A clinical study of Xiaoyan decoction combined with capecitabine and bevacizumab for the maintenance treatment of colorectal cancer
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摘要:
目的 探讨消岩汤联合卡培他滨和贝伐珠单抗在结直肠癌(colorectal cancer,CRC)维持治疗中的疗效和安全性。 方法 回顾性选取2016年1月至2021年12月于天津中医药大学第一附属医院接受一线标准化疗后进入维持治疗阶段的晚期CRC患者120例,分为治疗组(消岩汤联合卡培他滨和贝伐珠单抗维持治疗)60例和对照组(卡培他滨和贝伐珠单抗维持治疗)60例。比较两组间的无进展生存期(progression-free survival,PFS),总生存期(overall survival,OS)和安全性。 结果 两组患者在基线特征方面差异无统计学意义,治疗组显著延长了CRC患者的PFS(10.9个月 vs. 9.2个月,P=0.03),但OS未见显著获益(21.2个月 vs. 19.4个月,P=0.87)。消岩汤可改善患者神疲乏力(P=0.01)、恶心呕吐(P=0.01)、腹胀(P=0.02)的症状,且能减少恶心呕吐(P=0.04)及腹泻(P=0.02)的不良反应。 结论 消岩汤联合卡培他滨和贝伐珠单抗维持治疗可显著提高晚期CRC患者的PFS,减轻胃肠道系统不良反应且安全性良好。 Abstract:Objective To investigated the efficacy and safety of Xiaoyan decoction combined with capecitabine and bevacizumab for the maintenance treatment in patients with colorectal cancer (CRC). Methods At the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, a retrospective analysis was conducted for 120 advanced CRC patients who had completed first-line standard chemotherapy and entered maintenance therapy from January 2016 to December 2021. The treatment group (n=60) was treated with Xiaoyan decoction plus capecitabine and bevacizumab, whereas the control group (n=60) was treated with capecitabine and bevacizumab. Progression-free survival (PFS), overall survival (OS), and safety were evaluated. Results No significant difference in baseline characteristics was observed between the two groups. The treatment group experienced significantly prolonged PFS (10.9 months vs. 9.2 months, P=0.03), but no significant benefit was seen in OS (21.2 months vs. 19.4 months, P=0.87). Xiaoyan decoction was able to improve the symptoms of fatigue (P=0.01), vomiting (P=0.01), and abdominal distension (P=0.02) and reduce the severity of the adverse reactions of vomiting (P=0.04) and diarrhea (P=0.02). Conclusions Xiaoyan decoction combined with capecitabine and bevacizumab can significantly improve PFS in advanced CRC patients, reduce gastrointestinal adverse reactions, and provide good safety. -
表 1 两组患者基线特征比较
