替吉奥联合顺铂与5-氟尿嘧啶联合顺铂治疗晚期胃癌对照研究的Meta分析

目的:比较替吉奥联合顺铂方案(SP方案)和5-氟尿嘧啶联合顺铂方案(FP方案)一线治疗晚期胃癌的疗效及安全性。方法:计算机检索Pubmed、EMBASE、Cochrane Library、ASCO会议摘要、中国期刊全文数据库、中国生物医学文献数据库、中文科技期刊全文数据库等,同时追查纳入文献的参考文献,纳入SP方案对比FP方案治疗晚期胃癌的随机对照试验(RCT)。根据Cochrane Handbook 5.0的质量评价标准,用RevMan 5.0软件进行统计学分析。结果:纳入4项RCT,1 263例患者,Meta分析结果显示,采用SP方案与FP方案治疗后疗效相当(OR=1.58,95%CI:0.76～3.29,P=0.22),但可以降低3/4级血小板减少(OR=0.58,95%CI:0.40～0.85,P=0.004)及恶心呕吐(OR=0.70,95%CI:0.52～0.95,P=0.02)发生率;亚组分析(中国人群),纳入3项RCT,234例患者,Meta分析结果显示,与FP方案相比,SP方案可提高患者有效率(OR=2.39,95%CI:1.30～4.38,P=0.005),但不能降低不良反应发生率,差异均无统计学意义。结论:SP方案与FP方案在有效率方面疗效相当,但可以增加安全性,不良反应发生率与FP方案类似,但由于研究例数较少,该结论尚待进一步扩大样本量进行评估。     

含伊立替康方案一线治疗晚期胃癌的Meta分析

目的:采用Meta分析的方法探讨含伊立替康方案一线治疗晚期胃癌患者的疗效及安全性。方法:利用计算机检索中国生物医学文献数据库、中国期刊全文数据库、维普数据库、Cochrane Library、Pub Med、Embase及SCI等数据库,收集含伊立替康方案一线治疗晚期胃癌的临床随机对照试验(randomized control trail,RCT),主要结局指标包括总有效率(overall response rate,ORR)、无进展生存时间(progression free survival,PFS)、总生存期(overall survival,OS)及治疗的相关不良反应;以相对危险度(relative risk,RR)和风险比(hazard ratios,HR)为效应量,各效应量以95%可信区间(coni dence interval,CI)表示,采用Stata 12.0统计软件进行Meta分析。结果:最终共8个RCT,1 910例晚期胃癌患者纳入研究。Meta分析结果显示,伊立替康组患者的PFS(HR=0.82,95%CI:0.69~0.98,P=0.03)和OS(HR=0.88,95%CI:0.80~0.97,P=0.007)均较非伊立替康组明显延长,ORR(RR=1.56,95%CI:1.18~2.06,P=0.002)获得明显的提高。在不良反应方面,主要增加了患者腹泻事件的发生率(RR=3.57,95%CI:1.97~6.46,P<0.001),而中性粒细胞减少、血小板数减少、贫血、恶心及口腔黏膜炎事件的发生率差异无统计学意义。结论:以伊立替康为基础的化疗方案一线治疗晚期胃癌患者可提高ORR并延长PFS及OS;在不良反应方面,该方案增加了患者腹泻事件的发生率。     

GP方案与NP方案治疗晚期乳腺癌疗效的Meta分析

[目的]利用Meta分析研究吉西他滨联合顺铂(GP方案)及长春瑞滨联合顺铂(NP方案)治疗晚期乳腺癌的疗效。[方法]计算机检索万方数据库、中国知网数据库、Pub Med、Cochrane Library,纳入GP方案及NP方案治疗晚期乳腺癌的随机对照研究,检索时间为2004年1月至2015年8月。由2名评价员按纳入与排除标准独立筛选文献、提取资料并评价纳入研究的方法学质量后,所有数据均用Rev Man5.2软件处理。[结果]共纳入14个RCT,其中GP组545例,NP组547例。Meta分析结果显示,两组反应率(RR)(OR=1.19,95%CI:0.94~1.52)及疾病控制率(DCR)(OR=1.15,95%CI:0.87~1.53)无统计学差异。3级及以上不良反应包括白细胞减少症、血小板减少症、恶心呕吐、静脉炎。Begg漏斗图未发现发表偏倚。[结论]GP及NP方案对提高晚期乳腺癌患者RR及DCR的疗效肯定,临床效果相似,值得进一步研究。     

DCF和ECF方案治疗进展期胃癌的疗效观察

目的研究多西紫杉醇（希存）联合顺铂及5-Fu治疗进展期胃癌的近期疗效及不良反应。方法58例进展期胃癌患者随机分两组,DCF方案为治疗组（30例）,ECF方案为对照组（28例）。结果DCF方案组有效率为36.6%（11/30）,对照组有效率28.5%（8/28）,两者差异无显著性（P〉0.05）。毒副反应主要表现为白细胞减少、恶心、呕吐和脱发,两组相比较差异无显著性。结论DCF方案治疗晚期胃癌疗效较好,毒副反应可耐受。     

培美曲塞联合铂类一线治疗晚期NSCLC疗效与安全性Meta分析

目的:采用Meta分析的方法,评价培美曲塞联合铂类(PPC方案)一线治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的疗效和安全性。方法:计算机检索PubMed、EMBASE、Cochrane数据库、中国期刊全文数据库和中国生物医学文献数据库等,纳入PPC方案治疗初治的晚期NSCLC随机对照试验(randomizd controlled trail,RCT),2位研究者独立评估试验质量和提取数据;使用RevMan 5.2软件进行Meta分析。结果:共纳入6项RCT,包括3 057例晚期NSCLC患者。Meta分析结果显示,PPC方案治疗晚期NSCLC患者与其他含铂方案(PBR方案)比较,有效率(OR=1.18,95%CI:0.77~1.81,P=0.45)和1年生存率(OR=1.11,95%CI:0.82~1.49,P=0.51)差异无统计学意义;无疾病生存时间(progression free survival,PFS)差异无统计学意义(HR=1.01,95%CI:0.93~1.11,P=0.75);但在总的生存时间(overall survival,OS)方面,PPC方案略有优势(HR=0.92,95%CI:0.84~1.01,P=0.07),尤其是非鳞癌患者更能从中获益(HR=0.87,95%CI:0.77~0.99,P=0.03)。与PBR方案相比,PPC方案治疗晚期NSCLC患者3~4级白细胞减少、中性粒细胞减少以及粒缺性发热方面发生率较低,但3~4级消化道反应更为常见。结论:PPC方案一线治疗晚期NCSLC患者具有较好的疗效和安全性,尤其适合非鳞癌的患者。     

奈达铂与顺铂联合同期调强放疗治疗局部晚期鼻咽癌随机对照试验的Meta分析

摘 要：［目的］ 系统评价奈达铂与顺铂联合同期调强放疗(intensity modulated radiation therapy,IMRT)治疗局部晚期鼻咽癌(nasopharyngeal carcinoma,NPC)的疗效与安全性。［方法］ 计算机检索PubMed、EMBASE、The Cochrane Library、CNKI、CBM、VIP和万方等数据库,检索时间截至2018年5月,收集对比奈达铂与顺铂联合同期IMRT治疗局部晚期NPC的疗效与安全性的研究,由2名研究员分别对纳入的研究进行数据提取和质量评价,最后采用Cochrane协作网提供的Revman 5.3软件进行Meta分析。［结果］ 共纳入14项临床随机对照试验(randomised controlled trial,RCT),共计1709例患者。Meta分析结果显示：对于局部晚期NPC,两组2年总生存率、无进展生存率、无远处转移生存率及局控率相当,并且两组的总缓解率、鼻咽原发灶及颈部转移灶缓解率差异均无统计学意义。同步奈达铂化疗降低了胃肠道反应(RR=0.44,95%CI：0.30~0.64,P<0.0001)及肾毒性(RR=0.28,95%CI：0.17~0.47,P<0.00001)的发生率,但增加了血小板减少症(RR=1.36,95%CI：1.01~1.85,P=0.04)的发生风险。［结论］ 对于局部晚期NPC,同步奈达铂与同步顺铂联合同期IMRT在长期、近期疗效上相当,同步奈达铂能够减少胃肠道反应、肾毒性的发生,但同时增加了发生血小板减少症的风险。从疗效及安全性方面考虑,奈达铂能够替代顺铂联合同期IMRT治疗局部晚期NPC。     

金葡素联合顺铂与顺铂单药控制恶性胸腹水疗效的Meta分析

目的:评价金葡素联合顺铂与顺铂单药治疗恶性胸腹水的有效性与安全性。方法:检索中国生物医学文献数据库（1990-2014）、中国期刊全文数据库（1990-2014）、维普数据库（1990-2014.12）、万方数据库（1990-2014.12）、PubMed （1990-2014.12）、Cochrane Library（1990-2014.12）纳入金葡素联合顺铂（试验组）与顺铂单药（对照组）治疗恶性胸腹水的随机对照试验（RCT）,采用Jadad改良法制定的量表评价纳入研究的质量,RevMan 5.2进行Meta分析。结果:共检索到文献100篇,按照纳入与排除标准共纳入文献16篇。Meta分析结果:金葡素联合顺铂用药治疗恶性胸腹水有效率上明显优于顺铂单药［OR=2.12,95%CI（1.64,2.74）,P<0.000 01］,金葡素联合顺铂较顺铂单药组易引起发热［OR=2.26,95%CI(1.36,3.75),P=0.002］,但两组在胸闷胸痛［OR=1.09,95%CI(0.55,2.17),P=0.81］发生率上无明显差异,在胃肠道反应［OR=0.34,95%CI(0.18,0.64),P=0.000 7］、白细胞下降［OR=0.27,95%CI(0.16,0.46),P<0.000 01］发生率上金葡素联合顺铂组明显低于顺铂单药组,且在改善患者生活质量上优于顺铂单药［OR=4.83,95%CI(2.96,7.87),P<0.000 01］。结论:金葡素联合顺铂较顺铂单药组在治疗恶性胸腹水上更为有效,并且毒副反应轻,安全性高。     

培美曲塞联合铂类对比吉西他滨联合铂类治疗晚期非小细胞肺癌的meta分析

背景与目的培美曲塞联合铂类方案(PP方案)作为晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)一线化疗方案的疗效是否优于吉西他滨联合铂类方案(GP方案),目前尚无定论。本研究旨在评价采用PP方案与GP方案治疗晚期NSCLC的疗效及安全性。方法计算机检索Pubmed、EMBASE、Cochrane Library、中国期刊全文数据库、中国生物医学文献数据库、中文科技期刊全文数据库等,同时追查纳入文献的参考文献,纳入PP方案对比GP方案治疗晚期NSCLC的随机对照试验(randomized controlled trial,RCT)。根据Cochrane Handbook5.0的质量评价标准,用RevMan5.0软件进行统计学分析。结果共纳入4项RCT,2,235例患者,meta分析结果显示采用PP方案与GP方案治疗后在1年生存率(OR=1.09,95%CI:0.91-1.29)、有效率(OR=1.00,95%CI:0.40-2.52)等方面的差异无统计学意义,而在总生存时间(MD=0.26,95%CI:0.21-0.30)、脱发(OR=0.51,95%CI:0.39-0.66)及血液毒性等方面的差异有统计学意义。结论 PP方案与GP方案在1年生存率、有效率方面疗效相当,在总生存时间、不良反应等方面有差异,PP方案可能对不耐受血液毒性、脱发等患者更适合。     

DCF方案治疗晚期胃癌27例

目的 观察多西紫杉醇(DCT)联合顺铂(DDP)和5-氟尿嘧啶(5-Fu)组成的DCF方案治疗晚期胃癌的近期疗效和不良反应.方法 全组27例患者均经病理学证实并有可测量病灶,临床上属于晚期和手术后复发转移的Ⅳ期胃癌患者.DCT 75mg/m2,第1天,用DCT前常规予地塞米松、苯海拉明、西咪替丁进行预处理;DDP 25 mg/m2,第2天至第4天,常规给予水化利尿;5-Fu 750 mg/m2,化疗泵持续静脉滴注120 h.3周重复.结果 全组27例均可评价疗效,总有效率为48.1%,其中CR2例,PR 11例,SD 8例,PD 6例.主要不良反应为骨髓抑制和胃肠道反应.结论 :DCF方案治疗晚期胃癌疗效确切,毒性可耐受,值得临床推广应用.     

卡铂对比顺铂联合第三代化疗药一线治疗晚期NSCLC的Meta分析

背景与目的:卡铂与顺铂在治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的疗效是否相同目前并没有明确的证据,本研究旨在探讨卡铂为基础联合第三代化疗药物与顺铂为基础联合第三代化疗药物的两药方案一线治疗晚期NSCLC的差异.方法:通过计算机检索Medline(1954-2010年5月)、Central(the cochrane central register of controlled trials)(2010 issue3)、中国生物医学文献数据库(CBM)(1978-2010年5月)、中国期刊全文数据库(CNKI)(1979-2010年5月)、万方数据库(1950-2010年5月)等,收集国内外公开发表的关于卡铂对比顺铂联合第三代化疗药物的两药方案一线治疗晚期NSCLC的随机对照研究(RCT),应用统计软件Stata 11.0进行数据分析.研究人群为晚期NSCLC(ⅢB～Ⅳ期):干预措施为顺铂或卡铂联合第三代化疗药物(包括:紫杉醇、吉西他滨、多西他赛)一线治疗晚期NSCLC的两药方案;结局指标为死亡率、客观反心率和药物毒性,并分别以风险比(hazard ratio,HR)、优势比(odds ratio,OR)及各自的95%可信区间(95%CI)作为效应指标对结局进行比较.Galbraith或L'abbe作图法及Q统计量的I检验来检测各研究间的统计学异质性,双侧P<0.05为各研究间存在明显的异质性.采用Begg和Egger法对发表偏倚进行量化检测.结果:最终纳入分析的文章5篇,共2 330例患者,其中卡铂组1 161例,顺铂组1 169例.接受卡铂为基础化疗方案的患者较顺铂为基础化疗的患者在治疗随访期间有更高的死亡风险,结果接近有统计学意义(HR=1.10,95%CI:1.00～1.21,Z=1.96,P=0.05);卡铂为基础化疗方案较顺铂为基础的化疗方案在客观反应率方面不同,顺铂组优于卡铂组(OR=0.80,95%CI:0.66～0.95,Z=2.48,P=-0.013);卡铂为基础的化疗方案易出现血小板降低(OR=2.13,95%CI:1.56～2.92,Z=4.72,P=0.000),顺铂方案易出现化疗相关的恶心呕吐(OR=0.49,95%CI:0.38～0.62,Z=5.70,P=0.000)及肾毒性(OR=0.40,95%CI:0.17～0.97,Z=2.03,P=0.042).结论:卡铂为基础联合第三代化疗药一线治疗晚期NSCLC的化疗方案在生存率及客观反应率方面并不优于顺铂为基础的化疗方案.卡铂为基础的化疗方案血液系统毒性发生率较高,而非血液系统毒性发生率较低.     

Efficacy and Safety of Docetaxel or Epirubicin,Combinedwith Cisplatin and Fluorouracil, (DCF and ECF) Regimens as First Line Chemotherapy for Advanced Gastric Cancer: a Retrospective Analysis from Turkey

Objectives: Advanced gastric cancer (AGC) patients have a poor prognosis. The best benefit of chemotherapy is usually achieved by first line setting. Very few studies have compared combination regimens. This study was designed to compare two combination regimens. Methods: Patients with advanced gastric cancer receiving first line chemotherapy were retrospectively collected, and divided into two groups, receiving DCF (docetaxel, cisplatin and fluorouracil) or ECF (epirubicin, cisplatin and fluorouracil) regimens. Data were collected for theretrospective analysis in a single center. Results: Eighty-six patients were eligible for analysis. Median overall survival (OS) was 10.0 months in the ECF group and 11.0 months in the DCF group (p=0.31). Median progression free survival (PFS) for ECF and DCF was equal at 6.0 months. Second line chemotherapy were administered in more than one third of patients. Both regimens had similar toxicity. Conclusions: This is the first study investigating the outcomes of gastric cancer chemotherapy in this region. ECF and DCF regimens have similar efficacy and a similar tolerability profile for first line treatment of advanced gastric cancer. The decision of the first line chemotherapy in advanced gastric cancer could be improved with patient selection according to clinical parameters and molecular markers.     

Efficacy and Tolerability of Weekly Docetaxel,Cisplatin, and 5-Fluorouracil for Locally Advanced or Metastatic Gastric Cancer Patients with ECOG Performance Scores of 1 and 2

Background: Docetaxel, cisplatin, 5-fluorouracil (DCF) given every three weeks is an effective, but palliativeregimen and significantly toxic especially in patients who have a low performance score. Here, we aimed to evaluatethe efficacy and tolerability of a weekly formulation of DCF in locally advanced and metastatic gastric cancerpatients. Materials and Methods: 64 gastric cancer patients (13 locally advanced and 51 metastatic) whose ECOG(Eastern Cooperative Oncology Group) performance status (PS) was 1-2 and who were treated with at least twocycles of weekly DCF protocol as first-line treatment were included retrospectively. The weekly DCF protocolincluded 25mg/m2 docetaxel, 25mg/m2 cisplatin, and 24 hours infusion of 750mg/m2 5-fluorouracil, repeated everyweek. Disease and patient characteristics, prognostic factors, treatment response, grade 3-4 toxicity related totreatment, progression free survival (PFS) and overall survival (OS) were evaluated. Results: Of the patients, 41were male and 23 were female; the median age was 63 (29-82) years. Forty-one patients were ECOG-1 and 23were ECOG-2. Of the total, 81.2% received at least three cycles of chemotherapy. Partial response was observedin 28.1% and stabilization in 29.7%. Overall, the disease was controlled in 57.8% whereas progression was notedin 42.2%. The median time to progression was 4 months (95%CI, 2.8-5.2 months) and median overall survivalwas 12 months (95%CI, 9.2-14.8 months). The evaluation of patients for grade 3-4 toxicity revealed that 10.9%had anemia, 7.8% had thrombocytopenia and 10.9% had neutropenia. Non-hematologic toxicity included renaltoxicity (7.8%) and thrombosis (1.6%). Conclusions: In patients with locally advanced or metastatic gastriccancer who were not candidates for DCF administered every-3-weeks, a weekly formulation of DCF demonstratedmodest activity with minimal hematologic toxicity, suggesting that weekly DCF is a reasonable treatment optionfor such patients.     

Epirubicin, cisplatin and continuous infusion 5-fluorouracil (ECF) in locally advanced or metastatic gastric cancer: a single institution experience.

AIMS AND BACKGROUND: The role of chemotherapy in locally advanced or metastatic gastric cancer has been controversial, but chemotherapy has recently been shown to relieve tumor-related symptoms, improve quality of life and prolong survival when compared with best supportive care. Furthermore, palliative chemotherapy is also cost-effective. "Second-generation" combination chemotherapy regimens were developed in the 1980s with high activity in advanced or metastatic gastric cancer (EAP, FAMTX, PELF, ECF). In randomized studies, EAP demonstrated no difference in activity but a significantly higher overall toxicity and toxic death rate than FAMTX, and the ECF (epirubicin, cisplatin, 5-fluorouracil) regimen gave a survival and response advantage, tolerable toxicity, better quality of life and was more cost-effective than FAMTX. METHODS: Sixty patients with locally advanced or metastatic gastric cancer were treated with the ECF regimen (21 weeks of 5-fluorouracil given by continuous infusion through a central line at 200 mg/m2 for 24-hr combined with cisplatin at 60 mg/M2 iv and epirubicin at 50 mg/M2 iv beginning on day 1 and repeated every 3 weeks for 8 courses). There were 42 males and 18 females, with a median age of 64 years (range, 40-74). The median performance status was 1. The histologic type was adenocarcinoma in 44 patients and undifferentiated carcinoma in 16 (27%). Three patients had locally advanced disease (5%) and 57 had metastatic disease (95%). Seven patients (12%) had received prior chemotherapy for advanced disease. RESULTS: All patients were assessable for toxicity and 55 for response (5 had insufficient treatment). Toxicity was mild or moderate, and there was no toxic death. Incidence of WHO toxicity > or = 2 was nausea and vomiting in 3%, mucositis in 3%, leukopenia in 7%, anemia in 3%, and thrombocytopenia in 2%. Port-a-Cath toxicity was thrombosis in 4, dislocation in 2 and infection in 3 patients. Seven complete responses and 13 partial responses (overall response rate, 36%) were achieved, with a response rate of 39% in untreated and 17% in pretreated patients. Nine patients (16%) had stable disease and 26 (47%) progressive disease. Most patients felt symptomatically improved on ECF. CONCLUSIONS: Our study confirms that the ECF regimen has a favorable pattern of toxicity and is feasible on an outpatient basis. However, it did not confirm the high response rate reported in other phase II trials.     

DCF方案与OLF方案治疗晚期胃癌的临床观察

目的观察DCF方案和OLF方案治疗晚期胃癌的临床疗效和不良反应。方法 92例晚期胃癌患者随机分为2组,其中DCF组43例,OLF组49例。DCF方案:多烯紫杉醇35 mg/m2,静脉滴注,第1天及第8天;顺铂25 mg/m2,静脉滴注第2～4天;5-氟尿嘧啶500 mg/m2,持续静脉泵入,第1～5天,3周为1个周期。OLF方案:奥沙利铂130mg/m2,静脉滴注3 h,第1天;亚叶酸钙200 mg/m2,静脉滴注第1～5天;5-氟尿嘧啶500 mg/m2在亚叶酸钙后静脉滴注3 h,第1～5天,3周为1个周期。2组均治疗2个周期以上,按WHO标准评价客观疗效和不良反应。结果入组的92例患者均可评价疗效,DCF组有效率46.5%,中位进展时间为6.8个月,中位生存时间11.4个月;OLF组有效率32.7%,中位进展时间为5.1个月,中位生存时间10.1个月。不良反应中外周神经炎的发生率以OLF组显著(P<0.05),其余不良反应发生率差异无统计学意义。结论 DCF方案与OLF方案治疗晚期胃癌疗效确切,其中以DCF方案疗效略高,不良反应均能耐受。     

紫杉醇与多西紫杉醇分别联合顺铂及氟脲嘧啶治疗晚期胃癌的疗效比较

目的比较两种紫杉烷类（紫杉醇、多西紫杉醇）化疗药物分别联合顺铂及氟脲嘧啶治疗晚期胃癌患者的疗效及安全性。方法 48例病理为胃腺癌的Ⅳ期患者,随机分入两组：DCF组25例,TCF组23例。DCF组用药为多西紫杉醇（国产）40mg/m2第1,8天＋氟脲嘧啶500mg/m2第1～5天＋顺铂20mg/m2第1～5天,每三周重复;TCF组用药为紫杉醇（国产）85mg/m2第1,8天＋氟脲嘧啶500mg/m2第1～5天＋顺铂20mg/m2第1～5天,每三周重复。每两周期进行疗效及毒性评价,并进行无疾病进展生存期（PFS）统计。结果 DCF组完全缓解（CR）1例（4.0%）,部分缓解（PR）11例（44.0%）,总有效率48.0%,PFS6.2个月;TCF组CR1例（4.3%）,PR12例（52.2%）,总有效率为56.5%,PFS5.9个月,总有效率、PFS两组差异均无统计学意义。3～4级血液学不良反应：TCF组39.1%,DCF组72.0%,有显著性差异;3～4级非血液学毒性主要为恶心/呕吐,DCF组4例（16.0%）,TCF组5例（21.7%）,差异无统计学意义。其他少见毒性,包括DCF组腹泻1例（4.0%）,TCF组周围神经病变1例（4.3%）。结论紫杉醇与多西紫杉醇联合氟脲嘧啶、顺铂治疗晚期胃癌疗效相近,毒性不尽相同,但均可耐受。     

A phase II study of doxorubicin, cisplatin, and 5-fluorouracil in patients with advanced adenocarcinoma of the stomach or esophagus

Background: The combination of epirubicin, cisplatin, and infusional 5-fluorouracil (ECF) currently represents a standard and effective regimen for the treatment of advanced gastroesophageal cancer. The use of doxorubicin as an alternative to epirubicin in the ECF regimen has not been evaluated. Methods: Thirty-two patients with metastatic adenocarcinoma of the stomach, gastroesophageal junction, or esophagus were treated with cisplatin 60 mg/m² and doxorubicin 30 mg/m² repeated every 21 days, in combination with infusional 5-fluorouracil 200 mg/m²/day (ACF). Results: Major objective responses were observed in 28 percent of patients (46 percent previously untreated; 13 percent previously treated), with one complete response. The median progression-free survival was 4.0 months, and the median overall survival was 5.8 months (9.3 months previously untreated; 4.5 months previously treated). The major (Grade 3-4) toxicities were neutropenia (34 percent), anorexia (31 percent), nausea (28 percent), diarrhea (19 percent), and stomatitis (16 percent). Conclusion: In comparison with historical data taken from published trials of ECF, the ACF regimen appears similar in efficacy when differences in prior treatment status are taken into account. However, ACF appears to be associated with a higher incidence of major toxicities. Our findings therefore support the continued use of epirubicin rather than doxorubicin in combination chemotherapy regimens for advanced gastroesophageal cancer.     

Non-infusional 5-fluorouracil, doxorubicin and cisplatin in the treatment of locally advanced or metastatic gastro-oesophageal adenocarcinoma

To reduce the Hickman line-associated morbidity of continuous infusion 5-fluorouracil combined with epirubicin and cisplatin (ECF) and to investigate the need for infusional regimens, we conducted a retrospective study in patients with advanced gastro-oesophageal adenocarcinoma. Thirty-six patients, with histologically proven irresectable gastro-oesophageal adenocarcinoma were given: 60 mg/m 2 cisplatin on day 1, 35 mg/m 2 doxorubicin on day 1 and 500 mg/m 2 5-fluorouracil on days 1 and 8 (NIACF) every 3-weeks. A median of 3 cycles was administered. The principal toxicity was myelosuppression with grade III/IV neutropenia in 47% of cycles. Neutropenic fever occurred in 5% of the cycles; non-haematological toxicity was mild and there were no treatment-related deaths. Administered dose intensity was 96.1% for doxorubicin, 93.6% for cisplatin and 90.5% for 5-fluorouracil. There were 16 partial responses and 1 complete response (overall response rate 47%, 95% confidence interval CI 31-63%); 8 patients had stable disease. Median progression-free and overall survival rates were 5 months (95% CI 4-6) and 8 months (95% CI 6-10), respectively. NIACF is a well-tolerated regimen in advanced gastro-oesophageal adenocarcinoma that precludes the need for central venous access, with activity similar to that observed with ECF.     

Sequential chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil in patients with locally advanced head and neck cancer

The purpose of this phase II trial was to evaluate the toxicity of a sequential chemoradiotherapy approach using docetaxel, cisplatin, and 5-fluorouracil (5-FU) (DCF) with granulocyte colony-stimulating factor support in previously untreated patients with locally advanced head and neck cancer (HNC). Secondary endpoints included preliminary assessment of response. Patients with locally advanced HNC, a World Health Organization performance status 0 to 2, and no prior history of chemotherapy or radiotherapy were included. Treatment consisted of docetaxel 80 mg/m2 (1-hour infusion) on day 1, cisplatin 40 mg/m2 (1-hour infusion) on days 2 and 3, and 5-fluorouracil 1,000 mg/m2 (24-hour continuous infusion), on days 1 to 3, repeated every 28 days for a maximum of 4 cycles per patient. All patients received granulocyte colony stimulating factors subcutaneously between days 4 and 9. Radiation therapy (RT) to the primary tumor site and neck lymph nodes was planned within 5 weeks of the last cycle of chemotherapy. The primary tumor site received 60 to 70 Gy. Twenty patients (median age 56 years, range: 40-72 years) received a total of 60 cycles of DCF. The median number of cycles was 3 (range: 1-4 cycles). All patients were evaluable for toxicity and response. The most common acute nonhematologic toxicities from DCF induction chemotherapy included alopecia, mucositis, peripheral sensory neuropathy, onycholysis, and asthenia. Febrile neutropenia developed in two patients and grade IV diarrhea in one patient. There were no treatment-related deaths. The overall response rate (RR) after DCF induction chemotherapy was 90% (95% confidence interval [CI]: 76.8-103.1%). After the completion of RT, the overall RR was 95% with a complete response rate of 73% (95% CI: 49.9-90.1%). Organ preservation was achieved in eight patients with laryngeal cancer and one patient with base of tongue involvement. After a median follow-up of 36 months (range: 5-43 months) the median disease-free and overall survival have not been reached yet. The 1- and 2-year survival rates were 85% and 60%, respectively. Sequential chemoradiotherapy with DCF and growth factor support is feasible and very active, with durable responses in patients with locally advanced head and neck cancer. Further evaluation of this modality is justified in the context of a clinical trial.     

Preoperative docetaxel/cisplatin/5-fluorouracil chemotherapy in patients with locally advanced gastro-esophageal adenocarcinoma

Perioperative chemotherapy plus surgery improves survival compared to surgery alone in GE junctional (GEJ) and gastric adenocarcinomas. The docetaxel/cisplatin/5-fluorouracil (DCF) combination is superior to CF in patients with metastatic gastric cancer. We retrospectively evaluated the safety and efficacy of preoperative DCF chemotherapy in patients with locally advanced gastric and GEJ cancer. Twenty-one gastric and 10 gastroesophageal junctional (GEJ) cancer patients received 2-3 cycles of preoperative docetaxel 75 mg/m(2) and cisplatin 75 mg/m(2) on day 1, 5-FU 750 mg/m(2) (continuous infusion) on days 1-5 every 3 weeks. Clinical response was evaluated by comparing pre- and postchemotherapy CT scans. Overall survival (OS) and progression-free survival (PFS) were calculated from the initiation of chemotherapy. None of the patients achieved complete clinical remission while 11 (35%) patients achieved partial clinical remission. Ten patients with GEJ cancer (100%) and 13 with gastric cancer (62%) underwent curative surgery (P = 0.023). Seventeen (55%) patients experienced grade 3-4 chemotherapy-related adverse events. The most common adverse events were anemia, nausea/vomiting, diarrhea, and febrile neutropenia. At a median follow-up of 17.0 months, median OS and PFS were 26.1 months (95% CI: 22.7-29.5) and 18.8 months (95% CI: 9.9-27.7), respectively. The DCF regimen is active in patients with gastric and GEJ adenocarcinoma in the preoperative setting.