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Advancing Drug Development in Gynecologic Malignancies.

Beaver JA, Coleman RL, Arend RC, Armstrong DK, Bala S, Mills GB, Sood AK, Herzog TJ.

Clin Cancer Res. 2019 May 24. pii: clincanres.0619.2019. doi: 10.1158/1078-0432.CCR-19-0619. [Epub ahead of print]


Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody.

Maher VE, Fernandes LL, Weinstock C, Tang S, Agarwal S, Brave M, Ning YM, Singh H, Suzman D, Xu J, Goldberg KB, Sridhara R, Ibrahim A, Theoret M, Beaver JA, Pazdur R.

J Clin Oncol. 2019 May 22:JCO1900318. doi: 10.1200/JCO.19.00318. [Epub ahead of print]


Patient-Friendly Language to Facilitate Treatment Choice for Patients with Cancer.

Kim J, Gao J, Amiri-Kordestani L, Beaver JA, Kluetz P.

Oncologist. 2019 May 16. pii: theoncologist.2018-0761. doi: 10.1634/theoncologist.2018-0761. [Epub ahead of print] No abstract available.


Residual Disease after Neoadjuvant Therapy - Developing Drugs for High-Risk Early Breast Cancer.

Prowell TM, Beaver JA, Pazdur R.

N Engl J Med. 2019 Feb 14;380(7):612-615. doi: 10.1056/NEJMp1900079. No abstract available.


FDA Approval Summary: Pertuzumab for Adjuvant Treatment of HER2-Positive Early Breast Cancer.

Howie LJ, Scher NS, Amiri-Kordestani L, Zhang L, King-Kallimanis BL, Choudhry Y, Schroeder J, Goldberg KB, Kluetz PG, Ibrahim A, Sridhara R, Blumenthal GM, Pazdur R, Beaver JA.

Clin Cancer Res. 2019 May 15;25(10):2949-2955. doi: 10.1158/1078-0432.CCR-18-3003. Epub 2018 Dec 14.


FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy.

Suzman DL, Agrawal S, Ning YM, Maher VE, Fernandes LL, Karuri S, Tang S, Sridhara R, Schroeder J, Goldberg KB, Ibrahim A, McKee AE, Pazdur R, Beaver JA.

Oncologist. 2019 Apr;24(4):563-569. doi: 10.1634/theoncologist.2018-0084. Epub 2018 Dec 12.


National Cancer Institute Breast Cancer Steering Committee Working Group Report on Meaningful and Appropriate End Points for Clinical Trials in Metastatic Breast Cancer.

Seidman AD, Bordeleau L, Fehrenbacher L, Barlow WE, Perlmutter J, Rubinstein L, Wedam SB, Hershman DL, Hayes JF, Butler LP, Smith ML, Regan MM, Beaver JA, Amiri-Kordestani L, Rastogi P, Zujewski JA, Korde LA.

J Clin Oncol. 2018 Sep 13:JCO1800242. doi: 10.1200/JCO.18.00242. [Epub ahead of print]


Overview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016.

Zhou J, Vallejo J, Kluetz P, Pazdur R, Kim T, Keegan P, Farrell A, Beaver JA, Sridhara R.

J Natl Cancer Inst. 2019 May 1;111(5):449-458. doi: 10.1093/jnci/djy130.


Metastasis-free Survival - A New End Point in Prostate Cancer Trials.

Beaver JA, Kluetz PG, Pazdur R.

N Engl J Med. 2018 Jun 28;378(26):2458-2460. doi: 10.1056/NEJMp1805966. No abstract available.


Anti-PD-1 antibody treatment for melanoma - Authors' reply.

Beaver JA, Keegan P, Lemery S, Pazdur R, Theoret MR.

Lancet Oncol. 2018 May;19(5):e220. doi: 10.1016/S1470-2045(18)30251-1. No abstract available.


FDA Approval Summary: Niraparib for the Maintenance Treatment of Patients with Recurrent Ovarian Cancer in Response to Platinum-Based Chemotherapy.

Ison G, Howie LJ, Amiri-Kordestani L, Zhang L, Tang S, Sridhara R, Pierre V, Charlab R, Ramamoorthy A, Song P, Li F, Yu J, Manheng W, Palmby TR, Ghosh S, Horne HN, Lee EY, Philip R, Dave K, Chen XH, Kelly SL, Janoria KG, Banerjee A, Eradiri O, Dinin J, Goldberg KB, Pierce WF, Ibrahim A, Kluetz PG, Blumenthal GM, Beaver JA, Pazdur R.

