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Your search keyword '"M. Baris Karakullukcu"' showing total 2 results
Start Over Author "M. Baris Karakullukcu" Journal nature communications
2 results on '"M. Baris Karakullukcu"'

1. Neoadjuvant immunotherapy with nivolumab and ipilimumab induces major pathological responses in patients with head and neck squamous cell carcinoma

Author

Joris L. Vos, Joris B. W. Elbers, Oscar Krijgsman, Joleen J. H. Traets, Xiaohang Qiao, Anne M. van der Leun, Yoni Lubeck, Iris M. Seignette, Laura A. Smit, Stefan M. Willems, Michiel W. M. van den Brekel, Richard Dirven, M. Baris Karakullukcu, Luc Karssemakers, W. Martin C. Klop, Peter J. F. M. Lohuis, Willem H. Schreuder, Ludi E. Smeele, Lilly-Ann van der Velden, I. Bing Tan, Suzanne Onderwater, Bas Jasperse, Wouter V. Vogel, Abrahim Al-Mamgani, Astrid Keijser, Vincent van der Noort, Annegien Broeks, Erik Hooijberg, Daniel S. Peeper, Ton N. Schumacher, Christian U. Blank, Jan Paul de Boer, John B. A. G. Haanen, and Charlotte L. Zuur

Subjects
Science
Abstract

Immune checkpoint blockade has become standard care for patients with recurrent metastatic head and neck squamous cell carcinoma (HNSCC). Here the authors present the results of a non-randomized phase Ib/IIa trial, reporting safety and efficacy of neoadjuvant nivolumab monotherapy and nivolumab plus ipilimumab prior to standard-of-care surgery in patients with HNSCC. .

Published
2021
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2. Neoadjuvant immunotherapy with nivolumab and ipilimumab induces major pathological responses in patients with head and neck squamous cell carcinoma.

Author

Vos JL, Elbers JBW, Krijgsman O, Traets JJH, Qiao X, van der Leun AM, Lubeck Y, Seignette IM, Smit LA, Willems SM, van den Brekel MWM, Dirven R, Baris Karakullukcu M, Karssemakers L, Klop WMC, Lohuis PJFM, Schreuder WH, Smeele LE, van der Velden LA, Bing Tan I, Onderwater S, Jasperse B, Vogel WV, Al-Mamgani A, Keijser A, van der Noort V, Broeks A, Hooijberg E, Peeper DS, Schumacher TN, Blank CU, de Boer JP, Haanen JBAG, and Zuur CL

Subjects
Aged, Biomarkers, Tumor metabolism, Female, Fluorodeoxyglucose F18 chemistry, Head and Neck Neoplasms diagnostic imaging, Head and Neck Neoplasms pathology, Head and Neck Neoplasms surgery, Humans, Immune Checkpoint Inhibitors therapeutic use, Male, Middle Aged, Positron-Emission Tomography, Squamous Cell Carcinoma of Head and Neck diagnostic imaging, Squamous Cell Carcinoma of Head and Neck pathology, Squamous Cell Carcinoma of Head and Neck surgery, Exome Sequencing, Head and Neck Neoplasms drug therapy, Immunotherapy, Ipilimumab therapeutic use, Neoadjuvant Therapy, Nivolumab therapeutic use, Squamous Cell Carcinoma of Head and Neck drug therapy
Abstract

Surgery for locoregionally advanced head and neck squamous cell carcinoma (HNSCC) results in 30‒50% five-year overall survival. In IMCISION (NCT03003637), a non-randomized phase Ib/IIa trial, 32 HNSCC patients are treated with 2 doses (in weeks 1 and 3) of immune checkpoint blockade (ICB) using nivolumab (NIVO MONO, n = 6, phase Ib arm A) or nivolumab plus a single dose of ipilimumab (COMBO, n = 26, 6 in phase Ib arm B, and 20 in phase IIa) prior to surgery. Primary endpoints are feasibility to resect no later than week 6 (phase Ib) and primary tumor pathological response (phase IIa). Surgery is not delayed or suspended for any patient in phase Ib, meeting the primary endpoint. Grade 3‒4 immune-related adverse events are seen in 2 of 6 (33%) NIVO MONO and 10 of 26 (38%) total COMBO patients. Pathological response, defined as the %-change in primary tumor viable tumor cell percentage from baseline biopsy to on-treatment resection, is evaluable in 17/20 phase IIa patients and 29/32 total trial patients (6/6 NIVO MONO, 23/26 COMBO). We observe a major pathological response (MPR, 90‒100% response) in 35% of patients after COMBO ICB, both in phase IIa (6/17) and in the whole trial (8/23), meeting the phase IIa primary endpoint threshold of 10%. NIVO MONO's MPR rate is 17% (1/6). None of the MPR patients develop recurrent HSNCC during 24.0 months median postsurgical follow-up. FDG-PET-based total lesion glycolysis identifies MPR patients prior to surgery. A baseline AID/APOBEC-associated mutational profile and an on-treatment decrease in hypoxia RNA signature are observed in MPR patients. Our data indicate that neoadjuvant COMBO ICB is feasible and encouragingly efficacious in HNSCC., (© 2021. The Author(s).)

Published
2021
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