奥沙利铂联合卡培他滨治疗晚期胃癌23例

目的 观察奥沙利铂(L-OHP)联合卡培他滨(Cap)治疗晚期胃癌的近期疗效和安全性.方法 采用FOLFOX4方案,即L-OHP85 mg/m2静脉滴注2h,第1天,四氢叶酸钙(CF)200mg/m2静脉滴注2h,第1、2天,注射后立即静脉推注5-氟尿嘧啶(5-Fu)400mg/m2,第1、2天,5-Fu600mg/m2持续静脉滴注第1、2天;每2周重复,28 d为1个周期.改良XELOX方案,即L-OHP 85mg/m2静脉滴注2 h,第1天,Cap每天2000mg/m2分两次口服第1天至第10天,每2周重复,28 d为1个周期.2个周期化疗结束后进行疗效评价.结果 入组观察43例,总有效率为46.5%.其中FOLFOX4组有效率为45.0%,中位疾病进展时间(TTP)为24周;改良XELOX方案组总有效率为47.8%,中位TTP为27周.两组有效率和TTP比较差异无统计学意义.患者不良反应主要为外周神经感觉异常,症状可逆.结论 L-OHP联合Cap治疗晚期胃癌疗效较好,患者不良反应可耐受.     

XELOX与FOLFOX6方案一线治疗晚期结直肠癌的近期疗效及不良反应比较

目的:比较卡培他滨(希罗达)联合奥沙利铂(XELOX)方案与亚叶酸钙、5-氟尿嘧啶(5-FU)联合奥沙利铂(FOLFOX6)方案一线治疗晚期转移性结、直肠癌的疗效和不良反应.方法: 将62例晚期结、直肠癌患者随机分为两组,XELOX方案组(n=31):卡培他滨(capecitabine,Xeloda)1000mg/m2,2次/d,口服,第1天至第14天;奥沙利铂(oxaliplatin)130mg/m2,静脉滴注,持续3h,第1天;21天为1周期.FOLFOX6方案组(n=31):亚叶酸钙(CF)200mg/m2,静脉滴注,第1天,5-FU前;5-FU 400mg/m2,静脉推注,第1天,2400mg/m2,静脉持续滴注46h;奥沙利铂100mg/m2,静脉滴注,持续3h,第1天;14天为1周期. 结果: XELOX组缓解率(RR)为48.4%,中位肿瘤进展时间(TTP)6.8个月;FOLFOX6组RR为51.6%,TTP为7.1个月;两组比较各项指标差异无统计学意义(P＞0.05).不良反应中XELOX组手足综合征发生率高于FOLFOX组,Ⅲ、Ⅳ度中性粒细胞减少发生率低于FOLFOX6组.结论: XELOX 方案一线治疗晚期结、直肠癌有确切疗效,不良反应能耐受,与FOLFOX6方案相当,但XELOX方案用药更为方便,安全性更好.     

奥沙利铂联合氟尿嘧啶类药物二线治疗晚期胃癌的临床研究

目的观察奥沙利铂联合氟尿嘧啶类药物二线治疗晚期胃癌的近期疗效和安全性。方法采用FOLFOX4方案，即奥沙利铂(L-OHP)85mg／m^2静脉滴注2h，d1，四氢叶酸钙(CF)200mg/m^2静脉滴注2h，d1、d2，注射后立即静脉推注氟尿嘧啶(5-FU)400mg/m^2，d1、d2，5-FU 600mg／m^2持续静滴d1、d2；每二周重复，28天为一周期。或改良XELOX方案，即L-OHP 85mg／m^2静脉滴注2h，d1、d15，卡培他滨(Cap)1250mg／m^2分两次口服d1～d14，28天为一周期。二个周期化疗结束后进行疗效评价。结果入组观察43例，总有效率为30.2％。其中FOLFOX4组有效率为31.6％，中位TTP为6个月；改良XELOX方案组总有效率为29．2％，中位TTP为5个月。两组总有效率和TTP比较差异无显著性。毒副反应主要为外周神经感觉异常，症状可逆。结论奥沙利铂联合氟尿嘧啶类药物二线治疗晚期胃癌疗效较高，毒副反应可耐受。     