Clin Cancer Res. 2018 Sep 1;24(17):4066-4071. doi: 10.1158/1078-0432.CCR-18-0042. Epub 2018 Apr 12.


U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer.

Singh H, Walker AJ, Amiri-Kordestani L, Cheng J, Tang S, Balcazar P, Barnett-Ringgold K, Palmby TR, Cao X, Zheng N, Liu Q, Yu J, Pierce WF, Daniels SR, Sridhara R, Ibrahim A, Kluetz PG, Blumenthal GM, Beaver JA, Pazdur R.

Clin Cancer Res. 2018 Aug 1;24(15):3486-3491. doi: 10.1158/1078-0432.CCR-17-3628. Epub 2018 Mar 9.


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.

J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.


A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.

Beaver JA, Howie LJ, Pelosof L, Kim T, Liu J, Goldberg KB, Sridhara R, Blumenthal GM, Farrell AT, Keegan P, Pazdur R, Kluetz PG.

JAMA Oncol. 2018 Jun 1;4(6):849-856. doi: 10.1001/jamaoncol.2017.5618.


Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.

Schuck RN, Woodcock J, Zineh I, Stein P, Jarow J, Temple R, Permutt T, LaVange L, Beaver JA, Charlab R, Blumenthal GM, Dorff SE, Leptak C, Lemery S, Rogers H, Chowdhury B, Litwack ED, Pacanowski M.

Clin Pharmacol Ther. 2018 Aug;104(2):282-289. doi: 10.1002/cpt.1041. Epub 2018 Feb 23.


FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer.

Shah A, Bloomquist E, Tang S, Fu W, Bi Y, Liu Q, Yu J, Zhao P, Palmby TR, Goldberg KB, Chang CJG, Patel P, Alebachew E, Tilley A, Pierce WF, Ibrahim A, Blumenthal GM, Sridhara R, Beaver JA, Pazdur R.

Clin Cancer Res. 2018 Jul 1;24(13):2999-3004. doi: 10.1158/1078-0432.CCR-17-2369. Epub 2018 Feb 7.


Patients with melanoma treated with an anti-PD-1 antibody beyond RECIST progression: a US Food and Drug Administration pooled analysis.

Beaver JA, Hazarika M, Mulkey F, Mushti S, Chen H, He K, Sridhara R, Goldberg KB, Chuk MK, Chi DC, Chang J, Barone A, Balasubramaniam S, Blumenthal GM, Keegan P, Pazdur R, Theoret MR.

Lancet Oncol. 2018 Feb;19(2):229-239. doi: 10.1016/S1470-2045(17)30846-X. Epub 2018 Jan 18. Review.


Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma.

Ning YM, Maher VE, Beaver JA, Goldberg KB, Blumenthal GM, Pazdur R.

Oncologist. 2018 Feb;23(2):139-142. doi: 10.1634/theoncologist.2017-0415. Epub 2017 Nov 27. No abstract available.


Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement.

Kim ES, Bruinooge SS, Roberts S, Ison G, Lin NU, Gore L, Uldrick TS, Lichtman SM, Roach N, Beaver JA, Sridhara R, Hesketh PJ, Denicoff AM, Garrett-Mayer E, Rubin E, Multani P, Prowell TM, Schenkel C, Kozak M, Allen J, Sigal E, Schilsky RL.

J Clin Oncol. 2017 Nov 20;35(33):3737-3744. doi: 10.1200/JCO.2017.73.7916. Epub 2017 Oct 2.


FDA ovarian cancer clinical trial endpoints workshop: A Society of Gynecologic Oncology White Paper.

Herzog TJ, Ison G, Alvarez RD, Balasubramaniam S, Armstrong DK, Beaver JA, Ellis A, Tang S, Ford P, McKee A, Gershenson DM, Kim G, Monk BJ, Pazdur R, Coleman RL.

Gynecol Oncol. 2017 Oct;147(1):3-10. doi: 10.1016/j.ygyno.2017.08.012. Epub 2017 Aug 24. Review. No abstract available.


FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation-Associated Advanced Ovarian Cancer.

