Oral versus intravenous vinorelbine: clinical safety profile

The availability of chemotherapeutic drugs administrable by oral route represents a step forward in the management of cancer patients. Among oral agents, vinorelbine is particularly interesting for its pharmacological characteristics and clinical efficacy. Oral vinorelbine is rapidly absorbed (1.5-3 hours) with an elimination half-life of approximately 40 hours. It shows a low level of binding to plasma proteins (13%), is highly bound to platelets (78%) and has a hepatic metabolism and an absolute bioavailability of 40% with a moderate and similar interpatient variability for the two forms. Food has no influence on the pharmacokinetic profile of oral vinorelbine even if nausea/vomiting is less frequent and less severe in the fed patients than in the fasting patients. Therefore, to ensure patient comfort, it is recommended that oral vinorelbine is administered with a snack. All the metabolites of oral vinorelbine have been identified and, among these, only deacetyl-vinorelbine presented activity demonstrating that for both oral and intravenous (i.v.) routes of administration the drug has the same metabolism pattern. Oral vinorelbine is eliminated mainly in a unconjugated form via the bile. In this process, the CYP 3A4 isoform of cytochrome P450 is mostly involved. Absorption of oral vinorelbine is not delayed in elderly patients. After oral administration, blood concentrations of vinorelbine in elderly patients are within the range of values observed in younger patients. The absolute bioavailability is close to 38% in elderly whereas it is close to 40% in younger patients. This difference is not significant. As compared to the intravenous drug, oral vinorelbine demonstrated linear pharmacokinetics as well an absolute bioavailability of approximately 40%, and a reliable dose-correspondence of 80 mg/m2 oral form --> 30 mg/m2 i.v. and 60 mg/m2 oral --> 25 mg/m2 i.v. Therefore, i.v. and oral forms show similar interindividual variability, same metabolism pattern, reproducible intra-patient blood exposure, and same pharmacokinetic-pharmacodynamic relationship. Oral vinorelbine has shown significant activity in advanced non-small cell lung cancer. Given at 60 mg/m2/week for the first 3 administrations and then increased to 80 mg/m2/week achieved the same efficacy as i.v. vinorelbine in terms of progression-free survival, overall survival, objective response. Mild-to-moderate gastrointestinal toxicity, easily manageable with standard treatment was recorded. Reproducible efficacy compared to previously reported results with vinorelbine i.v. Also, in advanced breast cancer, oral vinorelbine has shown significant activity with a good therapeutic index. Albeit no formal comparison between the oral and the intravenous formulations of vinorelbine has been made, however, the oral route seems to offer major advantages to patients who are faced with a clear decrease in the frequency of hospital admissions as compared to that needed to give intravenous chemotherapy.     

Oral vinorelbine in the treatment of non-small-cell lung cancer

Introduction: Originally formulated as an intravenous (i.v.) agent, vinorelbine is also currently available as an oral chemotherapeutic agent. Oral vinorelbine has demonstrated significant activity in different settings for NSCLC, including adjuvant treatment for resected disease, concurrent chemoradiation for locally advanced NSCLC and palliative chemotherapy for recurrent/metastatic NSCLC, as part of combination schedules or as a single-agent treatment.

Areas covered: The authors explored the available data describing the use of oral vinorelbine in NSCLC. PubMed articles and abstracts presented at international conferences were analysed, and relevant trials were reported and discussed. Specific settings, including the treatment of elderly and unfit patients and metronomic schedules including oral vinorelbine, were evaluated. Available pharmacoeconomic data were also assessed.

Expert opinion: Oral vinorelbine is an appealing agent, particularly as part of combination regimens containing platinum derivatives, although it can have a role as a single-agent treatment as well. Its safety profile is generally favourable and its route of administration is generally preferred by patients receiving chemotherapy. Compared to i.v. vinorelbine and other antineoplastic agents, oral vinorelbine has been reported to be advantageous in terms of cost savings.     

