赫赛汀联合长春瑞滨治疗晚期乳腺癌疗效观察

目的：评价赫赛汀和长春瑞滨联合化疗在治疗晚期乳腺癌中的疗效和不良反应。方法：将50例晚期乳腺癌患者分为两组。26例患者采用赫赛汀联合长春瑞滨方案治疗：赫赛汀静脉滴注,首次4mg／kg,其后每周1次,2mg／kg,连续使用;长春瑞滨25mg／m2静脉滴注,d1,8;每3周为1周期。24例患者采用长春瑞滨和顺铂方案（NP方案）治疗：长春瑞滨40mg／天,d1,8;顺铂25mg／m2,d1,3,每3周为1周期。结果：赫赛汀联合长春瑞滨方案有效率为65．4％,NP方案有效率为54．2％,（P〈0．05）。结论：赫赛汀联合长春瑞滨治疗晚期乳腺癌是有效且安全的治疗方案,不良反应可耐受,可作为晚期乳腺癌一线方案应用。     

赫赛汀联合NP(长春瑞滨+顺铂)方案治疗蒽环类耐药晚期乳腺癌的临床分析

目的：观察赫赛汀联合NP（长春瑞滨＋顺铂）方案治疗蒽环类耐药晚期乳腺癌患者的临床疗效和毒副反应。方法：32例蒽环类耐药的晚期乳腺癌患者采用赫赛汀首次剂量为8mg／kg,随后减量至6mg／kg,化疗前1天使用。长春瑞滨25mg／m2静脉滴注,第1,8天使用。顺铂80mg／m2静脉滴注,分割为1—3天使用,21天为l周期。2个周期后评价近期疗效。结果：32例患者均可评价疗效和毒副反应,其中CR2例,PR13例,sD10例,PD7例。有效率46．9％（15／32）,疾病控制率78．1％（25／32）。主要毒性反应为骨髓抑制和胃肠反应。结论：赫赛汀联合NP（长春瑞滨＋顺铂）方案是治疗蒽环类耐药晚期乳腺癌有效的解救方案,不良反应可耐受。     

长春瑞滨联合顺铂治疗晚期乳腺癌的临床观察

目的:观察长春瑞滨联合顺铂(NP方案)治疗晚期乳腺癌的疗效及不良反应.方法:采用长春瑞滨联合顺铂治疗术后复发或转移性乳腺癌48例,长春瑞滨25mg/m2,静脉滴注,d1,8,顺铂70mg/m2,静脉滴注,d2,21天～28天为1周期.结果:全组有效率60.4%,中位生存时间25个月,1、3、5年生存率分别为77.1%、21.8%、5.5%.初治组疗效明显优于复治组(P=0.008);该方案对于既往是否使用蒽环类药物或紫杉醇类药物患者治疗的有效率差异无统计学意义(P＞0.05);转移灶1个～2个组和≥3个组治疗有效率差异无统计学意义(P=0.85).Ⅲ度～Ⅳ度不良反应主要表现为白细胞减少和胃肠道反应.结论:NP方案治疗晚期乳腺癌可获得较好的临床疗效.     

长春瑞滨联合表阿霉素或顺铂治疗晚期乳腺癌的临床比较

目的观察和评价长春瑞滨联合表阿霉素(NE方案)和长春瑞滨联合顺铂(NP方案)治疗晚期乳腺癌的疗效和不良反应。方法24例患者接受NE方案:长春瑞滨25 mg/m2,d1,8;表阿霉素35 mg/m2,d2,9。22例患者接受NP方案:长春瑞滨25 mg/m2,d1,8;顺铂30 mg/m2,d2~4。以上方案均为28 d重复,治疗至少两个周期以上进行疗效评价。结果NE组和NP组的总有效率分别为66.7%和59.1%,中位疾病进展时间分别为13.5个月和12.5个月,差异均无显著性。两种方案对软组织和淋巴结转移病灶均有相近的较高的有效率;NP方案对肺转移的有效率明显高于NE方案。两方案均有相近的较严重的骨髓毒性和脱发;NP方案Ⅲ~Ⅳ度恶心呕吐发生率和Ⅰ~Ⅱ度肾功能损害发生率明显高于NE方案;NE方案Ⅰ~Ⅱ度局部静脉炎、心电图异常和肝功能损害发生率明显高于NP方案。结论NE和NP方案是治疗晚期乳腺癌较为有效的化疗方案,对不同的转移部位或器官,疗效似有一定区别,毒副作用涉及范围及程度,亦似有一定区别。     

