Journal of Clinical Oncology

The 21-gene recurrence score (RS) is prognostic for distant recurrence (DR) and predictive for chemotherapy benefit in early breast cancer, whereas clinical-pathological factors are only prognostic. Integration of genomic and clinical features offers the potential to guide adjuvant chemotherapy use with greater precision.

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Long-Term Follow-Up of Ibrutinib Monotherapy in Symptomatic, Previously Treated Patients With Waldenstr?m Macroglobulinemia

Steven P. Treon , MD, PhD1,2; Kirsten Meid, MPH1; Joshua Gustine, MPH1; Guang Yang , MD1; Lian Xu, BS1; Xia Liu, MD1; Christopher J. Patterson, MAcc, MPH1; Zachary R. Hunter , PhD1; Andrew R. Branagan , MD, PhD2,3; Jacob P. Laubach , MD1,2; Irene M. Ghobrial , MD1,2; M. Lia Palomba , MD4; Ranjana Advani , MD5; and Jorge J. Castillo , MD1,2

doi : 10.1200/JCO.20.00555

Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 565-575.

We report the long-term findings and final analysis of a pivotal multicenter trial of ibrutinib monotherapy in previously treated patients with Waldenstr?m macroglobulinemia (WM).

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Prediction of Outcome in Patients With Chronic Lymphocytic Leukemia Treated With Ibrutinib: Development and Validation of a Four-Factor Prognostic Model

Inhye E. Ahn, MD1; Xin Tian, PhD2; David Ipe, MS3; Mei Cheng, PhD3; Maher Albitar, MD4,5; L. Claire Tsao, PhD3; Lei Zhang, MA3; Wanlong Ma, MS4,5; Sarah E. M. Herman, PhD1; Erika M. Gaglione, BA1; Susan Soto, MSN1; James P. Dean, MD, PhD3; and Adrian Wiestner, MD, PhD1

doi : 10.1200/JCO.20.00979

Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 576-585.

Randomized trials established the superiority of ibrutinib-based therapy over chemoimmunotherapy in chronic lymphocytic leukemia. Durability of progression-free survival (PFS) with ibrutinib can vary by patient subgroup. Clinical tools for prognostication and risk-stratification are needed.

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Nivolumab Plus Ipilimumab for Treatment-Naïve Metastatic Uveal Melanoma: An Open-Label, Multicenter, Phase II Trial by the Spanish Multidisciplinary Melanoma Group (GEM-1402)

José Mar?a Piulats, MD, PhD1,2,3; Enrique Espinosa, MD, PhD3,4; Luis de la Cruz Merino, MD, PhD5; Mar Varela, MD, PhD6; Lorenzo Alonso Carri?n, MD, PhD7; Salvador Mart?n-Algarra, MD, PhD8; Rafael L?pez Castro, MD, PhD9; Teresa Curiel, MD, PhD10; Delvys Rodr?guez-Abreu, MD, PhD11; Miriam Redrado, AS3; Montserrat Gomà, MD, PhD6; Antonio José Rull?n, MD, PhD1; Alfonso Calvo Gonz?lez, MD, PhD3; and Alfonso Berrocal-Jaime, MD, PhD12

doi : 10.1200/JCO.20.00550

Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 586-598.

This study aimed to assess the efficacy of the combination of nivolumab (nivo) plus ipilimumab (ipi) as a first-line therapy with respect to the 12-month overall survival (OS) in patients with metastatic uveal melanoma (MUM) who are not eligible for liver resection.

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Nivolumab and Ipilimumab in Metastatic Uveal Melanoma: Results From a Single-Arm Phase II Study

Meredith S. Pelster, MD1; Stephen K. Gruschkus, PhD2; Roland Bassett, PhD2; Dan S. Gombos, MD3; Michael Shephard, BSN4; Liberty Posada, BS4; Maura S. Glover, MS4; Rinata Simien, MS4; Adi Diab, MD4; Patrick Hwu, MD4; Brett W. Carter, MD5; and Sapna P. Patel, MD4

doi : 10.1200/JCO.20.00605

Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 599-607.

Metastatic uveal melanoma has poor overall survival (OS) and no approved systemic therapy options. Studies of single-agent immunotherapy regimens have shown minimal benefit. There is the potential for improved responses with the use of combination immunotherapy.

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Development and Validation of a Risk Tool for Predicting Severe Toxicity in Older Adults Receiving Chemotherapy for Early-Stage Breast Cancer

Allison Magnuson, DO1; Mina S. Sedrak, MD2; Cary P. Gross, MD3; William P. Tew, MD4; Heidi D. Klepin, MD5; Tanya M. Wildes, MD6; Hyman B. Muss, MD7; Efrat Dotan, MD8; Rachel A. Freedman, MD9; Tracey O'Connor, MD10; William Dale, MD2; Harvey J. Cohen, MD11; Vani Katheria, MS2; Anait Arsenyan, MS2; Abrahm Levi, BS2; Heeyoung Kim, MPH2; Supriya Mohile, MD1; Arti Hurria, MD2,†; and Can-Lan Sun, PhD2

doi : 10.1200/JCO.20.02063

Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 608-618.

