FOLFIRI方案二线治疗复发或转移性结直肠癌

目的 探讨FOLFIRI方案(伊立替康+5-氟尿嘧啶+醛氢叶酸)用于奥沙利铂治疗失败的复发或转移性结直肠癌的临床疗效和安全性.方法 为前瞻性、单组开放式、多中心临床研究.一线化疗失败的结直肠癌患者66例,接受FOLFIRI方案化疗,直至病情进展或不良反应不能耐受.每3个周期评价疗效,并观察不良反应.结果 61例患者可评价客观疗效,客观有效率为16.4%,疾病控制率为73.8%.59例患者随访资料完整,中位疾病进展时间(TTP)为5.0个月,中位至死亡时间(TTD)为9.9个月,中位生存时间为18.2个月.不良反应以中性粒细胞减少、恶心呕吐、急性胆碱能综合征、脱发、迟发性腹泻最常见.3和4度中性粒细胞减少的发生率为22.7%.结论 FOLFIRI方案二线治疗奥沙利铂化疗失败的晚期结直肠癌,有较高的肿瘤控制率,患者耐受性好,并可以延长患者的总生存期.     

雷替曲塞单药二线治疗老年晚期结直肠癌的临床研究

目的 探讨雷替曲塞单药二线治疗老年晚期结直肠癌的疗效和安全性.方法 将57例老年晚期结直肠癌患者随机分为试验组(29例)和对照组(28例).试验组采用雷替曲塞单药方案化疗,对照组采用FOLFIRI方案化疗,观察并比较2组治疗效果及不良反应.结果 试验组与对照组的客观有效率(RR)分别为13.8%和17.9%,疾病控制率(DCR)分别为58.6%和53.6%,差异无统计学意义(P>0.05).2组中位无进展生存时间(PFS)分别为4.4个月和4.9个月,差异无统计学意义(P>0.05).试验组在恶心、呕吐及腹泻方面的不良反应明显低于对照组,差异有统计学意义(P<0.05).结论 雷替曲塞单药方案二线治疗老年晚期结直肠癌疗效与FOLFIRI方案相当,且安全性更高,使用更方便.     

XELIRI与FOLFIRI方案治疗晚期结直肠癌的临床对照研究

为了评价XELIR方案和FOLFIRI方案对晚期结直肠癌近期疗效和毒副反应,对2006-07-08-2008-04-05接受XELIR化疗方案治疗的30例晚期结直肠癌患者进行回顾性分析,并与同期采用FOLFIRI化疗方案治疗的32例晚期结直肠癌患者比较,评价不同化疗方案的近期疗效和毒副反应。XELIR方案和FOLFIRI方案的总有效率分别为33.3%与34.4%,一线和二线有效率差异无统计学意义。XELIR组毒副反应以腹泻、手足综合征为主,FOLFI-RI组毒副反应以白细胞降低为主。初步研究结果显示,XELIR方案和FOLFIRI方案对晚期结直肠癌均有较好的临床疗效,化疗毒副反应有所不同,均可耐受。XELIR和FOLFIRI两种化疗方案均可作为晚期结直肠癌一或二线治疗方案。     

热疗联合FOLFIRI化疗治疗晚期结直肠癌的临床观察

目的:观察热疗联合FOLFIRI全身化疗治疗晚期结直肠癌的疗效和不良反应.方法:将2005年5月～2009年8月在我院住院治疗的53例晚期结直肠癌患者,随机分为A、B两组,A组(治疗组,26例)接受热疗联合FOLFIRI全身化疗,肿瘤局部区域热疗,温度43℃,每次60分钟,每周2次;B组(对照组,27例)接受常规FOLFIRI全身化疗.化疗方案为伊立替康180mg/m2,静脉滴入90 min,d1;亚叶酸钙 200mg/m2,静脉滴入2h,d1,2;5-氟尿嘧啶400mg/m2,静脉推注,d1,2,600mg/ m2,持续静滴22h,d1,2;14天为1个周期;治疗4个周期后,评价疗效及不良反应.结果:与常规全身化疗相比,热疗联合全身化疗组(A组)有效率、疾病无进展生存时间(PFS)及总生存期(OS)有明显提高,差异有统计学意义(P＜0.05),不良反应未增加.结论:对晚期结直肠癌患者,热疗联合FOLFIRI化疗疗效较好,不良反应能耐受.     

