紫杉醇腹腔灌注化疗治疗晚期卵巢癌临床研究

目的：探讨紫杉醇（PTX）腹腔灌注化疗联合顺铂（PDD）全身化疗治疗晚期卵巢癌患者的疗效和安全性。方法：2006年1月至2010年1月,给予33例TNMⅢ-Ⅳ期卵巢癌患者（Ⅲ期20例,Ⅳ期13例）PTX60mg/m2ip d1,5,10,PDD 40mg/m2iv d1-2,每21天为1周期,共2-4个周期,每2周期评定疗效。结果：总有效率（RR,CR＋PR）为78.79%,其中CR 60.61%、PR 18.18%。中位疾病进展时间（TTP）为22.3个月。2年生存率为81.82%。常见不良反应为骨髓抑制、腹痛、腹泻、胃肠道反应、脱发、口腔黏膜炎和肌肉关节痛等。结论：PTX 60mg/m2腹腔灌注d1,5,10联合PDD 40mg/m2静脉滴注d1,2方案治疗晚期卵巢癌疗效肯定,且不良反应可以耐受。     

多西紫杉醇腹腔灌注化疗治疗晚期胃癌Ⅱ期临床研究

目的:探讨多西紫杉醇(DOC)腹腔灌注化疗(intraperitoneal chemotherapy,IPC)联合亚叶酸钙(CF)/5-氟尿嘧啶(5-FU)/奥沙利铂(OXA)静脉用药治疗晚期胃癌的临床疗效和安全性。方法:2007年7月至2009年9月,给与43例TNMⅢb-Ⅳ期胃癌患者(Ⅲb期19例,Ⅳ24期例)DOC 40mg/m2腹腔灌注d1,8,CF200mg/m2静脉滴注d1-5,5-FU 375mg/m2静脉滴注d1-5,OXA 135mg/m2静脉滴注d1方案,每21天为一周期,共2-4个周期,每2周期评价疗效。结果:总有效率(CR+PR)为58.1%(25/43),其中CR6.9%(3/43)、PR51.2%(22/43)。中位疾病进展时间(mTTP)为7.5(2.3-14.2)个月。一年生存率为67.4%。常见不良反应为腹痛、腹泻、骨髓抑制、胃肠道反应、脱发、口腔黏膜炎和外周神经毒性等。结论:DOC 40mg/m2腹腔灌注d1,8,联合CF/5-FU/OXA方案静脉用药治疗晚期胃癌疗效肯定,且不良反应可以耐受。     

紫杉醇联合FUDR治疗晚期胃癌的临床观察

为了观察紫杉醇(PTX)联合脱氧氟尿苷(FUDR)/亚叶酸钙(CF)方案治疗晚期胃癌近期疗效及其不良反应,将58例晚期胃癌患者,采用PTX135mg/m2,静脉滴入3h,d1,CF100mg/m2,静脉滴入2h,d1～d5,FUDR425mg/m2,静脉滴入2h,d1,再续滴入FUDR350mg/(m2.d),微量化疗泵24h持续滴入(civ)d1～d5,21d为1个周期,至少完成2个周期。58例晚期胃癌患者,CR3例(5.2%),PR30例(51.7%),SD13例(22.4%),PD12例(20.7%),总有效率(CR PR)达56.9%。主要不良反应为骨髓抑制、脱发和肌肉酸痛,无化疗相关死亡。初步研究结果提示,PTX联合FUDR/CF方案一线治疗晚期胃癌具有较好的疗效和安全性。     

以多西紫杉醇为主联合化疗治疗晚期卵巢癌97例

目的 观察以多西紫杉醇(商品名:希存)为主联合化疗治疗晚期卵巢癌患者的疗效及不良反应.方法 对97例晚期卵巢癌患者施以1H多西紫杉醇75 mg/m2,第1天,静脉滴注(1 h),顺铂80mg/m2]或TC[多西紫杉醇75mg/m2,第1天,静脉滴注(1 h),卡铂300mg/m2第1天,静脉滴注并水化2 d]方案化疗,21 d为1个周期,化疗6～8个周期.以上两种方案在多西紫杉醇用药前12 h..给予地塞米松8mg口服,1次/12h,共3次.结果 CR9例,PR 74例,sD 6例,PD 8例,总有效率91.7%.最常见的不良反应为骨髓抑制,Ⅲ～Ⅳ度白细胞减少占15%,Ⅲ度血小板减少占6.5%,非血液学毒性轻微.结论 以多西紫杉醇为主联合化疗治疗晚期卵巢癌有较好的疗效,不良反应可以耐受.     

