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Pembrolizumab and Ipilimumab as Second-Line Therapy for Advanced Melanoma
Huppert, Laura A. MD1; Daud, Adil I. MD, MBBS1,,
doi : 10.1200/JCO.21.00943
Volume 39(24), 20 August 2021, p 2637-2639
Targeting Tumor-Rejection Antigens in Melanoma With Tumor-Infiltrating Lymphocytes
Chapman, Paul B. MD1,,
doi : 10.1200/JCO.21.01012
Volume 39(24), 20 August 2021, p 2640-2642
Oligometastases for Clinicians: Size Matters
Girard, Philippe MD1,,; Gossot, Dominique MD1,; Mariolo, Alessio MD1; Caliandro, Raffaele MD1; Seguin-Givelet, Agathe MD, PhD1,; Girard, Nicolas MD, PhD1,
doi : 10.1200/JCO.21.00445
Volume 39(24), 20 August 2021, p 2643-2646
Pembrolizumab Plus Ipilimumab Following Anti-PD-1/L1 Failure in Melanoma
Olson, Daniel J. MD1; Eroglu, Zeynep MD2,; Brockstein, Bruce MD3,; Poklepovic, Andrew S. MD4,; Bajaj, Madhuri MD5; Babu, Sunil MD6,; Hallmeyer, Sigrun MD7,; Velasco, Mario MD8,; Lutzky, Jose MD9,; Higgs, Emily BS1,; Bao, Riyue PhD10; Carll, Timothy C. MD1; Labadie, Brian MD1; Krausz, Thomas MD1; Zha, Yuanyuan PhD1; Karrison, Theodore PhD1; Sondak, Vernon K. MD2,; Gajewski, Thomas F. MD, PhD1,; Khushalani, Nikhil I. MD2,; Luke, Jason J. MD10,,
doi : 10.1200/JCO.21.00079
Volume 39(24), 20 August 2021, p 2647-2655
Combination of antiprogrammed cell death protein-1 (PD-1) plus anti-cytotoxic T-cell lymphocyte-4 (anti-CTLA-4) immunotherapy shows greater response rates (RRs) than anti-PD-1 antibody alone in melanoma, but RR after initial anti-PD-1 and programmed death ligand-1 (PD-L1) antibody progression awaits robust investigation. Anti-CTLA-4 antibody alone after anti-PD-1/L1 antibody progression has a historical RR of 13%. We report the results of the first prospective clinical trial evaluating ipilimumab 1 mg/kg plus pembrolizumab following progression on anti-PD-1 immunotherapy.
Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma
Sarnaik, Amod A. MD1,,; Hamid, Omid MD2,; Khushalani, Nikhil I. MD1,; Lewis, Karl D. MD3,; Medina, Theresa MD3,; Kluger, Harriet M. MD4,; Thomas, Sajeve S. MD5,; Domingo-Musibay, Evidio MD6,; Pavlick, Anna C. DO, MBA7,; Whitman, Eric D. MD8,; Martin-Algarra, Salvador MD, PhD9,; Corrie, Pippa PhD, FRCP10,; Curti, Brendan D. MD11,; Olah, Judit MD, DSc12; Lutzky, Jose MD13,; Weber, Jeffrey S. MD, PhD7,; Larkin, James M. G. MD, PhD14,; Shi, Wen MD, PhD15,; Takamura, Toshimi BA, BS15,; Jagasia, Madan MD15,; Qin, Harry PhD15,; Wu, Xiao PhD15,; Chartier, Cecile PhD15,; Graf Finckenstein, Friedrich MD15,; Fardis, Maria PhD, MBA15,; Kirkwood, John M. MD16,; Chesney, Jason A. MD, PhD17,
doi : 10.1200/JCO.21.00612
Volume 39(24), 20 August 2021, p 2656-2666
Effective treatment options are limited for patients with advanced (metastatic or unresectable) melanoma who progress after immune checkpoint inhibitors and targeted therapies. Adoptive cell therapy using tumor-infiltrating lymphocytes has demonstrated efficacy in advanced melanoma. Lifileucel is an autologous, centrally manufactured tumor-infiltrating lymphocyte product.
Pertuzumab Plus High-Dose Trastuzumab in Patients With Progressive Brain Metastases and HER2-Positive Metastatic Breast Cancer: Primary Analysis of a Phase II Study
Lin, Nancy U. MD1,,; Pegram, Mark MD2,; Sahebjam, Solmaz MD3,; Ibrahim, Nuhad MD4,; Fung, Anita PharmD5,; Cheng, Anna PharmD5,; Nicholas, Alan PhD5,; Kirschbrown, Whitney PharmD, PhD5,; Kumthekar, Priya MD6,
doi : 10.1200/JCO.20.02822
Volume 39(24), 20 August 2021, p 2667-2675
Effective therapies are needed for the treatment of patients with human epidermal growth factor receptor-2 (HER2)-positive metastatic breast cancer (MBC) with brain metastases. A trastuzumab radioisotope has been shown to localize in brain metastases of patients with HER2-positive MBC, and intracranial xenograft models have demonstrated a dose-dependent response to trastuzumab.
