Publications

Selected Tolerability Consortium Publications

2023

• Culakova E, Mohile SG, Peppone L, Ramsdale E, Mohamed M, Xu H, Wells M, Tylock R, Java J, Loh KP, Magnuson A, Jamieson L, Vogel V, Duberstein PR, Chapman BP, Dale W, Flannery MA. Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer. J Clin Oncol. 2023 Feb 1; 41(4): 835-846. doi: 10.1200/JCO.22.00738. PMID: 36356279; PMCID: PMC9901996
• Calsavara VF, Diniz MA, Tighiouart M, Ganz PA, Henry NL, Hays RD, Yothers G, Rogatko A. Simulation study comparing analytical methods for single-item longitudinal patient-reported outcomes data. Qual Life Res. 2023 Mar; 32(3): 827-839. doi: 10.1007/s11136-022-03267-z. PMID: 36245019 PMCID: PMC9992042
• Mohamed MR, Mohile SG, Juba KM, Awad H, Wells M, Loh KP, Flannery M, Culakova E, Tylock RG, Ramsdale EE. Association of polypharmacy and potential drug-drug interactions with adverse treatment outcomes in older adults with advanced cancer. Cancer. 2023 Apr 1; 129(7): 1096-1104. doi: 10.1002/cncr.34642. PMID: 36692475.
• Arana-Chicas E, Culakova E, Mohamed MR, Tylock R, Wells M, Flannery M, Mustian KM, Cupertino AP, Magnuson A, Mohile SG. Older adults with advanced cancer report pain not captured by clinician-graded Common Terminology Criteria for Adverse Events (CTCAE). J Geriatr Oncol. 2023 Apr; 14(3): doi: 101480.10.1016/j.jgo.2023.101480. PMID: 36989940; PMCID: PMC10106422.
• Hays RD, Gresham G, Ganz PA, Tighiouart M. Comparison of Simple-Summated Scoring and Toxicity Index Scoring of Symptom Bother in the NSABP B-30 Clinical Trial. Applied Research Quality Life. 2023 Apr; 18:697–707. doi: 10.1007/s11482-022-10103-6
• Ramsdale E, Kunduru M, Smith L, Culakova E, Shen J, Meng S, Zand M, Anand A. Supervised learning applied to classifying fallers versus non-fallers among older adults with cancer. J Geriatr Oncol. 2023 May; 14(4): 101498. doi: 10.1016/j.jgo.2023.101498. PMC10174263.
• Basch E, Dueck AC, Mitchell SA, Mamon H, Weiser M, Saltz L, Gollub M, Rogak L, Ginos B, Mazza GL, Colgrove B, Chang G, Minasian L, Denicoff A, Thanarajasingam G, Musher B, George T, Venook A, Farma J, O'Reilly E, Meyerhardt JA, Shi Q, Schrag D. Patient-Reported Outcomes During and After Treatment for Locally Advanced Rectal Cancer in the PROSPECT Trial (Alliance N1048). J Clin Oncol. 2023 Jul 20; 41(21): 3724-3734. doi:10.1200/JCO.23.00903. PMID: 37270691; PMCID: PMC10351948.
• Lee MK, Basch E, Mitchell SA, Minasian LM, Langlais BT, Thanarajasingam G, Ginos BF, Rogak LJ, Mendoza TR, Bennett AV, Schrag D, Mazza GL, Dueck AC. Reliability and validity of PRO-CTCAE(R) daily reporting with a 24-hour recall period. Qual Life Res. 2023 Jul; 32(7): 2047-2058. doi: 10.1007/s11136-023-03374-5. PMID: 36897529; PMCID: PMC10241696.
• O'Connell NS, Zhao F, Lee JW, Ip EH, Peipert JD, Graham N, Smith ML, Gareen IF, Carlos RC, Obeng-Gyasi S, Sparano JA, Shanafelt TD, Thomas ML, Cella D, Wagner LI, Gray R. Importance of Low- and Moderate-Grade Adverse Events in Patients' Treatment Experience and Treatment Discontinuation: An Analysis of the E1912 Trial. J Clin Oncol. 2023 Oct 6: JCO2300377. doi: 10.1200/JCO.23.00377. PMID: 37801678.
• Calsavara VF, Henry NL, Hays RD, Kim S, Luu M, Diniz MA, Gresham G, Cecchini RS, Yothers G, Ganz PA, Rogatko A, Tighiouart M. Dynamic Risk Prediction of Treatment Discontinuation Using Patient-Reported Outcomes Data in the Phase III NSABP B-35 Trial. Cancer Prev Res (Phila). 2023 Nov 1; 16(11): 631-639. doi: 10.1158/1940-6207.CAPR-23-0216. PMID: 37756580; PMCID: PMC10618646.

