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.     

吉西他滨固定剂量率输注联合奥沙利铂一线治疗晚期胰腺癌的Meta分析

背景与目的:有研究提示吉西他滨(Gemcitabine,GEM)固定剂量率(Fixed-dose rate,FDR)输注治疗晚期胰腺癌似有较好的疗效,Meta分析也显示含铂类联合化疗优于GEM单药化疗,本文试图通过Meta分析,探讨GEM FDR输注联合奥沙利铂(GEMOX)一线治疗晚期胰腺癌的地位和价值.方法:通过MEDLINE、EMBASE、ASCO等数据库及论文集检索国内外的相关文献.选择治疗组为GEMOX方案化疗,对照组为标准GEM单药化疗的晚期胰腺癌随机对照试验.由2位评价者分别按上述检索策略收集资料,按纳入标准入选,主要对总生存率及主要不良反应进行Meta分析.结果:从182篇文献中筛选出符合纳入标准的2个随机对照试验,共涉及869例患者.与GEM单药组比较,GEMOX组半年生存率提高9%(95%CI 0.03～0.16,P=0.005),1年生存率提高5%(95%CI-0.01～0.11,P=0.08),客观有效率提高6%(95%CI 0.02～0.10,P=0.006);WHO Ⅲ/Ⅳ度贫血发生率下降5%(95%CI-0.08～-0.01,P=0.01),恶心/呕吐提高13%(95%CI 0.08～0.18,P＜0.001),神经毒性增加14%(95%CI 0.04～0.24,P=0.009),粒细胞减少症、血小板减少症两组相似,差异无统计学意义.结论:现有的证据提示,GEM固定剂量率输注联合奥沙利铂组成的GEMOX方案一线治疗晚期胰腺癌可能有较好的应用前景,值得进行进一步的临床试验.     

吉西他滨联合奥沙利铂治疗晚期胰腺癌的临床观察

为观察吉西他滨（GEM）联合奥沙利铂（OXA）治疗晚期胰腺癌的有效性和安全性。对30例晚期胰腺癌患者,应用GEM1000mg/m2,静脉滴入30min,d1、d8;OXA100mg/m2,静脉滴入2h,d1,21d重复。至少接受2个周期的化疗。结果30例均可评价疗效,客观有效率20.00%,临床受益疗效分别为疼痛缓解率53.33%（16/30）,行为状态改善率45.33%（13/30）,体质量状态改善率36.33%（10/30）。主要不良反应为骨髓抑制、外周神经毒性及胃肠道反应,无治疗相关性死亡。初步研究结果显示,GEM联合OXA组成的GEMOX方案治疗晚期胰腺癌近期有效率较高,毒性较低,值得临床推广应用。     

健择联合奥沙利铂双周方案治疗胰腺癌作用探讨

目的：比较健择联合奥沙利铂双周化疗方案和健择单药每周方案治疗胰腺癌的疗效及不良反应方法：选择我科2003年11月至2005年1月胰腺癌患者30例．采用健择联合奥沙利铂双周化疗方案（设为A组：健择1000mg／m^2d1，奥沙利铂100mg／m^2d2，每隔14天进行1个周期）进行治疗；随机选择同时期使用健择单药方案（设为B组：健择1000mg／m^2单药，每周1次，连续3周，随后休息1周为1个周期）化疗的胰腺癌患者30例做对照,比较两方案治疗胰腺癌的疗效和不良反应的差异。结果：A组PR3例，SD21例，PD6例，1年生存率为16.7％（5／30）B组PR1例，SD14例，PD15例，1年生存率为10.0％（3／30）。化疗的主要不良反应包括：恶心、呕吐，骨髓抑制和外周神经毒性。结论：健择加奥沙利铂双周化疗方案在抑制肿瘤发展、延长生存期方面略优于传统健择单药方案，而两者不良反应大体相当，推荐临床使用。     

