Sørensen J B, Hansen H H, Dombernowsky P, Bork E, Malmberg R, Aabo K, Bødker B, Hansen M
J Clin Oncol. 1987 Aug;5(8):1169-77. doi: 10.1200/JCO.1987.5.8.1169.
Two hundred seventy-nine patients with previously untreated nonresectable adenocarcinoma of the lung (ACL) entered a prospective randomized trial, comparing vindesine (VDS) to a combination of lomustine (CCNU), cyclophosphamide (CTX), and methotrexate (MTX), and to a regimen including all four drugs. Response assessment was possible in 218 patients, while 259 were evaluable for survival. Response rates were similar (22%, 23%, and 27%, respectively) as were median durations of response (15 weeks overall) and survival (29 weeks overall). Patients with dose-limiting toxicity had significantly higher response rate and longer survival than patients without toxicity. The major toxicity was peripheral neuropathy with VDS treatment and myelosuppression with the other two regimens. The VDS single-agent activity in ACL was confirmed, but addition of VDS to the three-drug regimen did not increase activity. Future studies of VDS in combination with other active agents, and comparison to a matched control group on supportive care, are indicated.
279例先前未经治疗的不可切除肺腺癌(ACL)患者进入一项前瞻性随机试验,比较长春地辛(VDS)与洛莫司汀(CCNU)、环磷酰胺(CTX)和甲氨蝶呤(MTX)联合用药,以及与包含这四种药物的方案。218例患者可进行疗效评估,259例可进行生存评估。有效率相似(分别为22%、23%和27%),中位缓解持续时间(总体为15周)和生存期(总体为29周)也相似。出现剂量限制性毒性的患者比未出现毒性的患者有显著更高的有效率和更长的生存期。主要毒性反应是VDS治疗引起的周围神经病变以及其他两种方案引起的骨髓抑制。VDS单药在ACL中的活性得到证实,但在三药方案中加入VDS并未增加活性。表明未来需研究VDS与其他活性药物联合使用,并与匹配的支持治疗对照组进行比较。