INST OX-05-024: first line gemcitabine, oxaliplatin, and erlotinib for primary hepatocellular carcinoma and bile duct cancers: a multicenter Phase II trial

Autor: Yehuda Z. Patt, Kim A. Steinberg, Edward J. Bedrick, Waheed Murad, Ruofei Du, Sang Joon Lee, Fa-Chyi Lee, Pranshu Bansal, Ari D. Baron, Mohammed H. Fekrazad, Yanis Boumber
Rok vydání: 2017
Předmět:
Oncology
Adult
Male
Cancer Research
medicine.medical_specialty
Carcinoma
Hepatocellular
Organoplatinum Compounds
First line
Neutropenia
Deoxycytidine
Bile duct cancer
03 medical and health sciences
Erlotinib Hydrochloride
0302 clinical medicine
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Radiology
Nuclear Medicine and imaging
030212 general & internal medicine
Prospective Studies
HCC
neoplasms
Aged
Original Research
Bile duct
business.industry
Liver Neoplasms
Clinical Cancer Research
Middle Aged
medicine.disease
Survival Analysis
Gemcitabine
digestive system diseases
Oxaliplatin
medicine.anatomical_structure
Treatment Outcome
Bile Duct Neoplasms
Erlotinib
030220 oncology & carcinogenesis
Hepatocellular carcinoma
Female
Bile Duct Cancer
business
medicine.drug
Zdroj: Cancer Medicine
ISSN: 2045-7634
Popis: 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.
Databáze: OpenAIRE
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