单药吉西他滨治疗老年晚期非小细胞肺癌疗效观察

目的观察单药吉西他滨治疗老年晚期非小细胞肺癌的疗效和不良反应。方法收集Ⅲ～Ⅳ期老年非小细胞肺癌患者54例,根据是否应用吉西他滨分为试验组和对照组,试验组30例患者应用单药吉西他滨800～1 000 mg/m2,第1、8天静脉滴注,21天为1周期,至少2周期;对照组给予最佳支持治疗。结果30例患者均可评价疗效,其中,完全缓解0例,部分缓解9例,有效率为30.0%(9/30)。中位疾病进展时间（TTP）为4.9月,中位生存期为6.5月。主要不良反应多为Ⅰ～Ⅱ度骨髓抑制及皮疹。结论单药吉西他滨治疗老年晚期非小细胞肺癌是安全有效的。     

尼妥珠单抗联合化疗治疗转移性鼻咽癌的研究

目的观察尼妥珠单抗联合吉西他滨治疗晚期转移性鼻咽癌的近期疗效和不良反应。方法 13例既往接受过多方案化疗的晚期转移性鼻咽癌患者,接受尼妥珠单抗每周200 mg,静脉滴注;吉西他滨1 000 mg/m2,静脉滴注,d1、d8,每3周重复,每2周期评价疗效。结果 全组13例中,CR 2例(15.2%）,PR 6例(46.2%）,CR+PR 61.5%,1年生存率76.9%。不良反应主要为Ⅰ~Ⅱ度骨髓抑制。结论 尼妥珠单抗联合吉西他滨方案治疗晚期转移性鼻咽癌的近期疗效确切,耐受性好。     

吉西他滨单药治疗老年晚期非小细胞肺癌的临床观察

目的观察吉西他滨单药周剂量治疗老年晚期非小细胞肺癌的疗效和不良反应。方法对45例老年晚期非小细胞肺癌患者(年龄≥65岁)应用吉西他滨800¹000 mg/m2,第1、8天,31000 mg/m2,第1、8天,3⁴周为1个周期,至少治疗2个周期评价疗效和不良反应。结果全组总有效率为26.7%(12/45),临床受益率为71.1%(32/45),无疾病进展生存时间为4.2个月,中位生存时间为8.3个月,1年生存率为31.1%(14/45),主要不良反应为骨髓抑制、胃肠道反应、皮疹和肝肾功能受损。结论吉西他滨单药周剂量治疗老年晚期非小细胞肺癌耐受性较好,生活质量较高。     

吉西他滨联合卡培他滨治疗晚期肝癌的临床观察

为了观察吉西他滨联合卡培他滨治疗晚期肝癌的临床疗效及不良反应,选择无法手术及介入治疗的晚期原发性肝癌患者26例,给予吉西他滨1 000 mg/m2,持续静脉滴入30 min,d1、d8;卡培他滨1 000 mg/m2,口服,2次/d,d1～d14,21d为1个周期,入组的每例患者至少接受2个周期的治疗.结果PR 11例(42.3%),NC 6例(23.1%),PD 9例(34.6%),客观有效率(PR+CR)为42.3%(11/26);疾病控制率(PR+CR+SD)为65.4%(17/26).不良反应主要有血液学毒性(主要为中性粒细胞减少和血小板减少)和手足综合征,多为1～2度,耐受性良好.中住生存期(MST)6.8个月,1年生存率38.5%.初步研究结果提示,吉西他滨联合卡培他滨治疗晚期肝癌的疗效及患者依从性好,用药方便,费用相对低廉,值得临床进一步研究.     

RRM1阴性老年晚期肺鳞癌个体化化疗的随机对照研究

目的 探讨单药吉西他滨治疗核糖核苷酸还原酶M1(ribonucleotide reductase subunit M1,RRM1)表达阴性老年晚期肺鳞癌患者的临床疗效.方法 选取肿瘤组织中RRM1阴性的≥70岁晚期肺鳞癌患者77例,按随机数字表法分为试验组与对照组.试验组38例给予吉西他滨单药化疗(1000 mg/m2,静脉滴注30 min,第1、8天),对照组39例给予GP(吉西他滨+顺铂,吉西他滨1000 mg/m2,静脉滴注30 min,第1、8天;顺铂25 mg/m2,第1~3天)化疗,均21 d为1个周期.观察两组化疗不良反应、客观有效率及生存状况.结果 试验组与对照组客观有效率分别为52.6%(20/38)和56.4%(22/39),中位生存期分别为14.2个月和14.4个月,两组比较差异均无统计学意义(均P>0.05).两组血液学毒性发生率比较差异无统计学意义(P>0.05).试验组的恶心、呕吐发生率(5.5%,11/202)及尿素氮/肌酐(blood urea nitrogen/creatinine,BUN/Cr)升高发生率(0.5%,1/202)均低于对照组的16.3%(32/196)和6.1%(12/196)(均P<0.05).结论 RRM1阴性老年晚期肺鳞癌患者单药吉西他滨治疗与GP方案疗效相当,不良反应轻.     

