{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T22:38:16Z","timestamp":1787611096016,"version":"build-2736575974"},"reference-count":26,"publisher":"Public Library of Science (PLoS)","issue":"7","license":[{"start":{"date-parts":[[2022,7,28]],"date-time":"2022-07-28T00:00:00Z","timestamp":1658966400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001691","name":"Japan Society for the Promotion of Science","doi-asserted-by":"publisher","award":["Scientific Research (C) 20K09716"],"award-info":[{"award-number":["Scientific Research (C) 20K09716"]}],"id":[{"id":"10.13039\/501100001691","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Objectives<\/jats:title>\n<jats:p>The benefit of sequential therapy after immune checkpoint inhibitor (ICI) treatment for recurrent or metastatic head and neck squamous cell carcinoma (R\/M HNSCC) has been recently reported. Furthermore, there is a growing interest in the impact of cetuximab (Cmab)-containing salvage chemotherapy (SCT) and the therapeutic efficacy and adverse events (AEs) of Cmab administration prior to ICI administration.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Materials and methods<\/jats:title>\n<jats:p>We retrospectively reviewed the medical records of 52 patients with R\/M HNSCC treated with SCT (weekly paclitaxel [PTX], n = 7, or weekly PTX and Cmab [PC], n = 45).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>The objective response rate (ORR) and a disease control rate (DCR) was 53.3% and 91.1% in the PC group and 42.9% and 57.1% in the PTX group, respectively. There was a significant difference in the DCR between the PC and PTX groups (p = 0.0143). The overall survival (OS) and progression-free survival were significantly better in the PC group than in the PTX group. On the other hand, the incidence of drug-induced interstitial pneumonia (DI-IP) in R\/M HNSCC patients who received SCT was 21.2%. Patients in the PC group were divided according to whether they received Cmab (Group A) or did not receive Cmab (Group B) as palliative therapy prior to ICIs. Group B had a significantly better OS than Group A. Furthermore, our findings suggest that the incidence rate of DI-IP during SCT might be higher in Group B.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>Although PC following ICIs shows dramatic efficacy, careful monitoring of AEs, including DI-IP, is recommended.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0271907","type":"journal-article","created":{"date-parts":[[2022,7,28]],"date-time":"2022-07-28T18:26:03Z","timestamp":1659032763000},"page":"e0271907","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":22,"title":["Effectiveness and safety of weekly paclitaxel and cetuximab as a salvage chemotherapy following immune checkpoint inhibitors for recurrent or metastatic head and neck squamous cell carcinoma: A multicenter clinical study"],"prefix":"10.1371","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7736-9162","authenticated-orcid":true,"given":"Takahiro","family":"Wakasaki","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomomi","family":"Manako","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5765-9418","authenticated-orcid":true,"given":"Ryuji","family":"Yasumatsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirotaka","family":"Hara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Toh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muneyuki","family":"Masuda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7719-4187","authenticated-orcid":true,"given":"Moriyasu","family":"Yamauchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuichiro","family":"Kuratomi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emi","family":"Nishimura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toranoshin","family":"Takeuchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mioko","family":"Matsuo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rina","family":"Jiromaru","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuki","family":"Hashimoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noritaka","family":"Komune","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Nakagawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2022,7,28]]},"reference":[{"issue":"19","key":"pone.0271907.ref001","doi-asserted-by":"crossref","first-page":"1856","DOI":"10.1056\/NEJMoa1602252","article-title":"Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck","volume":"375","author":"RL Ferris","year":"2016","journal-title":"The New England journal of medicine"},{"issue":"10167","key":"pone.0271907.ref002","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1016\/S0140-6736(18)31999-8","article-title":"Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study.","volume":"393","author":"EEW Cohen","year":"2019","journal-title":"Lancet (London, England)."