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Items: 34

1.

Using a Benefit-Risk Analysis Approach to Capture Regulatory Decision Making: Melanoma.

Raju GK, Gurumurthi K, Domike R, Theoret MR, Pazdur R, Woodcock J.

Clin Pharmacol Ther. 2019 Apr 16. doi: 10.1002/cpt.1461. [Epub ahead of print]

PMID:
30993685
2.

Patient reported outcomes in anti-PD-1/PD-L1 inhibitor immunotherapy registration trials: FDA analysis of data submitted and future directions.

King-Kallimanis BL, Howie LJ, Roydhouse JK, Singh H, Theoret MR, Blumenthal GM, Kluetz PG.

Clin Trials. 2019 Jun;16(3):322-326. doi: 10.1177/1740774519836991. Epub 2019 Mar 18.

PMID:
30880446
3.

Age-related differences in patient-reported outcomes in patients with advanced lung cancer receiving anti-PD-1/PD-L1 therapy.

King-Kallimanis BL, Kanapuru B, Blumenthal GM, Theoret MR, Kluetz PG.

Semin Oncol. 2018 Aug;45(4):201-209. doi: 10.1053/j.seminoncol.2018.06.003. Epub 2018 Oct 25. Review.

PMID:
30482633
4.

FDA Approval Summary: Tisagenlecleucel for Treatment of Patients with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia.

O'Leary MC, Lu X, Huang Y, Lin X, Mahmood I, Przepiorka D, Gavin D, Lee S, Liu K, George B, Bryan W, Theoret MR, Pazdur R.

Clin Cancer Res. 2019 Feb 15;25(4):1142-1146. doi: 10.1158/1078-0432.CCR-18-2035. Epub 2018 Oct 11.

PMID:
30309857
5.

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
6.

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.

7.

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.

8.

Treatment Beyond Progression With Immune Checkpoint Inhibitors-Known Unknowns.

Blumenthal GM, Theoret MR, Pazdur R.

JAMA Oncol. 2017 Nov 1;3(11):1473-1474. doi: 10.1001/jamaoncol.2017.1819. No abstract available.

PMID:
28662228
9.

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.

10.

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.

11.

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.

12.

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.

13.

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.

14.

Seamless Oncology-Drug Development.

Prowell TM, Theoret MR, Pazdur R.

N Engl J Med. 2016 May 26;374(21):2001-3. doi: 10.1056/NEJMp1603747. Epub 2016 Apr 13. No abstract available.

PMID:
27074059
15.

Phase II trial of docetaxel, bevacizumab, lenalidomide and prednisone in patients with metastatic castration-resistant prostate cancer.

Madan RA, Karzai FH, Ning YM, Adesunloye BA, Huang X, Harold N, Couvillon A, Chun G, Cordes L, Sissung T, Beedie SL, Dawson NA, Theoret MR, McLeod DG, Rosner I, Trepel JB, Lee MJ, Tomita Y, Lee S, Chen C, Steinberg SM, Arlen PM, Gulley JL, Figg WD, Dahut WL.

BJU Int. 2016 Oct;118(4):590-7. doi: 10.1111/bju.13412. Epub 2016 Feb 19.

16.

Expansion Cohorts in First-in-Human Solid Tumor Oncology Trials.

Theoret MR, Pai-Scherf LH, Chuk MK, Prowell TM, Balasubramaniam S, Kim T, Kim G, Kluetz PG, Keegan P, Pazdur R.

Clin Cancer Res. 2015 Oct 15;21(20):4545-51. doi: 10.1158/1078-0432.CCR-14-3244.

17.

The risks and benefits of 5α-reductase inhibitors for prostate-cancer prevention.

Theoret MR, Ning YM, Zhang JJ, Justice R, Keegan P, Pazdur R.

N Engl J Med. 2011 Jul 14;365(2):97-9. doi: 10.1056/NEJMp1106783. Epub 2011 Jun 15. No abstract available.

PMID:
21675880
18.

Development of human anti-murine T-cell receptor antibodies in both responding and nonresponding patients enrolled in TCR gene therapy trials.

Davis JL, Theoret MR, Zheng Z, Lamers CH, Rosenberg SA, Morgan RA.

Clin Cancer Res. 2010 Dec 1;16(23):5852-61. doi: 10.1158/1078-0432.CCR-10-1280.

19.

Gene therapy using genetically modified lymphocytes targeting VEGFR-2 inhibits the growth of vascularized syngenic tumors in mice.

Chinnasamy D, Yu Z, Theoret MR, Zhao Y, Shrimali RK, Morgan RA, Feldman SA, Restifo NP, Rosenberg SA.

J Clin Invest. 2010 Nov;120(11):3953-68. doi: 10.1172/JCI43490. Epub 2010 Oct 11.

20.

Antiangiogenic agents can increase lymphocyte infiltration into tumor and enhance the effectiveness of adoptive immunotherapy of cancer.

Shrimali RK, Yu Z, Theoret MR, Chinnasamy D, Restifo NP, Rosenberg SA.

Cancer Res. 2010 Aug 1;70(15):6171-80. doi: 10.1158/0008-5472.CAN-10-0153. Epub 2010 Jul 14.

21.

Relationship of p53 overexpression on cancers and recognition by anti-p53 T cell receptor-transduced T cells.

