SOX联合贝伐单抗和mFOLFOX6联合贝伐单抗方案治疗转移性结直肠癌患者疗效和安全性比较
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摘要
目的评估SOX联合贝伐单抗对比m FOLFOX6联合贝伐单抗方案治疗转移性结直肠癌患者疗效和安全性。方法本队列研究纳入2010年1月至2013年12月就诊于北京市大兴区人民医院的87例转移性结直肠癌患者,其中45例患者接受S-1+奥沙利铂(SOX)联合贝伐单抗方案治疗,42例患者接受5-氟尿嘧啶/亚叶酸钙+奥沙利铂(m FOLFOX6)联合贝伐单抗方案治疗。结果 SOX+Bev和m FOLFOX6+Bev组的总有效率分别为53.33%(24/45)和47.62%(20/42),差异无统计学意义(P=0.594);两组患者无进展生存期分别为9.7和8.9个月(P=0.617),总生存期分别为23.1和21.9个月(P=0.715),差异无统计学意义。两组各不良反应发生率差异无统计学意义(P>0.05)。结论 SOX+Bev的联合治疗方案对转移性结直肠癌患者是有效且安全可行的。
Objective To evaluate the efficacy and safety of SOX combined with bevacizumab versus m FOLFOX6 combined with bevacizumab in patients with metastatic colorectal cancer. Methods Eighty-seven patients with metastatic colorectal cancer were collected in People' s Hospital of Beijing Daxing District from Jan. 2010 to Dec. 2013. Among them,45 patients were treated with SOX( S-1 + oxaliplatin) combined with bevacizumab,42 patients were treated with m FOLFOX6( 5-FU/LV + oxaliplatin) combined with bevacizumab. Results There was no significant difference in ORR between the two groups[53. 33%( 24/45) vs 47. 62%( 20/42),P = 0. 594]. The PFS of SOX + Bev and m FOLFOX6 +Bev groups were 9. 7 and 8. 9 months respectively( P = 0. 617); OS were 23. 1 and 21. 9 months respectively( P = 0. 715).There was no significant difference in the incidence of adverse drug reaction between the two groups( P > 0. 05). Conclusion The combination of SOX and Bev is effective and safe for patients with metastatic colorectal cancer.
Objective To evaluate the efficacy and safety of SOX combined with bevacizumab versus m FOLFOX6 combined with bevacizumab in patients with metastatic colorectal cancer. Methods Eighty-seven patients with metastatic colorectal cancer were collected in People' s Hospital of Beijing Daxing District from Jan. 2010 to Dec. 2013. Among them,45 patients were treated with SOX( S-1 + oxaliplatin) combined with bevacizumab,42 patients were treated with m FOLFOX6( 5-FU/LV + oxaliplatin) combined with bevacizumab. Results There was no significant difference in ORR between the two groups[53. 33%( 24/45) vs 47. 62%( 20/42),P = 0. 594]. The PFS of SOX + Bev and m FOLFOX6 +Bev groups were 9. 7 and 8. 9 months respectively( P = 0. 617); OS were 23. 1 and 21. 9 months respectively( P = 0. 715).There was no significant difference in the incidence of adverse drug reaction between the two groups( P > 0. 05). Conclusion The combination of SOX and Bev is effective and safe for patients with metastatic colorectal cancer.
引文
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[18]Kim JH,Zang DY,Chung IJ,et al.A muti-center,randomized phase II study of oxaliplatin and S-1 versus capecitabine and oxaliplatin in patients with metastatic colorectal cancer[J].J Cancer,2015,6(10):1041-1048.
[19]Maruo H,Suzuki K,Ishikawa S,et al.Study of S-1 and oxaliplatin(SOX)plus bevacizumab as first-line therapy in patients with unresectable colorectal cancer[J].Gan To Kagaku Ryoho,2014,41(13):2583-2586.
[20]Nishina T,Kato T,Yamazaki K,et al.A phaseⅡstudy of S-1,oxaliplatin,oral leucovorin,and bevacizumab combination therapy(SOLA)in patients with unresectable metastatic colorectal cancer[J].Cancer Chemother Pharmacol,2015,76(3):547-553.
[21]Wang ZQ,Zhang DS,Xu N,et al.PhaseⅡstudy of oxaliplatin combined with S-1 and leucovorin(SOL)for Chinese patients with metastatic colorectal cancer[J].Chin J Cancer,2016,35:8.
[22]Zang DY,Lee BH,Park HC,et al.PhaseⅡstudy with oxaliplatin and S-1 for patients with metastatic colorectal cancer[J].Ann Oncol,2009,20(5):892-896.
[23]Yamada Y,Takahari D,Matsumoto H,et al.Leucovorin,fluorouracil,and oxaliplatin plus bevacizumab versus S-1 and oxaliplatin plus bevacizumab in patients with metastatic colorectal cancer(SOFT):An open-label,non-inferiority,randomised phase 3trial[J].Lancet Oncol,2013,14(13):1278-1286.
[2]Bai Z,Wang J,Wang T,et al.Clinicopathologic parameters associated with postoperative complications and risk factors for tumor recurrence and mortality after tumor resection of patients with colorectal cancer[J].Clin Transl Oncol,2017.
[3]Atreya CE,Yaeger R,Chu E.Systemic therapy for metastatic colorectal cancer:From current standards to future molecular targeted approaches[J].Am Soc Clin Oncol Educ Book,2017,37:246-256.
