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Introduction <p>Standard of care (SoC) for resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) is surgery with adjuvant radiotherapy (RT) or chemoradiotherapy (for tumors at high risk of recurrence). As long-term prognosis is suboptimal with SoC, this study aimed to summarize findings from recent studies comparing alternative treatments to SoC.</p> Methods <p>A broad systematic literature review (search date: December 1, 2025) searched Embase, MEDLINE, and CENTRAL to identify randomized controlled trials evaluating surgery with RT and/or systemic treatments in the neoadjuvant and/or adjuvant setting in LA-HNSCC. Trials published since 2004 were included in this report if they compared interventions to SoC in terms of event-free survival (EFS) and overall survival (OS) or reported pathological response following neoadjuvant therapy.</p> Results <p>Fifty-six trials were included in the broader review, of which 25 were included in this report. Trials reporting EFS counted at least recurrence/progression and death as events, except one that did not provide a definition. Improvement in EFS (regardless of definition) was reported with the addition of perioperative pembrolizumab or addition of perioperative camrelizumab with neoadjuvant nab-paclitaxel + carboplatin to surgery + RT ± cisplatin, addition of adjuvant cetuximab or adjuvant cisplatin to surgery + RT, and addition of adjuvant nivolumab to surgery + RT + cisplatin. EFS with other interventions was comparable to SoC. OS was generally comparable between interventions and SoC. Across treatment arms with at least one neoadjuvant chemotherapy agent, pathological complete response rates ranged from 10.5% to 42.6% while it ranged from 0 to 12.9% in treatment arms without any neoadjuvant chemotherapy agent. Some trials reported an association between achieving pathological response and improved survival outcomes in exploratory analyses.</p> Conclusion <p>Immunotherapy shows promise as an addition to the SoC in LA-HNSCC. OS results are generally comparable and may still be immature in some trials. Evidence on pathological response suggests potential prognostic value for long-term survival outcomes.</p>

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Randomized Controlled Trials Comparing the Standard of Care to Alternative Treatments in Patients with Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma: A Systematic Literature Review

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月19日

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  • Ali Mojebi,
  • Yuexin Tang,
  • Sam Keeping,
  • Sanjay Merchant,
  • Behzad Bidadi,
  • Dandan Zheng

摘要

Introduction

Standard of care (SoC) for resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) is surgery with adjuvant radiotherapy (RT) or chemoradiotherapy (for tumors at high risk of recurrence). As long-term prognosis is suboptimal with SoC, this study aimed to summarize findings from recent studies comparing alternative treatments to SoC.

Methods

A broad systematic literature review (search date: December 1, 2025) searched Embase, MEDLINE, and CENTRAL to identify randomized controlled trials evaluating surgery with RT and/or systemic treatments in the neoadjuvant and/or adjuvant setting in LA-HNSCC. Trials published since 2004 were included in this report if they compared interventions to SoC in terms of event-free survival (EFS) and overall survival (OS) or reported pathological response following neoadjuvant therapy.

Results

Fifty-six trials were included in the broader review, of which 25 were included in this report. Trials reporting EFS counted at least recurrence/progression and death as events, except one that did not provide a definition. Improvement in EFS (regardless of definition) was reported with the addition of perioperative pembrolizumab or addition of perioperative camrelizumab with neoadjuvant nab-paclitaxel + carboplatin to surgery + RT ± cisplatin, addition of adjuvant cetuximab or adjuvant cisplatin to surgery + RT, and addition of adjuvant nivolumab to surgery + RT + cisplatin. EFS with other interventions was comparable to SoC. OS was generally comparable between interventions and SoC. Across treatment arms with at least one neoadjuvant chemotherapy agent, pathological complete response rates ranged from 10.5% to 42.6% while it ranged from 0 to 12.9% in treatment arms without any neoadjuvant chemotherapy agent. Some trials reported an association between achieving pathological response and improved survival outcomes in exploratory analyses.

Conclusion

Immunotherapy shows promise as an addition to the SoC in LA-HNSCC. OS results are generally comparable and may still be immature in some trials. Evidence on pathological response suggests potential prognostic value for long-term survival outcomes.