一般情况 治疗组(n=60) 对照组(n=60) P 性别 0.71 男 33(55.0) 35(58.3) 女 27(45.0) 25(41.7) 年龄(岁) 0.84 <60 18(30.0) 19(31.7) ≥60 42(70.0) 41(68.3) 原发肿瘤部位 0.39 右半 16(26.7) 12(20.0) 左半/直肠 44(73.3) 48(80.0) 病理分型 0.57 腺癌 52(86.7) 54(90.0) 黏液腺癌 8(13.3) 6(10.0) 分化程度 0.85 高分化 4(6.7) 3(5.0) 中分化 45(75.0) 44(73.3) 低分化 11(18.3) 13(21.7) 疗效评价 0.65 完全缓解 0 0 部分缓解 13(21.7) 11(18.3) 疾病稳定 47(78.3) 49(81.7) 转移器官数目(个) 0.86 1 28(46.7) 29(48.3) ≥2 32(53.3) 31(51.7) 淋巴结转移 0.47 是 51(85.0) 48(80.0) 否 9(15.0) 12(20.0) 既往接受手术 0.22 是 40(66.7) 46(76.7) 否 20(33.3) 14(23.3) 肝转移 0.45 是 40(66.7) 37(61.7) 否 20(33.3) 23(38.3) 肺转移 0.98 是 24(40.0) 19(31.7) 否 36(60.0) 41(68.3) 肿瘤分期(期) 0.99 ⅣA 28(46.7) 27(45.0) ⅣB 24(40.0) 25(41.7) ⅣC 8(13.3) 8(13.3) KPS评分(分) 0.54 70 24(40.0) 19 (31.7) 80 29(48.3) 35(58.3) 90 7(11.7) 6(10.0) 维持治疗周期(个) 0.46 ≤4 34(56.7) 38(63.3) >4 26(43.3) 22(36.7) ( )内单位为% 表 2 治疗后两组中医症状积分比较
(例) 一般情况 显著改善 部分改善 无变化 加重 缓解率(%) P 神疲乏力 0.01 治疗组 12 26 15 7 63.3 对照组 6 17 30 7 38.3 食少纳呆 0.11 治疗组 10 12 33 5 36.7 对照组 3 11 34 12 23.3 恶心呕吐 0.01 治疗组 12 11 33 4 38.3 对照组 4 6 42 8 16.7 口干 0.14 治疗组 4 5 45 6 15.0 对照组 0 4 52 4 6.7 腹胀 0.02 治疗组 10 14 31 5 40.0 对照组 6 6 41 7 20.0 腹痛 0.40 治疗组 6 11 38 5 28.3 对照组 5 8 40 7 21.7 大便稀溏 0.27 治疗组 7 9 37 7 26.7 对照组 4 7 42 7 18.3 大便干结 0.68 治疗组 8 9 38 5 28.3 对照组 5 10 38 7 25.0 便中带血 0.67 治疗组 7 8 43 2 25.0 对照组 8 5 43 4 21.7 总积分 0.03 治疗组 13 27 12 8 66.7 对照组 6 22 16 16 46.7 表 3 两组不良反应分级比较
(例) 不良反应 1级 2级 3级 4级 P 白细胞减少 0.64 治疗组 10 2 0 0 对照组 14 3 0 0 血红蛋白减少 0.53 治疗组 11 7 2 0 对照组 10 11 2 0 血小板减少 0.33 治疗组 5 0 0 0 对照组 3 3 0 0 恶心呕吐 0.04 治疗组 9 2 1 0 对照组 16 7 1 0 腹泻 0.02 治疗组 6 1 0 0 对照组 12 5 0 0 手足综合征 0.93 治疗组 8 3 0 0 对照组 9 2 0 0 血清转氨酶升高 0.47 治疗组 10 4 0 0 对照组 9 7 1 0 肌酐升高 0.55 治疗组 2 0 0 0 对照组 1 0 0 0 蛋白尿 0.40 治疗组 5 0 0 0 对照组 6 1 0 0 高血压 0.18 治疗组 8 2 0 0 对照组 7 5 1 0 表 4 维持治疗的单因素预后分析
影响因素 PFS OS χ2 P χ2 P 性别 1.80 0.18 0.07 0.80 年龄 0.28 0.60 0.44 0.51 原发部位 0.14 0.71 0.31 0.58 病理分型 0.01 0.96 0.20 0.65 分化程度 0.66 0.72 1.78 0.41 转移器官数目 2.19 0.15 2.80 0.09 肝转移 4.65 0.03 1.83 0.18 肺转移 0.21 0.65 0.11 0.74 肿瘤分期 11.58 0.01 11.13 0.01 入组时KPS评分 2.02 0.37 5.71 0.06 维持治疗周期 3.25 0.07 0.81 0.37 是否使用中药 4.28 0.04 0.06 0.80 表 5 PFS的多因素预后分析
影响因素 OR(95%CI) P 肝转移(是 vs. 否) 1.51(0.96~2.35) 0.070 肿瘤分期(ⅣA vs. ⅣC) 0.35(0.19~0.65) 0.009 肿瘤分期(ⅣB vs. ⅣC) 0.42(0.22~0.80) 0.010 使用中药(是 vs. 否) 0.65(0.44~0.97) 0.030 -
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