XELOX与FOLFOX6方案一线治疗晚期结直肠癌的近期疗效及不良反应比较

目的：比较卡培他滨（希罗达）联合奥沙利铂（XELOX）方案与亚叶酸钙、5-氟尿嘧啶（5-FU）联合奥沙利铂（FOLFOX6）方案一线治疗晚期转移性结、直肠癌的疗效和不良反应。方法：将62例晚期结、直肠癌患者随机分为两组,XELOX方案组（n=31）：卡培他滨（capecitabine,Xeloda）1000mg／m^2,2次／d,口服,第1天至第14天;奥沙利铂（oxaliplatin）130mg／m^2,静脉滴注,持续3h,第1天;21天为1周期。FOLFOX6方案组（n=31）：亚叶酸钙（CF）200mg／m^2,静脉滴注,第1天,5-FU前;5-FU400mg／m^2,静脉推注,第1天,2400mg／m^2,静脉持续滴注46h;奥沙利铂100mg／m^2,静脉滴注,持续3h,第1天;14天为1周期。结果：XELOX组缓解率（RR）为48．4％,中位肿瘤进展时间（TTP）6．8个月;FOLFOX6组RR为51．6％,TTP为7．1个月;两组比较各项指标差异无统计学意义（P〉0．05）。不良反应中XELOX组手足综合征发生率高于FOLFOX组,Ⅲ、Ⅳ度中性粒细胞减少发生率低于FOLFOX6组。结论：XELOX方案一线治疗晚期结、直肠癌有确切疗效,不良反应能耐受,与FOLFOX6方案相当,但XELOX方案用药更为方便,安全性更好。     

L-OHP联合5-FU/LV二线治疗晚期大肠癌2周方案与3周方案的临床比较

目的比较奥沙利铂(L-OHP)联合氟尿嘧啶/亚叶酸钙(5-FU/LV)的2周方案与3周方案二线治疗晚期结直肠癌的临床疗效及不良反应。方法晚期复治的结直肠癌病例,A组22例,予L-OHP85mg/m2,d1,静脉滴注3小时,同时或之后予CF200mg/m2,静脉滴注2小时,续5-FU400mg/m2,静脉推注,600mg/m2持续静脉滴注22小时,次日重复CF与5-FU。每2周重复1次,每2次计为l周期。B组24例,予L-OHP130mg/m2,d1,静脉滴注3小时,CF200mg/m2,静脉滴注2小时,续5-FU375~425mg/m2静脉滴注4~6小时,连用5天。每3周重复1次,每次计为1周期。结果A、B两组分别有21例和23例可评价,RR分别为19·05%和8·70%,中位TTP分别为4·0和3·0月,两组病例不良反应发生率相似,主要表现为消化道反应、神经系统毒性和脱发。结论L-OHP联合5-FU/LV的2周方案在临床疗效方面优于3周方案。     

