Kun He

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

Huanyu Chen, P. Keegan, R. Pazdur, 2013, Therapeutic innovation & regulatory science.

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

K. Goldberg, P. Keegan, Amy McKee, 2017, The oncologist.

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

Huanyu Chen, P. Keegan, R. Pazdur, 2017, Clinical Cancer Research.

FDA Review Summary: Mozobil in Combination with Granulocyte Colony-Stimulating Factor to Mobilize Hematopoietic Stem Cells to the Peripheral Blood for Collection and Subsequent Autologous Transplantation

J. Fourie, R. Pazdur, R. Justice, 2010, Oncology.

Liver transplantation combined with tyrosine kinase inhibitors for the treatment of hepatic metastatic giant gastrointestinal stromal tumors: A case report and literature review

J. Qian, Kun He, Ze-min Hu, 2022, Frontiers in Gastroenterology.

Automatic classification of gastric lesions in gastroscopic images using a lightweight deep learning model with attention mechanism and cost-sensitive learning

Wei Tian, Jingyang Li, Tian-ming Xu, 2022, Frontiers in Physics.

FDA Approval Summary: Sonidegib for Locally Advanced Basal Cell Carcinoma

Huanyu Chen, P. Keegan, R. Pazdur, 2017, Clinical Cancer Research.

U.S. Food and Drug Administration Approval: Vismodegib for Recurrent, Locally Advanced, or Metastatic Basal Cell Carcinoma

P. Keegan, R. Pazdur, A. Russell, 2013, Clinical Cancer Research.

FDA approval summary: crizotinib for the treatment of metastatic non-small cell lung cancer with anaplastic lymphoma kinase rearrangements.

Huanyu Chen, P. Keegan, R. Pazdur, 2014, The oncologist.

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

Gideon Blumenthal, Richard Pazdur, P. Keegan, 2016, The oncologist.

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

Huanyu Chen, P. Keegan, Amy McKee, 2016, Clinical Cancer Research.

FDA Approval Summary: Ramucirumab for Gastric Cancer

Huanyu Chen, K. He, P. Keegan, 2015, Clinical Cancer Research.

Benefit-Risk Summary of Crizotinib for the Treatment of Patients With ROS1 Alteration-Positive, Metastatic Non-Small Cell Lung Cancer

R. Pazdur, G. Blumenthal, Lola Luo, 2016, The oncologist.

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

P. Keegan, R. Pazdur, G. Blumenthal, 2016, The oncologist.

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

K. Goldberg, P. Keegan, Amy McKee, 2017, The oncologist.

FDA Approval Summary: Vemurafenib for Treatment of Unresectable or Metastatic Melanoma with the BRAFV600E Mutation

Justin C. Earp, Amy McKee, R. Pazdur, 2014, Clinical Cancer Research.

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.

S. Khozin, P. Keegan, R. Pazdur, 2014, The oncologist.

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

L. Fashoyin-Aje, Martha Donoghue, Huanyu Chen, 2018, The oncologist.

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

Huanyu Chen, K. He, K. Goldberg, 2017, Clinical Cancer Research.

Current Statistical Challenges in Oncology Clinical Trials in the Era of Targeted Therapy

R. Sridhara, Shenghui Tang, L. Nie, 2015 .

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

P. Keegan, R. Pazdur, G. Blumenthal, 2016, Clinical Cancer Research.

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

S. Khozin, P. Keegan, R. Pazdur, 2016, Clinical Cancer Research.

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

K. He, P. Keegan, R. Pazdur, 2017, Clinical Cancer Research.

FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as single agents for first-line treatment of advanced/metastatic PD-L1 high NSCLC.

Jiang Liu, Martha Donoghue, R. Pazdur, 2022, Clinical cancer research : an official journal of the American Association for Cancer Research.

U.S. Food and Drug Administration Approval: peginterferon-alfa-2b for the adjuvant treatment of patients with melanoma.

P. Keegan, R. Pazdur, Martin H. Cohen, 2012, The oncologist.

Vorinostat for Treatment of Cutaneous Manifestations of Advanced Primary Cutaneous T-Cell Lymphoma

K. He, R. Pazdur, R. Justice, 2007, Clinical Cancer Research.

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

P. Keegan, R. Pazdur, Hong Zhao, 2017, Clinical Cancer Research.

Approval : Alectinib for the Treatment of Metastatic ALK-Positive Non – Small Cell Lung Cancer Following

Huanyu Chen, P. Keegan, Amy McKee, 2016 .

Overestimation of the Effect Size in Group Sequential Trials

P. Cortazar, G. Blumenthal, R. Sridhara, 2012, Clinical Cancer Research.

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.

Richard Pazdur, Huanyu Chen, P. Keegan, 2013, The oncologist.

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

Lan Huang, P. Keegan, R. Pazdur, 2017, Clinical Cancer Research.

An FDA Pooled Analysis of Patients with Melanoma Treated with an Anti-PD1 Antibody Beyond RECIST Progression

Huanyu Chen, K. Goldberg, P. Keegan, 2018, The Lancet. Oncology.

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

Huanyu Chen, K. Goldberg, P. Keegan, 2018, The Lancet. Oncology.

Identification of Potential Predictors of Prognosis and Sorafenib-Associated Survival Benefits in Patients with Hepatocellular Carcinoma after Transcatheter Arterial Chemoembolization

Shangyu Wang, Zelong Yang, Yong Chen, 2022, Current oncology.

FDA Approval Summary: Lenvatinib for Progressive, Radio-iodine–Refractory Differentiated Thyroid Cancer

K. He, P. Keegan, R. Pazdur, 2015, Clinical Cancer Research.

FDA Approval Summary: TAS-102

K. He, P. Keegan, R. Pazdur, 2017, Clinical Cancer Research.

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

K. Goldberg, P. Keegan, Amy McKee, 2017, Clinical Cancer Research.

Treatment with camrelizumab plus tyrosine kinase inhibitors with or without TACE for intermediate-advanced hepatocellular carcinoma: a clinical efficacy and safety study

Jingdong Li, Yongfu Xiong, Yongheng Li, 2023, Oncologie.

Liposomal doxorubicin in combination with bortezomib for relapsed or refractory multiple myeloma.

R. Pazdur, R. Justice, R. Sridhara, 2007, Oncology.

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

Martha Donoghue, K. He, P. Keegan, 2012, Clinical Cancer Research.

PRESERVE-003: Phase 3, two-stage, randomized study of ONC-392 versus docetaxel in metastatic non-small cell lung cancers that progressed on PD-1/PD-L1 inhibitors.

M. Socinski, Yang Liu, P. Zheng, 2023, Journal of Clinical Oncology.

U.S. Food and Drug Administration Approval: Vismodegib for Recurrent, Locally Advanced, or Metastatic Basal Cell Carcinoma

P. Keegan, R. Pazdur, A. Russell, 2013, Clinical Cancer Research.

S. Khozin, P. Keegan, R. Pazdur, 2014, The oncologist.

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

P. Keegan, R. Pazdur, G. Blumenthal, 2016, Clinical Cancer Research.

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

Huanyu Chen, P. Keegan, R. Pazdur, 2014, Therapeutic innovation & regulatory science.