2022

• Henry NL, Rogatko A, Ganz PA. Evaluating the Association of Adverse Events and Patient-Reported Symptoms to Endocrine Therapy Tolerability. J Clin Oncol. 2022 Feb 1; 40(4): 430-431. doi: 10.1200/JCO.21.02387. PMID: 34882498; PMCID:PMC8797605.
• Langlais B, Mazza GL, Thanarajasingam G, Rogak LJ, Ginos B, Heon N, Scher HI, Schwab G, Ganz PA, Basch E, Dueck AC. Evaluating Treatment Tolerability Using the Toxicity Index With Patient-Reported Outcomes Data. J Pain Symptom Manage. 2022 Feb; 63(2): 311-320. doi: 10.1016/j.jpainsymman.2021.07.031. PMID: 34371138; PMCID: PMC8816875.
• Xu H, Mohamed M, Flannery M, Peppone L, Ramsdale E, Loh KP, Wells M, Jamieson L, Vogel VG, Hall BA, Mustian K, Mohile S, Culakova E. An Unsupervised Machine Learning Approach to Evaluating the Association of Symptom Clusters With Adverse Outcomes Among Older Adults With Advanced Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Mar 1; 6(3): e234198. doi: 10.1001/jamanetworkopen.2023.4198. PMID: 36947036; PMCID: PMC10034574.
• Presley CJ, Mohamed MR, Culakova E, Flannery M, Vibhakar PH, Hoyd R, Amini A, VanderWalde N, Wong ML, Tsubata Y, Spakowicz DJ, Mohile SG. A Geriatric Assessment Intervention to Reduce Treatment Toxicity Among Older Adults With Advanced Lung Cancer: A Subgroup Analysis From a Cluster Randomized Controlled Trial. Front Oncol. 2022 March; 12: 835582. doi: 10.3389/fonc.2022.835582. PMID: 35433441; PMCID: PMC9008713.
• Razaee ZS, Cook-Wiens G, Tighiouart M. A nonparametric Bayesian method for dose finding in drug combinations cancer trials. Stat Med. 2022 Mar 15; 41(6): 1059-1080. doi: 10.1002/sim.9316. PMID: 35075652; PMCID: PMC8881404.
• Obeng-Gyasi S, Graham N, Kumar S, Lee JW, Jacobus S, Weiss M, Cella D, Zhao F, Ip EH, O'Connell N, Hong F, Peipert DJ, Gareen IF, Timsina LR, Gray R, Wagner LI, Carlos RC. Examining allostatic load, neighborhood socioeconomic status, symptom burden and mortality in multiple myeloma patients. Blood Cancer J. 2022 Apr 1; 12(4): 53. doi: 10.1038/s41408-022-00648-y. PMID: 35365604; PMCID: PMC8975964.
• Mazza GL, Petersen MM, Ginos B, Langlais BT, Heon N, Gounder MM, Mahoney MR, Zoroufy AJ, Schwartz GK, Rogak LJ, Thanarajasingam G. Missing data strategies for the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Alliance A091105 and COMET-2. Qual Life Res. 2022 Apr;31(4):1069-80. PMID: 34420143; PMCID: PMC8859007
• Peipert JD, Smith ML, Team ES. Reconsidering tolerability of cancer treatments: opportunities to focus on the patient. Support Care Cancer. 2022 May; 30(5): 3661-3663. doi: 10.1007/s00520-021-06700-0. PMID: 35013779; PMCID: PMC9276550.
• Thanarajasingam G, Minasian LM, Bhatnagar V, Cavalli F, De Claro RA, Dueck AC, El-Galaly TC, Everest N, Geissler J, Gisselbrecht C, Gormley N, Gribben J, Horowitz M, Ivy SP, Jacobson CA, Keating A, Kluetz PG, Kwong YL, Little RF, Matasar MJ, Mateos MV, McCullough K, Miller RS, Mohty M, Moreau P, Morton LM, Nagai S, Nair A, Nastoupil L, Robertson K, Sidana S, Smedby KE, Sonneveld P, Tzogani K, van Leeuwen FE, Velikova G, Villa D, Wingard JR, Seymour JF, Habermann TM. Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies. Lancet Haematol. 2022 May; 9(5): e374-e384. doi: 10.1016/S2352-3026(22)00045-X. PMID: 35483398; PMCID: PMC9241484.
