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INST OX-05-024: first line gemcitabine, oxaliplatin, and erlotinib for primary hepatocellular carcinoma and bile duct cancers: a multicenter Phase II trial.
- Source :
- Cancer Medicine; Sep2017, Vol. 6 Issue 9, p2042-2051, 10p
- Publication Year :
- 2017
-
Abstract
- Hepatocellular Carcinoma ( HCC) incidence is increasing in the USA. Gemcitabine (G) and oxaliplatin (O) are active in HCC and biliary duct cancer ( BDC). Erlotinib (E) is an EGFR tyrosine kinase inhibitor ( TKI) with known activity against both. We sought to evaluate the efficacy of the combination G+O+E. Patients with either of the two diagnosis were treated in a phase II trial. Simons 2 stage design was used. A disease-control rate ( DCR), complete response ( CR) + partial response ( PR)+ stable disease ( SD) at 24 weeks of ≤20% and >40% (P0 and P1 of 0.2 and 0.4, respectively) were set as undesirable (null) and desirable results. 26 HCC and 7 BDC patients were accrued. In HCC, 1 PR, 10 SD, and 9 PDs were seen. DCR in HCC was 42%. Among seven (7) patients with BDC, one patient was not evaluable; one achieved a long lasting PR, and five patients had SD and DCR was 86%. Median overall survival ( OS) times and progression-free survivals ( PFS) were 196 and 149 days in HCC and 238 days and not reached in BDC. PFS at 26 weeks in HCC was 41% and at 21 weeks in BDC was 60%. Grade 3 toxicities in >5% of patients were fatigue (12.9%), neutropenia (9.6%), thrombocytopenia (9.6%), and diarrhea (6.4%). G+O+E exceeded both preset P0a and P1 of the primary objective with a PFS of 41% at 26 weeks for HCC and preliminary BDC data may warrant further investigations. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 20457634
- Volume :
- 6
- Issue :
- 9
- Database :
- Complementary Index
- Journal :
- Cancer Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 125219066
- Full Text :
- https://doi.org/10.1002/cam4.1138