FOLFIRI方案二线治疗晚期十二指肠癌的临床观察

目的 探讨FOLFIRI方案二线治疗晚期十二指肠癌的疗效和安全性。方法 回顾分析本院2008年6月至2016年1月接受FOLFIRI方案二线治疗的晚期十二指肠癌患者9例,分别采用RECIST 1.1版与NCI-CTC 4.0版标准评价近期疗效和不良反应。采用Kaplan-Meier法进行生存分析。结果 9例患者均可评价疗效和不良反应,共完成化疗41个周期,中位化疗4个周期（3～8个周期）。9例患者获PR 1例,SD 5例和PD 3例,总有效率和疾病控制率分别为11.1％和66.7％,中位无进展生存期为6.5个月,中位生存期为19.3个月。常见不良反应多为1～2级,主要为白细胞减少、中性粒细胞减少、贫血、乏力、恶心等。结论 FOLFIRI方案对一线治疗失败后的晚期十二指肠癌具有较好的疗效,且耐受性较好。     

FOLFIRI方案对晚期胃癌二线治疗的临床观察

目的观察和评价伊立替康（开普拓,CPT-11）联合氟尿嘧啶（5-Fu）与亚叶酸钙（CF）用于晚期胃癌患者的二线治疗的疗效及毒副反应。方法回顾性分析2004年5月至2008年12月38例晚期胃癌患者接受FOLFIRI方案作为二线治疗的资料。CPT-11给药剂量按180mg／m^2,第1天静滴30min：CF200mg／m^2,第1～2天静滴2h;5一Fu400mgm^2,第1～2天静脉推注;5-Fu600mg／m^2,第1～2天持续静滴22h。每2周为1个周期,每例至少接受3周期化疗后评价疗效。结果全组38例均可评价,有效率[完全缓解（CR）＋部分缓解（PR）]为18．4％（7／38）,稳定（SD）26．3％（10／38）,进展（PD）55．3％（21／38）。中位疾病进展时间（TTP）3．4个月,中位生存时间（MOS）9．1个月。治疗相关毒副反应主要为中性粒细胞减少及迟发性腹泻。结论FOLFIRI方案二线治疗晚期胃癌疗效肯定,可使部分患者临床获益,其毒副反应可以耐受。     

改良FOLFIRI方案治疗晚期胃癌

胃癌是我国最常见的恶性肿瘤之一，早期诊断、早期治疗是提高治愈率的关键。然而胃癌患者中Ⅳ期胃癌占37％～39％，Ⅰ～Ⅲ期可切除的胃癌患者有半数以上术后复发转移变成晚期胃癌。晚期胃癌失去彻底手术切除、治愈疾病的机会，以化疗为主的内科综合疗法显得尤为重要。收集我院2004年5月～2007年5月24例晚期胃癌，采用改良FOLFIRI方案化疗取得一定疗效，现报告如下。     

羟基喜树碱联合FOLFOX4方案二线治疗晚期胃癌

目的：评价羟基喜树碱（HCPT）联合FOLFOX4方案作为二线治疗晚期胃癌的疗效和毒性。方法：19例晚期胃癌患者,先给予奥沙利铂（L-OHP）85mg/m^2静脉滴注2h,第1天;亚叶酸钙（CF）200mg/m^2静脉滴注2h;随后5-FU400mg/m^2静脉快速冲入,5-FU600mg/m^2静脉滴注22h,第1～2天;HCPT10mg静脉滴注3h,第1～2天。2周重复,至少2个周期后评价疗效。结果：全组19例患者,17例可以进行疗效评价,完全缓解1例,部分缓解6例,稳定4例,进展6例,总有效率为41.2%。12例存在肝脏转移患者中,肝转移灶有效率50%。毒副作用主要是骨髓抑制、恶心呕吐、神经毒性,无化疗相关死亡。结论：羟基喜树碱联合FOLFOX4方案二线治疗晚期胃癌疗效肯定,特别是对于肝转移灶有效率高,毒副作用能够耐受。     

