FOLFOX4方案治疗晚期胃癌的临床观察

目的 观察FOLFOX4方案治疗晚期胃癌的近期疗效和毒副反应.方法 30例晚期胃癌患者,先给予FOLFOX4方案,即:奥沙利铂(L-OHP)85 mg/m2静脉点滴2 h,d1;亚叶酸钙(CF)200 mg/m2静脉点滴2 h,d1、d2,随后5-氟尿嘧啶(5-FU)400 mg/m2静脉推注,d1、d2,5-FU 600 mg/m2微泵持续滴注22 h,d1、d2.2周重复.4个周期后以WHO评价标准评价疗效和毒性.结果 全组30例均可评价,其中完全缓解(CR)2例,部分缓解(PR)16例,稳定(SD)7例,进展(PD)5例,总有效率(CR+PR)60%.中位肿瘤进展时间(TTP)5.5月,中位生存时间(MST)为9个月.毒副反应主要是骨髓抑制,白细胞降低发生率达83.3%,其次为胃肠道反应,恶心呕吐发生率为80.0%,口腔粘膜炎为21.3%,腹泻36.7%,无Ⅳ度胃肠道反应,周围神经毒性发生率为50.0%.结论 FOLFOX4方案治疗晚期胃癌的近期疗效较好,毒副反应可以耐受,值得进一步研究应用.     

转移性结直肠癌XELOX与FLOFOX6治疗方案的临床疗效与毒副反应观察

目的比较卡培他滨联合奥沙利铂(XELOX)方案与5-氟尿嘧啶/亚叶酸钙联合奥沙利铂(FOLFOX6)方案治疗转移性结直肠癌(metastatic colorectal cancer,MCRC)的近期疗效和毒副反应。方法 55例MCRC患者均存在远端器官的转移,均采用姑息治疗方法,将这些患者随机分为两组,XELOX治疗组29例,卡培他滨1 000 mg/m2,口服,2次/d,第1~14天;奥沙利铂130 mg/m2,静脉点滴,第1天;21 d为1个周期。FOLFOX6治疗组奥沙利铂130 mg/m2静脉输注2 h,第1天;亚叶酸钙200 mg/m2静脉输注2 h,第1~5天;5-氟尿嘧啶500 mg/m2静脉输注4~6 h,第1~5天,21 d为1个周期。两组均治疗2个周期以上。按照RECIST指南评定标准进行评价,主要终点是疾病进展时间(TTP)、生存时间(MST),毒副反应按照WHO抗癌药物常见毒性分级标准分为0~Ⅳ级。结果 XELOX治疗组疗效为51.7%,TTP为6.7个月,MST为14.5个月;FOLFOX6治疗组疗效为50.0%,TTP为7.3个月,MST为14.1个月,两治疗组三个指标差异均无统计学意义(P0.05)。毒副反应比较,二者在引起手足口综合征和神经毒性方面差异有统计学意义(P0.05),XELOX治疗组易引发手足口综合征,但是均以Ⅰ~Ⅱ的轻度反应为主,只有1例重度手足口综合征,而FOLFOX6治疗组则易引起神经毒性,大部分以轻度反应为主。FOLFOX6治疗组存在3例Ⅲ~Ⅳ级的重度白细胞减少病例。结论 XELOX治疗组与FOLFOX6治疗组相当,FOLFOX6治疗方案毒副反应较大,XELOX治疗方案较为安全。     

XELOX与FOLFOX4治疗方案对老年转移性结直肠癌序贯化疗的效果

目的探讨卡培他滨+奥沙利铂(OXA,XELOX)与OXA+亚叶酸钙(CF)+5-氟尿嘧啶(FU,FOLFOX4)治疗方案对老年转移性结直肠癌(CRC)序贯化疗的疗效。方法抽选79例老年转移性CRC患者,采用随机数字表法分为FOLFOX4组(n=39,一线采用FOLFOX4方案治疗)和XELOX组(n=40,一线采用XELOX方案治疗),两组化疗2～8个周期后均采用同等剂量的卡培他滨序贯化疗4～12个周期,评价两组客观疗效及不良反应。结果两组治疗总有效率、肿瘤进展时间(TTP)、生存时间(MST)差异无统计学意义(P0.05)。XELOX组手足综合征毒副反应略高于FOLFOX4组、FOLFOX4组Ⅲ～Ⅳ级恶心呕吐发生率略高于XELOX组,但差异无统计学意义(P0.05);两组余毒副反应差异无统计学意义(P0.05)。结论 XELOX与FOLFOX4方案在转移性CRC序贯化疗中疗效相当,毒副反应相近,均可作为转移性CRC的一线用药。     

