吉西他滨联合卡铂治疗晚期NSCLC的临床观察

目的:探讨吉西他滨联合卡铂治疗晚期非小细胞肺癌(NSCLC)的临床疗效.方法:将98例晚期NSCLC患者随机分入A组(吉西他滨联合卡铂)和B组(吉西他滨联合顺铂),A组给予吉西他滨1 000 mg/m2,d1～d2,静脉滴入,卡铂根据曲线下面积=5给药,d1,静脉滴入;B组在吉西他滨给药的同时,给予顺铂80 mg/m2,d1～d2,静脉滴入.21d为1个周期,至少治疗2个周期.比较两组治疗有效率、1年生存率、不良反应发生率及生活质量.结果:A组有效率(CR+PR)为39.7％(23/58),B组CR+PR 40.0％(16/40);A组与B组1年生存率分别为52.1％和45.0％,两组有效率及1年生存率均差异无统计学意义,P＞0.05;A组无Ⅲ+Ⅳ度胃肠道反应,显著少于B组的12.5％,P＜0.05;治疗后A组LCSS量表评分显著优于B组,P＜0.05.结论:吉西他滨联合卡铂或顺铂治疗晚期NSCLC同等有效,但前者不良反应少,患者耐受性好,生活质量高.     

吉西他滨联合奈达铂治疗晚期鼻咽癌32例临床观察

[目的]评价吉西他滨联合奈达铂治疗晚期鼻咽癌的疗效和毒副作用。[方法]64例晚期鼻咽癌患者随机分为治疗组和对照组,各32例,治疗组采用吉西他滨联合奈达铂治疗,对照组采用氟尿嘧啶联合顺铂治疗。评价两组疗效和毒副反应。[结果]治疗组：CR6例,PR20例,SD4例,PD2例,有效率81.25%;1年生存率93.75%。对照组：CR4例,PR16例,SD7例,PD5例,有效率62.50%;1年生存率81.25%。对照组消化道反应及口腔黏膜反应发生率均明显高于治疗组（P〈0.05）,而血小板抑制发生率治疗组明显高于对照组（P〈0.05）。[结论]吉西他滨联合奈达铂一线治疗晚期鼻咽癌近期疗效较好,安全性良好。     

吉西他滨联合顺铂治疗晚期乳腺癌临床疗效观察

目的比较晚期乳腺癌采用吉西他滨加顺铂与长春瑞滨加顺铂化疗的疗效、生存期和毒副作用。方法64例晚期乳腺癌患者随机分为两组,A组32例,采用吉西他滨加顺铂;B组32例,采用长春瑞滨加顺铂,进行疗效分析和毒副作用比较。结果A组CR 1例,PR 18例,总有效率59.4%,1年生存率53.1%,中位生存期8.9个月,肿瘤进展时间2～16个月,Karnofsky评分平均提高15分;B组CR 1例,PR 14例,总有效率46.9%,1年生存率34.4%,中位生存期7.7个月,肿瘤进展时间2～14个月,Karnofsky评分平均提高10分。两组间总有效率、1年生存率差异无显著性(P>0.05)。最常见的毒副反应为骨髓抑制,两组差异无显著性(P>0.05)。结论吉西他滨加顺铂治疗晚期乳腺癌疗效明显,耐受性好。     

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.     

吉西他滨联合顺铂治疗晚期非小细胞肺癌临床研究

目的比较晚期非小细胞肺癌采用吉西他滨加顺铂与长春瑞滨加顺铂化疗的疗效、生存期和毒副作用.方法 60例晚期非小细胞肺癌患者随机分为两组,A组30例,采用吉西他滨加顺铂;B组30例,采用长春瑞滨加顺铂,进行疗效分析和毒副作用比较.结果 A组CR 3例,PR 15例,总有效率60.0%,1年生存率33.3%,中位生存期9.4个月,肿瘤进展时间2～20个月,Karnofsky平均提高15分;B组CR 1例,PR 13例,总有效率46.7%,1年生存率16.7%,中位生存期6.4个月,肿瘤进展时间3～16个月,Karnofsky平均提高10分,两组间总有效率、1年生存率差异有显著性(P<0.05).最常见的毒副反应为骨髓抑制,A组为血小板减少,B组为白细胞减少.结论吉西他滨加顺铂治疗晚期非小细胞肺癌疗效明确,耐受性好.     

