Slota C, Norcross L, Comerford E, Sasane M, Zheng Y, Gnanasakthy A. Critical comments by Food and Drug Administration Reviewers on patient-reported outcomes in Food and Drug Administration Regulatory Submissions (2018-2021) [Editor's Choice]. Value Health. 2024 Jun;27(6):755-66. doi: 10.1016/j.jval.2024.02.011
Comerford E, Norcross L, Sasane M, Zheng Y, Gnanasakthy A. Patient-reported outcome (PRO) data in oncology NDAs approved by the FDA (2018–2021): a review of criticism and concerns in comments from regulators. Poster presented at the National Comprehensive Cancer Network (NCCN) 2024 Annual Conference; April 5, 2024. Orlando, FL. [abstract] J Natl Compr Canc Netw. 2024 Apr 5; 22(2.5). doi: 10.6004/jnccn.2023.7146
Sherif B, Burke M, Besse B, Solomon B, Bazhenova L, Kim DW, Lin JJ, Wolf J, Popat S, Goto K, de Langen AJ, Springfeld C, Reynolds M, Odom D, Yuan Y, Lee A, Blum SI, Thamake S, Ades F, Drilon A. Health-related quality-of-life of patients treated with repotrectinib for neurotrophic tyrosine receptor kinase (NTRK)-positive advanced solid tumors: results From TRIDENT-1. Poster presented at the ISPOR Europe 2023; November 14, 2023. Copenhagen, Denmark. [abstract] Value Health. 2023 Dec; 26(12 Supplement):S484. doi: 10.1016/j.jval.2023.09.2619
Bergerot C, Young Rha S, Pal S, Koralewski P, Stroyakovskiy D, Alekseev B, Parnis F, Castellano D, Lyun Lee J, Sunela K, Ciuleanu T, Heng D, Glen H, Wang J, Bennett L, Pan J, O'Hara K, Puente J. Health-related quality of life outcomes with two different starting doses of lenvatinib in combination with everolimus for previously treated renal cell carcinoma. Oncologist. 2023 Jan 18;28(1):59-71. doi: 10.1093/oncolo/oyac142
Motzer R, Porta C, Alekseev B, Rha SY, Choueiri TK, Mendez-Vidal MJ, Hong SH, Kapoor A, Goh JC, Eto M, Bennett L, Wang J, Pan JJ, Saretsky TL, Perini RF, He CS, Mody K, Cella D. Health-related quality-of-life outcomes in patients with advanced renal cell carcinoma treated with lenvatinib plus pembrolizumab or everolimus versus sunitinib (CLEAR): a randomised, phase 3 study. Lancet Oncol. 2022 Jun;23(6):768-80. doi: 10.1016/S1470-2045(22)00212-1
Kummar S, Berlin J, Mascarenhas L, van Tilburg CM, Geoerger B, Lassen UN, Schilder RJ, Turpin B, Nanda S, Keating K, Childs BH, Chirila C, Laetsch TW, Hyman DM, Drilon A, Hong DS. Quality of life in adult and pediatric patients with tropomyosin receptor kinase fusion cancer receiving larotrectinib. Curr Probl Cancer. 2021 Dec;45(6):100734. doi: 10.1016/j.currproblcancer.2021.100734
Xiao H, Blum S, Davenport E, Wang J, Hunter S, Li M, Kondo K. Health care resource utilization of patients with advanced gastric cancer/gastroesophageal junction cancer or esophageal adenocarcinoma: results of nivolumab plus chemotherapy versus chemotherapy from CheckMate 649. Poster presented at the AMCP Nexus 2021; October 18, 2021. [abstract] J Manag Care Pharm. 2021 Oct; 27(10-a):S19.
Elimova E, Wyrwicz L, Blum SI, Xiao H, Li M, Kondo K, Davenport E, Wang J, Hunter S, Moehler MH. Health-related quality of life (HRQOL) in patients (pts) with advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC) or esophageal adenocarcinoma (EAC): results of nivolumab plus chemotherapy (NIVO+chemo) versus chemo from CheckMate 649. Poster presented at the 2021 ASCO Quality Care Symposium; September 24, 2021.
Smith MR, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Le Berre MA, Mohamed AF, Odom D, Bartsch J, Snapir A, Sarapohja T, Fizazi K. Darolutamide and health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the phase III ARAMIS trial. Eur J Cancer. 2021 Jul 14;154:138-46.
Hofheinz RD, Bruix J, Demetri GD, Grothey A, Marian M, Bartsch J, Odom D. Effect of regorafenib in delaying definitive deterioration in health-related quality of life in patients with advanced cancer of three different tumor types. Cancer Manag Res. 2021 Jul 12;13:5523-33. doi: 10.2147/CMAR.S305939
Ciruelos EM, Rugo HS, Mayer IA, Levy C, Forget F, Delgado Mingorance JI, Safra T, Masuda N, Park YH, Juric D, Conte P, Campone M, Loibl S, Iwata H, Zhou X, Park J, Ridolfi A, Lorenzo I, Andre F. Patient-reported outcomes in patients with PIK3CA-mutated hormone receptor-positive, human epidermal growth factor receptor 2–negative advanced breast cancer from SOLAR-1. J Clin Oncol. 2021 Jun 20;39(18):2005-15. doi: 10.1200/JCO.20.01139
Wyrwicz L, Elimova E, Blum SI, Xiao H, Davenport E, Wang J, Hunter S, Li M, Kondo K, Mohler M. Health-related quality of life (HRQOL) in patients (pts) with advanced gastric cancer/gastroesophageal junction cancer (GC/GEJC) or esophageal adenocarcinoma (EAC): interim results of nivolumab plus chemotherapy (N+C) versus (C) from CheckMate 649. Poster presented at the 2021 ASCO Conference; June 4, 2021. [abstract] J Clin Oncol. 2021; 39(Suppl 15):4066. doi: 10.1200/JCO.2021.39.15_suppl.4066
Hofheinz R, Marian M, Bartsch J, Odom D. Effect of regorafenib in delaying definitive deterioration in health-related quality of life across three tumor types. Poster presented at the 2019 ESMO World Congress on Gastrointestinal Cancer Conference; July 2019. Barcelona, Spain.