奥沙利铂联合氟尿嘧啶和亚叶酸钙方案治疗70岁及以上转移性结直肠癌的疗效和安全性

目的 对比观察奥沙利铂联合氟尿嘧啶和亚叶酸钙方案(FOLFOX4)治疗70岁及以上转移性结直肠癌患者与70岁以下患者的不良反应和疗效.方法 61例转移性结直肠癌患者,其中≥70岁组28例,＜70岁组33例,两组患者均接受FOLFOX4方案化疗,14 d为1个周期,治疗期间观察不良反应,3个周期后评价疗效.结果 61例患者均可评价不良反应及疗效.主要不良反应为骨髓抑制、胃肠道反应及神经毒性,≥70岁组腹泻的发生率高于＜70岁组,但主要为1～2度不良反应.≥70岁组白细胞和中性粒细胞下降的发生率高于＜70岁组(92.8%比78.8%和39.3%比36.3%),但差异无统计学意义.≥70岁组神经系统毒性发生率为46.5%,＜70岁组为36.4%,均为1～2度,两组间差异无统计学意义.≥70岁组患者近期有效率为25%,疾病控制率为71.4%,中位疾病进展时间(TTP)为6个月,＜70岁组患者近期有效率24.2%,疾病控制率84.8%,中位TTP 7个月,两组有效率和疾病控制率差异无统计学意义,而＜70岁组患者的中位TTP比≥70岁组略长.结论FOLFOX4方案同样适用于≥70岁转移性结直肠癌患者,其耐受性较好且疗效肯定.

Abstract：

Objective To observe the safety and efficacy of FOLFOX4 regiment in elderly versus young patients with advanced colorectal cancer. Methods There were 61 patients enrolled in this study, with 28 elderly patients aged 70 years and over, 33 young patients aged less than 70 years.They suffered from advanced/recurrent colorectal cancer and received FOLFOX4 regiment (Oxaliplatin +CF+5-FU). Every 14 days were as a cycle, and the therapeutic safety and efficacy were evaluated after three cycles. Adverse events and response to treatment were compared between the elderly and young patients. Results The main adverse effects were myelosuppression, gastrointestinal disturbance and neurotoxicity. The incidence rate of diarrhea was significantly higher in elderly patients than in young patients, but the most of diarrhea were at grade Ⅰ - Ⅱ. The incidence rates of leucocyte decrease and neutrophil decrease were higher in elderly patients than in young patients (92. 8% vs. 78. 8%, 39.3% vs. 36.3%), but there were no statistically significant differences between them. The incidence rate of neurotoxicity was 46.5% in elderly patients and 36.4% in young patients (P＞0. 05). The recent efficacy rate was 25%, disease control rate was 71.4% and median time-to-progression (TTP) was 6 months in elderly patients and 24.2%, 84.8% and 7 months in young patients (all P＞0.05). Conclusions FOLFOX4 regiment is well-tolerated and effective in both young and elderly patients.     

