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논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2017.1
- 수록면
- 1,001 - 1,011 (11page)
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Purpose This phase II study examined whether the addition of simvastatin to afatinib provides a clinical benefit compared with afatinib monotherapy in previously treated patients with nonadenocarcinomatous non-small cell lung cancer (NA-NSCLC).
Materials and Methods Patients with advanced NA-NSCLC who progressed after one or two chemotherapy regimens were randomly assigned to a simvastatin (40 mg/day) plus afatinib (40 mg/day) (AS) arm or to an afatinib (A) arm. The primary endpoint was response rate (RR).
Results Sixty-eight patients were enrolled (36 in the AS arm and 32 in the A arm). The RR was 5.7% (95% confidence interval [CI], 0.7 to 19.2) for AS and 9.4% (95% CI, 2.0 to 25.0) for A (p=0.440). In arms AS and A, the median progression-free survival (PFS) was 1.0 versus 3.6 months (p=0.240) and the overall survival was 10.0 months versus 7.0 months (p=0.930), respectively. Skin rash, stomatitis, and diarrhea were the most common adverse events in both arms. More grade 3 or 4 diarrhea was observed in arm A (18.8% vs. 5.6% in arm AS). In all patients, the median PFS for treatment including afatinib was not correlated with the status of epidermal growth factor receptor (EGFR) mutation (p=0.122), EGFR fluorescence in situ hybridization (p=0.944), or EGFR immunohistochemistry (p=0.976). However, skin rash severity was significantly related to the risk of progression for afatinib (hazard ratio for skin rash grade 2 vs. grade < 2, 0.44; 95% CI, 0.25 to 0.78; p=0.005).
Conclusion There were no significant differences in the efficacy between AS and A arms in patients with NA-NSCLC.
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참고문헌 (21)
참고문헌 신청
Cortot AB / 2014 / Molecular mechanisms of resistance in epidermal growth factor receptor-mutant lung adenocarcinomas / Eur Respir Rev 23 : 356 ~ 366
Eisenhauer EA / 2009 / New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) / Eur J Cancer 45 : 228 ~ 247
Endo A / 2004 / The discovery and development of HMG-CoA reductase inhibitors / Atheroscler Suppl 5 : 67 ~ 80
Gazdar AF / 2010 / Epidermal growth factor receptor inhibition in lung cancer : the evolving role of individualized therapy / Cancer Metastasis Rev 29 : 37 ~ 48
Han JY / 2011 / A randomized phase II study of gefitinib plus simvastatin versus gefitinib alone in previously treated patients with advanced non-small cell lung cancer / Cl
Eisenhauer EA / 2009 / New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) / Eur J Cancer 45 : 228 ~ 247
Endo A / 2004 / The discovery and development of HMG-CoA reductase inhibitors / Atheroscler Suppl 5 : 67 ~ 80
Gazdar AF / 2010 / Epidermal growth factor receptor inhibition in lung cancer : the evolving role of individualized therapy / Cancer Metastasis Rev 29 : 37 ~ 48
Han JY / 2011 / A randomized phase II study of gefitinib plus simvastatin versus gefitinib alone in previously treated patients with advanced non-small cell lung cancer / Cl
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