Outcomes of Modified FOLFOX-6 as First Line Treatment in Patients with Advanced Gastric Cancer in a Single Institution; Retrospective Analysis

Abstract

I n t r o d u c t i o nIncreasing early diagnosis of gastric cancer has improved the survival rate. However, the prognosis for recurrent or unresectable gastric cancer remains poor. Various chemotherapy regimens have been developed for advanced gastric cancer patients based on the understanding that chemotherapy can increase the length and quality of life (1). However, only 10% of patients treated with chemotherapy survive for longer than 2 years (2).The older-generation 5-fluorouracil (FU) and cisplatin-based combination regimens have proven unsatisfactory, with a response rate of only 11% to 20%, and a median survival time ranging between 6 and 8 months (3,4). In recent randomized trials of a new-generation regimen with oral 5-FU and irinotecan, the overall response rate ranged from 25% to 41% (5,6). However, there remains no standard chemotherapeutic regimen for advanced gastric cancer due to concerns of chemotherapy-induced toxicity and inconsistent treatment responses.Oxaliplatin PurposeTreatment options for patients with advanced gastric cancer remain limited. Few studies have investigated the efficacy and tolerability of the combination regimen of oxaliplatin and 5-fluorouracil with leucovorin for patients with advanced gastric cancer. The goal of this study was to examine the efficacy and toxicity of a modified FOLFOX-6 (mFOLFOX-6) regimen as a first-line chemotherapy regimen for patients with advanced gastric cancer. From March, 2006, to December, 2007 patients with advanced gastric cancer received 100 mg/m 2 oxaliplatin and 100 mg/m 2 leucovorin on the first day of treatment, followed by 2,400 mg/m 2 of 5-fluorouracil on the first and second days of treatment every 2 weeks as a first-line treatment. Materials and Methods ResultsThe median age of the enrolled patients was 62 years (range; 30�75). Out of 82 patients, 34 cases (41.5%) were recurrent cases after curative resection, and the other 48 cases were unresectable or non-curative resectable cases. Their response was evaluated every 6 weeks. The overall response rate was 40.2%, with 2 (2.4%) complete response and 31 (37.8%) partial responses. The median time to progression (TTP) and overall survival (OS) time were 6.0 months (95% confidence interval [CI]: 4.69�7.31) and 13.0 months (7.99�18.0), respectively. The grade 3�4 hematologic toxicities observed included neutropenia (34.1%), thrombocytopenia (7.3%), and anemia (1.2%). The gastrointestinal toxicities observed included grade 3�4 nausea (9.8%) and vomiting (7.3%). Six patients (7.3%) experienced grade 3 neuropathy. No treatment-related deaths were recorded. ConclusionThe modified FOLFOX-6 regimen is effective and well tolerated as a first-line chemotherapy regimen for patients with advanced gastric cancer.

Comparative analysis of the efficacy and safety of modified FOLFOX-6 and DCF regimens as first-line treatment in advanced gastric cancer

“…In the present study, the mFOLFOX-6 regimen exhibited good efficacy, with an ORR of 37.0%, a median TTP of 6.5 months and a median OS of 11.4 months. The results of the present study were similar to those previously reported by studies investigating FOLFOX-6 (11,(21)(22)(23)(24)(25).…”

“…In terms of results, there was no significant difference between the DCF and mFOLFOX-6 arms; the ORR and efficacy data were comparable to the results of previous studies investigating the DCF and mFOLFOX regimens (7,8,17,(21)(22)(23)(24)(25).…”

“…The results of the V325 trial support the use of G-CSF in conjunction with the DCF protocol (7). In previous studies using FOLFOX-6 regimens for AGC, the rates of neutropenia, anemia and thrombocytopenia were 4.9-34.1, 1.2-20 and 0-7.3% respectively (21)(22)(23)(24)(25). The incidence of grade 3-4 adverse effects in the mFOLFOX-6 arm was similar to that reported by previous studies.…”

“…In several studies conducted over the last decade, a number of different FOLFOX regimens have exhibited satisfactory clinical activity and acceptable toxicity in patients with AGC. The effectiveness of a variety of FOLFOX-6 regimens in the treatment of AGC has been recently evaluated, with a reported ORR of 40.2-48% a TTP of 5.4-6.2 months and an OS of 8.6-13 months (11,(21)(22)(23)(24)(25). In the present study, the mFOLFOX-6 regimen exhibited good efficacy, with an ORR of 37.0%, a median TTP of 6.5 months and a median OS of 11.4 months.…”

Oxaliplatin, 5-fluorouracil and leucovorin (modified FOLFOX-6) as first-line chemotherapy for advanced gastric cancer patients with poor performance status

“…The overall RR was 31.8%, with a median TTP of 3.5 months and a median OS of 9.2 months. As expected in patients with poor PS, these results are inferior to those in other studies with various FOLFOX regimens (6)(7)(8)(9)(10)(11). However, the clinical outcomes in our study are comparable to those reported in a phase II study of mFOLFOX-4 for gastric cancer patients with malignant ascites (14).…”