吉西他滨单药治疗老年晚期非小细胞肺癌患者36例

目的 观察吉西他滨单药治疗老年晚期非小细胞肺癌(NSCLC)患者的疗效及不良反应.方法 对36例ⅢB～Ⅳ期老年NSCLC患者应用吉西他滨单药化疗(1000mg/m2,第1、8天静脉滴注),21 d为1个周期.2个周期后分别按实体瘤疗效评价标准(RECIST)和美国国立癌症研究所(NCI)常见毒性反应标准评价不良反应,同时评估生活质量改善指标.结果 本组36例患者中,完全缓解(CR)0例,部分缓解(PR)10例,稳定(SD)15例,进展(PD)11例,有效(CR+PR)率为27.8%,临床受益(CR+PR+SD)率为69.4%.中位无进展生存(PFS)期为5.1个月,中位总生存(OS)期为7.8个月,1年生存率为30.6%(11/36).患者不良反应主要表现为以白细胞和血小板减少为主的骨髓抑制,白细胞减少Ⅰ～Ⅱ度发生率为44.4%(16/36),Ⅲ～Ⅳ度11.1%(4/36);血小板减少Ⅰ～Ⅱ度发生率为38.9%(14/36),Ⅲ度2.8%(1/36),无Ⅳ度减少发生.结论 采用吉西他滨单药治疗老年晚期NSCLC患者疗效好、不良反应轻、安全,可作为老年晚期NSCLC患者的一线治疗方案.     

吉西他滨单药治疗老年晚期非小细胞肺癌患者36例

目的 观察吉西他滨单药治疗老年晚期非小细胞肺癌(NSCLC)患者的疗效及不良反应.方法 对36例ⅢB～Ⅳ期老年NSCLC患者应用吉西他滨单药化疗(1000mg/m2,第1、8天静脉滴注),21 d为1个周期.2个周期后分别按实体瘤疗效评价标准(RECIST)和美国国立癌症研究所(NCI)常见毒性反应标准评价不良反应,同时评估生活质量改善指标.结果 本组36例患者中,完全缓解(CR)0例,部分缓解(PR)10例,稳定(SD)15例,进展(PD)11例,有效(CR+PR)率为27.8%,临床受益(CR+PR+SD)率为69.4%.中位无进展生存(PFS)期为5.1个月,中位总生存(OS)期为7.8个月,1年生存率为30.6%(11/36).患者不良反应主要表现为以白细胞和血小板减少为主的骨髓抑制,白细胞减少Ⅰ～Ⅱ度发生率为44.4%(16/36),Ⅲ～Ⅳ度11.1%(4/36);血小板减少Ⅰ～Ⅱ度发生率为38.9%(14/36),Ⅲ度2.8%(1/36),无Ⅳ度减少发生.结论 采用吉西他滨单药治疗老年晚期NSCLC患者疗效好、不良反应轻、安全,可作为老年晚期NSCLC患者的一线治疗方案.     

吉西他滨联合顺铂治疗三阴性晚期乳腺癌的临床观察

目的:观察吉西他滨联合顺铂方案治疗对蒽环类和紫杉类耐药的晚期三阴性乳腺癌的近期疗效和不良反应。方法:32例对蒽环类和紫杉类耐药的晚期乳腺癌患者,经免疫组化证实ER、PR、HER-2均阴性,给予吉西他滨联合顺铂方案治疗,具体用药为:吉西他滨1000mg/m2静脉滴注,第1、8天;顺铂25mg/m2静脉滴注,第1-3天。21天为1周期,至少2个周期。每周期评价不良反应,每2周期后评价疗效,并随访观察肿瘤进展时间。结果:32例患者均可评价疗效与不良反应,获完全缓解(CR)1例(3.1%),部分缓解(PR)10例 (31.2%),稳定(SD)12例(37.5%),进展(PD)9例(28.1%),总有效率(CR+PR)为34.4%（11/32）;中位疾病进展时间为5.2个月。主要不良反应包括骨髓抑制和胃肠道反应,Ⅲ-Ⅳ级中性粒细胞减少及血小板减少发生率分别为33.3%和19.0%,无化疗相关性死亡。结论:吉西他滨联合顺铂方案对蒽环类和紫杉类耐药的晚期三阴性乳腺癌有较好的近期疗效,不良反应可耐受,安全性好。     

