Journal of Clinical Oncology




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Adjuvant Therapy With EGFR Tyrosine Kinase Inhibitors: Tempering Great Expectations With Realism

Saiama N. Waqar, MBBS, MSCI1,2 and Ramaswamy Govindan , MD1,2

doi : 10.1200/JCO.20.03297

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 697-700.

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Benefits of Digital Symptom Monitoring With Patient-Reported Outcomes During Adjuvant Cancer Treatment

Ethan Basch , MD1,2; Allison B. Leahy , MD3; and Amylou C. Dueck , PhD4

doi : 10.1200/JCO.20.03375

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 701-703.

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Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (POLARIS-02)

Feng-Hua Wang, MD, PhD1; Xiao-Li Wei, MD1; Jifeng Feng, MD, PhD2; Qi Li, MD, PhD3; Nong Xu, MD, PhD4; Xi-Chun Hu , MD, PhD5; Wangjun Liao, MD, PhD6; Yi Jiang, MD, PhD7; Xiao-Yan Lin, MD, PhD8; Qing-yuan Zhang, MD, PhD9; Xiang-Lin Yuan, MD, PhD10; Hai-Xin Huang, MD, PhD11; Ye Chen, MD, PhD12; Guang-Hai Dai , MD, PhD13; Jian-Hua Shi, MD, PhD14; Lin Shen , MD, PhD15; Shu-Jun Yang, MD, PhD16; Yong-Qian Shu, MD, PhD17; Yun-Peng Liu, MD, PhD18; Weifeng Wang, PhD19; Hai Wu, PhD20; Hui Feng, PhD20; Sheng Yao, PhD20; and Rui-Hua Xu , MD, PhD1,21

doi : 10.1200/JCO.20.02712 

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 704-712.

As yet, no checkpoint inhibitor has been approved to treat nasopharyngeal carcinoma (NPC). This study was aimed to evaluate the antitumor activity, safety, and biomarkers of toripalimab, a new programmed death-1 (PD-1) inhibitor for recurrent or metastatic NPC (RM-NPC) refractory to standard chemotherapy.

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Gefitinib Versus Vinorelbine Plus Cisplatin as Adjuvant Treatment for Stage II-IIIA (N1-N2) EGFR-Mutant NSCLC: Final Overall Survival Analysis of CTONG1104 Phase III Trial

Wen-Zhao Zhong , MD1; Qun Wang, MD2; Wei-Min Mao, MD3; Song-Tao Xu, MD2; Lin Wu , MD4; Yu-Cheng Wei, MD5; Yong-Yu Liu, MD6; Chun Chen, MD7; Ying Cheng , MD8; Rong Yin, MD9; Fan Yang, MD10; Sheng-Xiang Ren, MD11; Xiao-Fei Li, MD12; Jian Li, MD13; Cheng Huang, MD14; Zhi-Dong Liu, MD15; Shun Xu, MD16; Ke-Neng Chen, MD17; Shi-Dong Xu, MD18; Lun-Xu Liu , MD19; Ping Yu, MD20; Bu-Hai Wang, MD21; Hai-Tao Ma, MD22; Jin-Ji Yang , MD1; Hong-Hong Yan , MSc1; Xue-Ning Yang , MD1; Si-Yang Liu, MD1; Qing Zhou, MD1; and Yi-Long Wu , MD1 on behalf of the ADJUVANT investigators

doi : 10.1200/JCO.20.01820

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 713-722.

ADJUVANT-CTONG1104 (ClinicalTrials.gov identifier: NCT01405079), a randomized phase III trial, showed that adjuvant gefitinib treatment significantly improved disease-free survival (DFS) versus vinorelbine plus cisplatin (VP) in patients with epidermal growth factor receptor (EGFR) mutation-positive resected stage II-IIIA (N1-N2) non–small-cell lung cancer (NSCLC). Here, we report the final overall survival (OS) results.