单药顺铂与顺铂联合吉西他滨同步放化疗治疗中晚期宫颈癌的预后分析

摘 要：［目的］ 探讨中晚期宫颈鳞状细胞癌单药顺铂与顺铂联合吉西他滨同步放化疗的近期疗效、不良反应及生存率之间的差异。 ［方法］ 回顾分析121例宫颈鳞状细胞癌,FIGO分期为ⅡB~ⅢB期,卡氏评分≥70分。顺铂组（63例）接受外照射加锎252中子后装治疗及顺铂同步化疗;顺铂+吉西他滨组（58例）接受同样放疗及顺铂联合吉西他滨同步化疗。比较两组患者的近期疗效、不良反应及生存率。［结果］ 顺铂组近期有效（CR+PR）率为90.48%,顺铂+吉西他滨组近期有效率为91.38%,差异无统计学意义(P>0.05);顺铂+吉西他滨组中患者不良反应中骨髓抑制、肝功能损害与顺铂组相比,差异有统计学意义(P<0.05),其余不良反应无统计学差异;放射性肠炎和膀胱炎的发生率两组无差异;两组生存率差异无统计学意义(P>0.05)。 ［结论］ 在中晚期宫颈鳞状细胞癌的临床治疗中,对患者实施放射治疗的同时选择顺铂或顺铂联合吉西他滨的近期疗效和生存率之间无差异,联合用药增加患者的不良反应,还需探索更优的联合化疗方案。     

NP与GP方案治疗晚期非小细胞肺癌的临床对照研究

目的：评价吉西他滨联合顺铂方案与诺维本联合顺铂方案治疗晚期非小细胞肺癌的疗效及毒副反应。方法：经病理组织学或细胞学证实的64例晚期非小细胞肺癌患者,随机分为两组。A组32例,以诺维本（NVB）25mg/m^2,第1、8天溶于生理盐水100ml中快速静滴。顺铂80mg/m^2静滴,第1天;B组32例,以吉西他滨（GEM）1200mg/m^2静滴,第1、8天,DDP用法同A组。两方案均每3周重复,2周期以上评价疗效。结果：A、B两组的有效率分别为46.8%（15/32）和53.1%（17/32）;B组Ⅲ-Ⅳ度血小板减少高于A组,但Ⅲ-Ⅳ度白细胞减少及过敏明显低于A组。结论：A,B两组疗效、MST和1年生存率无明显差异（P〉0.05）;TTP有显著性差异（P〈0.05）。     

吉西他滨联合顺铂治疗晚期乳腺癌的临床观察

目的观察吉西他滨联合顺铂治疗晚期乳腺癌的疗效及不良反应。方法47例晚期乳腺癌患者采用吉西他滨1000mg/m^2,静脉滴注30min,d1,d8;顺铂25～40mg/m^2,d2～4。21d一周期,治疗2周期后评价疗效及不良反应。结果47例均可评价疗效,共完成周期数为206个。完全缓解（CR）4例,部分缓解（PR）17例,稳定（SD）15例,进展（PD）11例,总有效率（CR＋PR）44.7%,疾病控制率（CR＋PR＋SD）76.6%,中位疾病进展时间8.7个月,中位生存期为12.3个月（2.0～52.5个月）。主要不良反应为骨髓抑制、胃肠道反应。结论吉西他滨联合顺铂治疗晚期乳腺癌疗效较好,毒副反应轻,耐受性好,是晚期乳腺癌的有效治疗方案。     