低剂量吉西他滨单药治疗老年晚期非小细胞肺癌的观察

目的:观察低剂量吉西他滨单药治疗老年晚期非小细胞肺癌(NSCLC)的临床疗效。方法:国产吉西他滨600mg/m2,静脉滴注30分钟,第1、8、15天,28天为1周期,治疗65岁以上NSCLC患者31例。结果:31例患者共化疗95个周期,总有效率(CR PR)29.0%(9/31),临床受益率61.3%(19/31)。毒副作用以白细胞和血小板下降为常见,但均可耐受。结论:低剂量国产吉西他滨单药治疗老年NSCLC有着较好疗效且病人耐受性较好。     

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。     

一线序贯应用厄洛替尼与化疗治疗晚期非小细胞肺癌的临床研究

 目的　评价化疗后序贯给予厄洛替尼在一线治疗非小细胞肺癌（NSCLC）中的客观缓解率和不良反应。方法　23例PS 0～1分的ⅢB～Ⅳ期NSCLC患者一线接受GC化疗方案（吉西他滨1250 mg／m2 第1、8天,顺铂75 mg／m2 第1天或卡铂AUC＝5第1天）,并序贯给予厄洛替尼（150 mg,第15天至第28天）,每28 d为1个周期,观察患者的客观疗效及不良反应。结果　23例患者接受95个周期的化疗,所有患者均可评价疗效。完全缓解（CR）0例,部分缓解（PR）7例（30.4 %）,疾病稳定（SD）14例（60.9 %）,疾病进展（PD）2 例（8.7 %）;总体客观缓解（RR）30.4 %,疾病控制（DCR ）91.3 %。Ⅲ度以上不良反应为白细胞减少3例（13.0 %）,皮疹2例（8.7 %）,恶心呕吐、血小板减少各2例（8.7 %）,没有出现治疗相关的间质性肺病。结论　GC化疗方案序贯厄洛替尼治疗模式的近期疗效较好,不良反应在患者可耐受范围内,远期疗效有待进一步观察。     

恩度联合GP方案治疗晚期非小细胞肺癌的临床观察

目的探讨恩度联合吉西他滨、顺铂（GP）方案治疗晚期tP4,细胞肺癌（NSCLC）的临床疗效及不良反应。方法回顾性分析40例经组织病理学证实的晚期（ⅢB／Ⅳ期）非小细胞肺癌患者的临床资料。40例初治患者均接受恩度联合GP方案的化疗。GP：吉西他滨1000mg／m^2,第1、第8天,DDP25rag／m^2,第1—3天,每21天重复给药。同时给予恩度7．5mg／m^2,每次用量15mg,静点4小时,第1—14天连续给药,间歇7天重复。2个周期后进行疗效评定,观察其疾病进展时间及不良反应。结果全部患者均接受2个周期以上化疗,共化疗142个周期。40例患者中CR为0例,PR为17例,SD为13例,PD为10例,客观有效率CR＋PR（RR）为42．5％,疾病控制率为（CR＋PR＋SD）75．0％,中位疾病进展时间（mTTP）为11月。结论恩度联合GP方案治疗晚期非小细胞肺癌是一种安全、有效的治疗方法。不良反应轻,恢复快,患者耐受好。     

Gemcitabine alone or combined with cisplatin in relapsed or refractory multiple myeloma

