Abstract

BackgroundWe aimed to evaluate the safety and efficacy of TS-1 adjuvant chemotherapy in Taiwanese patients with gastric cancer.MethodsWe included in this study patients with locally advanced gastric cancer who received adjuvant TS-1 or 5-fluorouracil chemotherapy after curative surgery and extended lymph node dissection between 1 June 2008 and 31 December 2012 at Chang Gung Memorial Hospital. Patient characteristics, tumor features, safety profiles and compliance with TS-1 treatment were retrospectively analyzed from medical charts.ResultsForty patients received adjuvant chemotherapy with TS-1 and 193 with 5-fluorouracil within the study period. The 1- and 2-year overall survival rates were 90.6% and 87% in the TS-1 group and 95.4% and 86.8% in the 5-fluorouracil group (P = 0.34). The 1- and 2-year disease-free survival rates were 90.6% and 74.7% in the TS-1 group and 88% and 75.7% in the 5-fluorouracil group (P = 0.66). In the TS-1 group, tumor recurrence was more frequent in those with >15 metastatic lymph nodes than ≤15. Overall, 78.9%, 74.3%, 62.1% and 56% of patients underwent TS-1 treatment for at least 3, 6, 9 and 12 months, respectively. The most common adverse events of TS-1 were skin hyperpigmentation (55%), diarrhea (27.5%), dizziness (27.5%) and leucopenia (20%). Severe adverse events (SAEs; grade III or IV toxicity) were diarrhea (7.5%), stomatitis (7.5%), leukopenia (5%), vomiting (2.5%), anorexia (2.5%) and dizziness (2.5%). Patients who underwent total gastrectomy had a significantly greater risk of TS-1-related SAEs than patients who underwent subtotal gastrectomy (40% versus 8%, P = 0.014).ConclusionsThe incidence of SAEs during TS-1 therapy was more common in Taiwanese patients with gastric cancer who underwent total gastrectomy compared with those who underwent subtotal gastrectomy. Clinicians must be aware of and able to manage these SAEs to maximize patient compliance with adjuvant TS-1.

Highlights

  • We aimed to evaluate the safety and efficacy of TS-1 adjuvant chemotherapy in Taiwanese patients with gastric cancer

  • Patients diagnosed with gastric cancers who underwent curative gastrectomy and D2 lymph node dissection, and received intravenous 5-fluorouracil (5FU) adjuvant therapies in the same time period were retrospectively included to compare the efficacy between different adjuvant chemotherapies

  • There was no significant difference in patients received TS-1 treatment between types of curative surgery they received when comparing each subcategory of age, gender, tumor histological type, and T or N stage of the sixth edition American Joint Committee on Cancer (AJCC) staging system

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Summary

Introduction

We aimed to evaluate the safety and efficacy of TS-1 adjuvant chemotherapy in Taiwanese patients with gastric cancer. In Taiwan, Gastric cancer is relatively sensitive to chemotherapy in its advanced stages [6,7]; adjuvant chemotherapy is often administered to patients with gastric cancer after curative surgery to prevent tumor recurrence and prolong survival time. There was no consensus regarding the optimal adjuvant chemotherapeutic regimen, schedule or duration of treatment for gastric cancer until the results of three recently published phase III studies became available after 2007 [18,19,20]. This study was terminated before the target number of patients was reached because accrual was slower than expected and the benefit was limited in patients with serosa-negative locally advanced gastric cancer classified according to the Japanese staging system [21]

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