吉西他滨联合卡铂经肝动脉治疗Ⅲ期肝细胞癌的临床研究

目的探讨吉西他滨联合卡铂方案(GC方案)与超液化碘油乳剂治疗Ⅲ期肝细胞癌的疗效及安全性。方法61例Ⅲ期肝细胞癌患者采用GC方案与超液化碘油乳剂化疗栓塞治疗。治疗方案为卡铂300 mg/m~2行肝动脉灌注,结合吉西他滨1000 mg/m~2和超液化碘油5～30 ml混合成乳剂栓塞。参照WHO抗癌药物毒性分级标准观察毒性反应,Child-Pugh分级观察肝脏损害。随访患者生存期。结果本组CR 0例,PR 37例,SD 13例,PD 11例,总有效率60.7%。61例患者的血液学毒性表现为骨髓抑制作用,中性粒细胞计数下降,其中Ⅰ度占39.3%,Ⅱ度占29.5%,Ⅲ～Ⅳ度占18.0%。恶心呕吐Ⅱ～Ⅲ度占96.8%。肝脏Child-Pugh分级显示,术后16例由A级升至B级,2例由A级升至C级,6例由B级升至C级。随访61例患者的生存期为5～35个月,中位生存期20个月。结论GC方案联合超液化碘油乳剂化疗栓塞治疗Ⅲ期肝细胞癌是安全有效的,能够改善患者的生活质量。     

肝动脉化疗栓塞联合超级伽玛刀治疗原发性肝癌的临床研究

目的：观察肝动脉化疗栓塞（TACE）联合超级伽玛刀立体定向放疗治疗原发性肝癌的疗效。方法：46例患者中24例行TACE联合超级伽玛刀治疗,22例单纯TACE治疗。TACE经动脉灌注化疗药物5-氟尿嘧啶1000mg,表阿霉素40mg-80mg,丝裂霉素10mg-20mg,超液化碘油10ml-30ml栓塞。超级伽玛刀应用立体定向放射系统（SRT）进行治疗,计划治疗3—10枪点,单次剂量3Gy-6Gy,2—5次／wk,照射总量30Gy-50Gy。结果：TACE与超级伽玛刀联合治疗的有效率（CR＋PR）为70．8％,单纯TACE治疗的有效率（CR＋PR）为45．5％,差异有显著性（P〈0．05）。联合治疗组的1年生存率为66．7％,对照组为54．5％,差异有显著性（P〈0．05）。结论：超级伽玛刀联合TACE是治疗原发性肝癌的有效方法。     

DDC提高纳米级阿霉素磺油乳剂抗肿瘤作用的实验研究

目的：探讨二乙基二硫代氨基甲酸酯（DDC）对提高纳米级阿霉素碘油乳剂在体内外的抗肿瘤作用。方法：用MTT试验评价纳米级阿霉素碘油乳剂对耐药细胞及肿瘤细胞的杀灭作用，用SD大鼠建立Walk-256肝癌模型，通过肝动脉分别注入生理盐水、阿霉素、纳米级阿霉素碘油乳剂，DDC加纳米级阿霉素碘油乳剂以及DDC加阿霉素脂质体碘油乳剂，分别测定各组的肿瘤生长率和小鼠生命延长率。结果：经过DDC预处理后，阿霉素对阿霉素耐药肿瘤细胞SGC7901／CVR和SGC790／WT的IC50（μg/ml）分别从原来的18．40降至0．74和4．00降至0．32。未经DDC处理过的各组平均肿瘤生长率远高于预先用DDC处理过的各组（P＜0．01）。而小鼠生命延长率则明显低于预先用DDC处理过的各组（P＜0．05）。结论：用DDC预先处理抑制肿瘤细胞中的超氧化物歧化酶（SOD）可提高阿霉素的抗肿瘤作用。     