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Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer

Hossein Borghaei , DO, MS1; Scott Gettinger , MD2; Everett E. Vokes , MD3; Laura Q. M. Chow , MD, FRCPC4; Marco Angelo Burgio, MD5; Javier de Castro Carpeno , MD, PhD6; Adam Pluzanski, MD, PhD7; Oscar Arrieta , MD, MSc8; Osvaldo Arén Frontera, MD9; Rita Chiari, MD, PhD10; Charles Butts, MD, FRCPC11; Joanna W?jcik-Tomaszewska, MD12; Bruno Coudert , MD13; Marina Chiara Garassino, MD14; Neal Ready, MD, PhD15; Enriqueta Felip , MD, PhD16; Miriam Alonso Garc?a, MD17; David Waterhouse , MD, MPH18; Manuel Domine , MD, PhD19; Fabrice Barlesi, MD, PhD20; Scott Antonia, MD, PhD21; Markus Wohlleber, MD22; David E. Gerber , MD23; Grzegorz Czyzewicz, MD24; David R. Spigel , MD25; Lucio Crino, MD5; Wilfried Enst Erich Eberhardt, MD26; Ang Li, MS27; Sathiya Marimuthu, MD27; and Julie Brahmer, MD, MSc28

doi : 10.1200/JCO.20.01605

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 723-733.

Immunotherapy has revolutionized the treatment of advanced non–small-cell lung cancer (NSCLC). In two phase III trials (CheckMate 017 and CheckMate 057), nivolumab showed an improvement in overall survival (OS) and favorable safety versus docetaxel in patients with previously treated, advanced squamous and nonsquamous NSCLC, respectively. We report 5-year pooled efficacy and safety from these trials.

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Phase III Randomized Controlled Trial of eRAPID: eHealth Intervention During Chemotherapy

Kate Absolom, PhD1,2; Lorraine Warrington, PhD1; Eleanor Hudson, MSc3; Jenny Hewison, PhD, MSc2; Carolyn Morris, BA4; Patricia Holch, PhD1,5; Robert Carter, HND, OND1; Andrea Gibson, RGN1,6; Marie Holmes, MSc1; Beverly Clayton, RGN1; Zoe Rogers, MSc1; Lucy McParland, MSc3; Mark Conner, PhD7; Liz Glidewell, MA, PhD, MSc2; Barbara Woroncow, MA8; Bryony Dawkins, MSc2; Sarah Dickinson, BSc1; Claire Hulme, MA, PhD2,9; Julia Brown, MSc3; and Galina Velikova, MD, PhD1,6

doi : 10.1200/JCO.20.02015

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 734-747.

Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is an online eHealth system for patients to self-report symptoms during cancer treatment. It provides automated severity-dependent patient advice guiding self-management or medical contact and displays the reports in electronic patient records. This trial evaluated the impact of eRAPID on symptom control, healthcare use, patient self-efficacy, and quality of life (QOL) in a patient population treated predominantly with curative intent.

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Early Interdisciplinary Supportive Care in Patients With Previously Untreated Metastatic Esophagogastric Cancer: A Phase III Randomized Controlled Trial

Zhihao Lu, MD, PhD1; Yu Fang, MPH2; Chang Liu, BSc1; Xiaotian Zhang, MD, PhD1; Xiaowei Xin, MSc2; Yi He, MD3; Yanshuo Cao, MD, PhD1; Xi Jiao, BSc1; Tianqi Sun, BSc4; Ying Pang, MSc3; Yanli Wang, MCM2; Jun Zhou, MD, PhD1; Changsong Qi, MD, PhD1; Jifang Gong, MD, PhD1; Xicheng Wang, MD, PhD1; Jian Li, MD, PhD1; Lili Tang, MD3; and Lin Shen , MD, PhD1

doi : 10.1200/JCO.20.01254

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 748-756.

Effective interventions to improve prognosis in metastatic esophagogastric cancer (EGC) are urgently needed. We assessed the effect of the early integration of interdisciplinary supportive care for patients with metastatic EGC on overall survival (OS).

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Melflufen and Dexamethasone in Heavily Pretreated Relapsed and Refractory Multiple Myeloma

Paul G. Richardson , MD1; Albert Oriol, MD2; Alessandra Larocca, MD, PhD3; Joan Bladé, MD, PhD4; Michele Cavo, MD5; Paula Rodriguez-Otero, MD, PhD6; Xavier Leleu , MD, PhD7; Omar Nadeem, MD1; John W. Hiemenz, MD8; Hani Hassoun, MD9; Cyrille Touzeau , MD, PhD10,11,12; Adri?n Alegre, MD, PhD13; Agne Paner, MD14; Christopher Maisel, MD15; Amitabha Mazumder, MD16; Anastasios Raptis, MD17; Jan S. Moreb, MD18; Kenneth C. Anderson , MD1; Jacob P. Laubach , MD, MPP1; Sara Thuresson, MSc19; Marcus Thuresson , PhD19; Catriona Byrne , RN19; Johan Harmenberg , MD19; Nicolaas A. Bakker, MD, PhD19; and Mar?a-Victoria Mateos, MD, PhD20; on behalf of the HORIZON (OP-106) Investigators

doi : 10.1200/JCO.20.02259

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 757-767.

