长春瑞滨联合顺铂治疗晚期乳腺癌32例疗效分析

目的评价长春瑞滨联合顺铂治疗晚期乳腺癌的疗效和毒副反应.方法晚期乳腺癌32例采用长春瑞滨联合顺铂化疗.长春瑞滨25 mg/m2,静注,d1,d8;顺铂30mg/m2,静注,d1～3.3周为1周期,3周期后评价.结果CR 4例,PR15例,SD 5例,有效率(CR+PR)为59.4%,获益率(CR+PR+SD)为81.3%,中位缓解期为7.9个月.主要毒副反应为骨髓抑制,恶心、呕吐.结论长春瑞滨联合顺铂疗效确切,副作用可耐受,可望成为晚期乳腺癌的二线解救方案.     

国产长春瑞滨联合顺铂治疗晚期非小细胞肺癌46例疗效观察

目的:观察国产长春瑞滨(盖诺VNB)联合顺铂(DDP)治疗晚期非小细胞肺癌(NSCLC)近期临床疗效及毒副反应。方法:治疗46例病人,长春瑞滨25mg/m2,静滴d1、d8;顺铂(DDP)80mg/m2,静滴d1;21天为1周期,用药3~6个周期。结果:CR0例,PR22例,NC18例,PD6例,缓解期6~12个月,总有效率47.8%;毒副反应主要为白细胞减少占93.5%,其中Ⅲ~Ⅳ度占60.9%,其次为轻度胃肠道反应占30.4%。结论:国产长春瑞滨联合顺铂治疗晚期非小细胞肺癌疗效肯定,毒副反应可以耐受。     

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.     

长春瑞滨联合顺铂治疗晚期非小细胞肺癌的疗效观察

目的:观察长春瑞滨(NVB)联合顺铂(DDP)治疗晚期非小细胞肺癌(NSCLC)的临床疗效及毒副反应.方法:经病理组织学证实的20例晚期非小细胞肺癌患者,给予长春瑞滨40mg静脉滴注第1、8天,顺铂80mg/m2静脉滴注第1天,21天为1周期.每例患者至少完成2个周期化疗后,可评价疗效.结果:全组总有效率为40%(CR0例,PR 8例)主要毒副反应为骨髓抑制,多为Ⅱ～Ⅲ度,无蓄积性.结论:长春瑞滨联合顺铂治疗晚期非小细胞肺癌具有较好疗效,患者耐受性好.     

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。     

长春瑞滨联合顺铂治疗晚期非小细胞肺癌

目的:观察长春瑞滨联合顺铂治疗晚期非小细胞肺癌的疗效和毒副反应.方法:对经病理组织学或细胞学证实的46例晚期非小细胞肺癌患者,给予长春瑞滨与顺铂联合治疗,其中长春瑞滨25mg/m2,静脉滴注,第1、8天给药;顺铂90mg/m2,静脉滴注,分为第1-3天给药.21天为一周期,每位患者治疗3周期.结果:全组完全缓解2例,部分缓解19例,稳定21例,进展4例,总有效率为45.6%.最常见的毒副反应为骨髓抑制,Ⅲ度～Ⅳ度白细胞、白血板减少率分别为47.8%和8.7%,其余毒性反应均轻微可耐受.结论:长春瑞滨联合顺铂治疗晚期非小细胞肺癌疗效较好,毒性可以耐受.     

长春瑞滨联合顺铂治疗晚期头颈部肿瘤的临床观察

目的:观察长春瑞滨联合顺铂(NP方案)治疗晚期头颈部肿瘤的临床疗效和毒副反应。方法:58例晚期头颈部肿瘤患者,接受NP方案化疗。长春瑞滨(NVB)25mg/m2,快速静滴,第1、8天给药;顺铂(DDP)30mg/m2,静滴,第1～3天给药,21天为1周期。化疗2周期以上,然后按WHO标准评价临床疗效和毒副反应。结果:58例患者均可评价疗效,获得CR7例,PR21例,SD16例,PD14例,有效率为48.3%,中位肿瘤进展时间(TTP)为8.5个月。主要毒副反应为骨髓抑制、恶心呕吐和脱发。结论:长春瑞滨联合顺铂治疗晚期头颈部肿瘤的临床疗效较高,毒副反应轻,值得进一步研究。     

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.     

