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A phase II open-label clinical study of comparing nab-paclitaxel with pemetrexed as second-line chemotherapy for patients with stage IIIB/IV non-small-cell lung cancer

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Abstract

Current choices of second-line chemotherapy regimens for patients with advanced non-small-cell lung cancer (NSCLC) are extremely limited. We applied a new strategy of using nab-paclitaxel as single chemotherapy regimen in second-line setting for patients with unsuccessful first-line chemotherapy. The efficacy and safety were compared with patients who received standard second-line regimen pemetrexed. Patients with stage IIIB/IV NSCLC and unsuccessful first-line platinum-based chemotherapy were randomly divided into two arms. Arm I received pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of 3-week cycle. Arm II received nab-paclitaxel 150 mg/m2 i.v. on days 1 and 8 of 3-week cycle. The primary endpoint was overall survival (OS). One hundred and eleven patients were randomly assigned to receive pemetrexed (n = 56) and nab-paclitaxel (n = 55). Median OSs were 9.4 months (95 % CI 7.1–12.5 months) for pemetrexed and 9.9 months (95 % CI 8.2–11.9 months) for nab-paclitaxel. Median PFS was 4.6 months (95 % CI 2.7–6.1 months) for pemetrexed and 5.1 months (95 % CI 3.9–7.4 months) for nab-paclitaxel. While no CR was reported for either treatment, PRs + SDs were seen in 32/56 (57.1 %) patients in pemetrexed arm and 36/55 (65.5 %) patients in nab-paclitaxel arm. Grade 3 and grade 4 adverse events were comparable between two treatment arms. New second-line chemotherapy single-regimen nab-paclitaxel showed equivalent efficacy and toxicity profiles as pemetrexed in treating patients with NSCLC.

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Authors and Affiliations

  1. Department of Oncology, General Hospital of Chinese PLA, 28 Fuxing Road, Beijing, 100853, China

    Zhefeng Liu, Zhimin Wei, Yi Hu, Ping Fang, Shengjie Sun, Jinyu Li & Shunchang Jiao

  2. Department of Medical Statistics, General Hospital of Chinese PLA, 28 Fuxing Road, Beijing, 100853, China

    Lu Hao

  3. Health Division of Guard Bureau, General Staff Department of Chinese PLA, 81 Nanchang Street, Beijing, 100017, China

    Feng Gao

Authors
  1. Zhefeng Liu
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  2. Zhimin Wei
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  3. Yi Hu
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  4. Feng Gao
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  5. Lu Hao
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  6. Ping Fang
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  7. Shengjie Sun
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  8. Jinyu Li
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  9. Shunchang Jiao
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Correspondence to Shunchang Jiao.

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Liu, Z., Wei, Z., Hu, Y. et al. A phase II open-label clinical study of comparing nab-paclitaxel with pemetrexed as second-line chemotherapy for patients with stage IIIB/IV non-small-cell lung cancer. Med Oncol 32, 216 (2015). https://doi.org/10.1007/s12032-015-0660-5

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  • DOI: https://doi.org/10.1007/s12032-015-0660-5

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