吉西他滨联合顺铂方案治疗晚期乳腺癌临床研究

[目的]观察吉西他滨联合顺铂方案治疗晚期乳腺癌的近期疗效和毒副反应。[方法]38例晚期乳腺癌患者给予GP方案化疗：吉西他滨1000mg/m2,d1、d8,顺铂30mg/m2,d1～d3,21d为1个周期。每2个周期评价疗效。[结果]38例患者中位治疗周期数为6个周期（2～10个周期）,获CR 3例（7.9%）,PR 13例（34.2%）,SD 10例（26.3%）,PD 12例（31.6%）,总有效率（CR＋PR）为42.1%。主要毒副作用为骨髓抑制和胃肠道反应。Ⅲ度或Ⅲ度以上毒副反应为白细胞下降（36.84%）、中性粒细胞下降（36.84%）、血小板减少（15.79%）、呕吐（13.15%）和贫血（7.89%）。[结论]吉西他滨联合顺铂治疗晚期乳腺癌近期疗效好,毒副反应可以耐受,可作为晚期乳腺癌的治疗选择。     

吉西他滨联合顺铂二线治疗晚期乳腺癌

目的观察国产吉西他滨(泽菲)联合顺铂组成的GP方案二线治疗蒽环类或紫杉类耐药性晚期乳腺癌的疗效与安全性。方法2003~2005年以GP方案治疗蒽环类或紫杉类耐药性晚期乳腺癌29例,泽菲1250mg/m2静滴,第1、8天,顺铂80mg/m2静滴,第1天,每21天为1周期。以WHO标准评价疗效和毒性。结果29例患者,中位化疗周期数为3周期(2~4周期),其中CR1例(3·4%),PR14例(48·3%),SD8例(27·6%),PD6例(20·7%),有效率为51·7%。随访2年,中位TTP35周(12~44周),中位生存期为62周(45~81周)。主要毒性反应为恶心、呕吐与骨髓抑制。结论国产吉西他滨和顺铂联合方案治疗蒽环类或紫杉类耐药性晚期乳腺癌疗效较好,使用方便,毒性反应较轻,是二线治疗蒽环类或紫杉类耐药性晚期乳腺癌的有效解救方案。     

吉西他滨联合顺铂方案二线治疗晚期卵巢癌的临床研究

目的 对紫杉类和卡铂药物一线化疗后复发的晚期卵巢癌患者进行吉西他滨联合顺铂方案化疗,评估其疗效及毒性.方法 紫杉类和卡铂一线化疗后复发的晚期卵巢癌患者接受吉西他滨1.0 g/m2,i.v.,dl,d8;顺铂25mg/m2,i.v.,d1～d3; 21天为1个疗程,至少应用2个疗程,然后评价临床疗效和毒性,并进行随访.结果 30例患者治疗总缓解率53.3％.其中完全缓解3例,部分缓解13例,无缓解14例;中位疾病进展时间6.8个月（3～18.7个月）,中位生存期11.8个月.毒性反应主要是骨髓抑制和胃肠道反应,Ⅲ～Ⅳ度毒性反应发生率为60％.结论 一线接受紫杉类和卡铂化疗后复发的晚期卵巢癌患者行吉西他滨联合顺铂化疗是有效方案,毒性可耐受.     

吉西他滨联合顺铂治疗复发或转移性鼻咽癌的临床研究

目的 观察吉西他滨联合顺铂治疗复发或转移性鼻咽癌的临床疗效和不良反应。方法 吉西他滨1000mg／m^2，分别于第1天和第8天静脉点滴；顺铂80mg／m^2,第1天，或顺铂每天20mg／m^2,第1-4天，21天为1个周期，所有病例接受至少2个周期的化疗。结果 28例患者入组，完全缓解6例，部分缓解18例，总有效率为85．7％（24／28）。中位随访时间15个月（6～23个月），1年生存率为86％，中位疾病进展时间为8．6个月（2．5～18个月）。主要不良反应为骨髓抑制及恶心、呕吐，有4例（14％，4／28）发生了Ⅲ～Ⅳ度骨髓毒性。结论 吉西他滨联合顺铂方案治疗复发或转移性鼻咽癌有较好的疗效，患者耐受性好，值得临床进一步研究。     

