Mantovani G, Macciò A, Curreli L, Lampis B, Ghiani M, Bianchi A, Contu P
Department of Medical Oncology, University of Cagliari, Italy.
Oncol Rep. 1998 Jan-Feb;5(1):273-80. doi: 10.3892/or.5.1.273.
A phase III, single-institution, open, prospective, randomized, parallel study was carried out on head and neck cancer patients to compare a combination of low-dose (20 mg q.i.d.) oral metoclopramide (M) + i.m. Dexamethasone (D) with an oral 5-HT3-Receptor Antagonist (5-HT3-RA) alone in the prevention of high-dose (HD > or = 80 mg/m2) cisplatin-induced delayed emesis. 51 consecutive patients, all but two with advanced stage of disease, were treated for a total of 198 chemotherapic cycles: 23 patients entered Group A (5-HT3-RA) receiving a total of 108 cycles, 28 patients entered Group B (M + D) receiving a total of 90 cycles. The treatment groups were well matched for age, sex (almost all patients were males), ECOG PSR, stage of disease and alcohol intake. The efficacy of M + D was significantly higher than that of 5-HT3-RA in achieving complete protection (CR 88.9% vs 72.2%, chi2 9.9, p = 0.002) and major efficacy (ME: CR + MR) (94.5% vs 85.2%, chi2 5.6, p = 0.02). Generally, for both treatments (5-HT3-RA and M + D) a good control of delayed emesis was achieved in patients who had complete protection on acute emesis. A good control of acute emesis had a highly positive predictive value of delayed emesis for both treatments without significant difference between them (CR 85% for M + D and 82% for 5-HT3-RA; ME 88% for M + D and 92% for 5-HT3-RA). The failure (F) on acute emesis had a significantly higher negative predictive value of delayed emesis for M + D (98%) than 5-HT3-RA (67%). Our study is, to our knowledge, the first comparing M + D vs one 5-HT3-RA alone in the prevention of HD cisplatin-induced delayed emesis in a properly designed clinical trial. Our results show that M + D are more effective than 5-HT3-RA alone in the prevention of HD cisplatin induced delayed emesis, whereas 5-HT3-RA may be the treatment of choice in patients who had acute vomiting. Our study demonstrated not only the persistence of antiemetic efficacy but also increasing efficacy, during subsequent courses. Our results confirm that protection from acute emesis plays a major role in the appearance and control of delayed emesis.
一项针对头颈癌患者的III期单机构开放性前瞻性随机平行研究，比较了低剂量（每日4次，每次20 mg）口服甲氧氯普胺（M）+肌肉注射地塞米松（D）与单独使用口服5 - 羟色胺3受体拮抗剂（5 - HT3 - RA）预防高剂量（HD≥80 mg/m²）顺铂引起的延迟性呕吐的效果。连续51例患者（除2例疾病处于晚期外）共接受了198个化疗周期的治疗：23例患者进入A组（5 - HT3 - RA组），共接受108个周期；28例患者进入B组（M + D组），共接受90个周期。治疗组在年龄、性别（几乎所有患者为男性）、东部肿瘤协作组（ECOG）体力状态评分、疾病分期和酒精摄入量方面匹配良好。在实现完全保护（完全缓解率：88.9%对72.2%，卡方值9.9，p = 0.002）和主要疗效（ME：完全缓解 + 部分缓解）（94.5%对85.2%，卡方值5.6，p = 0.02）方面，M + D组的疗效显著高于5 - HT3 - RA组。总体而言，对于两种治疗方法（5 - HT3 - RA和M + D），在急性呕吐得到完全保护的患者中，延迟性呕吐得到了良好控制。对于两种治疗方法，急性呕吐的良好控制对延迟性呕吐具有高度阳性预测价值，且两者之间无显著差异（M + D组的完全缓解率为85%，5 - HT3 - RA组为82%；M + D组的主要疗效为88%，5 - HT3 - RA组为92%）。急性呕吐失败（F）对M + D组延迟性呕吐的阴性预测价值（98%）显著高于5 - HT3 - RA组（67%）。据我们所知，我们的研究是在一项设计合理的临床试验中，首次比较M + D与单独一种5 - HT3 - RA预防高剂量顺铂引起的延迟性呕吐的研究。我们的结果表明，在预防高剂量顺铂引起的延迟性呕吐方面，M + D比单独使用5 - HT3 - RA更有效，而5 - HT3 - RA可能是急性呕吐患者的治疗选择。我们的研究不仅证明了后续疗程中镇吐疗效的持续性，还证明了疗效的增加。我们的结果证实，预防急性呕吐在延迟性呕吐的出现和控制中起主要作用。