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。     

顺铂联合吉西他滨与联合紫杉醇治疗晚期非小细胞肺癌疗效分析

目的:观察顺铂联合吉西他滨以及顺铂联合紫杉醇治疗晚期非小细胞肺癌疗效以及毒副反应。方法:经病理组织学或细胞学证实的200例晚期非小细胞肺癌患者,随机分为吉西他滨组(GP组)与紫杉醇组(TP组)各100例。GP组:吉西他滨1000mg/m2,d1与d8,顺铂50mg/m2,d2-d4,均静脉滴注;TP组:紫杉醇150mg/m2,d1,顺铂60mg/m2,d1-d3。两组患者均每21天为一个周期,连用二个周期以上。结果:TP组总有效率(PR+CR)为50%,1年生存率为41%;GP组总有效率(PR+CR)为30%,1年生存率为36%。两组患者有效率有显著性差异(P=0.035),1年生存率无显著差异(P=0.745)。两组主要毒副反应不同,GP组血小板减少显著高于TP组,而TP组肌肉关节疼痛与呕吐显著高于GP组。结论:顺铂联合紫杉醇方案治疗效果优于顺铂联合吉西他滨方案,但是毒副反应较强。     

Gemcitabine alone or with cisplatin for the treatment of patients with locally advanced and/or metastatic pancreatic carcinoma: a prospective, randomized phase III study of the Gruppo Oncologia dell'Italia Meridionale

BACKGROUND: A prospective, randomized Phase III trial was performed to determine whether, compared with gemcitabine (GEM) alone, the addition of cisplatin (CDDP) to GEM was able to improve the time to disease progression and the clinical benefit rate in patients with advanced pancreatic adenocarcinoma. The objective response rate, overall survival rate, and toxicity patterns of patients in the two treatment arms were evaluated as secondary end points. METHODS: Patients with measurable, locally advanced and/or metastatic pancreatic adenocarcinoma were randomized to receive GEM (Arm A) or a combination of GEM and CDDP (Arm B). In Arm A, a dose of 1000 mg/m(2) GEM per week was administered for 7 consecutive weeks, and, after a 2-week rest, treatment was resumed on Days 1, 8, and 15 of a 28-day cycle for 2 cycles. In Arm B, CDDP was given at a dose of 25 mg/m(2) per week 1 hour before GEM at the same dose that was used in Arm A. On Day 22, only GEM was administered. Patients were restaged after the first 7 weeks of therapy and then again after the other 2 cycles. RESULTS: A total of 107 patients entered the trial: Fifty-four patients were randomized to Arm A, and 53 patients were randomized to Arm B. The median time to disease progression was 8 weeks in Arm A and 20 weeks in Arm B; this difference was statistically significant (P = 0.048). In Arm A, one complete response and four partial responses were recorded on the basis of an intent-to-treat analysis, with an overall response rate of 9.2% (95% confidence interval [95%CI], 3-20%). In Arm B, there were no complete responses, whereas 14 partial responses were achieved, with an overall response rate of 26.4% (95%CI, 15-40%). This difference in the overall response rates was statistically significant (P = 0.02). The tumor growth control rate (i.e., total number of patients who achieved complete responses, partial responses, and stable disease) was 42.6% (95%CI, 29-57%) in Arm A and 56.6% (95%CI, 42-70%) in Arm B. A clinical benefit was observed in 21 of 43 patients (49%) in Arm A and in 20 of 38 patients (52.6%) in Arm B without any significant difference. The median overall survival was 20 weeks for patients in Arm A and 30 weeks for patients in Arm B (P = 0.43). Toxicity was mild in both treatment arms, with no significant differences between the two groups except for the statistically higher incidence of Grade 1-2 asthenia in Arm B (P = 0.046). CONCLUSIONS: The addition of CDDP to GEM significantly improved the median time to disease progression and the overall response rate compared with GEM alone. The clinical benefit rate was similar in both arms, whereas the median overall survival rate was more favorable for Arm B, although the difference did not attain statistical significance. The authors conclude that the combination of CDDP and GEM currently may be considered as an optimal treatment for patients with locally advanced and/or metastatic adenocarcinoma of the pancreas.     