吉西他滨联合顺铂治疗转移性鼻咽癌的临床观察

目的 观察吉西他滨联合顺铂治疗转移性鼻咽癌的临床疗效和毒副反应.方法 30例转移性鼻咽癌均接受化疗.化疗方案:吉西他滨1000 mg/m2,静脉滴注,d1,8;顺铂20 mg/m2,静脉滴注,d1～8.21 d为1个周期,所有病例均接受至少2个周期的化疗.结果 30例转移性鼻咽癌中,完全缓解5例,部分缓解20例,总有效率为83.3%(25/30).中位随访时间16个月(6～24个月),中位疾病进展时间为8.8个月(3.5～18个月),1年生存率为86.7%.主要毒副反应为骨髓抑制和胃肠道反应.结论 吉西他滨联合顺铂方案治疗转移性鼻咽癌疗效较好,毒剐反应可耐受.     

吉西他滨联合顺铂治疗晚期复发性卵巢癌18例疗效观察

摘 要：［目的］ 评价吉西他滨联合顺铂（GP方案）对多线化疗失败的晚期复发性卵巢癌的疗效及不良反应。［方法］ 回顾性分析18例接受GP方案化疗的晚期复发性卵巢癌患者,结合实体瘤疗效评估标准评价其临床疗效和安全性。［结果］ GP方案化疗2个周期后,无完全缓解,部分缓解3例,病情稳定4例,进展11例,临床缓解率为16.7%（3/18）,疾病控制率为38.9%（7/18）;铂类敏感型与铂类耐药型复发患者的疾病控制率比较差异无统计学意义（P>0.05）。PFS为1.3～7.7个月,中位PFS为2.0个月。生存质量控制率为83.3%。主要不良反应为骨髓抑制及胃肠道反应。［结论］ GP方案对多线化疗失败的晚期复发性卵巢癌具有一定疗效,能够改善患者生存质量,且耐受性较好,不良反应小。     

吉西他滨联合顺铂治疗老年人肺癌

[目的]观察吉西他滨(Gemcitabine)联合顺铂(cisplatin,DDP)治疗老年人中晚期肺癌的临床疗效和不良反应.[方法]将79例老年人中晚期肺癌患者随机分为A、B两组,A组42例用GP方案(Gemcitabine 800mg/m2,iv,d1-8,DDP 30mg/m2,ivgtt,d1-3),B组37例用EP方案(VP-16 100mg,ivgtt,d1-5,DDP 30mg/m2,ivgtt,d1-3),将两组疗效及毒副反应进行比较.[结果]A组总有效率57.14%,B组总有效率27.03%,两组疗效比较.有显著性差异(P＜0.01).白细胞减少及其他副反应两组相近,血小板下降A组较多,但卡方检验.无显著差异(P＞0.25).[结论]GP方案治疗老年人中晚期肺癌疗效确切,多数患者耐受性好,值得临床推广应用.     

吉西他滨联合顺铂与单药吉西他滨治疗晚期胰腺癌的疗效比较

目的比较吉西他滨联合顺铂与单药吉西他滨治疗晚期胰腺癌的疗效。方法将53例局部晚期或转移性胰腺癌患者随机分两组,27例采用吉西他滨联合顺铂化疗(联合组),26例单纯应用吉西他滨化疗(单药组),对其疗效及毒副反应进行观察。结果可评估病例51例。联合组和单药组有效率分别为15.4%和12.0%(χ2=0.0031,P=0.9555),临床获益率(CR PR SD)分别为76.9%和44.0%(χ2=5.7955,P=0.0161);6个月生存率分别为73.1%和48.0%(χ2=3.3623,P=0.0667);CA199降低率分别为55.6%和47.6%(χ2=0.2444,P=0.6211);Ⅲ～Ⅳ度血液学毒性发生率分别为14.8%和11.5%(χ2=0.0029,P=0.9573)。结论吉西他滨联合顺铂与单药吉西他滨治疗晚期胰腺癌安全有效,前者在临床获益方面优于后者,在延长生存期方面也显示出一定的优势,但该差异未达到有显著性;在严重血液学毒性反应和降低CA199方面,二者差异无显著性。     

