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- Title
Phase II trial of combination treatment with S-1/cetuximab in patients with platinum-ineligible recurrent and/or metastatic squamous cell carcinoma of the head and neck.
- Authors
Taguchi, Jun; Shimizu, Yasushi; Ariga, Shin; Goda, Tomohiro; Ohhara, Yoshihito; Honma, Rio; Noguchi, Takuro; Takeuchi, Satoshi; Kinoshita, Ichiro; Amano, Toraji; Mizumachi, Takatsugu; Kano, Satoshi; Takahara, Miki; Abe, Takahisa; Homma, Akihiro; Dosaka-Akita, Hirotoshi
- Abstract
Background: The standard of care for first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) in patients who cannot tolerate platinum-based regimens has not been clarified. We aimed to develop a new treatment regimen for patients with R/M SCCHN who are ineligible for platinum-based therapy, by evaluating the effects and safety of tegafur/gimeracil/oteracil (S-1) and cetuximab. Methods: Platinum-ineligibility was defined as: elderly (aged ≥ 75 years), poor PS, comorbidity, platinum resistance and refusal to undergo platinum-based therapy. Patients received S-1 (80 mg/m2/day for 14 days followed by a seven-day break) and cetuximab (initial dose, 400 mg/m2, followed by 250 mg/m2 weekly) until disease progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR). Results: Between September 2014 and September 2018, we enrolled 23 patients. Among the 21 patients who were evaluable, 20 were male [median age, 69 years (range 49–82)]. The ORR was 9 (43%) of 21 patients [95% confidence interval (CI) 22–66]. One and eight patients achieved complete response (CR) and partial response (PR), respectively. The median overall survival (OS) was 13.7 months (95% CI 9.0–18.3) and progression-free survival (PFS) was 5.7 months (95% CI 3.1–8.2). Grade 3/4 adverse events included acneiform rash and skin reactions (33%), hypomagnesemia (19%), hand-foot syndrome (14%), fatigue (14%), mucositis (10%), and anorexia (10%). Conclusions: Combination treatment with S-1 and cetuximab was effective and tolerated well by patients with platinum-ineligible R/M SCCHN. Registered clinical trial number: UMIN000015123
- Subjects
SQUAMOUS cell carcinoma; HAND-foot syndrome; NECK; PROGRESSION-free survival; METASTASIS
- Publication
International Journal of Clinical Oncology, 2021, Vol 26, Issue 1, p51
- ISSN
1341-9625
- Publication type
Article
- DOI
10.1007/s10147-020-01788-6