卡培他滨单药二线治疗复发转移胃癌的临床研究

The clinical study of Capecitabine as a second-line treatment on patients with recurrent and metastatic gastric carcinoma

目的观察卡培他滨单药二线治疗复发转移胃癌的近期疗效、毒副作用和临床获益。方法 45例初次治疗后区域复发或/和广泛转移的胃癌患者随机分为两组,观察组22例,用单药卡培他滨2 000 mg/(m2.d),第l～14天,停药7 d,21 d为1周期。对照组23例,采用DC(多西他赛+顺铂)方案,多西他赛60 mg/m2,d1;顺铂25 mg/(m2.d),第1～3天,21 d为1周期。所有患者接受3～6个周期治疗,至少接受2周期后评价疗效及副作用。结果两组的近期有效率、中位生存时间和中位缓解期比较,差异均无统计学意义(P>0.05)。两组患者的Ⅲ度以上毒副作用主要为血液学毒性和消化道反应。对照组Ⅲ度以上的血液学毒性、恶性呕吐及便秘的发生率显著高于观察组(P<0.05),卡培他滨单药化疗的主要毒性作用是手足综合症。结论单药卡培他滨口服二线治疗复发转移性胃癌疗效好,与DC方案无显著性差异,毒副作用较联合方案小。

Objective To observe the shot-term effects and clinical benefits of capecitabine in second-line treatment of patients with recurrent and metastatic gastric carcinoma. Methods All of 45 patients with regional recurrent or/and widespread metastatic gastric carcinoma after their initial treatments,were randomly divided into two groups. Observation group was treated with single-agent capecitabine 2 000 mg/（m2 d）, for the 1-14 day, stopped the medicine in the next 7 days;one cycle of the treatment was 21 days. Control group was treated with DC （docetaxel＋ cisplatin）regimen, docetaxel： 60 mg/m2, dl; eisplatin：25 mg/（m2.d）, for 1-3 day, one treatment cycle was 21 days. All the patients were treated for 3-6 therapeutic cycles. Efficacy and adverse effects were assessed at least after 2 cycles. Results There was no significant dif- ference on shot-term efficacy, median survival time and median remission time between the observation group and the con- trol group （P 〉 0.05）. The main toxicity above degree IU between the two groups were hematotoxicity and alimentary canal reactions. The incidence of hematotoxicity, nausea, vomitting and constipation above degree IlI of the contrast group was superior to the observation group （P 〈 0.05）, the main toxic effect of capecitabine was HFSR. Conclusion The curative ef- fect of capecitabine as a second-line treatment on patients with recurrent and metastatic gastric carcinoma was effective, compared with DC regimen, it had no significant difference and the toxic and side-effect was less.