Journal of Clinical Oncology




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Increasing Donor Options in Allogenic Hematopoietic Cell Transplantation

Mohamad Mohty , MD, PhD1,2 and Florent Malard , MD, PhD1,2

doi : 10.1200/JCO.21.00622

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 1951-1954

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Documentation of Caregivers as a Standard of Care

Allison J. Applebaum , PhD1,2; Erin E. Kent , PhD3,4; and Wendy G. Lichtenthal , PhD1,2

doi : 10.1200/JCO.21.00402

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 1955-1958

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Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell–Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial

Martin Hutchings , PhD1; Franck Morschhauser, MD, PhD2; Gloria Iacoboni , MD3,4; Carmelo Carlo-Stella , MD5; Fritz C. Offner, MD, PhD6; Anna Sureda , MD, PhD7; Gilles Salles , MD8; Joaqu?n Mart?nez-Lopez, MD, PhD, MBA9; Michael Crump, MD10; Denise N. Thomas, MSc11; Peter N. Morcos, PharmD11; Cristiano Ferlini, MD11; Ann-Marie E. Br?ske, PhD12; Anton Belousov, PhD13; Marina Bacac, PhD13; Natalie Dimier, PhD14; David J. Carlile, PhD14; Linda Lundberg, PhD15; David Perez-Callejo, MD, PhD15; Pablo Uma?a, PhD13; Tom Moore, MD12; Martin Weisser, MD12; and Michael J. Dickinson , MBBS, DMedSci16

doi : 10.1200/JCO.20.03175

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 1959-1970

Glofitamab is a T-cell–engaging bispecific antibody possessing a novel 2:1 structure with bivalency for CD20 on B cells and monovalency for CD3 on T cells. This phase I study evaluated glofitamab in relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL). Data for single-agent glofitamab, with obinutuzumab pretreatment (Gpt) to reduce toxicity, are presented.

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National Marrow Donor Program–Sponsored Multicenter, Phase II Trial of HLA-Mismatched Unrelated Donor Bone Marrow Transplantation Using Post-Transplant Cyclophosphamide

Bronwen E. Shaw, MD, PhD1; Antonio Martin Jimenez-Jimenez, MD, MS2; Linda J. Burns, MD1; Brent R. Logan, PhD1; Farhad Khimani, MD3; Brian C. Shaffer, MD4; Nirav N. Shah, MD5; Alisha Mussetter, BS6; Xiao-Ying Tang, MPH1; John M. McCarty, MD7; Asif Alavi, MD8; Nosha Farhadfar, MD9; Katarzyna Jamieson, MD10; Nancy M. Hardy, MD11; Hannah Choe, MD12; Richard F. Ambinder, MD, PhD13; Claudio Anasetti, MD3; Miguel-Angel Perales, MD4; Stephen R. Spellman, MBS6; Alan Howard, PhD6; Krishna V. Komanduri, MD2; Leo Luznik, MD13; Maxim Norkin, MD, PhD14; Joseph A. Pidala, MD, PhD3; Voravit Ratanatharathorn, MD8; Dennis L. Confer, MD6; Steven M. Devine, MD6; Mary M. Horowitz, MD, MS1; and Javier Bola?os-Meade, MD13

doi : 10.1200/JCO.20.03502

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 1971-1982

Hematopoietic cell transplantation (HCT) is curative for hematologic disorders, but outcomes are historically inferior when using HLA-mismatched donors. Despite unrelated donor registries listing > 38 million volunteers, 25%-80% of US patients lack an HLA-matched unrelated donor, with significant disparity across ethnic groups. We hypothesized that HCT with a mismatched unrelated donor (MMUD) using post-transplant cyclophosphamide (PTCy), a novel strategy successful in overcoming genetic disparity using mismatched related donors, would be feasible and increase access to HCT.