优诺联合顺铂治疗晚期非小细胞肺癌35例临床分析

目的 观察优诺（国产长春瑞滨，NVB）联合顺铂治疗晚期非小细胞肺癌（NSCLC）的疗效及毒副反应。方法 35例晚期NSCLC，应用优诺25mg／m^2 i．vd1,8，顺铂30mg／m^2，i．vd1-3，21～28d为1周期，至少治疗2周期。结果 完全缓解（CR）3例，部分缓解（PR）11例，稳定（SD）15例，进展（PD）6例，有效率40％，主要毒副反应为骨髓抑制、胃肠道反应和静脉炎。结论 优诺联合顺铂治疗晚期NSCLC疗效高，毒副反应可耐受，可作为一线治疗方案。     

NP与GP方案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)方案与吉西他滨联合顺铂(GP)方案治疗晚期乳腺癌的疗效及毒副反应.方法 76例晚期乳腺癌被分为两组,并分别采用NP、GP方案化疗.NP组:长春瑞滨25 mg/m2,静脉滴注,d1～s;顺铂25 mg/m2,静脉滴注,d1～3.GP组:吉西他滨1 000 mg/m2,静脉滴注,d1～8;顺铂用法同NP组.21 d为1个周期.治疗2个周期后两组分别评价疗效和毒副反应.结果 NP组和GP组总有效率分别为52.5%和50.0%,差异无统计学意义(P>0.05);两组中位疾病进展时间分别为8.4、10.9个月,差异有统计学意义(P<0.05);两组中位生存期分别为11.6和12.9个月,差异无统计学意义(P>0.05).两组毒副反应均以骨髓抑制、胃肠道反应和静脉炎为主.结论 NP和GP方案对晚期乳腺癌均有较好的疗效,且毒副反应均可耐受,可作为蒽环、紫衫类药物治疗失败的晚期乳腺癌的替代方案.     

培美曲塞联合顺铂治疗复发性晚期非小细胞肺癌45例

目的 探讨培美曲塞联合顺铂治疗复发性晚期非小细胞肺癌(NSCLC)的疗效及毒副反应.方法45例经病理学确诊的复发性晚期NSCLC接受化疗:培美曲塞500 mg/m2,d1,静脉滴注;顺铂30 mg/m2,d1～3,静脉滴注,21 d为1个周期.2个周期后评价疗效及毒副反应.结果45例中,CR 0例、PR 23例、NC ...     

NP与MVP方案治疗晚期非小细胞肺癌的疗效比较

背景与目的:化疗是治疗晚期非小细胞肺癌(non-smallcelllungcancer,NSCLC)的主要方法,但目前临床治疗效果不能令人满意。本研究的目的为比较NP方案和MVP方案治疗NSCLC的近期疗效和不良反应,为临床治疗提供指导。方法:48例Ⅲ～Ⅳ期NSCLC采用NP方案,即长春瑞滨(vinorelbine,NVB)25mg/m2d1,8及顺铂(cisplatin,DDP)35mg/m2d1～3联合化疗;62例Ⅲ～Ⅳ期NSCLC采用MVP方案,即丝裂霉素(mitomycin,MMC)6mg/m2d1、长春地辛(vindesine,VDS)3mg/m2d1,8及DDP30mg/m2d1～3联合化疗。结果:NP组CR和PR共24例,有效率50%,中位缓解期5.5个月,中位生存期11个月;MVP组CR和PR32例,有效率51.6%,中位缓解期6.5个月,中位生存期14.5个月,两组疗效无显著性差异(P>0.05)。结论:NP方案与MVP方案治疗晚期NSCLC疗效相近,不良反应可耐受。建议NP方案采用深静脉给药或改进给药方法,能较好地解决NVB所致的静脉炎。     

Oral vinorelbine and cisplatin with concomitant radiotherapy in stage III non-small cell lung cancer (NSCLC): a feasibility study

