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Items: 20

1.

Outcomes of Older Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-Negative Metastatic Breast Cancer Treated With a CDK4/6 Inhibitor and an Aromatase Inhibitor: An FDA Pooled Analysis.

Howie LJ, Singh H, Bloomquist E, Wedam S, Amiri-Kordestani L, Tang S, Sridhara R, Sanchez J, Prowell TM, Kluetz PG, King-Kallimanis BL, Gao JJ, Ibrahim A, Goldberg KB, Theoret M, Pazdur R, Beaver JA.

J Clin Oncol. 2019 Sep 27:JCO1802217. doi: 10.1200/JCO.18.02217. [Epub ahead of print]

PMID:
31560580
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.

Blinding and Patient-Reported Outcome Completion Rates in US Food and Drug Administration Cancer Trial Submissions, 2007-2017.

Roydhouse JK, King-Kallimanis BL, Howie LJ, Singh H, Kluetz PG.

J Natl Cancer Inst. 2019 May 1;111(5):459-464. doi: 10.1093/jnci/djy181.

PMID:
30561711
4.

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.

PMID:
30552112
5.

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.

6.

Early Stage HER2-Positive Breast Cancers Not Achieving a pCR From Neoadjuvant Trastuzumab- or Pertuzumab-Based Regimens Have an Immunosuppressive Phenotype.

Force J, Howie LJ, Abbott SE, Bentley R, Marcom PK, Kimmick G, Westbrook K, Sammons SL, Parks M, Topping DL, Emerson R, Broadwater G, Hyslop T, Blackwell KL, Nair SK.

Clin Breast Cancer. 2018 Oct;18(5):410-417. doi: 10.1016/j.clbc.2018.02.010. Epub 2018 Feb 24.

PMID:
29615305
7.

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. Review.

PMID:
29494733
8.

Neoadjuvant use of ipilimumab in locally advanced melanoma.

Howie LJ, Tyler DS, Salama AK.

J Surg Oncol. 2015 Dec;112(8):841-3. doi: 10.1002/jso.24079.

PMID:
26768512
9.

Polls and policy: signals or substance.

Howie LJ, Peppercorn JM.

J Clin Oncol. 2015 Mar 10;33(8):819-20. doi: 10.1200/JCO.2014.59.8524. Epub 2015 Jan 26. No abstract available.

PMID:
25624434
10.

There is a mismatch between the medicare benefit package and the preferences of patients with cancer and their caregivers.

Taylor DH Jr, Danis M, Zafar SY, Howie LJ, Samsa GP, Wolf SP, Abernethy AP.

J Clin Oncol. 2014 Oct 1;32(28):3163-8. doi: 10.1200/JCO.2013.54.2605. Epub 2014 Aug 25.

11.

The ethics of clinical trials for cancer therapy.

Howie LJ, Peppercorn JM.

N C Med J. 2014 Jul-Aug;75(4):270-3.

12.

A comparison of FDA and EMA drug approval: implications for drug development and cost of care.

Howie LJ, Hirsch BR, Abernethy AP.

Oncology (Williston Park). 2013 Dec;27(12):1195, 1198-1200, 1202 passim. No abstract available.

13.

Wind-borne dispersal of a parasitoid: the process, the model, and its validation.

Kristensen NP, Schellhorn NA, Hulthen AD, Howie LJ, De Barro PJ.

Environ Entomol. 2013 Dec;42(6):1137-48. doi: 10.1603/EN12243. Epub 2013 Nov 11.

PMID:
24216288
14.

To stent or not to stent: an evidence-based approach to palliative procedures at the end of life.

Dy SM, Harman SM, Braun UK, Howie LJ, Harris PF, Jayes RL.

J Pain Symptom Manage. 2012 Apr;43(4):795-801. doi: 10.1016/j.jpainsymman.2011.12.269. Review.

15.

Trends and differential use of assistive technology devices: United States, 1994.

Russell JN, Hendershot GE, LeClere F, Howie LJ, Adler M.

Adv Data. 1997 Nov 13;(292):1-9.

PMID:
10182811
16.

Ophthalmic examination among adults with diagnosed diabetes mellitus.

Brechner RJ, Cowie CC, Howie LJ, Herman WH, Will JC, Harris MI.

JAMA. 1993 Oct 13;270(14):1714-8.

PMID:
8411502
17.

Self-monitoring of blood glucose by adults with diabetes in the United States population.

Harris MI, Cowie CC, Howie LJ.

Diabetes Care. 1993 Aug;16(8):1116-23.

PMID:
8375241
18.

Use of selected medical device implants in the United States, 1988.

Moss AJ, Hamburger S, Moore RM Jr, Jeng LL, Howie LJ.

Adv Data. 1991 Feb 26;(191):1-24. No abstract available.

PMID:
10170709
19.

Prevalence of selected chronic digestive conditions.

Drury TF, Howie LJ.

Vital Health Stat 10. 1979 Jul;10(123):1-55. No abstract available.

20.

Current estimates from the Health Interview Survey: United States--1977.

Howie LJ, Drury TF.

Vital Health Stat 10. 1978 Sep;(126):1-98. No abstract available.

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