日本研究:厄洛替尼对于晚期非小细胞肺癌的生存期未见改善

晚期非小细胞肺癌(NSCLC)的二线或三线方案：厄洛替尼(Erlotinib) vs. 多西他赛(Docetaxel)

日本学者发表在JCO的DELTA试验是对于IIIB期或IV期NSCLC且已接受一种或两种治疗方案的患者的。结果显示，对于这些未根据EGFR状态进行筛选的患者，与多西他赛治疗组相比，厄洛替尼组的无进展生存期(progression-free survival，PFS)和总生存期(overall survival，OS)未见改善。

Randomized Phase III Trial of Erlotinib Versus Docetaxel As Second- or Third-Line Therapy in Patients With Advanced Non–Small-Cell Lung Cancer: Docetaxel and Erlotinib Lung Cancer Trial (DELTA)
 

Abstract

Purpose To investigate the efficacy of erlotinib versus docetaxel in previously treated patients with advanced non–small-cell lung cancer (NSCLC) in an epidermal growth factor receptor (EGFR) –unselected patient population.

Patients and Methods The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), response rate, safety, and analyses on EGFR wild-type tumors. Patients with stage IIIB or IV NSCLC, previous treatment with one or two chemotherapy regimens, evaluable or measurable disease, and performance status of 0 to 2 were eligible.

Results From August 2009 to July 2012, 150 and 151 patients were randomly assigned to erlotinib (150 mg daily) and docetaxel (60 mg/m² every 3 weeks), respectively. EGFR wild-type NSCLC was present in 109 and 90 patients in the erlotinib and docetaxel groups, respectively. Median PFS for erlotinib versus docetaxel was 2.0 v 3.2 months (hazard ratio [HR], 1.22; 95% CI, 0.97 to 1.55; P = .09), and median OS was 14.8 v 12.2 months (HR, 0.91; 95% CI, 0.68 to 1.22; P = .53), respectively. In a subset analysis of EGFR wild-type tumors, PFS for erlotinib versus docetaxel was 1.3 v 2.9 months (HR, 1.45; 95% CI, 1.09 to 1.94; P = .01), and OS was 9.0 v 10.1 months (HR, 0.98; 95% CI, 0.69 to 1.39; P = .91), respectively.

Conclusion Erlotinib failed to show an improvement in PFS or OS compared with docetaxel in an EGFR-unselected patient population.

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非小细胞肺癌的分类: http://www.cancer.gov/cancertopics/pdq/treatment/non-small-cell-lung/Patient/page1

There are several types of non-small cell lung cancer.

Each type of non-small cell lung cancer has different kinds of cancercells. The cancer cells of each type grow and spread in different ways. The types of non-small cell lung cancer are named for the kinds of cells found in the cancer and how the cells look under a microscope:

• Squamous cell carcinoma (鳞癌) : Cancer that begins in squamous cells, which are thin, flat cells that look like fish scales. This is also called epidermoid carcinoma.
• Large cell carcinoma (大细胞癌) : Cancer that may begin in several types of large cells.
• Adenocarcinoma (腺癌) : Cancer that begins in the cells that line the alveoli and make substances such as mucus.

Other less common types of non-small cell lung cancer are: pleomorphic, carcinoidtumor, salivary gland carcinoma, and unclassified carcinoma.

有关非小细胞肺癌的clinical trials情况可参见维基链接:

Non-small-cell lung carcinoma - Wikipedia, the free ...

 

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