
2021

11. Molecular characterization of ESR1 variants in breast cancer

Author

Heeke, Arielle L., Elliott, Andrew, Feldman, Rebecca, O’Connor, Hazel F., Pohlmann, Paula R., Lynce, Filipa, Swain, Sandra M., Nunes, Maria R., Magee, Daniel, Oberley, Matthew J., Swenson, Jeffrey, Vidal, Gregory, Isaacs, Claudine, Schwartzberg, Lee, Korn, W. Michael, and Tan, Antoinette R.

Published
2022
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12. Fixed combination of oral NEPA (netupitant‐palonosetron) for the prevention of acute and delayed chemotherapy‐induced nausea and vomiting in patients receiving multiple cycles of chemotherapy: Efficacy data from 2 randomized, double‐blind phase III studies

Author

Schwartzberg, Lee, Karthaus, Meinolf, Rossi, Giorgia, Rizzi, Giada, Borroni, Maria E, Rugo, Hope S, Jordan, Karin, and Hansen, Vincent

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Dental/Oral and Craniofacial Disease, Clinical Research, Cancer, Clinical Trials and Supportive Activities, Digestive Diseases, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Administration, Oral, Anthracyclines, Antiemetics, Aprepitant, Cyclophosphamide, Dexamethasone, Double-Blind Method, Drug Combinations, Drug-Related Side Effects and Adverse Reactions, Female, Humans, Isoquinolines, Male, Middle Aged, Palonosetron, Pyridines, Quinuclidines, Treatment Outcome, CINV, delayed phase, efficacy, multiple cycles, NEPA, netupitant, Biochemistry and Cell Biology, Oncology and carcinogenesis
Abstract

AimTo assess the efficacy of oral NEPA (netupitant-palonosetron 300/0.50 mg) over multiple chemotherapy cycles.MethodsTwo randomized phase III studies evaluated a single dose of oral NEPA given on day 1 in chemotherapy-naive patients receiving anthracycline-cyclophosphamide (AC)-based (Study 1) or highly (HEC)/moderately (MEC) emetogenic chemotherapy (safety Study 2). Oral NEPA was compared with oral palonosetron 0.50 mg (Study 1) or oral aprepitant 125 mg day 1, 80 mg days 2-3/palonosetron 0.50 mg (Study 2; no formal statistical comparisons). Oral dexamethasone was administered in all treatment groups. Complete response (CR; no emesis/no rescue medication), no emesis, and no significant nausea (NSN) rates during acute (0-24 h) and delayed (>24-120 h) phases of chemotherapy cycles 1-4 in each study were evaluated.ResultsIn Study 1, 1450 patients received 5969 chemotherapy cycles; in Study 2, 412 patients received 1961 chemotherapy cycles. In each study, ≥75% of patients completed 4 or more cycles. In Study 1, oral NEPA was superior to palonosetron in preventing chemotherapy-induced nausea and vomiting (CINV) in the acute and delayed phases of cycle 1, with higher rates of CR (all P

Published
2019

18. An Open-Label Phase II Trial NCT03812393 to Evaluate the Efficacy and Safety of Neoadjuvant Neratinib Followed by Weekly Paclitaxel and Carboplatin Plus Neratinib in Early-Stage Triple-Negative Breast Cancer (TNBC) Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)

Author

John, Elizabeth, primary, Sekhon, Simran, additional, Laing, Lance, additional, Benn, Sonia, additional, Schwartzberg, Lee, additional, and Vidal, Gregory, additional

Published
2024
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21. Prolonged survival in patients with breast cancer and a history of brain metastases: results of a preplanned subgroup analysis from the randomized phase III BEACON trial

Author

Cortés, Javier, Rugo, Hope S, Awada, Ahmad, Twelves, Chris, Perez, Edith A, Im, Seock–Ah, Gómez-Pardo, Patricia, Schwartzberg, Lee S, Diéras, Veronique, Yardley, Denise A, Potter, David A, Mailliez, Audrey, Moreno-Aspitia, Alvaro, Ahn, Jin-Seok, Zhao, Carol, Hoch, Ute, Tagliaferri, Mary, Hannah, Alison L, and O’Shaughnessy, Joyce

