Real-world clinical outcomes and prognostic factors in Japanese patients with recurrent or metastatic squamous cell carc
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ORIGINAL ARTICLE
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) Tomoya Yokota1 · Yosuke Ota2 · Hirofumi Fujii3 · Takeshi Kodaira4 · Mototsugu Shimokawa5 · Torahiko Nakashima6 · Nobuya Monden7 · Akihiro Homma8 · Shinya Ueda9 · Tetsuo Akimoto10 Received: 28 July 2020 / Accepted: 15 October 2020 © Japan Society of Clinical Oncology 2020
Abstract 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. Keywords Squamous cell carcinoma of the head and neck · Cetuximab · Combination therapy · Observation study · Realworld data · Prognostic factors
* Tomoya Yokota [email protected] 1
6
Department of Otolaryngology, Kyushu Medical Center, Fukuoka, Japan
7
Department of Head and Neck Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
8
Department of Otolaryngology‑Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan
Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi, Sunto‑gun, Shizuoka 411‑8777, Japan
2
Department of Radiation Oncology, Hyogo Cancer Center Hospital, Akashi, Hyogo, Japan
3
Department of Clinical Oncology, Jichi Medical University, Sh
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