Phase II Feasibility Study of Adjuvant S-1 plus Docetaxel for Stage III Gastric Cancer Patients after Curative D2 Gastrectomy

Tamura, Shigeyuki; Fujitani, Kazumasa; Kimura, Yutaka; Tsuji, Takeshi; Matsuyama, Jin; Iijima, Shöhei; Imamura, Hiroshi; Inoue, Kentaro; Kobayashi, Kenji; Kurokawa, Yukinori; Furukawa, Hiroshi

doi:10.1159/000329090

Cited by 14 publications

(14 citation statements)

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“…Table 1. Details of feasibility, safety, and reasons for treatment discontinuation were described previously [13]. In brief, the completion rate of the planned four cycles of S-1 plus docetaxel was 79.2 % (95 % CI, 65.9-89.2 %), whereas the completion rate of four cycles of S-1 plus docetaxel and subsequent S-1 monotherapy for 1 year was 64.2 % (95 % CI, 49.8-76.9 %).…”

Section: Discussionmentioning

confidence: 99%

“…Four cycles of S-1 plus docetaxel followed by S-1 monotherapy up to 1 year after curative D2 gastrectomy showed superior feasibility, with 79.2 % (95 % CI, 65.9-89.2) feasibility for the four planned cycles of S-1 plus docetaxel and good compliance with S-1 monotherapy at 12 months after surgery in 64.2 % of patients with stage III gastric cancer [13]. Treatment compliance at 12 months was compatible with results of the ACTS-GC trial that established 1 year of adjuvant S-1 monotherapy as the Japanese standard of care [10].…”

Section: Os and Dfsmentioning

confidence: 95%

“…After four cycles of S-1 plus docetaxel, S-1 monotherapy (4 weeks on, 2 weeks off) was continued until 1 year after surgery. The criteria for dose reduction resulting from toxicity have been described elsewhere [13].…”

Section: Treatmentmentioning

confidence: 99%

“…For example, Takahari et al [12] have evaluated the feasibility of three cycles of S-1 plus cisplatin with subsequent S-1 monotherapy until 1 year after surgery for stage III gastric cancer. We have previously demonstrated that four cycles of S-1 plus docetaxel followed by S-1 monotherapy up to 1 year after surgery is a feasible regimen with moderate toxicity when used as adjuvant chemotherapy in patients with stage III gastric cancer after curative D2 gastrectomy [13].…”

Section: Introductionmentioning

confidence: 99%

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Three-year outcomes of a phase II study of adjuvant chemotherapy with S-1 plus docetaxel for stage III gastric cancer after curative D2 gastrectomy

et al. 2013

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Background We have previously reported the superior feasibility and safety of adjuvant S-1 plus docetaxel in patients with stage III gastric cancer during a prospective phase II study. We report 3-year follow-up data on patients enrolled in this study. Patients and methods Fifty-three patients with histologically confirmed stage III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were enrolled into this study. They received oral S-1 (80 mg/m 2 /day) for 2 consecutive weeks and intravenous docetaxel (40 mg/m 2 ) on day 1, repeated every 3 weeks (one cycle). Treatment was initiated within 45 days after surgery and repeated for four cycles, followed by S-1 monotherapy (4 weeks on, 2 weeks off) until 1 year after surgery. Three-year overall survival (OS) and disease-free survival (DFS) were evaluated. Results The OS rate at 3 years was 78.4 % [95 % confidence interval (CI), 67.9-90.6 %] and the DFS rate at 3 years was 66.2 % (95 % CI, 54.4-80.7 %). Subgroup analyses according to disease stage showed a 3-year OS and DFS rate of 85.7 % (95 % CI, 74.9-98.1 %) and 70.8 % (95 % CI, 57.1-87.8 %) for stage IIIA, and 62. 123Gastric Cancer (2014( ) 17:348-353 DOI 10.1007 yielded promising OS and DFS in stage IIIA gastric cancer patients who had undergone D2 gastrectomy. We believe that this regimen is a candidate for future phase III trials studying the optimal adjuvant chemotherapy regimen for stage III gastric cancer.

