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Clinical and pharmacokinetic study of sunitinib and docetaxel in women with advanced breast cancer.
Bergh, Jonas Mariani, G Cardoso, F Liljegren, A Awada, A Viganò, L Huang, X Verkh, L Kern, K Giorgetti, C
Bergh, Jonas
Mariani, G
Cardoso, F
Liljegren, A
Awada, A
Viganò, L
Huang, X
Verkh, L
Kern, K
Giorgetti, C
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Abstract
BACKGROUND: This exploratory study examined the pharmacokinetics, safety, and antitumor activity of sunitinib plus docetaxel in patients with HER-2-negative advanced breast cancer. PATIENTS AND METHODS: Patients with HER-2-negative disease who had received prior adjuvant anthracycline-based therapy received docetaxel (75 mg/m(2)) on day 1 of each 3-week cycle followed by sunitinib (37.5 mg/day for 2 weeks on Schedule 2/1) starting on day 2 (day 3 on cycle 2). RESULTS: Twenty-two patients were enrolled. No clinically significant drug-drug interactions were observed. The most common non-hematologic AE (any grade) was fatigue/asthenia. Grade 4 neutropenia occurred in 20/22 patients (91%; n = 7 had neutropenic fever). The safety profile was similar to each agent given individually. 14/19 (73.7%) evaluable patients had a PR and 5/19 (26.3%) had SD. CONCLUSIONS: Sunitinib plus docetaxel on Schedule 2/1 did not result in any clinically significant drug-drug interactions. This combination was manageable and exhibited antitumor activity.
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Date
2012-02-13
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Article
Citation
Clinical and pharmacokinetic study of sunitinib and docetaxel in women with advanced breast cancer. 2012, 21(4):507-513 Breast