吉西他滨联合顺铂治疗晚期乳腺癌96例临床观察

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。方法采用吉西他滨联合顺铂治疗晚期（术后复发或转移）乳腺癌96例。吉西他滨1000 mg/m2,静脉滴注,第1,8天;顺铂70 mg/m2,静脉滴注,第2天,21-28 d为一周期。结果总有效率为58.3%,中位病情进展时间7个月,中位生存时间20个月,1年生存率为60.2%,3年生存率23.1%,5年生存率5.8%。初治组有效率显著优于复治组（82.7%对29.5%,P〈0.05）,曾经使用过蒽环类药物和未使用过蒽环类药物患者有效率差异无显著性（51.4%对66.7%,P〉0.05）,曾经用过紫杉类药物和未使用紫杉类药物患者的有效率差异无显著性（50.0%对51.7%,P〉0.05）。有1-2个转移灶组和3个转移灶组有效率差异无显著性（68.9%对48.6%,P〉0.05）,此方案对于内脏、软组织、淋巴结转移灶有效率相近,骨转移灶有效率相对较低（28.6%）。主要不良反应为骨髓抑制、胃肠道反应、肝肾功能异常,多为Ⅰ-Ⅱ度;Ⅲ-Ⅳ度不良反应主要为白细胞减少和胃肠道反应,发生率分别为16.7%和12.5%。结论吉西他滨联合顺铂治疗晚期乳腺癌具有较好的疗效,不良反应可耐受。     

吉西他滨加顺铂治疗复发性卵巢癌

目的:评估吉西他滨联合顺铂治疗复发性卵巢癌的疗效及毒性。方法:28例复发性卵巢癌,用吉西他滨1000mg/m2和顺铂35mg/m2,静注,第1、8天,21天为1周期。结果:28例患者总有效率60.7%(95%可信区间41.7%-79.6%),其中CR5例(17.9%),PR12例(42.9%)。中位疾病进展时间5.5个月(2.5~20个月),中位生存期12.5个月。其中16例铂类耐药和12例铂类敏感患者的有效率、中位生存期分别为56.3%和66.7%(P=0.95)、10.5和14.5个月(P=0.003)。毒性主要是白细胞减少和血小板减少。结论:吉西他滨加顺铂是治疗复发性卵巢癌的有效方案,不仅可用于铂类敏感患者,也可用于铂类耐药患者。其毒性可以接受。     

吉西他滨联合洛铂与联合顺铂方案治疗术后辅助化疗失败的卵巢癌患者的疗效对比

目的:观察吉西他滨联合洛铂与联合顺铂方案治疗术后辅助化疗失败的卵巢癌患者的疗效及安全性。方法:自2011年6月21日至2016年5月30日,我科收治的初治失败的卵巢癌患者共73例入组,随机分为吉西他滨联合洛铂组（GL组）与吉西他滨联合顺铂组（GP组）,比较两方案在平均化疗周期数、总有效率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）及不良反应发生率等方面的差异。结果:两组患者的平均化疗周期数GL组（4.73±1.305）周期,GP组(4.03±1.341)周期,P=0.027,差异有统计学意义。ORR、DCR间的比较差异均无统计学意义（P=0.345;P=0.127）。GL组中位PFS为6.0个月（95%可信区间5.722~6.278个月）,GP组5.0个月（95%可信区间4.209~5.791个月）,P=0.414,无统计学差异。GL组中位OS为10.0个月（95%可信区间8.675~11.325个月）,GP组9.0个月（95%可信区间8.296~9.704个月）,P=0.308,无统计学差异。不良反应中,GL组轻中度血小板降低较多（P=0.006）,GP组有较多的轻中度肝功能异常（P=0.007）、中重度恶心（P=0.043）及中重度呕吐（P=0.019）。其余不良反应两组间无统计学差异。结论:GL方案对于初治失败的卵巢癌患者而言是安全有效的,可达到与GP方案类似的治疗效果,不良反应较GP方案轻,但需要注意血小板降低。     