紫杉醇联合顺铂治疗48例晚期鼻咽癌近期疗效分析

目的:评价晚期鼻咽癌(NPC)患者应用紫杉醇与顺铂联合化疗的临床疗效及安全性.方法:2003年6月～2005年8月采用紫杉醇联合顺铂治疗晚期鼻咽癌48例.中位化疗周期数3周期(2周期～5周期).紫杉醇(PTX)135mg/m2,静脉滴注d1;顺铂(DDP)80mg/m2,静脉滴注d1～2,21天为一个周期.结果:可评价疗效48例,CR6例(12.5%),PR19例(39.6%),NC 14例(29.1%),PD9例(18.7%),总有效率(CR+PR)52.1%,中位缓解期(DFS)为6.5(2～12)个月,中位肿瘤进展时间(TTP)7.6(2～14)个月.主要毒性为骨髓抑制、胃肠道反应和关节肌肉疼痛,Ⅲ度～Ⅳ度白细胞减少发生率为18.7%,无严重并发症发生.结论:紫杉醇联合顺铂治疗晚期鼻咽癌有较好的疗效,且不良反应可以耐受.     

全身化疗联合腹腔化疗治疗晚期卵巢癌的临床观察

目的 观察全身化疗联合腹腔化疗对晚期卵巢癌的疗效及毒副反应.方法 24例卵巢癌,用紫杉醇135 mg/m2,卡铂400 mg/m2静滴,每4周重复1次,共化疗2个周期,顺铂60 mg,地塞米松10 mg腹腔化疗,每2周1次,进行2～3个周期,中位疾病进展时间(MTTP)9个月(5～12个月),无复发生存期5个月,观察每次化疗毒副反应及疗效.结果 24例中CR 12例、PR 7例,RR 79.2%,毒副反应为剂量限制性骨髓抑制、消化道反应.结论 全身化疗联合腹腔化疗对晚期卵巢癌有较好疗效.     

紫杉醇联合顺铂治疗晚期食管癌近期临床观察

目的观察紫杉醇(PTX)加顺铂(DDP)联合化疗治疗晚期食管癌的近期疗效.方法 PTX 175 mg/m2,静脉滴注,第1天;DDP 80 mg/m2,静脉滴注,第1、2天.每21 d为一个周期,连用3周期评价疗效.结果可评价疗效者28例,其中CR 1例(3.5%),PR 19例(67.7%),总有效率为71.4%.毒副反应主要是骨髓抑制和恶心呕吐.结论 PTX DDP治疗晚期食管癌可获得较高疗效, 毒副反应能耐受,可作为晚期食管癌的有效治疗方案,值得进一步研究.     

健择为主联合方案治疗晚期非小细胞肺癌临床研究

目的观察健择为主联合化疗方案治疗晚期非小细胞肺癌的临床疗效及毒副反应.方法42例晚期非小细胞肺癌,26例采用健择1 000 mg/m2,d1、d8;DDP 30 mg/m2,d1～d3.16例采用健择1 000 mg/m2,d1、d8;紫杉醇60 mg/m2,d1、d8.两方案均3个周重复,3个周期以上评价疗效.结果42例中CR 1例,PR 20例,SD 14例,PD 7例,有效(CR+PR)率50%(21/42),初治有效率54.2%(13/24),复治有效率44.4%(8/18).健择+DDP组(其中24例为初治),CR 1 例,PR 12例,有效率50%(13/26).健择+紫杉醇组有效率50%(8/16).毒副反应主要为骨髓抑制和消化道反应,126个周期中Ⅲ～Ⅳ度粒细胞下降19例次(15.0%),Ⅲ～Ⅳ度血小板下降32例次(25.4%),Ⅲ～Ⅳ度消化道反应45例次(35.7%);Ⅱ～Ⅲ度肝功能损害50例次(39.6%).结论健择为主联合化疗方案治疗晚期非小细胞肺癌有较好疗效,毒副反应可耐受,特别是健择+紫杉醇治疗复治非小细胞肺癌有较高疗效,值得临床进一步研究观察.     

