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Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer.
Chang E, Hahn NM, Lerner SP, Fallah J, Agrawal S, Kamat AM, Bhatnagar V, Svatek RS, Jaigirdar AA, Bross P, Shore N, Kates M, Sachse K, Brewer JR, O'Donnell MA, Steinberg GD, Viviano CJ, Bloomquist E, Ribal MJ, Galsky MD, Oliver R, Black PC, Al-Ahmadie H, Brothers K, Pohar K, Dinney CP, Feng Z, Downs TM, Porten SP, Smith AB, Bangs R, Psutka SP, Agarwal N, Amiri-Kordestani L, Suzman DL, Pazdur R, Kluetz PG, Weinstock C. Chang E, et al. Among authors: bloomquist e. Bladder Cancer. 2023 Sep 25;9(3):271-286. doi: 10.3233/BLC-230056. eCollection 2023. Bladder Cancer. 2023. PMID: 38993184 Free PMC article.
Regulatory Considerations for Contribution of Effect of Drugs Used in Combination Regimens: Renal Cell Cancer Case Studies.
Brewer JR, Chang E, Agrawal S, Singh H, Suzman DL, Xu J, Weinstock C, Fernandes LL, Cheng J, Zhang L, Xie D, Goldberg KB, Bloomquist EW, Tang S, Sridhara R, Theoret MR, Pazdur R, Ibrahim A, Beaver JA. Brewer JR, et al. Among authors: bloomquist ew. Clin Cancer Res. 2020 Dec 15;26(24):6406-6411. doi: 10.1158/1078-0432.CCR-19-4229. Epub 2020 Jul 30. Clin Cancer Res. 2020. PMID: 32732222
A U.S. Food and Drug Administration-pooled Analysis of Frontline Combination Treatment Survival Benefits by Risk Groups in Metastatic Renal Cell Carcinoma.
Lee D, Gittleman H, Weinstock C, Suzman D, Bloomquist E, Agrawal S, Brave M, Brewer J, Fallah J, Singh H, Tang S, Ibrahim A, Pazdur R, Beaver JA, Amiri-Kordestani L. Lee D, et al. Among authors: bloomquist e. Eur Urol. 2023 Oct;84(4):373-378. doi: 10.1016/j.eururo.2023.05.030. Epub 2023 Jun 2. Eur Urol. 2023. PMID: 37271635
FDA Approval Summary: Ribociclib Indicated for Male Patients with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer.
Gao JJ, Osgood CL, Feng Z, Bloomquist EW, Tang S, Chang CJG, Ricks TK, Hou SC, Pierce WF, Rivera DR, Pazdur R, Kluetz PG, Amiri-Kordestani L. Gao JJ, et al. Among authors: bloomquist ew. Clin Cancer Res. 2023 Dec 15;29(24):5008-5011. doi: 10.1158/1078-0432.CCR-23-1133. Clin Cancer Res. 2023. PMID: 37594723 Free PMC article.
FDA Approval Summary: Olaparib in Combination With Abiraterone for Treatment of Patients With BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer.
Fallah J, Xu J, Weinstock C, Brave MH, Bloomquist E, Fiero MH, Schaefer T, Pathak A, Abukhdeir A, Bhatnagar V, Chiu HJ, Ricks T, John C, Hamed S, Lee C, Pierce WF, Kalavar S, Philip R, Tang S, Amiri-Kordestani L, Pazdur R, Kluetz PG, Suzman D. Fallah J, et al. Among authors: bloomquist e. J Clin Oncol. 2024 Feb 10;42(5):605-613. doi: 10.1200/JCO.23.01868. Epub 2023 Dec 21. J Clin Oncol. 2024. PMID: 38127780 Clinical Trial.
FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma.
Maguire WF, Lee D, Weinstock C, Gao X, Bulik CC, Agrawal S, Chang E, Hamed SS, Bloomquist EW, Tang S, Pazdur R, Kluetz PG, Amiri-Kordestani L, Suzman DL. Maguire WF, et al. Among authors: bloomquist ew. Clin Cancer Res. 2024 May 15;30(10):2011-2016. doi: 10.1158/1078-0432.CCR-23-3738. Clin Cancer Res. 2024. PMID: 38441576
US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments.
Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. Wedam SB, et al. Among authors: bloomquist e. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9. J Clin Oncol. 2018. PMID: 29522361 Free PMC article.
US Food and Drug Administration Approval Summary: Talazoparib in Combination With Enzalutamide for Treatment of Patients With Homologous Recombination Repair Gene-Mutated Metastatic Castration-Resistant Prostate Cancer.
Heiss BL, Chang E, Gao X, Truong T, Brave MH, Bloomquist E, Shah A, Hamed S, Kraft J, Chiu HJ, Ricks TK, Tilley A, Pierce WF, Tang L, Abukhdeir A, Kalavar S, Philip R, Tang S, Pazdur R, Amiri-Kordestani L, Kluetz PG, Suzman DL. Heiss BL, et al. Among authors: bloomquist e. J Clin Oncol. 2024 May 20;42(15):1851-1860. doi: 10.1200/JCO.23.02182. Epub 2024 Mar 7. J Clin Oncol. 2024. PMID: 38452327 Clinical Trial.
U.S. Food and Drug Administration Approval Summary: Ramucirumab for the Treatment of Metastatic Non-Small Cell Lung Cancer Following Disease Progression On or After Platinum-Based Chemotherapy.
Larkins E, Scepura B, Blumenthal GM, Bloomquist E, Tang S, Biable M, Kluetz P, Keegan P, Pazdur R. Larkins E, et al. Among authors: bloomquist e. Oncologist. 2015 Nov;20(11):1320-5. doi: 10.1634/theoncologist.2015-0221. Epub 2015 Oct 7. Oncologist. 2015. PMID: 26446239 Free PMC article. Clinical Trial.
Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples.
Amatya AK, Fiero MH, Bloomquist EW, Sinha AK, Lemery SJ, Singh H, Ibrahim A, Donoghue M, Fashoyin-Aje LA, de Claro RA, Gormley NJ, Amiri-Kordestani L, Sridhara R, Theoret MR, Kluetz PG, Pazdur R, Beaver JA, Tang S. Amatya AK, et al. Clin Cancer Res. 2021 Nov 1;27(21):5753-5756. doi: 10.1158/1078-0432.CCR-20-4912. Epub 2021 Jun 11. Clin Cancer Res. 2021. PMID: 34117032 Free PMC article. Review.
91 results