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Study of Gefitinib and Pemetrexed as First-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation

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Pathology & Oncology Research

Abstract

To evaluate the efficacy and safety of a combination regimen of gefitinib and pemetrexed as first-line chemotherapy in advanced EGFR-mutated non-small cell lung cancer (NSCLC) patients. Patients and methods Patients with advanced non-squamous NSCLC harboring asensitive EGFR mutation were included in this study and randomly divided into gefitinib + placebo group and gefitinib + pemetrexed group. Pemetrexed or placebo was administered on day 1 at a dose of 500 mg/m2, and gefitinib was sequentially administered on days 2 ~ 16. This treatment regimen was repeated every 3 weeks until disease progression. All investigators and participants were masked to treatment allocation. The overall response rate (ORR) and disease control rate (DCR) of gefitinib + pemetrexed group were higher than that of gefitinib + placebo group but only the difference of DCR between two groups was statistically significant (P < 0.05). The median progression-free survival (PFS) of gefitinib + placebo group and gefitinib + pemetrexed group were 14.0 months vs. 18 months respectively and the difference was statistically significant (P < 0.05). The 2-year PFS rates of gefitinib + pemetrexed group (20.00 %) was higher than that of gefitinib + placebo group (8.89 %) and the difference was statistically significant (P < 0.05). The median overall survival (OS) of gefitinib + placebo group and gefitinib + pemetrexed group were 32.0 months vs. 34 months respectively and the difference was not statistically significant (P > 0.05). The 3-year OS rates of gefitinib + pemetrexed group (44.44 %) was higher than that of gefitinib + placebo group (35.56 %) but the difference was not statistically significant (P > 0.05). Major grade 3 or 4 hematological toxicities included neutropenia, leukopenia and anemia. The main grade 3 or 4 non-hematological toxicities were infection, increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels, fatigue, diarrhea and pneumonitis. The difference of toxicities between two groups was not statistically significant (P > 0.05). The combination regimen of gefitinib + pemetrexed used in this study showed a higher ORR and DCR, longer median PFS and acceptable toxicity.

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Authors and Affiliations

  1. Department of Cardiothoracic Surgery, The Third People’s Hospital of Nantong, Jiangsu, China

    Chaolun An, Hongjun Chu, Fengwei Zhu, Rujian Lu, Hai Shi & Hongfei Zhang

  2. Department of Cardiothoracic Surgery, Changhai Hospital of Shanghai, Shanghai, China

    Jiajun Zhang

  3. Department of Pathology, The Third People’s Hospital of Nantong, Jiangsu, China

    Chunyan Gu & Feng Xiao

  4. Department of Human Anatomy, Medical College, Nantong University, 19 Qixiu Road, Nantong, Jiangsu Province, 226001, China

    Xin Yi

Authors
  1. Chaolun An
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  2. Jiajun Zhang
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  3. Hongjun Chu
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  4. Chunyan Gu
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  5. Feng Xiao
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  6. Fengwei Zhu
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  7. Rujian Lu
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  8. Hai Shi
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  9. Hongfei Zhang
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  10. Xin Yi
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Corresponding author

Correspondence to Xin Yi.

Additional information

Chaolun An, Jiajun Zhang and Hongjun Chu contributed equally to this study.

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An, C., Zhang, J., Chu, H. et al. Study of Gefitinib and Pemetrexed as First-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer Harboring EGFR Mutation. Pathol. Oncol. Res. 22, 763–768 (2016). https://doi.org/10.1007/s12253-016-0067-4

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  • DOI: https://doi.org/10.1007/s12253-016-0067-4

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