Duke University Medical Center, Durham, NC 27710, USA.
J Clin Oncol. 2011 Nov 20;29(33):4436-41. doi: 10.1200/JCO.2011.35.6923. Epub 2011 Oct 3.
The efficacy of cisplatin, irinotecan, and bevacizumab was evaluated in patients with extensive-stage small-cell lung cancer (ES-SCLC).
Patients with ES-SCLC received cisplatin 30 mg/m(2) and irinotecan 65 mg/m(2) on days 1 and 8 plus bevacizumab 15 mg/kg on day 1 every 21 days for six cycles on this phase II study. The primary end point was to differentiate between 50% and 65% 12-month survival rates.
Seventy-two patients were enrolled between March 2005 and April 2006; four patients canceled, and four were ineligible. Grade 3 or 4 toxicities included neutropenia (25%), all electrolyte (23%), diarrhea (16%), thrombocytopenia (10%), fatigue (10%), nausea (10%), hypertension (9%), anemia (9%), infection (7%), vascular access thrombosis (2%), stroke (2%), and bowel perforation (1%). Three deaths (5%) occurred on therapy as a result of pneumonitis (n = 1), stroke (n =1), and heart failure (n = 1). Complete response, partial response, and stable disease occurred in three (5%), 45 (70%), and 11 patients (17%), respectively. Progressive disease occurred in one patient (2%). Overall response rate was 75%. Median progression-free survival (PFS) was 7.0 months (95% CI, 6.4 to 8.4 months). Median overall survival (OS) was 11.6 months (95% CI, 10.5 to 15.1 months). Hypertension ≥ grade 1 was associated with improved OS after adjusting for performance status (PS) and age (hazard ratio [HR], 0.55; 95% CI, 0.31 to 0.97; P = .04). Lower vascular endothelial growth factor levels correlated with worse PFS after adjusting for age and PS (HR, 0.90; 95% CI, 0.83 to 0.99; P = .03).
PFS and OS times were higher compared with US trials in ES-SCLC with the same chemotherapy. However, the primary end point of the trial was not met. Hypertension was associated with improved survival after adjusting for age and PS.
评估顺铂、伊立替康和贝伐珠单抗在广泛期小细胞肺癌（ES-SCLC）患者中的疗效。
这项 II 期研究中，患者接受顺铂 30 mg/m²和伊立替康 65 mg/m²，分别于第 1 天和第 8 天给药，贝伐珠单抗 15 mg/kg，于第 1 天给药，每 21 天为一个周期，共进行 6 个周期。主要终点是区分 12 个月生存率 50%和 65%的差异。
2005 年 3 月至 2006 年 4 月期间共纳入 72 例患者；4 例患者取消治疗，4 例患者不符合条件。3 或 4 级毒性包括中性粒细胞减少症（25%）、所有电解质紊乱（23%）、腹泻（16%）、血小板减少症（10%）、疲劳（10%）、恶心（10%）、高血压（9%）、贫血（9%）、感染（7%）、血管通路血栓形成（2%）、中风（2%）和肠穿孔（1%）。3 例（5%）患者在治疗期间因肺炎（n=1）、中风（n=1）和心力衰竭（n=1）而死亡。完全缓解、部分缓解和稳定疾病的发生率分别为 3 例（5%）、45 例（70%）和 11 例（17%）。1 例（2%）患者疾病进展。总缓解率为 75%。中位无进展生存期（PFS）为 7.0 个月（95%CI，6.4 至 8.4 个月）。中位总生存期（OS）为 11.6 个月（95%CI，10.5 至 15.1 个月）。调整体能状态（PS）和年龄后，高血压≥1 级与 OS 改善相关（风险比[HR]，0.55；95%CI，0.31 至 0.97；P=0.04）。调整年龄和 PS 后，血管内皮生长因子水平较低与 PFS 较差相关（HR，0.90；95%CI，0.83 至 0.99；P=0.03）。
与美国的 ES-SCLC 临床试验相比，该研究中化疗相同的情况下 PFS 和 OS 时间更高。然而，试验的主要终点没有达到。调整年龄和 PS 后，高血压与生存改善相关。