Cognitive and Adaptive Functioning in Youth With Retinoblastoma: A Longitudinal Investigation Through 10 Years of Age
Willard, Victoria W. PhD1,; Qaddoumi, Ibrahim MD2,3,; Pan, Haitao PhD4; Hsu, Chia-Wei MS4; Brennan, Rachel C. MD2; Wilson, Matthew W. MD5,6; Rodriguez-Galindo, Carlos MD2,3; Goode, Kristin MS1; Parris, Kendra PhD1; Phipps, Sean PhD1
doi : 10.1200/JCO.20.03422
Volume 39(24), 20 August 2021, p 2676-2684
To describe the trajectory of cognitive and adaptive functioning in pediatric patients with retinoblastoma from diagnosis through age 10. This is an extension of a previous report that discussed findings from diagnosis through age 5.
Children's Oncology Group Phase III Trial of Reduced-Dose and Reduced-Volume Radiotherapy With Chemotherapy for Newly Diagnosed Average-Risk Medulloblastoma
Michalski, Jeff M. MBA, MD1,,; Janss, Anna J. MD2; Vezina, L. Gilbert MD3; Smith, Kyle S. PhD4; Billups, Catherine A. MS5; Burger, Peter C. MD6; Embry, Leanne M. PhD7; Cullen, Patricia L. PhD8; Hardy, Kristina K. PhD9,; Pomeroy, Scott L. MD, PhD10; Bass, Johnnie K. AuD, PhD11; Perkins, Stephanie M. MD1,; Merchant, Thomas E. DO12,; Colte, Paul D. PsyD13; Fitzgerald, Thomas J. MD14; Booth, Timothy N. MD15; Cherlow, Joel M. MD, PhD16; Muraszko, Karin M. MD17; Hadley, Jennifer MS4; Kumar, Rahul PhD4; Han, Yuanyuan PhD5; Tarbell, Nancy J. MD18,; Fouladi, Maryam MD19,; Pollack, Ian F. MD20; Packer, Roger J. MD21,; Li, Yimei PhD5; Gajjar, Amar MD22,; Northcott, Paul A. PhD4
doi : 10.1200/JCO.20.02730
Volume 39(24), 20 August 2021, p 2685-2697
Children with average-risk medulloblastoma (MB) experience survival rates of >= 80% at the expense of adverse consequences of treatment. Efforts to mitigate these effects include deintensification of craniospinal irradiation (CSI) dose and volume.
Therapeutic Implications of Germline Testing in Patients With Advanced Cancers
Stadler, Zsofia K. MD1,,; Maio, Anna BS1; Chakravarty, Debyani PhD2,; Kemel, Yelena MS2; Sheehan, Margaret MS1; Salo-Mullen, Erin MS1; Tkachuk, Kaitlyn BS1; Fong, Christopher J. PhD3,; Nguyen, Bastien PhD3; Erakky, Amanda BA4; Cadoo, Karen MD1,; Liu, Ying MD1,; Carlo, Maria I. MD1,; Latham, Alicia MD1,; Zhang, Hongxin MS5; Kundra, Ritika MS5,; Smith, Shaleigh MS5; Galle, Jesse BA1; Aghajanian, Carol MD1,; Abu-Rustum, Nadeem MD6,; Varghese, Anna MD1,; O'Reilly, Eileen M. MD1,4,; Morris, Michael MD1,; Abida, Wassim MD, PhD1,; Walsh, Michael MD1; Drilon, Alexander MD1,; Jayakumaran, Gowtham MS2; Zehir, Ahmet PhD2,5,; Ladanyi, Marc MD2,; Ceyhan-Birsoy, Ozge PhD2; Solit, David B. MD1,5,; Schultz, Nikolaus PhD3,5; Berger, Michael F. PhD2,5,; Mandelker, Diana MD2; Diaz, Luis A. Jr MD1,; Offit, Kenneth MD1; Robson, Mark E. MD1,
doi : 10.1200/JCO.20.03661
Volume 39(24), 20 August 2021, p 2698-2709
Tumor mutational profiling is increasingly performed in patients with advanced cancer. We determined the extent to which germline mutation profiling guides therapy selection in patients with advanced cancer.
