Cervantes A, Villar-Grimalt A, Abad A, Antón-Torres A, Belón J, Dorta J, Tres A, Camps C, Fonseca E, Massutí B
Dept. of Hematology and Medical Oncology, Hospital Clínico Universitario, Facultad de Medicina, Valencia, Spain.
Ann Oncol. 1993 Nov;4(9):753-7. doi: 10.1093/oxfordjournals.annonc.a058660.
Metastatic disease is a common problem in gastric cancer and the development of better chemotherapeutic regimens is a clear priority in gastrointestinal oncology.
Ninety consecutive, previously untreated patients with unresectable or measurable metastatic gastric cancer were included in a multicenter phase II trial with a combination of folinic acid (200 mg/m2) and 5-fluorouracil (400 mg/m2) days 1-3, with epidoxorubicin (60 mg/m2) and cisplatin (100 mg/m2) on day 2.
A total of 376 courses of FLEP were given, with a median of four courses per patient. Objective responses were observed in 32 (35%) patients (CI at 95%: 25.7%-46.3%). Eight (9%) patients experienced clinical complete remissions. Median time to progression was 25 weeks for the entire group of patients and 38 weeks for responders. Myelosuppression was the primary toxicity. WHO grade 3 leukopenia appeared in 26 patients (29%). Ten presented episodes of febrile neutropenia requiring hospitalization, but no toxic deaths were observed. Grades 3 and 4 thrombocytopenia were seen in 8 and 1 patients, respectively. Median survival time was 8 months for all treated patients and 11 months for responders.
The FLEP regimen is an active combination in advanced gastric cancer with moderate toxicity that warrants further testing in a phase III trial.
转移性疾病是胃癌的常见问题，制定更好的化疗方案显然是胃肠肿瘤学的首要任务。
90例连续的、未经治疗的不可切除或可测量的转移性胃癌患者被纳入一项多中心II期试验，在第1 - 3天联合使用亚叶酸（200 mg/m²）和5-氟尿嘧啶（400 mg/m²），在第2天使用表柔比星（60 mg/m²）和顺铂（100 mg/m²）。
共给予376个疗程的FLEP方案，每位患者中位数为4个疗程。32例（35%）患者观察到客观缓解（95%置信区间：25.7% - 46.3%）。8例（9%）患者实现临床完全缓解。整个患者组的中位进展时间为25周，缓解者为38周。骨髓抑制是主要毒性反应。26例患者（29%）出现世界卫生组织3级白细胞减少。10例出现需要住院治疗的发热性中性粒细胞减少发作，但未观察到毒性死亡。3级和4级血小板减少分别见于8例和1例患者。所有接受治疗患者的中位生存时间为8个月，缓解者为11个月。
FLEP方案在晚期胃癌中是一种有效的联合方案，毒性中等，值得在III期试验中进一步检验。
