伊立替康联合替吉奥与mFOLFIRI方案对晚期胃癌患者二线化疗的效果比较
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摘要
目的探讨伊立替康联合替吉奥方案与mFOLFIRI方案对晚期胃癌患者的二线化疗效果。方法选择2014年5月至2016年12月就诊于江苏省常熟市第一人民医院经一线治疗失败的进展期胃癌患者共58例,应用随机数字表法分为2组,对照组31例,观察组27例。观察组给予替吉奥联合伊立替康方案二线化疗,21 d为1个疗程,应用实体瘤疗效评价标准于2个疗程后进行疗效评价;对照组给予伊立替康+亚叶酸钙注射液+5-氟尿嘧啶的mFOLFIRI方案化疗,14 d为1个周期,2个周期为1个疗程,3个周期后进行疗效评价。比较2组患者无进展生存时间、总生存时间和不良反应发生率。结果 58例患者均可评价疗效,观察组疾病进展率低于对照组[33. 3%(9/27)比45. 2%(14/31)],疾病控制率高于对照组[66. 7%(18/27)比54. 8%(17/31)],差异均有统计学意义(均P <0.05)。观察组和对照组患者无进展生存时间分别为1.4～8.2和1.4～7.6个月,中位无进展生存时间分别为4.2和3.5个月,差异有统计学意义(P=0.026)。2组患者中位总生存时间比较差异无统计学意义(P=0.456)。观察组Ⅲ～Ⅳ度白细胞减少、中性粒细胞减少发生率均低于对照组,Ⅰ～Ⅳ度贫血、呕吐、乏力、口腔黏膜炎发生率低于对照组,差异均有统计学意义(均P<0.05)。结论与mFOLFIRI方案相比,伊立替康联合替吉奥方案二线治疗晚期胃癌可提高患者的疾病控制率及无进展生存时间,同时减轻不良反应,患者耐受性更好,但不能改善患者的有效率和总生存时间。
Objective To investigate the effects of irinotecan combined with tegafur and mFOLFIRI second-line chemotherapy on patients with advanced gastric cancer. Methods From May 2014 to December2016, 58 patients with advanced gastric cancer who failed in first-line chemotherapy were enrolled at Changshu No. 1 People's Hospital. They were randomly divided into control group(n = 31) and observation group( n = 27).The observation group was treated with irinotecan plus tegafur second-line chemotherapy; 1 course was 21 d; the efficacy was assessed according to Response Evaluation Criteria in Solid Tumors after 2 courses of therapy. The control group had mFOLFIRI second-line chemotherapy(irinotecan + calcium folinate + 5-fluorouracil); 1 cycle was 14 d; 1 course was 2 circles; the efficacy was assessed after 3 circles. Progression free survival(PFS), overall survival( OS) and adverse reactions were analyzed. Results Disease progression rate in the observation group was lower than that in the control group[ 33. 3%( 9/27) vs 45. 2%(14/31)](P<0. 05). Disease control rate in the observation group was higher than that in the control group [ 66. 7%( 18/27) vs 54. 8%( 17/31) ]( P < 0. 05).PFS time was 1. 4-8. 2 months in the observation group and 1. 4-7. 6 months in the control group was; the median PFS time was 4. 2 and 3. 5 months respectively; there was a significant difference between the two groups(P =0.026). OS showed no significant difference between the two groups(P =0.456). Incidences of grade Ⅲ-Ⅳleukopenia and neutropenia in the observation group were lower than those in the control group; incidences of grade I-Ⅳ anemia, vomiting, fatigue and mucositis in the observation group were lower than those in the control group(all 尸<0.05). Conclusions Compared with mFOLFIRI regimen, irinotecan plus tegafur second-line chemotherapyis more effective in improving disease control rate and PFS with less adverse reaction and better tolerance; it shows no positive effect on the total therapeutic rate and OS.
