[18F]FDG-PET accurately identifies pathological response early upon neoadjuvant immune checkpoint blockade in head and neck squamous cell carcinoma
European Journal of Nuclear Medicine and Molecular Imaging, vol. 49, pp. 2010–2022
Abstract
Abstract Purpose To investigate the utility of [ 18 F]FDG-PET as an imaging biomarker for pathological response early upon neoadjuvant immune checkpoint blockade (ICB) in patients with head and neck squamous cell carcinoma (HNSCC) before surgery. Methods In the IMCISION trial (NCT03003637), 32 patients with stage II‒IVb HNSCC were treated with neoadjuvant nivolumab with ( n = 26) or without ( n = 6) ipilimumab (weeks 1 and 3) before surgery (week 5). [ 18 F]FDG-PET/CT scans were acquired at baseline and shortly before surgery in 21 patients. Images were analysed for SUV max , SUV mean , metabolic tumour volume (MTV), and total lesion glycolysis (TLG). Major and partial pathological responses (MPR and PPR, respectively) to immunotherapy were identified based on the residual viable tumour in the resected primary tumour specimen (≤ 10% and 11–50%, respectively). Pathological response in lymph node metastases was assessed separately. Response for the 2 [ 18 F]FDG-PET-analysable patients who did not undergo surgery was determined clinically and per MR-RECIST v.1.1. A patient with a primary tumour MPR, PPR, or primary tumour MR-RECIST-based response upon immunotherapy was called a responder. Results Median ΔSUV max , ΔSUV mean , ΔMTV, and ΔTLG decreased in the 8 responders and were significantly lower compared to the 13 non-responders ( P = 0.05, P = 0.002, P < 0.001, and P < 0.001). A ΔMTV or ΔTLG of at least − 12.5% detected a primary tumour response with 95% accuracy, compared to 86% for the EORTC criteria. None of the patients with a ΔTLG of − 12.5% or more at the primary tumour site developed a relapse (median FU 23.0 months since surgery). Lymph node metastases with a PPR or MPR (5 metastases in 3 patients) showed a significant decrease in SUV max (median − 3.1, P = 0.04). However, a SUV max increase (median + 2.1) was observed in 27 lymph nodes (in 11 patients), while only 13 lymph nodes (48%) contained metastases in the corresponding neck dissection specimen. Conclusions Primary tumour response assessment using [ 18 F]FDG-PET-based ΔMTV and ΔTLG accurately identifies pathological responses early upon neoadjuvant ICB in HNSCC, outperforming the EORTC criteria, although pseudoprogression is seen in neck lymph nodes. [ 18 F]FDG-PET could, upon validation, select HNSCC patients for response-driven treatment adaptation in future trials. Trial registration https://www.clinicaltrials.gov/ , NCT03003637, December 28, 2016.
Authors 8
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The Netherlands Cancer Institute
Affiliation as printed
Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute, Amsterdam, The Netherlands
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Leiden University Medical Center · The Netherlands Cancer Institute · Amsterdam University Medical Centers
Affiliation as printed
Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute, Amsterdam, The Netherlands
Department of Maxillofacial Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands
Department of Otorhinolaryngology and Head and Neck Surgery, Leiden University Medical Center, Leiden, The Netherlands
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The Netherlands Cancer Institute
Affiliation as printed
Department of Pathology, The Netherlands Cancer Institute, Amsterdam, The Netherlands
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The Netherlands Cancer Institute
Affiliation as printed
Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands
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The Netherlands Cancer Institute
Affiliation as printed
Department of Radiation Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands
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The Netherlands Cancer Institute · Amsterdam University Medical Centers
Affiliation as printed
Department of Head and Neck Oncology and Surgery, The Netherlands Cancer Institute, Amsterdam, The Netherlands
Department of Maxillofacial Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands
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The Netherlands Cancer Institute
Affiliation as printed
Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands
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Wouter V. Vogel corresponding
The Netherlands Cancer Institute
Affiliation as printed
Department of Nuclear Medicine, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. w.vogel@nki.nl
Department of Radiation Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. w.vogel@nki.nl
Department of Radiation Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands
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