介入治疗配合适形放疗治疗原发性肝癌的临床观察

背景与目的：原发性肝癌最理想的治疗方法是手术切除，但近年文献报道小于5cm小肝癌切除的5年生存率稳定在50％左右，且能获手术治疗的病例仅占20％左右。肝动脉化疗栓塞术（TACE）治疗肝癌近期疗效好，被认为是非手术治疗的首选方法，但远期疗效不够理想，综合治疗是提高原发性肝癌疗效的必由之路。本研究探讨TACE配合三维适形放疗（3-DCRT）治疗原发性肝癌的疗效。方法：90例肝癌患者采用同期配对法分成两组，综合治疗组45例，采用3-DCRT＋TACE；对照组45例，单纯采用TACE。TACE方案先选择顺铂（DDP）80—120mg，羟基喜树碱（HCPT）30mg或氟尿嘧啶（5-FU）1000mg。再将多柔比星（阿霉素，ADM）或表柔比星（表阿霉素，EPI—ADM）50—100mg，或丝裂霉素（MMC）16mg，与超液化碘油10—30ml充分混合成乳剂缓缓注入，然后用1—2mm的明胶海绵栓塞供血动脉，两组均行TACE1—3次.3-DCRT采用6MVX射线，计划靶体积（PTV）〈512cm^3者单次剂量4.5—7Gy，5次／周，总DE45—56Gy；PTV≥512cm^3者单次剂量2．5—4．5Gy，5次／周，总DT 45—60Gy。结果：综合组近期疗效91．1％，对照组60％，两组差5辛有非常显著性（x^2=11．79，P〈0.01），1、2、3、5年生存率，综合组分别为88．9％，55．6％、33.3%、20.0％，对照组分别为51．1％、37．80k、20.0％、0（x^2=6．65，P〈0.01），中位生存期分别为27．3个月、16,7个月（x^2=4．75，P〈0．05）。综合组3-DCRT前PTV〈512cm^3者与PTV≥512cm^3者相比，前者3、5年生存率均大于后者（50％：20％，x：=4．5，P〈0．05；35％：8％，x^2=5.06，P〈0.05），肝功能A级和B级3年、5年生存分别为（48.3%：6．25％，x^2=8．195，P〈0．01；31％：0，x^2=4．42P〈0．05）PTV〈125cm^3者10例，其中6例生存时间超过5年，达60％。结论：TACE＋3-DCRT对不宜手术的原发性肝癌疗效好，影响预后的因素有PTV总剂量，肿瘤大小，以及肝功能分级。     

奈达铂联合氟尿嘧啶栓塞治疗中晚期肝癌的临床观察

目的 探讨奈达铂(NDP)联合氟尿嘧啶(5-FU)方案栓塞治疗中晚期肝癌的疗效及安全性.方法 202例中晚期肝癌患者采用NDP联合5-FU方案与超液化碘油乳剂化疗栓塞治疗,具体为:NDP 100mg/m2行肝动脉灌注,5-FU1000mg/m2和超液化碘油5～ 40ml混合成乳剂行肝动脉栓塞.参照WHO抗癌药物毒性分级...     

卡莫氟配合TACE治疗原发性肝癌的临床观察

目的探讨卡莫氟配合经肝动脉灌注化疗栓塞（TACE）治疗中晚期原发性肝癌的疗效。方法90例肝癌患者采用同期配对法分成两组,综合治疗组（试验组）45例,采用TACE＋卡莫氟,末次TACE术后2周口服卡莫氟,每次200 mg,每日3次,两周为1周期,间隔2周进行下一周期,共2-4周期;对照组45例,单纯采用TACE。TACE方案选择顺铂（DDP）60-100 mg、丝裂霉素（MMC）12-20 mg、5-Fu 1 000-1 500 mg,再将表柔比星（表阿霉素,EPI）50-70 mg与超液化碘油10-20 ml充分混合成乳剂缓缓注入,然后用1-2 mm的明胶海绵栓塞供血动脉,两组均行TACE2-3次。结果综合组（试验组）近期有效率91.1%,对照组60.0%,两组差异有非常显著性（χ2=11.79,P〈0.01）,综合组1,2,3,5年生存率分别为88.9%、55.6%、33.3%和20.0%,对照组分别为51.1%、37.8%、20.0%和0（χ2=6.65,P〈0.01）,中位生存期分别为27.3和16.7个月（χ2=4.75,P〈0.05）。肝功能A级和B级3年生存率分别为48.3%和6.3%（χ2=8.195,P〈0.01）;5年生存率分别为31．0％和0,χ2=4．42,P〈0．05）。结论 卡莫氟配合TACE为较好的治疗原发性肝癌的方法。     