58含长春瑞滨方案治疗(蒽环类/紫杉类治疗后)复发转移乳腺癌的临床观察

目的:观察含长春瑞滨方案对蒽环类/紫杉类药物治疗后复发转移性乳腺癌的有效性和安全性.方法:蒽环类,紫杉类药物治疗后复发转移性乳腺癌患者61例,其中58例可评价疗效;长春瑞滨联合顺铂(NP)41例,长春瑞滨25mg/m2,第1天和第8天.静脉滴注;顺铂75～80mg/m2,静脉滴注,分割为2～5天,3周为一周期;长春瑞滨联合卡培他滨或替加氟(NF)17例,长春瑞滨用法同NP组,卡培他滨800～1 000mg/m2,分早晚两次服用,第1～14天,或替加氟600mg/m2,第2～6天,3周为一周期.化疗过程中注意观察不良反应,根据不良反应的程度调整药物用量.每两周期评价疗效.结果:长春瑞滨联合顺铂(NP)组,CR 2例(4.9%),PR 23例(56.1%),SD 14例(34.1%),PD2例(4.9%),有效率为61.0%;长春瑞滨联合卡培他滨或替加氟(NF)组,CR 1例(5.9%),PR 8例(47.1%),SD 7例(41.2%).PD 1例(5.9%),有效率52.9%.常见的不良反应主要为骨髓抑制、胃肠道反应、手足综合症、神经毒性等.结论:含长春瑞滨方案治疗蒽环类,紫杉类药物治疗后复发转移乳腺癌疗效确切,毒性可耐受,是治疗复发转移性乳腺癌的较好方案.     

GP与NP方案治疗耐药晚期乳腺癌的临床观察

目的 比较吉西他滨联合顺铂(GP方案)和长春瑞滨联合顺铂(NP方案)治疗蒽环和(或)紫杉类耐药转移性乳腺癌的近期疗效和安全性。方法 采用GP方案(吉西他滨+顺铂)36例,吉西他滨1000mg/m²静脉滴注,第1,8天给药;顺铂75mg/m²分3次静脉滴注,第1-3天给予。采用NP方案(长春瑞滨+顺铂)32例,长春瑞滨25mg/m²,第1,8天给予;顺铂用法同A组。两方案均每3周重复,2个周期以上评价疗效。结果 两组有效率分别为55.6%(20/36)和53.1%(17/32),无统计学意义(χ²=0.0403,P=0.84)。GP组III-IV度血小板减少高于NP组,但NP组静脉炎相对较明显。结论 GP与NP方案治疗蒽环类和(或)紫杉类耐药的晚期乳腺癌有较高的有效率,可指导临床,且不良反应均可以耐受。     

长春瑞滨或紫杉醇联合顺铂治疗晚期乳腺癌的临床观察

目的观察长春瑞滨或紫杉醇联合顺铂治疗晚期乳腺癌的疗效和毒副反应。方法将200例晚期乳腺癌患者随机分为NP方案组和TP方案组2组,每组100例。NP方案组:长春瑞滨50 mg.d-1,d1,8;顺铂30 mg·m-2,d1～5。TP方案组:紫杉醇110～140 mg·m-2,d2;顺铂30 mg·m-2,d1～5。结果 NP方案组总有效率为61%,中位生存期为7.5个月;TP方案组总有效率为55%,中位生存期为7.2个月,比较差异均无统计学意义(P均>0.05)。结论 NP与TP方案治疗晚期乳腺癌疗效相当。     

顺铂联合长春瑞滨治疗晚期乳腺癌53例的临床研究

目的 观察顺铂(DDP)联合长春瑞滨(NVB)组成NP方案治疗晚期乳腺癌的疗效和毒副反应.方法 应用NP方治疗晚期乳腺癌53例,NVB 25 mg/m2,d1,8静脉滴注30 min,DDP 75 mg/m2,分为3～4 d静脉滴注,21～28 d为1周期.结果 全组53例共完成化疗154周期,中位化疗2～4周期,评价疗效,完全缓解1例,部分缓解29例,稳定12例,进展11例,有效率为(CR+PR)56.6%.毒副反应主要有Ⅱ～Ⅲ度消化系统反应,骨髓抑制尤其是血小板Ⅱ～Ⅲ度抑制.结论 顺铂联合长春瑞滨治疗晚期乳腺癌疗效好,毒副反应主要为消化系统反应及骨髓抑制,在5-HT抑制剂及集落刺激因子的辅助治疗下,患者能耐受,可以作为晚期乳腺癌的二线治疗方案.     