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Breast Cancer, Cancer, Neurosciences, Clinical Trials and Supportive Activities, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Brain metastases, Etirinotecan pegol, NKTR-102, Chemotherapy, Metastatic breast cancer, Clinical Sciences, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposeConventional chemotherapy has limited activity in patients with breast cancer and brain metastases (BCBM). Etirinotecan pegol (EP), a novel long-acting topoisomerase-1 inhibitor, was designed using advanced polymer technology to preferentially accumulate in tumor tissue including brain metastases, providing sustained cytotoxic SN38 levels.MethodsThe phase 3 BEACON trial enrolled 852 women with heavily pretreated locally recurrent or metastatic breast cancer between 2011 and 2013. BEACON compared EP with treatment of physician's choice (TPC; eribulin, vinorelbine, gemcitabine, nab-paclitaxel, paclitaxel, ixabepilone, or docetaxel) in patients previously treated with anthracycline, taxane, and capecitabine, including those with treated, stable brain metastases. The primary endpoint, overall survival (OS), was assessed in a pre-defined subgroup of BCBM patients; an exploratory post hoc analysis adjusting for the diagnosis-specific graded prognostic assessment (GPA) index was also conducted.ResultsIn the trial, 67 BCBM patients were randomized (EP, n = 36; TPC, n = 31). Treatment subgroups were balanced for baseline characteristics and GPA indices. EP was associated with a significant reduction in the risk of death (HR 0.51; P

Published
2017

23. 2023 updated MASCC/ESMO Consensus recommendations:Prevention of nausea and vomiting following moderately emetic risk antineoplastic agents

Author

Scotté, Florian, Schwartzberg, Lee, lihara, Hirotoshi, Aapro, Matti, Gralla, Richard, Hesketh, Paul J., Jordan, Karin, Chow, Ronald, Herrstedt, Jørn, Scotté, Florian, Schwartzberg, Lee, lihara, Hirotoshi, Aapro, Matti, Gralla, Richard, Hesketh, Paul J., Jordan, Karin, Chow, Ronald, and Herrstedt, Jørn

Abstract

Purpose: Review the literature to update the MASCC guidelines from 2015 for controlling nausea and vomiting with systemic cancer treatment of moderate emetic potential. Methods: A systematic literature review was completed using Medline, Embase, and Scopus databases. The literature search was done from June 2015 to January 2023 of the management of antiemetic prophylaxis for anticancer therapy of moderate emetic potential. Results: Of 342 papers identified, 19 were relevant to update recommendations about managing antiemetic prophylaxis for systemic cancer treatment regimens of moderate emetic potential. Important practice changing updates include the use of emetic prophylaxis based on a triple combination of neurokinin (NK)1 receptor antagonist, 5-HT3 receptor antagonist, and steroids for patients undergoing carboplatin (AUC ≥ 5) and women < 50 years of age receiving oxaliplatin-based treatment. A double combination of 5-HT3 receptor antagonist and steroids remains the recommended prophylaxis for other MEC. Based on the data in the literature, it is recommended that the administration of steroids should be limited to day 1 in moderately emetogenic chemotherapy regimens, due to the demonstration of non-inferiority between the different regimens. More data is needed on the emetogenicity of new agents at moderate emetogenic risk. Of particular interest would be antiemetic studies with the agents sacituzumab-govitecan and trastuzumab-deruxtecan. Experience to date with these agents indicate an emetogenic potential comparable to carboplatin > AUC 5. Future studies should systematically include patient-related risk assessment in order to define the risk of emesis with MEC beyond the emetogenicity of the chemotherapy and improve the guidelines for new drugs. Conclusion: This antiemetic MASCC-ESMO guideline update includes new recommendations considering individual risk factors and the optimization of supportive anti-emetic treatme

Published
2024

29. Androgen Receptor Is a Non-canonical Inhibitor of Wild-Type and Mutant Estrogen Receptors in Hormone Receptor-Positive Breast Cancers

