Phase II feasibility study of adjuvant chemotherapy with docetaxel/cisplatin/S-1 followed by S-1 for stage III gastric cancer

BMC Cancer. 2021 Oct 1;21(1):1073. doi: 10.1186/s12885-021-08795-4.

Abstract

Background: This study aimed to evaluate the feasibility, safety, and efficacy of postoperative adjuvant chemotherapy with docetaxel/cisplatin/S-1 (DCS) following S-1 therapy in patients with stage III gastric cancer after curative gastrectomy.

Methods: Patients with stage III gastric cancer who underwent D2 gastrectomy were enrolled. Adjuvant chemotherapy was initiated within 8 weeks of gastrectomy. The first cycle of chemotherapy consisted of S-1 monotherapy (day 1-14), followed by a 7-day rest period. Cycles 2 and 3 consisted of the following: S-1 (day 1-14) administration, followed by a 14-day rest period, and an intravenous infusion of cisplatin and docetaxel on days 1 and 15. After two cycles, S-1 was administered for up to 1 year.

Results: Thirty patients were enrolled between 2014 and 2017. Febrile neutropenia of grade 3 or higher was the most common hematological toxicity with 4 patients (13.3%). Other hematological toxicities of grade 3 or higher were as follows: neutropenia in 3 (10.0%), leukopenia in 3 (10.0%), and anemia in 2 (6.7%) patients. Most frequent non-hematological toxicity of grade 3 was anorexia (n = 4, 13.3%) and general fatigue (n = 3, 10.0%); no grade 4 non-hematological toxicities were observed. Twenty-five patients (83.3%) completed two cycles of DCS treatment and 18 (60.0%) completed subsequent S-1 treatment for 1 year. The relative dose intensity of docetaxel and cisplatin was 0.86 and that of S-1 was 0.88.

Conclusion: The DCS regimen can be acceptable as an adjuvant chemotherapy and offers an effective postoperative treatment option for stage III gastric cancer patients.

Trial registration number: UMIN000012785 .

Date of registry: 08/01/2014.

Keywords: Adjuvant chemotherapy; Docetaxel/cisplatin/S-1; Gastric cancer; R0 resection.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / pathology
  • Adenocarcinoma / surgery
  • Aged
  • Anemia / chemically induced
  • Anorexia / chemically induced
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Chemotherapy, Adjuvant / adverse effects
  • Chemotherapy, Adjuvant / methods
  • Chemotherapy-Induced Febrile Neutropenia / etiology
  • Cisplatin / administration & dosage
  • Cisplatin / adverse effects
  • Docetaxel / administration & dosage
  • Docetaxel / adverse effects
  • Drug Administration Schedule
  • Drug Combinations
  • Fatigue / chemically induced
  • Feasibility Studies
  • Female
  • Humans
  • Leukopenia / chemically induced
  • Male
  • Middle Aged
  • Neutropenia / chemically induced
  • Oxonic Acid / administration & dosage
  • Oxonic Acid / adverse effects
  • Patient Compliance
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / mortality
  • Stomach Neoplasms / pathology
  • Stomach Neoplasms / surgery
  • Tegafur / administration & dosage
  • Tegafur / adverse effects

Substances

  • Drug Combinations
  • S 1 (combination)
  • Tegafur
  • Docetaxel
  • Oxonic Acid
  • Cisplatin