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Phase II study of adjuvant chemotherapy with S1 plus oxaliplatin for Chinese patients with gastric cancer.

ABSTRACT: BACKGROUND:S-1 plus oxaliplatin(SOX) has been demonstrated to be effective and well tolerated for patients with metastatic gastric cancer. We conducted this phase II study to evaluate the feasibility of SOX as adjuvant chemotherapy for gastric cancer after curative resection. METHODS:Adjuvant chemotherapy consisted of six to eight cycles of S-1 plus oxaliplatin. Oxaliplatin was administered intravenously at a dose of 130 mg/m2 on day 1. S-1 was administered orally at a dose of 70 mg/m2 daily from day 1 to 14 of a 3-week cycle. A total of 58 patients were enrolled in this study. The primary end point of the trial was the treatment completion rate for six cycles. Secondary endpoints were safety, 1-year and 3-year of disease free survival (DFS) and overall survival (OS). RESULTS:A total of 58 patients were enrolled and 54 patients have been analysed. The completion rate of six cycles was 72.2%. Grade 4 toxicities included neutropenia (1.9%) and thrombocytopenia (3.7%). Grade 3 toxicities included leukopenia (5.6%), neutropenia (24.1%), thrombocytopenia (13.0%), nausea (7.4%), vomiting 13.0%), and diarrhea (13.0%). There was no grade 3 or higher peripheral sensory neuropathy and treatment-related death. The median follow-up time was 42.4 months. 1-year and 3-year DFS rate were 85.2 and 75.9%, respectively.1-year and 3-year OS were 98.1 and 85.2%, respectively. CONCLUSION:Adjuvant chemotherapy for GC with S-1 plus oxaliplatin is safe and feasible in Chinese patients. The optimal dose of oxaliplatin and optimal cycles of treatment still need to be further investigated. TRIAL REGISTRATION:clinicaltrials.gov identifier NCT01542294 . Trial registration date: 03/02/2012.

SUBMITTER: Wang G

PROVIDER: S-EPMC5944043 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Phase II study of adjuvant chemotherapy with S1 plus oxaliplatin for Chinese patients with gastric cancer.

Wang Guoxiu G Zhao Jiuda J Song Yan Y Zhang Wen W Sun Yongkun Y Zhou Aiping A Huang Jing J Du Feng F Yang Lin L

BMC cancer 20180509 1

<h4>Background</h4>S-1 plus oxaliplatin(SOX) has been demonstrated to be effective and well tolerated for patients with metastatic gastric cancer. We conducted this phase II study to evaluate the feasibility of SOX as adjuvant chemotherapy for gastric cancer after curative resection.<h4>Methods</h4>Adjuvant chemotherapy consisted of six to eight cycles of S-1 plus oxaliplatin. Oxaliplatin was administered intravenously at a dose of 130 mg/m<sup>2</sup> on day 1. S-1 was administered orally at a ...[more]

PMID: 29743043

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Project description:BackgroundSOX (oxaliplatin and S1, every 3 weeks) is one of the most common first-line chemotherapy for advanced or metastatic G/GEJ (gastric or gastroesophageal junction) cancer in Asia, but it has noticeable hematological and neurological toxicity. In China, the majority of gastric cancer patients are middle-aged and elderly with poor tolerance to 3-weekly chemotherapy. Therefore, we aimed to assess efficacy and safety of biweekly SOX for Chinese advanced G/GEJ cancer patients aged ≥ 60 years as the first-line treatment in a single arm phase 2 study.MethodsOxaliplatin was administered intravenously on day 1 at 85 mg/m2. S-1 was given at 80, 100 or 120 mg/day, depending on the body surface area (< 1.25 m2, 1.25 to < 1.5 m2, or ≥ 1.5 m2), twice daily, on day 1-10, every 2 weeks. The primary endpoint was objective response rate (ORR), and the secondary endpoints included progression free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR) and safety.ResultsBetween May 2016 and Sep 2018, 42 patients were enrolled. The median follow-up was 43.6 months. The ORR and DCR were 52.4% and 85.7%, respectively. The median PFS was 4.6 months (95%CI 2.486-6.714), and the median OS was 11.1 months (95%CI 8.001-14.199). The most common treatment-related adverse events (TRAEs) of any grade included thrombocytopenia (59.5%), neutropenia (57.1%), appetite loss (57.1%) and nausea (54.8%). Only two patients suffered from grade 3 TRAEs (4.8%), including neutropenia (1 patient, [2.4%]) and diarrhea (1 patient, [2.4%]). No ≥ grade 4 TRAEs occurred.ConclusionsBiweekly SOX seemed to have favorable tolerance without compromising the efficacy as the first-line therapy in Chinese elderly patients aged ≥ 60 years with advanced G/GEJ cancer.Trial registrationClinicalTrials.gov ID: NCT04694404 (5/1/2021). This study was approved by the Ethical Committee of National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, (17-048/1303).

Project description:Simple Summary Adjuvant chemotherapy regimens tegafur/gimeracil/oteracil (S-1) and capecitabine plus oxaliplatin (CAPOX) have predominated, owing to evidence of their remarkable oncologic outcomes, however, there has been a lack of studies on the difference in efficacy between the two regimens. We conducted pairwise meta-analyses comparing the efficacy of S-1 and CAPOX regimens for overall survival (OS) and disease-free survival (DFS) in stage II or III gastric cancer patients. In all stages (stages II and III), the five-year OS was not different between the two regimens (hazard ratio [HR] 0.96, 95% confidence interval [CI] 0.78–1.17; p = 0.56). Additionally, the five-year DFS was not different at any stage (HR 1.00, 95% CI 0.85–1.18; p = 0.21). The present meta-analysis showed that five-year OS and DFS for stage II or III gastric cancer patients were comparable between the S-1 and CAPOX adjuvant chemotherapy regimens. Abstract Background: Adjuvant chemotherapy (AC) regimens tegafur/gimeracil/oteracil (S-1) and capecitabine plus oxaliplatin (CAPOX) have predominated, however, there has been a lack of studies on their differences in efficacy. Methods: We conducted pairwise meta-analyses comparing the efficacy of S-1 and CAPOX regimens for overall survival (OS) and disease-free survival (DFS) in stage II or III GC patients. Results: Three studies were enrolled and analyzed using a forest plot for meta-analysis. Two of them were propensity score matching studies, and the remaining one was a retrospective observational study. In all stages, the five-year OS was not different between the two regimens (HR 0.96, 95% CI 0.78–1.17; p = 0.56). Additionally, the 5-year DFS was not different at any stage (HR 1.00, 95% CI 0.85–1.18; p = 0.21). After omitting the retrospective observational study, the five-year OS (HR 1.40, 95% CI 0.53–3.73) and DFS (HR 1.41, 95% CI 0.57–3.44) of S-1 tended to be better in stage II, and the five-year OS (HR 0.81, 95% CI 0.56–1.16) and DFS (HR 0.85, 95% CI 0.63–1.13) of CAPOX tended to be better in stage III, without statistical significance. Conclusions: In the present meta-analysis, the five-year OS and DFS for stage II or III GC patients were comparable between S-1 and CAPOX regimens as AC.

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Phase II study of adjuvant chemotherapy with S1 plus oxaliplatin for Chinese patients with gastric cancer.

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Phase II study of adjuvant chemotherapy with S1 plus oxaliplatin for Chinese patients with gastric cancer.

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