Journal of Clinical Oncology

Richardson, Paul G. MD1,,; Kumar, Shaji K. MD2,; Masszi, Tamas MD, PhD3,; Grzasko, Norbert MD, PhD4,5,; Bahlis, Nizar J. MD6,; Hansson, Markus MD, PhD7,8,; Pour, Ludek MD9; Sandhu, Irwindeep MD10,; Ganly, Peter BMBCh11; Baker, Bartrum W. MBChB12; Jackson, Sharon R. MBChB13,; Stoppa, Anne-Marie MD14,; Gimsing, Peter MD, DMSc15; Garderet, Laurent MD16,; Touzeau, Cyrille MD, PhD17,; Buadi, Francis K. MD2; Laubach, Jacob P. MD1; Cavo, Michele MD18,; Darif, Mohamed PhD19,; Labotka, Richard MD19,; Berg, Deborah RN, MSN19,; Moreau, Philippe MD17,

doi : 10.1200/JCO.21.00972

Volume 39(22), 1 August 2021, p 2430-2442

The double-blind, placebo-controlled, phase III TOURMALINE-MM1 study demonstrated a statistically significant improvement in progression-free survival with ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) versus placebo-Rd in patients with relapsed or refractory multiple myeloma. We report the final analyses for overall survival (OS).

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Pembrolizumab in Patients With Metastatic Breast Cancer With High Tumor Mutational Burden: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Alva, Ajjai S. MD1,; Mangat, Pam K. MS2,; Garrett-Mayer, Elizabeth PhD2,; Halabi, Susan PhD3,; Hansra, Damien MD4,; Calfa, Carmen J. MD5; Khalil, Maged F. MD6; Ahn, Eugene R. MD7,; Cannon, Timothy L. MD8,; Crilley, Pamela DO9,; Fisher, Julie G. MD10; Haslem, Derrick S. MD11; Shrestha, Sagun MD12; Antonelli, Kaitlyn R. BA2; Butler, Nicole L. MPH2; Warren, Sasha L. MS2; Rygiel, Andrew L. MPH2; Ranasinghe, Shamika MS2; Bruinooge, Suanna S. MPH2; Schilsky, Richard L. MD2,

doi : 10.1200/JCO.20.02923

Volume 39(22), 1 August 2021, p 2443-2451

The TAPUR Study is a phase II basket trial that aims to identify signals of antitumor activity of commercially available targeted agents in patients with advanced cancers harboring genomic alterations known to be drug targets. Results in a cohort of patients with metastatic breast cancer (mBC) with high tumor mutational burden (HTMB) treated with pembrolizumab are reported.

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Health-Related Quality of Life With Trastuzumab Monotherapy Versus Trastuzumab Plus Standard Chemotherapy as Adjuvant Therapy in Older Patients With HER2-Positive Breast Cancer

Taira, Naruto MD, PhD1,; Sawaki, Masataka MD, PhD2; Uemura, Yukari PhD3,; Saito, Tsuyoshi MD, PhD4,; Baba, Shinichi MD5; Kobayashi, Kokoro MD6; Kawashima, Hiroaki MD, PhD7; Tsuneizumi, Michiko MD, PhD8; Sagawa, Noriko MD, PhD9; Bando, Hiroko MD, PhD10,; Takahashi, Masato MD, PhD11,; Yamaguchi, Miki MD, PhD12,; Takashima, Tsutomu MD, PhD13,; Nakayama, Takahiro MD, PhD14,; Kashiwaba, Masahiro MD, PhD15,; Mizuno, Toshiro MD, PhD16,; Yamamoto, Yutaka MD, PhD17,; Iwata, Hiroji MD, PhD2,; Ohashi, Yasuo PhD18,; Mukai, Hirofumi MD, PhD19,; Kawahara, Takuya PhD20; for the RESPECT Study Group

doi : 10.1200/JCO.20.02751

Volume 39(22), 1 August 2021, p 2452-2462

We report findings on quality of life (QoL) in the RESPECT trial, which compared adjuvant trastuzumab monotherapy with trastuzumab plus chemotherapy in older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC).

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Treatment of Pediatric Adrenocortical Carcinoma With Surgery, Retroperitoneal Lymph Node Dissection, and Chemotherapy: The Children's Oncology Group ARAR0332 Protocol

Rodriguez-Galindo, Carlos MD1,2,; Krailo, Mark D. PhD3,4,; Pinto, Emilia M. PhD5,; Pashankar, Farzana MD6,; Weldon, Christopher B. MD7; Huang, Li MS3; Caran, Eliana M. MD8; Hicks, John MD9; McCarville, M. Beth MD10; Malkin, David MD11,; Wasserman, Jonathan D. MD, PhD12,; de Oliveira Filho, Antonio G. MD13; LaQuaglia, Michael P. MD14; Ward, Deborah A. PharmD15; Zambetti, Gerard PhD5,; Mastellaro, Maria J. MD16; Pappo, Alberto S. MD1,; Ribeiro, Raul C. MD1

doi : 10.1200/JCO.20.02871

Volume 39(22), 1 August 2021, p 2463-2473

Adrenocortical carcinoma (ACC) is a rare aggressive pediatric malignancy with distinct biology. Its treatment follows the principles developed for adults; pediatric-specific studies are scarce.