伊立替康联合雷替曲塞或5-FU二线治疗晚期结直肠癌的疗效比较

目的 比较伊立替康联合雷替曲塞方案与伊立替康联合5-FU方案二线治疗晚期结直肠癌的临床疗效。方法 选取经一线化疗失败行二线治疗的60例晚期结直肠癌患者,根据不同二线治疗方案,将其分为观察组和对照组,每组30例。观察组采用伊立替康联合雷替曲塞方案治疗,对照组采用伊立替康联合5-FU方案（FOLFIRI方案）,治疗结束后比较两组患者的近期疗效及不良反应,并观察总生存期（OS）和疾病进展时间（TTP）。结果 观察组和对照组患者的总有效率比较差异无统计学意义（26.67% vs 13.33%,χ²=1.67,P=0.20）;观察组患者疾病控制率高于对照组,差异有统计学意义（63.33% vs 36.67%,χ²=4.27,P=0.04）;观察组中位OS和中位TTP较对照组长,两组比较差异均有统计学意义（9.9个月 vs 7.5个月,χ²=4.461,P=0.012;5.0个月 vs  3.7个月,χ²=6.735,P=0.022）;观察组骨髓抑制、胃肠道不良反应等发生率与对照组比较差异无统计学意义（P＞0.05）。结论 伊立替康联合雷替曲塞二线治疗晚期结直肠癌疗效肯定,较FOLFIRI方案可延长生存期,不良反应更轻,可作为一线化疗失败患者的可选治疗方案。     

伊立替康二线治疗晚期结直肠癌疗效观察

背景与目的: 结直肠癌是癌症相关死亡的主要原因之一.对大多数晚期结直肠癌患者全身化疗是最佳的姑息治疗.20世纪90年代多项Ⅲ期临床研究证实拓扑异构酶Ⅰ抑制剂依立替康(开普拓,CPT-11)联合5-Fu、LV方案(FOLFIRI)治疗结直肠癌疗效显著.本研究旨在观察FOLFIRI方案二线治疗晚期结直肠癌的生存、疗效及毒副反应.方法: 60例经病理学证实的一线治疗失败后的进展期结直肠癌患者接受FOLFIRI方案化疗至少2个周期,伊立替康180 mg/m2,静脉滴注,第1天;四氢叶酸200 mg/m2,静脉滴注,第1、2天;5-FU400 mg/m2,静脉推注,第1、2天:5-FU 600 mg/m2,静脉持续滴注22 h,第1、2天,每2周重复.结果: 全组60例患者均能评价毒副反应,其中58例可评价疗效.全组无完全缓解(cR),部分缓解(PR)14例(24.14%),稳定(sD)30例(51.72%),总有效率(CR PR)2414%,疾病控制率(CR PR SD)75.86%,中位至疾病进展时间6.09个月,中位总生存期(OS)9.65个月.非血液学毒性不良反应轻微,大多为Ⅰ、Ⅱ度.只有2例患者出现Ⅲ度延迟性腹泻,1例患者出现Ⅲ度恶心呕吐. 常见的血液学毒性为粒细胞减少症.有5例患者出现Ⅲ度粒细胞减少症.没有发生粒缺性发热.结论: 伊立替康联合5-FU和叶酸二线治疗进展期结直肠癌有较高的近期疗效,不良反应可控.     