Balasubramaniam S, Beaver JA, Horton S, Fernandes LL, Tang S, Horne HN, Liu J, Liu C, Schrieber SJ, Yu J, Song P, Pierce W, Robertson KJ, Palmby TR, Chiu HJ, Lee EY, Philip R, Schuck R, Charlab R, Banerjee A, Chen XH, Wang X, Goldberg KB, Sridhara R, Kim G, Pazdur R.

Clin Cancer Res. 2017 Dec 1;23(23):7165-7170. doi: 10.1158/1078-0432.CCR-17-1337. Epub 2017 Jul 27.


Strategies to Maximize Patient Participation in Clinical Trials.

Rubin EH, Scroggins MJ, Goldberg KB, Beaver JA.

Am Soc Clin Oncol Educ Book. 2017;37:216-221. doi: 10.14694/EDBK_179803.


Reevaluating Eligibility Criteria - Balancing Patient Protection and Participation in Oncology Trials.

Beaver JA, Ison G, Pazdur R.

N Engl J Med. 2017 Apr 20;376(16):1504-1505. doi: 10.1056/NEJMp1615879. No abstract available.


FDA Approval of Nivolumab for the First-Line Treatment of Patients with BRAFV600 Wild-Type Unresectable or Metastatic Melanoma.

Beaver JA, Theoret MR, Mushti S, He K, Libeg M, Goldberg K, Sridhara R, McKee AE, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Jul 15;23(14):3479-3483. doi: 10.1158/1078-0432.CCR-16-0714. Epub 2017 Jan 10.


Enrollment of older adults on oncology trials: An FDA perspective.

Singh H, Beaver JA, Kim G, Pazdur R.

J Geriatr Oncol. 2017 May;8(3):149-150. doi: 10.1016/j.jgo.2016.11.001. Epub 2016 Dec 23. No abstract available.


An FDA Perspective on the Regulatory Implications of Complex Signatures to Predict Response to Targeted Therapies.

Beaver JA, Tzou A, Blumenthal GM, McKee AE, Kim G, Pazdur R, Philip R.

Clin Cancer Res. 2017 Mar 15;23(6):1368-1372. doi: 10.1158/1078-0432.CCR-16-1098. Epub 2016 Dec 19.


U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma.

Singh H, Brave M, Beaver JA, Cheng J, Tang S, Zahalka E, Palmby TR, Venugopal R, Song P, Liu Q, Liu C, Yu J, Chen XH, Wang X, Wang Y, Kluetz PG, Daniels SR, Papadopoulos EJ, Sridhara R, McKee AE, Ibrahim A, Kim G, Pazdur R.

Clin Cancer Res. 2017 Jan 15;23(2):330-335. doi: 10.1158/1078-0432.CCR-16-1073. Epub 2016 Oct 28.


Individualized Molecular Analyses Guide Efforts (IMAGE): A Prospective Study of Molecular Profiling of Tissue and Blood in Metastatic Triple-Negative Breast Cancer.

Parsons HA, Beaver JA, Cimino-Mathews A, Ali SM, Axilbund J, Chu D, Connolly RM, Cochran RL, Croessmann S, Clark TA, Gocke CD, Jeter SC, Kennedy MR, Lauring J, Lee J, Lipson D, Miller VA, Otto GA, Rosner GL, Ross JS, Slater S, Stephens PJ, VanDenBerg DA, Wolff AC, Young LE, Zabransky DJ, Zhang Z, Zorzi J, Stearns V, Park BH.

Clin Cancer Res. 2017 Jan 15;23(2):379-386. doi: 10.1158/1078-0432.CCR-16-1543. Epub 2016 Aug 3.


FDA Approval: Uridine Triacetate for the Treatment of Patients Following Fluorouracil or Capecitabine Overdose or Exhibiting Early-Onset Severe Toxicities Following Administration of These Drugs.

Ison G, Beaver JA, McGuinn WD Jr, Palmby TR, Dinin J, Charlab R, Marathe A, Jin R, Liu Q, Chen XH, Ysern X, Stephens O, Bai G, Wang Y, Dorff SE, Cheng J, Tang S, Sridhara R, Pierce W, McKee AE, Ibrahim A, Kim G, Pazdur R.

Clin Cancer Res. 2016 Sep 15;22(18):4545-9. doi: 10.1158/1078-0432.CCR-16-0638. Epub 2016 Jul 11. Review.


Circulating Plasma Tumor DNA.

Parsons HA, Beaver JA, Park BH.