FOLFIRI方案治疗晚期胃癌的疗效观察

目的:观察FOLFIRI方案治疗晚期胃癌的近期疗效和毒副反应.方法:26例晚期胃癌患者,予FOLFIRI方案:伊立替康(CPT-11)180mg/m2,静脉滴注1小时,第1天;亚叶酸钙(CF) 200mg/m2,静脉滴注2小时后5-氟脲嘧啶(5-Fu)400mg/m2静脉推注, 第1、2天,再予5-Fu 600mg/m2持续滴注22小时, 第1、2天.2 周重复.化疗4个周期.结果:全组26例均可评价疗效,其中完全缓解(CR) 1例,部分缓解(PR) 10例,无变化9 例,进展( PD) 6例,总有效率(CR+PR) 42.3 %.毒副反应主要是骨髓抑制,发生率为84.6%(22/26),其次为胃肠道反应,恶心呕吐发生率为76.9%(20/26),腹泻38.5 %(10/26), 皮肤粘膜反应为30.8%(8/26).结论:FOLFIRI方案治疗晚期胃癌的近期疗效好,毒副反应可耐受,可以推广.     

FOLFIRI方案二线治疗晚期大肠癌临床疗效观察

目的观察FOLFIRI方案二线治疗晚期大肠癌的临床疗效和不良反应。方法病理确诊的44例晚期大肠癌患者接受FOLFIRI方案化疗：伊立替康（CPT．11）150nlg／m^2,静脉滴注,第1天;亚叶酸钙（CF）200mg／m^2,静脉滴注2h,第1、2天;5-氟尿嘧啶（5-Fu）400mg／／112,静脉注射,第1、2天后予5-Fu600mg／m。持续静脉滴注22h,第1、2天;每2周重复,化疗2次为1个周期。治疗4～6个周期后按实体瘤疗效评定标准评价疗效及不良反应。结果全组病例均可评价疗效,其中完全缓解2例,部分缓解16例,有效率为40．9％;中位生存期11．3个月,中位疾病进展时间6．5个月。主要的不良反应为乙酰胆碱能综合征和迟发性腹泻及骨髓抑制。结论FOLFIRI方案作为二线方案治疗晚期大肠癌疗效肯定,可使大部分患者临床受益,不良反应可以耐受,值得临床进一步试用、研究。     

FOLFIRI方案治疗胃癌异时性卵巢转移的疗效

目的:观察FOLFIRI方案治疗胃癌异时性卵巢转移患者的近期疗效和安全性。方法:FOLFIRI方案治疗转移性胃癌30例,具体为:伊立替康180mg/m2,静脉滴注,第1天;亚叶酸钙200mg/m2,静脉滴注,第1、2天;5-FU 400mg/m2,静脉推注,第1、2天;5-FU 2 400mg/m2,输液泵持续泵入44~48小时。2周为一周期。3周后评价疗效。结果:30例均可评价疗效,完全缓解0例,部分缓解6例,稳定8例,疾病进展16例,总有效率为20%,疾病控制率为46.7%。主要毒副反应为血液学毒性和消化道症状,其中恶心、呕吐、转氨酶升高、口腔黏膜炎为I-II度。Ⅲ-Ⅳ度分别为白细胞减少,发生率20%;中性粒细胞减少,发生率23.3%;血小板减少,发生率为10%;腹泻,发生率为16.7%。结论:FOLFIRI方案治疗胃癌异时性卵巢转移有较好的疗效,毒性小,耐受性好。     

mFOLFOX6和FOLFIRI方案分别一线和二线治疗晚期胃癌疗效对比观察北大核心CSCD

目的观察m FOLFOX6和FOLFIRI方案分别一线和二线方案治疗晚期胃癌的疗效及不良反应。方法将62例晚期胃癌患者分为二组,对照组32例患者,一线采用m FOLFOX6方案治疗,疾病进展后,有25例患者二线采用FOLFIRI方案;观察组30例患者,一线采用FOLFIRI方案治疗,疾病进展后,有25例患者二线采用m FOLFOX6方案。对两组的疗效和不良反应做对比观察。结果对照组和观察组一线、二线治疗晚期胃癌ORR分别为37.5%、24.0%和40.0%、16.0%,差异均无统计学意义(P=0.801,P=0.662),中位无疾病进展时间分别为(5.0±0.25)月、(2.0±0.36)月和(6.0±0.81)月、(2.0±0.27)月,差异均无统计学意义(P=0.178,P=0.803)。二组OS无明显差别,分别为(10.0±1.06)月和(11.0±1.17)月(P=0.500)。两组不良反应以骨髓抑制、胃肠道、周围神经炎为主。其中一线治疗过程中,对照组外周神经炎发生率比观察组高,而观察组的腹泻发生率高于对照组。结论 m FOLFOX6和FOLFIRI方案分别一线和二线治疗晚期胃癌患者疗效相当,均可延长患者生存,不良反应可以耐受。     

