T-Cell Therapy for Lymphoma Using Nonengineered Multiantigen-Targeted T Cells Is Safe and Produces Durable Clinical Effects

Spyridoula Vasileiou, PhD1; Premal D. Lulla, MD1; Ifigeneia Tzannou, MD1; Ayumi Watanabe, BSc1; Manik Kuvalekar, MSc1; Wendy L. Callejas, BSc1; Mrinalini Bilgi, BSc1; Tao Wang, PhD1; Mengfen J. Wu, BSc1; Rammurti Kamble, MD1; Carlos A. Ramos, MD1; Rayne H. Rouce, MD1; Zihua Zeng, MD1; Adrian P. Gee, PhD1; Bambi J. Grilley, RPh1; Juan F. Vera, MD1; Catherine M. Bollard, MD1; Malcolm K. Brenner, MD, PhD1; Helen E. Heslop, MD1; Cliona M. Rooney, PhD1; Ann M. Leen, PhD1; and George Carrum, MD1

doi : 10.1200/JCO.20.02224

Journal of Clinical Oncology 39, no. 13 (May 01, 2021) 1415-1425.

Patients with relapsed lymphomas often fail salvage therapies including high-dose chemotherapy and mono-antigen–specific T-cell therapies, highlighting the need for nontoxic, novel treatments. To that end, we clinically tested an autologous T-cell product that targets multiple tumor-associated antigens (TAAs) expressed by lymphomas with the intent of treating disease and preventing immune escape.

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Phase III, Randomized, Placebo-Controlled Trial of CC-486 (Oral Azacitidine) in Patients With Lower-Risk Myelodysplastic Syndromes

Guillermo Garcia-Manero , MD1; Valeria Santini , MD2; Antonio Almeida, MD3; Uwe Platzbecker, MD4; Anna Jonasova, MD5; Lewis R. Silverman, MD6; Jose Falantes, MD7; Gianluigi Reda , MD8; Francesco Buccisano , MD9; Pierre Fenaux, MD10; Rena Buckstein, MD11; Maria Diez Campelo, MD12; Stephen Larsen , MBBS13; David Valcarcel , MD14; Paresh Vyas , MD15; Valentina Giai, MD16; Esther Natalie Ol?va , MD17; Jake Shortt , PhD18; Dietger Niederwieser , MD19; Moshe Mittelman, MD20,21; Luana Fianchi, MD22; Ignazia La Torre, MD23; Jianhua Zhong, PhD24; Eric Laille , MS24; Daniel Lopes de Menezes, PhD24; Barry Skikne, MD24,25; C. L. Beach, PharmD24; and Aristoteles Giagounidis, MD26

doi : 10.1200/JCO.20.02619

Journal of Clinical Oncology 39, no. 13 (May 01, 2021) 1426-1436.

Treatment options are limited for patients with lower-risk myelodysplastic syndromes (LR-MDS). This phase III, placebo-controlled trial evaluated CC-486 (oral azacitidine), a hypomethylating agent, in patients with International Prognostic Scoring System LR-MDS and RBC transfusion–dependent anemia and thrombocytopenia.

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Excellent Outcomes With Reduced Frequency of Vincristine and Dexamethasone Pulses in Standard-Risk B-Lymphoblastic Leukemia: Results From Children's Oncology Group AALL0932

Anne L. Angiolillo, MD1,2; Reuven J. Schore, MD1,2; John A. Kairalla, PhD3; Meenakshi Devidas, PhD4; Karen R. Rabin, MD, PhD5; Patrick Zweidler-McKay, MD, PhD6; Michael J. Borowitz, MD, PhD7; Brent Wood, MD, PhD8; Andrew J. Carroll, PhD9; Nyla A. Heerema, PhD10; Mary V. Relling, PhD11; Johann Hitzler, MD12; Ashley R. Lane, MS1; Kelly W. Maloney, MD13; Cindy Wang, MS3; Mylène Bassal, MDCM14; William L. Carroll, MD15; Naomi J. Winick, MD16; Elizabeth A. Raetz, MD15; Mignon L. Loh, MD17; and Stephen P. Hunger, MD18

doi : 10.1200/JCO.20.00494

Journal of Clinical Oncology 39, no. 13 (May 01, 2021) 1437-1447.

