Journal of Clinical Oncology

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The End of a Fantastic Voyage

Stephen A. Cannistra, MD1

doi : 10.1200/JCO.21.00861

Journal of Clinical Oncology 39, no. 15 (May 20, 2021) 1603-1608.

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Umbralisib, a Dual PI3K?/CK1? Inhibitor in Patients With Relapsed or Refractory Indolent Lymphoma

Nathan H. Fowler, MD1; Felipe Samaniego, MD1; Wojciech Jurczak, MD, PhD2; Nilanjan Ghosh, MD, PhD3; Enrico Derenzini , MD4,5; James A. Reeves, MD6; Wanda Knopi?ska-Pos?uszny, MD7; Chan Y. Cheah , DMSc8; Tycel Phillips , MD9; Ewa Lech-Maranda , MD, PhD10; Bruce D. Cheson, MD11; Paolo F. Caimi , MD12; Sebastian Grosicki, MD, PhD13; Lori A. Leslie , MD14; Julio C. Chavez, MD15; Gustavo Fonseca, MD16; Sunil Babu, MD17; Daniel J. Hodson , MD18; Spencer H. Shao, MD19; John M. Burke , MD20; Jeff P. Sharman, MD21; Jennie Y. Law, MD22; John M. Pagel , MD, PhD23; Hari P. Miskin, MSc24; Peter Sportelli, BS24; Owen A. O'Connor , MD, PhD24,25; Michael S. Weiss, JD24; and Pier Luigi Zinzani , MD, PhD26,27

doi : 10.1200/JCO.20.03433

Journal of Clinical Oncology 39, no. 15 (May 20, 2021) 1609-1618.

Phosphatidylinositol-3-kinase (PI3K) inhibitors have shown activity in relapsed or refractory (R/R) indolent non-Hodgkin lymphoma (iNHL). PI3K inhibitors have been hampered by poor long-term tolerability and toxicity, which interfere with continuous use. Umbralisib, a dual inhibitor of PI3K?/casein kinase-1?, exhibits improved selectivity for PI3K? compared with other PI3K inhibitors. This phase IIb trial was designed to evaluate the efficacy and safety of umbralisib in patients with R/R iNHL.

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Mutations in BRCA1/2 and Other Panel Genes in Patients With Metastatic Breast Cancer —Association With Patient and Disease Characteristics and Effect on Prognosis

Peter A. Fasching, MD1; Siddhartha Yadav, MD2; Chunling Hu, PhD3; Marius Wunderle, MD1; Lothar H?berle, PhD1,4; Steven N. Hart, PhD5; Matthias Rübner, PhD1; Eric C. Polley, PhD5; Kun Y. Lee, PhD3; Rohan D. Gnanaolivu, PhD5; Peyman Hadji, MD6; Hanna Hübner, PhD1; Hans Tesch, MD7; Johannes Ettl, MD8; Friedrich Overkamp, MD9; Michael P. Lux, MD10,11; Arif B. Ekici, PhD12; Bernhard Volz, PhD13; Sabrina Uhrig, PhD1; Diana Lüftner, MD14; Markus Wallwiener, MD15; Volkmar Müller, MD16; Erik Belleville, PhD17; Michael Untch, MD18; Hans-Christian Kolberg, MD19; Matthias W. Beckmann, MD1; André Reis, MD12; Arndt Hartmann, MD20; Wolfgang Janni, MD21; Pauline Wimberger, MD22,23,24,25,26,27; Florin-Andrei Taran, MD28; Tanja N. Fehm, MD29; Diethelm Wallwiener, MD30; Sara Y. Brucker, MD30; Andreas Schneeweiss, MD31; Andreas D. Hartkopf, MD30; and Fergus J. Couch, PhD3,5

doi : 10.1200/JCO.20.01200

Journal of Clinical Oncology 39, no. 15 (May 20, 2021) 1619-1630.

Among patients with metastatic breast cancer (mBC), the frequency of germline mutations in cancer susceptibility genes and the clinical relevance of these mutations are unclear. In this study, a prospective cohort of patients with mBC was used to determine mutation rates for breast cancer (BC) predisposition genes, to evaluate the clinical characteristics of patients with mutations, and to assess the influence of mutations on patient outcome.

