Comparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma

The main purposes: to determine the overall survival (OS) of patients who have locally advanced inoperable or metastatic HER2-negative gastric and gastroesophageal adenocarcinoma treated with first-line EOX (epirubicin + oxaliplatin + capecitabine) or mDCF (docetaxel + cisplatin + leucovorin + 5fluorouracil) palliative chemotherapy regimens

The secondary purposes: to determine safety (as assessed by adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0) and the progression-free survival (PFS)

Inclusion criteria

• Patients ≥ 18 years
• histologically confirmed inoperable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction;
• ECOG (Eastern Cooperative Oncology Group) performance status 0-2;
• adequate renal, hepatic, and hematologic function;
• measurable or nonmeasurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Patients with intraoperatively confirmed intraperitoneal metastases but without detectable disease in radiological studies were also eligible

Exclusion criteria

• HER2- positive tumors defined as either IHC 3+ or IHC 2+, the latter in combination with FISH+
• previous chemotherapy for metastatic or locally advanced disease
• surgery <3 weeks before the onset of the study treatment
• congestive heart failure
• significant dysphagia that would preclude oral administration of capecitabine
• concurrent malignant disease, except for adequately treated tumors with high likelihood of being cured (e.g. basal cell carcinoma of the skin, cervical cancer)
• clinical evidence of brain metastases