Liu Zhi-Fang, Guo Qi-Sen, Zhang Xi-Qin, Yang Xi-Gui, Guan Fang, Fu Zheng, Wang Ming-Yu
Department of Chemotherapy, Shandong Tumor Hospital and Institute, Jinan, China.
Am J Clin Oncol. 2008 Jun;31(3):259-63. doi: 10.1097/COC.0b013e31815d43ee.
The aim of the study was to assess the toxicity and the clinical activity of biweekly oxaliplatin (OXA) in combination with continuous infusional 5-fluorouracil (5-FU) and leucovorin (LV) administered every 2 weeks (modified FOLFOX-4 regimen) in elderly patients with advanced gastric cancer (AGC).
A total of 44 previously untreated AGC patients aged 65 or older were treated with OXA 85 mg m-2 on day 1, LV 200 mg m-2 as a 2-hour infusion followed by a 22-hour infusion of 5-FU 1000 mg m using a multichannel programmable pump, repeated for 2 consecutive days every 2 weeks.
All patients were assessable for toxicity and 40 patients for response. Median age was 69 years (65-83). The response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria was 52.5% (95% confidence interval: 44.6%-68.0%) with 3 complete responses, 18 partial responses, 11 stable diseases, and 8 progressions. Median time to progression was 6.5 months and median overall survival was 10.0 months. Toxicity was generally mild. Grade 3 hematologic toxicities of neutropenia, anemia, and thrombocytopenia were in 6.8%, 2.3%, and 4.5% of the patients, respectively. No grade 4 hematologic toxicities occurred. Grade 1 peripheral neuropathy was a common event (34.1%), whereas grade 3 peripheral neuropathy was recorded in only 1 (2.3%) patient. An acute hypersensitivity reaction was observed in 1 patient during administration.
The modified FOLFOX-4 regimen is an active and well-tolerated chemotherapy for elderly patients aged > or =65 years with AGC. OXA may occasionally cause mild hypersensitivity.
本研究旨在评估每2周给予奥沙利铂（OXA）联合持续输注5-氟尿嘧啶（5-FU）和亚叶酸钙（LV）（改良FOLFOX-4方案）对老年晚期胃癌（AGC）患者的毒性及临床活性。
共44例年龄65岁及以上、未经治疗的AGC患者，第1天接受85 mg/m²的OXA治疗，200 mg/m²的LV持续输注2小时，随后使用多通道可编程泵持续输注22小时1000 mg/m²的5-FU，每2周连续重复2天。
所有患者均可评估毒性，40例患者可评估疗效。中位年龄为69岁（65 - 83岁）。根据实体瘤疗效评价标准（RECIST），缓解率为52.5%（95%置信区间：44.6% - 68.0%），其中3例完全缓解，18例部分缓解，11例病情稳定，8例进展。中位疾病进展时间为6.5个月，中位总生存期为10.0个月。毒性一般较轻。3级血液学毒性中，中性粒细胞减少、贫血和血小板减少分别见于6.8%、2.3%和4.5%的患者。未发生4级血液学毒性。1级周围神经病变较为常见（34.1%），而3级周围神经病变仅见于1例（2.3%）患者。1例患者在给药期间出现急性过敏反应。
改良FOLFOX-4方案对年龄≥65岁的老年AGC患者是一种有效且耐受性良好的化疗方案。OXA偶尔可能引起轻度过敏反应。