Adv Exp Med Biol. 2016;882:259-76. doi: 10.1007/978-3-319-22909-6_11. Review.


Ki-67 is required for maintenance of cancer stem cells but not cell proliferation.

Cidado J, Wong HY, Rosen DM, Cimino-Mathews A, Garay JP, Fessler AG, Rasheed ZA, Hicks J, Cochran RL, Croessmann S, Zabransky DJ, Mohseni M, Beaver JA, Chu D, Cravero K, Christenson ES, Medford A, Mattox A, De Marzo AM, Argani P, Chawla A, Hurley PJ, Lauring J, Park BH.

Oncotarget. 2016 Feb 2;7(5):6281-93. doi: 10.18632/oncotarget.7057.


TMSB4Y is a candidate tumor suppressor on the Y chromosome and is deleted in male breast cancer.

Wong HY, Wang GM, Croessmann S, Zabransky DJ, Chu D, Garay JP, Cidado J, Cochran RL, Beaver JA, Aggarwal A, Liu ML, Argani P, Meeker A, Hurley PJ, Lauring J, Park BH.

Oncotarget. 2015 Dec 29;6(42):44927-40. doi: 10.18632/oncotarget.6743.


Neoadjuvant Therapy As a Platform for Drug Development: Current Controversies and Regulatory Perspectives.

Amiri-Kordestani L, Beaver JA, Cortazar P.

Oncology (Williston Park). 2015 Nov;29(11):843-4, 846. No abstract available.


NDRG1 links p53 with proliferation-mediated centrosome homeostasis and genome stability.

Croessmann S, Wong HY, Zabransky DJ, Chu D, Mendonca J, Sharma A, Mohseni M, Rosen DM, Scharpf RB, Cidado J, Cochran RL, Parsons HA, Dalton WB, Erlanger B, Button B, Cravero K, Kyker-Snowman K, Beaver JA, Kachhap S, Hurley PJ, Lauring J, Park BH.

Proc Natl Acad Sci U S A. 2015 Sep 15;112(37):11583-8. doi: 10.1073/pnas.1503683112. Epub 2015 Aug 31.


FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer.

Beaver JA, Amiri-Kordestani L, Charlab R, Chen W, Palmby T, Tilley A, Zirkelbach JF, Yu J, Liu Q, Zhao L, Crich J, Chen XH, Hughes M, Bloomquist E, Tang S, Sridhara R, Kluetz PG, Kim G, Ibrahim A, Pazdur R, Cortazar P.

Clin Cancer Res. 2015 Nov 1;21(21):4760-6. doi: 10.1158/1078-0432.CCR-15-1185. Epub 2015 Aug 31. Review.


Functional isogenic modeling of BRCA1 alleles reveals distinct carrier phenotypes.

Cochran RL, Cidado J, Kim M, Zabransky DJ, Croessmann S, Chu D, Wong HY, Beaver JA, Cravero K, Erlanger B, Parsons H, Heaphy CM, Meeker AK, Lauring J, Park BH.

Oncotarget. 2015 Sep 22;6(28):25240-51. doi: 10.18632/oncotarget.4595.


Detecting Plasma Tumor DNA in Early-Stage Breast Cancer--Reply.

Beaver JA, Park BH.

Clin Cancer Res. 2015 Aug 1;21(15):3570. doi: 10.1158/1078-0432.CCR-15-0994. No abstract available.


Comparison of cell stabilizing blood collection tubes for circulating plasma tumor DNA.

Toro PV, Erlanger B, Beaver JA, Cochran RL, VanDenBerg DA, Yakim E, Cravero K, Chu D, Zabransky DJ, Wong HY, Croessmann S, Parsons H, Hurley PJ, Lauring J, Park BH.

Clin Biochem. 2015 Oct;48(15):993-8. doi: 10.1016/j.clinbiochem.2015.07.097. Epub 2015 Jul 31.


MACROD2 overexpression mediates estrogen independent growth and tamoxifen resistance in breast cancers.

Mohseni M, Cidado J, Croessmann S, Cravero K, Cimino-Mathews A, Wong HY, Scharpf R, Zabransky DJ, Abukhdeir AM, Garay JP, Wang GM, Beaver JA, Cochran RL, Blair BG, Rosen DM, Erlanger B, Argani P, Hurley PJ, Lauring J, Park BH.

Proc Natl Acad Sci U S A. 2014 Dec 9;111(49):17606-11. doi: 10.1073/pnas.1408650111. Epub 2014 Nov 24.


