Govindan Ramaswamy, Crowley John, Schwartzberg Lee, Kennedy Peter, Williams Charles, Ekstrand Bradley, Sandler Alan, Jaunakais Dinah, Bolejack Vanessa, Ghalie Richard
Washington University School of Medicine, St Louis, MO 63110, USA.
J Clin Oncol. 2006 Oct 20;24(30):4848-54. doi: 10.1200/JCO.2006.07.7404.
To evaluate the effect of bexarotene on survival in patients with relapsed non-small-cell lung cancer (NSCLC).
Patients 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 > or = two different regimens that must have included a platinum and a taxane, received oral bexarotene 400 mg/m2/d plus concomitant levothyroxine and a lipid-lowering agent. Primary efficacy end point was survival.
For 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.
In 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.
评估贝沙罗汀对复发的非小细胞肺癌（NSCLC）患者生存率的影响。
ⅢB期伴有胸腔积液的NSCLC患者或Ⅳ期NSCLC患者，东部肿瘤协作组体能状态为0至2，且先前接受过≥两种不同方案的治疗（其中必须包括铂类和紫杉烷类），口服贝沙罗汀400mg/m²/天，同时服用左甲状腺素和降脂药。主要疗效终点为生存率。
146例接受贝沙罗汀治疗的可评估患者，中位年龄为66岁（范围34至87岁），51%为男性，既往治疗方案的中位数为3种（范围1至7种）。总体中位生存期为5个月（95%可信区间，4至7个月），1年生存率为23%（95%可信区间，16%至31%）。贝沙罗汀诱导的高甘油三酯血症和/或皮疹患者的生存期显著延长。在26例出现两种不良反应的患者中，中位生存期和1年生存率分别为12个月（95%可信区间，8至15个月）和48%。在40例未出现任何一种不良反应的患者中，中位生存期和1年生存率分别为2个月（95%可信区间，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药。对于其余患者，贝沙罗汀的不良反应一般为轻至中度。
在意向性治疗人群中，贝沙罗汀作为复发NSCLC的三线或后续治疗方案，未达到预期的6个月中位生存期。出现贝沙罗汀诱导的高甘油三酯血症和/或皮疹的患者生存期可能有所延长。在随机对照试验中证实这些观察结果很重要。
