Format
Sort by
Items per page

Send to

Choose Destination

Search results

Items: 1 to 50 of 124

1.

Evaluation of Blinded Independent Central Review of Tumor Progression in Oncology Clinical Trials: A Meta-analysis.

Zhang JJ, Chen H, He K, Tang S, Justice R, Keegan P, Pazdur R, Sridhara R.

Ther Innov Regul Sci. 2013 Mar;47(2):167-174. doi: 10.1177/0092861512459733.

PMID:
30227523
2.

Reply to Letter to the Editor: Local Evaluation and Blinded Central Review Comparison a Victim of Meta-analysis Shortcomings.

Zhang JJ, Chen H, He K, Tang S, Justice R, Keegan P, Pazdur R, Sridhara R.

Ther Innov Regul Sci. 2014 Mar;48(2):NP1-NP2. doi: 10.1177/2168479014520698. No abstract available.

PMID:
30227504
3.

Pulmonary Venous Waveforms Predict Rehospitalization and Mortality After Percutaneous Mitral Valve Repair.

Corrigan FE 3rd, Chen JH, Maini A, Lisko JC, Alvarez L, Kamioka N, Reginauld S, Gleason PT, Condado JF, Wei JW, Binongo JN, Keegan P, Howell S, Thourani VH, Block PC, Clements SD, Babaliaros VC, Lerakis S.

JACC Cardiovasc Imaging. 2018 Sep 6. pii: S1936-878X(18)30667-3. doi: 10.1016/j.jcmg.2018.07.014. [Epub ahead of print]

PMID:
30219407
4.

FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1.

Fashoyin-Aje L, Donoghue M, Chen H, He K, Veeraraghavan J, Goldberg KB, Keegan P, McKee AE, Pazdur R.

Oncologist. 2018 Aug 17. pii: theoncologist.2018-0221. doi: 10.1634/theoncologist.2018-0221. [Epub ahead of print]

PMID:
30120163
5.

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. 2018 Aug 4. doi: 10.1093/jnci/djy130. [Epub ahead of print]

PMID:
30085269
6.

FDA's Approval of the First Biosimilar to Bevacizumab.

Casak SJ, Lemery SJ, Chung J, Fuchs C, Schrieber SJ, Chow ECY, Yuan W, Rodriguez L, Gwise T, Rowzee A, Lim S, Keegan P, McKee AE, Pazdur R.

Clin Cancer Res. 2018 Sep 15;24(18):4365-4370. doi: 10.1158/1078-0432.CCR-18-0566. Epub 2018 May 9.

PMID:
29743182
7.

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.

PMID:
29726379
8.

Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy.

McCoach CE, Blumenthal GM, Zhang L, Myers A, Tang S, Sridhara R, Keegan P, Pazdur R, Doebele RC, Kazandjian D.

Ann Oncol. 2018 Feb 26. doi: 10.1093/annonc/mdy045. [Epub ahead of print] No abstract available.

PMID:
29529128
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.

PMID:
29494733
10.

FDA Approval Summary: Dabrafenib and Trametinib for the Treatment of Metastatic Non-Small Cell Lung Cancers Harboring BRAF V600E Mutations.

Odogwu L, Mathieu L, Blumenthal G, Larkins E, Goldberg KB, Griffin N, Bijwaard K, Lee EY, Philip R, Jiang X, Rodriguez L, McKee AE, Keegan P, Pazdur R.

Oncologist. 2018 Jun;23(6):740-745. doi: 10.1634/theoncologist.2017-0642. Epub 2018 Feb 7.

PMID:
29438093
11.

Benefit-Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib.

Pelosof L, Lemery S, Casak S, Jiang X, Rodriguez L, Pierre V, Bi Y, Liu J, Zirkelbach JF, Patel A, Goldberg KB, McKee AE, Keegan P, Pazdur R.

Oncologist. 2018 Apr;23(4):496-500. doi: 10.1634/theoncologist.2017-0422. Epub 2018 Jan 31.

12.