吉西他滨联合顺铂治疗复发转移食管癌的疗效及安全性探讨

目的:探讨吉西他滨联合顺铂治疗复发转移食管癌的疗效及安全性。方法:吉西他滨联合顺铂治疗70例复发或转移的食管鳞癌患者,记录其近期疗效,比较不同近期疗效患者的远期疗效及不良反应。结果:吉西他滨联合顺铂治疗复发转移食管癌患者的客观缓解率为31.43%,能显著延迟治疗有效患者的无进展生存期(progression-free survival,PFS),药物严重不良反应为血液毒性,但患者能耐受。结论:吉西他滨联合顺铂治疗复发转移食管癌具有一定的近期疗效和远期疗效,且安全可靠,值得临床推广。     

吉西他滨不同给药方式联合顺铂治疗晚期乳腺癌的临床疗效及安全性

目的:观察吉西他滨不同给药方式联合顺铂治疗蒽环类或紫杉醇类耐药乳腺癌的临床疗效及安全性。方法:选取2014年8月至2017年9月期间入住我院及安徽省立医院的晚期乳腺癌病人,既往接受含蒽环类或紫杉醇类药物的化疗方案,共60例,根据化疗方案的不同,分为对照组(30例)和观察组（30例）。对照组:吉西他滨 1 000 mg/m2 d1、8,顺铂25 mg/m2 d1～3;观察组:吉西他滨 1 000 mg/m2 d1、5,顺铂25 mg/m2 d1～3。结果:对照组客观有效率为33.33%,疾病控制率为73.33%,观察组客观有效率为40.00%,疾病控制率为80.00%,差异无统计学意义（P>0.05）。两组的主要不良反应均为白细胞减少、中性粒细胞减低、血小板减少、胃肠道反应及肝功能异常,Ⅲ-Ⅳ级不良反应发生率差异无统计学意义(P>0.05)。结论:应用吉西他滨联合顺铂治疗蒽环类或紫杉醇类耐药晚期乳腺癌患者时,缩短吉西他滨给药间期,可获得与对照组相当的疗效,同时不增加不良反应,缩短了住院时间,减少了住院费用,可在临床进一步研究应用。     

健择联合顺铂治疗晚期非小细胞肺癌(附50例)

目的:评价健择(Gemzar)联合顺铂(CDDP)治疗晚期非小细胞肺癌的疗效和毒性反应。方法:50例晚期非小细胞肺癌患者应用GP联合方案化疗,健择1000mg/m2,静滴半小时,第1,8天;顺铂25mg/m2,静滴1小时,第1天~5天,每21天为1周期,至少2周期。结果:50例中,CR0例,PR19例,CR PR为38%.在初治的23例中11例达PR,RR为47.8%;在27例复治病人中,8例达PR,RR为29.6%,主要不良反应为白细胞及血小板减少,绝大部分病人均能耐受。结论:健择联合顺铂方案对晚期非小细胞肺癌有较好疗效,不良反应可以耐受,可作为一、二线治疗方案。     

Phase II study of gemcitabine and cisplatin as first-line chemotherapy in inoperable biliary tract carcinoma.