顺铂加吉西他滨与顺铂加长春瑞滨一线治疗晚期非小细胞肺癌的对照研究

目的:探讨顺铂(DDP)加吉西他滨(GEM)与顺铂加长春瑞滨(NVB)治疗晚期非小细胞肺癌(NSCLC)的疗效、不良反应。方法:66例NSCLC患者分别接受GEM/DDP方案与NVB/DDP方案化疗GEM/DDP(GP)化疗方案:GEM1000mg.m-2d1、8DDP75mg.m-2,总剂量分为3d使用,dl~3NVB/DDP(NP)化疗方案:NVB25mg.m-2d1、8;DDP80mg.m-2,总剂量分为3d使用,d1~3。21d为一周期,所有病例均接受2个周期以上的治疗。观察两组的近期有效率、中位生存时间(MST)、1年生存率、不良反应。结果:GP和NP方案的有效率分别为41.6%和36.7%,中位生存期分别为10.3个月和9.6个月,1年生存率分别为44.4%和40.0%(P=0.33)。GP组的III~IV级血小板减少47.2%,显著高于NP组6.6%(P<0.01),而NP组的中性粒细胞减少高于GP组,分别为60%和33.3%(P<0.05)。结论:GP和NP方案治疗晚期NSCLC疗效相当,但毒性反应略有差别。     

吉西他滨或长春瑞滨联合顺铂治疗晚期非小细胞肺癌的系统评价

目的 利用Meta分析评价吉西他滨、长春瑞滨联合顺铂治疗晚期非小细胞肺癌的有效性与安全性。方法 检索Pubmed数据库和CHKD数据库,纳入随机对照试验,用专用软件Review Manager Version4.2.2进行系统评价。结果 共有7个英文期刊文献研究1 561例患者,10个中文期刊文献研究864例患者纳入系统评价。英文期刊文献Meta分析结果显示吉西他滨+顺铂方案与长春瑞滨+顺铂方案在总缓解率上无区别,在一年生存率上吉西他滨+顺铂方案方案优于长春瑞滨+顺铂方案,中文期刊文献Meta分析结果显示两套方案在总缓解率和一年生存率上均无显著性差异。关于毒性反应方面的报道,中英文期刊文献Meta分析结果一致,吉西他滨+顺铂方案中性粒细胞减少发生率低于长春瑞滨+顺铂方案,血小板减少发生率高于长春瑞滨+顺铂方案,恶心呕吐发生率差异无统计学意义。结论 中英文期刊文献在评价吉西他滨、长春瑞滨联合顺铂治疗晚期非小细胞肺癌的有效性上有区别。应重视提高中文期刊随机对照研究文献的质量,同时在晚期非小细胞肺癌治疗过程中,应结合患者具体情况,选择对患者生活质量影响较小的方案。     

长春瑞滨(NP)或吉西他滨(GP)联合顺铂治疗晚期非小细胞肺癌的成本效用研究

目的评价长春瑞滨(NP)或吉西他滨(GP)联合顺铂治疗晚期非小细胞肺癌(NSCLC)的疗效和成本效用。方法 60例晚期NSCLC患者,每组30例,化疗4周期后,评价疗效和成本效用。结果 NP组和GP组治疗的有效率分别为36.6%和40.0%,中位生存期分别为8.52和8.37月,统计学检验发现两者之间的差异无统计学意义,P>0.05。NP组和GP组治疗的一年生存率分别为36.6%和33.3%;2年生存率分别为16.6%和13.3%,成本效用比分别为1 123.41和1 556.61。结论 NP和GP方案治疗NSCLC疗效基本相似,但NP方案治疗的成本效用相对较好。     

Safety profile of platinum-based chemotherapy in the treatment of advanced non-small cell lung cancer in elderly patients

Non-small cell lung cancer (NSCLC) may be considered typical of advanced age. More than 50% of NSCLC patients are diagnosed at > 65 years of age and approximately one-third of all patients are > 70 years of age. Elderly patients tolerate chemotherapy poorly compared with their younger counterpart because of the progressive reduction of organ function and comorbidities related to age. For this reason, these patients are often not considered eligible for aggressive platinum-based chemotherapy, the standard medical treatment for advanced NSCLC. In clinical practice, single-agent chemotherapy should remain the standard treatment. Feasibility of platinum-based chemotherapy remains an open issue and has to be proven prospectively. Moreover, a multidimensional geriatric assessment for individualised treatment choice in NSCLC elderly patients is mandatory. This review focuses on the currently-available evidences for the treatment of elderly patients affected by advanced NSCLC with regards to the role and safety of platinum-based chemotherapy.     