长春瑞滨联合顺铂治疗晚期转移性乳腺癌疗效分析

目的观察长春瑞滨联合顺铂方案治疗晚期转移性乳腺癌的疗效与不良反应。方法32例转移性乳腺癌患者中,20例既往使用蒽环类治疗失败;6例既往使用紫杉类治疗失败;6例为一线治疗。长春瑞滨25 mg/m2,静脉滴注,第1,8天;顺铂30 mg/m2,静脉滴注,第2,3,4天,21 d为一周期,2周期后评价疗效。有效者化疗4周期以上。结果32例患者中,治疗后完全缓解(CR)6例,部分缓解(PR)16例,稳定(SD)6例,进展(PD)4例,有效率68.8%(22/32)。中位疾病进展时间为9.2个月,中位生存期15.8个月。主要不良反应为胃肠道反应以及白细胞减少,其中Ⅲ~Ⅳ度分别占37.5%及43.8%。结论长春瑞滨联合顺铂治疗晚期转移性乳腺癌疗效确切,不良反应可耐受。     

国产长春瑞滨联合顺铂治疗晚期乳腺癌35例临床观察

  目的 观察国产长春瑞滨联合顺铂（NP方案）治疗晚期乳腺癌的近期疗效和毒副作用。方法 国产长春瑞滨25 mg／m2，静脉滴注，第1、8天，顺铂30 mg／m2，静脉滴注，第1天至第3天，3 ~ 4周为1个周期，治疗复发、转移的晚期乳腺癌。结果 35例患者中CR 3例，PR 17例，总有效率为57.1 %；1年生存率77.1 %；不良反应主要是中性粒细胞减少，恶心、呕吐和血小板减少，Ⅲ～Ⅳ度发生率分别为37.1 %、22.9 %和17.1 %，Ⅲ～Ⅳ度外周静脉炎发生率为14.3 %。结论 NP方案是治疗晚期乳腺癌的有效二线方案之一     

国产长春瑞滨联合顺铂治疗晚期乳腺癌39例疗效分析

目的:评价国产长春瑞滨(盖诺,NVB)联合顺铂治疗晚期乳腺癌的疗效和毒副反应。方法:39例晚期乳腺癌患者采用长春瑞滨联合顺铂化疗,NVB 25mg/m2静脉滴注第1、8天,顺铂30mg/m2静脉滴注第1~3天,21天~28天为1周期,3周期以上评价疗效。结果:CR 4例,PR 16例,NC 13例,PD 6例,有效率(CR PR)为51.3%(20/39),主要毒副反应为骨髓抑制及消化道反应。结论:长春瑞滨联合顺铂治疗晚期乳腺癌疗效确切,可望成为晚期乳腺癌的二线解救方案。     

力尔凡联合长春瑞滨卡培他滨治疗晚期乳腺癌39例

目的：观察力尔凡联合长春瑞滨、卡培他滨方案治疗晚期乳腺癌的疗效及安全性.方法：39例有可测量病灶的转移性乳腺癌患者,按就诊先后顺序随机分为综合治疗组和对照组.对照组患者中心静脉持续滴注长春瑞滨,口服卡培他滨.综合治疗组在对照组用药的基础上加用力尔凡静脉滴注.结果：综合治疗组21例患者中CR 2例（9.5%）,PR 6例（28.6%）,MR 4例（19.1%）,总有效率为58.2%.对照组18例患者中,CR 1例（5.6%）,PR4例（22.2%）,MR 3例（16.6%）,总有效率为44.4%.综合治疗组的有效率明显高于对照组,且不良反应的发生率低于对照组.结论：力尔凡联合长春瑞滨、卡培他滨治疗晚期乳腺癌,可以起到增效减毒作用,并且使长春瑞滨、卡培他滨作为二线方案治疗晚期乳腺癌,不良反应可以耐受.     