贝伐单抗联合FOLFIRI方案一线治疗转移性结直肠癌的临床评价

目的评价贝伐单抗联合FOLFIRI方案一线治疗转移性结直肠癌的疗效和安全性。方法将40例转移性结直肠癌患者随机分为FOLFIRI组和FOLFIRI+贝伐单抗组。FOLFIRI组采用CPT-11(180 mg/m²)+甲酰四氢叶酸(200 mg/m²)+5-Fu(1 000 mg／m²)。FOLFIRI+贝伐单抗组采用贝伐单抗(每2周5 mg/kg)+FOLFIRI方案;两组患者均持续治疗至病情进展或毒性不能耐受。结果40例患者均可评价疗效和不良反应。FOLFIRI组和FOLFIRI+贝伐单抗组的治疗有效率分别为25％(5/20)和60％(12／20)（χ²=5.013,P=0.025),中位无疾病进展时间(DFS)分别为5.1和10.1月(χ²=9.703,P=0.002)。两组患者的1年生存率分别为48％和70%,中位生存时间(OS)分别为11.0月和18.0月,总生存期在两组间差异有统计学意义(χ²=5.852,P=0.016)。两组的主要不良反应为迟发性腹泻和中性粒细胞减少,FOLFIRI+贝伐单抗组增加的不良反应主要有高血压、出血、蛋白尿和心脏毒性,但患者可以耐受。结论FOLFIRI方案化疗联用贝伐单抗提高了晚期结直肠癌患者治疗的有效率,并延长了DFS及OS,不良反应患者可以耐受。     

晚期结直肠癌治疗及临床特点

目的:观察晚期结直肠癌一线治疗疗效及临床特征。方法:回顾性分析我科收治的159例晚期结直肠癌患者的临床资料。所有患者采用FOLFOX6/FOLFIRI方案进行一线化疗,观察一线治疗近期疗效及毒副反应。同时对159例晚期结直肠癌发生部位、转移部位、左右半结肠预后情况等进行临床观察分析。结果:我科晚期结直肠癌一线治疗有效率及PFS分别为49.1%,6.73个月。FOLFOX6组与FOLFIRI组有效率（50.0% vs 48.0%)和无进展生存期(6.41个月 vs 7.09个月）差异无统计学意义(P>0.05);FOLFOX6组毒副反应主要为末梢神经感觉异常。而FOLFIRI组为迟发性腹泻。左半结肠、右半结肠在治疗有效率RR方面（75.0% vs 22.2%,P<0.05）,差异有统计学意义。大肠癌的好发部位依次为直肠（60.4%）、左半结肠（22.6%）、右半结肠（17.0%）。晚期结直肠癌转易转移部位依次为肝（50.94%）、肺（40.25%）、骨（24.53%）,其中脑转移占3.77%。直肠癌与结肠癌肺转移率分别为（76.67% vs 30.00%）,差异具有显著意义(P<0.05)。直肠癌与结肠癌骨转移分别占（76.92% vs 23.08%）,差异具有显著意义(P<0.05)。结论:FOLFOX6方案与FOLFIRI方案治疗晚期结直肠癌疗效确切,两组近期疗效相似,均可作为晚期结直肠癌一线治疗,毒副反应可以耐受。大肠癌好发部位以直肠为主,区别于西方。晚期结直肠癌易转移部位依次为肝、肺、骨,且肺、骨转移多见于直肠癌,大肠癌脑转移逐渐增多。同时发现右半结肠癌较左半结肠癌疗效差,左、右半结肠应看做不同的器官。     