不同化疗方案治疗晚期非小细胞肺癌成本-效果分析

目的:从药物经济学角度,观察比较TC(TAX CBP)、GP(GEM DDP)和NP(NVB DDP)联合化疗方案的合理性。方法:50例晚期肺癌患者应用3种不同化疗方案治疗,TC组18例,NP组16例,GP组16例。结果:TC组有效率44.4%、NP组有效率37.5%、GP组有效率50.0%,3组之间的近期疗效无显著差异。主要毒性为骨髓抑制和胃肠道反应。C/E分别为410.33、362.63、313.05。结论:GP组治疗晚期非小细胞肺癌成本效果比较好,毒性反应可耐受,是目前治疗NSCLC的首选方案之一。     

国产吉西他滨联合卡铂治疗晚期非小细胞肺癌66例临床观察

目的观察国产吉西他滨联合顺铂组成的GEM+CBP方案治疗晚期非小细胞肺癌(NSCLC)的近期疗效与安全性。方法采用GP方案治疗晚期NSCLC 66例。吉西他滨1.0g/m2,第1、8、15天,静脉注射;卡铂300 mg/m2,第1天,静脉注射,每28天为1个周期,至少2个周期。结果近期疗效CR0例,PR28例,SD23例,PD11例,有效率为41%。初治组有效率为52.3%,显著高于复治组的25.6%(P<0.05)。不良反应主要为可耐受的骨髓抑制、恶心呕吐和肝功能损害。结论GEM+CBP方案对晚期NSCLC疗效较好,不良反应轻,是晚期NSCLC,特别是初治者的有效治疗方案。     

吉非替尼门诊治疗晚期非小细胞肺癌疗效观察

目的:评价吉非替尼门诊治疗晚期非小细胞肺癌的疗效及毒副反应。方法:对72例化疗失败或不能耐受化疗及不愿接受化疗的经病理或细胞学证实的晚期NSCLC患者给予吉非替尼250 mg,口服,qd,至病情进展或出现不可耐受的不良反应。结果:72例患者中无完全缓解患者,部分缓解25例(34.7%),稳定18例(25.0%),疾病控制率59.7%,进展29例(40.3%)。中位肿瘤进展时间(TTP)为7.0个月,1年生存率为52.7%。与药物相关的不良反应依次为痤疮样皮疹34例(47.2%),皮肤干燥21例(29.2%),腹泻19例(26.4%),恶心9例(12.5%),肝功能异常(ALT,AST升高)3例(4.2%)。结论:吉非替尼门诊治疗晚期NSCLC安全有效,毒副反应轻微,患者耐受性和依从性好。     

晚期非小细胞肺癌靶向治疗的研究进展

生物标志物检测使得许多晚期非小细胞肺癌(NSCLC)患者获益。近年来,针对表皮生长因子受体(EGFR)和间变性淋巴瘤激酶(ALK)突变呈阳性的NSCLC患者,以吉非替尼、厄洛替尼、阿法替尼为代表的表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)和以克唑替尼为代表的ALK-TKI取得了卓越的疗效。但是,大多数第一代EGFR-TKI和ALK-TKI的疗效因为不可避免的继发性耐药而被减弱。目前,第三代EGFR-TKI正是基于第二代EGFR-TKI的耐药机制研发而成。除此之外,还有许多针对其他突变位点的晚期NSCLC维持治疗的靶向抑制剂。遗憾的是,针对突变比例最大的K-RAS突变,尚无疗效确切的靶向药物。因此,基于肿瘤驱动基因突变机制的探索和靶向药物的开发是目前NSCLC的研究热点。     

吉非替尼治疗非小细胞肺癌的临床疗效观察

目的:分析吉非替尼治疗非小细胞肺癌的临床疗效。方法:调查我院2005年1月到2006年12月患非小细胞肺癌的住院病人40例,给予吉非替尼250 mg,每日1次口服。结果:总有效率为35.0%(完全缓解1例,部分缓解13例),疾病控制率为82.5%(完全缓解1例,部分缓解13例,基本稳定19例)。其中男性病人29例,女性病人11例,有效率分别为55.2%和36.4%(P<0.05)。主要不良反应是恶心呕吐37%、厌食25%、皮疹18%等。结论:吉非替尼治疗非小细胞肺癌有较好的疗效,不良反应较轻,可以提高大多数病人的生活和生存质量。     