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The Randomized AMBORA Trial: Impact of Pharmacological/Pharmaceutical Care on Medication Safety and Patient-Reported Outcomes During Treatment With New Oral Anticancer Agents

Pauline Dürr1,2; Katja Schlichtig2,3; Carolin Kelz2,3; Birgit Deutsch, MD2,3; Renke Maas, MD2,3; Michael J. Eckart, MD4; Jochen Wilke, MD5; Harald Wagner, MD5; Kerstin Wolff, MD2,6; Caroline Preu?, MD2,7; Valeska Brückl, MD2,8; Norbert Meidenbauer, MD2,8; Christian Staerk, PhD9; Andreas Mayr, PhD9; Rainer Fietkau, MD2,10; Peter J. Goebell, MD2,11; Frank Kunath, MD2,11; Matthias W. Beckmann, MD2,7; Andreas Mackensen , MD2,8; Markus F. Neurath, MD2,6; Marianne Pavel, MD2,6; Frank D?rje, PhD, MBA1,2; and Martin F. Fromm , MD2,3

doi : 10.1200/JCO.20.03088

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 1983-1994

Oral anticancer drugs (eg, kinase inhibitors) play an important role in cancer therapy. However, considerable challenges regarding medication safety of oral anticancer drugs have been reported. Randomized, controlled, multicenter studies on the impact of intensified clinical pharmacological/pharmaceutical care on patient safety and patient treatment perception are lacking.

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Ten-Year Outcome of Neoadjuvant Chemoradiotherapy Plus Surgery for Esophageal Cancer: The Randomized Controlled CROSS Trial

Ben M. Eyck, MD1; J. Jan B. van Lanschot, MD, PhD1,2; Maarten C. C. M. Hulshof, MD, PhD3; Berend J. van der Wilk, MD1; Joel Shapiro, MD, PhD1; Pieter van Hagen, MD, PhD1; Mark I. van Berge Henegouwen, MD, PhD4; Bas P. L. Wijnhoven, MD, PhD1; Hanneke W. M. van Laarhoven, MD, PhD5; Grard A. P. Nieuwenhuijzen, MD, PhD6; Geke A. P. Hospers, MD, PhD7; Johannes J. Bonenkamp, MD, PhD8; Miguel A. Cuesta, MD, PhD9; Reinoud J. B. Blaisse, MD10; Olivier R. Busch, MD, PhD4; Geert-Jan M. Creemers, MD, PhD11; Cornelis J. A. Punt, MD, PhD12,13; John Th. M. Plukker, MD, PhD14; Henk M. W. Verheul, MD, PhD15,16; Ernst J. Spillenaar Bilgen, MD, PhD17; Maurice J. C. van der Sangen, MD, PhD18; Tom Rozema, MD19,20; Fiebo J. W. ten Kate, MD, PhD21; Jannet C. Beukema, MD22; Anna H. M. Piet, MD23; Caroline M. van Rij, MD24; Janny G. Reinders, MD25; Hugo W. Tilanus, MD, PhD26; Ewout W. Steyerberg, PhD27,28; and Ate van der Gaast, MD, PhD29; for the CROSS Study Group

doi : 10.1200/JCO.20.03614

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 1995-2004

Preoperative chemoradiotherapy according to the chemoradiotherapy for esophageal cancer followed by surgery study (CROSS) has become a standard of care for patients with locally advanced resectable esophageal or junctional cancer. We aimed to assess long-term outcome of this regimen.

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Patient-Reported Outcomes in Patients With PIK3CA-Mutated Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer From SOLAR-1

Eva Maria Ciruelos, MD, PhD1; Hope S. Rugo , MD2; Ingrid A. Mayer , MD, MS3; Christelle Levy, MD4; Frédéric Forget, MD5; Juan Ignacio Delgado Mingorance, MD6; Tamar Safra , MD7; Norikazu Masuda , MD, PhD8; Yeon Hee Park, MD9; Dejan Juric , MD10; Pierfranco Conte , MD11; Mario Campone, MD, PhD12; Sibylle Loibl , MD13,14; Hiroji Iwata , MD15; Xiaolei Zhou, PhD16; Jinhee Park, PhD17; Antonia Ridolfi, MS18; Ines Lorenzo, PharmD19; and Fabrice André , MD, PhD20

doi : 10.1200/JCO.20.01139

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 2005-2015

In the phase III SOLAR-1 trial (NCT02437318), the PI3K?-selective inhibitor and degrader alpelisib significantly improved median progression-free survival when added to fulvestrant in patients with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)–mutated, hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer. We assessed health-related quality of life using patient-reported outcome measures in these patients.