SOX方案二线治疗晚期胃癌的疗效观察

目的:观察SOX方案（奥沙利铂联合替吉奥）二线治疗晚期胃癌的临床疗效和安全性。方法:经含蒽环类药物的ECF方案(表阿霉素联合顺铂、氟尿嘧啶)治疗失败后的晚期胃癌患者40例,应用奥沙利铂（OXA）联合替吉奥(S-1)方案:OXA 130mg/m2,第1天静脉滴注;S-1根据体表面积(BSA)按80、100或120mg/d给药,第1-14天每天分2次口服;持续至疾病进展或出现不可耐受的不良反应。每2个周期按照RECIST标准(1.1版)进行疗效评价及分析患者生活质量改善情况,按NCI-CTC(4.0版)评价不良反应并随访疾病进展时间。结果:40例可评价的患者中获得完全缓解2例,部分缓解11例,疾病稳定13例,疾病进展14例,有效率32.5%,总的疾病控制率为65%,大部分患者生活质量得到明显改善,中位疾病进展时间为3.7个月,主要不良反应为血象降低、轻度末梢神经病变、肝功能异常和消化道反应。结论:奥沙利铂联合替吉奥化疗方案二线治疗晚期胃癌效果明显,应用方便且不良反应少,患者耐受性良好,值得临床深入观察。     

姑息性切除治疗老年晚期胃癌疗效分析

胃癌ＴＮＭ分期的Ⅲ ｂ 期和Ⅳ期称为晚期胃癌［１］。我院自１９８９年１月至１９９５年１２月姑息性切除治疗老年人晚期胃癌７８例 ,治疗效果满意 ,现总结如下 :材料与方法一般资料 :７８例中 ,男性５９例 ,女性１９例 ,年龄６１岁～７９岁 ,平均年龄６６．２岁。发病部位 :位于Ａ区为主５１例 ,Ｍ区为主１７例 ,Ｃ区为主８例 ,皮革样癌２例。术前检查未发现远隔转移。无大量腹水及腹腔广泛转移。组织学类型 :腺癌４１例 ,粘液腺癌１６例 ,低分化癌１１例 ,未分化癌７例 ,印戒细胞癌３例。膨胀型４５例 ,浸润型３３型。合并症 :合并高血压…     

Simplified FOLFIRI in pre-treated patients with metastatic gastric cancer

Purpose  Second-line chemotherapy in patients with metastatic gastric cancer (MGC) pre-treated with cisplatin is not a standard option. We studied a combination of irinotecan, fluorouracil and folates. Methods  Patients progressive to cisplatin-based chemotherapy were enrolled. Irinotecan 180 mg/m², folinic acid 200 mg/m², and fluorouracil 400 mg/m² were given on day 1, immediately followed by fluorouracil 2,400 mg/m² 46 h continuous infusion (simplified FOLFIRI), every 2 weeks. Results  Between June 2002 and May 2003, 28 patients were treated. Median age was 57 years (range 38–68). Most patients had a distal primary (90%), and metastatic disease (71%). Partial response was obtained in six patients (21%, 95% CI 8–41) and stable disease in eight (21%, 95% CI 13–41). Among the six responsive patients three were refractory to docetaxel. At a median follow-up of 2.9 years median time to progression was 4 months (95% CI: 2–5), and median overall survival was 5 months (95% CI 4–9). Toxicity was mild, without treatment-related deaths or life-treating adverse events. Conclusions  Simplified FOLFIRI was moderately active and well tolerated in unselected patients with MGC pre-treated with cisplatin-based chemotherapy. Its role in patients refractory to taxanes is promising and warrants further investigation.     

FOLFIRI as a second-line therapy in patients with docetaxel-pretreated gastric cancer: a historical cohort

Background

The role of second-line therapy in gastric cancer patients mostly stemmed from clinical trials with monochemotherapy carried out in Asian countries. Nevertheless, these results cannot be broadly generalized as molecular studies suggested the existence of different sets of deregulated gene networks correlated with ethnicity. In the present study, we investigated the activity and safety of FOLFIRI given as a second-line therapy in metastatic gastric or gastro-esophageal junction cancer patients who experienced disease progression on or after first-line docetaxel-containing chemotherapy.

