Phase II trial of combination treatment with S-1/cetuximab in patients with platinum-ineligible recurrent and/or metasta

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ORIGINAL ARTICLE

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 Jun Taguchi1 · Yasushi Shimizu1   · Shin Ariga1 · Tomohiro Goda1 · Yoshihito Ohhara1 · Rio Honma1 · Takuro Noguchi1 · Satoshi Takeuchi1 · Ichiro Kinoshita1 · Toraji Amano1,2 · Takatsugu Mizumachi3 · Satoshi Kano3 · Miki Takahara4 · Takahisa Abe5 · Akihiro Homma3 · Hirotoshi Dosaka‑Akita1 Received: 29 April 2020 / Accepted: 10 September 2020 © Japan Society of Clinical Oncology 2020

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 platinumineligible R/M SCCHN. Registered clinical trial number: UMIN000015123 Keywords  S-1 · Cetuximab · Head and neck · Recurrent · Metastatic · Squamous cell carcinoma Electronic supplementary material  The online version of this article (https​://doi.org/10.1007/s1014​7-020-01788​-6) contains supplementary material, which is available to authorized users. * Yasushi Shimizu y‑[email protected] 1



Department of Medical Oncology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, North 15 West 7, Kita‑ku, Sapporo 060‑8638, Japan

2



Hokkaido University Hospital Clinical Research and Medical Innovation Center, North 14 West 5, Kita‑ku, Sapporo 060‑8648, Japan

3

Department of Otolaryngology‑Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, North 15 West 7, Kita‑ku, Sapporo 060‑8638, Ja

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