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. 2019 Nov 20;22(11):719–726. [Article in Chinese] doi: 10.3779/j.issn.1009-3419.2019.11.06

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肺癌脑转移患者临床试验数据来源

Data sources of clinical trials for lung cancer patients with brain metastasis

Study Year Treatment Outcome Citation
WBRT: whole brain radiotherapy; EGFR-TKI: epidermal growth factor receptor-tyrosine kinase inhibitor; SRS: stereotactic radiotherapy; ORR: objective response rate; mPFS: median progression-free survival; mOS: median overall survival; DCR: disease control rate; *: subgroup analysis for brain metastasis lung cancer patients.
Clinical trials for patients with brain metastasis
  BRAIN 2017 Icotinib vs WBRT mPFS: 6.8 mo vs 3.4 mo, imPFS: 10.0 mo vs 4.8 mo [36]
  CTONG-0803 2012 Erlotinib ORR: 58.3%; mPFS: 15.2 mo; imPFS: 10.1 mo; [15]
  Iuchi 2013 Gefitinib ORR: 87.8%; mPFS: 14.5 mo; mOS: 21.9 mo [14]
  Park 2012 Erlotinib or gefitinib DCR: 93%; mPFS: 6.6 mo; mOS: 15.9 mo [13]
  William 2016 EGFR-TKI+SRS or WBRT;WBRT+EGFR-TKI;SRS+EGFR-TKI mOS: 19.4 mo vs 29.9 mo vs 58.4 mo   [43]
  William 2017 EGFR-TKI+SRS or WBRT;WBRT+EGFR-TKI;SRS+EGFR-TKI mOS: 25 mo vs 30 mo vs 46 mo [42]
  BLOOM 2017 AZD3759 1st-line: ORR: 65%, iORR: 83%
2nd line: ORR: 28%
[28]
Subgroup analysis for patients with brain metastasis
  ALEX 2017 Alectinib vs crizotinib mPFS: 34.8 mo vs 10.9 mo, mPFS*: 27.7 mo vs 7.4 mo [30]
  ASCEND-4 2017 Ceritinib vs platinum-based chemotherapy mPFS: 16.6 mo vs 8.1 mo mPFS*: 10.7 mo vs 6.7 mo [41]
  AURA3 2016 Osimertinib vs platinum-pemetrexed ORR*: 71% vs 31%, mPFS*: 10.1 mo vs 4.4 mo, imPFS*: 8.5 mo vs 4.2 mo [39]
  FLAURA 2017 Osimertinib vs standard EGFR-TKI mPFS: 18.9 mo vs 10.2 mo, mPFS*: 15.2 mo vs 9.6 mo [27]
  J-ALEX 2017 Alectinib vs crizotinib mPFS: 34.1 mo vs 10.2 mo [29]
  LUX-Lung 3 & 6 2015 Afatinib vs cisplatin-based chemotherapy mPFS*: 8.2 mo vs 5.4 mo, ORR*: 70% vs 20% [37, 38]
  NCT01970865   2018   Lorlatinib   ORR: 90%, ORR*: 66.7% [31]  
  NCT01449461 2016 Brigatinib mPFS: 15.6 mo [32]
  PROFILE 1005 or 1007 2015 Crizotinib 1st line: DCR: 63%, iDCR: 56%, mPFS: 7 mo; 2nd line: DCR: 65%, iDCR: 2%, mPFS: 13.2 mo [16-18]
  PROFILE 1014 2014 Crizotinib vs chemotherapy ORR: 74% vs 45%, mPFS: 10.9 mo vs 7 mo, ORR*: 77% vs 28%, mPFS*: 9 mo vs 4 mo [40]
  ALTA 2017 Brigatinib ORR: 54%, mPFS: 12.9 mo [45]
  ASCEND-5 2017 Ceritinib vs chemotherapy mPFS: 5.4 mo vs 1.6 mo [46]
  NCT02737501 2018 Brigatinib vs crizotinib ORR: 71% vs 60%, iORR: 78% vs 29% [47]
  NCT01801111 2015 Alectinib ORR: 50%, mPFS: 8.9 mo [48]
  NCT01871805 2016 Alectinib ORR: 48%, mPFS: 8.1 mo [49]
  NCT01964157 2017 Ceritinib ORR: 62%, mPFS: 9.3 mo, mOS: 24 mo [50]
  NCT01336634 2016 Dabrafenib+trametinib ORR: 63.2%, mPFS: 9.7 mo [34]