适形放射治疗结合介入治疗不宜手术的原发性肝癌

目的：探讨肝动脉化疗栓塞（TACE）后采用三维适形放射治疗（3DCRT）原发性肝癌的疗效。方法：82例肝癌中41例TACE＋3DCRT（综合组），41例单纯TACE（对照组）。TACE先将氟尿嘧啶1000－1250mg和羟基喜树碱20－30mg注入动脉，再将顺铂60－80mg和丝裂霉14－20mg(或表阿霉素50－60mg)与超液化碘油10－30ml充分混合成乳剂注入，再用1－2mm明胶海绵颗粒栓塞肝动脉。2个组TACE均进行1－3次，3DCRT6采用6MV X射线，计划靶体积（PTV）≤216cm^3者单次剂量为5－8Gy，总剂量为DT40－56Gy；PTV＞216cm^3者单次剂量为4Gy，总剂量36－44Gy；二者均隔日1次，结果：综合组近期有效率（CR＋PR）为87．8％，对照组为58．5％，两组差异有显著性意义（X^2=8．94，P＜0．01）。1、2、3年生存率综合组分别为73．2％，58．7％和41．9％，对照组分别为54．8％，27．3％和12．8％，两组差异有显著性意义（X^2＝5．52，P＜0．05），综合组3DCRT前PTV≤216cm^3者与PTV＞216cm^3者相比，前者3年生存率大于后者（53．8％；20．0％；X^2＝4．72，P＜0．05）。肝功能A级和B级3年生存率分别为56．3％和14．3％，差异有显著性意义（X^2＝5．49，P＜0．05）。结论：TACE＋3DCRT治疗不宜手术的原发性肝癌疗效较好。     

含奥沙利铂与含顺铂方案肝动脉栓塞化疗治疗中晚期肝癌的疗效

目的分析含奥沙利铂（L—OHP）与含顺铂（DDP）方案行肝动脉化疗栓塞术（TACE）对中晚期原发性肝癌（HCC）的治疗效果和不良反应。方法将108例中晚期HCC患者随机分成2组。治疗组55例,行含L—OHP方案介入治疗,L—OHP 130mg／m^2,替加氟（FT207）500～750mg／m^2,用葡萄糖溶液稀释后分别注入血管,根据肿瘤病灶的大小以多柔比星（ADM）40mg／m^2＋超液化碘油10～30ml乳化后进行血管栓塞。对照组53例,行含DDP方案介入治疗,DDP40mg／m^2,FT207500～750mg／m^2,用葡萄糖溶液稀释后分别注入血管,根据肿瘤病灶的大小以ADM40mg／m^2＋超液化碘油10～30ml乳化后进行血管栓塞,并予水化利尿。结果治疗组近期有效率为67.3％（37／55）,与对照组[47．2％（25／53）]比较,差异有统计学意义（P〈0．05）。治疗组甲胎蛋白（AFP）下降率为73．1％（31／43）,与对照组[44．7％（17／38）]比较,差异有统计学意义（P〈0．05）。主要不良反应为消化道反应,治疗组恶心、呕吐发生率较对照组低,差异有统计学意义（P〈0．05）。两组骨髓抑制、肝功能受损、末梢神经炎发生率差异无统计学意义。两组均未见心、肾损害。结论采用以L—OHP为主的方案行TACE治疗中晚期肝癌疗效肯定,安全性好,患者耐受好。     

拓僖联合超液化碘油在肝转移瘤化疗栓塞中的初步应用

目的探讨对肝转移瘤以拓僖联合超液化碘油进行化疗栓塞(TACE)治疗的安全性与有效性.方法对28例肝转移瘤患者以拓僖为主的化疗药物联合超液化碘油进行化疗栓塞(TACE)治疗,评价其临床疗效及毒副反应.结果经拓僖为主的化疗药物联合超液化碘油进行TACE治疗后,总有效率78.6%(22/28).主要不良反应是骨髓抑制及肝功能损害,以Ⅰ、Ⅱ度为主,其次是发热、恶心呕吐及腹泻.结论以拓僖为主的化疗药物联合超液化碘油进行化疗栓塞(TACE)治疗肝转移瘤是一种安全有效的方法,其不良反应可耐受.     