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Association of Germline BRCA Pathogenic Variants With Diminished Ovarian Reserve: A Meta-Analysis of Individual Patient-Level Data

Volkan Turan, MD1,2; Matteo Lambertini, MD3,4; Dong-Yun Lee, MD5; Erica Wang, MD6; Florian Clatot, MD7; Beth Y. Karlan, MD8; Isabelle Demeestere, MD9; Heejung Bang, PhD10; and Kutluk Oktay, MD, PhD1,11

doi : 10.1200/JCO.20.02880

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 2016-2024

To determine whether germline BRCA (gBRCA) pathogenic variants are associated with decreased ovarian reserve.

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Neck Dissections Based on Sentinel Lymph Node Navigation Versus Elective Neck Dissections in Early Oral Cancers: A Randomized, Multicenter, and Noninferiority Trial

Yasuhisa Hasegawa, MD, PhD1; Kiyoaki Tsukahara, MD, PhD2; Seiichi Yoshimoto, MD, PhD3; Kouki Miura, MD, PhD4; Junkichi Yokoyama, MD, PhD5; Shigeru Hirano, MD, PhD6; Hirokazu Uemura, MD, PhD7; Masashi Sugasawa, MD, PhD8; Tomokazu Yoshizaki, MD, PhD9; Akihiro Homma, MD, PhD10; Kazuaki Chikamatsu, MD, PhD11; Mikio Suzuki, MD, PhD12; Akihiro Shiotani, MD, PhD13; Takashi Matsuzuka, MD, PhD1,14; Naoyuki Kohno, MD, PhD15; Masakazu Miyazaki, MD, PhD16; Isao Oze, MD, PhD17; Keitaro Matsuo, MD, PhD17; Shigeru Kosuda, MD, PhD18; and Yasushi Yatabe, MD, PhD3; for the HNCMM Research Group

doi : 10.1200/JCO.20.03637

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 2025-2036

This study aimed to compare patients with early oral cavity squamous cell carcinoma (OCSCC) (tumor category [T] 1-2, node-negative, and no distant metastasis) treated with traditional elective neck dissection (ND) with those managed by sentinel lymph node biopsy (SLNB) using survival and neck function and complications as end points.

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Appropriate Systemic Therapy Dosing for Obese Adult Patients With Cancer: ASCO Guideline Update

Jennifer J. Griggs , MD, MPH1; Kari Bohlke , ScD2; Edward P. Balaban, DO3; James J. Dignam, PhD4; Evan T. Hall , MD, MPhil5; R. Donald Harvey , PharmD6; Diane P. Hecht , PharmD, MEd7; Kelsey A. Klute, MD8; Vicki A. Morrison, MD9; T. May Pini , MD, MPH10; Gary L. Rosner , ScD11; Carolyn D. Runowicz , MD12; Michelle Shayne, MD13; Alex Sparreboom , PhD14; Sophia Turner, MSc15; Corrine Zarwan, MD16; and Gary H. Lyman , MD, MPH5

doi : 10.1200/JCO.21.00471

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 2037-2048

To provide recommendations for appropriate dosing of systemic antineoplastic agents in obese adults with cancer.

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Cardiac Failure Because of Osimertinib

Kartik Anand, MD and Joe Ensor , PhD

doi : 10.1200/JCO.21.00005

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 2049-2050

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Is Osimertinib-Induced Cardiotoxicity Really Harmless?

Kei Kunimasa , MD, PhD

doi : 10.1200/JCO.21.00266

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 2050-2051

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Reply to K. Anand et al and K. Kunimasa

Michael S. Ewer , MD, JD, PhD

doi : 10.1200/JCO.21.00502

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 2051-2052

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Erratum

doi : 10.1200/JCO.21.01212

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 2053-2053

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Erratum

doi : 10.1200/JCO.21.01191

Journal of Clinical Oncology 39, no. 18 (June 20, 2021) 2054-2054

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