Furuse K, Fukuoka M, Kuba M, Yamori S, Nakai Y, Negoro S, Katagami N, Takada Y, Kinuwaki E, Kawahara M, Kubota K, Sakuma A, Niitani H
Department of Internal Medicine, National Kinki Central Hospital for Chest Diseases, Osaka, Japan.
Ann Oncol. 1996 Oct;7(8):815-20. doi: 10.1093/oxfordjournals.annonc.a010760.
We compared the activity of vinorelbine (VRB) and vindesine (VDS) in a randomized crossover study in patients with previously untreated stages IIIB or IV non-small-cell lung cancer (NSCLC).
Two hundred four patients were assessable for response and toxicity. VRB was administered at a dose of 25 mg/m2 weekly and VDS at a dose of 3 mg/m2 weekly. Patients who failed to respond after 4 cycles of initial monotherapy were switched to a combination chemotherapy (VRB-->VDS + cisplatin (P) or VDS-->VRB + P).
Objective response was observed in 31.1% of patients in the VRB arm versus 8.9% of those in the VDS arm (P = 0.0002). The median duration of response to VRB was 18.5+ weeks (range, 7.9 to 107.5+ weeks) compared with 11.7+ weeks (range, 6.0 to 35.0+ weeks) for VDS. Of the 69 patients who failed to respond to initial monotherapy, 33 in the VRB group who subsequently received VDS + P did not respond and 13 (26.5%) of 49 initially on VDS who received subsequent VRB + P responded. The rates of grades 3 and 4 leukopenia were similar in the two monotherapy arms (VRB, 55.3% vs. VDS, 48.5%). However, grade 3 anemia was more frequent in the patients on VRB than in those on VDS. The incidence of peripheral neurotoxicity was significantly higher with VDS than with VRB (P = 0.002), but VRB induced a slightly higher rate of local cutaneous reaction than VDS (P = 0.012). With the combination of cisplatin and these vinca alkaloids, peripheral neurotoxicity was less frequent in the VRB group than in the VDS group.
Our results demonstrate that VRB yields a higher response rate than VDS in stage IIIB or IV NSCLC, with the same extent of toxicity in terms of leukocytopenia. The peripheral neurotoxic effects were also milder with VRB than with VDS. In second-line chemotherapy, there was a notable difference in response between the VRB + P and VDS + P regimens.
在一项随机交叉研究中，我们比较了长春瑞滨（VRB）和长春地辛（VDS）对先前未经治疗的IIIB期或IV期非小细胞肺癌（NSCLC）患者的疗效。
204例患者可评估疗效和毒性。VRB的给药剂量为25mg/m²，每周一次；VDS的给药剂量为3mg/m²，每周一次。初始单药治疗4个周期后未出现缓解的患者改为联合化疗（VRB组改为VDS+顺铂（P），VDS组改为VRB+P）。
VRB组31.1%的患者出现客观缓解，而VDS组为8.9%（P=0.0002）。VRB组的中位缓解持续时间为18.5+周（范围7.9至107.5+周），VDS组为11.7+周（范围6.0至35.0+周）。在69例初始单药治疗未缓解的患者中，VRB组随后接受VDS+P治疗的33例未缓解，而初始接受VDS治疗、随后接受VRB+P治疗的49例患者中有13例（26.5%）出现缓解。两个单药治疗组3/4级白细胞减少的发生率相似（VRB组为55.3%，VDS组为48.5%）。然而，VRB组3级贫血的发生率高于VDS组。VDS引起的外周神经毒性发生率显著高于VRB（P=0.002），但VRB引起的局部皮肤反应发生率略高于VDS（P=0.012）。与顺铂联合这些长春花生物碱时，VRB组外周神经毒性的发生率低于VDS组。
我们的结果表明，在IIIB期或IV期NSCLC患者中，VRB的缓解率高于VDS，在白细胞减少方面毒性程度相同。VRB引起的外周神经毒性也比VDS轻。在二线化疗中，VRB+P和VDS+P方案的缓解情况存在显著差异。