Melphalan flufenamide (melflufen) is a first-in-class peptide-drug conjugate that targets aminopeptidases and rapidly and selectively releases alkylating agents into tumor cells. The phase II HORIZON trial evaluated the efficacy of melflufen plus dexamethasone in relapsed and refractory multiple myeloma (RRMM), a population with an important unmet medical need.

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Augmented Reduced-Intensity Regimen Does Not Improve Postallogeneic Transplant Outcomes in Acute Myeloid Leukemia

Charles Craddock , MD1,2; Aimee Jackson, Bsc2; Justin Loke , MD1; Shamyla Siddique, Bsc2; Andrea Hodgkinson, PhD2; John Mason, Bsc2; Georgia Andrew , Bsc3; Sandeep Nagra, MBChB1; Ram Malladi, MD4; Andrew Peniket, MD5; Maria Gilleece , MD6; Rahuman Salim, MD7; Eleni Tholouli, MD8; Victoria Potter, MD9; Charles Crawley, MD4; Keith Wheatley, DPhil2; Rachel Protheroe, MD10; Paresh Vyas , MD5; Ann Hunter, MD11; Anne Parker , MD12; Keith Wilson, MD13; Jiri Pavlu , MD14; Jenny Byrne , MD15; Richard Dillon , MD16; Naeem Khan, PhD3; Nicholas McCarthy , PhD3; and Sylvie D. Freeman, MD3

doi : 10.1200/JCO.20.02308

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 768-778.

Reduced-intensity conditioning (RIC) regimens have extended the curative potential of allogeneic stem-cell transplantation to older adults with high-risk acute myeloid leukemia (AML) and myelodysplasia (MDS) but are associated with a high risk of disease relapse. Strategies to reduce recurrence are urgently required. Registry data have demonstrated improved outcomes using a sequential transplant regimen, fludarabine/amsacrine/cytarabine-busulphan (FLAMSA-Bu), but the impact of this intensified conditioning regimen has not been studied in randomized trials.

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Long-Term Mental Health Service Utilization Among Survivors of Testicular Cancer: A Population-Based Cohort Study

Michael J. Raphael, MD1,2; Sumit Gupta, MD, PhD3,4; Xuejiao Wei, MSc2,5; Yingwei Peng, PhD2,6,7; Claudio N. Soares, MD, PhD8; Philippe L. Bedard, MD9; D. Robert Siemens, MD2,10; Andrew G. Robinson, MD2,11; and Christopher M. Booth, MD2,5,6,11

doi : 10.1200/JCO.20.02298

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 779-786.

Testicular cancer survivors may experience mental illness as a consequence of their cancer diagnosis and treatment.

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Focal Boost to the Intraprostatic Tumor in External Beam Radiotherapy for Patients With Localized Prostate Cancer: Results From the FLAME Randomized Phase III Trial

Linda G. W. Kerkmeijer, MD, PhD1,2; Veerle H. Groen, MD1; Floris J. Pos, MD, PhD3; Karin Haustermans, MD, PhD4; Evelyn M. Monninkhof, PhD5; Robert Jan Smeenk, MD, PhD2; Martina Kunze-Busch, PhD2; Johannes C. J. de Boer, PhD1; Jochem van der Voort van Zijp, MD, PhD1; Marco van Vulpen, MD, PhD6; Cédric Draulans, MD, PhD4; Laura van den Bergh, MD, PhD7; Sofie Isebaert, PhD4; and Uulke A. van der Heide, PhD3

doi : 10.1200/JCO.20.02873

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 787-796.

This study investigates whether focal boosting of the macroscopic visible tumor with external beam radiotherapy increases biochemical disease-free survival (bDFS) in patients with localized prostate cancer.