人血管内皮抑制素联合长春瑞滨、顺铂治疗晚期非小细胞肺癌的疗效观察

目的 探讨重组人血管内皮抑素联合长春瑞滨、顺铂治疗晚期非小细胞肺癌的近期临床疗效及远期预后效果。方法 采用随机数字表法将福建省肿瘤医院肿瘤科2010-2013年收治的75例晚期非小细胞肺癌患者分为研究组37例和对照组38例,两组均采用长春瑞滨+顺铂进行治疗,研究组加用重组人血管内皮抑素治疗,对两组患者的近期疗效、远期预后进行随访观察比较。结果 研究组有一例ⅢB期患者达到完全缓解(CR)效果,对照组无患者达到CR效果。研究组患者的缓解率达到54.05%,显著高于对照组的31.58%(P>0.05);研究组的受益率为78.38%,高于对照组的68.42%,但差异不具有统计学意义。治疗后研究组的生活质量调查表(QOL)、美国东部肿瘤协作组织(ECOG)评分较治疗前均显著改善(P<0.05),同时优于治疗后的对照组,差异具有统计学意义(P<0.05)。研究组患者的白细胞减少率为51.35%、血小板减少率为10.81%,均显著的低于对照组白细胞减少率73.68%、血小板减少率31.58%,差异均具有统计学意义(P<0.05)。两组患者的胃肠道反应、肝功能损害毒副反应发生率比较差异不具有统计学意义(P>0.05)。研究组患者经过1年随访,失访1例患者,存活20例患者,存活率为54.05%;对照组患者经过1年随访,1例患者失访,存活14例患者,存活率为36.84%,研究组高于对照组,但差异不具有统计学意义;研究组的1年中位生存时间为305 d、对照组为270 d,研究组的1年中位生存时间显著长于对照组患者,差异具有统计学意义(P<0.05)。结论 重组人血管内皮抑素联合长春瑞滨、顺铂治疗晚期非小细胞肺癌可以提高患者的缓解率、降低不良反应,延长患者的生存时间。     

Gemcitabine and vinorelbine (GV) versus cisplatin, gemcitabine and vinorelbine (CGV) as first-line treatment in advanced non small cell lung cancer: Results of a prospective randomized phase II study

The objective of this study was to assess whether adding cisplatin to gemcitabine/vinorelbine combination improves the clinical outcome in patients with non-small-cell lung cancer (NSCLC). Chemotherapy-na?ve patients with advanced NSCLC; age < or = 75 years: Karnofsky performance status > or = 60%, and with adequate hematological, renal and hepatic function, were randomized into 2 treatment groups to receive Gemcitabine 1250 mg/m2 + vinorelbine 30 mg/m2 (GV group), or cisplatin 50 mg/m2 + gemcitabine 1000 mg/m2 + vinorelbine 25 mg/m2 (CGV group). All drugs were administered on days 1 and 8 every three weeks: From September 1999 to March 2003, 114 patients were enrolled. No statistically significant difference was observed in GV vs CGV group in objective response (37 versus 47%, respectively; P = 0.5), median time to progression (5 versus 5.8 months; P = 0.6), overall survival (9 versus 10 months; P = 0.9) and 1-year survival (26 versus 28%; P = 0.9). Conversely, toxicities were significantly higher for CGV, including grade 3-4 neutropenia (24 versus 45%); neutropenic fever (4 versus 14%, including one toxic death); grade 3-4 thrombocytopenia (2 versus 14%); and grade 3-4 emesis (2 versus 14%). Our results suggest that the combination of gemcitabine and vinorelbine is less toxic than three-drug combination with cisplatin while showing similar efficacy.     

