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Phase I study of sunitinib plus capecitabine/cisplatin or capecitabine/oxaliplatin in advanced gastric cancer

Cited 14 time in Web of Science Cited 16 time in Scopus
Authors
Lee, K. -W.; Park, S. R.; Oh, D. -Y.; Park, Y. -I.; Khosravan, R.; Lin, X.; Lee, S. -Y.; Roh, E. -J.; Valota, O.; Lechuga, M. J.; Bang, Yung-Jue
Issue Date
2013-12
Citation
Investigational New Drugs, Vol.31 No.6, pp.1547-1558
Keywords
Advanced gastric cancerCapecitabineCisplatinOxaliplatinPhase ISunitinib
Abstract
Background We evaluated the maximum tolerated dose (MTD) and safety of sunitinib plus capecitabine/cisplatin (XP) or capecitabine/oxaliplatin (XELOX) in Korean patients with advanced gastric cancer (GC). Methods Sunitinib (37.5 or 25 mg/day) was administered on a 2-week-on/1-week-off schedule with chemotherapy. Assessments included dose-limiting toxicity (DLT), safety, pharmacokinetics, and antitumor activity. Results Twenty-eight patients received sunitinib/XP; 48 received sunitinib/XELOX. The MTDs were: sunitinib 25 mg/day, cisplatin 80 mg/m(2), and capecitabine 1,000 mg/m(2); sunitinib 37.5 mg/day, oxaliplatin 110 mg/m(2), and capecitabine 800 mg/m(2); and sunitinib 25 mg/day, oxaliplatin 110 mg/m(2), and capecitabine 1,000 mg/m(2). DLTs at the MTDs comprised grade (G) 4 febrile neutropenia plus G3 diarrhea (n = 1; sunitinib/XP), dose delays due to hematologic toxicity (n = 2; both sunitinib/XP), G3 bleeding (menorrhagia; n = 1; sunitinib/XELOX), and G3 increased alanine aminotransferase levels (n = 1; sunitinib/XELOX). There was a high frequency of G3/4 hematologic adverse events observed with both treatment regimens, particularly with sunitinib/XP. Frequent non-hematologic, G3/4 adverse events were nausea, stomatitis, and hypophosphatemia with sunitinib/XP and hypophosphatemia and pulmonary embolism with sunitinib/XELOX. No drug-drug interactions were apparent. At the MTDs, median progression-free survival was 6.4 months and 5.5-8.0 months for sunitinib/XP and sunitinib/XELOX, respectively; and the objective response rate was 46.7 % and 43.5-45.5 % for sunitinib/XP and sunitinib/XELOX, respectively. Conclusions At the MTD, sunitinib/XELOX had an acceptable safety profile in patients with advanced GC.
ISSN
0167-6997
URI
https://hdl.handle.net/10371/173136
DOI
https://doi.org/10.1007/s10637-013-0032-y
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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