药物碘油乳剂介入治疗肝血管瘤的疗效观察

目的：观察药物碘油乳剂肝动脉介入栓塞治疗肝血管瘤的疗效。方法：经彩超及CT证实的患者38例，其中随机选取15例进行单纯碘油栓塞(对照组)，23例用药物碘油乳剂栓塞(治疗组)。结果：6个月后行CT复查，药物碘油乳剂组病灶明显缩小，有效率为95．65％，单纯碘油组肿瘤变化不明显，有效率为33．33％。结论：药物碘油乳剂在介入治疗肝血管瘤中起着明显的治疗作用。     

Pilot study of transcatheter arterial chemoembolization with degradable starch microspheres in patients with hepatocellular carcinoma

We prospectively evaluated the efficacy and safety of transcatheter arterial chemoembolization (TACE) with microembolization material, degradable starch microspheres (DSMs), and epirubicin, for treatment of multifocal hepatocellular carcinoma (HCC). Seventeen patients with multifocal HCC were treated. At the first treatment, DSMs were injected alone to determine the dose for embolization of the hepatic artery in each patient. After 4 weeks, TACE was performed every 4 to 6 weeks with a mixture of DSMs and epirubicin at a dose of 40 mg/m2. A necrotic area of more than 50% was produced in 6 patients by DSMs alone, and in 11 patients by TACE. The overall response rate was 52.9% (2 complete and 7 partial responses). The duration of the responses ranged from 4 to 21 months (median: 9 months). Common toxicities were transient abdominal pain, nausea/vomiting, fever, and leukopenia. In four patients, grade III or IV toxicity was observed as gamma-glutamyl transpeptidase elevation. TACE with DSMs had tumor necrosis efficacy with acceptable toxicity. The median survival time was 21.7 months, and the 2-year survival rate was 45.3%. Further investigation of the effects of DSM treatment on survival should be carried out.     

Phase II study of epirubicin in advanced soft tissue sarcoma

Thirty-seven patients (pts) with previously untreated and measurable advanced soft tissue sarcoma entered this phase II study: 22 men and 15 women were included. Median age was 58 (range: 20-71). The starting dose of epirubicin was 100 mg/m2 IV bolus every 3 wks. In the case of minimal myelosuppression, the dose was increased by 10 mg/m2 to 130 mg/m2 (Mean dose per cycle: 105 mg/m2). Median cumulative dose of epirubicin administered was 445 mg/m2 (range: 200-1320 mg/m2). From 32 evaluable pts, one had a complete response (CR), 5 a partial response (PR), (CR + PR = 18.7% +/- 13.8%), 12 showed no change (37.5%) and 14 had progressive disease. The number of complete or partial responses observed was not modified by increasing the doses of epirubicin. Median time to progression was 4 months. From 32 pts evaluable for toxicity, hematologic toxicity at d 21 was mild. Non hematological toxicities consisted of nausea and vomiting in 74% of pts (WHO grade 3 = 5%), stomatitis in 12.2% (WHO grade 3 = 3%) and alopecia in 91% (WHO grade 2-3 = 72%). No cardiac dysfunction was recorded during the treatment, even though 7 patients received more than 800 mg/m2 of epirubicin (median: 850 mg/m2, range: 810-1320 mg/m2). The results of this study show that epirubicin is an active drug in advanced soft tissue sarcoma.     