Mean Aortic pressure gradient and global longitudinal strain recovery after transcatheter aortic valve replacement - A retrospective analysis.

Corrigan FE, Zhou X, Lisko JC, Hayek SS, Parastatidis I, Keegan P, Howell S, Thourani V, Babaliaros VC, Lerakis S.

Hellenic J Cardiol. 2018 Jan 31. pii: S1109-9666(17)30429-3. doi: 10.1016/j.hjc.2018.01.006. [Epub ahead of print]

13.

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.

PMID:
29361469
14.

Predictors and Clinical Outcomes of Next-Day Discharge After Minimalist Transfemoral Transcatheter Aortic Valve Replacement.

Kamioka N, Wells J, Keegan P, Lerakis S, Binongo J, Corrigan F, Condado J, Patel A, Forcillo J, Ogburn L, Dong A, Caughron H, Simone A, Leshnower B, Devireddy C, Mavromatis K, Guyton R, Stewart J, Thourani V, Block PC, Babaliaros V.

JACC Cardiovasc Interv. 2018 Jan 22;11(2):107-115. doi: 10.1016/j.jcin.2017.10.021.

PMID:
29348004
15.

FDA Benefit-Risk Assessment of Osimertinib for the Treatment of Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation.

Odogwu L, Mathieu L, Goldberg KB, Blumenthal GM, Larkins E, Fiero MH, Rodriguez L, Bijwaard K, Lee EY, Philip R, Fan I, Donoghue M, Keegan P, McKee A, Pazdur R.

Oncologist. 2018 Mar;23(3):353-359. doi: 10.1634/theoncologist.2017-0425. Epub 2017 Dec 14.

16.

Exploratory analysis of the association of depth of response and survival in patients with metastatic non-small-cell lung cancer treated with a targeted therapy or immunotherapy.

McCoach CE, Blumenthal GM, Zhang L, Myers A, Tang S, Sridhara R, Keegan P, Pazdur R, Doebele RC, Kazandjian D.

Ann Oncol. 2017 Nov 1;28(11):2707-2714. doi: 10.1093/annonc/mdx414.

PMID:
29045514
17.

First FDA Approval Agnostic of Cancer Site - When a Biomarker Defines the Indication.

Lemery S, Keegan P, Pazdur R.

N Engl J Med. 2017 Oct 12;377(15):1409-1412. doi: 10.1056/NEJMp1709968. No abstract available.

PMID:
29020592
18.

FDA Approval Summary: Sonidegib-Response.

Shord SS, Casey D, Zhao H, Demko S, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Oct 1;23(19):5994. doi: 10.1158/1078-0432.CCR-17-2135. No abstract available.

PMID:
28972086
19.

FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond.

Pai-Scherf L, Blumenthal GM, Li H, Subramaniam S, Mishra-Kalyani PS, He K, Zhao H, Yu J, Paciga M, Goldberg KB, McKee AE, Keegan P, Pazdur R.

Oncologist. 2017 Nov;22(11):1392-1399. doi: 10.1634/theoncologist.2017-0078. Epub 2017 Aug 23.

20.

FDA Approval Summary: Trabectedin for Unresectable or Metastatic Liposarcoma or Leiomyosarcoma Following an Anthracycline-Containing Regimen.

Barone A, Chi DC, Theoret MR, Chen H, He K, Kufrin D, Helms WS, Subramaniam S, Zhao H, Patel A, Goldberg KB, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Dec 15;23(24):7448-7453. doi: 10.1158/1078-0432.CCR-17-0898. Epub 2017 Aug 3.

PMID:
28774898
21.

Urethral injection therapy for urinary incontinence in women.

Kirchin V, Page T, Keegan PE, Atiemo KO, Cody JD, McClinton S, Aluko P.

Cochrane Database Syst Rev. 2017 Jul 25;7:CD003881. doi: 10.1002/14651858.CD003881.pub4. Review.

PMID:
28738443
22.

Te Reo Māori: indigenous language acquisition in the context of New Zealand English.

