Randomized Phase III Trial of Adjuvant Chemotherapy with S-1 after Curative Treatment in Patients with Squamous-Cell Carcinoma of the Head and Neck (ACTS-HNC)

Abstract

BackgroundWe conducted a phase III study to evaluate S-1 as compared with UFT as control in patients after curative therapy for stage III, IVA, or IVB squamous-cell carcinoma of the head and neck (SCCHN).Patients and MethodsPatients were randomly assigned to the UFT group (300 or 400 mg day-1 for 1 year) or the S-1 group (80, 100, or 120 mg day-1 for 1 year). The primary end point was disease-free survival (DFS). Secondary end points were relapse-free survival, overall survival (OS), and safety.ResultsA total of 526 patients were enrolled, and 505 were eligible for analysis. The 3-year DFS rate was 60.0% in the UFT group and 64.1% in the S-1 group (HR, 0.87; 95%CI, 0.66-1.16; p = 0.34). The 3-year OS rate was 75.8% and 82.9%, respectively (HR, 0.64; 95% CI, 0.44-0.94; p = 0.022). Among grade 3 or higher adverse events, the incidences of leukopenia (5.2%), neutropenia (3.6%), thrombocytopenia (2.0%), and mucositis/stomatitis (2.4%) were significantly higher in the S-1 group.ConclusionsAlthough DFS did not differ significantly between the groups, OS was significantly better in the S-1 group than in the UFT group. S-1 is considered a treatment option after curative therapy for stage III, IVA, IVB SCCHN.Trial Registration ClinicalTrials.gov NCT00336947 http://clinicaltrials.gov/show/NCT00336947

Burden of Oral Mucositis: A Systematic Review and Implications for Future Research

“…There were 7 studies covering 2 topics each [3,13,14,15,16,17,18] and 7 meta-analyses [19,20,21,22,23,24,25]. 20 studies (29.4%) were from Europe [3,5,9,10,11,12,15,22,26,27,28,29,30,31,32,33,34,35,36,37,38,] 20 from the US [4,14,17,19,20,24,39,40,41,42,43,44,45,46,47,48,49,50,51,52], 3 studies (4.4%) from US plus Europe [23,53,54], 6 studies (8.8%) from Japan [16,55,56,57,58,59], 6 studies (8.8%) from China [18,25,60,61,62,63], 2 studies (3.0%) from Hong Kong [13,64,65], 3 studies (4.4%) from Canada [66,67,68], 3 studies (4.4%) from India [21,69,70] and 5 studies (7.4%) from other countries [7,71,72,73,74]. 21 studies (30.9%) used the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) scale for assessment of OM.…”

“…1 Studies on oral mucositis (OM). Incidence of OM was investigated in patients with hematopoietic stem cell transplantation (HSCT) in 14 studies (32.6%) [3,5,14,17,19,28,31,36,37,39,44,56,62,67], in head and neck cancer (HNC) patients in 13 studies (30.2%) [18,21,29,40,50,51,55,59,60,61,63,70,73], in patients with chemotherapy in 13 studies (30.2%) [15,16,22,23,24,25,30,34,38,46,48,58,71], with mixed tumor types and treatment in 1 study (2.3%) [13] and with palliative care in 2 studies (4.7%) [32,57]. Cost related to OM in patients undergoing HSCT was the focus in 4 studies [7,14,17,54], in HNC patients in 2 studies [43,47], in patients with chemotherapy in 6 studies [9,10,11,12,42,49,68], and in patients with mixed tumor types and treatment in 2 studies [20,45].…”

Salivary duct carcinoma treated with cetuximab-based targeted therapy: A case report

“…4A), the therapeutic strategy was changed to palliative chemotherapy and follow-up. We initiated treatment with 120-mg/day tegafur-gimeracil-oteracil potassium (S-1) daily for 2 weeks, followed by a 1-week rest (24), with concurrent continued weekly cetuximab. After 5 months of treatment, CT scans revealed stable disease (SD) regarding the left lung metastases (Fig.…”

Efficacy of adjuvant chemotherapy with S-1 in stage II oral squamous cell carcinoma patients: A comparative study using the propensity score matching method

“…This study was designed to evaluate the efficacy of adjuvant chemotherapy after curative surgery in patients with stage II OSCC. Tsukahara et al recently reported convincing evidence for the benefits of adjuvant chemotherapy in patients with advanced head and neck cancer, who underwent curative therapy including surgery, radiotherapy, and chemoradiotherapy [13]. Therefore, we believe that investigating the effects of S-1 adjuvant chemotherapy in patients with early-stage OSCC may be valuable for establishing new treatment strategies.…”

“…Recently, the Adjuvant Chemotherapy with S-1 after Curative Treatment in Patients with Head and Neck Cancer (ACTS-HNC) study, which enrolled patients with advanced head and neck squamous cell carcinoma (HNSCC), reported significantly better overall survival (OS) in the S-1 group than in the control group [13]. Furthermore, reports have confirmed the efficacy of S-1 after curative surgery in gastric and pancreatic cancer [10,14,15].…”