奥沙利铂与5-FU同步放化疗治疗局部晚期胰腺癌

目的回顾性分析奥沙利铂与5-FU同步放化疗治疗局部晚期胰腺癌的治疗结果,探讨局部晚期胰腺癌的治疗策略。方法对局部晚期胰腺癌56例,予以三维适形放疗同步配合5-FU＋奥沙利铂化疗,放疗剂量为56-60 Gy/28-30次/38-50天,5-FU 250 mg/（m2.d-1）持续静脉给药直至放疗结束,奥沙利铂40-50 mg/m^2,第1、8、15、22、29天。用Kaplan-Meier法估算患者的生存率。结果（1）全组患者中位无进展生存时间及总生存时间分别为5.1月及15.2月,无进展生存率（PFS）、总生存率（OS）分别为1年：42.8%、64.3%,2年：14.7%、21.6%。（2）完全缓解（CR）2例（3.6%）,部分缓解（PR）25例（44.6%）,有效率（RR=CR＋PR）为48.2%。（3）总的临床获益率（CBR）为66.1%,其中92.5%（37/40）疼痛减轻,73.2%（41/56）Karnofsky评分提高,14.3%（8/56）体重增加。（4）急性毒副反应主要为1~2级的骨髓抑制、消化道反应和感觉性神经炎,3级毒副反应只见于中性粒细胞下降（5.4%）和恶心呕吐（19.6%）,未发现4级毒副反应。未发现消化道出血、梗阻和放射性肝炎等远期并发症。（5）死亡的首位原因为远处转移,占59.6%（28/47）。结论（1）奥沙利铂与5-FU同步放化疗治疗局部晚期胰腺癌疗效较好,且安全可行,是个很有前途的治疗方案。（2）由于死亡的首位原因为远处转移,放化疗前予以诱导化疗可能会提高局部晚期胰腺癌的生存期。     

Weekly gemcitabine and cisplatin chemotherapy: a well-tolerated but ineffective chemotherapeutic regimen in advanced pancreatic cancer patients. A report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD).

BACKGROUND: This phase II study was initiated to determine the activity and toxicity of a combination of gemcitabine (GEM) and cisplatin (CDDP) in patients with pancreatic cancer. PATIENTS AND METHODS: CDDP 35 mg/m(2) was given as a 30-min infusion and GEM 1000 mg/m(2) as a 30-min infusion. Both drugs were administered once weekly for 2 consecutive weeks out of every 3 weeks to chemonaive patients with locally advanced or metastatic pancreatic cancer. RESULTS: Forty-five advanced pancreatic cancer patients received this regimen for a total of 180 cycles of chemotherapy. One complete and four partial responses have been observed for an overall response rate of 9% (95% confidence interval 10% to 11%). Twenty-one patients (46%) had stable disease and 19 progressed on therapy. The median time to progression was 3.6 months, with a median survival of 5.6 months. A clinical benefit was obtained in nine of 37 patients (24%). Side-effects were mainly represented by hematological toxicity. Grade 3/4 WHO toxicities included neutropenia (6% of the patients) and thrombocytopenia (11%). The dose of GEM and CDDP was reduced in 14 patients (31%) and treatment was delayed in 10 patients (22%). CONCLUSIONS: Our results in terms of response rate, clinical benefit and survival do not support an advantage for the combination of GEM and CDDP given by this schedule.     

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。     

Phase II trial of primary radiation therapy and concurrent chemotherapy for patients with locally advanced pancreatic cancer

OBJECTIVES: Primary chemoradiotherapy for locally advanced pancreatic cancer (LAPC) may improve local control, curative resection rate and long-term survival. We performed a phase II study to evaluate toxicity and activity of primary radiation therapy and concurrent chemotherapy with gemcitabine (GEM) twice weekly in patients (pts) with LAPC. METHODS: From 6/1999 to 6/2003, 23 LAPC pts received GEM 100 mg/m2 twice weekly in the first 15 pts and 50 mg/m2 in the last 8 pts, concurrently with radiotherapy (1.8 Gy/day for a total dose of 45 Gy). RESULTS: The treatment was completed in 19/23 pts. Toxicities: G3-4 hematological toxicity occurred in 35 and 4% respectively; G3 nausea and vomiting and gastrointestinal toxicity in 30%. Clinical benefit was found in 10/18 pts (55%). Overall response: partial response rate 4/18 (22%); stable disease 13/18 (72%); progressive disease 1/18 (6%). Six pts underwent pancreaticoduodenectomy with extended lymphadenectomy (5/6 pts pT3, 1/6 pts microscopic cancer foci, 1/6 N+, 5/6 negative retroperitoneal margin). MEDIAN SURVIVAL: 14 months for the entire group, 12 months for unresected pts, 20 months for resected pts. CONCLUSIONS: The treatment with GEM twice weekly at 50 mg/m2 associated with radiotherapy (45 Gy) is feasible and permits to obtain clinical benefit in a good percentage of pts. Objective response, median survival, and local and systemic control are similar to other studies and need further improvement.     

