替吉奥与卡培他滨对晚期乳腺癌有效性和安全性比较及药物疗效相关影响因素研究
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摘要
目的比较替吉奥与卡培他滨治疗晚期乳腺癌的有效性和安全性,并探讨影响氟尿嘧啶类药物疗效的相关因素。方法回顾性选自大连市中心医院2014年1月至2016年1月收治的94例对紫杉类及蒽环类耐药的晚期乳腺癌患者,根据用药方案的不同分成替吉奥组(n=47)与卡培他滨组(n=47)。其中替吉奥组根据体表面积设置给药剂量,给予替吉奥40～60 mg治疗,早、晚饭后口服,连用14 d,21 d重复;卡培他滨组给予卡培他滨2 000 mg/(m~2·d)治疗,分2次,连用14 d,21 d重复,两组均完成至少2个周期治疗。对两组患者进行近期疗效评估,同时评价化疗药物毒副作用发生情况。对影响近期疗效的因素进行单因素及多因素Logistics回归分析。结果替吉奥组总有效率、疾病控制率分别为29. 79%、65. 96%,卡培他滨组分别为31. 91%、70. 21%,两组总有效率及疾病控制率比较无统计学差异(P> 0. 05)。替吉奥组恶心呕吐、手足综合征发生率分别为10. 64%、4. 26%,与卡培他滨组的34. 04%、44. 68%比较均有明显下降,差异有统计学意义(P <0. 05);两组其他不良反应发生率比较差异无统计学意义(P> 0. 05)。单因素分析结果显示,肝转移、转移灶数目≥4个、术后无病生存期(DFS)≥3. 5年的晚期乳腺癌患者,近期疗效总有效率较低,差异有统计学意义(P <0. 05)。多因素分析结果显示,转移灶数目≥4个是影响晚期乳腺癌近期疗效的独立危险因素(OR=2. 841,P=0. 006),术后DFS≥3. 5年是独立保护因素(OR=0. 712,P=0. 000)。结论替吉奥与卡培他滨治疗晚期乳腺癌近期疗效相当,但替吉奥恶心呕吐、手足综合征发生率更低,安全性更高,转移灶数目、术后DFS均可影响氟尿嘧啶类药物的近期疗效。
Objective To compare effectiveness and safety of tiggio and capecitabine in advanced breast cancer,and explore the factors affecting the efficacy of fluorouracil drugs. Methods 94 cases with advanced breast cancer resistant to taxanes and anthracycline in our hospital from January 2014 to January 2016 were selected as research objectives and divided into tiggio group( n = 47) and capecitabine group( n = 47)according to drug. The dose was given according to the body surface area for tiggio group; provide 40 ～ 60 mg tiggio for treatment,tiggio was given orally after breakfast and dinner for continuous 14 d,21 d. The captopril group was given capecitabine 2 000 mg/( m~2·d) for treatment,twice per day for continuous 14 d,21 d. Two groups should finish at least 2 period of treatment. The short-term efficacy and the occurrence of toxic and toxic side effects of chemotherapy drugs at same time were evaluated. Univariate and multivariate logistic regression analysis was performed on the factors that affected the short term efficacy. Results Tiggio group's total effective rate and disease control rate were 29. 79%,65. 96% respectively,while capecitabine group's those rates were 31. 91%,70. 21%. There was no significant difference between the two groups in total effective rate and disease control rate( P > 0. 05). Tiggio group's incidence of nausea and vomiting,hand and foot syndrome were 10. 64%,4. 26% respectively,those were significant lower than capecitabine group's 34. 04%,44. 68%. The difference was statistically significant( P < 0. 05).There was no statistically significant difference in the incidence of other adverse events between the two groups( P > 0. 05). Univariate analysis showed cases with advanced breast cancer whose postoperative DFS ≥3. 5 year and the number of liver metastases,metastases ≥4 has less recent total effective rate,the difference was statistically significant( P < 0. 05). Multivariate analysis showed that,the number of metastases ≥4 is an independent risk factor affecting the short-term efficacy of advanced breast cancer( OR = 2. 841,P = 0. 006),postoperative DFS 3. 5 year is independent protecting factor( OR = 0. 712,P = 0. 000). Conclusion The efficacy of tiggio and capecitabine in the treatment of advanced breast cancer is similar,but tiggio has less incidence rate of nausea and vomiting,hand and foot syndrome with higher safety. The number of metastases,postoperative DFS can affect the short-term efficacy of fluorouracil drugs.
