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.
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.
Authors: Xin Zhang; Sudhir Raghavan; Michael Ihnat; Jessica E Thorpe; Bryan C Disch; Anja Bastian; Lora C Bailey-Downs; Nicholas F Dybdal-Hargreaves; Cristina C Rohena; Ernest Hamel; Susan L Mooberry; Aleem Gangjee Journal: Bioorg Med Chem Date: 2014-05-14 Impact factor: 3.641
Authors: Li Chen; Ciao-Sin Chen; Yihan Sun; N Lynn Henry; Kathleen A Stringer; Daniel L Hertz Journal: Cancer Chemother Pharmacol Date: 2021-06-05 Impact factor: 3.288
Authors: Gerald W Prager; Matthias Unseld; Fredrik Waneck; Robert Mader; Fritz Wrba; Markus Raderer; Thorsten Fuereder; Phillip Staber; Ulrich Jäger; Markus Kieler; Daniela Bianconi; Mir Alireza Hoda; Lukas Baumann; Alexander Reinthaller; Walter Berger; Christoph Grimm; Heinz Kölbl; Maria Sibilia; Leonhard Müllauer; Christoph Zielinski Journal: Oncotarget Date: 2019-01-29