奥沙利铂联合吉西他滨治疗晚期非小细胞肺癌的疗效观察

目的：观察奥沙利铂（OXA）联合吉西他滨（GEM）治疗晚期非小细胞肺癌（NSCLC）的疗效和毒副反应.方法：54例经病理组织学证实的NSCLC初治患者,临床分期Ⅲb-Ⅳ期,随机分为GEMOX组（GEM＋OXA）和GP组（GEM＋ DDP）.GEMOX组（GEM） 1000mg/m2,d1,d8;OXA 130mg/m2,d1.GP组（DDP） 25mg/m2,d1-3;GEM 1000mg/m2,d1,d8,二组均28d/周期.连用3个周期后评价有效率、中位生存时间和毒副反应.结果：GEMOX组28例中,CR 1例,PR 12例,NC 10例,PD 5例,有效率（RR）为46.4％,疾病控制率（DCR）为82.1％;GP组26例中,RR 42.3％,DCR 76.9％ （P =0.761）;中位生存时间GEMOX组7.1个月,GP组6.5个月（P＞0.05）.GEMOX组主要毒性反应为骨髓抑制,消化道反应如食欲不振（P＜0.001）及恶性、呕吐较GP组轻（P =0.006）,未发现明显的肝肾毒性、周围神经毒性等.结论：OXA联合GEM治疗晚期NSCLC的疗效与DDP联合GEM相当,但不良反应较轻,耐受性好.     

Gemcitabine plus oxaliplatin combination (GEMOX regimen) in pretreated patients with advanced non-small cell lung cancer (NSCLC): a multicenter phase II study

PURPOSE: To evaluate the activity and tolerance of gemcitabine in combination with oxaliplatin (GEMOX regimen) in pretreated patients with advanced non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Thirty-two patients with advanced NSCLC who had disease progression after a cisplatin- and taxane-based front-line regimen were treated with gemcitabine (1500 mg/m(2) on days 1 and 8) and oxaliplatin (130 mg/m(2) on day 8) every 3 weeks. The patients' median age was 62 years and the performance status (WHO) was 0 for 11, 1 for 17 and 2 for 4 patients. The treatment was second line for 22 (69%) and >or=third line for 10 (31%) patients. RESULTS: Partial response was achieved in 5 (16%) patients, stable disease in 8 (25%) and progressive disease in 19 (59%). Two patients with stable disease and one patient with progressive disease while on previous chemotherapy experienced a partial response with GEMOX regimen. The median duration of response was 2.5 months (range, 1-11.5), the median time to tumor progression 3 months (range, 1-18) and the median survival 5.6 months (range, 1-31). Grade III neutropenia occurred in five (16%) patients, grade III thrombocytopenia in two (6%) and grade III anemia in three (9%); moreover, grades II-III asthenia was reported in eight (25%) patients and grades II-III neurotoxicity in three (9%). CONCLUSION: The GEMOX combination is a relatively active and well tolerated second-line regimen in NSCLC patients pretreated with a taxane- and/or platinum-based chemotherapy.     

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.     

Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study

BACKGROUND: New systemic therapies are needed to improve the prognosis of patients with advanced-stage hepatocellular carcinoma (HCC). In a Phase II trial involving previously untreated patients with advanced HCC, the more favorable schedule from a previous pilot study was evaluated. METHODS: Thirty-four patients with previously untreated advanced-stage HCC were prospectively enrolled. The GEMOX regimen consisted of gemcitabine 1000 mg/m(2) on Day 1 and oxaliplatin 100 mg/m(2) on Day 2. The treatment was repeated every 2 weeks until disease progression or limiting toxicity. RESULTS: Thirty-two patients were assessable for efficacy and 33 for toxicity. In all, 323 treatment cycles were administered. No toxic deaths occurred. Hematological grade 3-4 toxicity consisted of thrombocytopenia (27% of patients) and neutropenia (24%), including 2 febrile neutropenia and anemia (9%). Grade 3 oxaliplatin-induced neurotoxicity was observed in 3 (9%) patients. The overall response rate was 18% (95% confidence interval [CI]: 8-34) and disease stabilization was observed in 58% of patients (including 5 minor responses), giving a disease control rate of 76%. Median progression-free and overall survival times were, respectively, 6.3 months (95% CI: 4.3-10.1 months) and 11.5 months (95% CI: 8.5-14.3 months). Treatment was significantly more effective in patients with nonalcoholic cirrhosis than in those with alcoholic cirrhosis. CONCLUSIONS: The GEMOX regimen seems to be well tolerated and active in advanced HCC, especially in patients with underlying nonalcoholic liver disease. A Phase II study of the GEMOX regimen plus cetuximab is ongoing.     

