期刊
ANNALS OF ONCOLOGY
卷 24, 期 6, 页码 1567-1573出版社
ELSEVIER
DOI: 10.1093/annonc/mdt002
关键词
docetaxel; irinotecan; liposomal irinotecan; oesophago-gastric cancer; phase II; second line
类别
资金
- PharmaEngine
- NHS
- NIHR Biomedical Research Centre
- Peter Stebbings Memorial Charity
Background: PEP02 is a novel highly stable liposomal nanocarrier formulation of irinotecan. This randomized phase II study evaluated the efficacy and safety of single agent PEP02 compared with irinotecan or docetaxel in the second-line treatment of advanced oesophago-gastric (OG) cancer. Patients and methods: Patients with locally advanced/metastatic disease who had failed one prior chemotherapy regimen were randomly assigned to PEP02 120 mg/m(2), irinotecan 300 mg/m(2) or docetaxel (Taxotere) 75 mg/m(2) every 3 weeks. The primary end point was objective response rate (OAR). Simon's two-stage design was used and the ORR of interest was 20% (alpha = 0.05, type II error beta = 0.10, null hypothesis of ORR was 5%). Results: Forty-four patients per arm received treatment, and 124 were assessable for response. The OAR statistical threshold for the first stage was reached in all arms. In the intent-to-treat (ITT) population, ORRs were 13.6% (6/44), 6.8% (3/44) and 15.9% (7/44) in the PEP02, irinotecan and docetaxel arms, respectively. The median progression-free survival (PFS) and overall survival were similar between the trial arms. Commonest grade 3-4 adverse event reported was diarrhoea in the PEP02 and irinotecan groups (27.3% versus 18.2%). Conclusion: The ORR associated with PEP02 was comparable with docetaxel and numerically greater than that of irinotecan. PEP02 warrants further evaluation in the advanced gastric cancer setting.
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