XELOX与FOLFOX4方案治疗进展期胃癌的随机对照临床研究

目的:评价卡培他滨联合奥沙利铂方案(XELOX)与氟尿嘧啶/亚叶酸钙联合奥沙利铂方案(FOLFOX4)治疗进展期胃癌的临床疗效及不良反应.方法:54例进展期胃癌患者随机分成两组,XELOX组28例,卡培他滨1000mg/m2,口服,2次/日,第1-14天;奥沙利铂135mg/m2,静脉点滴,第1天,21天为1个周期.FOLFOX4组26例,奥沙利铂85mg/m2,静脉点滴,第1天;亚叶酸钙200mg/m2,静滴2h后予氟尿嘧啶400mg/m2,推注,后续600mg/m2持续静滴2h,第1、2天,每2周重复,4周为1周期.两组均治疗4周期以上.结果:XELOX组有效率53.57%,中位TTP 5.8个月,MST 10个月,FOLFOX4组有效率46.15%,中位TTP 5.7个月,MST 9.8个月.两组近期有效率差异无显著性.不良反应比较,手足综合征以XELOX组显著(P<0.05),III/IV级恶心呕吐发生率以FOLFOX4组显著(P<0.05),其余不良反应除腹泻外发生率以FOLFOX4组稍高,但差异无显著性.结论:XELOX方案与FOLFOX4方案治疗进展期胃癌疗效确切,不良反应能耐受,两组近期疗效相似,不良反应以XELOX组更易耐受,尤其对一般情况欠佳及老年的患者耐受性好.     

介入、热疗联合FOLFOX辅助治疗术后Ⅲ期结肠癌患者的疗效分析

背景与目的:奥沙利铂(oxaliplatin,L-OHP)联合氟尿嘧啶(5-fluorouracil,5-FU)、亚叶酸钙(calcium folinatc,CF)方案为Ⅲ期结肠癌患者标准治疗方案,但L-OHP联合方案带来较多的不良反应,为此寻找不同的方法以减少药物毒性是治疗的关键.本文评价Ⅲ期结肠癌患者术后辅助介入、热疗联合化疗的临床疗效及不良反应.方法:回顾性分析2003年-2005年本科室治疗的123例Ⅲ期结肠癌术后患者的临床资料.根据不同的疗法,将患者随机分为3组.FOLFOX单纯化疗组(A组)57例,给予L-OHP 130 mg/m2静脉滴注,持续3.5 h,第1天;CF 200 mg/m2静脉滴注,持续2 h,第1～5天;5-FU 300 mg/m2静脉滴注,持续6 h,第1～5天;FOLFOX+介入治疗组(B组)35例,给予L-OHP、5-FU和CF,并以介入方式灌注肠系膜动脉,第1天,其余同A组;FOLFOX+热疗组(C组)31例,在A组基础上,于L-OHP静脉滴注时热疗.3种方案均为每3周重复1次,共8个周期.观察患者的3年无病存活率(disease-free survival,DFS)和5年存活率(overall survival,OS)及药物的不良反应等.结果:3组患者的DFS分别为71.9%、77.1%和77.4%,差异无统计学意义(P=0.793).3组患者的OS分别为56.1%、57.1%和58.1%,差异无统计学意义(P=0.984).B、C组患者的中性粒细胞减少及外周神经系统不良反应低于A组,差异有统计学意义(P＜0.001).结论:Ⅲ期结肠癌患者术后辅助治疗选择介入、热疗联合化疗安全、有效,临床疗效与文献报道相仿.     

XELOX方案治疗晚期结直肠癌临床观察

目的比较卡培他滨(希罗达)联合奥沙利铂(XELOX)方案与亚叶酸钙、氟尿嘧啶(5-Fu)联合奥沙利铂(FOLFOX4)方案一线治疗晚期转移性结直肠癌的疗效和不良反应。方法将56例晚期结直肠癌患者随机分为两组,XELOX方案组(28例):卡培他滨(capecitabine,Xeloda)1000mg/m2,Bid,口服,d1~14;奥沙利铂(oxaliplatin)130mg/m2,静脉滴注,持续2h,d1;21 d为1周期。FOLFOX4方案组(28例):奥沙利铂85 mg/m2,静脉点滴2 h,d1;醛氢叶酸200 mg/m2,静脉点滴2 h,d1、2;氟尿嘧啶400 mg/m2,莫非氏管静脉推注d1、2;氟尿嘧啶600 mg/m2,静脉持续滴注(化疗泵),持续22 h,d1、2,14 d为1周期。结果 XELOX组总有效率(RR)50.0%,中位肿瘤进展时间(TTP)7.0个月;FOLFOX4组RR为46.4%,TTP为6.8个月;两组比较各项指标差异无显著性(P>0.05)。不良反应中XELOX组手足综合征发生率高于FOLFOX4组,Ⅲ、Ⅳ度中性粒细胞减少发生率低于FOLFOX4组。结论 XELOX方案一线治疗晚期结直肠癌有确切疗效,不良反应可耐受,与FOL-FOX4方案相当,但XELOX方案用药更为方便,安全性更好。     

