摘要
目的:评价紫杉醇联合卡培他滨一线治疗晚期胃癌后卡培他滨维持治疗的疗效及安全性.方法:将76例符合标准的晚期胃癌患者随机分为A、B两组.A组36例给予紫杉醇联合卡培他滨(paclitaxel/xeloda,PACX)化疗,21 d为1周期,4周期后无进展者行卡培他滨维持治疗(1000 mg/m2,bid,d1-14,q3w)直至疾病进展或出现不能耐受的不良反应;B组40例给予卡培他滨联合顺铂(xeloda/cisplatin,XP)化疗,21 d为1周期,最多6周期后单纯观察.结果:PA C X方案和X P方案的缓解率(remission rate,RR)分别为52.78%(19/36)和45.00%(18/40),疾病控制率(disease control rate,DCR)分别为80.56%(29/36)和75.00%(30/40),两者比较差异无统计学意义(P=0.42);维持组和随访组的缓解率(RR)分别为17.24%(5/29)和0.00%(0/30),DCR分别为72.4%(21/29)和46.67%(14/30),两者比较有明显差异(P=0.024,P=0.043).维持组中位无疾病进展时间(median progression free survival time,mPFS)比随访组提高了1.23 mo(8.10 mo vs 6.86 mo,P=0.021),中位总生存时间(median overall survival t i m e,m O S)和1年生存率分别提高了2.41mo(14.74 mo vs 12.33 mo)和21.08%(69.23%vs 48.15%),但无统计学意义(P=0.081,P=0.118).PACX方案脱发及周围神经毒性的发生率较XP方案明显增高,但多为Ⅰ/Ⅱ度,而恶心呕吐的发生率则显著降低;维持组除手足综合症的发生率增高之外,余不良反应的发生率明显减少,无治疗相关性死亡.结论:紫杉醇联合卡培他滨一线治疗晚期胃癌后卡培他滨维持治疗的方案能增加缓解率和疾病控制率,延长无疾病进展时间,总生存时间和1年生存率有提高趋势,耐受性良好,较为经济和安全,值得进一步研究和临床应用.
AIM： To evaluate the efficacy and safety of paclitaxel plus capecitabine （PACX） with subsequent capecitabine maintenance as firstline chemotherapy for patients with advanced gastric cancer. METHODS： Seventy-six eligible patients were randomly assigned to either group A or group B. In group A, 36 patient were treated with the paclitaxel/capecitabine （PACX） regimen, with 21 days as a cycle. Patients who responded to the therapy after 4 cycles were given capecitabi- ne maintenance （1000 mg/m2, bid, d1-14, q3w） therapy until disease progression or intolerable toxicity. In group B, 40 patients were treated with the cisplatin/capecitabine （XP） regimen. A maximum of six cycles was given. RESULTS： There was no significant difference in remission rate （RR） or disease control rate （DCR） between groups A and B （52.78% vs 45.00%, 80.56% vs 75.00%, P = 0.42）. The RR and DCR were 17.24% and 72.4% in the maintenance group, and 0.00% and 46.67% in the follow-up group （P = 0.024, 0.043）. The median progression free survival time （mPFS） in the maintenance group was 1.3 mo longer than that in the follow-up group （8.10 mo vs 6.86 too, P =0.021）. The median over- all survival time （mOS） and one-year survival rate were 2.41 mo longer （14.74 mo vs 12.33 mo） and 21.08% higher （69.23% vs 48.15%） than those in the follow-up group, but the differences were not statistically significant （P =- 0.081, 0.118）. Com- pared with the XP regimen, the incidence rates of alopecia and peripheral neurotoxicity associated with the PACX regimen were significantly higher, although most of them were mild （grade I / Ⅱ）. The incidence rate of nausea and vomiting was lower in patients receiving the PACX regimen. In the maintenance group, only the incidence rate of hand-foot syndrome was raised, and the other toxicities were reduced obviously. No treatment- related death was found. CONCLUSION： Paclitaxel plus capecitabine with subsequent capecitabine maintenance therapy can increase the RR a
出处
《世界华人消化杂志》
CAS
北大核心
2014年第17期2456-2462,共7页
World Chinese Journal of Digestology
关键词
紫杉醇
卡培他滨
胃癌
Paclitaxel
Capecitabine, Gastric cancer