A phosphoproteomic screen demonstrates differential dependence on HER3 for MAP kinase pathway activation by distinct PIK3CA mutations.

Blair BG, Wu X, Zahari MS, Mohseni M, Cidado J, Wong HY, Beaver JA, Cochran RL, Zabransky DJ, Croessmann S, Chu D, Toro PV, Cravero K, Pandey A, Park BH.

Proteomics. 2015 Jan;15(2-3):318-26. doi: 10.1002/pmic.201400342. Epub 2014 Dec 28.


Familial GI Stromal Tumor With Loss of Heterozygosity and Amplification of Mutant KIT.

Forde PM, Cochran RL, Boikos SA, Zabransky DJ, Beaver JA, Meyer CF, Thornton KA, Montgomery EA, Lidor AO, Donehower RC, Park BH.

J Clin Oncol. 2016 Jan 20;34(3):e13-6. doi: 10.1200/JCO.2013.51.6633. Epub 2014 May 27. No abstract available.


Analysis of BRCA2 loss of heterozygosity in tumor tissue using droplet digital polymerase chain reaction.

Cochran RL, Cravero K, Chu D, Erlanger B, Toro PV, Beaver JA, Zabransky DJ, Wong HY, Cidado J, Croessmann S, Parsons H, Kim M, Wheelan SJ, Argani P, Ho Park B.

Hum Pathol. 2014 Jul;45(7):1546-1550. doi: 10.1016/j.humpath.2014.03.013. Epub 2014 Apr 13.


Detection of cancer DNA in plasma of patients with early-stage breast cancer.

Beaver JA, Jelovac D, Balukrishna S, Cochran R, Croessmann S, Zabransky DJ, Wong HY, Toro PV, Cidado J, Blair BG, Chu D, Burns T, Higgins MJ, Stearns V, Jacobs L, Habibi M, Lange J, Hurley PJ, Lauring J, VanDenBerg D, Kessler J, Jeter S, Samuels ML, Maar D, Cope L, Cimino-Mathews A, Argani P, Wolff AC, Park BH.

Clin Cancer Res. 2014 May 15;20(10):2643-2650. doi: 10.1158/1078-0432.CCR-13-2933. Epub 2014 Feb 6.


A PIK3CA mutation detected in plasma from a patient with synchronous primary breast and lung cancers.

Jelovac D, Beaver JA, Balukrishna S, Wong HY, Toro PV, Cimino-Mathews A, Argani P, Stearns V, Jacobs L, VanDenBerg D, Kessler J, Jeter S, Park BH, Wolff AC.

Hum Pathol. 2014 Apr;45(4):880-3. doi: 10.1016/j.humpath.2013.10.016. Epub 2013 Oct 31.


PIK3CA and AKT1 mutations have distinct effects on sensitivity to targeted pathway inhibitors in an isogenic luminal breast cancer model system.

Beaver JA, Gustin JP, Yi KH, Rajpurohit A, Thomas M, Gilbert SF, Rosen DM, Ho Park B, Lauring J.

Clin Cancer Res. 2013 Oct 1;19(19):5413-22. doi: 10.1158/1078-0432.CCR-13-0884. Epub 2013 Jul 25.


Needles in a haystack: finding recurrent genomic changes in breast cancer.

Cidado J, Beaver JA, Park BH.

Breast Cancer Res. 2013 Feb 19;14(1):304. doi: 10.1186/bcr3364. Review.


PIK3CA mutations and EGFR overexpression predict for lithium sensitivity in human breast epithelial cells.

Higgins MJ, Beaver JA, Wong HY, Gustin JP, Lauring JD, Garay JP, Konishi H, Mohseni M, Wang GM, Cidado J, Jelovac D, Cosgrove DP, Tamaki A, Abukhdeir AM, Park BH.

Cancer Biol Ther. 2011 Feb 1;11(3):358-67. Epub 2011 Feb 1.


Isozyme diversity in sour, sweet, and ground cherry.

Beaver JA, Iezzoni AF, Ramm CW.

Theor Appl Genet. 1995 May;90(6):847-52. doi: 10.1007/BF00222021.


Haemoglobin inhibition of fibrin polymerization and clotting.

Brezniak DV, Moon DG, Beaver JA, Fenton JW 2nd.

Blood Coagul Fibrinolysis. 1994 Feb;5(1):139-43.


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