Hyerim Ha, Sang Hoon Chun, Yun-Gyoo Lee, Hyun Chang, Jang Ho Cho, Der Sheng Sun, Sang Hee Cho, Jung Hye Kwon, Kyoung Eun Lee, In Gyu Hwang, Hyo Jung Kim, Bhumsuk Keam, Seong Hoon Shin, Sung-Bae Kim, Joo Hang Kim, Hwan Jung Yun
{"title":"p16在分子靶向药物或免疫检查点抑制剂治疗的头颈部鳞状细胞癌患者中的预测和预后价值：TRIUMPH研究的亚组分析","authors":"Hyerim Ha, Sang Hoon Chun, Yun-Gyoo Lee, Hyun Chang, Jang Ho Cho, Der Sheng Sun, Sang Hee Cho, Jung Hye Kwon, Kyoung Eun Lee, In Gyu Hwang, Hyo Jung Kim, Bhumsuk Keam, Seong Hoon Shin, Sung-Bae Kim, Joo Hang Kim, Hwan Jung Yun","doi":"10.1080/07357907.2026.2618577","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study is to assess the predictive and prognostic value of p16 in recurrent/metastatic HNSCC patients treated with molecular targeted agents (MTAs) or immune checkpoint inhibitors (ICIs).</p><p><strong>Study design: </strong>The TRIUMPH trial (NCT03292250) was a multi-arm phase II umbrella trial using next-generation sequencing for patients with HNSCC. Patients were assigned to specific treatment arms including PIK3CA, EGFR/HER2, FGFR, CDK4/6 inhibitors, and ICI based on their genomic profiles. We performed post hoc analysis using 86 patients who had available p16 immunohistochemistry results. ORR, PFS, and OS were analyzed by p16 positivity.</p><p><strong>Results: </strong>The p16 positivity rate was 33.7%. ORR was 20.7% for p16 (+) compared to 8.8% for p16 (-) patients (<i>P</i> = 0.072). Median PFS was 3.8 months for p16 (+) and 1.8 months for p16 (-) (<i>P</i> = 0.030). Median OS was 12.9 months for p16 (+) and 6.2 months for p16 (-) (<i>P</i> = 0.100).</p><p><strong>Conclusion: </strong>Patients with p16 (+) showed longer PFS and OS compared to p16 (-) patients. This suggests that p16 has prognostic and predictive values in HNSCC patients who are treated with MTAs or ICIs.</p>","PeriodicalId":9463,"journal":{"name":"Cancer Investigation","volume":" ","pages":"479-486"},"PeriodicalIF":1.9000,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Predictive and Prognostic Value of p16 in Head and Neck Squamous Cell Carcinoma Patients Treated with Molecular Targeted Agents or Immune Checkpoint Inhibitors: Subgroup Analysis of the TRIUMPH Study.\",\"authors\":\"Hyerim Ha, Sang Hoon Chun, Yun-Gyoo Lee, Hyun Chang, Jang Ho Cho, Der Sheng Sun, Sang Hee Cho, Jung Hye Kwon, Kyoung Eun Lee, In Gyu Hwang, Hyo Jung Kim, Bhumsuk Keam, Seong Hoon Shin, Sung-Bae Kim, Joo Hang Kim, Hwan Jung Yun\",\"doi\":\"10.1080/07357907.2026.2618577\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>The aim of this study is to assess the predictive and prognostic value of p16 in recurrent/metastatic HNSCC patients treated with molecular targeted agents (MTAs) or immune checkpoint inhibitors (ICIs).</p><p><strong>Study design: </strong>The TRIUMPH trial (NCT03292250) was a multi-arm phase II umbrella trial using next-generation sequencing for patients with HNSCC. Patients were assigned to specific treatment arms including PIK3CA, EGFR/HER2, FGFR, CDK4/6 inhibitors, and ICI based on their genomic profiles. We performed post hoc analysis using 86 patients who had available p16 immunohistochemistry results. ORR, PFS, and OS were analyzed by p16 positivity.</p><p><strong>Results: </strong>The p16 positivity rate was 33.7%. ORR was 20.7% for p16 (+) compared to 8.8% for p16 (-) patients (<i>P</i> = 0.072). Median PFS was 3.8 months for p16 (+) and 1.8 months for p16 (-) (<i>P</i> = 0.030). Median OS was 12.9 months for p16 (+) and 6.2 months for p16 (-) (<i>P</i> = 0.100).</p><p><strong>Conclusion: </strong>Patients with p16 (+) showed longer PFS and OS compared to p16 (-) patients. This suggests that p16 has prognostic and predictive values in HNSCC patients who are treated with MTAs or ICIs.</p>\",\"PeriodicalId\":9463,\"journal\":{\"name\":\"Cancer Investigation\",\"volume\":\" \",\"pages\":\"479-486\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2026-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancer Investigation\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/07357907.2026.2618577\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2026/2/6 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Investigation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/07357907.2026.2618577","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/2/6 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
Predictive and Prognostic Value of p16 in Head and Neck Squamous Cell Carcinoma Patients Treated with Molecular Targeted Agents or Immune Checkpoint Inhibitors: Subgroup Analysis of the TRIUMPH Study.
Objective: The aim of this study is to assess the predictive and prognostic value of p16 in recurrent/metastatic HNSCC patients treated with molecular targeted agents (MTAs) or immune checkpoint inhibitors (ICIs).
Study design: The TRIUMPH trial (NCT03292250) was a multi-arm phase II umbrella trial using next-generation sequencing for patients with HNSCC. Patients were assigned to specific treatment arms including PIK3CA, EGFR/HER2, FGFR, CDK4/6 inhibitors, and ICI based on their genomic profiles. We performed post hoc analysis using 86 patients who had available p16 immunohistochemistry results. ORR, PFS, and OS were analyzed by p16 positivity.
Results: The p16 positivity rate was 33.7%. ORR was 20.7% for p16 (+) compared to 8.8% for p16 (-) patients (P = 0.072). Median PFS was 3.8 months for p16 (+) and 1.8 months for p16 (-) (P = 0.030). Median OS was 12.9 months for p16 (+) and 6.2 months for p16 (-) (P = 0.100).
Conclusion: Patients with p16 (+) showed longer PFS and OS compared to p16 (-) patients. This suggests that p16 has prognostic and predictive values in HNSCC patients who are treated with MTAs or ICIs.
期刊介绍：
Cancer Investigation is one of the most highly regarded and recognized journals in the field of basic and clinical oncology. It is designed to give physicians a comprehensive resource on the current state of progress in the cancer field as well as a broad background of reliable information necessary for effective decision making. In addition to presenting original papers of fundamental significance, it also publishes reviews, essays, specialized presentations of controversies, considerations of new technologies and their applications to specific laboratory problems, discussions of public issues, miniseries on major topics, new and experimental drugs and therapies, and an innovative letters to the editor section. One of the unique features of the journal is its departmentalized editorial sections reporting on more than 30 subject categories covering the broad spectrum of specialized areas that together comprise the field of oncology. Edited by leading physicians and research scientists, these sections make Cancer Investigation the prime resource for clinicians seeking to make sense of the sometimes-overwhelming amount of information available throughout the field. In addition to its peer-reviewed clinical research, the journal also features translational studies that bridge the gap between the laboratory and the clinic.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