赫赛汀与化疗药物联合应用治疗转移性乳腺癌疗效分析

目的探讨赫赛汀与化疗药物联合应用治疗转移性乳腺癌的临床疗效及安全性。方法对4例人类表皮生长因子受体-2(HER-2)阳性转移性乳腺癌患者给予赫赛汀初始剂量4 mg/kg静脉滴注,之后2 mg/kg,每周1次,连续使用;异长春花碱(NVB)25 mg/m2静脉滴注15 min,第1、5天;顺铂(DDP)70 mg/m2静脉滴注3 h,第1～3天。每4周为1个疗程,至少进行2个疗程,观察患者的疗效及不良反应。结果 4例患者的生存时间为18～30个月,中位生存时间为25个月。治疗2个疗程后,有效率为75.0%,疾病控制率为100.0%;主要毒性为消化道反应及Ⅰ～Ⅱ度白细胞减少,未观察到心脏毒性。结论赫赛汀与NVP等化疗药物联合治疗HER-2阳性转移性乳腺癌具有较好的疗效与安全性,值得临床推广。     

Oral vinorelbine: pharmacology and treatment outcome in non-small cell bronchial carcinoma and breast carcinoma

The development of an oral formulation of vinorelbine (Navelbine softgelatine capsules, Pierre Fabre Pharma, Freiburg i.Br., Germany) represents a significant advance in the treatment of patients with cancer. Oral chemotherapy is more convenient for the patients and brings significant time savings. Vinorelbine is rapidly absorbed after oral ingestion. The bioavailability is in the range of 33 to 43% and is not affected by concomitant food intake or by vomiting occuring 1.5 h or later after dosing. No significant differences in the pharmacokinetics of oral vinorelbine were observed between elderly (> or =70 years) and younger patients. The recommended dose schedule for oral vinorelbine is 60 mg/m(2) weekly for the initial 3 weeks (cycle 1) and 80 mg/m(2) weekly thereafter. However, if severe neutropenia is encountered during the first cycle, treatment is continued with weekly doses of 60 mg/m(2). Bioavailability studies have demonstrated that oral vinorelbine doses of 60 and 80 mg/m(2) are comparable to intravenous doses of 25 and 30 mg/m(2), respectively. Several clinical studies have demonstrated that the new oral formulation of vinorelbine can be safely administered, even to elderly patients, and is comparable in activity to intravenous vinorelbine in advanced non-small cell lung cancer (NSCLC) and metastatic breast cancer (MBC). A randomized phase II comparison of oral vinorelbine at the recommended dose schedule vs. intravenous vinorelbine at 30 mg/(2) in patients with advanced NSCLC found no significant differences in response rate, progression-free and overall survival between the two treatments. In studies of combination chemotherapy using vinorelbine plus cisplatin or carboplatin in advanced NSCLC, or vinorelbine plus taxanes, capecitabine,epirubicin, or the monoclonal HER2/neu antibody trastuzumab in MBC, intravenous vinorelbine could be completely or partially replaced by oral vinorelbine, resulting in maintained efficacy, good tolerability and improved patient convenience. Concurrent chemoradiation with oral vinorelbine and cisplatin was shown to be well tolerated and produced significant down-staging in patients with locally advanced NSCLC. Metronomic chemotherapy is a new treatment approach designed to maximize the antiangiogenic effect. Oral vinorelbine given every other day at low doses is currently evaluated in patients with refractory solid tumors. Oral vinorelbine has also proven useful as a substitute for intravenous vinorelbine in patients experiencing intractable acute tumor pain during or after intravenous infusion of vinorelbine.     

Combination of trastuzumab and vinorelbine in metastatic breast cancer

BACKGROUND: Since the clinical introduction of trastuzumab (Herceptin) for metastatic breast cancers that overexpress human epidermal growth factor receptor 2 (HER2), this anticancer agent has played an important role in breast cancer treatment. We examined the effects of trastuzumab and vinorelbine (Navelbine) as a second- or third-line therapy in 24 patients whose HER2-positive tumors did not respond to or relapsed after administration of trastuzumab alone or in combination with taxane. METHODS: Trastuzumab was administered at 2 mg/kg (loading dose 4 mg/kg) once weekly and vinorelbine at 25 mg/m(2) once weekly. The median treatment duration was 118.5 days (range, 22-351 days). RESULTS: The response rate was 42% (95% confidence interval (CI): 22%-63%). The adverse events of NCI-CTC grade 3 or above consisted of neutropenia in three patients; other adverse events, including vasculitis, generalized fatigue, anemia and thrombocytopenia, were grade 1 or 2. All adverse events were reversible after treatment withdrawal and were easily manageable. CONCLUSION: A combination of trastuzumab and vinorelbine can be safely administered on an outpatient basis, and is useful in the treatment of patients with HER2-overexpressing metastatic breast cancer.     