Gemcitabine is a pyrimidine nucleoside analog with antitumor activity against solid tumor malignancies and leukemia. We evaluated its activity as a single agent and combining it with cisplatin in relapsed-refractory multiple myeloma (MM). Sixteen patients with advanced MM received intravenous gemcitabine 1250 mg/mq (days 1, 8 and 15) as a single agent for a total of 3 monthly courses. The responders received another three courses, and the non-responders received three courses of gemcitabine 1000 mg/mq (days 1, 8 and 15) plus cisplatin 80 mg/mq (day 1). No grade 4 hematological toxicity was seen after gemcitabine treatment, whereas > or = 3 grade neutropenia and thrombocytopenia were seen in 21 and 13% of the gemcitabine-cisplatin infusions, respectively. Non-hematological toxicity was negligible for both the regimens. After three courses of gemcitabine as a single agent, th e response rate was 31% (1 complete response, 1 partial response and 3 minimal response). Eight patients (50%) achieved stable disease and 3 (19%) had disease progression. Ten patients received gemcitabine-cisplatin and were evaluable for the response. Two patients progressed, four maintained stable disease whereas four patients, unresponsive to gemcitabine, obtained a response (3 partial response and 1 minimal response). With a median follow-up of 13 months (range 8-17.5), 7 patients (44%) died, 5 (31%) had disease progression, 1 (6%) relapsed, 1 was still in partial response (+11 months) and 2 (13%) had a stable disease. Median time to treatment failure (TTF) was 8 months (CI95%: 7.6-8.4) and median overall survival (OS) was 16 months (CI95%: 10-22). These results showed that gemcitabine and gemcitabine-cisplatin were feasible regimens and well tolerated in advanced relapsed-refractory MM. The response rates, the TTF and OS were similar to other salvage chemotherapy regimens; nevertheless, the quality of response was modest particularly after gemcitabine alone. Better results might be obtained combining gemcitabine with other chemotherapy compounds or with biologically based therapies.     

Single-agent gemcitabine in pretreated patients with non-small-cell lung cancer: results of an Argentinean multicentre phase II trial.

The activity and mild toxicity profile of single-agent gemcitabine therapy in untreated (chemonaive) patients with non-small-cell lung cancer (NSCLC) is well documented. This phase II trial was conducted to determine the objective tumour response rate and toxicity profile of single-agent gemcitabine in pretreated patients with NSCLC. Patients with histological evidence of advanced NCSLC stage IIIB or IV; at least one prior chemotherapy regimen including a platinum or taxane analogue; an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; clinically measurable disease; adequate bone marrow reserve; and adequate renal function; received 1000 mg m(-2) gemcitabine administered over 30 min on days 1, 8 and 15 of a 28-day cycle defined as 3 weekly treatments followed by 1 week of rest. Twenty-nine patients were evaluated for efficacy and 32 for toxicity. One patient achieved a complete response and five patients had a partial response resulting in a total response rate of 20.6% (95% confidence interval (CI) 6-34). Median response duration was 7 months (range 4-11 months). Twelve (41%) patients reached stable disease after two cycles of therapy and 11 (38%) patients had disease progression. Median progression-free survival time was 3 months and median overall survival time was 5.5 months. Toxicity was generally mild (grades 0-2). Severe (grade 3 or 4) haematological toxicities included grade 3 anaemia in one patient and grade 3 thrombocytopenia in two patients. Severe non-haematological toxicities included one patient each with grade 3 liver transaminase elevations, nausea/vomiting and diarrhoea. This study confirms the activity and safety of single-agent gemcitabine in pretreated patients with advanced NSCLC who are refractory or sensitive to first-line therapy.     

A phase II trial of gemcitabine and docetaxel in patients with chemotherapy-naive,advanced nonsmall cell lung carcinoma

BACKGROUND: The goals of the current study were to determine the safety and efficacy of a nonplatinum-containing doublet, gemcitabine and docetaxel, in the treatment of patients with chemotherapy-naive nonsmall cell lung carcinoma (NSCLC). METHODS: Thirty-two patients with advanced, chemotherapy-naive NSCLC were treated with gemcitabine (1000 mg/m(2)) and docetaxel (40 mg/m(2)) administered on Days 1 and 8 every 21 days. All patients were evaluable for toxicity and survival and 27 patients were evaluable for response. RESULTS: This combination was extremely well tolerated with Grade 3 or 4 neutropenia occurring in 6 of 32 patients (19%) (grading was based on the National Cancer Institute Common Toxicity Criteria). There were two episodes of Grade 3 thrombocytopenia and no episodes of Grade 3 or 4 anemia. Grade 3 or 4 nonhematologic toxicities included nausea (occurring in 1 of 32 patients), diarrhea (occurring in 1 of 32 patients), fatigue (occurring in 10 of 32 patients), fluid retention (occurring in 2 of 32 patients), anorexia (occurring in 4 of 32 patients), and transaminitis (occurring in 2 of 32 patients). Six patients experienced Grade 3 pneumonitis that was at least possibly related to the combination of gemcitabine and docetaxel. There was 1 complete response and 7 partial responses for an overall response rate of 30%. The 1-year and median survivals were 35% and 7.9 months, respectively. CONCLUSIONS: In the current study, the regimen of gemcitabine (1000 mg/m(2)) and docetaxel (40 mg/m(2)) administered on Days 1 and 8 every 21 days was well tolerated with manageable hematologic and nonhematologic toxicities. The responses were comparable to those achieved with platinum-based combination chemotherapy and the 2-year survival was an encouraging 19%. These data would support the further study of this nonplatinum doublet in patients with advanced NSCLC.     