国产奥沙利铂为主的联合化疗治疗晚期大肠癌临床研究

目的 观察国产注射用奥沙利铂(L-OHP)为主的联合化疗治疗晚期大肠癌的临床疗效和毒副反应.方法治疗组为A组,对照组为B组.A组L-OHP 130 mg/m2,静脉滴注,第1天,注射用亚叶酸钙(CF)200 mg/m2,静脉滴注,第1～5天,氟脲嘧啶脱氧核苷(FUDR)400 mg/m2,静脉滴注,第1～5天,21天为一个周期;B组:CF 200 mg/m2,静脉滴注,第1～5天,FUDR 400 mg/m2,静脉滴注,第1～5天,21天为一个周期.2周期后评定疗效.结果共收入病人51例,A组26例,有效率为46.2%,不良反应主要为感觉神经毒性、恶心、呕吐和白细胞下降;B组25例,有效率12.0%,不良反应主要为恶心、呕吐和白细胞下降,无神经毒性.结论 L-OHP,联合CF+FUDR化疗较CF+FUDR化疗疗效提高,病人的耐受良好,是治疗晚期大肠癌安全有效的方案.     

FOLFOX4方案治疗进展期大肠癌的近期疗效

目的 评价FOLFOX4方案治疗大肠癌的疗效及不良反应.方法对67例大肠癌患者分别采用⑴5-FU/CF方案:(CF 200 mg/m2,iv2小时,5-FU 500 mg/m2,iv22小时)d1～5,三周重复,三周为一疗程;⑵L-OHP+5-FU/CF方案:L-OHP 130 mg/m2,iv2小时,d1,5-FU/CF用法同⑴,三周重复,三周为一疗程;⑶FOLFOX4方案:L-OHP85 mg/m2,iv2小时,d1,(CF 200 mg/m2,iv2小时,5-FU 400mg/m2,冲击,然后5-FU 600 mg/m2,持续iv 22小时)d1、d2,双周重复,四周为一疗程.对三组疗效和副反应进行比较观察.结果 FOLFOX4组一年总生存率是92%,无进展生存期是14个月.三组疗效有明显差异.毒副反应主要是轻度胃肠道反应、骨髓抑制和肝功能损害,周围神经炎能耐受.结论 FOLFOX4方案治疗大肠癌疗效好,毒副反应轻,是治疗大肠癌理想的化疗方案.     

Randomized trial of radiation therapy (RT) plus dibromodulcitol (DBD) versus RT plus BCNU in high grade astrocytoma

Purpose: We performed a randomized trial to comparesurvival distributions and toxicity of radiation therapy (RT)and DBD with RT and BCNU in patientswith high-grade astrocytoma. Methods: A total of 238patients with supratentorial grade 3 and grade 4astrocytoma were studied. Patients were stratified by age,extent of surgery, tumor grade, and performance scoreand randomly assigned to receive RT 55-60 Gyand either DBD, 200 mg/m² orally on Days1–10 every five weeks or BCNU, 200 mg/m²intravenously every seven weeks. Median age was 60years; 62% were 55 years or older. Eighty-threepercent had subtotal resection, 58% had grade 4tumors, and 83% had performance scores of 0–2.Results: Survival distributions for all patients in thetwo arms were similar, with median survival of41 weeks in each arm. Time to progressiondistributions were virtually identical, with medians of 22weeks. BCNU produced significantly greater hematologic toxicity; medianleukocyte and platelet nadirs on the first cyclewere 3.6 vs. 4.7 (P=0.0001) and117 vs. 162 (P < 0.0001), and overallplatelet nadirs were 80.5 vs. 114 (P =0.0019). Non-hematologic toxicities were also significantly greater withBCNU, including nausea (57% vs. 31%; P <0.0001) and vomiting (45% vs. 17%; P <0.0001). Conclusion: This trial found no evidence ofdifferences in treatment efficacy when either DBD orBCNU is combined with radiation therapy for patientswith high-grade astrocytoma.     