Reese E, Keegan P, McNaughton S, Kingi TK, Carr PA, Schmidt J, Mohal J, Grant C, Morton S.

J Child Lang. 2018 Mar;45(2):340-367. doi: 10.1017/S0305000917000241. Epub 2017 Jul 6.

PMID:
28679455
23.

Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non-Small Cell Lung Cancer Trials: A Meta-analysis.

Blumenthal GM, Zhang L, Zhang H, Kazandjian D, Khozin S, Tang S, Goldberg K, Sridhara R, Keegan P, Pazdur R.

JAMA Oncol. 2017 Aug 10;3(8):e171029. doi: 10.1001/jamaoncol.2017.1029. Epub 2017 Aug 10.

24.

Time dependent pharmacokinetics of pembrolizumab in patients with solid tumor and its correlation with best overall response.

Li H, Yu J, Liu C, Liu J, Subramaniam S, Zhao H, Blumenthal GM, Turner DC, Li C, Ahamadi M, de Greef R, Chatterjee M, Kondic AG, Stone JA, Booth BP, Keegan P, Rahman A, Wang Y.

J Pharmacokinet Pharmacodyn. 2017 Oct;44(5):403-414. doi: 10.1007/s10928-017-9528-y. Epub 2017 Jun 1.

PMID:
28573468
25.

FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy.

Larkins E, Blumenthal GM, Yuan W, He K, Sridhara R, Subramaniam S, Zhao H, Liu C, Yu J, Goldberg KB, McKee AE, Keegan P, Pazdur R.

Oncologist. 2017 Jul;22(7):873-878. doi: 10.1634/theoncologist.2016-0496. Epub 2017 May 22.

26.

Readmission rates after transcatheter aortic valve replacement in high- and extreme-risk patients with severe aortic stenosis.

Forcillo J, Condado JF, Binongo JN, Lasanajak Y, Caughron H, Babaliaros V, Devireddy C, Leshnower B, Guyton RA, Block PC, Simone A, Keegan P, Khairy P, Thourani VH.

J Thorac Cardiovasc Surg. 2017 Aug;154(2):445-452. doi: 10.1016/j.jtcvs.2017.03.144. Epub 2017 Apr 18.

PMID:
28532575
27.

Characterization of outcomes in patients with metastatic non-small cell lung cancer treated with programmed cell death protein 1 inhibitors past RECIST version 1.1-defined disease progression in clinical trials.

Kazandjian D, Keegan P, Suzman DL, Pazdur R, Blumenthal GM.

Semin Oncol. 2017 Feb;44(1):3-7. doi: 10.1053/j.seminoncol.2017.01.001. Epub 2017 Feb 10. Review.

PMID:
28395760
28.

Paravalvular Regurgitation after Transcatheter Aortic Valve Replacement: Comparing Transthoracic versus Transesophageal Echocardiographic Guidance.

Hayek SS, Corrigan FE 3rd, Condado JF, Lin S, Howell S, MacNamara JP, Zheng S, Keegan P, Thourani V, Babaliaros VC, Lerakis S.

J Am Soc Echocardiogr. 2017 Jun;30(6):533-540. doi: 10.1016/j.echo.2017.02.002. Epub 2017 Apr 6.

PMID:
28391002
29.

FDA Approval Summary: Eribulin for Patients with Unresectable or Metastatic Liposarcoma Who Have Received a Prior Anthracycline-Containing Regimen.

Osgood CL, Chuk MK, Theoret MR, Huang L, He K, Her L, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Nov 1;23(21):6384-6389. doi: 10.1158/1078-0432.CCR-16-2422. Epub 2017 Feb 27.

PMID:
28242632
30.

FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma.

Chuk MK, Chang JT, Theoret MR, Sampene E, He K, Weis SL, Helms WS, Jin R, Li H, Yu J, Zhao H, Zhao L, Paciga M, Schmiel D, Rawat R, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Oct 1;23(19):5666-5670. doi: 10.1158/1078-0432.CCR-16-0663. Epub 2017 Feb 24.