Modulation of GemOx chemotherapy according to CIRS in elderly patients with advanced pancreatic cancer

The present study evaluated activity and toxicity of modulated doses of gemcitabine associated to oxaliplatin in patients with secondary CIRS and with locally advanced pancreatic adenocarcinoma (LAPC) and metastatic pancreatic adenocarcinoma (MPC). Since January 2006, untreated LAPC and MPC patients have been assessed with ADL, IADL, CIRS to modulate chemotherapy dosages according to co-morbidity stage. Patiens aged<75 years, co-morbidity stage primary/intermediate, or ≥75 years and co-morbidity stage primary, received gemcitabine 1,000 mg/m2 as a 10 mg/m2/min infusion on day 1 and oxaliplatin 70 mg/m2 as a 2-h infusion on day 2 every 2 weeks. Patiens aged<75 years, co-morbidity stage secondary or ≥75 years and co-morbidity stage intermediate/secondary patients received gemcitabine 800 mg/m2. Primary endpoint was the overall response rate (ORR). Secondary endpoints were disease control rate (DCR), PFS, OS and toxicity. Thirty-one patients were recruited: 26% (8/31) LAPC and 74% (23/31) MPC; median age 69 years. Co-morbidity stage primary/intermediate, 19; secondary, 12. Twenty-seven valuable patients: ORR 30% (CI±0.14); disease control rate 85% (CI±0.18). Median follow-up 13 months: median PFS and OS were 6 and 15 months, respectively. Valuable cycles 140. Grade 3/4 toxicity per patient: leukopenia, 18.5%; neutropenia, 55,5%; thrombocytopenia, 7.4%; SGOT/SGPT, 7.4%; gamma-GT, 7.4%; fever without neutropenia, 3.7%. Median received dose intensity: gemcitabine 400 mg/m2/w; oxaliplatin 35 mg/m2/w. Modulation of GemOx chemotherapy according, to CIRS stage in advanced pancreatic cancer confirms reported efficacy and tolerability.     

吉西他滨固定剂量率静滴联合奥沙利铂治疗晚期胆道癌的临床研究

[目的]评价吉西他滨固定剂量率静滴联合奥沙利铂（GEMOX方案）治疗晚期胆道癌的疗效和毒副作用。[方法]47例晚期胆道癌患者均接受吉西他滨1 000mg/m2,10mg/（m2.min）静滴,d1、8;奥沙利铂130mg/m2,静脉滴注2h,d1;每3周重复。至少化疗3个周期。[结果]47例患者均可评价疗效,无完全缓解病例,部分缓解9例（19.2%）,稳定22例（46.8%）,进展16例（34.0%）,总有效率（CR＋PR）为19.2%（9/47）。中位无进展生存期（PFS）4.7个月,中位总生存期（OS）9.3个月。主要毒副反应为中性粒细胞减少、血小板减少,恶心、呕吐,肝肾和外周神经毒性等。[结论]吉西他滨固定剂量率静滴联合奥沙利铂治疗晚期胆道癌有效,但其血液学毒性需引起重视。     

吉西他滨联合奥沙利铂治疗晚期胰腺癌

目的:观察吉西他滨(GEM)联合奥沙利铂(OXA)组成的GEMOX方案治疗国人晚期胰腺癌的有效性和安全性。方法:晚期胰腺癌22例,应用GEM1000mg/m2静滴30min,d1,d8;OXA100mg/m2静滴2h,d1,d8,21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:22例均可评价疗效,客观有效率18·18%,临床受益疗效分别为疼痛缓解率54·55%,行为状态改善率45·45%,体重状态改善率36·33%。主要不良反应为骨髓抑制、外周神经毒性及胃肠道反应,无治疗相关性死亡。结论:吉西他滨联合奥沙利铂组成的GEMOX方案治疗国人晚期胰腺癌近期有效率较高,毒性较低,值得临床推广应用。     