重组人血管内皮抑制素YH-16联合用药治疗晚期非小细胞肺癌的多中心Ⅱ期临床试验

目的:通过多中心Ⅱ期临床试验观察重组人血管内皮抑制素(YH-16)联合长春瑞滨(NVB)、顺铂(DDP)(NP方案)治疗晚期非小细胞肺癌(NSCLC)的疗效和安全性.方法:入组晚期NSCLC病例54例,给予YH-16 7.5mg·m-2(d1～14),NVB 25mg·m-2(d1,8)以及DDP 30mg·m-2(d2,3,4).21d为1周期,共2～3周期.并以同期33例有相同特征并行NP方案治疗的患者作对照.观察两组的有效率、肿瘤进展时间(TTP)、生存质量(QOL)和不良反应.结果:试验组与对照组有效率分别为37.0%和24.2%(P＞0.05);试验组中位TTP较单用NP组更长(分别为151d和100d,P=0.000).最常见的3或4度不良反应包括白细胞降低(分别为25.9%和33 3%,P＞0.05),中性粒细胞降低(分别为29.7%和39.4%,P＞0.05),贫血(分别为7 4%和9.1%,P＞0.05),恶心/呕吐(分别为3.7%和12.1%,P＞0.05).结论:YH-16联合NP方案与单用NP方案比较,有增加疗效和减低不良反应的趋势,值得进一步研究.     

国产异长春花碱与顺铂联合治疗老年晚期非小细胞肺癌的临床观察

目的:评价国产异长春花碱(艾克宁)与顺铂(DDP)联合治疗老年(大于65岁)晚期非小细胞肺癌(NSCLC)患者的疗效与安全性。方法:艾克宁25mg/m2静脉注入第1、第8天,顺铂30mg/m2静脉滴注第1天～第3天,每3周～4周为1周期,治疗晚期NSCLC患者63例,A组(>65岁)33例;B组(<65岁)30例。结果:A、B两组有效率分别为45.5%(15/33)、46.7%(14/30),无显著性差异(P>0.05),主要毒性为骨髓抑制、白细胞减少Ⅲ～Ⅳ度发生率A、B两组分别为54.5%(18/33)、46.7%(14/30),无显著性差异(P>0.05),胃肠道反应发生率A、B两组分别为54.5%(18/33)、60.0%(18/30),无显著性差异(P>0.05)。结论:艾克宁与DDP联合治疗老年晚期非小细胞肺癌患者,与非老年患者有同样好的疗效与安全性。     

晚期非小细胞肺癌两种一线化疗方案的疗效观察和药物经济学分析

目的 探讨晚期非小细胞肺癌（NSCLC）不同治疗方案的临床疗效和经济学效果,指导临床合理用药。方法 收集南京市胸科医院2015年1月-2016年12月符合要求的晚期NSCLC患者56例,通过随机数进行随机化分为培美曲塞+顺铂（PP组）30例和吉西他滨+顺铂（GP组）26例,观察两组治疗效果并对成本与效果进行回顾性分析。结果 PP组和GP组化疗方案的有效率分别为46.67%和42.31%,差异无统计学意义;PP组不良反应发生率与GP组存在显著统计学差异（P<0.05）;两组平均费用分别为31 985.48元和27 683.15元。PP组的平均住院天数（10.94 d）少于GP组（13.91 d）。与GP组相比,PP组每增加1个效果单位需要多投入的成本为986.77元。结论 从成本效果分析,PP组的化疗费用较高,但是安全性好于GP组。     

吉非替尼单药治疗化疗失败的晚期非小细胞肺癌31例

目的:初步了解吉非替尼(Iressa)单药治疗化疗失败的晚期非小细胞肺癌的近期疗效及不良反应.方法:选择住院31例非小细胞肺癌Ⅲb或Ⅳ期,并且行2个疗程以上含铂类药物的联合化疗后病情进展(PD)者,单剂口服Iressa 250mg,qd至出现PD.同时每周行1次胸部平片检查,每月1次胸部CT扫描.结果:31例中1例达到完全缓解(CR),7例部分缓解(PR),17例病情稳定(SD),完全缓解率为3.2%(95%可信限区间CI:0～17%),部分缓解率22.6%(95%CI:10%～41%),疾病控制率(包括所有缓解病例和病情稳定的病例)80.6%(95%CI:52%～92%).症状缓解率为51.6%(95%CI:33%～70%),缓解最为明显的症状为咳嗽和疼痛,出现症状缓解的中位时间为14d.最常见的不良反应为1～2度的皮疹和腹泻,无1例因不良反应而退出.结论:单药口服Iressa对于经化疗治疗失败的晚期非小细胞肺癌,具有较好的疗效和耐受性.     

