Campora E, Baldini E, Rubagotti A, Chiara S, Bruzzi P, Sertoli M R, Rosso R
Department of Medical Oncology, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.
J Chemother. 1990 Oct;2(5):336-9. doi: 10.1080/1120009x.1990.11739039.
Fifty-three breast cancer patients receiving adjuvant chemotherapy entered a double-blind randomized trial of lorazepam 2.5 mg orally prior to chemotherapy and repeated after 12 hours (Arm A) versus placebo (Arm B) with methylprednisolone (MPN) 375 mg in 3 equal doses: 125 mg i.v. prior to chemotherapy and repeated i.m. 6 and 12 hours later. Adjuvant therapy with 5-fluorouracil 600 mg/m2, 4'-epi-doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2 (FEC) day 1 was alternated every 21 days with cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, 5-fluorouracil 600 mg/m2 (CMF) day 1 for a total of 12 courses. The majority of patients experienced greater than or equal to 5 emetic episodes with FEC therapy (Arm A = 52%; Arm B = 55%). Mild and moderate nausea were reported by 60% and 68% of patients in Arms A and B, respectively. With CMF therapy complete control of emesis was observed in 33% (Arm A) and 35% (Arm B) of patients. The addition of lorazepam did not improve results either with FEC or CMF. Sedation was experienced by 86 to 92% of patients treated with lorazepam and amnesia was observed in 48-50% of cases. FEC therapy must be considered a highly emetic regimen and antiemetic therapy planned accordingly.
五十三名接受辅助化疗的乳腺癌患者进入一项双盲随机试验，试验内容为化疗前口服2.5毫克劳拉西泮并在12小时后重复给药（A组）与安慰剂（B组）对比，同时B组患者接受375毫克甲泼尼龙（MPN）分3等份剂量给药：化疗前静脉注射125毫克，6小时和12小时后分别肌肉注射一次。第1天给予5-氟尿嘧啶600毫克/平方米、表阿霉素60毫克/平方米、环磷酰胺600毫克/平方米（FEC方案）进行辅助治疗，每21天交替为第1天给予环磷酰胺600毫克/平方米、甲氨蝶呤40毫克/平方米、5-氟尿嘧啶600毫克/平方米（CMF方案），共进行12个疗程。大多数患者在接受FEC治疗时经历了大于或等于5次呕吐发作（A组=52%；B组=55%）。A组和B组分别有60%和68%的患者报告有轻度和中度恶心。在CMF治疗中，分别有33%（A组）和35%（B组）的患者呕吐得到完全控制。添加劳拉西泮在FEC或CMF治疗中均未改善结果。接受劳拉西泮治疗的患者中有86%至92%出现镇静作用，48%-50%的病例出现失忆。FEC治疗必须被视为一种高度致吐方案，并据此制定相应的止吐治疗计划。
