伊立替康联合卡培他滨与卡培他滨单药二线治疗晚期结直肠癌对比观察

目的:对比观察伊立替康联合卡培他滨与卡培他滨单药治疗FOLFOX4方案一线化疗失败的晚期结直肠癌的疗效及安全性。方法:选取有明确病理诊断、经FOLFOX4方案化疗失败的复发或转移结直肠癌患者共65例。随机分为联合组33例(伊立替康+卡培他滨)和单药组32例(卡培他滨),21d为1个周期。每例至少接受2个周期化疗后,评价2组临床受益反应、客观疗效及毒副反应,至少随访1a。结果:联合组总有效率(48.5%)、临床受益率(78.7%)、疾病进展时间(6.3±2.6)个月、平均生存期(12.6±7.3)个月与单药组(21.9%、50.0%、(4.8±2.1)个月、(8.1±6.4)个月)比较差异有统计学意义(均P<0.05)。2组共有的不良反应主要为恶心、呕吐及骨髓抑制,联合组明显较单药组反应严重(P<0.05或P<0.01),但对症治疗后不延误治疗。联合组特有的急性胆碱能综合征和迟发性腹泻发生率较高(69.7%、90.9%),但均在可控制、可耐受的范围之内。结论:伊立替康联合卡培他滨二线治疗FOLFOX4化疗失败的晚期结直肠癌患者可取得较高的临床受益率和总有效率,副反应可耐受。

Capecitabine Alone or in Combination with Irinotecan in the Second Line Treatment for Advanced Colorectai Cancer

OBJECTIVE： To evaluate the efficacy and safety of the combination chemotherapy with irinotecan plus capecitabine compared with single capecitabine in patients with metastatic colorectal cancer after failure of first line treatment with FOLFOX4. METHODS： Sixty five patients who were confirmed pathologically as having advanced or recurring colorectal cancer were enrolled after failure of chemotherapy with FOLFOX4 and randomly assigned to receive irinotecan plus capecitabine（combination group, n = 33） or capecitabine alone （single chemotherapy group, n = 32） for 21 days （n = 1 cycle）. The clinical benefit response （CBR）, objective therapeutic effect and adverse reaction in two groups were assessed after treatment for at least 2 consecutive cycles. And the patients were followed up for a least 1 year. RESULTS： There were significant differences between the combination group and the single capecitabine group in the total effective rate, CBR, the disease progression time （TTP） and the median survival time （48.5%, 78.7%, 6.3± 2.6 months and 12.6± 7.3 months, respectively in the combination group vs. 21.9%, 50.0%, 4.8± 2.1 months and 8.1± 6.4 months, respectively in the single capecitabine group） （all P 〈 0.05）. The common adverse effects for both groups were nausea, vomiting and myelosuppression. Compared to single capecitabine group, the adverse effects in the combination group were more serious （P〈0.05 or P〈0.01）, but the treatment was not delayed after symptomatic treatment. Moreover, the incidences of acute cholinergic system and tardive diarrhea which occurred only in the combination group reached as high as 69.7% and 90.9%, respectively, but under control within the limit of tolerance. CONCLUSION： The combination chemotherapy of irinotecan and capecitabine is remarkable in clinical benefit response and total effective rate and tolerable in toxicity in the second line treatment for patients with advanced colorectal cancer after failure of first line treatment with F