复方斑蝥胶囊联合FOLFOX6方案对晚期胃癌患者无进展生存期的影响

目的研究复方斑蝥胶囊联合FOLFOX6方案(氟尿嘧啶+奥沙利铂+亚叶酸钙片)对晚期胃癌患者无进展生存期的影响。方法 88例晚期胃癌患者根据治疗方案不同分为研究组(44例)和对照组(44例)。对照组给予FOLFOX6方案治疗,研究组给予复方斑蝥胶囊联合FOLFOX6方案治疗。对比两组治疗效果、毒副反应发生情况、治疗前后生存质量变化及无进展生存期(PFS)情况。结果研究组近期治疗总有效率、控制率高于对照组(P0.05);恶心呕吐、腹泻、血小板下降、肝功能异常、白细胞下降、口腔炎、脱发等毒副反应发生率与对照组比较差异无统计学意义(P0.05);治疗2个周期后研究组SF-36评分高于对照组(P0.05);平均PFS及中位PFS长于对照组(P0.05)。结论复方斑蝥胶囊联合FOLFOX6方案治疗晚期胃癌,能显著提高近期治疗效果,改善患者生存质量,延长PFS,且具有一定安全性。     

雷替曲塞联合奥沙利铂与5-氟尿嘧啶联合顺铂方案治疗晚期胃癌的临床观察

目的 观察雷替曲塞联合奥沙利铂（L-OHP）治疗晚期胃癌的近期疗效和毒性.方法 将80例晚期胃癌患者分为两组,A组40例,给予雷替曲塞3 mg/m2,静脉滴注15分钟,d1;奥沙利铂130 mg,/m2,静脉滴注2小时,d1,3周重复1次.B组患者40例,给予5-氟尿嘧啶（5-FU）750 mg/m2,静脉滴注,d1 ～5;顺铂25 mg/m2,静脉滴注,d1 ～3,28天重复1次.结果 A、B两组患者的有效率分别为47.5％和22.5％,两组比较差异有统计学意义（P＜0.05）.不良反应主要是骨髓抑制和消化道反应.结论 与5-FU联合顺铂的方案比较,雷替曲塞联合奥沙利铂治疗晚期胃癌临床疗效较好,不良反应轻.     

替吉奥或氟尿嘧啶联合顺铂治疗晚期食管癌疗效和安全性的比较

目的:观察替吉奥(S-1)联合顺铂(cisplatin,DDP)方案(S-1+DDP,SP方案)治疗晚期食管癌的疗效及安全性.方法:57例入组患者被随机分为2组,观察组28例采用替吉奥加顺铂治疗,替吉奥100mg/d[体表面积(body surface area,BSA)<1.5m2者]或120 mg/d(BSA>1.5 m2者),2次/d于早晚餐后顿服,连服14 d后停药7 d;DDP 75mg/m2,静脉滴注d1-3.对照组29例采用氟尿嘧啶(flurouracil,5-FU)联合顺铂(FP方案)治疗,亚叶酸钙(leucovorin,LV)200 mg/m2,静脉滴注d1-5,5-FU 600 mg/m2,连续静滴d1-5;DDP75 mg/m2,静脉滴注d1-3.以上化疗方案21 d为1个周期,每2个周期评价疗效.观察并比较临床疗效、不良反应、疾病进展时间(time to progression,TTP)及生存期(overall survival,OS)等指标.结果:观察组和对照组总有效率=完全缓解(complete remission,CR)+部分缓解(partial r e m i s s i o n,P R),分别为55.6%和27.6%,两组比较差异有显著性(P<0.05).临床获益率[CR+PR+疾病稳定(stable disease,SD)]分别为81.5%和55.2%,两组比较差异有显著性(P<0.05).不良反应方面观察组血小板减少及肝功能损害的发生率高于对照组,两组比较差异有显著性(P<0.05),恶心呕吐、口腔黏膜炎及手足综合征等不良反应差异均无统计学意义.中位无疾病进展生存时间观察组和对照组分别为7 mo和6 mo;中位生存时间两组分别为12 mo和9 mo,差异均有显著性(P<0.05).结论:替吉奥联合顺铂治疗晚期食管癌可显著提高近期疗效和延长生存期,不良反应可耐受,可替代标准FP方案成为治疗晚期食管癌的首选.     