Bevacizumab plus gemcitabine and oxaliplatin as first-line therapy for metastatic or locally advanced pancreatic cancer: a phase II trial

Purpose

The gemcitabine and oxaliplatin (GEMOX) has yielded among the longest progression-free survival durations in patients with advanced pancreatic cancer (APC). We postulated that adding bevacizumab would increase the effectiveness of GEMOX.

Methods

Eligible patients had stage III or IV pancreatic cancer, ECOG PS 0-2, and no prior gemcitabine. Treatment included 1,000?mg/m² intravenous gemcitabine over 100?min on day 1, 10?mg/kg intravenous bevacizumab on day 1, and 100?mg/m² oxaliplatin given on day 2. Cycles were repeated every 2?weeks. CT imaging was performed every 6?weeks.

Results

Fifty patients were enrolled: 14 had stage III disease, the remainder stage IV. Median age was 59?years. Fourty-five patients were ECOG 0-1. The grade 3?C4 toxicity rate was 94%; fatigue (47%) and nausea (40%) were frequent. One patient died after a bowel perforation; a second died of a CVA. The median PFS was 4.9?months; median survival was 11.9?months; 1?year survival was 42%. Locally advanced patients lived 12.8?months; metastatic patients lived 10.2?months. Patients developing grade 3 hypertension were more likely to have a radiologic response (P?=?.012); survival among the top and bottom quintiles of hypertension was 14.7 and 6.2?months, respectively. Survival correlated with baseline CA 19?C9 (P?=?.004) and radiologic response. The overall response rate was 36%; 34% demonstrated stable disease.

Conclusions

The GEMOX/bevacizumab regimen demonstrated an excellent median overall survival but did not meet our objective of a 14?month median survival. Toxicity was significant. We do not recommend further evaluation of this regimen.     

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。     

吉西他滨联合奥沙利铂治疗晚期胰腺癌30例

Objective: To evaluate the activity and safety of combination chemotherapy with gemcitabine plus oxaliplatin (GEMOX regimen) in patients of advanced pancreatic carcinoma. Methods: 30 patients with advanced pancreatic cancer were enrolled into this study. All patients received gemcitabine 1000 mg/m2, given by 30-minute intravenous infusion, on days 1 and 8 of each 21-day cycle. Oxaliplatin 100 mg/m2 was administered as a 2 h infusion on day 1 of each 21 day. Clinical outcomes for patients treated with two cycles of chemotherapy were evaluated according to WHO criteria. Results: All 30 patients were eligible for effectiveness and safety analysis. Objective response rate was approximately 20.0%. Clinical benefit response (CBR) was a composite of assessment of pain, performance status and body weight. The pain relief rate, improve-ment rate of performance status and body weight were 53.3%, 46.7% and 36.7%, respectively. The main adverse effects were bone marrow depression, peripheral nerve toxicity and gastrointestinal reaction. There was no treatment-related death during the chemotherapy. Conclusion: The high response rate with low toxicity observed in this study suggests that GEMOX regimen may be an effective alternative curative treatment for patients with advanced pancreatic carcinoma and can be used more extensively in clinical practice.     

Irinotecan plus gemcitabine results in no survival advantage compared with gemcitabine monotherapy in patients with locally advanced or metastatic pancreatic cancer despite increased tumor response rate.