贝伐珠单抗联合FOLFOX或FOLFIRI方案治疗转移性结直肠癌的临床研究

目的 观察贝伐珠单抗联合FOLFOX或FOLFIRI方案用于转移性结直肠癌一线及二线治疗的临床疗效和毒副反应。方法 回顾性分析2005年11月至2012年8月接受贝伐珠单抗联合FOLFOX或FOLFIRI方案作为一线及二线治疗的57例转移性结直肠癌患者的临床资料。采用RECIST 1.1版评价疗效,用NCI-CTC 3.0版评价不良反应,用Kaplan-Meier法进行生存分析。结果 57例结直肠癌患者中,19例（33.3％）获PR,28例（49.2％）获SD,有效率（RR）为33.3％,疾病控制率（DCR）为82.5％。贝伐珠单抗联合化疗用于一线与二线治疗患者的RR或DCR差异均无统计学意义（P＞0.05）;贝伐珠单抗联合FOLFOX方案与FOLFIRI方案的RR或DCR差异均无统计学意义（P＞0.05）。57例患者的无进展生存期（PFS）及总生存期（OS）分别为8.83个月及14.80个月。一线与二线治疗及贝伐珠单抗联合FOLFOX方案与FOLFIRI方案的中位PFS或OS差异均无统计学意义（P＞0.05）。主要不良反应包括白细胞减少、血小板减少及恶心呕吐。贝伐珠单抗相关的不良反应主要包括高血压3例,蛋白尿1例,鼻衄2例,均为1～2级,药物可以控制。结论 贝伐珠单抗联合化疗治疗转移性结直肠癌能够提高治疗疗效,不良反应可以耐受。     

沙利度胺联合FOLFIRI方案治疗晚期结肠直肠癌的临床观察

目的观察沙利度胺联合FOLFIRI方案治疗晚期结直肠癌的疗效及安全性。方法26例符合入组条件的晚期结肠直肠癌患者采用伊立替康（CPT-11）＋5-氟尿嘧啶（5-Fu）＋亚叶酸钙（LV）方案（即FOLFIRI方案）联合沙利度胺化疗。结果本组CR3例,PR9例,NC8例,有效率（CR＋PR）为46.15%（12/26）,临床获益率为76.92%;中位疾病进展时间（TTP）为4.5个月;主要毒副作用为恶心呕吐、粘膜炎、腹痛、腹泻、血液学毒性。结论沙利度胺联合FOLFIRI方案治疗晚期结肠直肠癌疗效确切,患者耐受性好。     

贝伐珠单抗联合双周方案一线治疗晚期大肠癌的疗效及与K-ras基因的关系

目的:探讨贝伐珠单抗（BEV）联合双周方案一线治疗晚期大肠癌的临床疗效及与K-ras基因的关系。方法:收集2008年1月至2014年2月解放军总医院收治、经病理确诊的46例K-ras基因状态明确的晚期大肠癌患者临床资料,其中K-ras野生型23例、K-ras突变型23例;回顾性分析了BEV联合FOLFIRI（20例）或FOLFOX（26例）方案在一线治疗晚期大肠癌中的疗效及毒副反应的情况,并分析K-ras基因突变与疗效的关系。结果:46例均可评价近期疗效,总ORR为39.1%,总DCR为91.3%,总中位PFS为7.5个月。以化疗方案分组,其中FOLFIRI+BEV组ORR为30.0%,DCR为95.0%,中位PFS为8.1个月;FOLFOX+BEV组ORR为46.2%,DCR为88.5%,中位PFS为6.5个月。以K-ras基因状态分组,K-ras突变组ORR为30.4%,DCR为91.3%,中位PFS为6.2个月;K-ras野生组ORR为47.8%,DCR为91.3%,中位PFS为9.9个月。以上差异均无统计学意义（P＞0.05）。结论:虽然K-ras突变组在近期、远期疗效低于K-ras野生组,但在两组中均可见应用BEV能获益,同时再次证实K-ras基因突变是患者预后不良因素之一,但不是BEV应用的禁忌症;在化疗方案方面,BEV联合FOLFIRI或FOLFOX标准双周方案可提高化疗的ORR及DCR,且毒副反应小,安全性较好。     