多西他赛联合FOLFOX4方案治疗晚期胃癌40例临床观察

目的探讨多西他赛＋FOLFOX4方案对晚期胃癌的疗效及毒副作用。方法晚期胃癌患者40例,给予以下化疗方案：多西他赛60 mg/m2静脉滴注,第1天;奥沙利铂85 mg/m2静脉滴注,第1天;亚叶酸钙（CF）200 mg/m2静脉滴注,第1、2天;5-氟尿嘧啶（5-Fu）400 mg/m2静脉推注,第1天,5-Fu 600 mg/m2持续静脉滴注46 h。14 d为1个周期,所有患者至少接受3个周期以上的化疗。结果 40例均可评价疗效,总有效率45.0%,中位生存时间9.3个月,中位肿瘤进展时间6.1个月。主要毒副反应为胃髓抑制、腹泻和脱发。结论多西他赛联合FOLFOX4方案治疗晚期胃癌的近期疗效好,毒副作用可以耐受。     

晚期胃肠道肿瘤时辰化疗效果观察

化疗是晚期胃肠道肿瘤的主要治疗手段,目前常用的化疗方案为醛氢叶酸(CF) 奥沙利铂(L-OHP) 5-氟尿嘧啶(5-FU).研究表明,时辰化疗可提高晚期胃肠道肿瘤化疗的有效率.2005年10月～2007年11月,我们采用L-OHP 5-FU CF联合化疗方案,应用多通道编程输液泵对64例晚期胃肠道肿瘤患者进行时辰化疗.现报告如下.     

西妥昔单抗联合FOLFOX6方案治疗转移性大肠癌疗效观察

目的观察西妥昔单抗联合FOLFOX6方案治疗转移性大肠癌的疗效。方法转移性大肠癌18例,应用西妥昔单抗首次400 mg/m2,以后250 mg/m2,1次/周;联合FOLFOX6方案,每2周重复1次;4个周期后评价疗效。结果本组PR 8例,SD 7例,有效率为57.1%,疾病控制率为83.3%,中位疾病进展时间9.4个月,中位生存期18.6个月。不良反应皮疹14例、中性粒细胞减少8例、迟发性腹泻7例、呕吐7例、发热5例、白细胞减少3例、血红蛋白减少2例、血小板下降2例。结论西妥昔单抗联合FOLFOX6方案治疗转移性大肠癌效果良好。     

外周穿刺中心静脉导管在胃肠癌FOLFOX6化学治疗方案中的临床应用

目的探讨外周穿刺中心静脉导管(PICC)在胃肠癌FOLFOX6化学治疗方案中的临床应用.观察其疗效和不良反应.方法 59例胃肠癌行FOLFOX6方案化学治疗患者,采用经外周静脉中心静脉置管(PICC)结合便携式化学治疗泵给药.方案为:奥沙利铂100 mg/m2静脉点滴2 h,第1天;亚叶酸钙400 mg/m2静脉点滴2 h,第1天;5-氟脲嘧啶(5-FU)400 mg/m2静推,第1天;后以5-FU 2.4 g/m2,入化学治疗泵持续静脉输注46 h,每2周重复.结果全组有效率49.2%(29/59),完全缓解10例、部分缓解19例、稳定17例、疾病进展13例.不良反应主要是外周神经炎、胃肠道反应、骨髓抑制,所有反应在停止治疗后可恢复.平均PICC置管时间为62 d;其中10.2%出现静脉炎,3.4%出现导管堵塞,6.8%出现导管移位,未出现严重相关并发症.结论胃肠癌患者采用经PICC管结合化学治疗泵FOLFOX6方案化学治疗,不仅提高化学治疗效果,降低不良反应,同时提高患者生活质量,值得临床推广.     

硫普罗宁对晚期结直肠癌患者FOLFOX4方案化疗效果的影响

目的探讨硫普罗宁在晚期直肠癌FOLFOX4方案化疗中的临床应用价值。方法将60例晚期结直肠癌患者随机分为观察组和对照组,每组各30例。对照组患者采用FOLFOX4化疗方案治疗;观察组患者在应用FOLFOX4方案化疗的同时静滴硫普罗宁治疗。观察比较两组的疗效和毒副反应。结果观察组患者的近期疗效略高于对照组,但差异无统计学意义(P0.05)。观察组患者肝功能损害和中性粒细胞减少程度低于对照组,差异有统计学意义(P0.05)。结论硫普罗宁能减轻晚期结直肠癌患者化疗所致的肝功能损害和中性粒细胞减少,但不能明显提高化疗的近期疗效。     

