| Autor: |
Zuur, L., Vos, J. L., Elbers, J. B., Krijgsman, O., Qiao, X., van der Leun, A., Smit, L., van den Brekel, M. W., Tan, B., Jasperse, B., Vogel, W. V., Willems, S. M., Al-Mamgani, A., Peeper, D., Schumacher, T. N., Blank, C. U., de Boer, J. P., Haanen, J. B. A. G. |
| Přispěvatelé: |
Damage and Repair in Cancer Development and Cancer Treatment (DARE), Guided Treatment in Optimal Selected Cancer Patients (GUTS) |
| Jazyk: |
angličtina |
| Rok vydání: |
2020 |
| Zdroj: |
Annals of Oncology, 31(Suppl. 4). Oxford University Press |
| ISSN: |
0923-7534 |
| Popis: |
Background Nivolumab (NIVO) alone or with ipilimumab (COMBO) immune checkpoint blockade (ICB) prior to curative surgery has shown promising results in multiple tumor types. We completed a phase Ib/II study with neoadjuvant NIVO or COMBO in resectable head and neck squamous cell carcinoma (HNSCC) and show safety, efficacy and correlative biomarker results. Methods 32 stage II-IVB HNSCC patients indicated for curative (salvage) surgery were treated with NIVO (240mg, weeks 1&3, N=6) or NIVO (240mg, weeks 1&3) + IPI (1mg/kg, week 1, N=26) prior to surgery in week 5. Imaging was performed at baseline and week 4. AEs were reported in terms of CTCAE. Pathological response (pR) was defined as % change in viable tumor cells from baseline to on-treatment; ≥90% pR was considered (near-) complete response (pCR). WES and RNAseq were performed on paired tumor biopsies. Results 32 (31 HPV-negative) patients started treatment (stage II n=3, III n=8, IVA-B n=11, recurrent disease n=10). 6 patients included with recurrent disease had had previous (C)RT. 1 patient discontinued ICB after one course due to patient’s preference. Surgery was not postponed in any patient. 3/32 patients did not undergo surgery: 1 due to unresectable PD and 2 due to reasons unrelated to ICB or disease. Grade 3-4 irAEs in 11/32 patients were well manageable. (Near-)pCR in the primary tumor was seen in 9/29 evaluable patients (31%). Another 31% of patients had 20-89% pR. At 14 months median FU, RFS for patients with (near-)pCR was 100%, significantly better than patients with |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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