A randomized phase 2 trial of erlotinib versus pemetrexed as second-line therapy in the treatment of patients with advanced EGFR wild-type and EGFR FISH-positive lung adenocarcinoma

Authors

  • Ning Li MD,

    1. Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
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    • The first 3 authors contributed equally to this article.

  • Wei Ou MD,

    1. Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
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    • The first 3 authors contributed equally to this article.

  • Hua Yang MD,

    1. Department of Thyroid and Breast Surgery, The Central Hospital of Wuhan, Wuhan, China
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    • The first 3 authors contributed equally to this article.

  • Qian-Wen Liu MD,

    1. Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
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  • Song-Liang Zhang MD,

    1. Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
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  • Bao-Xiao Wang MD,

    1. College of Clinical Medicine, Guangzhou Medical University, Guangzhou, China
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  • Si-Yu Wang MD

    Corresponding author
    1. Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China
    • Corresponding author: Prof Si-Yu Wang, MD, Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, 651 Dongfeng Rd East, Guangzhou, 510060, China; Fax: (011) 86 20 87343439; wsysums@163.net.

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  • Presented in part as a poster at the 15th World Conference on Lung Cancer; October 27-30, 2013; Sydney, New South Wales, Australia.

  • The authors would like to thank all patients who participated in the study.

Abstract

BACKGROUND

The current study was undertaken to investigate the efficacy and safety of erlotinib versus pemetrexed as second-line therapy for patients with advanced epidermal growth factor receptor (EGFR) wild-type and EGFR fluorescence in situ hybridization (FISH)-positive lung adenocarcinoma.

METHODS

In this open-label, randomized, phase 2 study, patients with EGFR wild-type and EGFR FISH-positive adenocarcinoma who had developed disease progression after 1 prior platinum-based chemotherapy were randomly assigned (1:1) to receive erlotinib or pemetrexed until the time of disease progression or death, unacceptable toxicity, or a request for discontinuation by the patient. The primary endpoint was progression-free survival (PFS).

RESULTS

A total of 123 patients were enrolled (61 in the erlotinib arm and 62 in the pemetrexed arm). The median PFS was 4.1 months (95% confidence interval [95% CI], 1.6 months-6.6 months) in the erlotinib group versus 3.9 months (95% CI, 2.7 months-5.1 months) in the pemetrexed group. The difference in PFS between the 2 treatment groups was not significant (hazard ratio, 0.92; 95% CI, 0.62-1.37 [P = .683]). The objective response rate appeared to be higher among patients receiving erlotinib compared with those receiving pemetrexed (19.7% vs 8.1%; P = .062). The 3 most commonly recorded adverse events were rash (54.1%), fatigue (19.7%), and diarrhea (16.4%) in the erlotinib group and fatigue (25.8%), nausea (24.2%), and anorexia (14.5%) in the pemetrexed group.

CONCLUSIONS

There were no significant differences noted with regard to efficacy between erlotinib and pemetrexed in the second-line setting for patients with advanced EGFR wild-type and EGFR FISH-positive lung adenocarcinoma. Both regimens appear to be effective treatment options for these patients. Cancer 2014;120:1379–1386. © 2014 American Cancer Society.

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