Cavanna Luigi, Artioli Fabrizio, Codignola Claudio, Lazzaro Antonio, Rizzi Anna, Gamboni Alessandro, Rota Luigina, Rodinò Carmelina, Boni Fabrizio, Iop Aldo, Zaniboni Alberto
Department of Oncology, Hospital of Piacenza, Italy.
Am J Clin Oncol. 2006 Aug;29(4):371-5. doi: 10.1097/01.coc.0000221358.57089.f2.
Treatment options for advanced or metastatic gastric cancer (A/MGC) are limited and inclusion of novel substances is necessary. Few studies have confirmed the activity and tolerability of the combination of oxaliplatin (OXA) and 5-fluorouracil (5-FU) modulated with leucovorin (LV) administrated to patients with A/MGC. The goal of current study was to evaluate the efficacy and toxicity of Folfox-4 regimen in patients with A/MGC.
Fifty-six patients were treated with Folfox-4 regimen. Treatment was continued until disease progression, unacceptable toxicity or until a patient chose to discontinue treatment. Responses to treatment and toxicity were recorded according to the WHO criteria and NCI toxicity criteria.
All patients were assessable for toxicity and response. Patients (71.4% male, 28.6% female) had a median age of 65 years (range, 28-78). All patients had histologically confirmed metastatic (89.3%) or advanced (10.7%) gastric cancer. Response was evaluated every 6 weeks; 1 complete (1.8%) and 23 (41.1%) partial remission were observed (overall response rate 42.9%). Twenty patients (35.7%) showed stable disease and 12 (21.4%) had a progressive disease. Median overall survival, time to progression and follow up were 10 months, 6 months, and 11.5 months, respectively. WHO grade 3 or 4 hematologic toxicities included leucopenia, neutropenia, thrombocytopenia, and anemia. No patient experienced neutropenic fever. Other grade 3/4 toxicities included nausea, vomiting, diarrhea, stomatitis, and anorexia. Three patients (5.3%) experienced grade 3 peripheral neuropathy. No treatment-related deaths were recorded.
Folfox-4 regimen is active and well tolerated in patients with advanced/metastatic gastric cancer.
晚期或转移性胃癌（A/MGC）的治疗选择有限，纳入新物质很有必要。很少有研究证实奥沙利铂（OXA）与亚叶酸钙（LV）调节的5-氟尿嘧啶（5-FU）联合应用于A/MGC患者的活性和耐受性。本研究的目的是评估Folfox-4方案对A/MGC患者的疗效和毒性。
56例患者接受Folfox-4方案治疗。治疗持续至疾病进展、出现不可接受的毒性或患者选择停止治疗。根据世界卫生组织（WHO）标准和美国国立癌症研究所（NCI）毒性标准记录治疗反应和毒性。
所有患者均可评估毒性和反应。患者（男性占71.4%，女性占28.6%）的中位年龄为65岁（范围28 - 78岁）。所有患者均经组织学证实为转移性（89.3%）或晚期（10.7%）胃癌。每6周评估一次反应；观察到1例完全缓解（1.8%）和23例部分缓解（41.1%）（总缓解率42.9%）。20例患者（35.7%）病情稳定，12例（21.4%）病情进展。中位总生存期、疾病进展时间和随访时间分别为10个月、6个月和11.5个月。WHO 3级或4级血液学毒性包括白细胞减少、中性粒细胞减少、血小板减少和贫血。无患者发生中性粒细胞减少性发热。其他3/4级毒性包括恶心、呕吐、腹泻、口腔炎和厌食。3例患者（5.3%）出现3级周围神经病变。未记录到与治疗相关的死亡。
Folfox-4方案对晚期/转移性胃癌患者有活性且耐受性良好。