Objective To compare effectiveness and safety of tiggio and capecitabine in advanced breast cancer,and explore the factors affecting the efficacy of fluorouracil drugs. Methods 94 cases with advanced breast cancer resistant to taxanes and anthracycline in our hospital from January 2014 to January 2016 were selected as research objectives and divided into tiggio group( n = 47) and capecitabine group( n = 47)according to drug. The dose was given according to the body surface area for tiggio group; provide 40 ～ 60 mg tiggio for treatment,tiggio was given orally after breakfast and dinner for continuous 14 d,21 d. The captopril group was given capecitabine 2 000 mg/( m~2·d) for treatment,twice per day for continuous 14 d,21 d. Two groups should finish at least 2 period of treatment. The short-term efficacy and the occurrence of toxic and toxic side effects of chemotherapy drugs at same time were evaluated. Univariate and multivariate logistic regression analysis was performed on the factors that affected the short term efficacy. Results Tiggio group's total effective rate and disease control rate were 29. 79%,65. 96% respectively,while capecitabine group's those rates were 31. 91%,70. 21%. There was no significant difference between the two groups in total effective rate and disease control rate( P > 0. 05). Tiggio group's incidence of nausea and vomiting,hand and foot syndrome were 10. 64%,4. 26% respectively,those were significant lower than capecitabine group's 34. 04%,44. 68%. The difference was statistically significant( P < 0. 05).There was no statistically significant difference in the incidence of other adverse events between the two groups( P > 0. 05). Univariate analysis showed cases with advanced breast cancer whose postoperative DFS ≥3. 5 year and the number of liver metastases,metastases ≥4 has less recent total effective rate,the difference was statistically significant( P < 0. 05). Multivariate analysis showed that,the number of metastases ≥4 is an independent risk factor affecting the short-term efficacy of advanced breast cancer( OR = 2. 841,P = 0. 006),postoperative DFS 3. 5 year is independent protecting factor( OR = 0. 712,P = 0. 000). Conclusion The efficacy of tiggio and capecitabine in the treatment of advanced breast cancer is similar,but tiggio has less incidence rate of nausea and vomiting,hand and foot syndrome with higher safety. The number of metastases,postoperative DFS can affect the short-term efficacy of fluorouracil drugs.
引文
[1]关萌,周美美,宋艳秋.吉西他滨联合卡培他滨治疗晚期乳腺癌的临床观察[J].中国妇幼保健,2014,29(9):1442-1444.
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[3] Kunisaki C,Takahashi M,Ono HA,et al. Biweekly Docetaxel and S-1 combination chemotherapy as first-line treatment for elderly patients with advanced gastric cancer[J]. Anticancer Res,2013,33(2):697-704.
[4] Ronot M,Bouattour M,Wassermann J,et al. Alternative Response Criteria(Choi,European association for the study of the liver,and modified Response Evaluation Criteria in Solid Tumors[RECIST])versus RECIST 1. 1 in patients with advanced hepatocellular carcinoma treated with sorafenib[J]. Oncologist,2014,19(4):394-402.
[5]姜敏,曾越灿,迟峰,等.替吉奥联合吉西他滨或长春瑞滨治疗晚期乳腺癌的疗效分析[J].医学研究杂志,2016,45(11):61-65.
[6]祝朝富,李卓虹,安佰平,等.长春瑞滨联合卡培他滨或替吉奥治疗紫杉类及蒽环类耐药晚期乳腺癌的效果分析[J].临床肿瘤学杂志,2017,22(3):227-231.
[7]张会强,王涛,边莉,等.铂方案治疗HER2阴性蒽环和紫杉类治疗失败晚期乳腺癌的临床研究[J].中华肿瘤防治杂志,2014,21(22):1820-1824.
[8] Ishizuna K,Ninomiya J,Ogawa T,et al. Effectiveness and safety of Tegafur gimeracil oteracil potassium(TS-1)for metastatic breast cancer:A Single-Center Retrospective Study[J]. Gan To Kagaku Ryoho,2014,41(13):2577-2582.
[9] Berretta M,Di Francia R. Comment of"Tegafur gimeracil oter combined with oxaliplatin for advanced colorectal cancer."Is it cost effectiveness[J]? Eur Rev Med Pharmacol Sci,2016,20(1):5-6.
[10] Hong JY,Park YH,Choi MK,et al. Characterization of durable responder for capecitabine monotherapy in patients with anthracyclineand taxane-pretreated metastatic breast cancer[J/CD]. Clin Breast Cancer,2015,15(5):e287-292.
[11]黄国军,王光红,高超,等.替吉奥与卡培他滨联合奥沙利铂治疗晚期结直肠癌的临床研究[J].中国临床药理学杂志,2015,31(3):181-183.