Topotecan plus carboplatin versus standard therapy with paclitaxel plus carboplatin (PC) or gemcitabine plus carboplatin (GC) or pegylated liposomal doxorubicin plus carboplatin (PLDC): a randomized phase III trial of the NOGGO-AGO-Study Group-AGO Austria and GEICO-ENGOT-GCIG intergroup study (HECTOR)

The combination of carboplatin and topotecan in platinum-sensitive relapsed ovarian cancer could not improve progression-free survival or overall survival compared with established standard regimens.BackgroundRandomized, phase III trial to evaluate safety and efficacy of topotecan and carboplatin (TC) compared with standard platinum-based combinations in platinum-sensitive recurrent ovarian cancer (ROC).Patients and methodsPatients were randomly assigned in a 1:1 ratio to the experimental TC arm (topotecan 0.75 mg/m²/ days 1–3 and carboplatin AUC 5 on day 3 every 3 weeks) or to one of the standard regimes [(PC) paclitaxel plus carboplatin; (GC) gemcitabine plus carboplatin; (PLDC) pegylated liposomal doxorubicin and carboplatin] which could be chosen by individual preference but before randomization. The primary end point was progression-free survival (PFS) after 12 months. Overall survival (OS), response rate, toxicity, quality of life and treatment preference regarding standard treatment were defined as secondary end points.ResultsA total of 550 patients were recruited. The PFS rate after 12 months was 37.0% for TC compared with 40.2% in the standard combinations (P = 0.470). The overall response rate was 73.1% for TC versus 75.1% for standard combinations (P = 0.149). After a median follow-up of 20 months, the median PFS was 10 months [95% confidence interval (CI) 9.4–10.6] and did not differ between both arms (P = 0.414). The median OS was 25 months in the TC arm versus 31 months in the standard arm (95% CI: 22.4–27.6 resp. 26.0–36.0; P = 0.163). Severe hematologic toxicities (grade 3/4) were rare in the experimental arm (P < 0.001), with 17.4% leucopenia, 27.8% neutropenia and 15.9% thrombopenia.ConclusionThe combination of carboplatin and topotecan was well tolerated with significant lower rates of severe hematological toxicities but did not improve PFS or OS in platinum-sensitive relapsed ovarian cancer compared with established standard regimens.     

Mitomycin C plus vindesine plus etoposide (MEV) versus mitomycin C plus vindesine plus cisplatin (MVP) in stage IV non-small-cell lung cancer: A phase III multicentre randomised trial