Theoret MR, Cohen CJ, Nahvi AV, Ngo LT, Suri KB, Powell DJ Jr, Dudley ME, Morgan RA, Rosenberg SA.

Hum Gene Ther. 2008 Nov;19(11):1219-32. doi: 10.1089/hgt.2008.083.

22.

TSCOT+ thymic epithelial cell-mediated sensitive CD4 tolerance by direct presentation.

Ahn S, Lee G, Yang SJ, Lee D, Lee S, Shin HS, Kim MC, Lee KN, Palmer DC, Theoret MR, Jenkinson EJ, Anderson G, Restifo NP, Kim MG.

PLoS Biol. 2008 Aug 5;6(8):e191. doi: 10.1371/journal.pbio.0060191.

23.

Phase I trial of an enhanced prostate-specific antigen-based vaccine and anti-CTLA-4 antibody in patients with metastatic androgen-independent prostate cancer.

Theoret MR, Arlen PM, Pazdur M, Dahut WL, Schlom J, Gulley JL.

Clin Genitourin Cancer. 2007 Jun;5(5):347-50. No abstract available.

PMID:
17645835
24.

CTLA-4 dysregulation of self/tumor-reactive CD8+ T-cell function is CD4+ T-cell dependent.

Gattinoni L, Ranganathan A, Surman DR, Palmer DC, Antony PA, Theoret MR, Heimann DM, Rosenberg SA, Restifo NP.

Blood. 2006 Dec 1;108(12):3818-23. Epub 2006 Aug 1.

25.

Cross-priming utilizes antigen not available to the direct presentation pathway.

Donohue KB, Grant JM, Tewalt EF, Palmer DC, Theoret MR, Restifo NP, Norbury CC.

Immunology. 2006 Sep;119(1):63-73. Epub 2006 Jun 8.

26.

Immunological and antitumor effects of IL-23 as a cancer vaccine adjuvant.

Overwijk WW, de Visser KE, Tirion FH, de Jong LA, Pols TW, van der Velden YU, van den Boorn JG, Keller AM, Buurman WA, Theoret MR, Blom B, Restifo NP, Kruisbeek AM, Kastelein RA, Haanen JB.

J Immunol. 2006 May 1;176(9):5213-22.

27.

Acquisition of full effector function in vitro paradoxically impairs the in vivo antitumor efficacy of adoptively transferred CD8+ T cells.

Gattinoni L, Klebanoff CA, Palmer DC, Wrzesinski C, Kerstann K, Yu Z, Finkelstein SE, Theoret MR, Rosenberg SA, Restifo NP.

J Clin Invest. 2005 Jun;115(6):1616-26.

28.

Vaccine-stimulated, adoptively transferred CD8+ T cells traffic indiscriminately and ubiquitously while mediating specific tumor destruction.

Palmer DC, Balasubramaniam S, Hanada K, Wrzesinski C, Yu Z, Farid S, Theoret MR, Hwang LN, Klebanoff CA, Gattinoni L, Goldstein AL, Yang JC, Restifo NP.

J Immunol. 2004 Dec 15;173(12):7209-16.

29.

Poor immunogenicity of a self/tumor antigen derives from peptide-MHC-I instability and is independent of tolerance.

Yu Z, Theoret MR, Touloukian CE, Surman DR, Garman SC, Feigenbaum L, Baxter TK, Baker BM, Restifo NP.

J Clin Invest. 2004 Aug;114(4):551-9.

30.

IL-15 enhances the in vivo antitumor activity of tumor-reactive CD8+ T cells.

Klebanoff CA, Finkelstein SE, Surman DR, Lichtman MK, Gattinoni L, Theoret MR, Grewal N, Spiess PJ, Antony PA, Palmer DC, Tagaya Y, Rosenberg SA, Waldmann TA, Restifo NP.

Proc Natl Acad Sci U S A. 2004 Feb 17;101(7):1969-74. Epub 2004 Feb 4.

31.

High efficiency TCR gene transfer into primary human lymphocytes affords avid recognition of melanoma tumor antigen glycoprotein 100 and does not alter the recognition of autologous melanoma antigens.

Morgan RA, Dudley ME, Yu YY, Zheng Z, Robbins PF, Theoret MR, Wunderlich JR, Hughes MS, Restifo NP, Rosenberg SA.

J Immunol. 2003 Sep 15;171(6):3287-95.

32.

Tumor regression and autoimmunity after reversal of a functionally tolerant state of self-reactive CD8+ T cells.

Overwijk WW, Theoret MR, Finkelstein SE, Surman DR, de Jong LA, Vyth-Dreese FA, Dellemijn TA, Antony PA, Spiess PJ, Palmer DC, Heimann DM, Klebanoff CA, Yu Z, Hwang LN, Feigenbaum L, Kruisbeek AM, Rosenberg SA, Restifo NP.

J Exp Med. 2003 Aug 18;198(4):569-80.

33.

Assumptions of the tumor 'escape' hypothesis.

Restifo NP, Antony PA, Finkelstein SE, Leitner WW, Surman DP, Theoret MR, Touloukian CE.

Semin Cancer Biol. 2002 Feb;12(1):81-6. Review.

34.

The future of interleukin-2: enhancing therapeutic anticancer vaccines.

Overwijk WW, Theoret MR, Restifo NP.

Cancer J Sci Am. 2000 Feb;6 Suppl 1:S76-80. Review.

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