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TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors

Tagawa, Scott T. MD, MS1,,; Balar, Arjun V. MD2,; Petrylak, Daniel P. MD3,; Kalebasty, Arash Rezazadeh MD4,; Loriot, Yohann MD, PhD5,; Flechon, Aude MD, PhD6,; Jain, Rohit K. MD7,; Agarwal, Neeraj MD8,; Bupathi, Manojkumar MD, MS9,; Barthelemy, Philippe MD, PhD10,; Beuzeboc, Philippe MD, PhD11; Palmbos, Phillip MD, PhD12,; Kyriakopoulos, Christos E. MD13,; Pouessel, Damien MD, PhD14,; Sternberg, Cora N. MD1,; Hong, Quan MD15,; Goswami, Trishna MD15,; Itri, Loretta M. MD15,; Grivas, Petros MD, PhD16,

doi : 10.1200/JCO.20.03489

Volume 39(22), 1 August 2021, p 2474-2485

Patients with metastatic urothelial carcinoma (mUC) who progress on platinum-based combination chemotherapy (PLT) and checkpoint inhibitors (CPIs) have limited options that offer objective response rates (ORRs) of approximately 10% with a median overall survival (OS) of 7-8 months. Sacituzumab govitecan (SG) is a TROP-2-directed antibody-drug conjugate with an SN-38 payload that has shown preliminary activity in mUC.

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Randomized Phase III Trial of Gemcitabine and Cisplatin With Bevacizumab or Placebo in Patients With Advanced Urothelial Carcinoma: Results of CALGB 90601 (Alliance)

Rosenberg, Jonathan E. MD1,,; Ballman, Karla A. PhD2,; Halabi, Susan PhD3,4,; Atherton, Pamela J. MS5; Mortazavi, Amir MD6,; Sweeney, Christopher MD7,; Stadler, Walter M. MD8,; Teply, Benjamin A. MD9,; Picus, Joel MD10,; Tagawa, Scott T. MD11,; Katragadda, Sreedhar MD12,; Vaena, Daniel MD13,; Misleh, Jamal MD14; Hoimes, Christopher DO, PhD15,16,; Plimack, Elizabeth R. MD17,; Flaig, Thomas W. MD18,; Dreicer, Robert MD19,; Bajorin, Dean MD1,; Hahn, Olwen MD8,; Small, Eric J. MD20,; Morris, Michael J. MD1,

doi : 10.1200/JCO.21.00286

Volume 39(22), 1 August 2021, p 2486-2496

The combination of gemcitabine and cisplatin (GC) is a standard therapy for metastatic urothelial carcinoma. Based on data that angiogenesis plays a role in urothelial carcinoma growth and progression, a randomized placebo-controlled trial was performed with the primary objective of testing whether patients treated with GC and bevacizumab (GCB) have superior overall survival (OS) than patients treated with GC and placebo (GCP).

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Phase II Study of Maintenance Rucaparib in Patients With Platinum-Sensitive Advanced Pancreatic Cancer and a Pathogenic Germline or Somatic Variant in BRCA1, BRCA2, or PALB2

Reiss, Kim A. MD1,2,,; Mick, Rosemarie MS1,3,; O'Hara, Mark H. MD1,2,; Teitelbaum, Ursina MD1,2; Karasic, Thomas B. MD1,2,; Schneider, Charles MD1,2; Cowden, Stacy RN1; Southwell, Traci RN1; Romeo, Janae MBE1; Izgur, Natallia RN1; Hannan, Zain M. BA1; Tondon, Rashmi MD1,4; Nathanson, Katherine MD1,2; Vonderheide, Robert H. MD, DPhil1,2,; Wattenberg, Max M. MD1,2,; Beatty, Gregory MD, PhD1,2,; Domchek, Susan M. MD1,2,

doi : 10.1200/JCO.21.00003

Volume 39(22), 1 August 2021, p 2497-2505

Olaparib, a poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi), is approved as maintenance therapy for patients with advanced pancreatic cancer (PC) and a germline BRCA1 or BRCA2 pathogenic variant (PV). This investigator-initiated, single-arm phase II study assessed the role of the PARPi rucaparib as maintenance therapy in advanced PC with germline or somatic PV in BRCA1, BRCA2, or PALB2.

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Impact of Palliative Care Involvement on End-of-Life Care Patterns Among Adolescents and Young Adults With Cancer: A Population-Based Cohort Study

Kassam, Alisha MD, MPH1,2,3,; Gupta, Abha MD1,3; Rapoport, Adam MD, MHSc3,4,5,; Srikanthan, Amirrtha MD, MHSc6,7; Sutradhar, Rinku PhD8; Luo, Jin MSc8; Widger, Kimberley RN, PhD4,9; Wolfe, Joanne MD, MPH10,11; Earle, Craig MD, MSc8; Gupta, Sumit MD, PhD1,3,8,12,

doi : 10.1200/JCO.20.03698

Volume 39(22), 1 August 2021, p 2506-2515

Evidence suggests that adolescents and young adults (AYAs) with cancer (defined as age 15-39 years) receive high-intensity (HI) medical care at the end-of-life (EOL). Previous population-level studies are limited and lack information on the impact of palliative care (PC) provision. We evaluated prevalence and predictors of HI-EOL care in AYAs with cancer in Ontario, Canada. A secondary aim was to evaluate the impact of PC physicians on the intensity of EOL care in AYAs.

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