OBJECTIVES: The prognosis for patients with unresectable biliary tract cancer is poor and existing chemotherapy is relatively ineffective. Therefore, a need exists for new, effective chemotherapeutic regimens. The aim of this study was to determine the efficacy and safety profile of gemcitabine plus cisplatin in patients with unresectable biliary tract cancer (cholangiocarcinoma) and gall bladder cancer. METHODS: From December 2000 to July 2002, 43 patients received gemcitabine 1250 mg/m(2) in a 30-min i.v. infusion on d1, 8 and cisplatin 75 mg/m(2) in a 2-h i.v. infusion on d1 (with appropriate hydration), every 3 weeks. ELIGIBILITY: Normal hematologic parameters and creatinine levels; serum bilirubin < 5 mg/dl. RESULTS: Forty-three patients enrolled; 40 were assessable (three patients were not assessable due to incomplete treatment; they chose to discontinue chemotherapy after the first cycle). There were 23 males and 17 females, median age 50 years (range 31-69), median Karnofsky PS 80%. Tumor types: cholangiocarcinoma (39), gall bladder cancer (1). Median number of chemotherapy courses was four (range 1-8). Overall response rate was 27.5% (PR in 11 pts), with 32.5% SD and/or minor response. Median survival time was 36 weeks. Grade 3 hematologic toxicity: anemia (4.33%), leukopenia (1.73%). Non-hematologic toxicity (i.e. rash, nausea, vomiting, neuropathy and myalgia) ranged from mild to moderate. CONCLUSIONS: Gemcitabine plus cisplatin is active in biliary tract carcinoma. These data warrant further investigation of single-agent gemcitabine versus gemcitabine plus cisplatin or its derivative, i.e. oxaliplatin.     

吉西他滨联合顺铂治疗晚期非小细胞肺癌

目的观察吉西他滨联合顺铂治疗晚期非小细胞肺癌的疗效和安全性．方法吉西他滨联合顺铂治疗37例初治的晚期非小细胞肺癌病人。吉西他滨1000mg／m^2,静脉滴注,d1,d8;顺铂30mg／m^2,静脉滴注,d1～3,21d为一周期．每例病人治疗24周期。结果全组37例均可评价疗效,完全缓解者占2．7％（1／37）,部分缓解者占45．9％（17／37）,稳定者占40．6％（15／37）,进展者占10．8％（4／37）,有效率（RR）为48．6％。中位进展时间（TTP）为6．5mo,中位生存期为10．7mo,1年生存率为43．2％（16137）。主要不良反应为血液学毒性,Ⅲ～Ⅳ度白细胞下降者占24.3％（9／37）,Ⅲ度血小板下降者占10．8％（4／37）,无Ⅳ度下降者。恶心呕吐发生率为78.4％,仅2例为毒性反应Ⅲ度。结论吉西他滨联合顺铂治疗晚期非小细胞肺癌有较好的疗效,病人不良反应可以耐受。     

Intraarterial chemotherapy with gemcitabine and cisplatin in locally advanced or recurrent penile squamous cell carcinoma

The prognosis of locally advanced or recurrent squamous cell carcinoma （SCC） of the penis after conventional treatment is dismal. This study aimed to evaluate the therapeutic effects of intraarterial chemotherapy with gemcitabine and cisplatin on locally advanced or recurrent SCC of the penis. Between April 1999 and May 2011, we treated 5 patients with locally advanced penile SCC and 7 patients with recurrent disease with intraarterial chemotherapy. The response rate and toxicity data were analyzed, and survival rates were calculated. After 2 to 6 cycles of intraarterial chemotherapy with gemcitabine and cisplatin, 1 patients with Iocoregionally advanced disease achieved a complete response, and 4 achieved partial response. Of the 7 patients with recurrent disease, 2 achieved complete response, 3 achieved partial response, 3 had stable disease, and 1 developed progressive disease. An objective tumor response was therefore achieved in 10 of the 12 patients. The median overall survival for the patients was 24 months （range, 10-50 months）. Three out of 10 patients who responded were long-term survivors after intraarterial chemotherapy. Intraarterial chemotherapy with gemcitabine and cisplatin may be effective and potentially curative in Iocoregionally advanced or recurrent penile SCC. The contribution of this therapy in the primary management of advanced or recurrent penile SCC shouJd be prospectively investigated.     

