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多西他赛-卡铂化疗联合西妥昔单抗治疗局部晚期或转移性非小细胞肺癌(NSCLC)--非随机 II 期研究 TaxErb 的结果。

Docetaxel-carboplatin chemotherapy combined with cetuximab in patients with locally advanced or metastatic non small-cell lung cancer (NSCLC)--results of the nonrandomised phase II study TaxErb.

机构信息

Klinik Löwenstein gGmbH, Department of Medical Oncology, Im Geißhölzle 62, 74245 Löwenstein, Germany.

出版信息

Lung Cancer. 2012 Mar;75(3):348-52. doi: 10.1016/j.lungcan.2011.08.006. Epub 2011 Sep 9.

Abstract

This open label, single arm phase II study was designed to evaluate the efficacy and safety of the addition of cetuximab to first line chemotherapy with carboplatin and weekly docetaxel in patients with advanced non small-cell lung cancer (NSCLC). From February 2007 to December 2008 74 patients with NSCLC (stage IIIB and IV), ECOG PS ≤2 and no prior systemic chemotherapy were enrolled and treated with carboplatin (area under the curve=5 on day 1) and docetaxel (35 mg/m(2) on days 1, 8, and 15). Cycles were repeated every 4 weeks for a minimum of 4 and a maximum of 6 cycles. Cetuximab (400mg/m(2) on day 1 with subsequent doses of 250 mg/m(2) weekly) was administered until progression or intolerable toxicity up to a maximum treatment duration of 12 months. The primary endpoint was the overall response rate (CR+PR) according to RECIST. Secondary endpoints were progression-free survival (PFS), overall survival (OS) and toxicity. Patients received a median of 4 cycles of docetaxel-carboplatin-chemotherapy. The median number of administrations of cetuximab was 14. Sixty-seven patients were evaluable for response. Partial response was seen in 29/67 patients corresponding to an overall response rate (ORR) of 43.3% (95%CI, 28.5-53.7). No patient experienced complete response. The clinical benefit rate (PR+SD) was 79.1%. The 1-year rates for PFS and OS were 11.2% and 64.4%, respectively. Median PFS was 4.8 months (95%CI, 3.70-5.31) and median OS 12.9 months (95%CI 8.26-∞). Adverse events were mainly grades 1-2. Skin toxicity (76% of pts), dyspnea (36.5%) and anemia (31.1%) were most frequent. Results from this phase II study suggest that the addition of cetuximab to first-line doublet carboplatin and weekly docetaxel results in a considerable clinical efficacy with an acceptable toxicity profile for patients with advanced or metastatic NSCLC.

摘要

这项开放标签、单臂二期研究旨在评估在晚期非小细胞肺癌(NSCLC)患者中,厄洛替尼联合一线化疗(卡铂和每周紫杉醇)的疗效和安全性。从 2007 年 2 月至 2008 年 12 月,共纳入 74 例 NSCLC(IIIb 期和 IV 期)、ECOG PS≤2 且无既往全身化疗的患者,接受卡铂(第 1 天 AUC=5)和紫杉醇(第 1、8 和 15 天 35mg/m2)治疗。每 4 周重复 1 个周期,至少 4 个周期,最多 6 个周期。厄洛替尼(第 1 天 400mg/m2,随后剂量为 250mg/m2,每周 1 次)直至疾病进展或不耐受毒性,最大治疗时间为 12 个月。主要终点为根据 RECIST 评估的总缓解率(CR+PR)。次要终点为无进展生存期(PFS)、总生存期(OS)和毒性。患者接受中位数为 4 个周期的多西紫杉醇-卡铂-化疗。厄洛替尼的中位数给药次数为 14 次。67 例患者可评估疗效。29/67 例患者部分缓解,总缓解率(ORR)为 43.3%(95%CI,28.5-53.7)。无完全缓解的患者。临床获益率(PR+SD)为 79.1%。1 年时的 PFS 和 OS 率分别为 11.2%和 64.4%。中位 PFS 为 4.8 个月(95%CI,3.70-5.31),中位 OS 为 12.9 个月(95%CI,8.26-∞)。不良事件主要为 1-2 级。皮肤毒性(76%的患者)、呼吸困难(36.5%)和贫血(31.1%)最常见。这项二期研究的结果表明,厄洛替尼联合一线卡铂和每周紫杉醇治疗晚期或转移性 NSCLC 患者,具有显著的临床疗效,且毒性可接受。

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