不同剂量吉西他滨联合卡铂一线治疗晚期非小细胞肺癌的临床疗效

[目的]比较不同剂量吉西他滨联合卡铂一线治疗晚期非小细胞肺癌的疗效和不良反应。[方法]回顾性分析行一线GC方案化疗的晚期非小细胞肺癌患者,共83例,均接受吉西他滨1250mg/m2（38例）或1000mg/m2（45例）联合卡铂（AUC=5）化疗。Kaplan-Meier法进行生存分析和比较。[结果]吉西他滨高剂量组（1250mg/m2）中位无进展生存期为5.2个月,低剂量组（1000mg/m2）中位无进展生存期为4.8个月（P=0.67）,中位总生存期分别为14.5个月和15.8个月,差异亦无统计学意义（P=0.65）。两组有效率分别为31.6%和35.6%（P=0.70）,疾病控制率分别为78.9%和73.3%（P=0.55）。吉西他滨高剂量组血小板降低比例高于低剂量组。[结论]与1250mg/m2化疗组相比,吉西他滨1000mg/m2联合卡铂一线治疗晚期非小细胞肺癌患者疗效及生存期相当,但不良反应降低。     

奥沙利铂联合吉西他滨治疗晚期胆道系统肿瘤的临床观察

目的 观察奥沙利铂联合吉西他滨治疗晚期胆道系统肿瘤的疗效及不良反应。方法 收集2008年1月至2011年3月均经影像和病理组织学确诊的晚期胆道系统肿瘤38例,具体用药方案：奥沙利铂85mg/m²静滴2h,d₁;吉西他滨835 mg/m2静滴30min,d_¹、d₈,21天为1周期。化疗2个周期评价疗效,并记录不良反应。结果 38例均可评价疗效,获CR 1例,PR 7例,有效率（RR）为21.1%(8/38)。主要不良反应包括骨髓抑制、外周神经毒性及恶心呕吐,均未出现重度不良反应。结论 奥沙利铂联合吉西他滨治疗晚期胆道系统肿瘤患者的近期疗效较好,不良反应可以耐受,值得深入研究。     

吉西他滨联合奥沙利铂治疗晚期肝内胆管细胞癌28例

[目的]观察吉西他滨联合奥沙利铂治疗晚期肝内胆管细胞癌临床效果及毒副作用。[方法]28例肝内胆管细胞癌患者均给予吉西他滨1000mg/m2,d1、8;奥沙利铂85mg/m2,d1,21d为1个疗程。观察近期疗效、疼痛缓解程度和毒副反应。[结果]化疗后PR6例(21.43%),SD12例(42.86%),PD10例(35.71%),化疗期间无死亡病例。疼痛程度化疗前后比较差异有统计学意义(P<0.05)。毒副作用以血液系统多见,其次为胃肠道反应和外周神经毒性。[结论]吉西他滨联合奥沙利铂治疗晚期肝内胆管细胞癌具有较好的近期疗效,能缓解患者疼痛,且毒副反应可以耐受。     

吉西他滨联合顺铂或奥沙利铂治疗晚期非小细胞肺癌87例

[目的]比较吉西他滨联合顺铂或奥沙利铂治疗晚期非小细胞肺癌(NSCLC)的疗效和毒副反应。[方法]87例晚期NSCLC患者分为两组:顺铂组42例,吉西他滨1000mg/m2,d1,d8;顺铂25mg/m2,d1～d3。奥沙利铂组45例,吉西他滨1000mg/m2,d1,d8;奥沙利铂130mg/m2,d1。28d/周期。评价有效率、疾病进展时间和毒副反应。[结果]顺铂组与奥沙利铂组的有效率分别为28.6%和31.1%(P=0.8),中位疾病进展时间分别为6.2个月(4.0~8.5个月)和5.7个月(4.5~7.8个月)(P=0.07)。两组主要毒副反应为胃肠道反应、周围神经毒性及骨髓毒性。顺铂组胃肠道反应的发生率(81.0%)明显高于奥沙利铂组(51.1%)(χ2=8.6,P=0.0)。奥沙利铂组的周围神经毒性的发生率(57.8%)明显高于顺铂组4.8%(χ2=28.0,P=0.0)。[结论]吉西他滨联合顺铂或奥沙利铂是晚期NSCLC的有效方案,均可作为晚期NSCLC的一线治疗方案。     