AALL0932 evaluated two randomized maintenance interventions to optimize disease-free survival (DFS) while reducing the burden of therapy in children with newly diagnosed NCI standard-risk (SR) B-acute lymphoblastic leukemia (B-ALL).

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Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up

Martine Piccart, MD, PhD1; Marion Procter, PhD2; Debora Fumagalli, MD, PhD3; Evandro de Azambuja, MD, PhD1; Emma Clark, MSc4; Michael S. Ewer, MD, JD, PhD5; Eleonora Restuccia, MD6; Guy Jerusalem, MD, PhD7; Susan Dent, BSc, MD8; Linda Reaby, AM, PHD9,10; Hervé Bonnefoi, MD11; Ian Krop, MD, PhD12; Tsang-Wu Liu, MD13; Tadeusz Pie?kowski, MD, PhD14; Masakazu Toi, MD, PhD15; Nicholas Wilcken, PhD16,17; Michael Andersson, MD, DMSci19,18; Young-Hyuck Im, MD, PhD19; Ling Ming Tseng, MD20; Hans-Joachim Lueck, MD21; Marco Colleoni, MD22; Estefania Monturus, PhD6; Mihaela Sicoe, MSc3; Sébastien Guillaume, MSc1; José Bines, MD, PhD23; Richard D. Gelber, PhD24; Giuseppe Viale, MD25; and Christoph Thomssen, MD26 for the APHINITY Steering Committee and Investigators

doi : 10.1200/JCO.20.01204

Journal of Clinical Oncology 39, no. 13 (May 01, 2021) 1448-1457.

APHINITY, at 45 months median follow-up, showed that pertuzumab added to adjuvant trastuzumab and chemotherapy significantly improved invasive disease–free survival (IDFS) (hazard ratio 0.81 [95% CI, 0.66 to 1.00], P = .045) for patients with early human epidermal growth factor receptor 2 (HER2)–positive breast cancer (BC), specifically those with node-positive or hormone receptor (HR)–negative disease. We now report the preplanned second interim overall survival (OS) and descriptive updated IDFS analysis with 74 months median follow-up.

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Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies

Aleix Prat , MD, PhD1,2,3,4,5; Anwesha Chaudhury , PhD6; Nadia Solovieff, PhD6; Laia Paré , PhD2,3; Débora Martinez, PhD2,3; Nuria Chic, MD1,2,3; Olga Mart?nez-S?ez, MD1,2,3; Fara Bras?-Maristany , PhD1,2,3; Agnes Lteif, MD7; Tetiana Taran, MD8; Naveen Babbar, PhD7; and Fei Su, PhD7

doi : 10.1200/JCO.20.02977

Journal of Clinical Oncology 39, no. 13 (May 01, 2021) 1458-1467.

The prognostic and predictive value of intrinsic subtypes in hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer treated with endocrine therapy and ribociclib (RIB) is currently unknown. We evaluated the association of intrinsic subtypes with progression-free survival (PFS) in the MONALEESA trials.

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HER2 Expression, Test Deviations, and Their Impact on Survival in Metastatic Gastric Cancer: Results From the Prospective Multicenter VARIANZ Study

Ivonne Haffner , PhD1; Katrin Schierle , MD2; Elba Raim?ndez , PhD3,4; Birgitta Geier, PhD5; Dieter Maier, PhD5; Jan Hasenauer , PhD3,4,6; Birgit Luber, PhD7; Axel Walch , MD8; Katharina Kolbe, MD1; Jorge Riera Knorrenschild, MD9; Albrecht Kretzschmar, MD10; Beate Rau , MD11; Ludwig Fischer von Weikersthal, MD12; Miriam Ahlborn, PD13; Gabriele Siegler, MD14; Stefan Fuxius, MD15; Thomas Decker, MD16; Christian Wittekind, MD2; and Florian Lordick, MD1,17

doi : 10.1200/JCO.20.02761

Journal of Clinical Oncology 39, no. 13 (May 01, 2021) 1468-1478.