Phase II study of combination chemotherapy with gemcitabine and cisplatin for patients with metastatic pancreatic cancer

OBJECTIVE: The objectives of this study were to evaluate the efficacy and toxicity of combination chemotherapy with gemcitabine and cisplatin in patients with metastatic pancreatic cancer. METHODS: Patients na?ve to chemotherapy who had histologically or cytologically confirmed metastatic pancreatic adenocarcinoma were entered. Gemcitabine was given at a dose of 1000 mg/m2 over 30 min on days 1, 8 and 15, and cisplatin was given at a dose of 80 mg/m2 over 150 min on day 1, in 28-day cycles. RESULTS: A total of 38 patients were enrolled in this study between August 2001 and December 2003. There were no complete responses and 10 partial responses, resulting in an overall response rate of 26% (95% CI: 13.4-43.1%]. Twenty-one patients (55%) had stable disease, whereas 7 (18%) had progressive disease. The median time to progression was 4.2 months and the median overall survival was 7.5 months with a 1-year survival rate of 24%. Grade 3-4 toxicities included neutropenia in 26 patients (68%), thrombocytopenia in 19 (50%), anorexia in 15 (39%) and nausea in nine (24%). There was only one episode of neutropenic fever and there were no significant bleeding episodes or treatment-related deaths. CONCLUSION: The combination of gemcitabine and cisplatin administered by this schedule produced a good response rate associated with moderate but manageable toxicities in patients with metastatic pancreatic cancer.     

Biweekly cisplatin and gemcitabine in patients with advanced biliary tract cancer

Treatment with cisplatin and gemcitabine demonstrates a survival benefit in patients with advanced biliary tract cancer (ABTC). However, the weekly administration can add significant toxicities that may prohibit prolonged treatment. Based on previous studies, we implemented a modified biweekly regimen of GC in an attempt to optimize the prescribed regimen with an improved toxicity profile, added convenience to patients while maintaining efficacy. Patients with ABTC were treated with fixed dose rate (FDR) gemcitabine (1,000 mg/m²/min) and cisplatin 20 mg/m² on days 1 and 15 of every 28‐day cycle. Patients received treatment until time of progression, death, or discontinuation due to intolerance. Collected data included demographics, clinico‐pathologic features, toxicities, and survival. Kaplan‐Meier curves were used to calculate the median overall survival (OS) and progression free survival (PFS). The study included 107 evaluable pts with unresectable ABTC who received the biweekly regimen. Sites of tumor included gallbladder (21.5%), ampullary (3.7%), and bile duct (74.8%). Median number of cycles was 6 (1–27). Median PFS was 8.34 (6.74, 9.23) months and median OS was 10.32 (9.10, 11.43) months. Most common grade ≥3 adverse events included neutropenia (11%), fatigue (10%), and thrombocytopenia (6.4%). Biweekly FDR GC in ABTC is associated with a more favorable toxicity profile while maintaining efficacy similar to that observed in prior clinical trials. Minimal toxicities were observed despite a prolonged course for many patients. Further prospective trials should consider evaluating the role of biweekly GC regimen in ABTC, including a potentially more favorable platform in novel experimental strategies.     

吉西他滨单药与联合顺铂化疗治疗中老年晚期非小细胞肺癌的疗效观察

目的:评价吉西他滨联合顺铂治疗非小细胞肺癌(NSCLC)与单独使用吉西他滨的疗效与安全性.方法:140例晚期NSCLC(Ⅲb/Ⅳ期)患者随机均分为吉西他滨联合顺铂组(n=70)和单独使用吉西他滨组(n=70).联合给药组患者静脉注射吉西他滨(1 250 mg/m2,第1、8天)和顺铂(75 mg/m2,第1天);单独给药组患者静脉注射吉西他滨(1 250 mg/m2,第1、8天).每21天为一个疗程,共持续4个疗程.结果:吉西他滨与顺铂联合给药组疗效优于吉西他滨单独给药组(P＜0.05).而在血细胞减少、血红蛋白减少以及恶心呕吐等不良反应上,吉西他滨单独给药组低于联合给药组,但组间比较差异无统计学意义(P＞0.05).治疗后2年的随访结果也显示经吉西他滨与顺铂联合治疗的患者1年有效率及中位生存期均优于吉西他滨单独治疗组(P＜0.05).结论:吉西他滨联合顺铂治疗中老年晚期非小细胞肺癌疗效确切,未明显增加不良反应,患者耐受性好,值得临床推广.