PMID- 35901098 OWN - NLM STAT- MEDLINE DCOM- 20220801 LR - 20220815 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 17 IP - 7 DP - 2022 TI - 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. PG - e0271907 LID - 10.1371/journal.pone.0271907 [doi] LID - e0271907 AB - OBJECTIVES: 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. MATERIALS AND METHODS: 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). RESULTS: 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. CONCLUSION: Although PC following ICIs shows dramatic efficacy, careful monitoring of AEs, including DI-IP, is recommended. FAU - Wakasaki, Takahiro AU - Wakasaki T AUID- ORCID: 0000-0001-7736-9162 AD - Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. AD - Department of Head and Neck Surgery, National Hospital Organization, Kyushu Cancer Center, Fukuoka, Japan. FAU - Manako, Tomomi AU - Manako T AD - Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Yasumatsu, Ryuji AU - Yasumatsu R AUID- ORCID: 0000-0002-5765-9418 AD - Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. AD - Department of Otorhinolaryngology-Head and Neck Surgery, Faculty of Medicine, Kindai University, Osaka, Japan. FAU - Hara, Hirotaka AU - Hara H AD - Department of Head and Neck Surgery, National Hospital Organization, Kyushu Cancer Center, Fukuoka, Japan. FAU - Toh, Satoshi AU - Toh S AD - Department of Head and Neck Surgery, National Hospital Organization, Kyushu Cancer Center, Fukuoka, Japan. FAU - Masuda, Muneyuki AU - Masuda M AD - Department of Head and Neck Surgery, National Hospital Organization, Kyushu Cancer Center, Fukuoka, Japan. FAU - Yamauchi, Moriyasu AU - Yamauchi M AUID- ORCID: 0000-0002-7719-4187 AD - Department of Otolaryngology, Head and Neck Surgery, Saga University Hospital, Saga, Japan. FAU - Kuratomi, Yuichiro AU - Kuratomi Y AD - Department of Otolaryngology, Head and Neck Surgery, Saga University Hospital, Saga, Japan. FAU - Nishimura, Emi AU - Nishimura E AD - Department of Otorhinolaryngology, Kitakyushu Municipal Medical Center, Kitakyushu, Japan. FAU - Takeuchi, Toranoshin AU - Takeuchi T AD - Department of Otorhinolaryngology, Kitakyushu Municipal Medical Center, Kitakyushu, Japan. FAU - Matsuo, Mioko AU - Matsuo M AD - Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Jiromaru, Rina AU - Jiromaru R AD - Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Hashimoto, Kazuki AU - Hashimoto K AD - Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Komune, Noritaka AU - Komune N AD - Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. FAU - Nakagawa, Takashi AU - Nakagawa T AD - Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20220728 PL - United States TA - PLoS One JT - PloS one JID - 101285081 RN - 0 (Immune Checkpoint Inhibitors) RN - P88XT4IS4D (Paclitaxel) RN - PQX0D8J21J (Cetuximab) SB - IM MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - *Cetuximab/adverse effects MH - *Head and Neck Neoplasms/drug therapy/etiology MH - Humans MH - *Immune Checkpoint Inhibitors MH - Neoplasm Recurrence, Local/pathology MH - *Paclitaxel/adverse effects MH - Retrospective Studies MH - Squamous Cell Carcinoma of Head and Neck/drug therapy/etiology PMC - PMC9333293 COIS- The authors have declared that no competing interests exist. EDAT- 2022/07/29 06:00 MHDA- 2022/08/02 06:00 PMCR- 2022/07/28 CRDT- 2022/07/28 13:54 PHST- 2021/11/15 00:00 [received] PHST- 2022/07/10 00:00 [accepted] PHST- 2022/07/28 13:54 [entrez] PHST- 2022/07/29 06:00 [pubmed] PHST- 2022/08/02 06:00 [medline] PHST- 2022/07/28 00:00 [pmc-release] AID - PONE-D-21-36204 [pii] AID - 10.1371/journal.pone.0271907 [doi] PST - epublish SO - PLoS One. 2022 Jul 28;17(7):e0271907. doi: 10.1371/journal.pone.0271907. eCollection 2022.