BACKGROUND: Concurrent chemoradiotherapy has improved survival in inoperable stage III non-small cell lung cancer (NSCLC). This phase I trial was performed in order to establish a dose recommendation for oral vinorelbine in combination with cisplatin and simultaneous radiotherapy. PATIENTS AND METHODS: Previously untreated patients with stage IIIB NSCLC received concurrent chemoradiotherapy with 66 Gy and 2 cycles of cisplatin and oral vinorelbine which was administered at 3 different levels (40, 50 and 60 mg/m2). This was to be followed by 2 cycles of cisplatin/ vinorelbine oral consolidation chemotherapy. The study goal was to determine the maximal recommended dose of oral vinorelbine during concurrent treatment. RESULTS: 11 stage IIIB patients were entered into the study. The median radiotherapy dose was 66 Gy. Grade 3-4 toxicity included neutropenia, esophagitis, gastritis and febrile neutropenia. The dose-limiting toxicity for concurrent chemoradiotherapy was esophagitis. 9 patients received consolidation chemotherapy, with neutropenia and anemia/thrombocytopenia grade 3 being the only toxicities. The overall response was 73%. CONCLUSION: Oral vinorelbine 50 mg/m2 (days 1, 8, 15 over 4 weeks) in combination with cisplatin 20 mg/m2 (days 1-4) is the recommended dose in combination with radiotherapy (66 Gy) and will be used for concurrent chemoradiotherapy in a forthcoming phase III trial testing the efficacy of consolidation chemotherapy in patients not progressing after chemoradiotherapy.     

长春瑞宾联合顺铂或顺铂/丝裂霉素一线治疗不可手术非小细胞肺癌

目的比较长春瑞宾联合顺铂和丝裂霉素(MNP)和长春瑞宾联合顺铂(NP)一线治疗晚期非小细胞肺癌(NSCLC)的疗效与安全性.方法65例经细胞学或病理确诊的NSCLC患者分别接受MNP或NP方案化疗.长春瑞宾25 mg/m2静注,d18 c;顺铂为75 mg/m2,静脉滴注d1;MNP方案中丝裂霉素用法为6 mg/m2,静注第1天.两方案均每3周重复,两周期后评价疗效,并随访毒副反应.结果两组中位化疗周期数均为3.NP组PR为11例,总体有效率为33%;PD 5例(15%);MNP组PR为12例(38%),PD为5例(16%),与NP组相比,差异无显著性(P＞0.05).常见副反应有白细胞减少、贫血、便秘、恶心、呕吐等.MNP组Ⅲ与Ⅳ度白细胞减少症发生率高达41%;有3例因中性粒细胞减少并发感染而发热,其中1例死亡.NP与MNP组中位生存期分别为12与11个月,差异无统计学意义.结论长春瑞宾联合顺铂和丝裂霉素一线治疗晚期NSCLC在疗效上不优于长春瑞宾联合顺铂,毒副反应增加;不应作为晚期NSCLC的常规一线方案.     

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.     

A multicenter phase I trial of metronomic oral vinorelbine plus cisplatin in patients with NSCLC

The purpose of the present study was to determine the maximum-tolerated doses (MTDs) and the dose-limiting toxicities of a metronomic administration of oral vinorelbine and cisplatin in patients with advanced/metastatic NSCLC. Twenty-six patients with advanced/metastatic NSCLC were enrolled. Escalating doses of vinorelbine (40–70 mg p.o./trice per week) and cisplatin (70–85 mg/m² intravenous infusion) were administered on day 1 every 3 weeks. ΜΤDs were reached at 60 mg thrice/week p.o. for vinorelbine and 85 mg/m² for cisplatin. Grade 4 neutropenia, febrile neutropenia and grade 4 diarrhea were the dose-limiting events during the first cycle of chemotherapy. The most common grade III-IV hematologic toxicity was neutropenia occurring in seven (27%) patients, while non-hematological toxicities were relatively infrequent and mostly of grade I or II. Objective responses were observed in 20.8% of patients with measurable disease. The regimen of metronomic administration and cisplatin is feasible and active in patients with NSCLC.     

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。     

Phase II trial of oral vinorelbine in combination with cisplatin followed by consolidation therapy with oral vinorelbine in advanced NSCLC

