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Phase II trial of gefitinib in pretreated Chinese women with advanced non-small-cell lung cancer

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Abstract

A phase II clinical trial was performed to evaluate the efficacy and safety of gefitinib on pretreated Chinese female non-small-cell lung cancer (NSCLC) patients. Chinese female patients with locally advanced or metastatic NSCLC who failed at least one platinum-based chemotherapy received gefitinib monotherapy (250 mg/day) between April 2002 and January 2010. The primary endpoint was overall response rate (ORR), and secondary endpoints were overall survival (OS) and progression-free survival (PFS). Of the 40 evaluable female patients, the ORR was 62.5%. All patients have responded with one (2.5%) complete response, 24 (60%) partial response, 12 (30%) stable disease, and 3 (7.5%) progressive disease. The OS and PFS were 20 months (95% CI: 11.9–28 months) and 13 months (95% CI: 8.0–17.9 months), respectively. Survival (OS and PFS) were longer in patients with good performance status and in patients older than 65 years (P < 0.05). The most frequently observed toxicities were rash/dry skin (80%), diarrhea (42.5%), and vomiting/anorexia (32.5%). Four patients developed grade 3 toxicities (rash and diarrhea) but did not require either dose reduction or discontinuation. Gefitinib is a highly effective and well-tolerated agent for Chinese women with pretreated advanced NSCLC.

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Authors and Affiliations

  1. Department of Medical Oncology, The First Hospital Affiliated to Medical School of Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, China

    Jing Deng, Wei Jia Fang, Xiao Chen Zhang, Jing Chen, Jiong Qian, Hai Bo Mou & Nong Xu

  2. Department of Oncological Surgery, The First Hospital Affiliated to Medical School of Zhejiang University, 79 Qingchun Road, 310003, Hangzhou, Zhejiang, China

    Li Song Teng

  3. Department of Radiotherapy, Shaoxing People’s Hospital, 312000, Shaoxing, Zhejiang, China

    Dong Ping Wu

  4. Department of Medical Oncology, Xiaoshan Hospital, 311200, Hangzhou, Zhejiang, China

    Hong Ming Fang

  5. Department of Medical Oncology, Mingzhou Hospital, 315000, Ningbo, Zhejiang, China

    Bin Bin Chu

Authors
  1. Jing Deng
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  2. Wei Jia Fang
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  3. Xiao Chen Zhang
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  4. Dong Ping Wu
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  5. Hong Ming Fang
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  6. Jing Chen
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  7. Jiong Qian
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  8. Hai Bo Mou
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  9. Bin Bin Chu
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  10. Nong Xu
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  11. Li Song Teng
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Correspondence to Nong Xu or Li Song Teng.

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Deng, J., Fang, W.J., Zhang, X.C. et al. Phase II trial of gefitinib in pretreated Chinese women with advanced non-small-cell lung cancer. Med Oncol 29, 595–599 (2012). https://doi.org/10.1007/s12032-011-9891-2

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  • DOI: https://doi.org/10.1007/s12032-011-9891-2

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