},{"issue":"10212","key":"pone.0271907.ref003","doi-asserted-by":"crossref","first-page":"1915","DOI":"10.1016\/S0140-6736(19)32591-7","article-title":"Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study.","volume":"394","author":"B Burtness","year":"2019","journal-title":"Lancet (London, England)."},{"issue":"11","key":"pone.0271907.ref004","doi-asserted-by":"crossref","DOI":"10.3390\/cancers12113427","article-title":"Real-World, Long-Term Outcomes of Nivolumab Therapy for Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck and Impact of the Magnitude of Best Overall Response: A Retrospective Multicenter Study of 88 Patients.","volume":"12","author":"T Matsuki","year":"2020","journal-title":"Cancers"},{"issue":"10","key":"pone.0271907.ref005","doi-asserted-by":"crossref","first-page":"2852","DOI":"10.1002\/hed.26331","article-title":"Two-year follow-up of a randomized phase III clinical trial of nivolumab vs. the investigator\u2019s choice of therapy in the Asian population for recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141).","volume":"42","author":"CJ Yen","year":"2020","journal-title":"Head & neck."},{"key":"pone.0271907.ref006","doi-asserted-by":"crossref","first-page":"104525","DOI":"10.1016\/j.oraloncology.2019.104525","article-title":"Relationship between immune-related adverse events and the long-term outcomes in recurrent\/metastatic head and neck squamous cell carcinoma treated with nivolumab.","volume":"101","author":"M Matsuo","year":"2020","journal-title":"Oral oncology"},{"key":"pone.0271907.ref007","doi-asserted-by":"crossref","first-page":"108","DOI":"10.1016\/j.oraloncology.2018.07.005","article-title":"Clinical outcomes with therapies for previously treated recurrent\/metastatic head-and-neck squamous cell carcinoma (R\/M HNSCC): A systematic literature review.","volume":"84","author":"M Lala","year":"2018","journal-title":"Oral oncology."},{"issue":"8","key":"pone.0271907.ref008","doi-asserted-by":"crossref","DOI":"10.3390\/cancers12082299","article-title":"Prognostic Biomarkers of Salvage Chemotherapy Following Nivolumab Treatment for Recurrent and\/or Metastatic Head and Neck Squamous Cell Carcinoma.","volume":"12","author":"T Wakasaki","year":"2020","journal-title":"Cancers"},{"issue":"16","key":"pone.0271907.ref009","doi-asserted-by":"crossref","first-page":"2549","DOI":"10.1200\/JCO.2005.04.9866","article-title":"Predictive Factors for Interstitial Lung Disease, Antitumor Response, and Survival in Non\u2013Small-Cell Lung Cancer Patients Treated With Gefitinib.","volume":"24","author":"M Ando","year":"2006","journal-title":"Journal of Clinical Oncology"},{"issue":"6","key":"pone.0271907.ref010","doi-asserted-by":"crossref","first-page":"724","DOI":"10.1016\/j.anl.2017.01.005","article-title":"The efficiency and adverse events of radiotherapy with cetuximab for Japanese head and neck cancer patients","volume":"44","author":"K Hirasawa","year":"2017","journal-title":"Auris, nasus, larynx."},{"key":"pone.0271907.ref011","doi-asserted-by":"crossref","first-page":"105129","DOI":"10.1016\/j.oraloncology.2020.105129","article-title":"Drug-induced interstitial lung disease in recurrent and\/or metastatic head and neck cancer patients treated with cetuximab and\/or nivolumab.","volume":"113","author":"M Matsuo","year":"2021","journal-title":"Oral oncology"},{"issue":"1","key":"pone.0271907.ref012","doi-asserted-by":"crossref","first-page":"116","DOI":"10.1016\/j.anl.2019.05.001","article-title":"Outcome of chemotherapy following nivolumab treatment for recurrent and\/or metastatic head and neck squamous cell carcinoma.","volume":"47","author":"T Wakasaki","year":"2020","journal-title":"Auris, nasus, larynx."},{"issue":"1","key":"pone.0271907.ref013","doi-asserted-by":"crossref","first-page":"95","DOI":"10.1097\/CAD.0000000000001006","article-title":"Safety and efficacy of cetuximab-containing chemotherapy after immune checkpoint inhibitors for patients with squamous cell carcinoma of the head and neck: a single-center retrospective study","volume":"32","author":"T Kurosaki","year":"2021","journal-title":"Anticancer Drugs"},{"issue":"Suppl 2","key":"pone.0271907.ref014","doi-asserted-by":"crossref","first-page":"S18","DOI":"10.1038\/sj.bjc.6602063","article-title":"Interstitial lung disease associated with drug therapy","volume":"91","author":"P Camus","year":"2004","journal-title":"British journal of cancer"},{"issue":"3","key":"pone.0271907.ref015","doi-asserted-by":"crossref","first-page":"669","DOI":"10.1093\/annonc\/mdw647","article-title":"High incidence of interstitial lung disease following practical use of osimertinib in patients who had undergone immediate prior nivolumab therapy","volume":"28","author":"M Kotake","year":"2017","journal-title":"Annals of oncology: official journal of the European Society for Medical Oncology"},{"issue":"9","key":"pone.0271907.ref016","doi-asserted-by":"crossref","first-page":"5277","DOI":"10.21873\/anticanres.14532","article-title":"Salvage Chemotherapy After Nivolumab for Recurrent or Metastatic Head and Neck Carcinoma","volume":"40","author":"C Fushimi","year":"2020","journal-title":"Anticancer research"},{"key":"pone.0271907.ref017","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1016\/j.ejca.2019.08.026","article-title":"Response to salvage chemotherapy after progression on immune checkpoint inhibitors in patients with recurrent and\/or metastatic squamous cell carcinoma of the head and neck","volume":"121","author":"K Saleh","year":"2019","journal-title":"European journal of cancer (Oxford, England: 1990)."