Khan S, Zimovetz E, Healey P, Copley-Merriman K. Biologics in ulcerative colitis (UC): treatment guidelines, health technology assessments (HTA). Poster presented at the 2015 ISPOR 18th Annual European Congress; November 2015. Milan, Italy. [abstract] Value Health. 2015 Nov; 18(7):A633.
Zhou X, Wang J, Zhang J, Copley-Merriman C, Torigoe Y, Reyes C, Seymour JF, Offner FC, Trneny M, Salles GA. Symptoms and toxicity of rituximab maintenance relative to observation following immunochemotherapy in patients with follicular lymphoma. Hematology. 2015 Apr;129(36). doi: 10.1179/1607845414Y.0000000179
Nabhan C, Byrtek M, Dawson KL, Zhou X, Ziemiecki RM, Zelenetz AD, Friedberg JW, Cerhan JR, Flowers CR. Differences in disease characteristics, treatment patterns, and outcomes between men (M) and women (W) with follicular lymphoma (FL): prospective evaluation of 2650 US patients (pts). Poster presented at the ASCO; May 2014.
Martin P, Byrtek M, Dawson K, Ziemiecki RM, Friedberg JW, Cerhan JR, Flowers CR, Link BK. Patterns of delivery of chemoimmunotherapy to patients with follicular lymphoma in the United States: results of the National Lymphocare Study. Cancer. 2013 Dec 1;119(23):4129-36. doi: 10.1002/cncr.28350
Yardley DA, Hortobagyi GN, Lebrun F, Beck JT, Neven P, Baselga J, Ziemiecki RM. Patient-reported physical, emotional, and social functioning in advanced breast cancer: insights from BOLERO-2. Poster presented at the Breast Cancer Symposium; September 7, 2013. San Francisco, United States. Previously presented at the American Society of Clinical Oncology.
Harrison CN, Mesa RA, Kiladjian J-J, Al-Ali H-K, Gisslinger H, Knoops L, Squier M, Sirulnik A, Mendelson E, Zhou X, Copley-Merriman C, Hunter DS, Levy RS, Cervantes F, Passamonti F, Barbui T, Barosi G, Vannucchi AM. Health-related quality of life and symptoms in patients with myelofibrosis treated with ruxolitinib versus best available therapy. Br J Haematol. 2013 Jul;162(2):229-39. doi: 10.1111/bjh.12375
Yardley DA, Hortobagyi GN, Lebrun F, Beck JT, Neven P, Baselga J, Ziemiecki RM. Patient-reported physical, emotional, and social functioning in advanced breast cancer: insights from BOLERO-2. Poster presented at the American Society of Clinical Oncology; June 2013.
Nooka AK, Nabhan C, Zhou X, Taylor MD, Byrtek M, Miller TP, Friedberg JW, Zelenetz AD, Link BK, Cerhan JR, Sinha R, Shenoy PJ, Levy D, Dawson K, Hirata JH, Flowers CR. Examination of the follicular lymphoma international prognostic index (FLIPI) in the National LymphoCare study (NLCS): a prospective US patient cohort treated predominantly in community practices. Ann Oncol. 2013 Feb 1;24(2):441-8.
Nastaoupil LJ, Sinha R, Byrtek M, Zhou X, Taylor M, Friedberg J, Link B, Cerhan J, Dawson K, Flowers C. Characteristics and effectiveness of rituximab (R) maintenance regimens among US patients diagnosed with follicular lymphoma (FL) 2004-2007. Poster presented at the 17th Congress of the European Hematology Association; June 14, 2012. Amsterdam, The Netherlands. [abstract] Haematologica. 2012 Jul 16; 97(s1):95-6. Previously presented at the 53rd Annual Meeting of the American Society of Hematology.
Bennett L, Zhao Z, Barber B, Zhou X, Peeters M, Zhang J, Xu F, Wiezorek J, Douillard JY. Health-related quality of life in patients with metastatic colorectal cancer treated with panitumumab in first- or second-line treatment. Br J Cancer. 2011 Nov 1;105(10):1495-502.
Schmidt RA, Ackerman SJ, Newstead GM, Quam JP, Mordin MM, Anastassopoulos K, Nishikawa RM. Comparative feature analysis of computed radiography for mammography (CRM) soft copy display vs. crm hard copy film: an observer performance study. Poster presented at the 90th Scientific Assembly and Annual Meeting of the Radiology Society of North America; November 2004.
Quam JP, Ackerman SJ, Mordin MM, Bassett LW. Conspicuity and characterization of findings on computed radiography for mammography vs. screen-film mammography: results from a prospective clinical trial. Poster presented at the 89th Scientific Assembly and Annual Meeting of the Radiology Society of North America; November 2003.
Trump DL, Wilding G, Miller K, Small E, Soulie P, Trachtenberg J, Raabe N, Heyes AE, Das-Gupta A. Pilot trials of ZD1839 ('Iressa'), an orally active, selective epidermal growth factor receptor tyrosine kinase inhibitor, in combination with mitoxantrone/prednisolone or docetaxel/estramustine in patients with hormone-refractory prostate cancer. Presented at the American Urology Association; April 2003. Chicago, IL.