[4]Suenaga M,Mizunuma N,Matsusaka S,et al.Retrospective analysis on the efficacy of bevacizumab with FOLFOX as a first-line treatment in Japanese patients with metastatic colorectal cancer[J].Asia Pac J Clin Oncol,2014,10(4):322-329.
[5]Vaidyanathan G,Groman A,Wilding G,et al.Stop and go FOLFOX plus bevacizumab chemotherapy in the first-line treatment of metastatic colorectal cancer[J].Oncology,2010,79(1/2):67-71.
[6]Watanabe K,Kawahara H,Enomoto H,et al.Feasibility study of oxaliplatin with oral S-1 or capecitabine as first-line therapy for patients with metastases from colorectal cancer[J].Anticancer Res,2013,33(9):4029-4032.
[7]Liu H,Wang Y,Li G,et al.Clinical study of tegafur-gimeraciloteracil potassium capsule(s-1)and oxaliplatin combination chemotherapy in advanced colorectal cancer[J].J Cancer Res Ther,2015,11(2):331-335.
[8]Li J,Xu R,Xu J,et al.PhaseⅡstudy of S-1 plus leucovorin in patients with metastatic colorectal cancer:Regimen of 1 week on,1 week off[J].Cancer Sci,2017,108(10):2045-2051.
[9]Hong YS,Park YS,Lim HY,et al.S-1 plus oxaliplatin versus capecitabine plus oxaliplatin for first-line treatment of patients with metastatic colorectal cancer:A randomised,non-inferiority phase 3 trial[J].Lancet Oncol,2012,13(11):1125-1132.
[10]Shirao K,Ohtsu A,Takada H,et al.PhaseⅡstudy of oral S-1 for treatment of metastatic colorectal carcinoma[J].Cancer,2004,100(11):2355-2361.
[11]Yasui H,Muro K,Shimada Y,et al.A phase 3 non-inferiority study of 5-FU/l-leucovorin/irinotecan(FOLFIRI)versus irinotecan/S-1(IRIS)as second-line chemotherapy for metastatic colorectal cancer:Updated results of the FIRIS study[J].J Cancer Res Clin Oncol,2015,141(1):153-160.
[12]Baba H,Yamada Y,Takahari D,et al.S-1 and oxaliplatin(SOX)plus bevacizumab versus m FOLFOX6 plus bevacizumab as firstline treatment for patients with metastatic colorectal cancer:Updated overall survival analyses of the open-label,non-inferiority,randomised phaseⅢ:SOFT study[J].ESMO Open,2017,2(1):e135.
[13]Liu YJ,Zhu GP,Guan XY.Comparison of the NCI-CTCAE version 4.0 and version 3.0 in assessing chemoradiation-induced oral mucositis for locally advanced nasopharyngeal carcinoma[J].Oral Oncol,2012,48(6):554-559.
[14]Aras M,Erdil TY,Dane F,et al.Comparison of WHO,RECIST1.1,EORTC,and PERCIST criteria in the evaluation of treatment response in malignant solid tumors[J].Nucl Med Commun,2016,37(1):9-15.
[15]National Cancer Institute.Common Terminology Criteria for Adverse Events v.3.0and v.4.0(CTCAE).Available at:http://ctep.cancer.gov/protocol Development/electronic applications/ctc.htm.Accessed June 14,2011
[16]Meyerhardt JA,Mayer RJ.Systemic therapy for colorectal cancer[J].N Engl J Med,2005,352(5):476-487.
[17]冷霜,任芳,郭艳辉.替吉奥联合奥沙利铂化疗在老年胃癌中的应用价值[J].医学综述,2013,19(24):4577-4579.
[18]Kim JH,Zang DY,Chung IJ,et al.A muti-center,randomized phase II study of oxaliplatin and S-1 versus capecitabine and oxaliplatin in patients with metastatic colorectal cancer[J].J Cancer,2015,6(10):1041-1048.
[19]Maruo H,Suzuki K,Ishikawa S,et al.Study of S-1 and oxaliplatin(SOX)plus bevacizumab as first-line therapy in patients with unresectable colorectal cancer[J].Gan To Kagaku Ryoho,2014,41(13):2583-2586.
[20]Nishina T,Kato T,Yamazaki K,et al.A phaseⅡstudy of S-1,oxaliplatin,oral leucovorin,and bevacizumab combination therapy(SOLA)in patients with unresectable metastatic colorectal cancer[J].Cancer Chemother Pharmacol,2015,76(3):547-553.
[21]Wang ZQ,Zhang DS,Xu N,et al.PhaseⅡstudy of oxaliplatin combined with S-1 and leucovorin(SOL)for Chinese patients with metastatic colorectal cancer[J].Chin J Cancer,2016,35:8.
[22]Zang DY,Lee BH,Park HC,et al.PhaseⅡstudy with oxaliplatin and S-1 for patients with metastatic colorectal cancer[J].Ann Oncol,2009,20(5):892-896.
[23]Yamada Y,Takahari D,Matsumoto H,et al.Leucovorin,fluorouracil,and oxaliplatin plus bevacizumab versus S-1 and oxaliplatin plus bevacizumab in patients with metastatic colorectal cancer(SOFT):An open-label,non-inferiority,randomised phase 3trial[J].Lancet Oncol,2013,14(13):1278-1286.