沙利度胺联合吉西他滨、奥沙利铂方案治疗晚期肝内胆管细胞癌的近期疗效观察

目的 观察沙利度胺联合吉西他滨、奥沙利铂方案治疗晚期肝内胆管细胞癌的近期疗效.方法 26例晚期肝内胆管细胞癌采用沙利度胺联合吉西他滨、奥沙利铂方案治疗:沙利度胺100～200 mg口服,每晚1次,吉西他滨850～1000 mg/m2,静脉滴注30rain,d1,8;奥沙利铂130 mg/m2,静脉滴注2 h,d1,21 d为1个周期.结果 全组26例中,CR 0例,PR 9例,SD 7例,PD 10例,总有效率34.6%.结论 沙利度胺联合吉西他滨、奥沙利铂方案治疗晚期肝内胆管细胞癌具有较好的近期疗效.     

吉西他滨固定剂量率静滴治疗晚期胰腺癌28例

[目的]评价健择（吉西他滨）固定剂量率静滴治疗晚期胰腺癌的疗效和毒副反应。[方法]28例经组织病理学或细胞学诊断的晚期胰腺癌患者,采用健择固定速率静脉滴注（每分钟10mg/m2）,1200mg/m2,静滴120min,d1,d8,d15,每28d重复,至少化疗2个周期。[结果]28例患者均可评价疗效,PR6例,SD15例,PD7例,总有效率21.43%。疼痛缓解率50.00%（14/28）,行为状态改善率42.86%（12/28）,体重改善率35.71%（10/28）,TTP3.0个月,MST8.2个月,6个月生存率46.2%,1年生存率28.6%,2年生存率17.9%。毒副反应主要为血液学毒性,无治疗相关性死亡。[结论]健择固定剂量率静滴治疗晚期胰腺癌具有较高的有效率及临床受益反应率,毒副反应可以耐受。     

吉西他滨联合顺铂治疗47例老年晚期非小细胞肺癌

[目的]观察吉西他滨（商品名健择）联合顺铂治疗老年晚期非小细胞肺癌（NSCLC）的近期疗效、毒副反应。[方法]健择（GEM）1000mg/m2静滴30min,d1,8;顺铂30mg/m2,静滴d1～3;21d为一个周期。完成2个周期以上评价疗效。[结果]47例老年晚期NSCLC患者共行化疗189个周期,全组总有效率38.3%。（全组42例均可评价,有效率为38.3%）。主要毒副反应为胃肠反应（Ⅲ～Ⅳ度为23.4%）和血液学毒性（Ⅲ～Ⅳ度白细胞下降率为27.7%,Ⅲ～Ⅳ度血小板下降率为14.9%）。[结论]健择联合顺铂治疗老年人非小细胞肺癌,有效率高,毒副反应轻,可以耐受。     

吉西他滨联合奥沙利铂治疗复发性鼻咽癌的疗效

目的探讨吉西他滨联合奥沙利铂(GEMOX方案)治疗晚期鼻咽癌的临床疗效和安全性。方法选取2011年1月至2014年12月间佛山市第一人民医院采用GEMOX方案治疗晚期顺铂、氟尿嘧啶(5-Fu)耐药的鼻咽癌患者52例,吉西他滨1 000 mg/m2静滴,第1、8天;奥沙利铂65 mg/m2静滴,第1、8天,21 d为1个周期,每2个周期评价疗效1次。结果 52例患者共完成120个周期化疗,每例患者完成2~6个周期,平均3.7个周期,其中部分缓解10例(19.2%),稳定24例(46.2%),进展18例(34.6%);总有效率19.2%,疾病控制率65.4%;无进展生存期(PFS)2~24个月中位PFS为6.5个月;主要毒副反应为白细胞减少、血小板减少、恶心呕吐和肝功能损害,均以1~2度为主,患者耐受性好。结论 GEMOX方案治疗顺铂、5-Fu耐药的晚期鼻咽癌疗效好,不良反应可耐受,值得临床推广。     

吉西他滨联合顺铂治疗晚期非小细胞肺癌20例临床观察

目的观察吉西他滨联合顺铂化疗治疗晚期非小细胞肺癌的疗效.方法采用吉西他滨联合顺铂方案治疗晚期非小细胞肺癌20例,吉西他滨1 000mg/m2,静滴30～60分钟滴完.后用顺铂30mg/m2静滴,均为第1、8、15天给药,28天为1周期.结果部分缓解8例,稳定10例,进展2例,总有效率为40%.结论吉西他滨联合顺铂治疗晚期非小细胞肺癌疗效较好,毒性反应可以耐受.     