Methods

Patients with histologically confirmed metastatic gastric cancer who failed docetaxel-containing first-line therapy and who received FOLFIRI in second line were eligible for the study. Seventy patients treated at three Italian cancer centers between 2005 and 2012 entered the study. Patients received every 2 weeks irinotecan 180 mg/m² as 1 h infusion on day 1, folinic acid 100 mg/m² intravenously days 1–2, and fluorouracil as a 400 mg/m² bolus and then 600 mg/m² continuous infusion over 22 hours days 1–2.

Results

We observed 1(1.4%) complete response, 15 (21.4%) partial response, for an overall response rate of 22.8% (95% confidence interval (CI): 13.4-32.3). Stable disease was recorded in 21 (30%) patients. Median progression-free survival and overall survival were 3.8 months (95% CI: 3.3-4.4) and 6.2 months (95% CI: 5.3-7.1), respectively. The treatment was well tolerated, as the most common G3-4 toxicities were neutropenia (28.5%) and diarrhea (14.5%).

Conclusions

FOLFIRI appears an effective and safe treatment option for pretreated metastatic gastric cancer patients, and deserves further investigation in randomized clinical trials.     

The efficacy and toxicity of irinotecan with leucovorin and bolus and continuous infusional 5-fluorouracil (FOLFIRI) as salvage therapy for patients with advanced gastric cancer previously treated with platinum and taxane-based chemotherapy regimens

Abstract

There is no established standard salvage chemotherapy in the second-line setting for patients with advanced gastric cancer (AGC) pre-treated with platinum and taxane-based chemotherapy. Our study aims to evaluate the safety and efficacy of FOLFIRI regimen (irinotecan with leucovorin and bolus and continuous infusion with 5-fluorouracil) as a salvage chemotherapy regimen in patients with AGC. Medical records of 97 patients with AGC who received second-line FOLFIRI regimen between March 2006 and February 2011 were examined. Complete and partial responses were observed in 3 (3·1%) and 23 (23·7%) patients, respectively. The median time to progression (TTP) was 3·5 months (95% CI: 2·4–4·6) and the median overall survival (OS) was 10·5 months (95% CI: 8·8–12·2). The most common observed grade 3/4 toxicities were neutropenia (23·7%), diarrhea (6·2%), and stomatitis (5·2%). FOLFIRI regimen is safe and effective in the second-line treatment of AGC patients pre-treated with cisplatin and taxanes.     

A retrospective observational study on the safety and efficacy of first-line treatment with bevacizumab combined with FOLFIRI in metastatic colorectal cancer

Background:

Combination of bevacizumab and FOLFIRI has currently become one of the standard therapeutic regimens. However, published information is still limited. The objective of the present retrospective observational study is to analyse the response and toxicity of first-line treatment with FOLFIRI+bevacizumab in patients with metastatic colorectal cancer (mCRC).

Methods:

Data were collected from patients from nine Spanish sites diagnosed with mCRC, ECOG⩽2, whose first treatment for advanced disease was at least three cycles of FOLFIRI+bevacizumab.

Results:

A total of 95 patients were enrolled into the study: 64.2% males, median age of 59 years (53.2–67.1 years), ECOG=0–1 in 96.9% of patients. The main site of primary tumour was the colon (69.7%), and most metastases occurred in the liver (71.6%). Clinical benefit was detected in 67.4% (57.0–76.6; 95% confidence interval (CI)), with 8.4% of CR and 42.1% of PR. Median TTP was 10.6 months (10.0–11.3; 95% CI), PFS was 10.6 months (9.8–11.3; 95% CI), and OS was 20.7 months (17.1–24.2; 95% CI). Main grade I–II toxicities included haematological toxicity (35.8%), diarrhea (27.3%), mucositis (25.3%), asthenia (19.0%), haemorrhages (11.6%), and emesis (10.6%). Toxicities reaching grades III–IV were haematological toxicity (9.5%), diarrhea (8.5%), mucositis (5.3%), hepatic toxicity (2.1%), asthenia (2.1%), proteinuria (1.1%), emesis (1.1%), pain (1.1%), and colics (1.1%).

Conclusion:

Results of this study support the beneficial effect of adding bevacizumab to FOLFIRI regimen in terms of efficacy and show a favourable tolerability profile.     

