Project 1.1

A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supp

Blackwell, Kimberly, Roman Donskih, Michael C Jones, Allen Nixon, Maria J. Vidal, Roumen Nakov, Pritibha Singh, Gregor Schaffar, Pere Gascón, and Nadia Harbeck. "A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supp." Oncologist 21, no. 7 (2016): 789-94.

Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome.

Roe, Matthew T., Derek D. Cyr, Debra Eckart, Phillip J. Schulte, Michael A. Morse, Kimberly L. Blackwell, Neal E. Ready, Yousuf S Zafar, Anne W. Beaven, John H. Strickler et al. "Ascertainment, classification, and impact of neoplasm detection during prolonged treatment with dual antiplatelet therapy with prasugrel vs. clopidogrel following acute coronary syndrome." Eur Heart J 37, no. 4 (2016): 412-22.

Celecoxib With Neoadjuvant Chemotherapy for Breast Cancer Might Worsen Outcomes Differentially by COX-2 Expression and ER Status: Exploratory Analysis of the REMAGUS02 Trial.

Hamy, Anne-Sophie, Sandrine Tury, Xiaofei Wang, Junheng Gao, Jean-Yves Pierga, Sylvie Giacchetti, Etienne Brain, Barbara Pistilli, Michel Marty, Marc Espié et al. "Celecoxib With Neoadjuvant Chemotherapy for Breast Cancer Might Worsen Outcomes Differentially by COX-2 Expression and ER Status: Exploratory Analysis of the REMAGUS02 Trial." J Clin Oncol 37, no. 8 (2019): 624-635.

Comparing oncology clinical programs by use of innovative designs and expected net present value optimization: Which adaptive approach leads to the best result?

Parke, Tom, Olga Marchenko, Vladimir Anisimov, Anastasia Ivanova, Christopher Jennison, Inna Perevozskaya, and Guochen Song. "Comparing oncology clinical programs by use of innovative designs and expected net present value optimization: Which adaptive approach leads to the best result?" J Biopharm Stat 27, no. 3 (2017): 457-476.

Effect of Erlotinib Plus Bevacizumab vs Erlotinib Alone on Progression-Free Survival in Patients With Advanced EGFR-Mutant Non-Small Cell Lung Cancer: A Phase 2 Randomized Clinical Trial.

Stinchcombe, Thomas E., Pasi A. Jänne, Xiaofei Wang, Erin M. Bertino, Jared Weiss, Lyudmila Bazhenova, Lin Gu, Christie Lau, Cloud Paweletz, Anthony Jaslowski et al. "Effect of Erlotinib Plus Bevacizumab vs Erlotinib Alone on Progression-Free Survival in Patients With Advanced EGFR-Mutant Non-Small Cell Lung Cancer: A Phase 2 Randomized Clinical Trial." JAMA Oncol 5, no. 10 (2019): 1448-1455.

Endpoint surrogacy in oncological randomized controlled trials with immunotherapies: a systematic review of trial-level and arm-level meta-analyses.

Zhang, Jianrong, Wenhua Liang, Hengrui Liang, Xiaofei Wang, and Jianxing He. "Endpoint surrogacy in oncological randomized controlled trials with immunotherapies: a systematic review of trial-level and arm-level meta-analyses." Ann Transl Med 7, no. 11 (2019): 244.

Enrollment Trends and Disparity Among Patients With Lung Cancer in National Clinical Trials, 1990 to 2012.

Pang, Herbert H., Xiaofei Wang, Thomas E. Stinchcombe, Melisa L. Wong, Perry Cheng, Apar Kishor Ganti, Daniel J. Sargent, Ying Zhang, Chen Hu, Sumithra J. Mandrekar et al. "Enrollment Trends and Disparity Among Patients With Lung Cancer in National Clinical Trials, 1990 to 2012." J Clin Oncol 34, no. 33 (2016): 3992-3999.

Phase II, randomized, placebo-controlled study of dovitinib in combination with fulvestrant in postmenopausal patients with HR, HER2 breast cancer that had progressed during or after prior endocrine therapy.

Musolino, Antonino, Mario Campone, Patrick Neven, Neelima Denduluri, Carlos H. Barrios, Javier Cortes, Kimberly Blackwell, Hatem Soliman, Zsuzsanna Kahan, Hervé Bonnefoi et al. "Phase II, randomized, placebo-controlled study of dovitinib in combination with fulvestrant in postmenopausal patients with HR, HER2 breast cancer that had progressed during or after prior endocrine therapy." Breast Cancer Res 19, no. 1 (2017): 18.

PIK3CA mutations enable targeting of a breast tumor dependency through mTOR-mediated MCL-1 translation.

Anderson, Gray R., Suzanne E. Wardell, Merve Cakir, Lorin Crawford, Jim C. Leeds, Daniel P. Nussbaum, Pallavi S. Shankar, Ryan S. Soderquist, Elizabeth M. Stein, Jennifer P. Tingley et al. "PIK3CA mutations enable targeting of a breast tumor dependency through mTOR-mediated MCL-1 translation." Sci Transl Med 8, no. 369 (2016): 369ra175.