PMID:
28235882
31.

FDA Approval Summary: TAS-102.

Marcus L, Lemery SJ, Khasar S, Wearne E, Helms WS, Yuan W, He K, Cao X, Yu J, Zhao H, Wang Y, Stephens O, Englund E, Agarwal R, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Jun 15;23(12):2924-2927. doi: 10.1158/1078-0432.CCR-16-2157. Epub 2017 Feb 17.

32.

End-stage renal disease and severe aortic stenosis: Does valve replacement improve one-year outcomes?

Condado JF, Maini A, Leshnower B, Thourani V, Forcillo J, Devireddy C, Mavromatis K, Sarin EL, Stewart J, Guyton R, Simone A, Keegan P, Lerakis S, Block PC, Babaliaros V.

Catheter Cardiovasc Interv. 2017 May;89(6):1109-1115. doi: 10.1002/ccd.26875. Epub 2017 Feb 17.

PMID:
28211605
33.

FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma.

Barone A, Hazarika M, Theoret MR, Mishra-Kalyani P, Chen H, He K, Sridhara R, Subramaniam S, Pfuma E, Wang Y, Li H, Zhao H, Zirkelbach JF, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Oct 1;23(19):5661-5665. doi: 10.1158/1078-0432.CCR-16-0664. Epub 2017 Feb 8.

PMID:
28179454
34.

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials-Response.

Kluetz PG, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R.

Clin Cancer Res. 2016 Nov 15;22(22):5618. doi: 10.1158/1078-0432.CCR-16-2140. No abstract available.

35.

U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab.

Hazarika M, Chuk MK, Theoret MR, Mushti S, He K, Weis SL, Putman AH, Helms WS, Cao X, Li H, Zhao H, Zhao L, Welch J, Graham L, Libeg M, Sridhara R, Keegan P, Pazdur R.

Clin Cancer Res. 2017 Jul 15;23(14):3484-3488. doi: 10.1158/1078-0432.CCR-16-0712. Epub 2017 Jan 13.

36.

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.

37.

FDA Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma.

Casey D, Demko S, Shord S, Zhao H, Chen H, He K, Putman A, Helms W, Keegan P, Pazdur R.

Clin Cancer Res. 2017 May 15;23(10):2377-2381. doi: 10.1158/1078-0432.CCR-16-2051. Epub 2017 Jan 10.

38.

FDA's Approach to Regulating Biosimilars.

Lemery SJ, Ricci MS, Keegan P, McKee AE, Pazdur R.

Clin Cancer Res. 2017 Apr 15;23(8):1882-1885. doi: 10.1158/1078-0432.CCR-16-1354. Epub 2016 Dec 29.

39.

Osimertinib for the Treatment of Metastatic EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer.

Khozin S, Weinstock C, Blumenthal GM, Cheng J, He K, Zhuang L, Zhao H, Charlab R, Fan I, Keegan P, Pazdur R.

Clin Cancer Res. 2017 May 1;23(9):2131-2135. doi: 10.1158/1078-0432.CCR-16-1773. Epub 2016 Dec 6.

40.

Does minimalist transfemoral transcatheter aortic valve replacement produce better survival in patients with severe chronic obstructive pulmonary disease?

Condado JF, Haider MN, Lerakis S, Keegan P, Caughron H, Thourani VH, Devireddy C, Leshnower B, Mavromatis K, Sarin EL, Stewart J, Guyton R, Forcillo J, Patel A, Simone A, Block PC, Babaliaros V.

Catheter Cardiovasc Interv. 2017 Mar 1;89(4):775-780. doi: 10.1002/ccd.26683. Epub 2016 Nov 12.

PMID:
27862901
41.

Statistical Considerations in Evaluating a Biosimilar Product in an Oncology Clinical Study.

He K, Chen H, Gwise T, Casak S, Lemery S, Keegan P, Pazdur R, Sridhara R.

Clin Cancer Res. 2016 Nov 1;22(21):5167-5170. Epub 2016 Aug 31.

42.

FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non-Small Cell Lung Cancer Following Crizotinib.

Larkins E, Blumenthal GM, Chen H, He K, Agarwal R, Gieser G, Stephens O, Zahalka E, Ringgold K, Helms W, Shord S, Yu J, Zhao H, Davis G, McKee AE, Keegan P, Pazdur R.

Clin Cancer Res. 2016 Nov 1;22(21):5171-5176. Epub 2016 Jul 13.

43.

Should We Perform Carotid Doppler Screening Before Surgical or Transcatheter Aortic Valve Replacement?

Condado JF, Jensen HA, Maini A, Ko YA, Rajaei MH, Tsai LL, Devireddy C, Leshnower B, Mavromatis K, Sarin EL, Stewart J, Guyton RA, Babaliaros V, Chen EP, Halkos M, Simone A, Keegan P, Block PC, Thourani VH; Emory Structural Heart and Valve Center.

Ann Thorac Surg. 2017 Mar;103(3):787-794. doi: 10.1016/j.athoracsur.2016.06.076. Epub 2016 Oct 4.

PMID:
27717427
44.

Clinician Perspectives on Current Issues in Lung Cancer Drug Development.

Waqar SN, Bonomi PD, Govindan R, Hirsch FR, Riely GJ, Papadimitrakopoulou V, Kazandjian D, Khozin S, Larkins E, Dickson DJ, Malik S, Horn L, Ferris A, Shaw AT, Jänne PA, Mok TS, Herbst R, Keegan P, Pazdur R, Blumenthal GM.

J Thorac Oncol. 2016 Sep;11(9):1387-96. doi: 10.1016/j.jtho.2016.05.009. Epub 2016 Jul 9. Review.

45.

Does a Higher Society of Thoracic Surgeons Score Predict Outcomes in Transfemoral and Alternative Access Transcatheter Aortic Valve Replacement?

Jensen HA, Thourani VH, Forcillo J, Condado JF, Binongo JN, Babaliaros V, Lasanajak Y, Leshnower B, Devireddy C, Guyton R, Mavromatis K, Block P, Simone A, Keegan P, Stewart J, Tsai LL, Rajaei MH, Lerakis S, Sarin EL.

Ann Thorac Surg. 2016 Aug;102(2):474-82. doi: 10.1016/j.athoracsur.2016.02.020. Epub 2016 May 19.

PMID:
27209615
46.

FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1.

Sul J, Blumenthal GM, Jiang X, He K, Keegan P, Pazdur R.

Oncologist. 2016 May;21(5):643-50. doi: 10.1634/theoncologist.2015-0498. Epub 2016 Mar 29.

47.

FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy.

Kazandjian D, Suzman DL, Blumenthal G, Mushti S, He K, Libeg M, Keegan P, Pazdur R.

Oncologist. 2016 May;21(5):634-42. doi: 10.1634/theoncologist.2015-0507. Epub 2016 Mar 16.

48.

FDA Approval of Gefitinib for the Treatment of Patients with Metastatic EGFR Mutation-Positive Non-Small Cell Lung Cancer.

Kazandjian D, Blumenthal GM, Yuan W, He K, Keegan P, Pazdur R.

Clin Cancer Res. 2016 Mar 15;22(6):1307-12. doi: 10.1158/1078-0432.CCR-15-2266. Review.

49.

Biomechanical and biochemical regulation of cathepsin K expression in endothelial cells converge at AP-1 and NF-κB.

Keegan PM, Anbazhakan S, Kang B, Pace BS, Platt MO.

Biol Chem. 2016 May;397(5):459-68. doi: 10.1515/hsz-2015-0244.

PMID:
26760306
50.

Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms.

Kluetz PG, Slagle A, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE, Chen WH, Sridhara R, Farrell AT, Keegan P, Kim G, Pazdur R.

Clin Cancer Res. 2016 Apr 1;22(7):1553-8. doi: 10.1158/1078-0432.CCR-15-2035. Epub 2016 Jan 12.

Supplemental Content

Loading ...
Support Center