Phase II trial of bexarotene capsules in patients with advanced non-small-cell lung cancer after failure of two or more previous therapies
Phase II trial of bexarotene capsules in patients with advanced non-small-cell lung cancer after failure of two or more previous therapies
复制标题
DOI：
10.1200/jco.2006.07.7404
复制
发表时间：
2006-10-20
影响因子：
45.3
通讯作者：
Ghalie, Richard
中科院分区：
文献类型：
--
作者：
Govindan, Ramaswamy;Crowley, John;Ghalie, Richard
目的评估贝沙罗汀对复发性非小细胞肺癌（NSCLC）患者生存率的影响。患者和方法具有胸腔积液的IIIB期NSCLC或IV期NSCLC的患者，其具有东部肿瘤协作组（Eastern Cooperative Oncology Group）性能状态0至2，并且先前用≥两种不同的方案治疗，所述方案必须包括铂和紫杉烷，接受口服贝沙罗汀400 mg/m（2）/d，并同时接受左旋甲状腺素和降脂药。主要疗效终点是survival.Results146评估患者治疗贝沙罗汀，中位年龄为66岁（范围，34至87岁），51%是男性，和先前的方案的中位数为3（范围，1至7）。总体中位生存期为5个月（95% CI，4 - 7个月），1年生存率为23%（95% CI，16%-31%）。贝沙罗汀诱导的高脂血症和/或皮疹患者的生存期显著延长。在26例同时出现两种不良反应的患者中，中位和1年生存率分别为12个月（95%CI，8 - 15个月）和48%。在40例无不良反应的患者中，中位和1年生存率分别为2个月（95%CI，2至5个月）和15%（P = 0.0002）。20例患者（14%）因贝沙罗汀相关毒性而停止治疗。对于其余患者，贝沙罗汀的不良反应一般为轻度至中度。ConclusionIn意向治疗人群，贝沙罗汀作为复发性NSCLC的第三线或后续治疗没有达到预期的中位生存期6个月。发生贝沙罗汀诱导的高甘油三酯血症和/或皮疹的患者的生存期可能延长。在随机对照试验中证实这些观察结果很重要。
PurposeTo evaluate the effect of bexarotene on survival in patients with relapsed non-small-cell lung cancer (NSCLC).Patients and MethodsPatients with stage IIIB NSCLC with pleural effusion or stage IV NSCLC, who had Eastern Cooperative Oncology Group performance status 0 to 2, and were previously treated with >= two different regimens that must have included a platinum and a taxane, received oral bexarotene 400 mg/m(2)/d plus concomitant levothyroxine and a lipid-lowering agent. Primary efficacy end point was survival.ResultsFor the 146 assessable patients treated with bexarotene, median age was 66 years ( range, 34 to 87 years), 51% were men, and the median number of prior regimens was three ( range, one to seven). The overall median survival was 5 months (95% CI, 4 to 7 months) and the 1-year survival was 23% ( 95% CI, 16% to 31%). Survival was significantly longer in patients with bexarotene-induced hypertriglyceridemia and/or skin rash. In 26 patients who had both adverse effects, the median and 1-year survival rates were 12 months ( 95% CI, 8 to 15 months) and 48%, respectively. In 40 patients who had neither adverse effect, median and 1-year survival rates were 2 months ( 95% CI, 2 to 5 months) and 15%, respectively ( P =.0002). Twenty patients (14%) discontinued therapy because of bexarotene-related toxicity. For the remaining patients, adverse reactions to bexarotene were generally mild to moderate.ConclusionIn the intent-to-treat population, bexarotene given as third or subsequent line of therapy for relapsed NSCLC did not achieve the intended median survival of 6 months. Survival may have been extended in patients who developed bexarotene-induced hypertriglyceremia and/or skin rash. It is important to confirm these observations in a randomized controlled trial.