血浆D-二聚体水平与转移性胃癌患者生存期的关系

Objective:The principal purpose of this study was to determine the relationship between level of plasma D-dimer and survival time in metastatic gastric cancer patients.Methods:We retrospectively collected the data of plasma D-dimer in metastatic gastric cancer patients admitted in our Department (Department of Oncology,The Affiliated Changzheng Hospital,The Second Military Medical University,Shanghai,China) from October 2006 to October 2008 and analyzed the relationship between level of plasma D-dimer and s...     

Exploration of potential prognostic biomarkers in aflibercept plus FOLFIRI in Japanese patients with metastatic colorectal cancer

Aflibercept plus 5‐fluorouracil/levofolinate/irinotecan (FOLFIRI) is a second‐line treatment for metastatic colorectal cancer. This ancillary exploratory analysis of data in Japanese people was aimed at exploring the relationship between a set of potential prognostic biomarkers and efficacy endpoints following aflibercept plus FOLFIRI therapy. Sixty‐two patients with metastatic colorectal cancer received aflibercept (4 mg/kg) plus FOLFIRI every 2 weeks. Seventy‐eight potential protein biomarkers were chosen for analysis based on their roles in angiogenesis, tumor progression, and tumor‐stroma interaction. Plasma levels of biomarkers at baseline and at pre‐dose 3 (day 1 of treatment cycle 3) were measured in all patients by ELISA. Relationships between these levels and efficacy endpoints were assessed. Ten potential biomarkers had a ±30% change from baseline to pre‐dose 3 (adjusted P < .001), with the greatest changes occurring in placental growth factor (median: +4716%) and vascular endothelial growth factor receptor 1 (+2171%). Baseline levels of eight potential biomarkers correlated with overall survival in a univariate Cox regression analysis: extracellular newly identified receptor for advanced glycation end‐products binding protein, insulin‐like growth factor‐binding protein 1, interleukin‐8, kallikrein 5, pulmonary surfactant‐associated protein D, tissue inhibitor of metalloproteinases 1, tenascin‐C, and tumor necrosis factor receptor 2. None correlated with progression‐free survival or maximum tumor shrinkage. Pre‐dose 3 levels did not correlate with any efficacy endpoints. Preliminary data show that these eight biomarkers could be associated with overall survival. ClinicalTrials.gov identifier: NCT01882868.     

An open-label, single-arm, phase 2 trial of panitumumab plus FOLFIRI as second-line therapy in patients with metastatic colorectal cancer

Background

This prospective analysis evaluated the effect of tumor KRAS status on efficacy of second-line panitumumab plus folinic acid/5-fluorouracil/irinotecan (FOLFIRI).

Methods

This phase 2, open-label, single-arm study enrolled patients with unresectable, measurable metastatic colorectal cancer (mCRC) after failure of first-line treatment with oxaliplatin-based chemotherapy plus bevacizumab. Patients received panitumumab 6 mg/kg plus FOLFIRI every 2 weeks until disease progression or intolerability. Tumor assessments per Response Evaluation Criteria in Solid Tumors (RECIST) were performed by the investigators every 8 weeks from weeks 8-32 and every 12 weeks thereafter. KRAS status was determined by real-time polymerase chain reaction (PCR) on DNA extracted from fixed tumor sections. Efficacy endpoints included objective response rate, progression-free survival (PFS), and overall survival (OS). Safety endpoints included incidence of adverse events (AEs). Endpoints were evaluated by tumor KRAS status.

Results

Of 116 patients enrolled, 109 patients with known tumor KRAS status received treatment; 59% had wild-type KRAS, and 41% had mutant KRAS. Fifteen patients (23%) with wild-type KRAS and 7 patients (16%) with mutant KRAS had a complete or partial response to treatment. Median PFS was 26 weeks (95% CI, 19-33 weeks) and 19 weeks (95% CI, 12-25 weeks) in the wild-type KRAS and mutant KRAS strata, respectively. Median OS was 50 weeks (95% CI, 39-76 weeks) and 31 weeks (95% CI, 23-47 weeks) in wild-type KRAS and mutant KRAS strata, respectively. Skin-related toxicities (86% of all patients) and diarrhea (74%) were the most common AEs.

Conclusion

Panitumumab plus FOLFIRI numerically improved objective response rate, PFS, and OS in favor of patients with wild-type KRAS tumors. The safety profile was consistent with panitumumab plus FOLFIRI trials in similar patient populations.