多西紫杉醇腹腔灌注化疗治疗晚期胃癌Ⅱ期临床研究

目的：探讨多西紫杉醇（DOC）腹腔灌注化疗（intraperitoneal chemotherapy,IPC）联合亚叶酸钙（CF）/5-氟尿嘧啶（5-FU）/奥沙利铂（OXA）静脉用药治疗晚期胃癌的临床疗效和安全性。方法：2007年7月至2009年9月,给与43例TNMⅢb-Ⅳ期胃癌患者（Ⅲb期19例,Ⅳ24期例）DOC 40mg/m^2腹腔灌注d1,8,CF200mg/m^2静脉滴注d1-5,5-FU 375mg/m^2静脉滴注d1-5,OXA 135mg/m^2静脉滴注d1方案,每21天为一周期,共2-4个周期,每2周期评价疗效。结果：总有效率（CR＋PR）为58.1%（25/43）,其中CR6.9%（3/43）、PR51.2%（22/43）。中位疾病进展时间（mTTP）为7.5（2.3-14.2）个月。一年生存率为67.4%。常见不良反应为腹痛、腹泻、骨髓抑制、胃肠道反应、脱发、口腔黏膜炎和外周神经毒性等。结论：DOC 40mg/m^2腹腔灌注d1,8,联合CF/5-FU/OXA方案静脉用药治疗晚期胃癌疗效肯定,且不良反应可以耐受。     

紫杉醇联合顺铂治疗48例晚期鼻咽癌近期疗效分析

目的:评价晚期鼻咽癌(NPC)患者应用紫杉醇与顺铂联合化疗的临床疗效及安全性。方法:2003年6月~2005年8月采用紫杉醇联合顺铂治疗晚期鼻咽癌48例。中位化疗周期数3周期(2周期~5周期)。紫杉醇(PTX)135mg/m2,静脉滴注d1;顺铂(DDP)80mg/m2,静脉滴注d1~2,21天为一个周期。结果:可评价疗效48例,CR6例(12.5%),PR19例(39.6%),NC 14例(29.1%),PD9例(18.7%),总有效率(CR PR)52.1%,中位缓解期(DFS)为6.5(2~12)个月,中位肿瘤进展时间(TTP)7.6(2~14)个月。主要毒性为骨髓抑制、胃肠道反应和关节肌肉疼痛,Ⅲ度~Ⅳ度白细胞减少发生率为18.7%,无严重并发症发生。结论:紫杉醇联合顺铂治疗晚期鼻咽癌有较好的疗效,且不良反应可以耐受。     

Combined intraperitoneal and intravenous chemotherapy for women with optimally debulked ovarian cancer: results from an intergroup phase II trial.

PURPOSE: The median survival time for women with optimally debulked adenocarcinoma of the ovary treated with intravenous (IV) chemotherapy is 41 to 52 months, and the 2-year survival rate is 65% to 70%. Recent studies evaluating intraperitoneal (IP) chemotherapy have reported a median survival time of 49 to 63 months and 2-year survival rates of 70% to 80%. This phase II trial was undertaken to evaluate the feasibility of and 2-year survival rate achieved by the combination of IP paclitaxel, IP cisplatin, and IV paclitaxel in women with optimally debulked, stage III ovarian cancer. PATIENTS AND METHODS: Treatment consisted of paclitaxel 135 mg/m(2) IV over 24 hours on days 1 to 2, cisplatin 100 mg/m(2) IP on day 2, and paclitaxel 60 mg/m(2) IP on day 8 administered every 21 days for six cycles. RESULTS: In 68 assessable women with optimal stage III ovarian cancer, the 2-year survival rate was 91%, and the median survival time was 51 months. The 2-year disease-free survival rate was 66%, and median disease-free survival time was 33 months. Ninety-six percent of all patients experienced at least one grade 3 to 4 adverse event during therapy, with the most common events being neutropenia (79%), nausea (50%), vomiting (34%), and fatigue/malaise/lethargy (24%). Seventy-one percent of patients completed all six cycles of IV/IP therapy as planned. CONCLUSION: Combined IV and IP chemotherapy with cisplatin and paclitaxel is associated with a very promising 2-year survival rate in women with optimally debulked ovarian cancer. The ultimate impact of this approach on overall survival requires further evaluation in a randomized trial setting.     

