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Eribulin mesylate for the treatment of patients with refractory metastatic breast cancer: use of a "physician's choice" control arm in a randomized approval trial.
Donoghue M, Lemery SJ, Yuan W, He K, Sridhara R, Shord S, Zhao H, Marathe A, Kotch L, Jee J, Wang Y, Zhou L, Adams WM, Jarral V, Pilaro A, Lostritto R, Gootenberg JE, Keegan P, Pazdur R. Donoghue M, et al. Among authors: he k. Clin Cancer Res. 2012 Mar 15;18(6):1496-505. doi: 10.1158/1078-0432.CCR-11-2149. Epub 2012 Jan 26. Clin Cancer Res. 2012. PMID: 22282463
Overestimation of the effect size in group sequential trials.
Zhang JJ, Blumenthal GM, He K, Tang S, Cortazar P, Sridhara R. Zhang JJ, et al. Among authors: he k. Clin Cancer Res. 2012 Sep 15;18(18):4872-6. doi: 10.1158/1078-0432.CCR-11-3118. Epub 2012 Jul 2. Clin Cancer Res. 2012. PMID: 22753584
Approval summary: Cetuximab in combination with cisplatin or carboplatin and 5-fluorouracil for the first-line treatment of patients with recurrent locoregional or metastatic squamous cell head and neck cancer.
Cohen MH, Chen H, Shord S, Fuchs C, He K, Zhao H, Sickafuse S, Keegan P, Pazdur R. Cohen MH, et al. Among authors: he k. Oncologist. 2013;18(4):460-6. doi: 10.1634/theoncologist.2012-0458. Epub 2013 Apr 10. Oncologist. 2013. PMID: 23576486 Free PMC article.
U.S. Food and Drug Administration approval summary: Erlotinib for the first-line treatment of metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations.
Khozin S, Blumenthal GM, Jiang X, He K, Boyd K, Murgo A, Justice R, Keegan P, Pazdur R. Khozin S, et al. Among authors: he k. Oncologist. 2014 Jul;19(7):774-9. doi: 10.1634/theoncologist.2014-0089. Epub 2014 May 27. Oncologist. 2014. PMID: 24868098 Free PMC article.
4,602 results