Objective To investigate the effects of irinotecan combined with tegafur and mFOLFIRI second-line chemotherapy on patients with advanced gastric cancer. Methods From May 2014 to December2016, 58 patients with advanced gastric cancer who failed in first-line chemotherapy were enrolled at Changshu No. 1 People's Hospital. They were randomly divided into control group(n = 31) and observation group( n = 27).The observation group was treated with irinotecan plus tegafur second-line chemotherapy; 1 course was 21 d; the efficacy was assessed according to Response Evaluation Criteria in Solid Tumors after 2 courses of therapy. The control group had mFOLFIRI second-line chemotherapy(irinotecan + calcium folinate + 5-fluorouracil); 1 cycle was 14 d; 1 course was 2 circles; the efficacy was assessed after 3 circles. Progression free survival(PFS), overall survival( OS) and adverse reactions were analyzed. Results Disease progression rate in the observation group was lower than that in the control group[ 33. 3%( 9/27) vs 45. 2%(14/31)](P<0. 05). Disease control rate in the observation group was higher than that in the control group [ 66. 7%( 18/27) vs 54. 8%( 17/31) ]( P < 0. 05).PFS time was 1. 4-8. 2 months in the observation group and 1. 4-7. 6 months in the control group was; the median PFS time was 4. 2 and 3. 5 months respectively; there was a significant difference between the two groups(P =0.026). OS showed no significant difference between the two groups(P =0.456). Incidences of grade Ⅲ-Ⅳleukopenia and neutropenia in the observation group were lower than those in the control group; incidences of grade I-Ⅳ anemia, vomiting, fatigue and mucositis in the observation group were lower than those in the control group(all 尸<0.05). Conclusions Compared with mFOLFIRI regimen, irinotecan plus tegafur second-line chemotherapyis more effective in improving disease control rate and PFS with less adverse reaction and better tolerance; it shows no positive effect on the total therapeutic rate and OS.
引文
[1]符涛,季加孚.胃癌诊疗的热点和问题[J].中国肿瘤临床,2016,43(1):2-5. DOI:10.3969/j.issn. 1000-8179.2016.01.224.Fu T, Ji JF. The foci and problems in diagnosis and treatment of gastric cancer[J]. Chinese Journal of Clinical Oncology, 2016,43(1):2-5. DOI:10.3969/j.issn. 1000-8179.2016.01.224.
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[5] Yang L, Jiang X, Yan H, et al. Irinotecan-containing doublet treatment versus irinotecan monotherapy as second-line choice for advanced gastric cancer[J]. BMC Gastroenterol, 2018,18(1):43. DOI:10.1186/s12876-018-0772-4.
[6] Kwon HJ, Park MI, Park SJ, et al. Efficacy and safety of FOLFIRI after failure of FOLFOX-4 in advanced gastric cancer[J]. Korean J Gastroenterol, 2015,66(1):10-16. DOI:10. 4166/kjg. 2015.66.1.10.
[7]林能明,马胜林.新编抗肿瘤药物学[M].北京:军事医学科学出版社,2014:129.Lin NM, Ma SL. Practical cancer chemotherapy drug manual[M].Beijing:Military Medical Science Press, 2014:129.
[8]周琴,朱海鹏,胡军,等.替吉奥治疗老年晚期胃癌的临床观察[J].中国医药,2013,8(12):1726-1727. DOI:10. 3760/cma. j. issn. 1673-4777.2013. 12.018.Zhou Q, Zhu HP, Hu J,et al. Clinical study of tegafur treating elderly advanced gastric cancer[J]. China Medicine,2013,8(12):1726-1727. DOI:10. 3760/cma. j. issn. 1673-4777. 2013.12.018.