PURPOSE:: To compare mitomycin C plus vindesine plus etoposide (MEV) vs.mitomycin C plus vindesine plus cisplatin (MVP) in the treatmentof stage IV non-small-cell lung cancer. PATIENTS AND METHODS:: 204 patients were entered in a phase III multicentre randomisedtrial from June 1990 to December 1994 and stratified accordingto the ECOG performance status (0–1 vs. 2). MVP was givenin the following dosages: mitomycin C 8 mg/m² + vindesine 3mg/m² + cisplatin 100 mg/m² i.v. day 1 and vindesine 3 mg/m²i.v. day 8 with cycles repeated every 4 weeks. MEV was givenin the following dosages: mitomycin C 8 mg/m² + vindesine 3mg/m² i.v. day 1 and etoposide 100 mg/m² i.v. days 1 to 3 withcycles repeated every 3 weeks. For both treatments a maximumof 6 cycles was planned. Response and toxicity were evaluatedaccording to WHO. Subjective responses were assessed by numericalscales. Analyses were made on the basis of intent to treat. RESULTS:: The objective response rate was 21.4% (1 CR + 21 PR among 103patients) in the MEV and 28.7% (1 CR + 28 PR among 101 patients)in the MVP arm (P=0.48). Symptoms were similar in the two arms.196 patients progressed and 182 died. The median times to progressionwere 10 weeks (95% CI 9–12) and 12 weeks (95% CI 10–15)and median survivals were 29 weeks (95% CI 25–36) and28 weeks (95% CI 25–35) in the MEV and MVP arms, respectively.The relative risks of progressing and of dying were 0.89 (95%CL 0.66–1.20) and 0.96 CL 0.71–1.30), respectively,for patients receiving MVP as compared with those receivingMEV at multivariate analysis adjusted by sex, age, histologictype, number of metastatic sites, performance status at entry,and centre. CONCLUSIONS:: In the present study, no significant dfferences were observedin response rate, survival or palliation of symptoms betweenthe MEV and MVP regimens, while toxicity was significantly morefrequent and severe with MVP. Thus, MEV should be considereda reasonable alternative to the MVP regimen in the treatmentof stage IV NSCLC. chemotherapy, non-cisplatin-containing, regimen, stage IV NSCLC     

Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (mGemOx): final results of a multicenter randomized phase II trial in advanced pancreatic cancer.

BACKGROUND: To compare the efficacy and safety of three different chemotherapy doublets in the treatment of advanced pancreatic cancer (PC). PATIENTS AND METHODS: At total of 190 patients were randomly assigned to receive capecitabine 1000 mg/m(2) twice daily on days 1-14 plus oxaliplatin 130 mg/m(2) on day 1 (CapOx), capecitabine 825 mg/m(2) twice daily on days 1-14 plus gemcitabine 1000 mg/m(2) on days 1 and 8 (CapGem) or gemcitabine 1000 mg/m(2) on days 1 and 8 plus oxaliplatin 130 mg/m(2) on day 8 (mGemOx). Treatment cycles were repeated every three weeks. The primary end point was progression-free survival (PFS) rate at 3 months; secondary end points included objective response rate, carbohydrate antigen 19-9 response, clinical benefit response, overall survival and toxicity. RESULTS: The PFS rate after 3 months was 51% in the CapOx arm, 64% in the CapGem arm and 60% in the mGemOx arm. Median PFS was estimated with 4.2 months, 5.7 months and 3.9 months, respectively (P = 0.67). Corresponding median survival times were: 8.1 months (CapOx), 9.0 months (CapGem) and 6.9 months (mGemOx) (P = 0.56). Grade 3/4 hematological toxicities were more frequent in the two Gem-containing arms; grade 3/4 non-hematological toxicity rates did not exceed 15% in any arm. CONCLUSION: CapOx, CapGem and mGemOx have similar clinical efficacy in advanced PC. Each regimen has a distinct but manageable tolerability profile.     

A randomized study comparing interferon (IFN alpha) plus low-dose cytarabine and interferon plus hydroxyurea (HU) in early chronic-phase chronic myeloid leukemia (CML)

This multicenter randomized phase III study was designed to compare the efficacy and toxicity of IFN alpha-2c (3.5 MU/d) in combination with either araC (10 mg/m(2) d1-10) or hydroxyurea (HU: 25 mg/kg per day) in newly diagnosed CML patients. A total of 114 patients were randomized. Following a median observation period of 36 (range 1-73) months the major cytogenetic response rates were 25 and 27% and the 4-year survival probabilities 62.5 and 63% for the araC and HU group, respectively. While the overall toxicity profile was comparable between both groups, patients in the HU arm exhibited a slightly higher degree of WHO grades 3 and 4 non-hematological toxicities.     

