Ramalingam Suresh S, Dahlberg Suzanne E, Langer Corey J, Gray Robert, Belani Chandra P, Brahmer Julie R, Sandler Alan B, Schiller Joan H, Johnson David H
Division of Hematology-Oncology, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, USA.
J Clin Oncol. 2008 Jan 1;26(1):60-5. doi: 10.1200/JCO.2007.13.1144.
Fit elderly patients with advanced non-small-cell lung cancer (NSCLC) benefit from platinum-based, two-drug chemotherapy. Bevacizumab (B) in combination with carboplatin (C) and paclitaxel (P) improves survival for advanced, nonsquamous NSCLC, as evidenced in Eastern Cooperative Oncology Group (ECOG) 4599. We conducted a subset analysis of ECOG 4599 to determine the outcome for elderly patients.
ECOG 4599 randomly assigned patients with advanced nonsquamous NSCLC to PC or to PCB. We analyzed outcome in patients who were at least 70 years of age at the time of study entry. Patient characteristics, efficacy, and toxicity data were compared between PC and PCB for the elderly. Outcomes for elderly and younger patients (< 70 years) treated with PCB were also compared.
Among elderly patients (n = 224; 26%), there was a trend towards higher response rate (29% v 17%; P = .067) and progression-free survival (5.9 v 4.9 months; P = .063) with PCB compared with PC, although overall survival (PCB = 11.3 months; PC = 12.1 months; P = .4) was similar. Grade 3 to 5 toxicities occurred in 87% of elderly patients with PCB versus 61% with PC (P < .001), with seven treatment-related deaths in the PCB arm compared with two with PC. Elderly patients had higher incidence of grade 3 to 5 neutropenia, bleeding, and proteinuria with PCB compared with younger patients.
In elderly NSCLC patients, PCB was associated with a higher degree of toxicity, but no obvious improvement in survival compared with PC. Data from this unplanned, retrospective analysis justify prospective evaluation of the therapeutic index of PCB regimen in elderly patients.
适合接受治疗的老年晚期非小细胞肺癌（NSCLC）患者可从铂类两药化疗中获益。贝伐单抗（B）联合卡铂（C）和紫杉醇（P）可改善晚期非鳞状NSCLC患者的生存期，这在东部肿瘤协作组（ECOG）4599研究中得到了证实。我们对ECOG 4599进行了亚组分析，以确定老年患者的治疗结果。
ECOG 4599将晚期非鳞状NSCLC患者随机分为PC组或PCB组。我们分析了研究入组时年龄至少70岁的患者的治疗结果。比较了老年患者PC组和PCB组的患者特征、疗效和毒性数据。还比较了接受PCB治疗的老年患者和年轻患者（<70岁）的治疗结果。
在老年患者（n = 2) ，尽管总生存期相似（PCB = 11.3个月；PC = 12.1个月；P = 0.4），但与PC组相比，PCB组的缓解率（29%对17%；P = 0.067）和无进展生存期（5.9个月对4.9个月；P = 0.063）有升高趋势。PCB组87%的老年患者发生3至5级毒性反应，而PC组为61%（P < 0.001），PCB组有7例治疗相关死亡，而PC组有2例。与年轻患者相比，老年患者接受PCB治疗时3至5级中性粒细胞减少、出血和蛋白尿的发生率更高。
在老年NSCLC患者中，PCB与更高程度的毒性相关，但与PC组相比生存期无明显改善。这项非计划的回顾性分析数据证明有必要对老年患者PCB方案的治疗指数进行前瞻性评估。