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NF106: A Neurofibromatosis Clinical Trials Consortium Phase II Trial of the MEK Inhibitor Mirdametinib (PD-0325901) in Adolescents and Adults With NF1-Related Plexiform Neurofibromas

Brian D. Weiss , MD1; Pamela L. Wolters , PhD2; Scott R. Plotkin , MD, PhD3; Brigitte C. Widemann, MD2; James H. Tonsgard, MD4; Jaishri Blakeley , MD5; Jeffrey C. Allen , MD6; Elizabeth Schorry , MD1; Bruce Korf , MD, PhD7; Nathan J. Robison, MD8; Stewart Goldman, MD9; Alexander A. Vinks , PhD, PharmD1; Chie Emoto, PhD1; Tsuyoshi Fukuda, PhD1; Coretta T. Robinson, MPH7; Gary Cutter , PhD7; Lloyd Edwards , PhD7; Eva Dombi , MD2; Nancy Ratner, PhD1; Roger Packer, MD10; and Michael J. Fisher, MD11

doi : 10.1200/JCO.20.02220

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 797-806.

Patients with neurofibromatosis type 1 (NF1) frequently develop plexiform neurofibromas (PNs), which can cause significant morbidity. We performed a phase II trial of the MAPK/ERK kinase inhibitor, mirdametinib (PD-0325901), in patients with NF1 and inoperable PNs. The primary objective was response rate based on volumetric magnetic resonance imaging analysis.

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Clinical Outcomes and Patient-Matched Molecular Composition of Relapsed Medulloblastoma

Rahul Kumar , PhD1,2; Kyle S. Smith, PhD1; Maximilian Deng, MD3; Colt Terhune, BA4; Giles W. Robinson , MD4; Brent A. Orr , MD, PhD6; Anthony P. Y. Liu , MBBS1,4; Tong Lin, PhD5; Catherine A. Billups , MS5; Murali Chintagumpala, MD7; Daniel C. Bowers , MD8; Timothy E. Hassall , MD9; Jordan R. Hansford , MD10; Dong Anh Khuong-Quang , PhD10; John R. Crawford, MD11; Anne E. Bendel, MD12; Sridharan Gururangan , MD13; Kristin Schroeder , MD, MPH13; Eric Bouffet , MD14; Ute Bartels , MD14; Michael J. Fisher, MD15; Richard Cohn, MD16; Sonia Partap , MD17; Stewart J. Kellie, MD18; Geoffrey McCowage, MD18; Arnold C. Paulino, MD19; Stefan Rutkowski, MD20; Gudrun Fleischhack , MD21; Girish Dhall, MD22; Laura J. Klesse , MD, PhD8; Sarah Leary , MD23; Javad Nazarian, PhD24; Marcel Kool, PhD25; Pieter Wesseling , MD26; Marina Ryzhova , MD27; Olga Zheludkova , MD28; Andrey V. Golanov , MD29; Roger E. McLendon, MD30; Roger J. Packer, MD31; Christopher Dunham , MD32; Juliette Hukin , MB33; Maryam Fouladi, MD34; Claudia C. Faria, MD35; Jose Pimentel, MD36; Andrew W. Walter , MD37; Nada Jabado, MD, PhD38; Yoon-Jae Cho, MD39; Sebastien Perreault, MD40; Sidney E. Croul, MD41; Michal Zapotocky , MD, PhD42; Cynthia Hawkins , MD, PhD43; Uri Tabori , MD43; Michael D. Taylor, MD, PhD43; Stefan M. Pfister , MD27; Paul Klimo Jr, MD44; Frederick A. Boop, MD44; David W. Ellison, MD, PhD6; Thomas E. Merchant , DO, PhD45; Arzu Onar-Thomas, PhD5; Andrey Korshunov, MD46; David T. W. Jones, PhD3,49; Amar Gajjar , MD4; Vijay Ramaswamy , MD, PhD43,48; and Paul A. Northcott, PhD1

doi : 10.1200/JCO.20.01359

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 807-821.

We sought to investigate clinical outcomes of relapsed medulloblastoma and to compare molecular features between patient-matched diagnostic and relapsed tumors.