FOLFOX3 in heavily pretreated patients with metastatic colorectal cancer

BACKGROUND: The combination of oxaliplatin, 5-fluorouracil (5FU) and leucovorin (LV) has shown to be active and safe as first- or second-line chemotherapy for metastatic colorectal cancer (MCC). PATIENTS AND METHODS: The outcome of patients with MCC who had progressive disease after at least two lines of palliative chemotherapy and who were subsequently treated with oxaliplatin, 5FU and LV was reviewed. Patients received FOLFOX3 consisting of oxaliplatin (85 mg/m2) on day 1, LV (500 mg/m2) as a two-hour infusion on days 1 and 2, and 5FU (3000 mg/m2) as a 46-hour infusion starting on day 1 in a cycle of two weeks. RESULTS: A total of 28 patients were treated with a median number of 9.5 cycles (range 1-24) at a mean dose intensity of 73%. Six patients discontinued treatment due to toxicity, of whom three had sensory neuropathy grade 2. Six patients experienced grade 3 toxicity: nausea (1), vomiting (1), diarrhoea (1), leucopenia (2) and thrombocytopenia (1); grade 4 toxicity was not observed. Twenty-five patients were evaluable for response, of whom four achieved a partial response (response rate 14%, based on intention to treat). The median progression-free survival was 5.8 months and the median overall survival was 8.5 months. CONCLUSION: For heavily pretreated patients with MCC, the FOLFOX3 regimen is a fairly safe and effective treatment.     

Epirubicin,Cisplatin,5-FU combination chemotherapy in sorafenib-refractory metastatic hepatocellular carcinoma

AIM:To evaluate the clinical efficacy and safety of epirubicin,cisplatin,and 5-FU combination chemotherapy for the sorafenib-refractory metastatic hepatocellular carcinoma(HCC).METHODS:From April 2009 to June 2012,31 patients who were diagnosed with metastatic and progressive HCC after sorafenib treatment were retrospectively reviewed.Patients were treated with the combination of epirubicin(50 mg/m2Ⅳ;day 1),cisplatin(60 mg/m2Ⅳ;day 1),and 5-FU(1000 mg/m2Ⅳ;day 1-3)[Epirubicin,cisplatin,5-FU combination(ECF)],repeated every 4 wk.RESULTS:The overall response rate was 12.9%.Patients who responded to ECF chemotherapy showed a longer overall survival(OS)and time to progression(TTP)relative to those in the non-responder group(OS:20.4 mo vs 4.9 mo,P<0.001,TTP:9.4 mo vs 2.2 mo,P<0.001).Patients with a stable primary liver mass also exhibited a longer OS and TTP relative to those with progressive disease(OS:13.4 mo vs 5.3 mo,P=0.003;TTP:9.4 mo vs 2.3 mo,P=0.003).The most common hematologic toxicity was thrombocytopenia(87.2%),and the incidence of grade 3-4 neutropenia was 53.9%.Age older than 60,a stable primary mass,and a good response to chemotherapy were prognostic factors for OS and TTP.CONCLUSION:This combination cytotoxic chemotherapy can serve as another treatment option after sorafenib failure for the subset of patients with advanced metastatic HCC.     