手术加顺铂腹腔灌注及联合化疗治疗晚期上皮性卵巢癌的疗效观察

目的：对晚期上皮性卵巢癌患者行手术加顺铂腹腔灌注及联合化疗，并对其疗效进行评价，以期对治疗提供帮助。方法：从我院1995年6月－1997年6月住院治疗的卵巢癌患者中筛选出晚期上皮性卵巢癌31例，均行手术治疗，术后采用PAC方案联合化疗。顺铂50－70mg/m^2腹腔灌注，阿霉素40－60mg/m^2、环磷酰胺600－800mg/m^2静脉推注，平均4－5周为一疗程，总疗程数6－12个。结果：Ⅲ期患者总有效率为77．8％；3年生存率59．1％，5年生存率为31．8％。Ⅳ期患者总有效率为66．7％；3年生存率33．3％，5年生存率为0。结论：彻底的手术加顺铂腹腔灌注并辅以静脉联合化疗为治疗晚期上皮性卵巢癌的有效途径，可相应提高患者的生活质量及生存率。     

三种化疗方案治疗晚期非小细胞肺癌的疗效分析

目的:评价MVP(MMC VDS PDD)、NP(Vinorelbine PDD)、TP(Paclitaxel PDD)三种化疗方案治疗晚期非小细胞肺癌的疗效.方法:114例晚期非小细胞肺癌患者分为3组,MVP组36例,MMC(丝裂霉素)8mg/m2,静脉推注,d1;Vindesine(长春地辛)3mg/m2,静脉点滴,d1,8;PDD(顺铂)80mg/m2,静脉点滴,d3.NP组4l例,Vinorelbine(长春瑞宾)25mg/m2,静脉点滴,d1,8,PDD 80mg/m2,静脉点滴,d3.TP组37例,Paclitaxel(紫杉醇)175mg/m2,静脉点滴,d1,PDD 80mg/m2,静脉点滴,d3.每4周为1周期,至少2周期.结果:MVP、NP及TP的有效率分别为33.2%、34.1%、40.5%;中位生存期分别为8.2个月、7.1个月、9.1个月;1年生存率分别为30.5%、34.1%、37.8%.主要不良反应MVP组为骨髓抑制及恶心、呕吐;NP组为骨髓抑制、恶心、呕吐及静脉炎;TP组为骨髓抑制、恶心、呕吐、肌肉关节疼痛及脱发.结论:MVP、NP及TP化疗方案在治疗晚期非小细胞肺癌的有效率、中位生存期及1年生存率相似,毒性可耐受.     

Dose-dense cisplatin/paclitaxel. a well-tolerated and highly effective chemotherapeutic regimen in patients with advanced ovarian cancer

A randomised phase I/II trial with weekly cisplatin 70 mg/m(2) (days 1, 8, 15, 29, 36, 43) in combination with escalating doses of paclitaxel either 4-weekly or weekly was conducted in 49 patients with ovarian cancer; patients were chemotherapy-nai;ve or had a first relapse after platinum-based chemotherapy. Paclitaxel could be safely escalated to 225 mg/m(2) 4-weekly or 100 mg/m(2) weekly, with fatigue as the major adverse event. Myelosuppression, renal toxicity and neurotoxicity were mild to moderate. Pharmacokinetic analysis showed an approximately 2-fold reduction of DNA-adduct formation in leucocytes compared with cisplatin without paclitaxel. No pharmacokinetic interaction was found between paclitaxel and cisplatin. After (re-)induction, additional chemotherapy consisted of conventional paclitaxel/cisplatin, paclitaxel/carboplatin, paclitaxel single agent or carboplatin/cyclophosphamide. The overall response rate was 94% in 17 evaluable chemotherapy-nai;ve patients and 84% in 25 patients with recurrent disease. Median progression-free survival (PFS) was 17 months (chemotherapy-nai;ve: 23 months, recurrent: 11 months) and median overall survival was 41 months (chemotherapy-nai;ve: 48 months, recurrent: 24 months). In conclusion, both cisplatin/paclitaxel regimens showed excellent activity with manageable toxicity in patients with advanced ovarian cancer.     

