Department of Medical Oncology, National Cancer Institute, via Franco Gallini 2, 33081, Aviano, Italy.
Clin Drug Investig. 2012 Nov;32(11):755-60. doi: 10.1007/s40261-012-0001-9.
First-line bevacizumab-based therapy has been shown to improve outcomes in patients with advanced non-squamous non-small-cell lung cancer (NSCLC). The recent international phase IV SAiL study (a Study of Avastin [bevacizumab] in combination with platinum-containing chemotherapy in patients with advanced or recurrent non-squamous cell Lung cancer) evaluated the safety and efficacy of bevacizumab combined with standard chemotherapy regimens in routine clinical practice. Here we report the results of a subanalysis of baseline characteristics and efficacy data for Italian patients enrolled in SAiL.
In the SAiL study, patients with untreated locally advanced, metastatic or recurrent non-squamous NSCLC received bevacizumab (7.5 or 15 mg/kg) every 3 weeks plus chemotherapy for up to six cycles, followed by single-agent bevacizumab until disease progression. Efficacy was assessed in terms of time to disease progression (TTP) and overall survival (OS).
The Italian intent-to-treat population comprised 215 patients from a SAiL population of 2212 patients. At baseline, Italian patients tended to have less advanced disease than the overall population. Thus, the proportion of patients at enrollment with tumour stage IIIb and IV was 23.7 and 76.3 %, respectively, for the Italian population versus 19.7 and 80.3 % for the whole SAiL population. In addition, a higher proportion of Italian patients had an Eastern Cooperative Oncology Group performance status of 0 (72.6 vs. 37.2 %) and the prevalence of co-morbid conditions was lower in Italian patients (59.5 % of Italian patients reported a co-morbid condition and 60.0 % were receiving non-oncological treatment compared with 73.3 and 73.4 %, respectively, of SAiL patients overall). The mean exposures to bevacizumab and to chemotherapy were comparable between the Italian patient group and overall patient population, although cisplatin doublets were more commonly employed in Italian patients whereas carboplatin doublets were more commonly employed in the overall SAiL population. The median TTP and OS times for Italian and SAiL populations were comparable (TTP, 7.8 months vs. 7.8 months; OS, 14.8 months vs. 14.6 months).
The results of this subanalysis of the SAiL study of bevacizumab treatment in routine clinical practice suggest that Italian oncologists tend to prescribe bevacizumab to a selected population of patients with less advanced disease than is the case in the overall population. Nevertheless, the first-line use of bevacizumab in combination with chemotherapy offers clinical benefits to Italian patients with advanced or recurrent non-squamous NSCLC.
一线贝伐珠单抗治疗已被证明可改善晚期非鳞状非小细胞肺癌（NSCLC）患者的预后。最近的国际 IV 期 SAiL 研究（Avastin [贝伐珠单抗]联合含铂化疗治疗晚期或复发性非鳞状细胞肺癌的研究）评估了贝伐珠单抗联合标准化疗方案在常规临床实践中的安全性和疗效。在此，我们报告了 SAiL 中入组的意大利患者的基线特征和疗效数据的亚组分析结果。
在 SAiL 研究中，未经治疗的局部晚期、转移性或复发性非鳞状 NSCLC 患者接受贝伐珠单抗（7.5 或 15 mg/kg）每 3 周 1 次联合化疗最多 6 个周期，随后单药贝伐珠单抗治疗直至疾病进展。根据无进展生存期（TTP）和总生存期（OS）评估疗效。
意大利意向治疗人群包括 215 例患者，来自 2212 例患者的 SAiL 人群。在基线时，意大利患者的疾病进展程度低于总体人群。因此，入组时肿瘤分期为 IIIb 和 IV 期的患者比例分别为意大利人群的 23.7%和 76.3%，而整个 SAiL 人群的比例为 19.7%和 80.3%。此外，意大利患者的东部肿瘤协作组体能状态评分 0 级的比例较高（72.6%比 37.2%），合并症的发生率较低（59.5%的意大利患者报告合并症，60.0%接受非肿瘤治疗，而 SAiL 患者总体分别为 73.3%和 73.4%）。与整个 SAiL 人群相比，意大利患者组与总体患者人群的贝伐珠单抗和化疗平均暴露量相当，尽管顺铂双药联合方案在意大利患者中更为常用，而卡铂双药联合方案在整个 SAiL 人群中更为常用。意大利人群和 SAiL 人群的中位 TTP 和 OS 时间相当（TTP：7.8 个月比 7.8 个月；OS：14.8 个月比 14.6 个月）。
对贝伐珠单抗治疗常规临床实践的 SAiL 研究的这一亚组分析结果表明，意大利肿瘤学家倾向于为疾病进展程度低于总体人群的患者处方贝伐珠单抗。然而，贝伐珠单抗联合化疗一线治疗可为晚期或复发性非鳞状 NSCLC 意大利患者带来临床获益。