含奥沙利铂方案与FOLFIRI方案一线化疗对K-ras基因不同状态晚期大肠癌患者的疗效及预后影响比较

目的 探究含奥沙利铂方案与FOLFIRI方案对Ⅳ期结直肠癌化疗疗效及预后影响的差别与K-ras基因状态的关系。方法 收集2010年1月至2012年1月的118例接受含奥沙利铂方案或FOLFIRI方案化疗的Ⅳ期结直肠癌患者临床资料,统计患者的治疗有效率（ORR）、疾病控制率（DCR）、无进展生存时间（PFS）和总生存期（OS）。采用χ²检验比较各组临床因素差别和两种治疗方案的有效率及疾病控制率,采用Kaplan-Meier法比较无进展生存时间以及总生存期。结果 118例患者中,接受含奥沙利铂方案化疗的K-ras突变型患者PFS及OS较接受FOLFIRI方案化疗患者延长（P=0.048;P=0.037）,ORR及DCR较接受FOLFIRI方案化疗患者无明显差别（P=0.961;P=0.931）。接受含奥沙利铂方案化疗的K-ras野生型患者ORR、DCR、PFS及OS较接受FOLFIRI方案化疗患者无明显差别（P=0.900;P=0.802;P=0.738;P=0.904）。结论 采用含奥沙利铂方案一线化疗较FOLFIRI方案对K-ras突变型Ⅳ期结直肠癌患者更有优势,而对于K-ras野生型Ⅳ期结直肠癌患者,含奥沙利铂方案与FOLFIRI方案疗效及预后情况相当。     

贝伐单抗联合FOLFIRI方案治疗晚期结直肠癌的临床观察

目的 观察贝伐单抗联合FOLFIRI方案治疗晚期结直肠癌的临床疗效及不良反应,评价其有效性和安全性。方法 回顾性分析2009年-2011年收治的经病理学确诊的晚期结直肠癌病例42例,其中22例采用贝伐单抗联合FOLFIRI方案治疗（研究组）,20例采用单纯FOLFIRI方案治疗（对照组）,观察其疗效和不良反应,并进行随访。结果 42例患者均可评价疗效和不良反应。研究组和对照组的客观有效率分别为45.4%,20.0%;中位生存期分别为15.7月,12.0月,差异均具有统计学意义（P＜0.05）;治疗后两组的肿瘤标志物均有所下降,其中仅研究组CEA差异具有统计学意义（P＜0.05）,余均无统计学意义（P＞0.05）。研究组较对照组增加的不良反应主要有高血压、出血等,发生率分别为27.3%、22.7%,但均为Ⅰ～Ⅱ级,经药物治疗后均可控制,不影响化疗的连续性。结论 贝伐单抗联合FOLFIRI方案治疗晚期结直肠癌能够提高疗效,延长生存时间,且患者耐受性较好,具有较好的临床应用前景。     

Phase II clinical trial of second-line FOLFIRI plus bevacizumab for patients with metastatic colorectal cancer: AVASIRI trial

Objective

FOLFIRI is a standard chemotherapy regimen for the treatment of metastatic colorectal cancer. Although some studies have shown its efficacy in combination with bevacizumab as first-line chemotherapy, there are no data to support FOLFIRI plus bevacizumab as second-line chemotherapy in patients with this form of cancer. The aim of this study was to evaluate the efficacy and safety of FOLFIRI and bevacizumab as second-line chemotherapy in patients with metastatic colorectal cancer.

Methods

Eligible patients were ??20?years old, previously treated (except with irinotecan [CPT-11] and bevacizumab), with an Eastern Cooperative Oncology Group performance status of 0, 1, or 2, and adequate organ function. Twenty-five eligible patients received FOLFIRI with bevacizumab at a dose of 10?mg/kg given intravenously on day 1. All therapy was administered every 2?weeks until disease progression. The primary endpoint was the response rate.

Results

Twenty-five patients were enrolled between February 2008 and March 2009. The median age was 62 (range 38?C73) years, the male/female distribution was 20/5, 16 patients had performance status 0 and 9 had performance status 1, and the proportion of patients who were oxaliplatin pretreated/untreated was 16/9. The overall response rate was 32% (90% confidence interval [CI]: 17.0?C50.4%), with 8 patients showing partial responses, 15 with stable disease, and 2 with disease progression. Median progression-free survival was 11.6?months (95% CI: 6.9?C16.4). Median overall survival was 21.4?months (95% CI: 12.0?C30.8). The grade 3/4 adverse events with treatment were neutropenia (64%), leukopenia (16%), diarrhea (8%), anorexia (8%), and febrile neutropenia (8%). The bevacizumab-related grade 3/4 adverse event was hypertension, which was observed in 12% of patients.