Changes in tumor marker levels as a predictor of gemcitabine effect on patients with unresectable or recurrent pancreatic cancer

We studied on possible association between the tumor marker (CEA, CA 19-9, and SPan-1) change and the clinical outcome after treatment with gemcitabine (GEM) in 23 patients with unresectable or recurrent pancreatic cancer. GEM was administered intravenously at a standard dose of 1000 mg/m2 weekly. One course consisted of weekly administration for 3 weeks followed by 1 week's rest. When the adverse effect did not allow the weekly administration, GEM was given bi-weekly without dose modification. Objective responses were evaluated by computed tomography and tumor marker change. Two or more courses were given for only 6 (26.1%) patients. The number of patients, administered GEM 6 or more times including by the weekly and bi-weekly method, was 12 (52.2%). Antitumor effects were evaluable in 16 patients. The clinical efficacies were 1 partial response (PR), 6 stable disease (SD), and 9 progressive disease (PD). Decreases in tumor marker levels were recognized in 9 of the 16 patients. The median survival time (MST) of the PR+NC group was significantly longer than that of the PD group (9 vs 3.5 months; p=0.0151). MST of those in the decreasing tumor marker group was significantly longer than the group with no decreases in the tumor markers (7.0 vs 5.5 months; p = 0.0478). The adverse effects at grade 3 or more were 4 (17.3%) leukopenia, 2 (8.7%) thrombocytopenia, and 1 (4.3%) skin toxicity. In conclusion, the tumor marker change after GEM treatment may be a predictor of preferable prognosis in patients with pancreatic cancer.     

A randomised phase II trial of weekly high-dose 5-fluorouracil with and without folinic acid and cisplatin in patients with advanced biliary tract carcinoma: results of the 40955 EORTC trial

Previous small phase II trials have demonstrated that the combination of 5-fluorouracil (5FU) and cisplatin(CDDP) could have clinical activity in metastatic biliary tract cancer. This randomised phase II trial was designed to assess the activity and safety of a high-dose infusional weekly 5FU alone (HDFU) and the combination of 5FU, folinic acid (FA) and CDDP. Patients were included if they had histologically proven locally advanced or metastatic biliary tract carcinoma, World Health Organisation (WHO) performance status < or = 2, bilirubin <2 x upper normal limit, adequate haematological and renal functions and had not received prior chemotherapy, even in the adjuvant setting. Treatments: Arm A (HDFU) consisted of cycles of 5FU 3 g/m(2) intravenously (i.v.), 24 h infusion, weekly, for 6 weeks, followed by 1 week rest, every 7 weeks; Arm B (5FU+FA+CDDP) consisted of cycles of 5FU 2.0 g/m(2) i.v. with folinic acid 500 mg/m(2), 2 h-infusion, weekly, for 6 weeks, followed by 1 week rest plus cisplatin 50 mg/m(2), once every two weeks, for 6 weeks, followed by 1 week rest, every 7 weeks. From February 1997 to June 1999, 58 patients were randomised (29 in each arm). Patients had a median age of 58 years in Arm A and 62 years in Arm B, locally advanced disease was present in 21% of the patients in Arm A and 11% in Arm B. WHO performance status of 0/1/2 was noted in 48%/45%/7% of the patients in Arm A and 54%/43%/4% in Arm B. In both arms, the most common metastatic sites were the liver and peritoneum. Twenty-eight patients were eligible in each arm and one patient did not start the allocated therapy in Arm B. The median number of cycles was 2 [range 1-12] in Arm A and 2 [range 1-6] in Arm B. Responses for the eligible patients who started their allocated therapy were as follows: Complete Response (CR) 0% in Arm A, 4% in Arm B, Partial Response (PR) 7% in Arm A, 15% in Arm B resulting in an overall response rate [95% CI] of 7.1% in Arm A [0.9-23.5%] and 19% [6.3-38.1%] in Arm B. Disease stabilisation was observed in 46% in Arm A and 44% in Arm B. National Cancer Institute of Canada (NCIC) grade 3-4 adverse events (% of patients in Arm A/Arm B) were neutropenia 4%/26%, thrombopenia 0%/7%, stomatitis 0%/4%, vomiting 7%/14%, diarrhoea 0%/11% and neurotoxicity 4%/0%. There was one early toxic death in Arm B. The median overall survival (OS) [95% CI] was in Arm A/Arm B: 5.0 [4.0-7.4] months/8.0 [5.8-11.8] months and the median progression-free survival (PFS) was 3.3 [1.7-4.7] months/3.3 [2.3-6.7] months. Cisplatin in combination with 5FU+FA showed a higher activity than HDFU, but was more toxic. These results are not sufficient to start a phase III trial. However, our group is planning a phase III trial comparing 5FU+folinic acid versus the same schedule+oxaliplatin a platinum analogue.     