• Basch E, Thanarajasingam G, Dueck AC. Methodological standards for using the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) in cancer clinical trials. Clin Trials. 2022 Jun; 19(3): 274-276. doi: 10.1177/17407745221093922. PMID: 35575014
• Otto E, Culakova E, Meng S, Zhang Z, Xu H, Mohile S, Flannery MA. Overview of Sankey flow diagrams: Focusing on symptom trajectories in older adults with advanced cancer. J Geriatr Oncol. 2022 Jun; 13(5): 742-746. doi: 10.1016/j.jgo.2021.12.017. PMID: 35000890; PMCID: PMC9232856.
• Ramsdale E, Mohamed M, Yu V, Otto E, Juba K, Awad H, Moorthi K, Plumb S, Patil A, Vogelzang N, Dib E, Mohile S. Polypharmacy, Potentially Inappropriate Medications, and Drug-Drug Interactions in Vulnerable Older Adults With Advanced Cancer Initiating Cancer Treatment. Oncologist. 2022 Jul 5; 27(7): e580-e588. doi: 10.1093/oncolo/oyac053. PMID: 35348764; PMCID: PMC9255971.
• Thanarajasingam G, Basch E, Mead-Harvey C, Bennett AV, Mazza GL, Schwab G, Roydhouse J, Rogak LJ, Dueck AC. An Exploratory Analysis of the "Was It Worth It?" Questionnaire as a Novel Metric to Capture Patient Perceptions of Cancer Treatment. Value Health. 2022 Jul; 25(7): 1081-1086. doi: 10.1016/j.jval.2021.11.1368. PMID: 35779938; PMCID: PMC9250647.
• Ganz PA, Hays RD, Spritzer KL, Rogatko A, Ko CY, Colangelo LH, Arora A, Hopkins JO, Evans TL, Yothers G. Health-related quality of life outcomes after neoadjuvant chemoradiotherapy for rectal cancer in NRG Oncology/NSABP R-04. Cancer. 2022 Sep 1; 128(17): 3233-3242. doi: 10.1002/cncr.34341. PMID: 35749631; PMCID: PMC9540677.
• Gong J, Thomassian S, Kim S, Gresham G, Moshayedi N, Ye JY, Yang JC, Jacobs JP, Lo S, Nissen N, Gaddam S, Tighiouart M, Osipov A, Hendifar A. Phase I trial of Bermekimab with nanoliposomal irinotecan and 5-fluorouracil/folinic acid in advanced pancreatic ductal adenocarcinoma. Sci Rep. 2022 Sep 2; 12(1): 15013. doi: 10.1038/s41598-022-19401-3. PMID: 36056179; PMCID: PMC9440135.
• Henry NL, Kim S, Hays RD, Diniz MA, Tighiouart M, Gresham G, Luu M, Cecchini RS, Yothers G, Rogatko A, Ganz PA. Toxicity Index, patient-reported outcomes, and persistence of breast cancer chemotherapy-associated side effects in NRG Oncology/NSABP B-30. NPJ Breast Cancer. 2022 Nov 19; 8(1): 123. doi: 10.1038/s41523-022-00489-9. PMID: 36402796; PMCID: PMC9675799.
• Peipert JD, Shaunfield S, Kaiser K, Moreno PI, Fox RS, Kircher S, Mohindra N, Ip E, Zhao F, Wagner L, Cella D. How do patients interpret and respond to a single-item global indicator of cancer treatment tolerability? Support Care Cancer. 2022 Dec 16; 31(1): 37. doi: 10.1007/s00520-022-07484-7. PMID: 36525100; PMCID: PMC10356672.