5-FU,folinic acid and cisplatin (LV5FU2-P) for unresectable pancreatic cancer

AIM: To prospectively evaluate efficacy and tolerance of the 5-fluorouracil + folinic acid + cisplatin (LV5FU2-P) combination in the treatment of unresectable pancreatic carcinoma. PATIENTS AND METHODS: Between March 1998 and June 2000, 35 patients, mean age 61 years (37-75), with advanced (n=2) or metastatic (n=33) pancreatic cancer and initial performance status (WHO) of 0 (n=9), 1 (n=14) or 2 (n=12) were enrolled in the study. Two consecutive groups of patients were treated twice monthly, the first group (n=19) received the LV5FU2 regimen: a 2 hour-infusion of leucovorin 200 mg/m(2), 5-FU bolus 400 mg/m(2), followed by 22-hour continuous infusion of 5-FU 600 mg/m(2) on 2 consecutive days and cisplatin 50 mg/m(2) on day 2. The second group (n=16) received a simplified schedule with bolus leucovorin 40 mg/m(2), 5-FU bolus 400 mg/m(2) on day 1, followed by 5-FU 2400 mg/m(2) 48-hour infusion and cisplatin 50 mg/m(2) on day 2. Clinical symptoms and performance status were monitored together with weight changes. Tumor assessment was performed every 2 months. RESULTS: Three patients (9%) exhibited grade 4 neutropenia and grade 3 toxicity occurred in 31% of the patients (neutropenia: n=3, thrombocytopenia: n=1, vomiting: n=3, mucositis: n=3, diarrhea: n=1). There were no treatment-related deaths. Objective response was observed in 10 patients (29%, 95% confidence interval: 20-40%) including one complete response. Median progression-free survival and overall survival were 4.5 and 9 months, respectively. Six-months and 1-year survival rates were 70% and 25%, respectively. Weight gain was observed in 40% of the patients and performance status improved in 50%. CONCLUSION: LV5FU2-P regimen is active and well tolerated. It should be compared to gemcitabine as a first line therapy in advanced and metastatic pancreatic cancer.     

重组人血管内皮抑制素联合FOLFOX4方案治疗晚期结直肠癌的临床对照研究

背景：临床前和临床研究结果显示重组人血管内皮抑制素能抑制血管内皮细胞增殖、血管生成和肿瘤生长．且耐受性良好。目的：评价重组人血管内皮抑制素联合FOLFOX4方案治疗晚期结直肠癌（ACRC）的反应率（RR）、临床获益率（CBR）、中位疾病进展时间（TTP）和肿瘤进展率,观察患者生活质量（QOL）改善情况和药物不良反应。方法：收集50例病理学诊断为Ⅳ期、初治或复治、Karnofsky评分（KPS）≥60分的ACRC患者,随机分为试验组和对照组。试验组25例,联合应用FOLFOX4方案和重组人血管内皮抑制素（7．5mg／m^2,d1-14）。对照组25例,应用FOLFOX4方案＋安慰剂（0．9％NaCl溶液,用法同重组人血管内皮抑制素）。结果：50例患者均可评价疗效。试验组总RR（44．0％对16．0％,P-0．062）、总CBR（76．0％对48．0％,P=0．041）、总中位TTP（7．8个月对5．0个月,P=0．040）和QOL改善率（64．0％对36．0％,P=0．048）均高于对照组,肿瘤进展率低于对照组（P〈0．05）。初治患者中,试验组RR、CBR和中位TTP均显著高于对照组（P〈0．05）;复治患者中,试验组和对照组上述指标无明显差异。两组间不良反应发生率差异无统计学意义。结论：重组人血管内皮抑制素联合FOLFOX4方案能明显提高ACRC患者,尤其是初治患者的RR．延长中位TTP,在一定程度上改善患者的QOL,且安全性较好。     

Oral Xeloda plus bi-platinu two-way combined chemotherapy in treatment of advanced gastrointestinal malignancies

