Phase II trial of concurrent chemoradiotherapy with S-1 versus weekly cisplatin for locoregionally advanced nasopharyngeal carcinoma

Abstract

Abstract. This is a prospective randomized trial performed to compare the efficacy of concurrent chemoradiotherapy (CCRT) + S-1 (oral fluoropyrimidine) with that of CCRT + cisplatin in patients with locoregionally advanced nasopharyngeal carcinoma. A total of 105 eligible patients were randomly assigned to receive CCRT with S-1 (S-1 arm, n=50) or cisplatin weekly (control arm, n=55). Patients in the S-1 arm received CCRT plus S-1 (40-60 mg, twice daily for 4 consecutive weeks. Patients in the control arm received standard CCRT with weekly cisplatin. All the patients were included in an intention-to-treat survival analysis. Our results demonstrated that the S-1 and control arms did not differ significantly in terms of complete response, partial response, progression-free survival or overall survival (all P-values >0.05). However, the two arms varied significantly regarding certain grade 3-4 toxicities, including leukopenia, 5.5 vs. 22.0% (P= 0.013); mucositis, 20.0 vs. 46.0% (P= 0.004); dermatitis, 15.5 vs. 32.7% (P=0.011); and nausea, 9.1 vs. 41.6% (P<0.001) for the S-1 and control arms, respectively. In conclusion, CCRT with S-1 was found to be similar in efficacy but superior in terms of toxicity compared to the standard CCRT with weekly cisplatin. IntroductionNasopharyngeal carcinoma (NPC) is widespread in Southern China and Southeastern Asia, although it is less common in North America and Western Europe. Among head and neck carcinomas, NPC is characterized by clinical, pathological, phenotypic and biological heterogeneity (1). Radical external radiotherapy (RT) has always been the mainstay of treatment for all-stage NPC (2). Currently, although patients with early-stage NPC may be cured by RT alone, the majority of NPC patients present with stage III or IV disease and have a poor prognosis (3). Numerous attempts have been made to improve the outcome of locoregionally advanced NPC (4).As NPC has been found to be radiosensitive as well as chemosensitive and responds well to various chemotherapeutic agents, such as cisplatin, fluorouracil and paclitaxel (5-9), combined chemotherapy and RT have become the standard treatment strategy for locoregionally advanced NPC (10,11), particularly concurrent chemoradiotherapy (CCRT), on the basis of the INT 0099 trial (12). Randomized trials of induction chemotherapy followed by RT alone have resulted in encouraging response rates and improvement in disease-free survival (DFS), but not overall survival (OS) (13). The development of a sequential schedule of induction chemotherapy followed by chemoradiotherapy is a logical strategy to maximize the benefit from the two approaches, which has been widely used in Southern China. However, the high incidence of severe toxicity with this approach is the biggest obstacle to its wider application in the treatment of Asian patients with advanced NPC. The majority of the trials consistently demonstrated that CCRT increased acute toxicity by ~30%. Although most of these toxicities were recovered uneventfully, they were associated with 1...

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A retrospective study of concurrent chemoradiotherapy plus S-1 adjuvant chemotherapy on curative effect for treatment of patients with N3 stage nasopharyngeal carcinoma

“…S-1 is an oral anticancer drug of fluorouracil derivative and can be converted to 5-Fu in vivo, with the advantages of convenient, efficient, and light side effects. 7 The aim of the study was to investigate whether N3M0 stage NPC treatment could be optimized by concurrent chemoradiotherapy plus S-1 adjuvant chemotherapy.…”

Effects of S-1 combined with radiotherapy in the treatment of nasopharyngeal cancer: a meta-analysis based on randomized controlled trials

“…And several studies have demonstrated that S-1 was also effective for nasopharyngeal carcinoma. Wen et al [ 16 ] performed a phase II clinical trial of concurrent chemoradiotherapy with S-1 versus weekly cisplatin for locoregionally advanced nasopharyngeal carcinoma. In this prospective study, the author recruited 105 locally advanced nasopharyngeal carcinoma and randomly divided into chemoradiotherapy plus S-1 group and cisplation group.…”