Author

Ponnusamy, Suriyan, Asemota, Sarah, Schwartzberg, Lee S., Guestini, Fouzia, McNamara, Keely M., Pierobon, Mariaelena, Font-Tello, Alba, Qiu, Xintao, Xie, Yingtian, Rao, Prakash K., Thiyagarajan, Thirumagal, Grimes, Brandy, Johnson, Daniel L., Fleming, Martin D., Pritchard, Frances E., Berry, Michael P., Oswaks, Roy, Fine, Richard E., Brown, Myles, Sasano, Hironobu, Petricoin, Emanuel F., Long, Henry W., and Narayanan, Ramesh

Published
2019
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30. Safety, Efficacy, and Patient-Reported Health-Related Quality of Life and Symptom Burden with Nivolumab in Patients with Advanced Non–Small Cell Lung Cancer, Including Patients Aged 70 Years or Older or with Poor Performance Status (CheckMate 153)

Author

Spigel, David R., McCleod, Michael, Jotte, Robert M., Einhorn, Lawrence, Horn, Leora, Waterhouse, David M., Creelan, Ben, Babu, Sunil, Leighl, Natasha B., Chandler, Jason C., Couture, Felix, Keogh, George, Goss, Glenwood, Daniel, Davey B., Garon, Edward B., Schwartzberg, Lee S., Sen, Rohini, Korytowsky, Beata, Li, Ang, Aanur, Nivedita, and Hussein, Maen A.

Published
2019
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34. Sorafenib or Placebo with Either Gemcitabine or Capecitabine in Patients with HER-2–Negative Advanced Breast Cancer That Progressed during or after Bevacizumab

Author

Schwartzberg, Lee S, Tauer, Kurt W, Hermann, Robert C, Makari-Judson, Grace, Isaacs, Claudine, Beck, J Thaddeus, Kaklamani, Virginia, Stepanski, Edward J, Rugo, Hope S, Wang, Wei, Bell-McGuinn, Katherine, Kirshner, Jeffrey J, Eisenberg, Peter, Emanuelson, Richard, Keaton, Mark, Levine, Ellis, Medgyesy, Diana C, Qamar, Rubina, Starr, Alexander, Ro, Sunhee Kwon, Lokker, Nathalie A, and Hudis, Clifford A

Subjects
Cancer, Breast Cancer, Clinical Research, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Adult, Aged, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Breast Neoplasms, Capecitabine, Deoxycytidine, Disease Progression, Disease-Free Survival, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Fatigue, Female, Fluorouracil, Humans, Kaplan-Meier Estimate, Middle Aged, Niacinamide, Phenylurea Compounds, Receptor, ErbB-2, Skin Diseases, Sorafenib, Stomatitis, Treatment Outcome, Gemcitabine, Receptor, erbB-2, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeWe assessed adding the multikinase inhibitor sorafenib to gemcitabine or capecitabine in patients with advanced breast cancer whose disease progressed during/after bevacizumab.Experimental designThis double-blind, randomized, placebo-controlled phase IIb study (ClinicalTrials.gov NCT00493636) enrolled patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer and prior bevacizumab treatment. Patients were randomized to chemotherapy with sorafenib (400 mg, twice daily) or matching placebo. Initially, chemotherapy was gemcitabine (1,000 mg/m(2) i.v., days 1, 8/21), but later, capecitabine (1,000 mg/m(2) orally twice daily, days 1-14/21) was allowed as an alternative. The primary endpoint was progression-free survival (PFS).ResultsOne hundred and sixty patients were randomized. More patients received gemcitabine (82.5%) than capecitabine (17.5%). Sorafenib plus gemcitabine/capecitabine was associated with a statistically significant prolongation in PFS versus placebo plus gemcitabine/capecitabine [3.4 vs. 2.7 months; HR = 0.65; 95% confidence interval (CI): 0.45-0.95; P = 0.02], time to progression was increased (median, 3.6 vs. 2.7 months; HR = 0.64; 95% CI: 0.44-0.93; P = 0.02), and overall response rate was 19.8% versus 12.7% (P = 0.23). Median survival was 13.4 versus 11.4 months for sorafenib versus placebo (HR = 1.01; 95% CI: 0.71-1.44; P = 0.95). Addition of sorafenib versus placebo increased grade 3/4 hand-foot skin reaction (39% vs. 5%), stomatitis (10% vs. 0%), fatigue (18% vs. 9%), and dose reductions that were more frequent (51.9% vs. 7.8%).ConclusionThe addition of sorafenib to gemcitabine/capecitabine provided a clinically small but statistically significant PFS benefit in HER2-negative advanced breast cancer patients whose disease progressed during/after bevacizumab. Combination treatment was associated with manageable toxicities but frequently required dose reductions.