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。     

吉西他滨联合奥沙利铂治疗晚期胰腺癌患者的疗效

背景与目的:吉西他滨是目前治疗晚期胰腺癌的最有效的药物之一,初步的研究显示,与奥沙利铂联合(GEMOX)的疗效优于吉西他滨单药,但国内使用GEMOX方案治疗胰腺癌的研究报道并不多.本研究目的是观察GEMOX方案治疗晚期胰腺癌患者的有效率、生存期和毒副反应,为临床治疗提供指导.方法:本研究为单中心、回顾性临床分析.选择32例未接受过化疗的初治Ⅲ～Ⅳ期胰腺癌患者,所有患者均至少接受2个周期的GEMOX方案(吉西他滨1000 mg/m2,静脉滴入,d1、d8;奥沙利铂85～130 mg/m2,静脉滴入,d1;每21 d重复)化疗.结果:28例患者可评价疗效,8例部分缓解(partial remission,PR),8例病情稳定(stable disease,SD),12例病情进展(progressive disease,PD),4例不能评估(not assessable,NA),总有效率为25.0%,临床获益率46.9%(15例),中位无进展生存期(progression-free survival,PFS)为4.7个月,中位生存期8.6个月,1年生存率为32.6%.骨髓抑制的总发生率为70.9%,其中Ⅲ、Ⅳ度的发生率为32.3%(白细胞下降的发生率为19.4%,血红蛋白下降的发生率为12.9%,血小板下降的发生率为22.6%).恶心、呕吐和腹泻的发生率为56.2%,其中Ⅲ度呕吐2例.肝功能异常的总发生率为25.0%,全部为Ⅰ、Ⅱ度.外周神经毒性发生率为43.8%,全部为Ⅰ度.无化疗相关的死亡.结论:GEMOX方案是治疗晚期胰腺癌的有效方案,总体临床耐受性良好,其主要的不良反应为骨髓抑制.     

Phase II clinical study of gemcitabine in the treatment of patients with advanced nasopharyngeal carcinoma after the failure of platinum-based chemotherapy

Purpose This study was designed to evaluate the anti-tumor activity and toxicity profile of gemcitabine in the treatment of patients with advanced nasopharyngeal carcinoma (NPC) who had been pretreated with platinum-based chemotherapy. Method This is an open label, single arm phase II trial. All patients were treated with single agent of gemcitabine. Gemcitabine was given in the dosage of 1.0 g/m² on days 1, 8, 15, each cycle repeated every 4 weeks. Gemcitabine was added to 100 ml normal saline infused over 30 min. Result About 32 patients were enrolled in this trial. Thirty patients were assessable for response to treatment. Fourteen patients had a partial response (PR), giving an overall response rate of 43.8% (14/32); 9 patients had stable disease (28.1%) and 7 progressed disease (21.9%). The median time to progression was 5.1 months and median survival time was 16 months, 1 year survival rate was 67%, 2 year overall survival rate was 12%. A total of 11 patients (34.4%) experienced grade 3 and 4 toxicity and the main toxicity was myelosuppression. the non-hematology toxicity was minimal. Conclusion The effectiveness of gemcitabine was higher and side effects were minimal in advanced NPC patients after platinum-based chemotherapy failed. This paper was presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, 2004.     

吉西他滨联合奈达铂与紫杉醇治疗顺铂耐药的转移性鼻咽癌

 目的　观察吉西他滨联合奈达铂与紫杉醇治疗对顺铂耐药的转移性鼻咽癌的近期疗效及不良反应。 方法　15例顺铂方案化疗失败的转移性鼻咽癌患者。吉西他滨1000 mg／m2,第1、8天;奈达铂70 mg／m2,第1天;紫杉醇135 mg／m2,第1天;21 d为1个疗程,疗效评价采用RECIST 3.0标准。结果　全组15例患者CR 1例 ,PR 5例 ,SD 6例 ,PD 3例 ,总有效（CR+PR）率40.0 %。中位TTP为4.7个月,中位生存期为6.3个月。主要不良反应为血液学毒性,Ⅲ＋Ⅳ度骨髓抑制的发生率分别为：白细胞减少40.0 %、贫血6.7 %、血小板减少20.0 %。其他不良反应轻微。结论　吉西他滨联合奈达铂与紫杉醇的化疗方案可作为顺铂耐药转移性鼻咽癌的二线方案。