Department of Pharmacy, Shizuoka Cancer Center, Shizuoka Department of Pharmacy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo.
Department of Biostatistics, Yokohama City University School of Medicine, Yokohama.
Ann Oncol. 2016 Aug;27(8):1601-6. doi: 10.1093/annonc/mdw220. Epub 2016 Jun 29.
There has been no phase III study of comparing the efficacy of first- and second-generation 5-HT3 receptor antagonists in the triplet regimen with dexamethasone and aprepitant for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy (HEC).
Patients with a malignant solid tumor who would receive HEC containing 50 mg/m(2) or more cisplatin were randomly assigned to either palonosetron (0.75 mg) arm (Arm P) or granisetron (1 mg) arm (Arm G), on day 1, both arms with dexamethasone (12 mg on day 1 and 8 mg on days 2-4) and aprepitant (125 mg on day 1 and 80 mg on days 2-3). The primary end point was complete response (CR; no vomiting/retching and no rescue medication) at the 0-120 h period and secondary end points included complete control (CC; no vomiting/retching, no rescue medication, and no more than mild nausea) and total control (TC; no vomiting/retching, no rescue medication, and no nausea).
Between July 2011 and June 2012, 842 patients were enrolled. Of 827 evaluable, 272 of 414 patients (65.7%) in Arm P had a CR at the 0-120 h period when compared with 244 of 413 (59.1%) in Arm G (P = 0.0539). Both arms had the same CR rate of 91.8% at the acute (0-24 h) period, while at the delayed (24-120 h) period, Arm P had a significantly higher CR rate than Arm G (67.2% versus 59.1%; P = 0.0142). In secondary end points, Arm P had significantly higher rates than Arm G at the 0-120 h period (CC rate: 63.8% versus 55.9%, P = 0.0234; TC rate: 47.6% versus 40.7%, P = 0.0369) and delayed periods (CC rate: 65.2% versus 55.9%, P = 0.0053; TC rate: 48.6% versus 41.4%, P = 0.0369).
The present study did not show the superiority of palonosetron when compared with granisetron in the triplet regimen regarding the primary end point.
UMIN000004863.
目前尚无比较第一代和第二代 5-HT3 受体拮抗剂与地塞米松和阿瑞匹坦三联方案在预防高致吐性化疗（HEC）后化疗引起的恶心和呕吐方面疗效的 III 期研究。
接受含有 50mg/m(2) 或更多顺铂的 HEC 治疗的恶性实体瘤患者，随机分配至帕洛诺司琼（0.75mg）臂（Arm P）或格拉司琼（1mg）臂（Arm G），两组均于第 1 天给予地塞米松（第 1 天 12mg，第 2-4 天 8mg）和阿瑞匹坦（第 1 天 125mg，第 2-3 天 80mg）。主要终点为 0-120 小时期间完全缓解（CR；无呕吐/干呕和无解救药物），次要终点包括完全控制（CC；无呕吐/干呕、无解救药物和无恶心）和总控制（TC；无呕吐/干呕、无解救药物和无恶心）。
2011 年 7 月至 2012 年 6 月，共纳入 842 例患者。在 827 例可评估患者中，Arm P 中 414 例患者中有 272 例（65.7%）在 0-120 小时期间达到 CR，而 Arm G 中 413 例患者中有 244 例（59.1%）（P=0.0539）。两组在急性（0-24 小时）期的 CR 率相同（91.8%），而在延迟期（24-120 小时），Arm P 的 CR 率明显高于 Arm G（67.2%比 59.1%；P=0.0142）。在次要终点方面，Arm P 在 0-120 小时期间的 CC 率（63.8%比 55.9%，P=0.0234）和 TC 率（47.6%比 40.7%，P=0.0369）以及延迟期（CC 率：65.2%比 55.9%，P=0.0053；TC 率：48.6%比 41.4%，P=0.0369）均明显高于 Arm G。
与格拉司琼相比，本研究未显示帕洛诺司琼在三联方案中在主要终点方面具有优越性。
UMIN000004863。