Limited tools exist to predict the risk of chemotherapy toxicity in older adults with early-stage breast cancer.

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Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133)

Stephen V. Liu , MD1; Martin Reck , MD, PhD2; Aaron S. Mansfield , MD3; Tony Mok, MD4; Arnaud Scherpereel , MD, PhD5; Niels Reinmuth, MD, PhD6; Marina Chiara Garassino, MD7; Javier De Castro Carpeno , MD8; Raffaele Califano, MD9; Makoto Nishio , MD10; Francisco Orlandi, MD11; Jorge Alatorre-Alexander, MD12; Ticiana Leal , MD13; Ying Cheng , MD14; Jong-Seok Lee, MD15; Sivuonthanh Lam, PharmD16; Mark McCleland, PhD16; Yu Deng, PhD16; See Phan, MD16; and Leora Horn , MD17

doi : 10.1200/JCO.20.01055

Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 619-630.

IMpower133 (ClinicalTrials.gov identifier: NCT02763579), a randomized, double-blind, phase I/III study, demonstrated that adding atezolizumab (anti-programmed death-ligand 1 [PD-L1]) to carboplatin plus etoposide (CP/ET) for first-line (1L) treatment of extensive-stage small-cell lung cancer (ES-SCLC) resulted in significant improvement in overall survival (OS) and progression-free survival (PFS) versus placebo plus CP/ET. Updated OS, disease progression patterns, safety, and exploratory biomarkers (PD-L1, blood-based tumor mutational burden [bTMB]) are reported.

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Duration of Adjuvant Doublet Chemotherapy (3 or 6 months) in Patients With High-Risk Stage II Colorectal Cancer

Timothy J. Iveson , MD, FRCP1; Alberto F. Sobrero , MD2; Takayuki Yoshino , MD, PhD3; Ioannis Souglakos, MD, PhD4; Fang-Shu Ou , PhD5; Jeffrey P. Meyers, BA5; Qian Shi , PhD5; Axel Grothey, MD6; Mark P. Saunders, MD, PhD7; Roberto Labianca, MD8; Takeharu Yamanaka , PhD9; Ioannis Boukovinas, MD, PhD, PharmaD10; Niels H. Hollander , MD11; Fabio Galli, MSc12; Kentaro Yamazaki, MD, PhD13; Vassilis Georgoulias, MD, PhD14; Rachel Kerr, BSc (Hons), MBChB (Hons), FRCP, PhD15; Eiji Oki , MD, PhD, FACS16; Sara Lonardi , MD17; Andrea Harkin , BA18; Gerardo Rosati , MD19; and James Paul , BSc (Hons)18

doi : 10.1200/JCO.20.01330

Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 631-641.

As oxaliplatin results in cumulative neurotoxicity, reducing treatment duration without loss of efficacy would benefit patients and healthcare providers.

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Microsatellite Instability in Patients With Stage III Colon Cancer Receiving Fluoropyrimidine With or Without Oxaliplatin: An ACCENT Pooled Analysis of 12 Adjuvant Trials

Romain Cohen, MD, PhD1,2; Julien Taieb, MD, PhD3; Jack Fiskum2; Greg Yothers, PhD4; Richard Goldberg, MD5; Takayuki Yoshino, MD6; Steven Alberts, MD7; Carmen Allegra, MD8; Aimery de Gramont, MD, PhD9; Jean-Francois Seitz, MD10; Michael O'Connell, MD7; Daniel Haller, MD11; Norman Wolmark, MD12; Charles Erlichman, MD7; Alberto Zaniboni, MD13; Sara Lonardi, MD14; Rachel Kerr, MD15; Axel Grothey, MD16; Frank A. Sinicrope, MD7; Thierry André, MD1; and Qian Shi, PhD2

doi : 10.1200/JCO.20.01600

Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 642-651.

In patients with stage III colon cancer (CC) whose tumors demonstrate microsatellite instability (MSI), the efficacy of adjuvant fluoropyrimidine (FP) with or without oxaliplatin has not been clearly demonstrated and the prognostic value of MSI remains uncertain.