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。     

三维适形放疗同步奥沙利铂联合吉西他滨化疗治疗局部晚期胰腺癌的临床观察

目的 探讨三维适形放疗(3DCRT)同步奥沙利铂联合吉西他滨化疗治疗局部晚期胰腺癌的疗效和毒副反应.方法 入组局部晚期胰腺癌30例均接受3DCRT,总剂量45.0～50.4 Gy,5～6周内完成.在放疗的同时接受化疗,放疗结束后继续化疗2～4个周期,方案为:奥沙利铂100mg/m2,静脉滴注,d1;吉西他滨1 000 ...     

吉西他滨联合奥沙利铂治疗进展期胰腺癌(附40例)

目的:观察吉西他滨(择菲GEM)联合奥沙利铂(艾恒OXA)组成的GEMOX方案治疗进展期胰腺癌的有效性和安全性。方法:进展期胰腺癌40例,应用GEM800mg/m2静滴半小时,d1,d8;OXA60mg/m2静滴2小时,d2,d9;21天重复。至少接受2个周期的化疗,按照WHO标准进行评价。结果:观察化疗后肿瘤原发病灶的变化情况及化疗的不良反应。临床有效率为17.5%,具有较好的耐受性,不良反应主要有骨髓抑制和消化系统反应。结论:健择联合艾恒治疗进展期胰腺癌疗效较好,不良反应可以耐受。     

吉西他滨加奥沙利铂治疗老年晚期非小细胞肺癌的临床观察

目的:观察吉西他滨加奥沙利铂治疗老年非小细胞肺癌的近期疗效和毒性反应。方法:吉西他滨1000mg/m2,静脉滴注,第1、8天;奥沙利铂130mg/m2,静脉滴注,第1天,21天为一个周期。结果:全组35例共化疗92个周期。CR 2.9%(1/35)、PR 40%(14/35)、NC 25.7%(9/35)、PD 31.4%(11/35),有效率CR PR42.9%(15/35),临床受益率CR PR NC 68.6%(24/35)。中位缓解期6.5个月。主要毒副反应为骨髓抑制,Ⅲ级~Ⅳ级白细胞减少14.3%(5/35),Ⅲ级~Ⅳ级血小板减少11.4%(4/35)。神经毒性发生率71.4%,均为轻度。结论:吉西他滨加奥沙利铂对老年晚期非小细胞肺癌有效率较高,临床受益率大,毒性反应可耐受。     

Weekly gemcitabine, paclitaxel, oxaliplatin combination chemotherapy in patients with Cisplatin-refractory germ cell tumor: preliminary experience

Although the overall cure rate for advanced germ cell tumor (GCT) is high, the prognosis for patients with cisplatin-refractory GCT remains poor. Gemcitabine, paclitaxel, and oxaliplatin have shown significant activity as single agents in these patients. We investigated the activity and tolerance of a weekly gemcitabine, paclitaxel, oxaliplatin chemotherapy regimen. From September 2000 to February 2002, 9 patients with cisplatin-refractory GCT were treated with gemcitabine 800 mg/m2, paclitaxel 70 mg/m2, and oxaliplatin 50 mg/m2, days 1, 8, and 15, every 4 weeks. Only 1 patient stayed on schedule. In 7 patients, chemotherapy treatment was modified due to grade 3-4 hematological toxicity, whereas in another patient, who received high-dose chemotherapy 2 months before, chemotherapy was administered biweekly. In total, 21 cycles were administered with a median of 2 cycles for each patient. One patient achieved a partial remission lasting 5 months, 1 had disease stabilization for 5 months, whereas 7 had progressive disease. This chemotherapy regimen was not feasible in our patient population. Recently, oxaliplatin at full doses, but not as weekly administration, has appeared to possess activity in cisplatin-refractory GCT. Thus, we plan a phase II study protocol of the oxaliplatin and gemcitabine combination at full doses every 3 weeks.     

A dose-escalation and pharmacokinetic study of gemcitabine and oxaliplatin in patients with advanced solid tumors.

