Phase II study of gemcitabine, oxaliplatin in combination with panitumumab in KRAS wild-type unresectable or metastatic biliary tract and gallbladder cancer.
Abstract | BACKGROUND: METHODS: Patients with histologically confirmed, previously untreated, unresectable or metastatic KRAS wild-type biliary tract or gallbladder adenocarcinoma with ECOG performance status 0-2 were treated with panitumumab 6 mg kg(-1), GEM 1000 mg m(-2) (10 mg m(-2) min(-1)) and OX 85 mg m(-2) on days 1 and 15 of each 28-day cycle. The primary objective was to determine the objective response rate by RECIST criteria v.1.1. Secondary objectives were to evaluate toxicity, progression-free survival (PFS), and overall survival. RESULTS: Thirty-one patients received at least one cycle of treatment across three institutions, 28 had measurable disease. Response rate was 45% and disease control rate was 90%. Median PFS was 10.6 months (95% CI 5-24 months) and median overall survival 20.3 months (95% CI 9-25 months). The most common grade 3/4 adverse events were anaemia 26%, leukopenia 23%, fatigue 23%, neuropathy 16% and rash 10%. CONCLUSIONS:
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Authors | A F Hezel, M S Noel, J N Allen, T A Abrams, M Yurgelun, J E Faris, L Goyal, J W Clark, L S Blaszkowsky, J E Murphy, H Zheng, A A Khorana, G C Connolly, O Hyrien, A Baran, M Herr, K Ng, S Sheehan, D J Harris, E Regan, D R Borger, A J Iafrate, C Fuchs, D P Ryan, A X Zhu |
Journal | British journal of cancer
(Br J Cancer)
Vol. 111
Issue 3
Pg. 430-6
(Jul 29 2014)
ISSN: 1532-1827 [Electronic] England |
PMID | 24960403
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- KRAS protein, human
- Organoplatinum Compounds
- Proto-Oncogene Proteins
- Oxaliplatin
- Deoxycytidine
- Panitumumab
- Proto-Oncogene Proteins p21(ras)
- ras Proteins
- Gemcitabine
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Topics |
- Adenocarcinoma
(drug therapy, mortality, secondary)
- Adult
- Aged
- Antibodies, Monoclonal
(administration & dosage)
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Biliary Tract Neoplasms
(drug therapy, mortality, pathology)
- Deoxycytidine
(administration & dosage, analogs & derivatives)
- Disease-Free Survival
- Female
- Gallbladder Neoplasms
(drug therapy, mortality, pathology)
- Humans
- Kaplan-Meier Estimate
- Lymphatic Metastasis
- Male
- Middle Aged
- Organoplatinum Compounds
(administration & dosage)
- Oxaliplatin
- Panitumumab
- Proto-Oncogene Proteins
(genetics)
- Proto-Oncogene Proteins p21(ras)
- Treatment Outcome
- ras Proteins
(genetics)
- Gemcitabine
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