AIM: To compare the effect, adverse events, cost-effectiveness and dose intensity (DI) of oral Xeloda vs calcium folinate (CF)/5-FU combination chemotherapy in patients with advanced gastrointestinal malignancies, both combined with bi-platinu two-way chemotherapy. METHODS: A total of 131 patients were enrolled and randomly selected to receive either oral Xeloda (X group) or CF/5-FU (control group). Oral Xeloda 1 000 mg/m2 was administered twice daily from d 1 to 14 in X group, while CF 200 mg/m2 was taken as a 2-h intravenous infusion followed by 5-FU 600 mg/m2 intravenously for 4-6 h on d 1-5 in control group. Cisplatin and oxaliplatin were administered in the same way to both the groups: cisplatin 60-80 mg/m2 by hyperthermic intraperitoneal administration, and oxaliplatin 130 mg/m2 intravenously for 2 h on d 1. All the drugs were recycled every 21 d, with at least two cycles. Pyridoxine 50 mg was given t.i.d. orally for prophylaxis of the hand-foot syndrome (HFS). Then the effect, adverse events, cost-effectiveness and DI of the two groups were evaluated. RESULTS: Hundred and fourteen cases (87.0%) finished more than two chemotherapy cycles. The overall response rate of them was 52.5% (X group) and 42.4% (control group) respectively. Tumor progression time (TTP) was 7.35 mo vs 5.95 mo, and 1-year survival rate was 53.1% vs 44.5%. There was a remarkable statistical significance of TTP and 1-year survival between the two groups. The main Xeloda-related adverse events were myelosuppression, gastrointestinal toxicity, neurotoxicity and HFS, which were mild and well tolerable. Therefore, no patients withdrew from the study due to side effects before two chemotherapy cycles were finished. Both groups finished pre-arranged DI and the relative DI was nearly 1.0. The average cost for 1 patient in one cycle was Y9 137.35 (X group) and Y8 961.72 (control group), or US $1100.89 in X group and $1 079.73 in control group. To add 1% to the response rate costs ￥161.44 vs ￥210.37 respectively (US $19.45 vs $25.35). One-month prolongation of TTP costs ￥1 243.18 vs ￥1506.17 (US $149.78 vs $181.47). Escalation of 1% of 1-year survival costs ￥172.74 vs ￥201.64 (US $20.75 vs $24.29). CONCLUSION: Oral Xeloda combined with bi-platinu two-way combination chemotherapy is efficient and tolerable for patients with advanced gastrointestinal malignancies; meanwhile the expenditure is similar to that of CF/5-FU combined with bi-platinu chemotherapy, and will be cheaper if we are concerned about the increase of the response rate, TTP or 1-year-survival rate pharmacoeconomically.     

Phase II clinical trial of advanced and metastatic gastric cancer based on continuous infusion of 5-fluorouracil combined with epirubicin and oxaliplatin

PURPOSE: To evaluate the efficacy and tolerability of systematic treatment of unresectable advanced or metastatic gastric cancer (A/MGC) based on EOF5 regimen (the combination of epirubicin, oxaliplatin and 5-day continuous infusion of 5-fluorouracil). PATIENTS AND METHODS: Twenty-six patients (18 males, 8 females; age range, 35-72 years) with histologically confirmed metastatic (n = 23) or unresectable advanced (n = 3) gastric adenocarcinoma with (n = 6) or without previous chemotherapy (n = 20) were consented to receive EOF5 (epirubicin 50 mg/m(2) and oxaliplatin 130 mg/m(2) on day 1, followed by continuous infusion of 5-fluorouracil 375-425 mg/m(2) day(-1) on day 1-5), and the treatment cycle was repeated every 3 weeks. Responses to treatment and toxicity were evaluated every 2 cycles. RESULTS: In the first-line treatment group of 20 patients, complete (CR) and partial (PR) remission were observed in two (10%) and six (30%) patients, respectively with an overall response rate of 40%). Eleven (55%) patients showed stable (SD) and one (5%) progressive disease (PD). One-year survival rate, time to progression (TTP) and median overall survival (OS) were 45%, 9.7 and 12.5 months, respectively. In the second-line treatment group of six patients, the numbers of CR, PR, SD and PD were 0, 1, 4 and 1, respectively. Symptomatic response rates were 88.2, 76.9, 89.5, and 88.9% for abdominal pain, distention, anorexia and weight loss. The mean Karnofsky performance status score was increased (P < 0.001) and maintained after two and four cycles treatment. The major adverse events were nausea/vomiting, oral mucositis, peripheral neuropathy, phlebitis, constipation and myelosuppression. CTC grade 3 or 4 hematologic toxicities included leucopenia (7.7%), neutropenia (15.4%), thrombocytopenia (19.2%), and anemia (3.8%). No treatment-related deaths were recorded. CONCLUSIONS: EOF5 regimen shows good efficacy and an acceptable safety profile in A/MGC patients, and would be a suitable alternative regimen for this indication.     

