PMID- 36001247
OWN - NLM
STAT- MEDLINE
DCOM- 20221028
LR  - 20221028
IS  - 1437-7772 (Electronic)
IS  - 1341-9625 (Linking)
VI  - 27
IP  - 11
DP  - 2022 Nov
TI  - Real-world clinical outcomes in Japanese patients with locally advanced squamous 
      cell carcinoma of the head and neck treated with radiotherapy plus cetuximab: a 
      prospective observational study (JROSG12-2).
PG  - 1675-1683
LID - 10.1007/s10147-022-02228-3 [doi]
AB  - BACKGROUND: Radiotherapy plus cetuximab (bioradiotherapy: BRT) is a standard 
      option in the treatment of locally advanced squamous cell carcinoma of the head 
      and neck (LA-SCCHN). Published data on its safety and efficacy in real-world 
      settings is limited. Here, we conducted a prospective multi-institutional 
      observational study to evaluate clinical outcomes of BRT in patients with 
      LA-SCCHN. METHODS: We analyzed real-world data of all patients who underwent BRT 
      from 2013 to 2016. The primary endpoint was 1-year progression-free survival 
      (PFS). Secondary endpoints were 1-year locoregional PFS (LPFS), treatment 
      completion rate (TCR), and adverse events (AEs). RESULTS: A total of 171 patients 
      with a minimum 1-year follow-up were analyzed. Median age was 67 (36-85) years, 
      and 37 patients (21.6%) were aged 75 years or older. 1-year PFS and LPFS were 
      51.5 and 56.1%, respectively. N stage (p = 0.049) was significantly associated 
      with PFS. TCR was 77.2%. Cetuximab was definitively discontinued in 30 patients 
      (17.5%), in 15 cases due to severe mucositis. N stage, T stage, and comorbidity 
      were significantly associated with TCR. Major AEs of grade 3 or higher were 
      pharyngeal mucositis (48.5%), radiation dermatitis (45.6%), and oral mucositis 
      (40.4%). Pneumonitis was observed in 12 patients (7.0%); 6 cases (3.5%) were 
      grades 3-4 and 2 (1.2%) were grade 5. CONCLUSION: As a result of the large number 
      of elderly patients in clinical practice,　toxicity reduced TCR. BRT-induced 
      pneumonitis, which is sometimes fatal, was found to be more frequent than with 
      chemotherapy plus cetuximab.
CI  - (c) 2022. The Author(s) under exclusive licence to Japan Society of Clinical 
      Oncology.
FAU - Ota, Yosuke
AU  - Ota Y
AUID- ORCID: 0000-0001-5853-0977
AD  - Department of Radiation Oncology, Hyogo Cancer Center, 13-70 Kitaouji-cho, Akashi 
      City, Hyogo, 673-8558, Japan. yosukeota@hyogo-cc.jp.
FAU - Kodaira, Takeshi
AU  - Kodaira T
AD  - Department of Radiation Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
FAU - Fujii, Hirofumi
AU  - Fujii H
AD  - Department of Clinical Oncology, Jichi Medical University, Shimotsuke, Japan.
FAU - Shimokawa, Mototsugu
AU  - Shimokawa M
AD  - Department of Biostatistics, Yamaguchi University Graduate School of Medicine, 
      Yamaguchi, Japan.
FAU - Yokota, Tomoya
AU  - Yokota T
AD  - Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto, Japan.
FAU - Nakashima, Torahiko
AU  - Nakashima T
AD  - Department of Otolaryngology, National Hospital Organization Kyushu Medical 
      Center, Fukuoka, Japan.
FAU - Monden, Nobuya
AU  - Monden N
AD  - Department of Head and Neck Surgery, National Hospital Organization Shikoku 
      Cancer Center, Matsuyama, Japan.
FAU - Homma, Akihiro
AU  - Homma A
AD  - Department of Otolaryngology-Head and Neck Surgery, Faculty of Medicine and 
      Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
FAU - Ueda, Shinya
AU  - Ueda S
AD  - Department of Gastroenterology-Medical Oncology, Iseikai Hospital, Osaka, Japan.
FAU - Akimoto, Tetsuo
AU  - Akimoto T
AD  - Department of Radiation Oncology, National Cancer Center Hospital East, Kashiwa, 
      Japan.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20220824
PL  - Japan
TA  - Int J Clin Oncol
JT  - International journal of clinical oncology
JID - 9616295
RN  - PQX0D8J21J (Cetuximab)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Receptors, Antigen, T-Cell)
SB  - IM
MH  - Aged
MH  - Humans
MH  - Cetuximab/adverse effects
MH  - Squamous Cell Carcinoma of Head and Neck/drug therapy/radiotherapy
MH  - *Mucositis/chemically induced/drug therapy
MH  - *Head and Neck Neoplasms/drug therapy/radiotherapy
MH  - Prospective Studies
MH  - Japan
MH  - Chemoradiotherapy/adverse effects
MH  - *Carcinoma, Squamous Cell/drug therapy/radiotherapy
MH  - *Antineoplastic Agents/therapeutic use
MH  - Receptors, Antigen, T-Cell/therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
OTO - NOTNLM
OT  - Bioradiotherapy
OT  - Cetuximab
OT  - Pneumonitis
OT  - Real world
OT  - Squamous cell carcinoma of the head and neck
EDAT- 2022/08/25 06:00
MHDA- 2022/10/29 06:00
CRDT- 2022/08/24 11:21
PHST- 2022/02/12 00:00 [received]
PHST- 2022/07/26 00:00 [accepted]
PHST- 2022/08/25 06:00 [pubmed]
PHST- 2022/10/29 06:00 [medline]
PHST- 2022/08/24 11:21 [entrez]
AID - 10.1007/s10147-022-02228-3 [pii]
AID - 10.1007/s10147-022-02228-3 [doi]
PST - ppublish
SO  - Int J Clin Oncol. 2022 Nov;27(11):1675-1683. doi: 10.1007/s10147-022-02228-3. 
      Epub 2022 Aug 24.