Conclusions

The FOLFIRI plus bevacizumab regimen is an active, well-tolerated second-line chemotherapy treatment for patients with metastatic colorectal cancer.     

Capecitabine Plus Irinotecan Versus 5-FU/Leucovorin Plus Irinotecan in the Treatment of Colorectal Cancer: A Meta-analysis

BackgroundThe XELIRI regimen and FOLFIRI regimen are used as the first-line treatment of metastatic colorectal cancer. A comparison of findings from different studies that examined the efficacy and safety of these 2 regimens often show conflicting results. This metaanalysis compared the XELIRI and FOLFIRI regimens in the treatment of mCRC.Patients and MethodsSix studies comparing the safety and efficacy of XELIRI- and FOLFIRI-based treatment of mCRC were identified from MEDLINE, Cochrane, EMBASE, and Google Scholar (until January 31, 2013) databases.ResultsNo significant difference in ORR, PFS, or OS between XELIRI and FOLFIRI as first-line therapy in patients with colorectal cancer was found in this analysis. Except for XELIRI being associated with a higher incidence of diarrhea, both treatment regimens had similar safety profiles.ConclusionBoth XELIRI and FOLFIRI regimens had similar efficacy as first-line treatment in patients with mCRC with similar adverse event profiles. Our findings suggest that XELIRI and FOLFIRI are appropriate first-line treatment options for mCRC patients.     

西妥昔单抗联合化疗治疗晚期结直肠癌的临床观察

目的：观察西妥昔单抗联合含伊立替康方案治疗国人晚期结直肠癌的近期疗效和毒副反应。方法：１４例经病理组织学检查确诊的晚期结直肠癌患者入组,为西妥昔单抗联合伊立替康单药或ＦＯＬＦＩＲＩ方案,西妥昔单抗首次给予负荷剂量４００ｍｇ／ｍ^２,而后每周维持量为２５０ｍｇ／ｍ^２。３例患者行Ｋ-ｒａｓ检测。结果：可评价病例１２例,其中ＰＲ２例,ＳＤ５例,ＲＲ１６.７％,ＤＣＲ５８.３％。１２例患者中位ＴＴＰ为９.３周。ＭＳＴ为４１.３周。２例Ｋ-ｒａｓ野生型的患者中,１例获得ＰＲ,ＴＴＰ为３２周;１例ＳＤ。１例Ｋ-ｒａｓ突变型的患者治疗２周期后ＰＤ。与西妥昔单抗相关的毒副反应为痤疮样皮疹（７８.６％）和过敏反应（１４.２％）。结论：西妥昔单抗联合化疗治疗国人晚期结直肠癌安全有效。     