Third-Party BK Virus-Specific Cytotoxic T Lymphocyte Therapy for Hemorrhagic Cystitis Following Allotransplantation
Olson, Amanda MD1; Lin, Ruitao PhD2; Marin, David MD1,; Rafei, Hind MD1,; Bdaiwi, Mustafa H. MD1; Thall, Peter F. PhD2; Basar, Rafet MD1,; Abudayyeh, Ala MD3; Banerjee, Pinaki PhD1,; Aung, Fleur M. MD4,; Kaur, Indresh PhD1; Abueg, Glorette RN1; Rao, Sheetal PhD1; Chemaly, Roy MD, MPH5,; Mulanovich, Victor MD5,; Al-Atrash, Gheath DO, PhD1; Alousi, Amin M. MD1,; Andersson, Borje S. MD1; Anderlini, Paolo MD1; Bashir, Qaiser MD1,; Castro, Karla M. BS1; Daher, May MD1,; Galvan, Isabel M. BA1; Hosing, Chitra MD1,; Im, Jin S. MD, PhD1; Jones, Roy B. MD, PhD1,; Kebriaei, Partow MD1,; Khouri, Issa MD1,; Mehta, Rohtesh MD, MPH1,; Molldrem, Jeffrey MD1; Nieto, Yago MD, PhD1,; Oran, Betul MD1,; Popat, Uday MD1,; Qazilbash, Muzaffar MD1,; Rondon, Gabriela MD1; Saini, Neeraj MBBS1; Spencer, Bryan BS1; Srour, Samer MBChB1,; Washington, Dominique MS1; Barnett, Melissa MPAS1; Champlin, Richard E. MD1,; Shpall, Elizabeth J. MD1,; Rezvani, Katayoun MD, PhD1,,
doi : 10.1200/JCO.20.02608
Volume 39(24), 20 August 2021, p 2710-2719
BK virus-associated hemorrhagic cystitis (BKV-HC) is a common complication of allogenic hematopoietic stem cell transplantation (AHSCT), particularly in recipients of alternative donor transplants, which are being performed in increasing numbers. BKV-HC typically results in painful hematuria, urinary obstruction, and renal dysfunction, without a definitive therapeutic option.
Updated Standardized Definitions for Efficacy End Points (STEEP) in Adjuvant Breast Cancer Clinical Trials: STEEP Version 2.0
Tolaney, Sara M. MD, MPH1,2,,; Garrett-Mayer, Elizabeth PhD3,; White, Julia MD4,; Blinder, Victoria S. MD5; Foster, Jared C. PhD6; Amiri-Kordestani, Laleh MD7; Hwang, E. Shelley MD, MPH8; Bliss, Judith M. MSc9,; Rakovitch, Eileen MD10,; Perlmutter, Jane PhD, MBA11; Spears, Patricia A. BS12,; Frank, Elizabeth EdM1,; Tung, Nadine M. MD13,; Elias, Anthony D. MD14,; Cameron, David MD15,; Denduluri, Neelima MD16,; Best, Ana F. PhD6; DiLeo, Angelo MD, PhD17,; Baizer, Lawrence PhD18; Butler, Lynn Pearson MS19; Schwartz, Elena PhD18; Winer, Eric P. MD1,2,; Korde, Larissa A. MD20
doi : 10.1200/JCO.20.03613
Volume 39(24), 20 August 2021, p 2720-2731
The Standardized Definitions for Efficacy End Points (STEEP) criteria, established in 2007, provide standardized definitions of adjuvant breast cancer clinical trial end points. Given the evolution of breast cancer clinical trials and improvements in outcomes, a panel of experts reviewed the STEEP criteria to determine whether modifications are needed.
Treatment De-intensification for HPV-Positive Oropharynx Cancer: What Is Currently Acceptable?
Cmelak, Anthony J. MD; Ferris, Robert L. MD, PhD; Chen, Allen M. MD; Seiwert, Tanguy MD; Burtness, Barbara MD
doi : 10.1200/JCO.21.00594
Volume 39(24), 20 August 2021, p 2732-2733
De-Escalation in HPV: Near Yet Elusive
Kalra, Babusha DNB; Sinha, Shwetabh MD; Laskar, Sarbani Ghosh MD
doi : 10.1200/JCO.21.00635
Volume 39(24), 20 August 2021, p 2733-2734
Reply to A. J. Cmelak et al and B. Kalra et al
Yom, Sue S. MD; Torres-Saavedra, Pedro A. PhD; Le, Quynh-Thu MD
doi : 10.1200/JCO.21.00882
Volume 39(24), 20 August 2021, p 2734-2735
Reply to A. J. Cmelak et al and B. Kalra et al
Chundury, Anupama MD; Cosper, Pippa F. MD; Kim, Sung MD
doi : 10.1200/JCO.21.00885
Volume 39(24), 20 August 2021, p 2735-2736