Pooled Analysis of Individual Patient Data on Concurrent Chemoradiotherapy for Stage III Non-Small-Cell Lung Cancer in Elderly Patients Compared With Younger Patients Who Participated in US National Cancer Institute Cooperative Group Studies.

Stinchcombe, Thomas E., Ying Zhang, Everett E. Vokes, Joan H. Schiller, Jeffrey D. Bradley, Karen Kelly, Walter J. Curran, Steven E. Schild, Benjamin Movsas, Gerald Clamon et al. "Pooled Analysis of Individual Patient Data on Concurrent Chemoradiotherapy for Stage III Non-Small-Cell Lung Cancer in Elderly Patients Compared With Younger Patients Who Participated in US National Cancer Institute Cooperative Group Studies." J Clin Oncol 35, no. 25 (2017): 2885-2892.

Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.

Harbeck, Nadia, Oleg Lipatov, Mona Frolova, Dmitry Udovitsa, Eldar Topuzov, Doina Elena Ganea-Motan, Roumen Nakov, Pritibha Singh, Anita Rudy, and Kimberly Blackwell. "Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer." Future Oncol 12, no. 11 (2016): 1359-67.

Reporting and Guidelines in Propensity Score Analysis: A Systematic Review of Cancer and Cancer Surgical Studies.

Yao, Xiaoxin I., Xiaofei Wang, Paul J. Speicher, Shelley E Hwang, Perry Cheng, David H. Harpole, Mark F. Berry, Deborah Schrag, and Herbert H. Pang. "Reporting and Guidelines in Propensity Score Analysis: A Systematic Review of Cancer and Cancer Surgical Studies." J Natl Cancer Inst 109, no. 8 (2017).

Toxicity Related to Radiotherapy Dose and Targeting Strategy: A Pooled Analysis of Cooperative Group Trials of Combined Modality Therapy for Locally Advanced Non-Small Cell Lung Cancer.

Schild, Steven E., Wen Fan, Thomas E. Stinchcombe, Everett E. Vokes, Suresh S. Ramalingam, Jeffrey D. Bradley, Karen Kelly, Herbert H. Pang, and Xiaofei Wang. "Toxicity Related to Radiotherapy Dose and Targeting Strategy: A Pooled Analysis of Cooperative Group Trials of Combined Modality Therapy for Locally Advanced Non-Small Cell Lung Cancer." J Thorac Oncol 14, no. 2 (2019): 298-303.

Translational Breast Cancer Research Consortium (TBCRC) 022: A Phase II Trial of Neratinib for Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer and Brain Metastases.

Freedman, Rachel A., Rebecca S. Gelman, Jeffrey S. Wefel, Michelle E. Melisko, Kenneth R. Hess, Roisin M. Connolly, Catherine H. Van Poznak, Polly A. Niravath, Shannon L. Puhalla, Nuhad Ibrahim et al. "Translational Breast Cancer Research Consortium (TBCRC) 022: A Phase II Trial of Neratinib for Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer and Brain Metastases." J Clin Oncol 34, no. 9 (2016): 945-52.

Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial.

Diéras, Véronique, David Miles, Sunil Verma, Mark Pegram, Manfred Welslau, José Baselga, Ian E. Krop, Kim Blackwell, Silke Hoersch, Jin Xu et al. "Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial." Lancet Oncol 18, no. 6 (2017): 732-742.

Using Structural Equation Modeling to Assess the Links between Tobacco Smoke Exposure, Volatile Organic Compounds, and Respiratory Function for Adolescents Aged 6 to 18 in the United States.

Shook-Sa, Bonnie E., Ding-Geng Chen, and Haibo Zhou. "Using Structural Equation Modeling to Assess the Links between Tobacco Smoke Exposure, Volatile Organic Compounds, and Respiratory Function for Adolescents Aged 6 to 18 in the United States." Int J Environ Res Public Health 14, no. 10 (2017).

Validation of Progression-Free Survival as a Surrogate Endpoint for Overall Survival in Malignant Mesothelioma: Analysis of Cancer and Leukemia Group B and North Central Cancer Treatment Group (Alliance) Trials.

Wang, Xiaofei, Xiaoyi Wang, Lydia Hodgson, Stephen L. George, Daniel J. Sargent, Nate R. Foster, Apar Kishor Ganti, Thomas E. Stinchcombe, Jeffrey Crawford, Robert Kratzke et al. "Validation of Progression-Free Survival as a Surrogate Endpoint for Overall Survival in Malignant Mesothelioma: Analysis of Cancer and Leukemia Group B and North Central Cancer Treatment Group (Alliance) Trials." Oncologist 22, no. 2 (2017): 189-198.
Subscribe to Project 1.1