A phase II study of combination therapy with oral S-1 and cisplatin in elderly patients with advanced gastric cancer

  • Yusuke Sasaki
  • Satoru Iwasa
  • Shunsuke Okazaki
  • Masahiro Goto
  • Yasushi Kojima
  • Atsushi Naganuma
  • Kengo Nagashima
  • Yushi Nagai
  • Hidekazu Hirano
  • Yoshitaka Honma
  • Atsuo Takashima
  • Ken Kato
  • Tetsuya Hamaguchi
Original Article

Abstract

Background

A combination of S-1 and cisplatin is recognized as one of the standard first-line chemotherapy regimens for patients with advanced gastric cancer. However, demographic analyses of pivotal phase III studies have showed that only a minority of treated patients were aged 76 years or older. The purpose of this phase II study was to evaluate the safety and efficacy of combination therapy with S-1 and cisplatin in elderly patients with chemotherapy-naive advanced gastric cancer.

Methods

Patients aged 76 years or older received S-1 40 mg/m2 orally twice daily for 21 days and cisplatin 60 mg/m2 intravenously infused at day 8 of each 35-day cycle. Dose modification was performed according to creatinine clearance. The primary endpoint was overall survival (OS). Secondary endpoints included response rate, progression-free survival (PFS), time to treatment failure (TTF), and adverse events.

Results

A total of 40 patients were enrolled. Median OS was 12.3 months, PFS was 7.8 months, and TTF was 4.3 months. The response rate was 54%. The most common grade 3–4 adverse events were anorexia (25%), neutropenia (23%), hyponatremia (20%), anemia (18%), and febrile neutropenia (8%). No treatment-related death occurred.

Conclusions

Combination chemotherapy with S-1 and cisplatin is an effective and well-tolerated regimen for elderly patients with advanced gastric cancer when the dose is adjusted according to renal function.

Keywords

Cisplatin Elderly patient Gastric cancer S-1 

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Copyright information

© The International Gastric Cancer Association and The Japanese Gastric Cancer Association 2017

Authors and Affiliations

  • Yusuke Sasaki
    • 1
  • Satoru Iwasa
    • 1
  • Shunsuke Okazaki
    • 2
  • Masahiro Goto
    • 3
  • Yasushi Kojima
    • 4
  • Atsushi Naganuma
    • 5
  • Kengo Nagashima
    • 6
  • Yushi Nagai
    • 7
  • Hidekazu Hirano
    • 1
  • Yoshitaka Honma
    • 1
  • Atsuo Takashima
    • 1
  • Ken Kato
    • 1
  • Tetsuya Hamaguchi
    • 1
  1. 1.Gastrointestinal Medical Oncology DivisionNational Cancer Center HospitalTokyoJapan
  2. 2.Medical Oncology DivisionNational Hospital Organization Kyoto Medical CenterKyotoJapan
  3. 3.Cancer Chemotherapy CenterOsaka Medical College HospitalOsakaJapan
  4. 4.Department of GastroenterologyNational Center for Global Health and MedicineTokyoJapan
  5. 5.Department of GastroenterologyNational Hospital Organization Takasaki General Medical CenterGunmaJapan
  6. 6.Department of Global Clinical ResearchChiba University Graduate School of MedicineChibaJapan
  7. 7.Clinical Trial Support OfficeNational Cancer Center HospitalTokyoJapan

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