[12]聂力,邵腾飞,葛卫红.替吉奥单药联合西药强调放疗同步治疗老年晚期非小细胞肺癌的效果[J].中国医药导报,2017,14(17):4-7.
[13]代醒,李向柯,吴海波,等.替吉奥单药治疗老年晚期乳腺癌的临床疗效及安全性[J].肿瘤防治研究,2013,40(5):481-484.
[14]焦洋,宁洁,王芳,等.晚期乳腺癌替吉奥与卡培他滨治疗疗效及安全性对比研究[J].中华肿瘤防治杂志,2016,23(7):452-456.
[15] Yamamoto D,Iwase S,Yoshida H,et al. Efficacy of S-1 in patients with capecitabine-resistant breast cancer-Japan Breast Cancer Research Network(JBCRN)04-1 trial[J]. Anticancer Res,2010,30(9):3827-3831.
[16]郭晨明,吴楠,郭丽英.我国HER-2阳性乳腺癌预后影响因素的Meta分析[J].中国普通外科杂志,2016,25(2):264-270.
[2]胡耶芳.低剂量卡培他滨治疗晚期乳腺癌药效及安全性评价[J].宁夏医科大学学报,2014,36(3):299-302.
[3] Kunisaki C,Takahashi M,Ono HA,et al. Biweekly Docetaxel and S-1 combination chemotherapy as first-line treatment for elderly patients with advanced gastric cancer[J]. Anticancer Res,2013,33(2):697-704.
[4] Ronot M,Bouattour M,Wassermann J,et al. Alternative Response Criteria(Choi,European association for the study of the liver,and modified Response Evaluation Criteria in Solid Tumors[RECIST])versus RECIST 1. 1 in patients with advanced hepatocellular carcinoma treated with sorafenib[J]. Oncologist,2014,19(4):394-402.
[5]姜敏,曾越灿,迟峰,等.替吉奥联合吉西他滨或长春瑞滨治疗晚期乳腺癌的疗效分析[J].医学研究杂志,2016,45(11):61-65.
[6]祝朝富,李卓虹,安佰平,等.长春瑞滨联合卡培他滨或替吉奥治疗紫杉类及蒽环类耐药晚期乳腺癌的效果分析[J].临床肿瘤学杂志,2017,22(3):227-231.
[7]张会强,王涛,边莉,等.铂方案治疗HER2阴性蒽环和紫杉类治疗失败晚期乳腺癌的临床研究[J].中华肿瘤防治杂志,2014,21(22):1820-1824.
[8] Ishizuna K,Ninomiya J,Ogawa T,et al. Effectiveness and safety of Tegafur gimeracil oteracil potassium(TS-1)for metastatic breast cancer:A Single-Center Retrospective Study[J]. Gan To Kagaku Ryoho,2014,41(13):2577-2582.
[9] Berretta M,Di Francia R. Comment of"Tegafur gimeracil oter combined with oxaliplatin for advanced colorectal cancer."Is it cost effectiveness[J]? Eur Rev Med Pharmacol Sci,2016,20(1):5-6.
[10] Hong JY,Park YH,Choi MK,et al. Characterization of durable responder for capecitabine monotherapy in patients with anthracyclineand taxane-pretreated metastatic breast cancer[J/CD]. Clin Breast Cancer,2015,15(5):e287-292.
[11]黄国军,王光红,高超,等.替吉奥与卡培他滨联合奥沙利铂治疗晚期结直肠癌的临床研究[J].中国临床药理学杂志,2015,31(3):181-183.
[12]聂力,邵腾飞,葛卫红.替吉奥单药联合西药强调放疗同步治疗老年晚期非小细胞肺癌的效果[J].中国医药导报,2017,14(17):4-7.
[13]代醒,李向柯,吴海波,等.替吉奥单药治疗老年晚期乳腺癌的临床疗效及安全性[J].肿瘤防治研究,2013,40(5):481-484.
[14]焦洋,宁洁,王芳,等.晚期乳腺癌替吉奥与卡培他滨治疗疗效及安全性对比研究[J].中华肿瘤防治杂志,2016,23(7):452-456.
[15] Yamamoto D,Iwase S,Yoshida H,et al. Efficacy of S-1 in patients with capecitabine-resistant breast cancer-Japan Breast Cancer Research Network(JBCRN)04-1 trial[J]. Anticancer Res,2010,30(9):3827-3831.
[16]郭晨明,吴楠,郭丽英.我国HER-2阳性乳腺癌预后影响因素的Meta分析[J].中国普通外科杂志,2016,25(2):264-270.