西妥昔单抗联合ＦＯＬＦＩＲＩ方案治疗晚期大肠癌的临床观察

目的：观察和评价西妥昔单抗（爱必妥）联合ＦＯＬＦＩＲＩ方案治疗国人晚期大肠癌患者的疗效及毒副反应。方法：回顾性分析２００６年６月～２００８年１２月我院经病理证实的晚期大肠癌患者４３例,爱必妥４００ｍｇ／ｍ２,第１次;以后２５０ｍｇ／ｍ^２,每周１次,或者５００ｍｇ／ｍ^２,每２周１次;伊立替康（开普拓）１８０ｍｇ／ｍ^２,第１天,静滴３０分钟;亚叶酸钙２００ｍｇ／ｍ^２,第１、２天,静滴２小时;氟尿嘧啶（５－ＦＵ）４００ｍｇ／ｍ^２,静推,第１、２天,５－ＦＵ６００ｍｇ／ｍ^２,持续静滴２２小时,第１、２天,每２周重复。每例至少接受４周期化疗后评价疗效。结果：全组４３例均可评价,有效率（ＣＲ＋ＰＲ）为３４．９％ （１５／４３）,ＳＤ４８．８％ （２１／４３）,ＰＤ１６．３％ （７／４３）。中位疾病进展时间（ＴＴＰ）８．９个月,中位生存期（ＯＳ）１９．３个月。治疗相关毒副反应主要为皮疹、迟发性腹泻及中性粒细胞减少。结论：西妥昔单抗联合ＦＯＬＦＩＲＩ方案治疗国人晚期大肠癌疗效肯定,可使大部分患者临床获益,其毒副反应可以耐受。     

Phase II study of combined chemotherapy with irinotecan and S-1 (IRIS) plus bevacizumab in patients with inoperable recurrent or advanced colorectal cancer

Abstract Background. In Japan, a study comparing the effectiveness and safety of irinotecan plus S-1 (IRIS) with those of a combination of 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) as second-line treatment in patients with advanced or recurrent colorectal cancer demonstrated that IRIS was non-inferior to FOLFIRI. We previously reported that IRIS is also effective as first-line treatment. Patients and methods. Eligibility criteria included inoperable recurrent colorectal cancer with a confirmed diagnosis of adenocarcinoma, age ≥20 years, and no history of prior chemotherapy. S-1 (40-60 mg twice daily) was given orally on Days 1 to 14, and irinotecan (100 mg/m(2)) and bevacizumab (5 mg/kg) were given intravenously on Days 1 and 15 of a 28-day cycle. The primary endpoint was safety. The secondary endpoints included overall response (OR), progression-free survival (PFS), and overall survival (OS). Results. A total of 52 eligible patients were enrolled from October 2007 through March 2009. In safety analysis, the incidences of grade 3 or 4 adverse reactions were as follows: neutropenia, 27%; hypertension, 21%; and diarrhea, 17%. The overall response rate was 57.7%. Median progression-free survival was 16.7 months. Conclusion. IRIS plus bevacizumab is a well-tolerated, highly effective chemotherapeutic regimen that is easy to administer.     

Phase II trial of an alternating regimen consisting of first-line mFOLFOX6 plus bevacizumab and FOLFIRI plus bevacizumab for patients with metastatic colorectal cancer: FIREFOX plus bevacizumab trial (KSCC0801)

Objectives

The purpose of this phase II study was to explore the efficacy and safety of an alternating regimen consisting of folinic acid, 5-fluorouracil (5-FU) and oxaliplatin (mFOLFOX6) plus bevacizumab, and folinic acid, 5-FU and irinotecan (FOLFIRI) plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer.

Methods

Fifty-two patients with metastatic colorectal cancer received an alternating regimen consisting of four cycles of mFOLFOX6 plus bevacizumab followed by four cycles of FOLFIRI plus bevacizumab until disease progression. The primary endpoint was progression-free survival.

Results

The median age was 60 years (range 37–75 years). Median progression-free survival was 14.2 months (95 % confidence interval [CI] 10.6–16.3) and median overall survival was 28.4 months (95 % CI 22.6–39.1). The overall response rate was 60.0 % (95 % CI 45.2–73.6). Regarding toxicity, the commonest grade 3–4 hematological adverse events were neutropenia (34.6 %) and leukopenia (7.7 %), and the commonest grade 3–4 non-hematological adverse events were anorexia (13.5 %), fatigue (9.6 %), nausea (9.6 %), and vomiting (9.6 %). Bevacizumab-related grade 3–4 adverse events included hypertension (1.9 %) and thrombosis (1.9 %).

Conclusions

An alternating regimen consisting of mFOLFOX6 plus bevacizumab and FOLFIRI plus bevacizumab is an effective and well-tolerated first-line chemotherapy combination for patients with metastatic colorectal cancer.