Phase II trial of paclitaxel by three-hour infusion for advanced gastric cancer with short premedication for prophylaxis against paclitaxel-associated hypersensitivity reactions
Phase II trial of paclitaxel by three-hour infusion for advanced gastric cancer with short premedication for prophylaxis against paclitaxel-associated hypersensitivity reactions
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DOI：
10.1023/a:1011680507956
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发表时间：
2001-08-01
影响因子：
50.5
通讯作者：
Taguchi, T
中科院分区：
文献类型：
--
作者：
Yamada, Y;Shirao, K;Taguchi, T
目的：为了确定紫杉醇作为3小时输注给药的抗肿瘤活性和毒性，并估计使用短期预防方案的晚期胃癌患者超敏反应的发生率。60例晚期可测量胃癌患者，体能状态为0 - 2，既往最多接受过一种化疗方案，在紫杉醇给药前30分钟给予地塞米松、苯海拉明和雷尼替丁的短程术前用药后，用紫杉醇210 mg/m2治疗3小时以上。每三周重复一个周期。26例患者（43%）既往接受过转移性疾病化疗，6例患者接受过辅助化疗。结果：60例患者中有14例（23%，95%CI：13%~ 36%）有客观缓解，其中13例（13/26）有明显缓解。28例既往未接受化疗的患者中有6例（21%）和26例既往接受过转移性疾病治疗的患者中有7例（27%）发生PR，无完全缓解。中位缓解持续时间为152天。研究治疗耐受性良好。60例患者中有22例（37%）发生了3级或4级中性粒细胞减少，这是最常见和最严重的毒性。1例患者发生3级周围神经病变。仅9例患者（15%）发生超敏反应，均为1级。结论：紫杉醇3小时输注是一种有效且安全的胃癌短程术前用药方案。紫杉醇似乎对其他胃癌活性药物无交叉耐药。
Purpose: To determine the antitumor activity and toxicity of paclitaxel administered as a three-hour infusion and to estimate the incidence of hypersensitivity reactions using a short-course prophylaxis regimen in patients with advanced gastric cancer.Patients and methods: Sixty patients with advanced measurable gastric cancer and performance status 0 to 2, who had received at most one prior chemotherapy regimen, were treated with paclitaxel 210 mg/m(2) over three hours following a short-course premedication with dexamethasone, diphenhydramine and ranitidine administered 30 min prior to the delivery of paclitaxel. Cycles were repeated every three weeks. Twenty-six patients (43%) had received prior chemotherapy for metastatic disease and six patients had received adjuvant chemotherapy. The response rate to prior chemotherapy was 50% (13 of 26).Results: Objective responses were observed in 14 of 60 patients (23%; 95% confidence interval (95% CI): 13%-36%). Six of twenty-eight (21%) patients with no prior chemotherapy and 7 of 26 (27%) previously treated patients for metastatic disease developed a PR. There were no complete responses. The median duration of response was 152 days. The study treatment was well tolerated. Twenty-two of sixty patients (37%) experienced grade 3 or 4 neutropenia, which was the most common and serious toxicity. Grade 3 peripheral neuropathy occurred in one patient. Hypersensitivity reactions were observed in only nine patients (15%) and were all grade 1.Conclusions: A three-hour infusion of paclitaxel is both an active and safe treatment for gastric cancer using the short-course premedication schedule. Paclitaxel appears to be non-cross resistant to other active agents for gastric cancer.