Published
2013

39. RESILIENCE: Phase III Randomized, Double-Blind Trial Comparing Sorafenib With Capecitabine Versus Placebo With Capecitabine in Locally Advanced or Metastatic HER2-Negative Breast Cancer

Author

Baselga, José, Zamagni, Claudio, Gómez, Patricia, Bermejo, Begoña, Nagai, Shigenori E., Melichar, Bohuslav, Chan, Arlene, Mángel, Lászlo, Bergh, Jonas, Costa, Frederico, Gómez, Henry L., Gradishar, William J., Hudis, Clifford A., Rapoport, Bernardo L., Roché, Henri, Maeda, Patricia, Huang, Liping, Meinhardt, Gerold, Zhang, Joshua, and Schwartzberg, Lee S.

Published
2017
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40. Health-related quality of life in patients with locally recurrent or metastatic breast cancer treated with etirinotecan pegol versus treatment of physician's choice: Results from the randomised phase III BEACON trial

Author

Twelves, Chris, Cortés, Javier, O'Shaughnessy, Joyce, Awada, Ahmad, Perez, Edith A., Im, Seock–Ah, Gómez-Pardo, Patricia, Schwartzberg, Lee S., Diéras, Véronique, Yardley, Denise A., Potter, David A., Mailliez, Audrey, Moreno-Aspitia, Alvaro, Ahn, Jin-Seok, Zhao, Carol, Hoch, Ute, Tagliaferri, Mary, Hannah, Alison L., and Rugo, Hope S.

Published
2017
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47. Improving biomarker testing in advanced non-small-cell lung cancer and metastatic colorectal cancer: experience from a large community oncology network in the USA

Author

Schwartzberg, Lee, primary, Daniel, Davey, additional, Vaena, Daniel, additional, Slater, Dennis, additional, Staszewski, Harry, additional, Fang, Bruno, additional, Seneviratne, Lasika, additional, Yu, Elaine, additional, Price, Richard, additional, Szado, Tania, additional, Meyer, Craig S, additional, Shah, Anuj, additional, and Ma, Esprit, additional

Published
2023
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48. Supplementary Figure S2 from Efficacy and Determinants of Response to HER Kinase Inhibition in HER2-Mutant Metastatic Breast Cancer

Author

Smyth, Lillian M., primary, Piha-Paul, Sarina A., primary, Won, Helen H., primary, Schram, Alison M., primary, Saura, Cristina, primary, Loi, Sherene, primary, Lu, Janice, primary, Shapiro, Geoffrey I., primary, Juric, Dejan, primary, Mayer, Ingrid A., primary, Arteaga, Carlos L., primary, de la Fuente, Macarena I., primary, Brufksy, Adam M., primary, Spanggaard, Iben, primary, Mau-Sørensen, Morten, primary, Arnedos, Monica, primary, Moreno, Victor, primary, Boni, Valentina, primary, Sohn, Joohyuk, primary, Schwartzberg, Lee S., primary, Gonzàlez-Farré, Xavier, primary, Cervantes, Andrés, primary, Bidard, François-Clement, primary, Gorelick, Alexander N., primary, Lanman, Richard B., primary, Nagy, Rebecca J., primary, Ulaner, Gary A., primary, Chandarlapaty, Sarat, primary, Jhaveri, Komal, primary, Gavrila, Elena I., primary, Zimel, Catherine, primary, Selcuklu, S. Duygu, primary, Melcer, Myra, primary, Samoila, Aliaksandra, primary, Cai, Yanyan, primary, Scaltriti, Maurizio, primary, Mann, Grace, primary, Xu, Feng, primary, Eli, Lisa D., primary, Dujka, Melanie, primary, Lalani, Alshad S., primary, Bryce, Richard, primary, Baselga, José, primary, Taylor, Barry S., primary, Solit, David B., primary, Meric-Bernstam, Funda, primary, and Hyman, David M., primary

