Mantovani G, Macciò A, Bianchi A, Curreli L, Ghiani M, Proto E, Santona M C
Department of Medical Oncology, University of Cagliari, Italy.
Cancer. 1996 Mar 1;77(5):941-8.
A single-institution, prospective, randomized, open controlled trial was carried out on head and neck cancer patients to compare granisetron (GRA), ondansetron (OND), and tropisetron (TRO) in the prevention of cisplatin-induced acute nausea and vomiting. All patients were chemotherapy-naive and treated with cisplatin on Day 1 (80 to 100 mg/m2).
One hundred seventeen patients were treated for a total of 463 cycles of cisplatin-based chemotherapy and randomized to receive 24 mg of OND intravenously (i.v.), 3 mg of GRA i.v., or 5 mg of TRO i.v. for the control of acute nausea and emesis.
In the GRA group, complete response (CR) was obtained in 119 of 165 cycles (72.1%), major response (MR) in 32 cycles (19.4%), minor response (MiR) in 5 cycles (3%), and a failure (F) in 9 cycles (5.5%). In the OND group, CR was obtained in 110 of 150 cycles (73.3%), MR in 31 cycles (20.7%), MiR in 2 cycles (1.3%), and F in 7 cycles (4.7%). In the TRO group, CR was obtained in 100 of 148 cycles (67.6%), MR in 26 cycles (17.6%), MiR in 15 cycles (10.1%), and F in 7 cycles (4.7%). Major efficacy (CR + MR) was obtained in 151 of 165 cycles (91.5%) for GRA, in 141 of 150 cycles (94.0%) for OND, and in 126 of 148 cycles (85.2%) for TRO. The difference in major efficacy between OND and TRO was statistically significant. When comparing MiR, both GRA and OND were more effective than TRO. No other significant differences were observed among the three antiemetic agents.
Although our results were achieved in an open trial, they show that GRA and OND are equally effective antiemetic agents in the prevention of cisplatin induced acute nausea and vomiting. TRO provides almost the same protection but is not as effective as OND for major efficacy. All three antiemetics can be administered safely to patients undergoing chemotherapy with cisplatin at doses of 80 mg/m2 or more.
在头颈癌患者中开展了一项单机构、前瞻性、随机、开放对照试验，以比较格拉司琼（GRA）、昂丹司琼（OND）和托烷司琼（TRO）预防顺铂所致急性恶心和呕吐的效果。所有患者均为初治化疗患者，于第1天接受顺铂治疗（80至100mg/m²）。
117例患者共接受了463周期基于顺铂的化疗，并随机分为静脉注射24mg OND、3mg GRA或5mg TRO以控制急性恶心和呕吐。
在GRA组中，165个周期中有119个周期获得完全缓解（CR，72.1%），32个周期获得主要缓解（MR，19.4%），5个周期获得轻微缓解（MiR，3%），9个周期治疗失败（F，5.5%）。在OND组中，150个周期中有110个周期获得CR（73.3%），31个周期获得MR（20.7%），2个周期获得MiR（1.3%），7个周期治疗失败（F，4.7%）。在TRO组中，148个周期中有100个周期获得CR（67.6%），26个周期获得MR（17.6%），15个周期获得MiR（10.1%），7个周期治疗失败（F，4.7%）。GRA组165个周期中有151个周期获得主要疗效（CR+MR，91.5%），OND组150个周期中有141个周期获得主要疗效（94.0%），TRO组148个周期中有126个周期获得主要疗效（85.2%）。OND和TRO之间的主要疗效差异具有统计学意义。比较MiR时，GRA和OND均比TRO更有效。在三种止吐药之间未观察到其他显著差异。
尽管我们的结果是在开放试验中取得的，但它们表明GRA和OND在预防顺铂所致急性恶心和呕吐方面是同样有效的止吐药。TRO提供了几乎相同的保护作用，但在主要疗效方面不如OND有效。所有三种止吐药都可以安全地用于接受80mg/m²或更高剂量顺铂化疗的患者。