BACKGROUND: Gemcitabine and oxaliplatin have broad antineoplastic activity and favorable toxicity. We conducted a phase I study to determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of the combination in patients with advanced solid tumors. PATIENTS AND METHODS: Sixty-eight patients with advanced stage solid tumors were enrolled. Treatment was first-line for 35% of patients, second-line for 27%, and third-line for 38%. Gemcitabine was administered at escalating doses of 1000-2000 mg/m(2) as a 30-min intravenous (i.v.) infusion on days 1 and 8 and oxaliplatin at 60-130 mg/m(2) as a 4-h i.v. infusion on day 8 every 21 days without growth factor support. RESULTS: The MTD was defined at gemcitabine 1800 mg/m(2) on days 1 and 8 and oxaliplatin 130 mg/m(2) on day 8. Twelve dose levels were evaluated and DLTs occurring during the first cycle consisted of grade 4 neutropenia, grade 3 asthenia or mucositis and grade 1-3 neutropenia or thrombocytopenia resulting in treatment delays. A total of 266 cycles were administered with only one episode of febrile neutropenia and no toxic deaths. Seven (3%) and 26 (10%) cycles were complicated by grade 4 and 3 neutropenia, respectively, three (1%) and 13 (5%) by grade 4 and 3 thrombocytopenia, and eight (3%) by grade 3 anemia. The most common non-hematological toxicity was grade 2/3 asthenia observed in 23% of cycles. Responses were observed in patients with a variety of epithelial neoplasms. The pharmacokinetic study revealed no significant interaction between the two drugs. CONCLUSIONS: The combination of gemcitabine and oxaliplatin has excellent tolerability and promising activity in patients with advanced solid tumors. As the MTD exceeds the recommended single-agent dose for gemcitabine, and a dose-response effect has not been established, we recommend using both drugs at full doses, e.g. gemcitabine 1200-1400 mg/m(2) on days 1 and 8 and oxaliplatin 130 mg/m(2) on day 8 for further phase II studies.     

Gemcitabine and oxaliplatin for patients with advanced or metastatic pancreatic cancer: a North Central Cancer Treatment Group (NCCTG) phase I study.

BACKGROUND: The study was performed to determine the maximum tolerated dose (MTD) of gemcitabine and oxaliplatin in patients with advanced or metastatic pancreatic adenocarcinoma (ACA). PATIENTS AND METHODS: Pancreatic ACA patients, with previously untreated advanced or metastatic disease, were enrolled in a dose escalation study of gemcitabine and oxaliplatin. Oxaliplatin was given intravenously on day 1 and gemcitabine intravenously on days 1 and 8 of a 3-week cycle. Doses of both drugs were increased with sequential cohorts of patients until dose-limiting toxicity (DLT) was observed. RESULTS: A total of 18 patients were enrolled to three dose levels. DLT of neutropenia and a severe infection was noted at a dose of gemcitabine 1250 mg/m2 and oxaliplatin 130 mg/m2. Hematological toxicity and nausea and vomiting were the most common grade 3/4 toxicities. The MTD, gemcitabine 1000 mg/m2 and oxaliplatin 100 mg/m2, was well tolerated. Three confirmed responses were seen. CONCLUSIONS: The MTD of gemcitabine and oxaliplatin in patients with pancreatic ACA was determined. A phase II study of this combination is ongoing and will be reported separately at a later date.     

Phase II Clinical Study on the GEMOX Regimen as Secondline Therapy for Advanced Ovarian Cancer

Aim: To investigate the effectiveness and adverse effects of gemcitabine by fixed-dose rate infusion plusoxaliplatin (GEMOX regimen) as second-line therapy for advanced ovarian cancer. Methods: 64 patients withadvanced ovarian cancer were divided into an experimental group (44 cases) and a control group (20 cases).The experimental group was treated with continuous intravenous infusion of gemcitabine at 1000 mg/m2 with afixed-dose rate of 10 mg/m2/min, on days 1 and 8 and oxaliplatin at 100 mg/m2 on day 1, IVGTT, repeated every3 weeks. The control group was treated with intravenous infusion of gemcitabine at 1000 mg/m2 within 30 minon days 1 and and oxaliplatin at 100 mg/m2 on day 1, IVGTT, again repeated every 3 weeks. CT scans or MRIwere used for review every 1-2 cycles. Results: The effective rate in the experimental group was significantly highthan control group (43.2% vs 35.0%; P < 0.05), with no obvious difference of hematologic or non-hematologictoxicity between the two groups (P > 0.05). Conclusion: GEMOX regimen is very effective to treat advancedovarian cancer, with low toxicity, good tolerance and improved life quality in patients.     

