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Lessons From ADAURA on Adjuvant Cancer Drug Trials: Evidence, Ethics, and Economics
Bishal Gyawali, MD, PhD1,2,3 and Howard (Jack) West, MD4
doi : 10.1200/JCO.20.01762
no. 3 (January 20, 2021) 175-177.
Contemporary Multi-Institutional Cohort of 550 Cases of Phyllodes Tumors (2007-2017) Demonstrates a Need for More Individualized Margin Guidelines
Laura H. Rosenberger, MD, MS1,2; Samantha M. Thomas, MS2,3; Suniti N. Nimbkar, MD4; Tina J. Hieken, MD5; Kandice K. Ludwig, MD6; Lisa K. Jacobs, MD7; ...
doi : 10.1200/JCO.20.02647
no. 3 (January 20, 2021) 178-189.
Phyllodes tumors (PTs) are rare breast neoplasms, which have little granular data on margins. Current guidelines recommend ? 1 cm margins; however, recent data suggest narrower margins are sufficient, and for benign PT, a negative margin may not be necessary.
Pan-AKT Inhibitor Capivasertib With Docetaxel and Prednisolone in Metastatic Castration-Resistant Prostate Cancer: A Randomized, Placebo-Controlled Phase II Trial (ProCAID)
Simon J. Crabb, PhD1,2,3; Gareth Griffiths, PhD1,2; Ellice Marwood, BSc1,2; Denise Dunkley, BSc1,2,3; Nichola Downs, PGCert1,2; Karen Martin, BSc1,2; ...
doi : 10.1200/JCO.20.01576
no. 3 (January 20, 2021) 190-201.
Capivasertib is a pan-AKT inhibitor. Preclinical data indicate activity in metastatic castration-resistant prostate cancer (mCRPC) and synergism with docetaxel.
Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study
James W. F. Catto, MBChB, PhD1; Kathryn Gordon, BSc2; Michelle Collinson, MS2; Heather Poad, BSc2; Maureen Twiddy, PhD3; Mark Johnson, MD4; ...
doi : 10.1200/JCO.20.01665
no. 3 (January 20, 2021) 202-214.
High-grade nonmuscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease. Treatments include intravesical maintenance Bacillus Calmette-Guerin (mBCG) and radical cystectomy (RC). We wanted to understand whether a randomized trial comparing these options was possible.
Survival Impact of Anti-GD2 Antibody Response in a Phase II Ganglioside Vaccine Trial Among Patients With High-Risk Neuroblastoma With Prior Disease Progression
Irene Y. Cheung, ScD1; Nai-Kong V. Cheung, MD, PhD1; Shakeel Modak, MD1; Audrey Mauguen, PhD2; Yi Feng, MS1; Ellen Basu, MD, PhD1; ...
doi : 10.1200/JCO.20.01892
no. 3 (January 20, 2021) 215-226.
Anti-GD2 monoclonal antibody (mAb) has proven efficacy in high-risk neuroblastoma (HR-NB). A small phase I GD2/GD3 vaccine trial (n = 15) described long-term survival and a favorable safety profile among patients with a history of disease progression (PD). The kinetics of mounting antibody response to vaccine and its prognostic impact on survival are now investigated in a phase II study (ClinicalTrials.gov identifier: NCT00911560).
Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial
Aurore Perrot, MD, PhD1; Thierry Facon, MD2; Torben Plesner, MD3; Saad Z. Usmani, MD, PhD4; Shaji Kumar, MD5; Nizar J. Bahlis, MD6; ...
doi : 10.1200/JCO.20.01370
no. 3 (January 20, 2021) 227-237.
To evaluate the effects of daratumumab, lenalidomide, and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) on patient-reported outcomes (PROs) in the phase III MAIA study.
Defining Clinical Utility of Tumor Biomarker Tests: A Clinician's Viewpoint
Daniel F. Hayes, MD1
doi : 10.1200/JCO.20.01572
no. 3 (January 20, 2021) 238-248.
Tumor biomarker tests (TBTs) are used to guide therapeutic strategies for patients with cancer. However, the regulatory environment for TBTs in the United States is inconsistent and, in general, TBTs are poorly valued. The National Academy of Medicine has recommended that TBTs should not be used in general practice until they are shown to have analytical validity and clinical utility. The latter term, first coined by the Evaluation of Genomic Applications in Practice and Prevention Initiative, has been widely stated but is indeterminately defined.
Knuckles
Kathryn E. Hitchcock, MD, PhD1
doi : 10.1200/JCO.20.03165
no. 3 (January 20, 2021) 249-250.
Neratinib in HER2-Positive Breast Cancer With Brain Metastases
Tim Johannes Adrianus Dekker, PhD
doi : 10.1200/JCO.20.02385
no. 3 (January 20, 2021) 251-252.
Neratinib Plus Capecibine in Patients With HER2-Positive Metastatic Breast Cancer
Dun-Chang Mo, MD, Peng-Hui Luo, MD, Jian-Feng Huang, MD, Shang-Xiao Huang, MD, and Han-Lei Wang, MD
doi : 10.1200/JCO.20.02378
no. 3 (January 20, 2021) 252-253.
Comparative Effectiveness Research Needs to Consider Optimal Dosing and Scheduling
Andrew D. Seidman, MD, Elisa de Stanchina, PhD, Larry Norton, MD, and Aki Morikawa, MD
doi : 10.1200/JCO.20.02355
no. 3 (January 20, 2021) 253-254.
Reply to T. J. A. Dekker, D.-C. Mo et al, and A. Seidman et al
Cristina Saura, MD, PhD, Mafalda Oliveira, MD, PhD, Sung-Bae Kim, MD, PhD, Thomas Yau, MD, MBBS, Toshimi Takano, MD, and Adam Brufsky, MD, PhD
doi : 10.1200/JCO.20.02963
no. 3 (January 20, 2021) 254-255.
Subgroup Analysis From SOLO1 Trial
Seema Gulia, MD, DM, and Sudeep Gupta, MD, DM
doi : 10.1200/JCO.20.02467
no. 3 (January 20, 2021) 255-255.
Reply to S. Gulia et al
Paul DiSilvestro, MD, Elizabeth S. Lowe, MD, ScM, and Ralph Bloomfield, MSc
doi : 10.1200/JCO.20.03081
no. 3 (January 20, 2021) 256-256.