诺维本联合阿霉素一线治疗72例转移性乳腺癌

目的 分析72例接受诺维本加表阿霉素联合化疗方案一线治疗转移性乳腺癌患者的疗效及毒性。方法 72例未经化疗的转移性乳腺癌患者，接受诺维本25mg／m^2每周，静滴d1、d8，表阿霉素静注d1，每3周重复。结果 72例可评价疗效、毒性、生存期，完全缓解12．5％(9／72)，部分缓解65．3％(47／72)，稳定18．1％(13／72)，进展4．2％(3／72)，CR PR77．8％(56／72)。WHO血液血毒性：在360个化疗疗程中，Ⅲ和Ⅳ度粒细胞减少分别是32％和16％，Ⅲ和Ⅳ度非血液血毒性低。中位病变进展时间(TTP)为13个月(1～23月)，中位生存期为25个月(3～34月)。结论 诺维本联合表阿霉素一线治疗转移性乳腺癌疗效高、毒性低。     

A phase II study of capecitabine plus oxaliplatin (XELOX)

Background: Capecitabine and oxaliplatin are both effective and well-tolerated monotherapies for the treatment of advanced colorectal cancer (CRC). Oxaliplatin has also been shown to be very effective when combined with 5-FU/LV in the first-line setting. Aim of the Study: Assess the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with previously untreated advanced CRC. Methods: Fifty-three patients with measurable disease received capecitabine 1,000 mg/m² twice daily on d 1–14 and oxaliplatin 130 mg/m² on d 1, every 3 wk. Of these, 52 were evaluable for safety and 49 for antitumor response. Results: There was a low rate of grade 1/2 adverse events; grade 3/4 events included leukopenia (10%), neutropenia (6%), thrombocytopenia (2%), nausea/vomiting (4%), and diarrhea (4%). The overall response rate was 39% (95% CI, 25–54%) and median time to disease progression was 7.8 mo. Conclusions: XELOX is an active and well-tolerated first-line treatment for advanced CRC. Randomized phase III studies are ongoing to compare XELOX with FOLFOX in view of the comparable efficacy and safety but superior convenience of XELOX therapy.     

吉西他滨联合顺铂与吉西他滨联合诺维本治疗晚期非小细胞肺癌的临床研究

背景与目的:含铂联合方案虽然已成为治疗非小细胞肺癌的标准方案,但其严重的毒副反应促使人们寻找新的代替方案.本研究拟观察比较吉西他滨联合顺铂(GP方案)与吉西他滨联合诺维本(GN方案)治疗晚期非小细胞肺癌的疗效,生存率及毒副反应.方法:对82例经病理或细胞学证实的晚期非小细胞肺癌的初治或手术、放疗后患者给予联合化疗,随机分为GP组或GN组.GP方案组42例,GN方案组40例,两组病例具有可比性.GP组吉西他滨1000 mg/m2,静脉滴注,d1、8,顺铂80 mg/m2,静脉滴注d1,GN组吉西他滨1 000 mg/m2静脉滴注,d1、8,诺维本25 mg/m2,静脉推注d1、8.21天为1个疗程.每例病人治疗2个疗程以上.结果:GP组总有效率(PR+CR)为28.6%,1年生存率为64%,中位生存期8.78个月;GN组总有效率(PR+CR)25%,1年生存率66%,中位生存期9.87个月.两组间有效率、1年生存率比较差异无显著性.最常见的毒副反应为恶心,呕吐,GP组和GN组的3～4度反应发生率分别为52.38%和2.5%,差别有统计学意义(P=0.0005).其余毒副反应轻微,可耐受.结论:吉西他滨联合顺铂与吉西他滨联合诺维本相比,疗效相似,非铂类方案的毒副反应小于含铂类方案.