Capecitabine Versus S-1 in Elderly Advanced Gastric Cancer (AGC): Randomized Trial

Randomized Multicenter Phase II Trial of Capecitabine Versus S-1 as First-line Treatment in Elderly Patients With Advanced or Recurrent Unresectable Gastric Cancer

A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of age and older. In addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. However, clinical trials on gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which have been reported to have clinically significant response rates and survival with mild or negligible toxicities, have been widely used for the patients with AGC. However, few studies have been conducted in elderly patients.

Inclusion Criteria:

• Pathologically proven gastric or gastroesophageal junction adenocarcinoma
• Metastatic or recurrent unresectable disease
• Measurable lesions (according to Response Evaluation Criteria in Solid Tumors [RECIST])
• Age: 65-85 years old
• Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2
• Adequate bone marrow function: absolute neutrophile counts(ANC) ≥ 1,500/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 9 g/dl)
• Adequate renal function (serum creatinine≤ 1.5)
• Adequate liver function (serum bilirubin ≤ 2 x upper limits of normal [UNL], aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x UNL)
• No prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior to study treatment is allowed with the exception of capecitabine or S-1) Written informed consent was signed by the patient

Exclusion Criteria:

• Previous palliative chemotherapy
• Known allergy to study drugs
• CNS metastasis
• Significant medical comorbidities
• Active ongoing infection which antibiotic treatment is needed.
• Previous ( within 5 years) history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ.