吉西他滨联合适形放疗与吉西他滨联合顺铂对局部晚期胰腺癌的疗效比较

目的：比较吉西他滨联合适形放疗与吉西他滨联合顺铂对局部晚期胰腺癌的疗效。方法：前瞻性分析了2002年3月-2005年8月收治的56例局部晚期胰腺癌患者的疗效，其中26例采用吉西他滨联合适形放疗（放化组），30例采用吉西他滨联合顺铂（化疗组）。结果：可评估病例54例，放化组有效率（CR＋PR）为68．O％，化疗组有效率（CR＋PR）为37．9％，两组差异有统计学意义（P=0．0275）。放化组和化疗组的6月生存率分别为84．O％和62．1％（P=0．0728）；12月生存率分别为64．O％和37．9％（P=0．0561）。两组差异无统计学意义。放化组和化疗组的临床获益率（CBR）分别为84．0％和69．0％，两者差异无统计学意义（P=0．1976）。放化组和化疗组的严重不良事件总发生率分别为36．0％和44．8％，无统计学差异（P=0．5103）。结论：在近期疗效方面，吉西他滨联合适形放疗的近期疗效优于吉西他滨联合顺铂；而远期生存率，吉西他滨联合适形放疗虽然显示出一定的优势，但无统计学意义，二者在CBR和严重不良事件发生率无明显差异。     

吉西他滨单药或与顺铂联合治疗胰腺癌的临床疗效评价

目的 评价吉西他滨单药以及与顺铂联合治疗局部晚期或转移性胰腺炎的疗效。临床受益反应,生存时间和毒性反应。方法 42例患者随机分为吉西他滨单药组（A组20例）和吉西他滨 顺铂联合组（B组22例）,A组;吉西他滨1000mg/m^2,每周1次,连用7周,休息1周;随后相同剂量每周1次,连用3周,休息1周,B组;吉西他滨1000mg/m^2,每周1次,连用3周,顺铂60mg/m^2,第15天给药,休息1周,每4周重复,边境用药3个周期。结果 42例患者中,可评价客观疗效者34例（A组16例,B组18例,可评价临床受益反应（CBR）者36例（A组16例,B组20例）,可进行毒性反应评估者40例（A组19例,B组21例）,A组：PR1例（6.3%)。MR4例（25.0%),SD7例（43.8%)。PD4例（25.0%)。B组;PR2例（11.0%)。MR3例（16.7%),SD8例（44.4%),PD5例（27.8%)。PR MR SD率A组为75.0%。B组为72.2%。CBR有效率A组为87.5%(14/16),B组为70.0%(14/20)。两组3个月生存率均为100%,6个月生存率分别为81.3%和61.6%。12个月生存率分别为31.3%和11.1%。B组Ⅲ、Ⅳ度血液学毒性反应发生率略高于A组,两组相比,差异无显著性。结论 吉西他滨单药以及与顺铂联合一线治疗局部晚期或转移性胰腺癌有一定的客观疗效。可明显改善患者的生活质量。延长了生存时间,患者耐受良好。     

吉西他滨联合顺铂二线治疗晚期乳腺癌的临床观察

目的：探讨吉西他滨联合顺铂二线治疗晚期乳腺癌的疗效和不良反应。方法：选择蒽环类和（或）紫杉类化疗后的转移性乳腺癌患者30例,采用吉西他滨1000mg／m^ 2,静脉滴注,第1、8天;顺铂25mg／m^2,静脉滴注,第1—3天,21d为1周期,至少2周期后评价疗效。结果：CR2例（6．7％）,PRl2例（40．0％）,总有效率为46．7％。中位生存期12．8个月,中位TTP5．6个月。主要不良反应为骨髓抑制及胃肠道反应。结论：吉西他滨联合顺铂二线治疗晚期乳腺癌的近期疗效较好,患者耐受性好,值得临床推广。     

吉西他滨维持治疗晚期非小细胞肺癌疗效观察

目的：观察吉西他滨维持治疗晚期非小细胞肺癌的有效性。方法：56例IIIB-IV期非小细胞肺癌患者接受4周期吉西他滨联合顺铂化疗（吉西他滨1250mg／m^2＋生理盐水100ml静脉滴注,d1-3;顺铂25mg／m^2＋生理盐水500ml静脉滴注,d1-3）,每21天为一周期。对获得CR＋PR＋SD的43例患者随机分为试验组（22例）和对照组（21例）,试验组予吉西他滨维持化疗（吉西他滨1250mg／m^2＋生理盐水100ml静脉滴注,d1,8,0）,每21天为一周期,行4周期化疗;对照组予对症支持治疗。结果：试验组和对照组的有效率分别为59．1％、23．8％,TTP分别为6．0、2．4个月,OS分别为18．6、11．3个月,P〈0．01,差异有统计学意义;毒性反应两组无明显差异。结论：吉西他滨单药维持化疗可以延长初治有效NSCLC患者的,TTP、OS,累积毒性无显著增加。     

国产吉西他滨联合顺铂治疗63例晚期非小细胞肺癌的临床观察

目的：评价吉西他滨联合顺铂治疗晚期非小细胞肺癌的疗效和毒性。方法：60例患者采用吉西他滨1000mg／m^2，iv，d1-8顺铂75mg／m^2，iv，d。125mg／m^2，iv，d1-3，化疗。每3周期评价疗效。结果：初治病例RR44．6％，复治病例RR30．8％。主要不良反应为骨髓抑制。结论：吉西他滨联合顺铂冶疗晚期非小细胞肺癌具有较高有效率，毒性可以耐受。     

吉西他滨治疗14例晚期胰腺癌

目的：研究吉西他滨（gemcitabine)治疗晚期胰腺癌的疗效。方法：14例进行展期胰腺癌患者,用吉西他滨第1周800mg/m^2,第2周1000mg/m^2,第3周1200mg/m^2,每周1次,每次以0．9％生理盐水100ml溶解后静脉滴注,30分钟滴完,连续3周,随后休息1周为一疗程。以后每4周重复一次,共6个疗程。结果：疼痛缓解有效率为64％（9／14）,处长了中位生存期,平均为8．7个月。临床受益反应为43％。吉西他滨治疗晚期胰腺癌能显著改善晚期胰腺癌患者的临床症状,减轻疼痛。生活质量有明显提高。结论：吉西他滨可作为晚期胰腺癌综合治疗时首选的化疗药物。     

GP和TP方案治疗晚期非小细胞肺癌的随机对照临床研究

背景与目的 目前铂类药物为基础的化疗被认为是治疗晚期非小细胞肺癌（NSCI．C）的标准方案。本研究的目的是比较紫杉醇联合顺铂（TP方案）与吉西他滨联合顺铂（GP方案）治疗晚期NSCLC的近期疗效和毒性作用。方法 77例初治晚期NSCLC患者随机分为TP组和GP组，TP组39例，GP组38例。TP组：紫杉醇135mg／m^2，第1天；顺铂30mg／m^2，第1～3天。GP组：吉西他滨1000mg／m^2，第1、8天；顺铂30mg／m^2，第1～3天。化疗2～3周期后对两组的临床疗效和毒性反应进行评价。结果 TP组有效率为46．2％，GP组为42．1％，两组间比较差异无统计学意义（P〉0．05）。GP组不良反应以血小板降低为主，TP组以白细胞降低为主，均可耐受。结论 吉西他滨或紫杉醇联合顺铂治疗晚期NSCLC具有较好的耐受性和临床疗效，不良反应有所不同，但都可以耐受。     

吉西他滨联合顺铂及西艾克治疗晚期非小细胞肺癌临床疗效观察

目的：观察吉西他滨联合西艾克和顺铂治疗晚期非小细胞肺癌的疗效和毒副作用。方法：对经病理组织学证实的32例非小细胞肺癌患者给予吉西他滨0.8g/m^2静脉滴入，d1、d8、d15；西艾克4mg静脉滴入，d1、d8；顺铂30mg/m^2静脉滴入，d1-d3,28d为1个周期。结果：全组CR 2例，PR12例，NC11例，PD7例，总有效率达43．75％。初治有效率达56．25％，复治达31．25％，两组经统计学比较，差异有显著性（P＜0．05）。毒性反应为白细胞减少和血小板减少。结论：吉西他滨联合顺铂和西艾克疗效较高，毒性可耐受。     

吉西他滨联合卡铂用于晚期鼻咽癌二线治疗的临床观察

 目的 观察吉西他滨（泽菲国产吉西他滨）联合卡铂的联合方案治疗晚期复治鼻咽癌的近期疗效及毒性反应。方法 32例均为一线含顺铂方案化疗失败的晚期鼻咽癌病人。吉西他滨1000mg／m²，d1.8；卡铂400mg／m²，d1；21天为1周期。完成2周期后评价疗效及毒性。结果 32例中CR4例，占12．5％；PR16例，占50．0％；总缓解率（CR＋PR）62．5％。SD8例（25％），PD4例（12．5％）。中位缓解时间4．5个月。骨髓抑制为主要毒性：Ⅲ／Ⅳ度白细胞下降为43．6％，4例合并感染发热；Ⅲ／Ⅳ度血小板下降为21．8％。胃肠道反应轻微。结论 吉西他滨与卡铂的联合方案对一线含顺铂方案化疗失败的晚期鼻咽癌有较高的缓解率，毒性反应轻，值得作为二线方案推广使用。     

铂类为基础的三种化疗方案治疗晚期非小细胞肺癌的临床研究

目的：观察紫杉醇（paclitaxel，Taxel）、长春瑞滨（vinorelbine，NVB）、吉西他滨（gemcitabine，GEM）分别联合顺铂（cisplatin，DDP）方案对晚期非小细胞肺癌（non—small cell lung cancer，NSCLC）的疗效及毒副反应。方法：93例晚期非小细胞肺癌患者随机分为TP组（紫杉醇＋顺铂）32例、NP组（长春瑞滨＋顺铂）31例、GP组（吉西他滨＋顺铂）30例。给药方法：紫杉醇135mg／m^2，第1天；长春瑞滨25mg／m^2，吉西他滨1000mg／m^2，均在第1、8天使用；顺铂80mg／m^2，分2天使用。统计各组有效率（CR＋PR）、中位生存期（median duration of survival）、1年生存率（1year survival rate）。结果：TP组有效率（CR＋PR）为43．8％，中位生存期为8．6月，1年生存率为32．1％；NP组有效率为38．7％，中位生存期为8．4月，1年生存率为26．5％；GP组有效率为36．7％，中位生存期为9．4月，1年生存率为38．1％，三组间疗效无显著差异（P〉0．05）。主要不良反应为骨髓抑制、消化道反应，均可耐受。11P组骨髓抑制发生率相对较高，NP组静脉炎发生率高于TP、GP组，有显著性差异（P〈0．05）。结论：三种联合化疗方案对晚期NSCLC疗效确切，三种方案间无显著差异，均可作为一线化疗方案在临床应用。     

吉西他滨为基础的化疗方案治疗进展期胰腺癌的临床研究

背景与目的:进展期胰腺癌预后差.吉西他滨可以改善胰腺癌患者的生存质量,但吉西他滨联合方案疗效是否优于单药,还存在争议,国内更缺乏相关的临床研究.本研究目的是比较吉西他滨为基础的联合化疗方案与吉西他滨单药治疗进展期胰腺癌的疗效.方法:回顾性分析2000～2005年收治的40例经临床或病理确诊的进展期胰腺癌临床资料,其中吉西他滨单药组15例,吉西他滨剂量为1 000 mg/m2,每周1次,连用7周,休息2周,之后每周1次,连用3周,4周重复;吉西他滨联合治疗组25例,联合化疗方案包括吉西他滨1 000 mg/m2,每周1次,连用2周,分别联合:(1)氟尿嘧啶425～600 mg/m2,静脉滴注或持续静脉泵入,d1-5,3周重复;(2)顺铂60～75 mg/m2,分第1、2天,3周重复;(3)奥沙利铂85～130 mg/m2,d1,3周重复;(4)卡培他滨l000 mg/m2,2次/天,d1-14,3周重复.采用Kaplan-Meier生存曲线分析患者的生存期,并比较两组间的临床受益反应、中位疾病进展时间、中位生存时间和不良反应.结果:吉西他滨联合组与单药组患者的临床受益反应均得到改善(56.0% vs.46.7%),但疾病控制率、中位生存时间、临床受益反应在两组之间差异无统计学意义(P＞0.05),不良反应的发生率也相似(P＞0.05).对Ⅲ～Ⅳ期患者进行分层分析,发现吉西他滨联合组疾病控制率高于单药组(75.0% vs.45.5%),但无统计学意义(P=0.13).结论:吉西他滨联合方案与单药治疗进展期胰腺癌相比,疗效、临床受益反应、中位生存时间两组相似.     

A phase I/II study of combination chemotherapy with gemcitabine and 5-fluorouracil for advanced pancreatic cancer

BACKGROUND: In an effort to improve efficacy of single-agent gemcitabine in pancreatic cancer, several studies have examined the effects of 5-FU combined with gemcitabine. However, no studies to date have been performed in Japanese patients. We thus conducted a phase I/II study of gemcitabine and infusional 5-FU in Japanese patients to determine a recommended dosage for this combination and clarify efficacy and toxicity. METHODS: Phase I evaluated the frequency of dose limiting toxicity of two 5-FU dosages (400 and 500 mg/m(2)/day) infused continuously over 5 days combined with gemcitabine 1000 mg/m(2) x 3 every 4 weeks. Results from phase I determined the recommended dosage to be examined in phase II for effect on survival period, clinical benefit response (CBR), tumor response and safety. RESULTS: A total of 34 chemo-naive patients were entered into the study. All had a Karnofsky performance of > or =50 points and distant metastases. Dose limiting toxicities in phase I determined the recommended 5-FU dosage at 400 mg/m(2)/day. Grade 3-4 hematological toxicities (neutropenia, leukopenia and thrombocytopenia) were the most common severe toxicities. For the 28 patients administered the recommended dosage, 1-year survival rate was 14.3%, median survival time 7.1 months and progression free survival 3.2 months. Seven patients achieved a 25% overall response rate and three showed 27.3% improvement in CBR. CONCLUSION: Although a meaningful survival benefit over single-agent gemcitabine was not demonstrated, 5-FU 400 mg/m(2)/day infused continuously over 5 days in combination with gemcitabine 1000 mg/m(2) x 3 every 4 weeks appeared to be a moderately effective palliative treatment with low toxicity in Japanese patients with metastatic pancreatic cancer.     

Gemcitabine combined with continuous infusion 5-fluorouracil in advanced and symptomatic pancreatic cancer: a clinical benefit-oriented phase II study

Gemcitabine and 5-fluorouracil are the only two compounds with reproducible activity against advanced pancreatic cancer (APC). We have evaluated a novel combination of gemcitabine and 5-fluorouracil on the clinical benefit response (CBR) end point. Eleven consecutive patients with symptomatic APC were entered in a two-stage phase II trial. Gemcitabine was administered by intravenous (i.v.) bolus injection at the dose of 1,000 mg m(-2) on days 1, 8, 15 and 5-fluorouracil 500 mg m(-2) was given by continuous i.v. infusion on days 1-5. Treatment was repeated every 28 days. A CBR was achieved in 7/11 patients. The mean time to loss of CBR was 26.5 weeks (range 14-18, median 22). Toxicity was mild and no APC patient experienced WHO grade 3 toxicity. The gemcitabine/5-fluorouracil combination is well tolerated and produces a symptomatic relief in the majority of APC patients.     

DF和DCF方案治疗晚期胃癌的临床对比研究

目的:比较DF(DOC+5-FU+CF)和DCF(DOC+DDP+5-FU+CF)方案治疗晚期胃癌的近期疗效及不良反应。方法:将61例经病理确诊的晚期胃癌患者随机分为两组。A组28例,采用DF方案化疗:多西他赛(DOC)75 mg/m2,静脉滴注,第1天;亚叶酸钙(CF)200mg/m2静脉滴注,第1天,2小时后5-氟尿嘧啶(5-FU)500mg静脉推注,随后5-FU2500mg/m2持续120小时化疗泵静脉内注入,21天为1周期。B组33例,采用DCF方案化疗:顺铂(DDP)25mg/m2,第1-3天,多西他赛、亚叶酸钙、5-氟尿嘧啶用法同DF组,21天为1周期。对两组的近期疗效、疾病进展时间和不良反应进行比较。结果:A组和B组的客观有效率分别为53.6%(15/28)和51.5%(17/33),无显著性差异(P=0.610),中位疾病进展时间分别为5.6个月和5.3个月,亦无显著性差异(P=0.362)。主要不良反应白细胞减少和恶心、呕吐的差异具有显著性(P均<0.05)。结论:DF和DCF方案治疗晚期胃癌有较好疗效,且疗效相似,在不良反应方面,DF方案优于DCF方案。     