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Clinical Implications of Minimal Residual Disease Detection in Infants With KMT2A-Rearranged Acute Lymphoblastic Leukemia Treated on the Interfant-06 Protocol

Janine Stutterheim , MD, PhD1; Inge M. van der Sluis, MD, PhD1; Paola de Lorenzo, PhD2,3; Julia Alten, MD4; Philip Ancliffe, MD5; Andishe Attarbaschi , MD6; Benoit Brethon, MD7; Andrea Biondi , MD3; Myriam Campbell, MD8; Giovanni Cazzaniga , PhD9; Gabriele Escherich, MD10; Alina Ferster, MD11; Rishi S. Kotecha , MBChB, PhD12,13; Birgitte Lausen, MD, PhD14; Chi Kong Li , MD15; Luca Lo Nigro, MD, PhD16; Franco Locatelli , MD, PhD17; Rolf Marschalek, PhD18; Claus Meyer, PhD18; Martin Schrappe, MD, PhD19; Jan Stary, MD, PhD20; Ajay Vora, MD5; Jan Zuna, MD, PhD21; Vincent H. J. van der Velden, PhD22; Tomasz Szczepanski, MD, PhD23; Maria Grazia Valsecchi, PhD2; and Rob Pieters , MD, PhD, MSc1,24

doi : 10.1200/JCO.20.02333

Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 652-662.

Infant acute lymphoblastic leukemia (ALL) is characterized by a high incidence of KMT2A gene rearrangements and poor outcome. We evaluated the value of minimal residual disease (MRD) in infants with KMT2A-rearranged ALL treated within the Interfant-06 protocol, which compared lymphoid-style consolidation (protocol IB) versus myeloid-style consolidation (araC, daunorubicin, etoposide/mitoxantrone, araC, etoposide).

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Risk-Based Selection of Individuals for Oral Cancer Screening

Li C. Cheung, PhD1; Kunnambath Ramadas, MD2; Richard Muwonge, MSc3; Hormuzd A. Katki, PhD1; Gigi Thomas, MDS4; Barry I. Graubard, PhD1; Partha Basu, PhD, MD3; Rengaswamy Sankaranarayanan, MD3; Thara Somanathan, MD4; and Anil K. Chaturvedi, PhD5

doi : 10.1200/JCO.20.02855

Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 663-674.

We evaluated proof of principle for resource-efficient, risk-based screening through reanalysis of the Kerala Oral Cancer Screening Trial.

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Patient-Reported Symptom Burden as a Predictor of Emergency Department Use and Unplanned Hospitalization in Head and Neck Cancer: A Longitudinal Population-Based Study

Christopher W. Noel, MD1,2,3; Rinku Sutradhar, PhD2,3; Haoyu Zhao, MPH3; Victoria Delibasic, BHSc3; David Forner, MD, MSc2,4; Jonathan C. Irish, MD, MSc5; Jonathan Kim, MD6; Zain Husain, MD6; Alyson Mahar, PhD7; Irene Karam, MD6; Danny J. Enepekides, MD, MPH1,8; Kelvin K. W. Chan, MD, MSc, PhD9; Simron Singh, MD, MPH9; Julie Hallet, MD, MSc2,3,8; Natalie G. Coburn, MD, MPH2,3,8; and Antoine Eskander, MD, ScM1,2,3,8

doi : 10.1200/JCO.20.01845

Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 675-684.

To determine the association between patient-reported symptom burden and subsequent emergency department use and unplanned hospitalization (ED/Hosp) in a head and neck cancer (HNC) patient population.

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Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer: ASCO Guideline Update

Neelima Denduluri, MD1; Mark R. Somerfield , PhD2; Mariana Chavez-MacGregor, MD, MSc3; Amy H. Comander , MD4; Zoneddy Dayao, MD5; Andrea Eisen, MD6,7; Rachel A. Freedman , MD, MPH8; Ragisha Gopalakrishnan , MD9; Stephanie L. Graff , MD10; Michael J. Hassett , MD, MPH8; Tari A. King, MD8,11; Gary H. Lyman , MD, MPH12; Gillian Rice Maupin, JD13; Raquel Nunes, MD14; Cheryl L. Perkins, MD, RPh15; Melinda L. Telli, MD16; Maureen E. Trudeau, MD6,7; Antonio C. Wolff , MD14; and Sharon H. Giordano , MD, MPH3

doi : 10.1200/JCO.20.02510

Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 685-693.

The aim of this work is to update key recommendations of the ASCO guideline adaptation of the Cancer Care Ontario guideline on the selection of optimal adjuvant chemotherapy regimens for early breast cancer and adjuvant targeted therapy for breast cancer.

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Nelarabine in Pediatric and Young Adult T-Cell Acute Lymphoblastic Leukemia—Clearly Beneficial?

Anurag K. Agrawal , MD, Jennifer Michlitsch, MD, Carla Golden, MD, Caroline A. Hastings , MD, Robert Raphael, MD, and James H. Feusner, MD

doi : 10.1200/JCO.20.02973

Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 694-694.

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Reply to A. K. Agrawal et al

Kimberly P. Dunsmore , MD, Stuart S. Winter , MD, Meenakshi Devidas , PhD, Naomi J. Winick, MD, William L. Carroll, MD, and Stephen P. Hunger , MD

doi : 10.1200/JCO.20.03370

Journal of Clinical Oncology 39, no. 6 (February 20, 2021) 695-696.

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