PURPOSE: This phase III, randomized, open-label, multicenter study compared the overall survival associated with irinotecan plus gemcitabine (IRINOGEM) versus gemcitabine monotherapy (GEM) in patients with chemotherapy-naive, locally advanced or metastatic pancreatic cancer. PATIENTS AND METHODS: IRINOGEM patients received starting doses of gemcitabine 1,000 mg/m2 and irinotecan 100 mg/m2 given weekly for 2 weeks every 3-week cycle. GEM patients received gemcitabine 1,000 mg/m2 weekly for 7 of 8 weeks (induction) and then weekly for 3 of 4 weeks. The primary end point of the trial was survival. Secondary end points included tumor response, time to tumor progression (TTP), changes in CA 19-9, and safety. RESULTS: In each arm, 180 randomly assigned patients comprised the intent-to-treat population evaluated for efficacy; 173 IRINOGEM and 169 GEM patients were treated. Median survival times were 6.3 months for IRINOGEM (95% CI, 4.7 to 7.5 months) and 6.6 months for GEM (95% CI, 5.2 to 7.8 months; log-rank P =.789). Tumor response rates were 16.1% (95% CI, 11.1% to 22.3%) for IRINOGEM and 4.4% (95% CI, 1.9% to 8.6%) for GEM (chi2 P <.001). Median TTP was 3.5 months for IRINOGEM versus 3.0 months for GEM (log-rank P =.352). However, subset analyses in patients with locally advanced disease suggested a TTP advantage with IRINOGEM versus GEM (median, 7.7 v 3.9 months). CA 19-9 progression was positively correlated with tumor progression. The incidence of grade 3 diarrhea was higher in the IRINOGEM group but grade 3 to 4 hematologic toxicities and quality-of-life outcomes were similar. CONCLUSION: IRINOGEM safely improved the tumor response rate compared with GEM but did not alter overall survival.     

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。     

沙利度胺联合GEMOX方案治疗中晚期肝癌的临床观察

目的观察沙利度胺联合吉西他滨及奥沙利铂（GEMOX方案）治疗原发性肝癌的有效性和安全性。方法对15例中晚期肝癌患者行沙利度胺（400 mg/天）,吉西他滨（1 000 mg/m2,第1,8天）及奥沙利铂（130 mg/m2,第1天）方案联合化疗2,1天为1个周期。以RECIST标准评价疗效,以NCI标准评价不良反应。结果 15例患者均可评价客观疗效及不良反应。其总有效率（RR）为40.0%（6/15）,疾病控制率（DCR）为73.3%（11/15）。中位疾病进展时间（TTP）5.5个月。治疗后KPS评分明显改善。结论沙利度胺联合吉西他滨及奥沙利铂治疗原发性肝癌安全有效,耐受性良好。     

Combination of low-dose cisplatin and gemcitabine for treatment of elderly patients with advanced non-small-cell lung cancer

PURPOSE: To evaluate the feasibility, toxicity and efficacy of the combination of low-dose cisplatin (CDDP) and gemcitabine (GEM) in elderly patients with advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: This phase II trial included 46 patients aged 70 years or older with previously untreated advanced NSCLC. All patients were evaluable for response and toxicity. Treatment consisted of CDDP 50 mg/m(2) on day 1 plus GEM 1000 mg/m(2) on days 1 and 8. The regimen was repeated every 21 days. Patients received a minimum of three courses unless progressive disease was detected. RESULTS: A total of 190 GEM-CDDP courses were administered (median 4.1 courses per patient). The chemotherapy regimen was well tolerated. No patients developed grade 4 toxicity. Grade 3 toxicities were as follows: neutropenia in six patients (13%), and anemia, thrombopenia and nausea/vomiting in one (2%) each. Two patients (4%) had mild nephrotoxicity. Of the 46 patients, 16 had a partial response (35%, 95% confidence interval, CI, 28-52%), 17 (37%) remained stable and 13 (28%) had disease progression. Eastern Cooperative Oncology Group performance status improved in 17 patients (37%), whereas 25 (54%, 95% CI 44-74%) showed a clinical benefit. Median time to progression was 20 weeks. Overall median survival was 44 weeks, with a 1-year actuarial survival rate of 35%. CONCLUSIONS: The combination of low-dose CDDP and GEM for elderly patients with advanced NSCLC is an effective and well-tolerated chemotherapeutic approach.     

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.