[9]黄凯,倪健凤,宋丽杰,等.替吉奥或卡培他滨联合紫杉醇治疗进展期胃癌的疗效比较[J].中国现代医生,2012,50(5):66-67,69. DOI:10.3969/j. issn. 1673-9701.2012.05.031.Huang K, Ni JF, Song LJ, et al. Efficacy of Paclitaxel combind with Tegafur or capecitabine in the treatment of advanced gastric cancer[J]. China Modem Doctor, 2012,50(5):66-67,69. DOI:10.3969/j. issn. 1673-9701.2012.05.031.
[10] Chon HJ, Rha SY, Park HS, et al. Salvage chemotherapy of biweekly irinotecan plus S-1(biweekly IRIS)in previously treated patients with advanced gastric cancer[J]. Cancer Chemother Pharmacol,2011,68(4):991-999. DOI:10.1007/s00280-011-1560-9.
[11]常青.伊立替康联合替吉奥二线治疗晚期胃癌的临床观察[J].现代肿瘤医学,2016,24(14):2254-2256.DOI:10.3969/j. issn. 1672-4992.2016.14.023.Chang Q. The effect of irinotecan combined with TS-1 in the treatment of advanced gastric cancer as second-line chemotherapy regimen[J]. Journal of Modern Oncology, 2016,24(14):2254-2256. DOI:10.3969/j.issn. 1672-4992.2016.14.023.
[12]崔勇霞,罗执芬,卢创新,等.伊立替康联合替吉奥或5-氟尿嘧啶方案二线治疗晚期胃癌的疗效观察[J].肿瘤防治研究,2014,41(7):808-810. DOI:10. 3971/j. issn. 1000-8578. 2014.07.026.Cui YX, Luo ZF, Lu CX, et al. Clinical observation of irinotecan combined with tegafur or 5-fluorouracil as second-line chemotherapy for advanced gastric cancer[J].Cancer Research on Prevention and Treatment, 2014,41(7):808-810. DOI:10. 3971/j. issn.1000-8578.2014.07.026.
[13] Maugeri-SaccàM, Pizzuti L, Sergi D, et al. FOLFIRI as a second-line therapy in patients with docetaxel-pretreated gastric cancer:a historical cohort[J]. J Exp Clin Cancer Res, 2013,32:67. DOI:10.1186/1756-9966-32-67.
[14]童刚领,程勃然,陈晓秋,等.mFOLFOX6和FOLFIRI方案分别一线和二线治疗晚期胃癌疗效对比观察[J].肿瘤防治研究,2017,44(7):489-492. DOI:10. 3971/j. issn. 1000-8578. 2017.17.0077.Tong GL, Cheng BR, Chen XQ, et al. Comparison of clinical effect between mFOLFOX6 and FOLFIRI regimen as alternately first-and second-line therapy on advanced gastric cancer patients[J].Cancer Research on Prevention and Treatment, 2017,44(7):489-492. DOI:10.3971/j.issn. 1000-8578.2017.17.0077.
[2] Mahipal A, Choi M, Kim R. Second-line treatment of advanced gastric cancer:Where do we stand?[J]. J Natl Compr Canc Netw, 2015,13(10):1281-1292.
[3] Fuse N, Nagahisa-Oku E, Doi T, et al. Effect of RECIST revision on classification of target lesions and overall response in advanced gastric cancer patients[J]. Gastric Cancer, 2013,16(3):324-328. DOI:10.1007/s10120-012-0187-9.
[4] Kanagavel D, Fedyanin M, Tryakin A, et al. Second-line treatment of metastatic gastric cancer:Current options and future directions[J].World J Gastroenterol, 2015,21(41):11621-11635. DOI:10.3748/wjg.v21. i41.11621.
[5] Yang L, Jiang X, Yan H, et al. Irinotecan-containing doublet treatment versus irinotecan monotherapy as second-line choice for advanced gastric cancer[J]. BMC Gastroenterol, 2018,18(1):43. DOI:10.1186/s12876-018-0772-4.