Comparison of cisplatin-paclitaxel combination versus cisplatin-etoposide in patients with small-cell lung cancer: a Phase III study

Cisplatin-paclitaxel and cisplatin-etoposide combination therapies were compared in limited and extensive disease in patients with small-cell lung cancer. The primary objectives were to determine median and overall survival, time to tumor progression and tolerance and the secondary objective, the response rate. From January 2003 till July 2007, 108 patients were enrolled in the study. All patients had histologically- or cytologically-confirmed small-cell lung cancer. All patients were chemotherapy and radiotherapy naive. The patients were designated to receive six cycles: in the investigational Arm A, cisplatin, 80 mg/m(2) and paclitaxel 175 mg/m(2) were infused on day 1 (1 cycle) and repeated every 3 weeks. In the control Arm B, cisplatin, 80 mg/m(2) was administered on day 1 and etoposide, 120 mg/m(2) per day was given on days 1-3 (1 cycle), every 3 weeks. In Arm A, 6 (11.3%) patients achieved a complete response and 32 (58.1%), a partial response; in Arm B, 7 (12.7%) patients achieved a complete response and 32 (58.2%) a partial response. The median survival time in Arm A patients was 12 months and in Arm B, 13 months, p=0.354. The time to tumor progression (TTP) was 8 and 6 months for Arms A and B, respectively (p=0.060). Toxicity, although common in both Arms, was acceptable. Neutropenia, anemia and diarrhea were higher in the control Arm. The cisplatin-paclitaxel combination is not superior to cisplatin-etoposide with respect to survival, TTP, toxicity and response rate. The former combination could be applied as an alternative chemotherapy regimen for patients with limited or advanced small-cell lung cancer.     

中晚期卵巢癌术后顺铂腹腔联合紫杉醇静脉化疗的临床观察

目的:观察顺铂腹腔联合紫杉醇静脉化疗治疗中晚期卵巢癌术后患者的临床疗效和安全性.方法:回顾性分析我院2006-01-2009-12行细胞减灭术Ⅱ～Ⅳ期卵巢癌76例患者,顺铂腹腔联合紫杉醇静脉化疗36例为治疗组,并以同期行顺铂联合紫杉醇静脉化疗患者40例作为对照.比较两组患者无进展生存期(PFS)、生存率和不良反应.结果:治疗组PFS 27个月,对照组PFS 23个月,P＜0.05.治疗组1、2和3年生存率分别为97.22％(35/36)、94.44％(34/36)和88.88％(32/36),对照组1、2和3年生存率分别为95.00％(38/40)、90.00％(36/40)和77.50％(31/40).治化疗组呕吐及肾功能损伤低于对照组,而腹痛高于对照组.结论:顺铂腹腔联合紫杉醇静脉化疗治疗中晚期卵巢癌术后患者可延长患者PFS及生存率,毒副反应轻,值得临床应用.     

Dose intensification of platinum compounds with glutathione protection as induction chemotherapy for advanced ovarian carcinoma.

Based on previous clinical experience indicating the tolerability and efficacy of high-dose cisplatin with glutathione protection in the treatment of advanced ovarian cancer, this study was undertaken to explore the efficacy and feasibility of an alternative high-dose, platinum-based approach including a combination of high-dose cisplatin plus carboplatin as induction chemotherapy of advanced ovarian carcinoma and intervention surgery. Fifty consecutive eligible patients with untreated stage III or IV epithelial ovarian cancer received 40 mg/m(2) cisplatin daily on days 1-4 and 160 mg/m(2) carboplatin on day 5. The cycle was repeated after 28 days. Patients received glutathione (2,500 mg) before each cisplatin or carboplatin administration and standard intravenous hydration. After 2 courses of induction chemotherapy, the patients underwent surgical reevaluation with debulking, when possible, followed by a further 3 cycles of 120 mg/m(2) cisplatin (i.e. 40 mg/m(2) daily for 3 consecutive days plus 600 mg/m(2) cyclophosphamide on day 3) except in instances of lack of response. All eligible patients were assessed for response and toxicity. The toxicity was moderate with lack of significant nephrotoxicity. Neurotoxicity and ototoxicity were acceptable and in no patient was treatment discontinued for those toxic effects. Myelotoxicity was somewhat more severe than that observed with our previous study with high-dose cisplatin and probably related to the addition of carboplatin. Of the 40 responsive patients, 23 (46%) had a pathological complete response and 4 (8%) had a clinical complete response (without second-look laparotomy). The efficacy of the present protocol was also documented by overall survival (median survival >48 months), which appeared to be better than expected with the current therapy in this group with advanced/bulky disease. The impressive efficacy suggests a possible contribution of reduced glutathione itself in improving the outcome, as supported by preclinical studies. The results of this study should be placed in context with current platinum-based therapy including paclitaxel.