A phase I dose-escalating study of docetaxel plus folinic acid and 5-fluorouracil in anthracycline-pretreated patients with metastatic breast cancer

BACKGROUND: Since the need for nonanthracycline-containing chemotherapy regimens increases with the increased use of anthracyclines in earlier stages of breast cancer, we investigated the feasibility of the combination of docetaxel and 5-fluorouracil (5-FU) with folinic acid (FA). PATIENTS AND METHODS: Anthracycline-pretreated patients with metastatic breast cancer were eligible. Docetaxel was administered as a one-hour infusion every three weeks on day 1, FA 500 mg/m2 (fixed dose) as a two-hour infusion on days 1 and 15 and 5-FU as a 24-hour infusion on days 1 and 15. The dose levels tested were (docetaxel/5FU in mg/m2): 60/1800, 75/1800, 85/1800, 100/1800, and 100/2100. RESULTS: Altogether 28 patients were accrued and treated in this multicentre open-label study. Dose-limiting toxicities (DLTs) were not observed at dose level I, and in two patients in each of the higher dose levels. DLTs observed were grade III/IV infection (n=4), febrile neutropenia (n=2), diarrhoea (n=1) and erythema (n=1). Partial responses were observed in 10 out of 24 evaluable patients (42%, 95% confidence interval 22.1 to 63.4%). Dose escalation beyond the highest dose level (100/2100) was deemed inappropriate, because these dose levels correspond to recommended dose levels for each drug as a single agent. CONCLUSION: Combination of docetaxel (100 mg/m2, one-hour infusion q3 weeks on day 1), FA (500 mg/m2, two-hour infusion on days 1 and 15) and 5-FU (2100 mg/m2, 24-hour infusion on days 1 and 15) is a feasible regimen with encouraging activity in anthracycline-pretreated patients.     

Irinotecan plus weekly 5-fluorouracil and leucovorin as salvage treatment for patients with metastatic colorectal cancer: a phase II trial

BACKGROUND: A phase II study was conducted to evaluate the toxicity and efficacy of irinotecan/5-fluorouracil/leucovorin (CPT-11/5-FU/LV (AIO schedule)) as salvage treatment in patients with metastatic colorectal cancer. PATIENTS AND METHODS: 33 patients relapsing after oxaliplatin (L-OHP)-based first-line chemotherapy were enrolled. Their median age was 69 years, 20 (61%) patients were male, and performance status (WHO) was 0, 1, and 2 in 15, 16 and 2 patients respectively; prior surgery 20 (61%) patients; adjuvant chemotherapy 11 (33%) patients, and adjuvant radiotherapy 6 (18%) patients. The number of metastatic sites was 1, 2, and > or =3 in 11, 11, and 11 patients, respectively. CPT-11 was administered on day 1 at the dose of 80 mg/m(2) in 30-90 min infusion and LV (500 mg/m(2)) on the same day as a 2-hour infusion followed by 5-FU (2,600 mg/m(2)/day) as a 22-hour infusion on day 1 for 6 subsequent weeks. The regimen was repeated every 7 weeks. RESULTS: All patients were evaluable for toxicity and for response. Complete response was achieved in 2 patients (6%) and partial response in 4 patients (12%) (RR 18%, CI 5.95-35.43%); 13 patients (40%) had stable disease, and 14 (42%) progressive disease. After a median follow-up period of 9 months, the median duration of response was 5 months, the median time to progression 7.5 months, and OS 14 months. Grade 3-4 neutropenia occurred in 13 patients (39%), febrile neutropenia in 3 (9%), grade 2 anemia in 11 (33%), grade 4 thrombocytopenia in 1 (3%). Grade 3-4 diarrhea occurred in 12 patients (36%), grade 3-4 neurotoxicity in 3 (9%), and grade 3 asthenia in 4 (12%). No treatment-related deaths occurred. The median dose intensity was 85% for CPT-11, and 88% for 5-FU and LV. CONCLUSIONS: The combination of weekly CPT-11 and infusional 5-FU/LV is an active and relatively well-tolerated regimen as salvage treatment in MCC.