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Outcomes by Clinical and Molecular Features in Children With Medulloblastoma Treated With Risk-Adapted Therapy: Results of an International Phase III Trial (SJMB03)

Amar Gajjar, MD1; Giles W. Robinson, MD1; Kyle S. Smith, PhD2; Tong Lin, PhD3; Thomas E. Merchant, DO, PhD4; Murali Chintagumpala, MD5; Anita Mahajan, MD6; Jack Su, MD5; Eric Bouffet, MD7; Ute Bartels, MD7; Tal Schechter, MD7; Tim Hassall, MD8; Thomas Robertson, MD9; Wayne Nicholls, MD8; Sridharan Gururangan, MRCP10; Kristin Schroeder, MD, MPH11; Michael Sullivan, MBChB, DCH, PhD12; Greg Wheeler, MBBS13; Jordan R. Hansford, MSc, MBBS12; Stewart J. Kellie, MBBS14; Geoffrey McCowage, MD14; Richard Cohn, MB15; Michael J. Fisher, MD16; Matthew J. Krasin, MD4; Clinton F. Stewart, PharmD17; Alberto Broniscer, MD, MS18; Ivo Buchhalter, PhD19; Ruth G. Tatevossian, MD, PhD20; Brent A. Orr, MD, PhD20; Geoff Neale, PhD21; Paul Klimo Jr, MD22; Frederick Boop, MD22; Ashok Srinivasan, MD23; Stefan M. Pfister, MD24; Richard J. Gilbertson, MD, PhD25; Arzu Onar-Thomas, PhD4; David W. Ellison, MD, PhD2; and Paul A. Northcott, PhD2

doi : 10.1200/JCO.20.01372

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 822-835.

SJMB03 (ClinicalTrials.gov identifier: NCT00085202) was a phase III risk-adapted trial that aimed to determine the frequency and clinical significance of biological variants and genetic alterations in medulloblastoma.

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Melflufen: A Next-Generation Nitrogen Mustard

Sarah A. Holstein, MD, PhD1; Jens Hillengass, MD2; and Philip L. McCarthy, MD2

doi : 10.1200/JCO.20.03326

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 836-839.

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Chemotherapy in Combination With Radiotherapy for Definitive-Intent Treatment of Stage II-IVA Nasopharyngeal Carcinoma: CSCO and ASCO Guideline

Yu-Pei Chen, MD1; Nofisat Ismaila , MD2; Melvin L. K. Chua , MD PhD3; A. Dimitrios Colevas, MD4; Robert Haddad , MD5; Shao Hui Huang , MD, MRT(T)6; Joseph T. S. Wee, MD3; Alexander C. Whitley, MD7; Jun-Lin Yi , MD8; Sue S. Yom , MD9; Anthony T. C. Chan , MD10; Chao-Su Hu, MD11; Jin-Yi Lang, MD12; Quynh-Thu Le , MD4; Anne W. M. Lee, MD13; Nancy Lee , MD14; Jin-Ching Lin, MD15; Brigette Ma , MD10; Thomas J. Morgan, MR16; Jatin Shah, MD14; Ying Sun, MD1; and Jun Ma , MD1

doi : 10.1200/JCO.20.03237

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 840-859.

The aim of this joint guideline is to provide evidence-based recommendations to practicing physicians and other healthcare providers on definitive-intent chemoradiotherapy for patients with stage II-IVA nasopharyngeal carcinoma (NPC).

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Clinical Trials for Real-World Elderly Patients With Metastatic Soft-Tissue Sarcomas: The Importance of Study Design and Patient-Reported Outcomes

Eugenie Younger , MD, Olga Husson , PhD, and Winette T. A. van der Graaf , MD, PhD

doi : 10.1200/JCO.20.02747

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 860-861.

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Misuse of Noninferiority Margin: How Much Margin Is Ethical?

Vinod Sharma, MD, DM and Akash Kumar , MD, DM

doi : 10.1200/JCO.20.02772

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 861-862.

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Suggestion for Research Design: Noninferiority Design in Elderly Patients With Soft-Tissue Sarcoma

Masaki Uchihara , MD, Kenichi Yoshimura, PhD, Akihiko Shimomura , MD, PhD, Yukino Kawamura , MD, and Chikako Shimizu, MD, PhD

doi : 10.1200/JCO.20.02907

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 862-863.

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Reply to E. Younger et al, V. Sharma et al, and M. Uchihara et al

Viktor Grünwald , MD, Xiaofei Liu , MSc, Markus Schuler , MD, and Sebastian Bauer , MD

doi : 10.1200/JCO.20.03272

Journal of Clinical Oncology 39, no. 7 (March 01, 2021) 864-865.

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