吉西他滨联合奥沙利铂治疗进展期胰腺癌（附40例）

目的：观察吉西他滨（择菲GEM）联合奥沙利铂（艾恒OXA）组成的GEMOX方案治疗进展期胰腺癌的有效性和安全性。方法：进展期胰腺癌40例,应用GEM800mg／m2静滴半小时,d1,d3;OXA60mg／m2静滴2小时,d2,d9;21天重复。至少接受2个周期的化疗,按照WHO标准进行评价。结果：观察化疗后肿瘤原发病灶的变化情况及化疗的不良反应。临床有效率为17．5％,具有较好的耐受性,不良反应主要有骨髓抑制和消化系统反应。结论：健择联合艾恒治疗进展期胰腺癌疗效较好,不良反应可以耐受。     

紫杉醇联合奥沙利铂治疗老年晚期胃癌

目的:探讨紫杉醇联合奥沙利铂(奥正南)治疗老年晚期胃癌的疗效和不良反应及对生活质量的影响。方法:65例老年晚期胃腺癌患者中,19例为初次化疗患者,15例为曾接受术后化疗,31例为未手术而接受过化疗的患者。紫杉醇80mg/m2d1,d8,静脉滴注3小时;奥沙利铂85mg/m2d2;21天为1个周期。结果:所有患者均接受2个周期的化疗后进行评效,完全缓解11例,部分缓解21例,有效率为49.2%,临床控制率为87.7%。主要不良反应为胃肠道反应,脱发,关节肌肉疼痛及骨髓抑制。结论:紫杉醇联合奥沙利铂对老年晚期胃癌疗效肯定,不良反应小,是治疗老年晚期胃癌的有效方案之一。     

Phase I-II and pharmacokinetic study of gemcitabine combined with oxaliplatin in patients with advanced non-small-cell lung cancer and ovarian carcinoma.

BACKGROUND: The aim of this study was to determine the toxicity profile, the recommended dose (RD) and the pharmacokinetic parameters, and to evaluate the antitumor activity of gemcitabine combined with oxaliplatin in patients with advanced non-small-cell lung cancer (NSCLC) and ovarian carcinoma (OC). METHODS: Gemcitabine was administered as a 30-min infusion followed by a 2-h infusion of oxaliplatin, repeated every 2 weeks. Doses of gemcitabine and oxaliplatin ranged from 800 to 1500 and 70 to 100 mg/m(2), respectively. RESULTS: Forty-four patients (26 males, 18 females; median age 55 years) including 35 NSCLC (five platinum pretreated) and nine OC patients (all platinum pretreated) received a total of 355 cycles. All patients were evaluable for toxicity. No dose-limiting toxicity at any dose level occurred during the first two cycles; therefore, the highest dose-level of gemcitabine (1500 mg/m(2)) and oxaliplatin (85 mg/m(2)) was considered as the RD. Hematological toxicity was moderate amongst the 22 patients treated (167 cycles) at that dose level. Thirteen cycles were associated with grade 3-4 non-febrile neutropenia in six patients, and eight cycles with grade 3-4 thrombocytopenia in two patients. Other toxicities were mild to moderate, consisting of asthenia and peripheral neurotoxicity. Four of the 35 patients treated with oxaliplatin 85 mg/m(2) experienced grade 3 neurotoxicity requiring treatment discontinuation at cycle 10. In the range of the doses used, gemcitabine and its main metabolite 2',2'-difluorodeoxyuridine appeared not to be affected by oxaliplatin 70-100 mg/m(2). Of the 44 patients evaluable for activity, 12 NSCLC patients experienced objective responses (one complete and 11 partial responses) and three OC patients showed tumor stabilization lasting for 6 months with a 50% decrease of CA 125 level. Two partial responses (NSCLC) and one tumor stabilization (OC) occurred in platinum-resistant patients. CONCLUSIONS: The combination of gemcitabine and oxaliplatin could be safely administered on an out-patient schedule in patients with advanced NSCLC and OC. The RD was gemcitabine 1500 mg/m(2) and oxaliplatin 85 mg/m(2) every 2 weeks. Promising antitumor activity was reported in patients with NSCLC and platinum-pretreated OC, and thus, deserves further evaluation.