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Section: Discussionmentioning

confidence: 99%

Section: Os and Dfsmentioning

confidence: 95%

Section: Treatmentmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Three-year outcomes of a phase II study of adjuvant chemotherapy with S-1 plus docetaxel for stage III gastric cancer after curative D2 gastrectomy

et al. 2013

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“…and either cisplatin 51 or docetaxel52 have been performed, with favorable results, and these combinations have been proposed for future Phase III trials.…”

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confidence: 99%

The role of S-1 in the treatment of gastric cancer

Blum¹,

Suzuki²,

Takenaka³

et al. 2011

GICTT

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Gastric cancer is a lethal disease and continues to be the second leading cause of cancer death worldwide. Surgical resection remains the main treatment for early stages with complete resection having the potential for a cure. Recent data suggest that surgery alone is inferior to surgery plus some form of adjunctive therapy. Unfortunately, most patients with gastric cancer are diagnosed in advanced stages, rendering palliative systemic therapy as the only choice of treatment. The most common chemotherapy combination as a first-line treatment in advanced gastric cancer (AGC) includes a platinum compound, a fluoroporyrimidine and a taxane (in the United States) or an antracycline (in Europe). Fluoropyrimidines have been the backbone in the chemotherapy regimens for the treatment of gastric cancer. There has been considerable interest in oral fluoropyrimidines. S-1 is a fourth-generation oral fluoropyrimidine that combines tegafur, which is a prodrug of 5-fluorouracil (5-FU), and two biochemical modulators: (1) 5-chloro-2,4-dihydroxypyridine, a powerful but reversible inhibitor of dihydropyrimidine dehydrogenase that prevents 5-FU degradation, and (2) potassium oxonate, which reduces gastrointestinal (GI) toxicity by inhibition of 5-FU phosphorylation in the GI mucosa. S-1 has produced an advantage in the postoperative setting in a large Phase III trial and has also been evaluated as a preoperative chemotherapy in gastric cancer, but in the preoperative setting, there are no completed Phase III clinical trials. Nonetheless, S-1 is considered, as a single agent, as the standard of care in Japan for the adjuvant treatment of resected gastric cancer and in combination with cisplatin in the advanced setting based on level 1 evidence in Phase III trials. S-1 is now widely available and has been approved in 27 European countries as a first-line treatment for AGC. S-1 is generally well tolerated with a low toxicity profile. It is a novel agent that provides a convenient and safe advantage over intravenous fluoropyrimidine in AGC.

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The role of oxaliplatin in the adjuvant setting of different Lauren’s type of gastric adenocarcinoma after D2 gastrectomy: a real-world study

Cheng

Wang

et al. 2018

Gastric Cancer

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Background To compare the efficacy of oxaliplatin-based and oxaliplatin-free adjuvant chemotherapies in patients with different Lauren type gastric cancers after D2 gastrectomy. Methods From our established gastric cancer database, patients with pathological stage II and III gastric cancer who received adjuvant chemotherapy after D2 gastrectomy at Zhongshan Hospital of Fudan University were analyzed. Patients who received different adjuvant chemotherapy regimens were divided into two subgroups: oxaliplatin-based and oxaliplatin-free subgroup. Clinical outcomes were analyzed according to pathological stage and different Lauren types. Results From Jan 2010 to June 2017, a total of 580 patients met all the eligibility criteria and were enrolled. The median DFS for all the patients was 24.37 months and the median OS was 56.70 months. In patients with intestinal type gastric cancer, the median DFS of the oxaliplatin-based subgroup was significantly longer than that of oxaliplatin-free subgroup (48.73 vs. 18.33 months, P < 0.001). The median OS was not reached in the oxaliplatin-based subgroup and 54.33 months in the oxaliplatin-free subgroup (P = 0.006). In patients with diffuse type gastric cancer, neither DFS nor OS differed significantly between two subgroups. In multivariate analysis, oxaliplatin-based adjuvant chemotherapy was independent positive predictor of DFS (HR 0.40; 95% CI 0.28-0.59; P < 0.001) and OS (HR 0.35; 95% CI 0.20-0.62; P < 0.001) in patients with intestinal type gastric cancer.Conclusions The results of our study suggested that oxaliplatin-based adjuvant chemotherapy was more effective in patients with intestinal type gastric cancer after D2 gastrectomy but showed no more survival benefit in patients with diffuse type.

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Phase II Feasibility Study of Adjuvant S-1 plus Docetaxel for Stage III Gastric Cancer Patients after Curative D2 Gastrectomy

Cited by 14 publications

References 30 publications

Three-year outcomes of a phase II study of adjuvant chemotherapy with S-1 plus docetaxel for stage III gastric cancer after curative D2 gastrectomy

Three-year outcomes of a phase II study of adjuvant chemotherapy with S-1 plus docetaxel for stage III gastric cancer after curative D2 gastrectomy

The role of S-1 in the treatment of gastric cancer

The role of oxaliplatin in the adjuvant setting of different Lauren’s type of gastric adenocarcinoma after D2 gastrectomy: a real-world study

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