Targeted and Cytotoxic Therapy in Coordinated Sequence (TACTICS): Erlotinib, Bevacizumab, and Standard Chemotherapy for Non-Small-Cell Lung Cancer, A Phase II Trial
Targeted and Cytotoxic Therapy in Coordinated Sequence (TACTICS): Erlotinib, Bevacizumab, and Standard Chemotherapy for Non-Small-Cell Lung Cancer, A Phase II Trial
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DOI：
10.1016/j.cllc.2011.10.001
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发表时间：
2012-03-01
影响因子：
3.6
通讯作者：
Vokes, Everett E.
中科院分区：
文献类型：
--
作者：
Cohen, Ezra E. W.;Subramanian, Janakiraman;Vokes, Everett E.
这项II期研究（ClinicalTrials.gov ID: NCT00607165）的目的是在未选择的非小细胞肺癌（NSCLC）患者中有效地结合现有的靶向和细胞毒性化疗。该研究达到了主要终点，无进展率为46%，厄洛替尼和贝伐单抗的联合耐受性良好。考虑到适度的益处和厄洛替尼一线治疗主要适用于表皮生长因子受体（EGFR）酪氨酸激酶（TK）突变激活的患者，我们认为该方案不需要在未选择的NSCLC患者中进一步评估。背景：本试验的重点是将现有靶向治疗和细胞毒性化疗最佳结合治疗未选择的晚期非小细胞肺癌（NSCLC）患者。方法：先前未经治疗的晚期非鳞状NSCLC患者符合本试验的条件。在模块A中，患者接受最多4个周期的厄洛替尼150 mg/天和贝伐单抗15 mg/kg每3周。在模块b中，患者接受卡铂（AUC = 6）、紫杉醇200 mg/m2和贝伐单抗15 mg/kg的治疗，疗程为4个周期。在模块A中，没有进展性疾病的患者接受厄洛替尼每日150 mg的维护性治疗，在模块c中接受贝伐单抗15 mg/kg每3周的维护性治疗。结果：48名患者入组了这项多中心II期试验。大多数患者为男性（62.5%）和白人（77.1%），IV期疾病（93.8%）和腺癌组织学类型（66.7%）。模块A的总体回应率为10.4%，模块B为15.1%，模块C为5.5%。该研究达到了主要终点，模块a的非进展率为45.8%，中位总生存期（OS）为12.6个月。结论：新型全身治疗方案在晚期非小细胞肺癌患者中是可行的。然而，在未选择的非小细胞肺癌患者中，尚无进一步发展该方案的作用。临床肺癌杂志，Vol. 13, No. 2, 123-8 (C) 2012。版权所有。
The aim of this phase II study (ClinicalTrials.gov ID: NCT00607165) was to effectively combine existing targeted and cytotoxic chemotherapy in unselected patients with non small-cell lung cancer (NSCLC). The study achieved it primary endpoint, with a nonprogression rate of 46%, and the combination of erlotinib and bevacizumab was well tolerated. Given the modest benefit and the fact that frontline treatment with erlotinib is primarily indicated in patients with activating epidermal growth factor receptor (EGFR) tyrosine kinase (TK) mutations, we do not feel that this regimen requires further evaluation in unselected patients with NSCLC.Background: This trial focused on optimally combining existing targeted therapies and cytotoxic chemotherapy in the treatment of unselected patients with advanced non-small-cell lung cancer (NSCLC). Methods: Patients with previously untreated advanced-stage nonsquamous NSCLC were eligible for this trial. In module A, patients received up to 4 cycles of erlotinib 150 mg daily and bevacizumab 15 mg/kg every 3 weeks. Patients then received carboplatin (AUC = 6), paclitaxel 200 mg/m2, and bevacizumab 15 mg/kg for 4 cycles in module B. Patients who did not have progressive disease in module A received maintenance erlotinib 150 mg daily and bevacizumab 15 mg/kg every 3 weeks in module C. Results: Forty-eight patients were enrolled in this multicenter phase II trial. Most patients were male (62.5%) and white (77.1%) with stage IV disease (93.8%) and adenocarcinoma histologic type (66.7%). The overall response rate in module A was 10.4%, in module B it was 15.1%, and in module C it was 5.5%. The study achieved its primary endpoint, with a nonprogression rate of 45.8% in module A. The median overall survival (OS) was 12.6 months. Conclusion: The novel systemic therapy regimen is feasible in patients with advanced NSCLC. However there is no further role for developing this regimen in unselected patients with NSCLC. Clinical Lung Cancer, Vol. 13, No. 2, 123-8 (C) 2012 Elsevier Inc. All rights reserved.