吉西他滨联合顺铂或氟尿嘧啶治疗晚期胰腺癌临床疗效的比较

目的　比较GP方案 (吉西他滨 顺铂 )与GF方案 (吉西他滨 氟尿嘧啶 )治疗晚期胰腺癌的近期疗效和毒副作用。方法　经病理组织学或细胞学检查证实的 60例胰腺癌患者 ,随机分为GP组和GF组 ,各 3 0例。GP组给予吉西他滨 10 0 0mg/m2加生理盐水 10 0ml,静脉滴注 3 0min ,第 1、8、15天 ;顺铂 40mg ,静脉滴注 ,第 15、16、17天。GF组给予吉西他滨 10 0 0mg/m2 加生理盐水 10 0ml ,静脉点滴 3 0min ,第 1、8、15天 ;氟尿嘧啶 5 0 0mg/m2 加 5 %GS 5 0 0ml ,静脉滴注时间超过 6h ,第 1～ 5天。结果　GP组PR 3例 ,MR 5例 ,NC 12例 ,PD 5例 ,PR MR为 3 2 .0 % ,中位生存期为 8.7个月 ,临床受益反应率 (CBR )为 5 7.7% (15 /2 6) ,CA 19 9水平下降超过 5 0 %者达 48.1% (13 /2 7)。GF组PR 3例 ,MR 8例 ,NC 9例 ,PD 4例 ,PR MR为 45 .8% ,中位生存期为 10 .1个月 ,CBR 82 .1% (2 3 /2 8) ,CA19 9水平下降超过 5 0 %者达 5 3 .6% (15 /2 8)。 2组比较 ,CBR有显著性差异 (P <0 .0 5 ) ,GF疗效较佳。不良反应主要为白细胞减少和血小板减少 ,2组无显著性差异。结论　含吉西他滨的联合化疗方案与以往单药方案比较 ,疗效高、副作用小、患者中位生存期长 ,临床受益反应率 (CBR )高 ;GP方案和GF方案比较 ,后者CBR更高 (5     

Phase II study of gemcitabine combined with radiation therapy in patients with localized,unresectable pancreatic cancer

BACKGROUND AND OBJECTIVES: Gemcitabine is an active agent in pancreatic cancer, with known radiosensitizing properties. Therefore, a phase II study was conducted to evaluate the efficacy of gemcitabine combined with radiation therapy in patients with localized unresectable adenocarcinoma of the pancreas. METHODS: Weekly gemcitabine at a dose of 1,000 mg/m(2) for 7 weeks was given as an induction phase. Patients who showed both clinical benefit response (CBR) and reduced or stable tumor size on computed tomography (CT) scan entered the chemoradiotherapy phase of the treatment. This consisted of gemcitabine 400 mg/m(2) weekly x3 every 28 days for 2 cycles, given concurrently with radiotherapy, for a total dose of 50.4 Gy in 28 fractions. After completion of radiotherapy, gemcitabine was continued as maintenance. RESULTS: Twenty patients entered this study. Ten patients (50%) achieved CBR to gemcitabine in the induction phase; these patients had no objective tumor progression and were therefore enrolled in the chemoradiotherapy phase. Four patients (20%) had a partial response, and three patients (15%) underwent pancreatectomy. Two patients had negative surgical margins, and in one patient histologic examination of the residual mass showed only fibrosis. The median survival for the entire group was 8 months, and the median survival has not yet been reached for the chemoradiotherapy group. CONCLUSIONS: Treatment with gemcitabine concomitant with radiation therapy according to the present schedule is well tolerated and can provide prolonged CBR and disease stabilization in patients with localized, unresectable pancreatic cancer.     

Phase III study of gemcitabine in combination with fluorouracil versus gemcitabine alone in patients with advanced pancreatic carcinoma: Eastern Cooperative Oncology Group Trial E2297.

