Open AccessINST OX‐05‐024: first line gemcitabine, oxaliplatin, and erlotinib for primary hepatocellular carcinoma and bile duct cancers: a multicenter Phase II trial
Author(s) -
Patt Yehuda Z.,
Murad Waheed,
Fekrazad Mohammed H.,
Baron Ari D.,
Bansal Pranshu,
Boumber Yanis,
Steinberg Kim,
Lee SangJoon,
Bedrick Ed,
Du Ruofei,
Lee Fa Chyi
Publication year - 2017
Publication title -
cancer medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.403
H-Index - 53
ISSN - 2045-7634
DOI - 10.1002/cam4.1138
Subject(s) - medicine , gastroenterology , hepatocellular carcinoma , gemcitabine , oxaliplatin , erlotinib , neutropenia , phases of clinical research , oncology , cancer , colorectal cancer , chemotherapy , epidermal growth factor receptor
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 PD s 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.