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A Phase II Open-Label Randomized Clinical Trial of Preoperative Durvalumab or Durvalumab plus Tremelimumab in Resectable Head and Neck Squamous Cell Carcinoma. 2024
Chang Gon Kim, and
Min Hee Hong, and
Dahee Kim, and
Brian Hyohyoung Lee, and
Hyunwook Kim, and
Chan-Young Ock, and
Geoffrey Kelly, and
Yoon Ji Bang, and
Gamin Kim, and
Jung Eun Lee, and
Chaeyeon Kim, and
Se-Heon Kim, and
Hyun Jun Hong, and
Young Min Park, and
Nam Suk Sim, and
Heejung Park, and
Jin Woo Park, and
Chang Geol Lee, and
Kyung Hwan Kim, and
Goeun Park, and
Inkyung Jung, and
Dawoon Han, and
Jong Hoon Kim, and
Junha Cha, and
Insuk Lee, and
Mingu Kang, and
Heon Song, and
Chiyoon Oum, and
Seulki Kim, and
Sukjun Kim, and
Yoojoo Lim, and
Seunghee Kim-Schulze, and
Miriam Merad, and
Sun Och Yoon, and
Hyun Je Kim, and
Yoon Woo Koh, and
Hye Ryun Kim
Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
Clinical implications of neoadjuvant immunotherapy in patients with locally advanced but resectable head and neck squamous cell carcinoma (HNSCC) remain largely unexplored. Patients with resectable HNSCC were randomized to receive a single dose of preoperative durvalumab (D) with or without tremelimumab (T) before resection, followed by postoperative (chemo)radiotherapy based on multidisciplinary discretion and 1-year D treatment. Artificial intelligence (AI)-powered spatial distribution analysis of tumor-infiltrating lymphocytes and high-dimensional profiling of circulating immune cells tracked dynamic intratumoral and systemic immune responses. Of the 48 patients enrolled (D, 24 patients; D+T, 24 patients), 45 underwent surgical resection per protocol (D, 21 patients; D+T, 24 patients). D±T had a favorable safety profile and did not delay surgery. Distant recurrence-free survival (DRFS) was significantly better in patients treated with D+T than in those treated with D monotherapy. AI-powered whole-slide image analysis demonstrated that D+T significantly reshaped the tumor microenvironment toward immune-inflamed phenotypes, in contrast with the D monotherapy or cytotoxic chemotherapy. High-dimensional profiling of circulating immune cells revealed a significant expansion of T-cell subsets characterized by proliferation and activation in response to D+T therapy, which was rare following D monotherapy. Importantly, expansion of specific clusters in CD8+ T cells and non-regulatory CD4+ T cells with activation and exhaustion programs was associated with prolonged DRFS in patients treated with D+T. Preoperative D±T is feasible and may benefit patients with resectable HNSCC. Distinct changes in the tumor microenvironment and circulating immune cells were induced by each treatment regimen, warranting further investigation.
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