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- Title
A phase I clinical trial of hepatic arterial infusion of oxaliplatin and oral capecitabine, with or without intravenous bevacizumab, in patients with advanced cancer and predominant liver involvement.
- Authors
Fountzilas, Elena; Krishnan, Elangovan; Janku, Filip; Fu, Siqing; Karp, Daniel D.; Naing, Aung; Subbiah, Vivek; Hong, David S.; Piha-Paul, Sarina A.; Vining, David J.; Tsimberidou, Apostolia-Maria
- Abstract
<bold>Background: </bold>We investigated hepatic arterial infusion (HAI) oxaliplatin combined with capecitabine +/- bevacizumab in advanced cancer with predominant liver involvement.<bold>Methods: </bold>Patients received HAI oxaliplatin (140 mg/m2) and escalating doses of capecitabine (500, 750, and 1000 mg/m2), with (Group 1) or without (Group 2) bevacizumab (10 mg/kg IV). A 3 + 3 dose design was used, followed by an expansion phase.<bold>Results: </bold>From 9/2009 to 2/2014, 61 patients (34 men, 27 women) were enrolled (Group 1 = 44; Group 2 = 17). Patients were treated in Group 2 if they had contraindications to bevacizumab (n = 13) or if there was no opening in Group 1 (n = 4). The median age was 60 years (range, 20-88). The most common cancers were colorectal (22 patients), liver (12), pancreatic (7), breast (4), and biliary tract (4). The median number of prior therapies was 3 (range, 1-12); 32 (53%) patients had received oxaliplatin. The dose-limiting toxicity was Grade 3 diarrhea and occurred in 2 patients receiving 1000 mg/m2 capecitabine. The maximum tolerated dose was HAI oxaliplatin 140 mg/m2, capecitabine 750 mg/m2, and bevacizumab 10 mg/kg. The most common toxicities were nausea/vomiting, anemia, thrombocytopenia, neutropenia, and hypomagnesemia. The rates of partial response and stable disease ≥ 4 months were 22% and 39% (Group 1) and 9% and 0% (Group 2). The respective median time to treatment failure and overall survival were 3 and 6.9 months (Group 1) and 1.5 and 5.9 months (Group 2).<bold>Conclusion: </bold>HAI oxaliplatin combined with capecitabine +/- bevacizumab was well-tolerated and was associated with favorable outcomes in selected patients.
- Subjects
CANCER patients; BEVACIZUMAB; HEPATIC arterial infusion chemotherapy; OXALIPLATIN; THROMBOCYTOPENIA; NEUTROPENIA; HYPOMAGNESEMIA
- Publication
Cancer Chemotherapy & Pharmacology, 2018, Vol 82, Issue 5, p877
- ISSN
0344-5704
- Publication type
journal article
- DOI
10.1007/s00280-018-3680-y