注射用曲妥珠单抗治疗晚期乳腺癌临床验证结果

目的 验证单克隆抗体制剂注射用曲妥珠单抗(trastuzumab,商品名赫赛汀^*)对晚期乳腺癌的疗效和不良反应。方法 对经病理诊断的晚期乳腺癌应用赫赛汀^*治疗。第1次给予负荷剂量4mg／kg静脉滴注,以后剂量改为2mg／kg,每周1次。注射3个月以上评价临床疗效。结果 3l例患者中,治疗后完全缓解(CR)2例,部分缓解(PR)6例,稳定(SD)7例,进展(PD)16例,CR PR共8例,有效率为25.8％(ITT分析)。患者年龄、一般状况对疗效有一定影响,而病理类型、病变部位、既往治疗和病理her-2阳性程度对疗效无明显影响。该药不良反应轻微,而且和一般化疗不同。结论 赫赛汀^*对中国乳腺癌患者疗效肯定,安全性较好,为一较安全、有效的新型乳腺癌治疗药物。     

Phase I study of vinorelbine and carboplatin combination in patients with taxane and anthracycline pretreated advanced breast cancer

AIM: To define the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of the carboplatin-vinorelbine combination in pretreated patients with advanced breast cancer. PATIENTS AND METHODS: Patients with histologically confirmed metastatic breast cancer relapsing or progressing after prior taxane and anthracycline containing chemotherapy were enrolled. Cohorts of 3-6 patients were treated at successive dose levels (DLs) with escalated doses of carboplatin [range, area under the curve (AUC) 4-6] on day 1 and vinorelbine (range, 20-35 mg/m(2)) on days 1 + 8 recycled every 28 days. RESULTS: Twenty-seven patients with a median age of 58 years and performance status (WHO) of 0-2 were treated at 6 DLs. All patients were assessable for toxicity and 20 for response. DLT was reached at carboplatin 6 AUC and vinorelbine 35 mg/m(2), and therefore, this was considered as the MTD. Prophylactic G-CSF administration could not allow further dose escalation. The recommended dose for further phase II testing was defined at carboplatin 6 AUC on day 1 and vinorelbine 30 mg/m(2) on days 1 and 8. Among 98 administered treatment cycles 41 (42%) and 7 (7%) were complicated with grades 3 and 4 neutropenia and thrombocytopenia, respectively. Nonhematologic toxicities included grade 2 peripheral neuropathy in 3 cycles and grades 2 and 3 fatigue in 32 (32%). CONCLUSION: The present study determined the feasibility of the combination of carboplatin at AUC 6 (day 1) and vinorelbine at 30 mg/m(2) (days 1 and 8 ) without G-CSF support in patients with taxane and anthracycline pretreated advanced breast cancer. Phase II studies at these doses should follow in order to determine the activity of the regimen.     

洛铂联合长春瑞滨治疗晚期非小细胞肺癌的临床观察

背景与目的：化疗是晚期非小细胞肺癌（NSCLC）的主要治疗手段,但顺铂（DDP）和卡铂（CBP）的毒性较大,患者对化疗的耐受性及依从性较差。洛铂（LBP）是第3代新型铂类抗癌药,国外研究表明LBP与DDP的抗癌活性相似,但肾毒性和胃肠道反应较轻,且可能对部分DDP耐药的肿瘤患者有效。本研究观察国产LBP联合长春瑞滨（诺维本,NVB）治疗晚期NSCLC的疗效和不良反应。方法：64例经病理组织学证实的NSCLC初治患者,临床分期Ⅲ8～Ⅳ期,随机分为NL组（NVB＋LBP）和即组（NVB＋DDP）;NL组LBP 30mg／m^2静滴,第1天,NVB 25mg／m^2,陕速静滴,第1,8天;NP组顺铂（DDP）30mg／m^2静滴,第2～4天,NVB25mg／m^2快速静滴,第1,8N,2组均21～28d为1个周期,连用3个周期后进行疗效评价,观察中位生存时间。结果：NL组34例中,CR1例,PR 13例,NC15例,PD5例,有效率（RR）41．2％,疾病控制率（DCR）85．3％;NP组RR43．3％,DCR 83．3％（X^2=0．05,P〉0．05）;中位生存时间NL组8．6个月,XP组8．9个月（P〉0．05）。NL组主要毒性反应为骨髓抑制,消化道反应如食欲不振（X^2=4．69,P〈0．05）及恶性、呕吐较XP组为轻（X^2=7．43,P〈0．01）,未发现明显的肝肾毒性、周围神经毒性等。结论：国产LBP联合NVB治疗晚期NSCLC的疗效与DDP联合NVB相当,但不良反应较轻,耐受性好。