[6] Kwon HJ, Park MI, Park SJ, et al. Efficacy and safety of FOLFIRI after failure of FOLFOX-4 in advanced gastric cancer[J]. Korean J Gastroenterol, 2015,66(1):10-16. DOI:10. 4166/kjg. 2015.66.1.10.
[7]林能明,马胜林.新编抗肿瘤药物学[M].北京:军事医学科学出版社,2014:129.Lin NM, Ma SL. Practical cancer chemotherapy drug manual[M].Beijing:Military Medical Science Press, 2014:129.
[8]周琴,朱海鹏,胡军,等.替吉奥治疗老年晚期胃癌的临床观察[J].中国医药,2013,8(12):1726-1727. DOI:10. 3760/cma. j. issn. 1673-4777.2013. 12.018.Zhou Q, Zhu HP, Hu J,et al. Clinical study of tegafur treating elderly advanced gastric cancer[J]. China Medicine,2013,8(12):1726-1727. DOI:10. 3760/cma. j. issn. 1673-4777. 2013.12.018.
[9]黄凯,倪健凤,宋丽杰,等.替吉奥或卡培他滨联合紫杉醇治疗进展期胃癌的疗效比较[J].中国现代医生,2012,50(5):66-67,69. DOI:10.3969/j. issn. 1673-9701.2012.05.031.Huang K, Ni JF, Song LJ, et al. Efficacy of Paclitaxel combind with Tegafur or capecitabine in the treatment of advanced gastric cancer[J]. China Modem Doctor, 2012,50(5):66-67,69. DOI:10.3969/j. issn. 1673-9701.2012.05.031.
[10] Chon HJ, Rha SY, Park HS, et al. Salvage chemotherapy of biweekly irinotecan plus S-1(biweekly IRIS)in previously treated patients with advanced gastric cancer[J]. Cancer Chemother Pharmacol,2011,68(4):991-999. DOI:10.1007/s00280-011-1560-9.
[11]常青.伊立替康联合替吉奥二线治疗晚期胃癌的临床观察[J].现代肿瘤医学,2016,24(14):2254-2256.DOI:10.3969/j. issn. 1672-4992.2016.14.023.Chang Q. The effect of irinotecan combined with TS-1 in the treatment of advanced gastric cancer as second-line chemotherapy regimen[J]. Journal of Modern Oncology, 2016,24(14):2254-2256. DOI:10.3969/j.issn. 1672-4992.2016.14.023.
[12]崔勇霞,罗执芬,卢创新,等.伊立替康联合替吉奥或5-氟尿嘧啶方案二线治疗晚期胃癌的疗效观察[J].肿瘤防治研究,2014,41(7):808-810. DOI:10. 3971/j. issn. 1000-8578. 2014.07.026.Cui YX, Luo ZF, Lu CX, et al. Clinical observation of irinotecan combined with tegafur or 5-fluorouracil as second-line chemotherapy for advanced gastric cancer[J].Cancer Research on Prevention and Treatment, 2014,41(7):808-810. DOI:10. 3971/j. issn.1000-8578.2014.07.026.
[13] Maugeri-SaccàM, Pizzuti L, Sergi D, et al. FOLFIRI as a second-line therapy in patients with docetaxel-pretreated gastric cancer:a historical cohort[J]. J Exp Clin Cancer Res, 2013,32:67. DOI:10.1186/1756-9966-32-67.
[14]童刚领,程勃然,陈晓秋,等.mFOLFOX6和FOLFIRI方案分别一线和二线治疗晚期胃癌疗效对比观察[J].肿瘤防治研究,2017,44(7):489-492. DOI:10. 3971/j. issn. 1000-8578. 2017.17.0077.Tong GL, Cheng BR, Chen XQ, et al. Comparison of clinical effect between mFOLFOX6 and FOLFIRI regimen as alternately first-and second-line therapy on advanced gastric cancer patients[J].Cancer Research on Prevention and Treatment, 2017,44(7):489-492. DOI:10.3971/j.issn. 1000-8578.2017.17.0077.