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Real-world clinical outcomes and prognostic factors in Japanese patients with recurrent or metastatic squamous cell carcinoma of head and neck treated with chemotherapy plus cetuximab: a prospective observation study (JROSG12-2)

International journal of clinical oncology, 2021-02, Vol.26 (2), p.316-325 [Peer Reviewed Journal]

Japan Society of Clinical Oncology 2020 ;Japan Society of Clinical Oncology 2020. ;ISSN: 1341-9625 ;EISSN: 1437-7772 ;DOI: 10.1007/s10147-020-01817-4 ;PMID: 33125596

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Title:
Real-world clinical outcomes and prognostic factors in Japanese patients with recurrent or metastatic squamous cell carcinoma of head and neck treated with chemotherapy plus cetuximab: a prospective observation study (JROSG12-2)
Author: Yokota, Tomoya ; Ota, Yosuke ; Fujii, Hirofumi ; Kodaira, Takeshi ; Shimokawa, Mototsugu ; Nakashima, Torahiko ; Monden, Nobuya ; Homma, Akihiro ; Ueda, Shinya ; Akimoto, Tetsuo
Subjects: Adverse events ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Asian Continental Ancestry Group ; Cancer Research ; Cetuximab - administration & dosage ; Cetuximab - adverse effects ; Chemotherapy ; Clinical outcomes ; Head and Neck Neoplasms - drug therapy ; Humans ; Hypokalemia ; Immunotherapy ; Japan ; Lymph nodes ; Medical prognosis ; Medicine ; Medicine & Public Health ; Metastases ; Metastasis ; Middle Aged ; Monoclonal antibodies ; Multivariate analysis ; Neoplasm Recurrence, Local - drug therapy ; Neutropenia ; Oncology ; Original Article ; Patients ; Platinum ; Pneumonitis ; Prognosis ; Prospective Studies ; Squamous cell carcinoma ; Squamous Cell Carcinoma of Head and Neck - drug therapy ; Surgical Oncology ; Targeted cancer therapy ; Treatment Outcome
Is Part Of: International journal of clinical oncology, 2021-02, Vol.26 (2), p.316-325
Description: Background The aims of this study are to evaluate the efficacy and safety of first-line treatment with chemotherapy plus cetuximab in real-world patients with recurrent or metastatic squamous cell carcinoma of the head and neck (RM-SCCHN) and to identify prognostic factors for overall survival (OS). Methods This is a prospective observation study involving 20 oncology institutions in Japan. Patients with RM-SCCHN treated with a first-line therapy consisting of cetuximab plus any chemotherapy regimen between December 2013 and February 2017 were enrolled. The primary objective of the study was 1-year OS. Secondary objectives included response rate and adverse events. Results Of 120 patients recruited, 114 patients were analyzed. Median age was 64 years. Cetuximab in combination with platinum plus 5-FU (EXTREME regimen) was chosen in 86 patients (75.4%). The median OS was 12.4 months. A point estimate of the 1-year survival rate was 51.1%. Overall response rate was 26.3%. Grade 3 or worse adverse events included neutropenia (22.8%), hypokalemia (9.6%), acneiform rash (7.0%), pneumonitis (1.8%), and infusion-related reaction (0.9%). On multivariate analysis, regional lymph node metastasis, absence of intervention by dermatologists, lack of response to therapy, skin metastasis, and non-EXTREME regimen were identified as independent unfavorable prognostic factors for OS. Conclusion The combination of cetuximab plus chemotherapy was tolerable and efficacious in patients with RM-SCCHN in a real-world setting. Clinical outcomes and prognostic factors extracted from this study provide a reference of the current clinical practice as well as for the future development of novel therapy in RM-SCCHN.
Publisher: Singapore: Springer Singapore
Language: English
Identifier: ISSN: 1341-9625
EISSN: 1437-7772
DOI: 10.1007/s10147-020-01817-4
PMID: 33125596
Source: MEDLINE
ProQuest Central

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Real-world clinical outcomes and prognostic factors in Japanese patients with recurrent or metastatic squamous cell carcinoma of head and neck treated with chemotherapy plus cetuximab: a prospective observation study (JROSG12-2)

Japan Society of Clinical Oncology 2020 ;Japan Society of Clinical Oncology 2020. ;ISSN: 1341-9625 ;EISSN: 1437-7772 ;DOI: 10.1007/s10147-020-01817-4 ;PMID: 33125596

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