立体适形放射治疗联合肝动脉化疗栓塞治疗肝细胞性肝癌的临床研究

目的 观察立体适形放射治疗（3DCRT）联合肝动脉化疗栓塞（TACE）治疗肝细胞性肝癌（HCC）的疗效和患者的耐受性。方法 46例HCC患者,先采用TACE治疗1-3次,再进行3DCRT.2Gy／次,每天1次,每周5d。肿瘤剂量30-54 Gy,总疗程3-6周。放疗结束后采用世界卫生组织（WHO）标准评价疗效,采用美国国立癌症研究所（NCI）的毒性标准和美国放射治疗肿瘤组（RTOG）的毒副反应评价标准评价急慢性肝脏毒副反应及其他毒副反应。结果 46例患者中,部分缓解（PR）8例,稳定（SD）35例,进展（PD）3例。全组患者中位生存时间16个月,1、2、3年生存率分别为60．9％、39．1％和28．3％。1、2、3年局部控制率分别为73．9％、56．5％和39．1％。1、2、3年远处转移率分别为15．2％、21．7％和34．8％。单因素分析表明,T分期、广州会议分期、门脉癌栓（PVT）、放疗前肝硬化Child-Pugh分级和肿瘤照射剂量对生存率的影响有统计学意义。Cox多因素分析显示,肿瘤照射剂量和肝硬化Child-Pugh分级是HCC患者预后的独立影响因素。5例患者发生急性肝脏毒副反应,1级2例,3级3例。3例出现1级上消化道急性损伤,其中1例出现轻度上消化道出血。10例出现1或2级外周血白细胞降低。2例出现放射性肝病。结论 3DCRT联合TACE综合治疗HCC安全、有效,值得进一步研究。     

粒子植入放疗联合肝动脉化疗栓塞治疗肝癌的临床研究

目的观察局部125I粒子植入放疗联合肝动脉化疗栓塞(TACE)治疗肝细胞性肝癌疗效和患者耐受性。方法56例患者先采用TACE治疗1-3次,再行CT引导下125I粒子植入放疗。125I粒子植入12周后采用世界卫生组织标准评价疗效,采用美国国立癌症研究所毒性标准和美国放疗肿瘤组毒副反应评价标准评价急慢性肝脏毒副反应及其他毒副反应。结果56例中部分缓解18例,稳定36例,进展2例。全组中位生存时间31个月,1、3年生存率分别为88%、54%。1、3年局部控制率分别为93%、70%。1、3年远处转移率分别为9%、13%。单因素分析表明T分期、门脉癌栓、放疗前肝硬化Child-pugh分级、肿瘤数目和125I粒子空间排列对生存率有影响。多因素分析显示125I粒子空间排列、肿瘤数目和肝硬化Child-pugh分级是患者预后独立影响因素。5例发生急性肝脏毒副反应,1级2例,3级3例。9例出现1级上消化道急性损伤,其中1例出现轻度上消化道出血,8例表现为恶性、呕吐。10例出现1、2级外周血白细胞降低。2例出现放射性肝病。结论局部125I粒子植入放疗联合TACE综合治疗安全、有效,值得进一步研究。     

Epirubicin--docetaxel combination in first-line chemotherapy for patients with metastatic breast cancer: final results of a dose-finding and efficacy study

