A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma
- Authors
- Roy, AC[Roy, A. C.]; Park, SR[Park, S. R.]; Cunningham, D[Cunningham, D.]; Kang, YK[Kang, Y. K.]; Chao, Y[Chao, Y.]; Chen, LT[Chen, L. T.]; Rees, C[Rees, C.]; Lim, HY[Lim, H. Y.]; Tabernero, J[Tabernero, J.]; Ramos, FJ[Ramos, F. J.]; Kujundzic, M[Kujundzic, M.]; Cardic, MB[Cardic, M. B.]; Yeh, CG[Yeh, C. G.]; de Gramont, A[de Gramont, A.]
- Issue Date
- Jun-2013
- Publisher
- OXFORD UNIV PRESS
- Keywords
- docetaxel; irinotecan; liposomal irinotecan; oesop
- Citation
- ANNALS OF ONCOLOGY, v.24, no.6, pp.1567 - 1573
- Indexed
- SCIE
SCOPUS
- Journal Title
- ANNALS OF ONCOLOGY
- Volume
- 24
- Number
- 6
- Start Page
- 1567
- End Page
- 1573
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/60450
- DOI
- 10.1093/annonc/mdt002
- ISSN
- 0923-7534
- Abstract
- 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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Collections - Medicine > Department of Medicine > 1. Journal Articles
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