Published
2023
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49. Data from Efficacy and Determinants of Response to HER Kinase Inhibition in HER2-Mutant Metastatic Breast Cancer

Author

Smyth, Lillian M., primary, Piha-Paul, Sarina A., primary, Won, Helen H., primary, Schram, Alison M., primary, Saura, Cristina, primary, Loi, Sherene, primary, Lu, Janice, primary, Shapiro, Geoffrey I., primary, Juric, Dejan, primary, Mayer, Ingrid A., primary, Arteaga, Carlos L., primary, de la Fuente, Macarena I., primary, Brufksy, Adam M., primary, Spanggaard, Iben, primary, Mau-Sørensen, Morten, primary, Arnedos, Monica, primary, Moreno, Victor, primary, Boni, Valentina, primary, Sohn, Joohyuk, primary, Schwartzberg, Lee S., primary, Gonzàlez-Farré, Xavier, primary, Cervantes, Andrés, primary, Bidard, François-Clement, primary, Gorelick, Alexander N., primary, Lanman, Richard B., primary, Nagy, Rebecca J., primary, Ulaner, Gary A., primary, Chandarlapaty, Sarat, primary, Jhaveri, Komal, primary, Gavrila, Elena I., primary, Zimel, Catherine, primary, Selcuklu, S. Duygu, primary, Melcer, Myra, primary, Samoila, Aliaksandra, primary, Cai, Yanyan, primary, Scaltriti, Maurizio, primary, Mann, Grace, primary, Xu, Feng, primary, Eli, Lisa D., primary, Dujka, Melanie, primary, Lalani, Alshad S., primary, Bryce, Richard, primary, Baselga, José, primary, Taylor, Barry S., primary, Solit, David B., primary, Meric-Bernstam, Funda, primary, and Hyman, David M., primary

Published
2023
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50. Supplementary Data from Efficacy and Determinants of Response to HER Kinase Inhibition in HER2-Mutant Metastatic Breast Cancer

Author

Smyth, Lillian M., primary, Piha-Paul, Sarina A., primary, Won, Helen H., primary, Schram, Alison M., primary, Saura, Cristina, primary, Loi, Sherene, primary, Lu, Janice, primary, Shapiro, Geoffrey I., primary, Juric, Dejan, primary, Mayer, Ingrid A., primary, Arteaga, Carlos L., primary, de la Fuente, Macarena I., primary, Brufksy, Adam M., primary, Spanggaard, Iben, primary, Mau-Sørensen, Morten, primary, Arnedos, Monica, primary, Moreno, Victor, primary, Boni, Valentina, primary, Sohn, Joohyuk, primary, Schwartzberg, Lee S., primary, Gonzàlez-Farré, Xavier, primary, Cervantes, Andrés, primary, Bidard, François-Clement, primary, Gorelick, Alexander N., primary, Lanman, Richard B., primary, Nagy, Rebecca J., primary, Ulaner, Gary A., primary, Chandarlapaty, Sarat, primary, Jhaveri, Komal, primary, Gavrila, Elena I., primary, Zimel, Catherine, primary, Selcuklu, S. Duygu, primary, Melcer, Myra, primary, Samoila, Aliaksandra, primary, Cai, Yanyan, primary, Scaltriti, Maurizio, primary, Mann, Grace, primary, Xu, Feng, primary, Eli, Lisa D., primary, Dujka, Melanie, primary, Lalani, Alshad S., primary, Bryce, Richard, primary, Baselga, José, primary, Taylor, Barry S., primary, Solit, David B., primary, Meric-Bernstam, Funda, primary, and Hyman, David M., primary

Published
2023
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