吉西他滨单药化疗与联合化疗治疗进展期胰腺癌的疗效观察

目的观察比较吉西他滨单药与联合化疗治疗进展期胰腺癌的疗效。方法回顾性分析了大连医科大学附属一院2002年至2009年收治的45例进展期胰腺癌患者的临床资料,吉西他滨单药组17例,剂量为1000mg/m2,d1、8,三周为一周期;吉西他滨联合治疗组28例,联合化疗方案包括吉西他滨1000mg/m2,d1、8,分别联合：（1）氟尿嘧啶425～600mg/m2,静滴或持续静脉泵入,d1～5;（2）顺铂60～75mg/m2,分3～4d静脉滴入;（3）奥沙利铂85～130mg/m2,d1,静脉滴入;（4）卡培他滨1000mg/m2,每天两次口服,d1～14。21d为一周期。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率、中位疾病进展时间、中位生存时间及不良反应。结果吉西他滨联合组及单药组的临床收益率均得到提高,但两组间比较临床受益率、疾病控制率、中位生存时间均无统计学意义。结论吉西他滨联合化疗方案与吉西他滨单药治疗进展期胰腺癌相比,疗效、临床受益率、中位生存期均相似。     

吉西他滨联合替吉奥胶囊治疗晚期胰腺癌的疗效观察

目的探讨吉西他滨联合替吉奥胶囊化疗方案与吉西他滨单药治疗进展期胰腺癌的疗效。方法对2008年1月至2011年1月收治的52例晚期胰腺癌患者的临床资料进行回顾性分析,其中28例采用吉西他滨联合替吉奥胶囊方案治疗(A组);24例采用吉西他滨单药治疗(B组)。采用Kaplan-Meier法分析患者的生存时间,并比较两组患者的客观缓解率、临床受益反应(CBR)、中位疾病进展时间、中位生存时间和不良反应。结果 A组有效率明显高于B组(32.1%vs.20.8%),差异有统计学意义(P=0.039)。A组疾病控制率(DCR)高于B组(67.9%vs.45.8%),但差异无统计学意义(P=0.230)。A组患者CBR缓解率高于B组(72.1%vs.46.9%),差异无统计学意义(P=0.41)。A组的中位生存时间为10.2个月(95%CI:8.0～11.8个月),高于B组的8.03个月(95%CI:3.8～10.9个月),差异有统计学意义(P=0.045);A、B两组的中位疾病进展时间分别为3.6个月和3.0个月(P=0.721)。A组的6个月生存率(72.7%)略高于B组(66.8%),但差异无统计学意义(P>0.05)。两组不良反应的发生率也相似(P>0.05)。结论吉西他滨联合替吉奥胶囊治疗方案与单药治疗晚期胰腺癌相比,在客观疗效、中位生存时间表现出一定优势,疾病控制率及临床受益反应也有所提高,且不良反应可耐受,是晚期胰腺癌的有效治疗方案。