2021

• Mohamed MR, Ramsdale E, Loh KP, Xu H, Patil A, Gilmore N, Obrecht S, Wells M, Nightingale G, Juba KM, Faller B, Onitilo A, Bradley T, Culakova E, Holmes H, Mohile SG. Association of Polypharmacy and Potentially Inappropriate Medications With Physical Functional Impairments in Older Adults With Cancer. J Natl Compr Canc Netw. 2021 Jan 22; 19(3): 267-274. doi: 10.6004/jnccn.2020.7628. PMID: 33482631; PMCID: PMC8295406.
• Basch E, Becker C, Rogak LJ, Schrag D, Reeve BB, Spears P, Smith ML, Gounder MM, Mahoney MR, Schwartz GK, Bennett AV, Mendoza TR, Cleeland CS, Sloan JA, Bruner DW, Schwab G, Atkinson TM, Thanarajasingam G, Bertagnolli MM, Dueck AC. Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Clin Trials. 2021 Feb;18(1):104-114. doi: 10.1177/1740774520975120. Epub 2020 Dec 1. PMID: 33258687; PMCID: PMC7878323.
• Gresham G, Mazza GL, Langlais B, King-Kallimanis B, Rogak LR, Patient Tolerability Consortia Standardization Working Group. Graphical Representations of Patient Tolerability Data: Recommendations from the National Cancer Institute (NCI) Cancer Moonshot Standardization Working Group. J Clin Oncol 39, no. 15_suppl, May 28 2021
• Hays R, Ganz PA, Spritzer KL, Rogatko A. Applying the Toxicity Index t Patient-Reported Symptom Data: An example using the European Organization for Research and Treatment of Cancer Colorectal Cancer-Specific Quality of Life Questionnaire. Clin Ther. 2021 Jun 25; 43(7):1245-1252. doi: 10.1016/j.clinthera.2021.05.011. PMID: 34183169.
• Flannery MA, Culakova E, Canin BE, Peppone L, Ramsdale E, Mohile SG. Understanding Treatment Tolerability in Older Adults With Cancer. J Clin Oncol. 2021 Jul 1; 39(19): 2150-2163. doi: 10.1200/JCO.21.00195. PMID: 34043433; PMCID: PMC8238902.
• Diniz MA, Gresham G, Kim S, Luu M, Henry NL, Tighiouart M, Yothers G, Ganz PA, Rogatko A. Visualizing adverse events in clinical trials using correspondence analysis with R-package visae. BMC Med Res Methodol. 2021 Nov 9;21(1):244. doi: 10.1186/s12874-021-01368-w. PMID: 34753452; PMCID: PMC8579548.
• Mohile SG, Mohamed MR, Xu H, Culakova E, Loh KP, Magnuson A, Flannery MA, Obrecht S, Gilmore N, Ramsdale E, Dunne RF, Wildes T, Plumb S, Patil A, Wells M, Lowenstein L, Janelsins M, Mustian K, Hopkins JO, Berenberg J, Anthony N, Dale W. Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): a cluster-randomised study. Lancet. 2021 Nov 20; 398(10314): 1894-1904. doi: 10.1016/S0140-6736(21)01789-X. PMID: 34741815; PMCID: PMC8647163.
• Mohamed MR, Kyi K, Mohile SG, Xu H, Culakova E, Loh KP, Flannery M, Obrecht S, Ramsdale E, Patil A, Dunne RF, DiGiovanni G, Hezel A, Burnette B, Desai N, Giguere J, Magnuson A. Prevalence of and factors associated with treatment modification at first cycle in older adults with advanced cancer receiving palliative treatment. J Geriatr Oncol. 2021 Nov; 12(8): 1208-1213. doi: 10.1016/j.jgo.2021.06.007. PMID: 34272204; PMCID: PMC8557119.
• Ramsdale E, Snyder E, Culakova E, Xu H, Dziorny A, Yang S, Zand M, Anand A. An introduction to machine learning for clinicians: How can machine learning augment knowledge in geriatric oncology? J Geriatr Oncol. 2021 Nov; 12(8): 1159-1163. doi: 10.1016/j.jgo.2021.03.012. PMID: 33795205; PMCID: PMC8478967.
• Henry NL, Kim S, Hays RD, Diniz MA, Luu M, Cecchini RS, Yothers G, Rogatko A, Ganz PA. Toxicity Index, Patient-Reported Outcomes, and Early Discontinuation of Endocrine Therapy for Breast Cancer Risk Reduction in NRG Oncology/NSABP B-35. J Clin Oncol. 2021 Dec 1; 39(34): 3800-3812. doi: 10.1200/JCO.21.00910. PMID: 34554865; PMCID: PMC8629339.
• Ip EH, Saldana S, Miller KD, Carlos RC, Gareen IF, Sparano JA, Graham N, Zhao F, Lee JW, O'Connell NS, Cella D, Peipert JD, Gray RJ, Wagner LI. Tolerability of bevacizumab and chemotherapy in a phase 3 clinical trial with human epidermal growth factor receptor 2-negative breast cancer: A trajectory analysis of adverse events. Cancer. 2021 Dec 15; 127(24): 4546-4556. doi: 10.1002/cncr.33992. PMID: 34726788; PMCID: PMC8887554.
• Diniz M, Luu M. visae: Visualization of Adverse Events. R package version 0.1.0. https://cran.r-project.org/web/packages/visae/index.html. 2021.
• Langlais B, Dueck A. ProAE: Tools for PRO-CTCAE scoring, analysis, and graphical display. R package version 0.2.0. https://cran.r-project.org/web/packages/ProAE/index.html. 2021.