BACKGROUND: Among the cytotoxic agents commonly combined with cisplatin in the treatment of advanced NSCLC, vinorelbine has led to significant outcome improvements. Adding more than four cycles of the combination regimen increase toxicities. The availability of an oral form of vinorelbine appeared as a particularly convenient way to provide a consolidation treatment to patients who have achieved an objective response or stable disease. PATIENTS AND METHODS: This multi-centre phase II open-label, non-comparative study was designed to evaluate the treatment with four cycles of the combination chemotherapy with oral vinorelbine at the dose of 60 mg/m2 on day 1 and day 8 for the first cycle and then 80 mg/m2 plus cisplatin 80 mg/m2 on day 1 every 3 weeks followed for patients with objective response or stable disease by consolidation therapy with oral vinorelbine at 80 mg/m2 weekly on patients with unresectable localised or metastatic non-small-cell lung cancer (NSCLC). The primary endpoint was tumor response. The secondary objectives were progression free-survival, overall survival and toxicity assessment. Visual analogue scales (VAS) filled by the patients were also used to evaluate subjective changes under treatment, reflecting patients' clinical benefit. RESULTS: Fifty-six patients enrolled into the study from April 2001 to April 2002 received the combination regimen. Twenty-five patients (43.9%) also received the subsequent consolidation treatment. Partial tumor responses were obtained in 13 patients (26.5%, 95% CI 15.0-41.1) of 49 evaluable patients. Stable disease was observed in 22 (44.9%) of patients. The median duration of response was 6 months (95% CI 4.3-8.2). The median progression free-survival was 4.2 months (95% CI 2.8-6). The median overall survival time was 10 months (95% CI 7.4-14) and the 1 year survival was 42.6%. The main toxicities recorded were haematological. Grade 3 and 4 neutropenia were observed in 16 patients (29.1%). Nausea, vomiting and fatigue were the major non-haematological toxicities reported. Among the symptoms recorded by the patients on VAS scales (appetite, fatigue, pain, cough, dyspnea, haemoptysis), except anorexia, all symptoms were improved during the combination therapy and in the consolidation phase. CONCLUSION: This study confirms that the efficacy of the cisplatin/oral vinorelbine combination in NSCLC is comparable to cisplatin/I.V. vinorelbine. This study also suggests that consolidation therapy with vinorelbine alone may probably prolong the efficacy of the combination regimen. The convenience offered to patients by an oral form of vinorelbine is a definite asset for consolidation therapy.     

Oral vinorelbine in combination with cisplatin: a novel active regimen in advanced non-small-cell lung cancer.

BACKGROUND: A phase II trial of alternating i.v. and oral vinorelbine in combination with cisplatin was designed to determine the response rate, safety profile, progression-free survival, overall survival and quality of life (QoL) in advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Fifty-six chemotherapy-na?ve patients received cisplatin 100 mg/m(2) and i.v. vinorelbine 25 mg/m(2) on day 1, followed by oral vinorelbine 60 mg/m(2) on days 8, 15 and 22, every 28 days. RESULTS: After an independent review, the response rate was 33% [95% confidence interval (CI) 20% to 46%]. Median progression-free and overall survival were 5.5 months (95% CI 3.7-6.4) and 8.9 months (95% CI 8.8-11.7), respectively. The most frequent hematological toxicities were neutropenia (grade 3-4 in 73% of patients) and anemia (grade 3-4 in 11% of patients). Grade 3-4 infections and non-hematological toxicities occurred occasionally. QoL for lung cancer related symptoms was stable or improved. CONCLUSIONS: The efficacy and safety of the alternating vinorelbine schedule (i.v. on day 1, oral on days 8, 15 and 22) in combination with cisplatin in advanced NSCLC are similar to those of the standard regimen using exclusively i.v. vinorelbine, whereas ease of administration and patient comfort may favor the novel approach.     

A phase II study of oral vinorelbine in combination with cisplatin conducted in Taiwan in patients with unresectable localized or metastatic non-small cell lung carcinoma

BACKGROUND: Intravenous vinorelbine plus cisplatin is widely prescribed for the treatment of NSCLC. The objective of this phase II study was to define the efficacy of an oral form of vinorelbine combined with cisplatin for first line treatment of advanced/metastatic NSCLC. PATIENTS AND METHODS: From September 2002 to December 2003, 46 chemotherapy-naive patients received 80 mg/m(2) of cisplatin on day 1 and oral vinorelbine at 60 mg/m(2) on days 1 and 8, every 3 weeks. RESULTS: After an independent panel review, the response rate was 37.5 % [95% confidence interval (CI): 22.7-54.2%] in the evaluable population and 32.6% [95% CI: 19.5-48] in the intent-to-treat population. Median progression-free survival was 5.6 months and overall survival was 11.2 months. Grades 3 and 4 neutropenia was observed in 58.7% of patients, with febrile neutropenia and neutropenic infection in 4.3 and 8.7% of patients, respectively. The main non-haematological toxicities were hypotension, fatigue (8.7% for each) and gastrointestinal disorders with rare grades 3 and 4. CONCLUSIONS: These results suggest that the combination of cisplatin at 80 mg/m(2) on day 1 with oral vinorelbine at 60 mg/m(2) on days 1 and 8, every 3 weeks, is an active regimen, associated with acceptable toxicity. Oral vinorelbine is therefore a good alternative to the i.v. formulation.