Objective: To compare the clinical efficacy and safety between doublet and triplet neo-adjuvant chemotherapy regimens for patients with unresectable advanced gastric cancer.
Methods: All patients diagnosed with unresectable advanced gastric cancer were randomly divided into doublet (group A) and triplet groups (group B). In group A, patients received two kinds of chemotherapy drugs and their counterparts in group B were administered with three kinds of chemotherapy drugs. The primary-endpoint was the rate of patients converted to resection for unresectable advanced gastric cancer. The secondary-end points included the response rate of the neoadjuvant chemotherapy, survival and adverse events.
Results: In total, 288 patients admitted to the Affiliated Hospital of Changchun University of Traditional Chinese Medicine were recruited in this study and divided into group A (n=140) and B (n=148). The response rate after preoperative chemotherapy between two groups were 48.6% and 48.7% respectively (P=0.981). After 4 rounds of chemotherapy, 78 patients (55.7%) in group A received R0 surgery and 62.1% patients (92/148) in group B underwent radical operation. The median duration of follow-up was 17.5 months (range 3.3 to 71.5 months). The median progression-free survival (PFS) of two groups were 15.0 months and 14.0 months (P=0.442). The Overall Survival (OS) between groups A and B was the same (29.1 months and 30.0 months, P=0.144). Group B had more serious adverse effect in leukopenia, fatigue and vomiting, etc.
Conclusions: For unresectable advanced gastric cancer, more effective interventions including triple chemotherapy drugs did not produce more benefit on survival and other clinically relevant outcomes, and had more toxic effect.