Subcutaneous Granulocyte-Macrophage Colony-Stimulating Factor in Mucositis Induced by an Adjuvant 5-Fluorouracil plus Leucovorin Regimen
Subcutaneous Granulocyte-Macrophage Colony-Stimulating Factor in Mucositis Induced by an Adjuvant 5-Fluorouracil plus Leucovorin Regimen
复制标题
皮下粒细胞-巨噬细胞集落刺激因子在 5-氟尿嘧啶佐剂加亚叶酸疗法诱发的粘膜炎中的应用
作者：
A. Rossi;G. Rosati;D. Colarusso;L. Manzione
目的：目的检测皮下注射粒细胞-巨噬细胞集落刺激因子（GM-CSF）对5-氟尿嘧啶（5-FU）联合亚叶酸（LV）辅助治疗的结直肠癌伴粘膜炎患者的活性。研究方法：31例接受5-FU 370 mg/m2和LV 100 mg/m2辅助治疗，每4周一次，持续5天，并报告≥ 2级粘膜炎的患者参加了本研究。第6 - 10天皮下注射GM-CSF 4 µg/kg/天，在报告粘膜炎的周期后的周期中不降低化疗剂量。粘膜炎消失或减少至1001级被记录为治疗成功。基线毒性为：12例患者发生2级口腔炎，9例患者发生3级口腔炎; 1、4和8例患者分别发生4、3和2级腹泻。结果：给予77个周期的GM-CSF。20例（64.5%）患者获得成功。分别在5例（16.1%）2级和8例（25.8%）3级口腔炎患者中以及分别在1例（3.2%）和5例（16.1%）3级和2级腹泻患者中可评估疗效。2例同时患有2级口腔炎和腹泻的患者报告了成功（3.2%）。7例（22.5%）患者无疗效证据。在4例（12.9%）患者中，由于2级过敏反应，在首次给予GM-CSF后停止治疗。结论：GM-CSF皮下给药缓解了患者5-FU/LV诱导的粘膜炎症状，副作用可接受，允许维持全剂量化疗。
Objective: To test the activity of subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF) administration in patients with colorectal cancer treated with adjuvant 5-fluorouracil (5-FU) plus leucovorin (LV) and suffering from mucositis. Methods: Thirty-one patients treated with adjuvant 5-FU 370 mg/m2 and LV 100 mg/m2 for 5 days every 4 weeks and reporting grade ≧2 mucositis participated in the study. Subcutaneous GM-CSF 4 µg/kg/day from days 6 to 10 was administered without chemotherapy dose reductions in the cycle that followed the cycle during which mucositis was reported. The disappearance of mucositis or a decrease by ≧1 grade was recorded as a therapeutic success. Baseline toxicity was: grade 2 stomatitis in 12 patients and grade 3 in 9; grade 4, 3 and 2 diarrhoea in 1, 4 and 8 patients, respectively. Results: Seventy-seven GM-CSF cycles were administered. A success was achieved in 20 (64.5%) patients. The efficacy was assessable in 5 (16.1%) patients with grade 2 and in 8 (25.8%) with grade 3 stomatitis, respectively, as well as in 1 (3.2%) and 5 (16.1%) patients with grade 3 and 2 diarrhoea, respectively. Success (3.2%) was reported in 2 patients suffering from both grade 2 stomatitis and diarrhoea. In 7 (22.5%) patients there was no evidence of efficacy. In 4 (12.9%) patients the treatment was stopped after the first administration of GM-CSF due to a grade 2 allergic reaction. Conclusions: The subcutaneous administration of GM-CSF relieved patients from symptoms of 5-FU/LV-induced mucositis with acceptable side effects permitting the maintenance of full-dose chemotherapy.