2020

• Dueck AC, Scher HI, Bennett AV, Mazza GL, Thanarajasingam G, Schwab G, Weitzman AL, Rogak LJ, Basch E. Assessment of Adverse Events From the Patient Perspective in a Phase 3 Metastatic Castration-Resistant Prostate Cancer Clinical Trial. JAMA Oncol. 2020 Feb 1;6(2):e193332. doi: 10.1001/jamaoncol.2019.3332. Epub 2020 Feb 13. PMID: 31556911; PMCID: PMC6764147.
• Atkinson TM, Dueck AC, Satele DV, Thanarajasingam G, Lafky JM, Sloan JA, Basch E. Clinician vs Patient Reporting of Baseline and Postbaseline Symptoms for Adverse Event Assessment in Cancer Clinical Trials. JAMA Oncol. 2020 Mar 1; 6(3): 437-439. doi: 10.1001/jamaoncol.2019.5566. PMID: 31876902; PMCID: PMC6990818.
• Cella D. In our patient-centered era, it is time we gave patient-reported outcomes their due. Cancer. 2020 Jun 1; 126(11): 2592-2593. doi: 10.1002/cncr.32763. PMID: 32237234; PMCID: PMC7220818.
• Thanarajasingam G, Leonard JP, Witzig TE, Habermann TM, Blum KA, Bartlett NL, Flowers CR, Pitcher BN, Jung SH, Atherton PJ, Tan A, Novotny PJ, Dueck AC. Longitudinal Toxicity over Time (ToxT) analysis to evaluate tolerability: a case study of lenalidomide in the CALGB 50401 (Alliance) trial. Lancet Haematol. 2020 Jun;7(6):e490-e497. doi: 10.1016/S2352-3026(20)30067-3. PMID: 32470440; PMCID: PMC7457391.
• Diniz M, Kim S, Tighiouart M. A Bayesian Adaptive Design in Cancer Phase I Trials Using Dose Combinations with Ordinal Toxicity Grades. Stats. 2020 Jul 17;3(3): 221-238. doi:10.3390/stats3030017. PMID: 3307319; PMCID: PMC7561046.
• Gresham G, Diniz MA, Razaee ZS, Luu M, Kim S, Hays RD, Piantadosi S, Tighiouart M, Yothers G, Ganz PA, Rogatko A. Evaluating Treatment Tolerability in Cancer Clinical Trials Using the Toxicity Index. J Natl Cancer Inst. 2020 Dec 14;112(12):1266-1274. doi: 10.1093/jnci/djaa028. PMID: 32091598; PMCID: PMC7735773.
• Razaee ZS, Amini AA, Diniz MA, Tighiouart M, Yothers G, Rogatko A. On the properties of the toxicity index and its statistical efficiency. Stat Med. 2021 Mar 15;40(6):1535-1552. doi: 10.1002/sim.8858. Epub 2020 Dec 20. PMID: 33345351; PMCID: PMC7953898.

2019

• Diniz MA, Tighiouart M, Rogatko A. Comparison between continuous and discrete doses for model based designs in cancer dose finding. PLoS One. 2019 14(1): e0210139. doi: 10.1371/journal.pone.0210139. PMID: 30625194; PMCID: PMC6326565.

2018 and earlier

• Basch E, Rogak LJ, Dueck AC. Methods for Implementing and Reporting Patient-reported Outcome (PRO) Measures of Symptomatic Adverse Events in Cancer Clinical Trials. Clin Ther. 2016 Apr;38(4):821-30. doi: 10.1016/j.clinthera.2016.03.011. Epub 2016 Apr 2. PMID: 27045992; PMCID: PMC4851916.
• Le-Rademacher JG, Hillman S, Storrick E, Mahoney MR, Thall PF, Jatoi A, Mandrekar SJ. Adverse Event Burden Score-A Versatile Summary Measure for Cancer Clinical Trials. Cancers (Basel). 2020 Nov 4;12(11):3251. doi: 10.3390/cancers12113251. PMID: 33158080; PMCID: PMC7694214.
• Thanarajasingam G, Atherton PJ, Novotny PJ, Loprinzi CL, Sloan JA, Grothey A. Longitudinal adverse event assessment in oncology clinical trials: the Toxicity over Time (ToxT) analysis of Alliance trials NCCTG N9741 and 979254. Lancet Oncol. 2016 May;17(5):663-70. doi: 10.1016/S1470-2045(16)00038-3. Epub 2016 Apr 12. PMID: 27083333; PMCID: PMC4910515.
• Rogatko A, Babb JS, Wang H, Slifker MJ, Hudes GR. Patient characteristics compete with dose as predictors of acute treatment toxicity in early phase clinical trials. Clin Cancer Res. 2004 Jul 15;10(14):4645-51. doi: 10.1158/1078-0432.CCR-03-0535. PMID: 15269136.