PURPOSE: Gemcitabine is generally considered to constitute first-line therapy for pancreatic cancer. To determine whether the addition of fluorouracil (5-FU) improves on the results from single-agent gemcitabine, the Eastern Cooperative Oncology Group (ECOG) compared gemcitabine plus bolus 5-FU with gemcitabine alone for patients with advanced pancreatic carcinoma. PATIENTS AND METHODS: This trial involved patients with biopsy-proven, advanced carcinoma of the pancreas not amenable to surgical resection. Patients were randomized to receive either gemcitabine alone (1,000 mg/m(2)/wk) weekly for 3 weeks of every 4 or to receive gemcitabine (1,000 mg/m(2)/wk) followed by 5-FU (600 mg/m(2)/wk) weekly on the same schedule. The primary end point of the trial was survival, with secondary end points of time to progression and response rate. RESULTS: Of 327 patients enrolled over 18 months, 322 were eligible. Overall, the median survival was 5.4 months for gemcitabine alone and 6.7 months for gemcitabine plus 5-FU (P =.09). Progression-free survival for gemcitabine alone was 2.2 months, compared with 3.4 months for gemcitabine plus 5-FU (P =.022). Objective responses were uncommon and were observed in only 5.6% of patients treated with gemcitabine and 6.9% of patients treated with gemcitabine plus 5-FU. Most toxicities were hematologic or gastrointestinal; no significant differences were noted between the two treatment arms. CONCLUSION: 5-FU, administered in conjunction with gemcitabine, did not improve the median survival of patients with advanced pancreatic carcinoma compared with single-agent gemcitabine. Further studies with other combinations of gemcitabine and 5-FU are not compelling, and clinical trial resources should address other combinations and novel agents.     

顺铂加5—氟尿嘧啶联合治疗晚期食管癌156例

目的 观察顺铂＋５－氟尿嘧啶（ＤＤＰ＋５－Ｆｕ）方案治疗食管癌的疗效。方法 中晚期食管癌１５６例，其中２４例除原发灶外别有远处转移，初治１４０例，复治１６例，以ＤＤＰ周期剂量不同分为Ａ，Ｂ两组，两组５－Ｆｕ用量，用法相同，Ａ组ＤＤＰ７５－１００ｍｇ／ｍ＾２，Ｂ组ＤＤＰ５０～７４ｍｇ／ｍ＾２。结果 原发灶肿瘤完全缓解２６例，部分缓解７１例，病情稳定４０例，进展１９例，总有效率６２．２％（９７／１５６     

健择联合顺铂治疗晚期非小细胞肺癌疗效分析

目的:观察健择(gemcitabine,GEM)/顺铂(DDP)每周给药方案治疗晚期非小细胞肺癌(nonsmallcelllungcancel,NSCLC)的近期疗效和毒性反应。方法:37例晚期NSCLC,分别于d1、d8和d15联合应用GEM(1000mg/m2)和DDP(25mg/m2),28d为1个周期。治疗至少2个周期评价疗效。结果:36例可评价疗效,所有患者无CR,PR12例,NC15例,PD9例,总有效率为33.3%(12/36)。37例可评价毒性,3、4度粒细胞减少、血小板减少分别为13.5%(5/37)和16.2%(6/37)。结论:GEM/DDP每周给药方案疗效与其他GEM/DDP联合方案疗效相仿,但毒性反应明显低于其他方案,可用于老年患者或一般状况较差患者的治疗。     

长春瑞滨联合顺铂、亚叶酸钙／5-氟脲嘧啶治疗晚期食管癌

目的：观察长春瑞滨（NVB）联合亚叶酸钙（CF）、5-氟脲嘧啶（5-Fu）和顺铂（DDP）方案治疗晚期食管癌的近期疗效和毒性反应。方法：NVB25mg／m^2静脉注入，第1、8天给药；CF200mg静滴，第2天-6天给药；5．Fu500mg／m^2静滴6小时，第2天-6天给药；DDP35mg／m^2静滴，第2天-4天给药。28天为一个周期，完成2周期化疗后评价疗效。结果：23例晚期食管癌患者中，完全缓解2例（8．7％），部分缓解10例（43．5％），总有效率为52．2％。毒副反应主要是骨髓抑制、胃肠道反应、静脉炎。结论：NVB联合DDP、CF及5-Fu方案治疗晚期食管癌疗效较好，毒副反应可以耐受，是一个较好的联合化疗方案。