},{"issue":"6","key":"pone.0271907.ref018","doi-asserted-by":"crossref","first-page":"Lmt12","DOI":"10.2217\/lmt-2019-0001","article-title":"Treatment effect and safety profile of salvage chemotherapy following immune checkpoint inhibitors in lung cancer","volume":"4","author":"M Tone","year":"2019","journal-title":"Lung cancer management"},{"issue":"4","key":"pone.0271907.ref019","doi-asserted-by":"crossref","first-page":"1016","DOI":"10.1093\/annonc\/mdr367","article-title":"Phase II study of the combination of cetuximab and weekly paclitaxel in the first-line treatment of patients with recurrent and\/or metastatic squamous cell carcinoma of head and neck.","volume":"23","author":"R Hitt","year":"2012","journal-title":"Annals of oncology: official journal of the European Society for Medical Oncology"},{"issue":"11","key":"pone.0271907.ref020","doi-asserted-by":"crossref","first-page":"1116","DOI":"10.1056\/NEJMoa0802656","article-title":"Platinum-based chemotherapy plus cetuximab in head and neck cancer","volume":"359","author":"JB Vermorken","year":"2008","journal-title":"The New England journal of medicine"},{"key":"pone.0271907.ref021","doi-asserted-by":"crossref","first-page":"125","DOI":"10.1016\/j.ejca.2021.09.025","article-title":"Impact of previous nivolumab treatment on the response to taxanes in patients with recurrent\/metastatic head and neck squamous cell carcinoma","volume":"159","author":"E Guiard","year":"2021","journal-title":"European journal of cancer (Oxford, England: 1990)."},{"issue":"1","key":"pone.0271907.ref022","doi-asserted-by":"crossref","first-page":"54","DOI":"10.1016\/j.cellimm.2015.02.003","article-title":"Using chemo-drugs or irradiation to break immune tolerance and facilitate immunotherapy in solid cancer","volume":"294","author":"Y Zheng","year":"2015","journal-title":"Cellular immunology"},{"issue":"19","key":"pone.0271907.ref023","doi-asserted-by":"crossref","first-page":"3167","DOI":"10.1200\/JCO.2009.26.7609","article-title":"Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates.","volume":"28","author":"JR Brahmer","year":"2010","journal-title":"Journal of clinical oncology: official journal of the American Society of Clinical Oncology"},{"issue":"1","key":"pone.0271907.ref024","doi-asserted-by":"crossref","first-page":"106","DOI":"10.1016\/j.jtho.2017.10.011","article-title":"Increased Response Rates to Salvage Chemotherapy Administered after PD-1\/PD-L1 Inhibitors in Patients with Non-Small Cell Lung Cancer.","volume":"13","author":"SE Park","year":"2018","journal-title":"J Thorac Oncol"},{"issue":"11","key":"pone.0271907.ref025","doi-asserted-by":"crossref","first-page":"3275","DOI":"10.1002\/hed.26374","article-title":"Role of programmed death-ligand 1 in predicting the treatment outcome of salvage chemotherapy after nivolumab in recurrent\/metastatic head and neck squamous cell carcinoma","volume":"42","author":"Y Ueki","year":"2020","journal-title":"Head & neck"},{"key":"pone.0271907.ref026","doi-asserted-by":"crossref","DOI":"10.3389\/fonc.2018.00339","article-title":"Paclitaxel Plus Cetuximab as 1st Line Chemotherapy in Platinum-Based Chemoradiotherapy-Refractory Patients With Squamous Cell Carcinoma of the Head and Neck.","volume":"8","author":"T Enokida","year":"2018","journal-title":"Frontiers in Oncology"}],"updated-by":[{"DOI":"10.1371\/journal.pone.0303720","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2024,5,9]],"date-time":"2024-05-09T00:00:00Z","timestamp":1715212800000}}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0271907","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,7,28]],"date-time":"2022-07-28T18:26:44Z","timestamp":1659032804000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0271907"}},"subtitle":[],"editor":[{"given":"Apar Kishor","family":"Ganti","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2022,7,28]]},"references-count":26,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2022,7,28]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0271907","relation":{"correction":[{"id-type":"doi","id":"10.1371\/journal.pone.0303720","asserted-by":"object"}]},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,7,28]]}}}