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Time Trends in Receipt of Germline Genetic Testing and Results for Women Diagnosed With Breast Cancer or Ovarian Cancer, 2012-2019

Allison W. Kurian, MD, MSc1; Kevin C. Ward, PhD, MPH2; Paul Abrahamse, MA3; Irina Bondarenko, MS3; Ann S. Hamilton, PhD4; Dennis Deapen, DrPH4; Monica Morrow, MD5; Jonathan S. Berek, MD, MMSc6; Timothy P. Hofer, MD, MSc7; and Steven J. Katz, MD, MPH3

doi : 10.1200/JCO.20.02785

Journal of Clinical Oncology 39, no. 15 (May 20, 2021) 1631-1640.

Genetic testing is important for breast and ovarian cancer risk reduction and treatment, yet little is known about its evolving use.

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Impact of Organ Function–Based Clinical Trial Eligibility Criteria in Patients With Diffuse Large B-Cell Lymphoma: Who Gets Left Behind?

Arushi Khurana, MBBS1; Raphael Mwangi, MS2; Grzegorz S. Nowakowski, MD1; Thomas M. Habermann, MD1; Stephen M. Ansell, MD, PhD1; Betsy R. LaPlant, MS2; Brian K. Link, MD3; James R. Cerhan, MD, PhD2; Matthew J. Maurer, MS2; and Thomas E. Witzig, MD1

doi : 10.1200/JCO.20.01935

Journal of Clinical Oncology 39, no. 15 (May 20, 2021) 1641-1649.

Exclusion of patients needing urgent treatment or requiring novel biomarkers before enrollment has impacted the ability to enroll real-world patients in frontline trials of diffuse large B-cell lymphoma (DLBCL). The impact of baseline organ function–based eligibility criteria on this effect and clinical trial exclusion is less well-understood.

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Long-Term Follow-Up of CD19-CAR T-Cell Therapy in Children and Young Adults With B-ALL

Nirali N. Shah, MD1; Daniel W. Lee, MD1,2; Bonnie Yates, CNP1; Constance M. Yuan, MD, PhD3,4; Haneen Shalabi, DO1; Staci Martin, PhD1; Pamela L. Wolters, PhD1; Seth M. Steinberg, PhD5; Eva H. Baker, MD, PhD6; Cindy P. Delbrook, RN1; Maryalice Stetler-Stevenson, MD, PhD3,4; Terry J. Fry, MD1,7; David F. Stroncek, MD8; and Crystal L. Mackall, MD1,9,10,11

doi : 10.1200/JCO.20.02262

Journal of Clinical Oncology 39, no. 15 (May 20, 2021) 1650-1659.

CD19 chimeric antigen receptor (CD19-CAR) T cells induce high response rates in children and young adults (CAYAs) with B-cell acute lymphoblastic leukemia (B-ALL), but relapse rates are high. The role for allogeneic hematopoietic stem-cell transplant (alloHSCT) following CD19-CAR T-cell therapy to improve long-term outcomes in CAYAs has not been examined.

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Impact of a Genomic Test on Treatment Decision in a Predominantly African American Population With Favorable-Risk Prostate Cancer: A Randomized Trial

Adam B. Murphy, MD, MBA, MSCI1,2,3; Michael R. Abern, MD4; Li Liu, PhD5; Heidy Wang, MS5; Courtney M. P. Hollowell, MD2; Roohollah Sharifi, MD3; Patricia Vidal, MD2; Andre Kajdacsy-Balla, MD, PhD6; Marin Sekosan, MD7; Karen Ferrer, MD7; Shoujin Wu, MD8; Marlene Gallegos, MD8; Patrice King-Lee, BA6; Lisa K. Sharp , PhD9; Carol E. Ferrans, PhD10; and Peter H. Gann , MD, ScD6

doi : 10.1200/JCO.20.02997

Journal of Clinical Oncology 39, no. 15 (May 20, 2021) 1660-1670.

The Genomic Prostate Score (GPS), performed on biopsy tissue, predicts adverse outcome in prostate cancer (PCa) and has shown promise for improving patient selection for active surveillance (AS). However, its impact on treatment choice in high-risk populations of African Americans is largely unknown and, in general, the effect of the GPS on this difficult decision has not been evaluated in randomized trials.

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