The aim of the study was to define a regular and tolerable dose of the epirubicin-docetaxel combination in first-line chemotherapy of patients with metastatic breast cancer. Sixty-five women with measurable and/or evaluable disease were treated with epirubicin escalated from 60 to 110 mg/m(2) according to 5 dose levels, in combination with a fixed dose of 75 mg/m(2) docetaxel, every 21 days for 6 cycles, without preventive use of hematopoietic growth factors or antibiotics. Forty-three women received adjuvant chemotherapy, consisting of anthracyline- or anthracenedione-based regimens in 39 cases (60%). Twenty-seven women were treated in the phase I study (3 at epirubicin 60 mg/m(2), and 6 at each subsequent dose level). Dose-limiting toxicity consisted of grade III asthenia and febrile neutropenia (epirubicin 75 mg/m(2)), grade IV thrombopenia and grade III asthenia (epirubicin 90 mg/m(2)), grade IV stomatitis and grade III diarrhea (epirubicin 100 mg/m(2)), and grade III diarrhea (epirubicin 110 mg/m(2)). In the phase II study, an additional 38 women were treated at epirubicin 90 mg/m(2) and epirubicin 100 mg/m(2). During the 349 cycles delivered, grade IV neutropenia occurred in 90%; febrile neutropenia requiring hospitalization occurred in 62 (17.8%) and lasted more than 3 days in 12 (3.4%). Nonhematologic toxicity was acceptable. Three left ventricular ejection fraction depressions occurred and normalized during follow-up. The overall response rate in the 62 evaluable women was 69.4% (range: 58--81%), with a median duration of 7.8 months. After 26 months of follow-up, the median time to progression was 9.1 months and median overall survival was 22.7 months. On the basis of efficacy and toxicity, the recommended dose of the combination is epirubicin 100 mg/m(2) plus docetaxel 75 mg/m(2).     

Single Agent Epirubicin in Squamous Cell Cervical Cancer: A phase II trial

Thirty consecutive patients with FIGO stage III-IV, squamous cell uterine cervix cancer were entered in a phase II trial evaluating activity and safety of epirubicin when given at a dose of 80 mg/m² i.v., every 3 weeks. Two complete responses (including a pathological complete remission) plus 3 partial responses were observed among 27 evaluable patients with a response rate of 18.5% (95% confidence limits = 7.6%-36.4%). the median time to progression and median survival for all treated patients were 3 and 8 months respectively. Treatment was well tolerated. Haematological toxicity was mild. WHO grade 4 toxicity was not observed. the median total cumulative dose of epirubicin was 360 mg/m² (80-840 mg/m²). Congestive heart failure was not noted. Further studies in cervical cancer with higher doses of epirubicin as single agent or in combination with other non-myelotoxic drugs are indicated.     

A phase II study of epirubicin and thalidomide in unresectable or metastatic hepatocellular carcinoma

BACKGROUND: The median survival time for patients with unresectable hepatocellular carcinoma (HCC) is <6 months, and no effective standard systemic chemotherapy is available. Both epirubicin (Ellence); Pfizer Pharmaceuticals, New York, NY, http://www.pfizer.com) and thalidomide (Thalomid); Celgene Corporation, Warren, NJ, http://www.celgene.com) have reported activity for HCC as single agents, and they have different mechanisms of action and nonoverlapping toxicities. Therefore, we performed a phase II study using the combination of epirubicin and thalidomide in patients with unresectable and metastatic HCC. METHODS: Nineteen patients with measurable, unresectable, or metastatic HCC were enrolled. All patients were required to have adequate major organ function and performance status. The treatment consisted of weekly epirubicin at a dose of 20 mg/m(2) administered i.v. and daily thalidomide at a dose of 200 mg orally given as a 3-weeks-on/1-week-off schedule. Intrapatient dose escalation of thalidomide was allowed every 2 weeks up to 800 mg daily as long as tolerated. Physical examinations, toxicity assessments, and serum chemistry analyses were performed weekly, and tumor measurements were conducted every 8 weeks. RESULTS: All 19 patients enrolled into the study were evaluable for toxicity assessment and 17 patients were evaluable for response assessment. A total of 71 cycles of chemotherapy was administered, with a median of two cycles administered to each patient (range 1-14). No complete or partial responses were observed. Seven patients (41%) had stable disease, with a median duration of 6 months (range 5-14). The median survival time for all 19 patients was 196 days (95% confidence interval 93-302). The treatment was generally well tolerated. Treatment-related toxicities included constipation (grade 3, 5%; grade 2, 37%; grade 1, 21%), fatigue (grade 3, 5%; grade 2, 42%), and sensory neuropathy (grade 2, 5%; grade 1, 32%). Four patients required dose reductions of thalidomide due to treatment-related toxicities, and the median tolerated dose of thalidomide was 200 mg daily. CONCLUSIONS: The combination of epirubicin and thalidomide was well tolerated when administered in the schedule used in this study. This regimen has limited activity in HCC, with some patients achieving stable disease and clinical benefit. There is a need for defining more effective systemic therapies for HCC.     

