Schuette Wolfgang, Schneider Claus-Peter, Engel-Riedel Walburga, Schumann Christian, Kohlhaeufl Martin, Serke Monika Heidi Ursel, Hoeffken Gert, Kortsik Cornelius, Reck Martin
Department of Internal Medicine II, Hospital Martha-Maria Halle-Doelau, Halle.
Department of Pneumonology, Central Hospital, Bad Berka.
Lung Cancer (Auckl). 2017 Nov 6;8:217-229. doi: 10.2147/LCTT.S142972. eCollection 2017.
The aim of the study was to investigate in terms of noninferiority the efficacy and safety of a monochemotherapy regimen of pemetrexed plus bevacizumab (BevPem) versus carboplatin/pemetrexed plus bevacizumab (BevCPem) in elderly patients as first-line treatment for advanced metastatic or recurrent nonsquamous non-small-cell lung cancer (NSCLC).
65Plus was a Phase III, randomized, open-label study. In total, 253 patients received BevPem (n=119) or BevCPem (n=134). The primary outcome measure was progression-free survival. Secondary end points were overall survival, tumor response, and safety outcomes. Evaluations were performed for the whole study population and stratified according to Eastern Cooperative Oncology Group (ECOG) performance status (PS).
Noninferiority of BevPem in comparison to BevCPem could not be demonstrated for the overall population (=0.7864). Significant superiority of the combined treatment BevCPem was seen in patients of ECOG PS 0-1 (median PFS 5.1 vs 6.9 months, HR 1.353, 95% CI 1.03-1.777), while the opposite tendency was observed in patients with ECOG PS 2 (median PFS 2.9 vs 1.5 months, HR 0.628, 95% CI 0.195-2.025). Overall, better tolerability was found for the BevPem group, irrespective of ECOG PS.
Results from the 65plus study give evidence that BevPem and BevCPem treatments may exert differential effects on PFS, depending on the patients ECOG PS. It appears that patients with better ECOG PS (0-1) benefited more from the combined treatment with carboplatin, while the group comprising more severely impaired patients (ECOG PS 2) benefited more from the monochemotherapy.
本研究旨在就非劣效性，调查培美曲塞联合贝伐单抗（BevPem）单药化疗方案与卡铂/培美曲塞联合贝伐单抗（BevCPem）在老年患者中作为晚期转移性或复发性非鳞状非小细胞肺癌（NSCLC）一线治疗的疗效和安全性。
65Plus是一项III期随机开放标签研究。共有253例患者接受BevPem（n = 119）或BevCPem（n = 134）治疗。主要结局指标为无进展生存期。次要终点为总生存期、肿瘤反应和安全性结局。对整个研究人群进行评估，并根据东部肿瘤协作组（ECOG）体能状态（PS）进行分层。
对于总体人群，无法证明BevPem相对于BevCPem具有非劣效性（=0.7864）。在ECOG PS 0 - 1的患者中，联合治疗BevCPem显示出显著优势（中位无进展生存期5.1个月对6.9个月，风险比1.353，95%置信区间1.03 - 1.777），而在ECOG PS 2的患者中观察到相反趋势（中位无进展生存期2.9个月对1.5个月，风险比0.628，95%置信区间0.195 - 2.025）。总体而言，无论ECOG PS如何，BevPem组的耐受性更好。
65plus研究结果表明，BevPem和BevCPem治疗对无进展生存期可能产生不同影响，这取决于患者的ECOG PS。似乎ECOG PS较好（0 - 1）的患者从卡铂联合治疗中获益更多，而包括受损更严重患者（ECOG PS 2）的组从单药化疗中获益更多。