橙皮苷对TGF-β1诱导的A549非小细胞肺癌细胞上皮间质转化的影响

目的：探讨橙皮苷对转化生长因子-β1（transforming growth factor-β1,TGF-β1）诱导的人非小细胞肺癌细胞上皮-间质转化的影响。方法：以A549人非小细胞肺癌细胞系作为研究对象。用MTT法,分别检测橙皮苷对正常培养条件或TGF-β1刺激下细胞增殖的影响。应用2种方法评估橙皮苷对TGF-β1刺激条件下A549细胞的上皮间质转化：圆形度值定量评估细胞的形态变化;双抗体夹心酶联免疫吸附法（enzyme linked-immuno-sorbent assay,ELISA）检测上皮细胞钙黏蛋白（E-cadherin,E-cad）、ɑ-平滑肌肌动蛋白（ɑ-smooth muscle actin,ɑ-SMA）、基质金属蛋白酶抑制因子-1（tissue inhibitors of metalloproteinases-1,TIMP-1）和基质金属蛋白酶-9（metallopreoteinases-9,MMP-9）水平。结果：0~40 μmol·L^-1的橙皮苷对正常培养条件或TGF-β1刺激后A549细胞的增殖没有显著影响。5 ng·mL^-1 TGF-β1能够诱导A549细胞的上皮间质转化：由上皮特征的铺路石状的细胞形态转化为梭形形态,圆形度值减少;E-cad分泌量减少和ɑ-SMA合成量增加。另外,MMP-9分泌量增加,MMP-9/TIMP-1比值增加。在细胞出现形态改变后,应用橙皮苷（20 μmol·L^-1或40 μmol·L^-1）能够降低ɑ-SMA、MMP-9水平和MMP-9/TIMP-1比值,增加E-cad水平,对细胞的圆形度值没有影响。结论：橙皮苷减轻TGF-β1诱导的非小细胞肺癌细胞的上皮间质转化程度,对非小细胞肺癌的转移和扩散有一定的抑制作用。     

Anaplastic lymphoma kinase inhibitors in phase I and phase II clinical trials for non-small cell lung cancer

Introduction: Crizotinib is a first-in-class ALK tyrosine kinase inhibitor (TKI), which has proven its superiority over standard platinum-based chemotherapy for the first-line therapy of ALK-rearranged non-small cell lung cancer (NSCLC) patients. The development of acquired resistance to crizotinib represents an ongoing challenge with the central nervous system being one of the most common sites of relapse. Ceritinib and alectinib are approved second-generation ALK TKIs. Several novel ALK inhibitors, more potent and with different selectivity compared to crizotinib, are currently in development.

Areas covered: This review will focus on new ALK inhibitors, currently in phase 1 or 2 clinical studies. We will also comment on the mechanisms of resistance to ALK inhibition and the strategies to delay or overcome resistance.

Expert opinion: The therapeutic management of ALK-rearranged NSCLC has been greatly improved. Next-generation ALK inhibitors have shown differential potency against ALK rearrangements and ALK resistance mutations. The molecular profile of the tumor at the time of disease progression to crizotinib is crucial for the sequencing of novel ALK TKIs. Ongoing clinical studies will address key issues, including the optimal therapeutic algorithm and whether combinational approaches are more effective than single ALK inhibition for the outcome of ALK-rearranged NSCLC patients.     

Phase II trial of alternating intravenous and oral vinorelbine in combination with cisplatin in advanced non-small cell lung cancer

Summary Cisplatin-based chemotherapy is the standard treatment for advanced non-small cell lung cancer (NSCLC). Several platinum-based doublets have been tested in phase II/III trials with equivalent results in terms of tumour response and survival. Our study was designed to evaluate activity, tolerability and convenience of alternating intravenous (i.v.) and oral vinorelbine in combination with cisplatin in advanced NSCLC. Forty chemo-naive patients with stage IV or relapsed unresectable disease and good performance status were enrolled to receive i.v. cisplatin 40 mg/m² on days 1 and 2 plus i.v. vinorelbine 25 mg/m² on day 1, every 3 weeks. Oral vinorelbine 60 mg/m² was given at home on day 5, without checking of blood cell count. A total of 175 treatment cycles were delivered. The overall response rate was 30% (one complete, 11 partial responses). Median time to progression and overall survival were 5 and 10 months, respectively. The main toxicity was haematological, with grade 3–4 neutropenia observed in 75% of patients, without febrile neutropenia. Non-haematological toxicity was mild. This schedule of cisplatin and vinorelbine treatment showed a good toxicity profile and an efficacy similar to other standard regimens. Oral vinorelbine could be administered safely at home on day 5.