Trastuzumab is the only approved targeted drug for first-line treatment of human epidermal growth factor receptor 2–positive (HER2+) metastatic gastric cancer (mGC). However, not all patients respond and most eventually progress. The multicenter VARIANZ study aimed to investigate the background of response and resistance to trastuzumab in mGC.

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Expanding the Toolbox of Adoptive Cell Immunotherapy

Nasheed M. Hossain, MD1 and Patrick J. Stiff, MD1

doi : 10.1200/JCO.21.00295

Journal of Clinical Oncology 39, no. 13 (May 01, 2021) 1479-1482.

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VACANT WON'T LEAVE ME

Susan J. Sample, PhD, MFA1,2,3

doi : 10.1200/JCO.21.00131

Journal of Clinical Oncology 39, no. 13 (May 01, 2021) 1483-1484.

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Neoadjuvant Chemotherapy, Endocrine Therapy, and Targeted Therapy for Breast Cancer: ASCO Guideline

Larissa A. Korde, MD1; Mark R. Somerfield , PhD2; Lisa A. Carey , MD3; Jennie R. Crews, MD4; Neelima Denduluri , MD5; E. Shelley Hwang , MD6; Seema A. Khan , MD7; Sibylle Loibl , MD, PhD8; Elizabeth A. Morris, MD9; Alejandra Perez, MD10; Meredith M. Regan , ScD11; Patricia A. Spears, BS3; Preeti K. Sudheendra , MD12; W. Fraser Symmans , MD13; Rachel L. Yung , MD4; Brittany E. Harvey , BS2; and Dawn L. Hershman , MD14

doi : 10.1200/JCO.20.03399

Journal of Clinical Oncology 39, no. 13 (May 01, 2021) 1485-1505.

To develop guideline recommendations concerning optimal neoadjuvant therapy for breast cancer.

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Regarding the Addition of CDK4/6 Inhibitor to Postoperative Endocrine Therapy in Patients With HR-Positive HER2-Negative High-Risk Breast Cancer

Kazuki Hashimoto , MD and Akihiko Shimomura , MD, PhD

doi : 10.1200/JCO.20.03215

Journal of Clinical Oncology 39, no. 13 (May 01, 2021) 1506-1507.

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Reply to K. Hashimoto and A. Shimomura

Stephen R. D. Johnston , MD, PhD, Nadia Harbeck , MD, PhD, Masakazu Toi , MD, PhD, Miguel Martin , MD, PhD, Joyce O'Shaughnessy, MD, and Priya Rastogi, MD

doi : 10.1200/JCO.20.03477

Journal of Clinical Oncology 39, no. 13 (May 01, 2021) 1507-1508.

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Adjuvant Chemotherapy in Patients With Stage I-IIIA Large-Cell Neuroendocrine Carcinoma: Should a Different Approach Be Applied Than for Small-Cell Lung Cancer?

Jules L. Derks , MD, PhD, Ernst-Jan M. Speel, PhD, and Anne-Marie C. Dingemans , MD, PhD

doi : 10.1200/JCO.20.03598

Journal of Clinical Oncology 39, no. 13 (May 01, 2021) 1508-1509.

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Reply to J. L. Derks et al

Hirotsugu Kenmotsu , MD, PhD, Seiji Niho , MD, PhD, Masahiro Tsuboi , MD, PhD, Masashi Wakabayashi, ME, Junko Eba, MD, Hisao Asamura, MD, PhD, Yuichiro Ohe , MD, PhD, and Shun-ichi Watanabe, MD, PhD

doi : 10.1200/JCO.21.00107

Journal of Clinical Oncology 39, no. 13 (May 01, 2021) 1509-1510.

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