Salvage treatment with epirubicin and/or paclitaxel in metastatic breast cancer patients relapsed after high-dose chemotherapy with peripheral blood progenitor cells

AIMS AND BACKGROUND: To evaluate feasibility and efficacy of paclitaxel as a single agent or in combination with epirubicin in breast cancer taxane-naive patients who have failed previous high-dose chemotherapy. METHODS: Since February 1995, we have treated 32 patients in first relapse or progression after high-dose chemotherapy. Nineteen patients had metastatic breast cancer, 12 more than 3 involved axillary lymph nodes, and 1 inflammatory breast cancer at inclusion to the program. The median time to relapse after high-dose chemotherapy was 12 months (range, 2-43). At relapse, 12 patients were treated with epirubicin (90 mg/m2) plus paclitaxel (175 mg/m2) administered on day 1 every 21 days. In 20 patients who had previously received more than 350 mg/m2 of a cumulative dose of epirubicin and in one patient pretreated with chemotherapy containing mitoxantrone, we employed paclitaxel (175 mg/m2) alone. A median number of five courses was administered (range, 2-10). RESULTS: The overall response rate after 3 courses (29 of 32 patients were assessable) was 55% and after 6 courses (21 of 32 patients were assessable) was 57%. The median time to progression was 7 months (95% CI, 5.7-9.2), and median survival was 27.5 months (95% CI, 17.8-37.0). Toxicity was recorded for 180 cycles (epirubicin + paclitaxel for 62 cycles and paclitaxel alone for 118 cycles). The main toxicity in both regimens was hematologic. We observed WHO grade 3-4 neutropenia (in 8 patients, 25%), for which G-CSF (5 microg/kg/day s.c.) was employed. WHO grade 3-4 thrombocytopenia occurred in 2 patients (6%) and WHO grade 3 anemia in 1 patient (3%). CONCLUSIONS: Our study showed that paclitaxel (alone or in combination with epirubicin) is feasible as salvage treatment in heavily pretreated patients.     

Neoadjuvant treatment of locally advanced carcinoma of the uterine cervix with epirubicin, paclitaxel and cisplatin

PURPOSE: The present study was conducted to explore whether neoadjuvant chemotherapy with a combination of epirubicin, paclitaxel and cisplatin could improve the operability and pathological response rate in locally advanced cervical cancer patients. METHODS: Between April 1996 and July 2000, 42 patients with carcinoma of the uterine cervix, FIGO stage Ib(2)-IVa, were treated with two or three 21-day cycles of an epirubicin 100 mg/m(2), paclitaxel 175 mg/m(2), cisplatin 100 mg/m(2) regimen. RESULTS: All patients were eligible for evaluation of toxicity and response. A total of 92 courses of therapy were administered. Three patients had a 20% reduction from the starting dose due to haematological toxicity. Grade 3-4 leukopenia was observed in 15% of cycles, requiring G-CSF support in half of them. Major non-haematological toxicity consisted of grade 3 alopecia (100%), and grade 3 nausea and vomiting (40%). A total of 33 clinical responses (78.5%, 95% CI 63.8-93.2) were recorded, 8 complete responses (CR) and 25 partial responses (PR). Of the 42 patients, 32 (76.2%) underwent radical surgery. At pathological examination 8 complete or microscopic pathological responses, 17 PRs, and 9 patients with stable disease were observed. The median follow-up time was 17 months for the 42 patients enrolled (range 3-62 months). Among the patients submitted to radical surgery, five recurrences were observed, with a median disease-free survival of 47 months. Median overall survival had not been reached at the time of this report. These results appear to be in the range reported for other neoadjuvant cisplatin-based regimens not including paclitaxel. CONCLUSIONS: Neoadjuvant chemotherapy with the epirubicin, paclitaxel and cisplatin combination followed by radical surgery proved to be a safe and effective approach to advanced cervical cancer.