Markman M, Kennedy A, Webster K, Kulp B, Peterson G, Belinson J
Department of Gynecology/Obstetrics, Department of Hematology/Medical Oncology, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio 44195, USA.
Gynecol Oncol. 1998 Oct;71(1):113-5. doi: 10.1006/gyno.1998.5168.
The objective of this study was to determine the efficacy of a low-dose oral granisetron plus intravenous dexamethasone prophylactic antiemetic regimen in patients receiving carboplatin-based chemotherapy.
Patients with gynecologic malignancies being treated with either single-agent carboplatin or a carboplatin-paclitaxel regimen received a single 1-mg oral dose of granisetron 30 min prior to chemotherapy plus intravenous dexamethasone (20 mg) as prophylaxis for emesis. Patients either had not previously been treated with chemotherapy or had not received any cytotoxic drugs for >/=4 months prior to study entry. Effectiveness was evaluated based on the degree of control of nausea and vomiting during the 24 h following treatment.
Of the 32 patients participating in this phase 2 trial, only 2 (6%) experienced any degree of nausea or vomiting within the first 24 h of chemotherapy administration. Both of these individuals had carcinomatosis and were experiencing emesis prior to chemotherapy. One patient developed mild delayed nausea >24 h after treatment. No major or minor toxic effects of the antiemetic regimen observed.
A 1-mg dose of oral granisetron plus intravenous dexamethasone (20 mg) is a safe, effective, and relatively inexpensive prophylactic antiemetic regimen for patients receiving single-agent carboplatin or combination carboplatin-paclitaxel chemotherapy.
本研究的目的是确定低剂量口服格拉司琼联合静脉注射地塞米松预防性止吐方案在接受以卡铂为基础的化疗患者中的疗效。
接受单药卡铂或卡铂 - 紫杉醇方案治疗的妇科恶性肿瘤患者在化疗前30分钟接受1毫克口服格拉司琼单剂量治疗，并静脉注射地塞米松（20毫克）作为呕吐预防措施。患者要么之前未接受过化疗，要么在研究入组前≥4个月未接受任何细胞毒性药物治疗。根据治疗后24小时内恶心和呕吐的控制程度评估有效性。
在参与这项2期试验的32名患者中，只有2名（6%）在化疗给药后的头24小时内出现了任何程度的恶心或呕吐。这两名患者均患有癌性腹膜炎，且在化疗前就出现呕吐。一名患者在治疗后>24小时出现轻度延迟性恶心。未观察到止吐方案的任何严重或轻微毒性作用。
对于接受单药卡铂或卡铂 - 紫杉醇联合化疗的患者，1毫克剂量的口服格拉司琼联合静脉注射地塞米松（20毫克）是一种安全、有效且相对便宜的预防性止吐方案。
