Title |
SAKK 24/09: safety and tolerability of bevacizumab plus paclitaxel vs. bevacizumab plus metronomic cyclophosphamide and capecitabine as first-line therapy in patients with HER2-negative advanced stage breast cancer - a multicenter, randomized phase III trial
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Published in |
BMC Cancer, October 2016
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DOI | 10.1186/s12885-016-2823-y |
Pubmed ID | |
Authors |
Christoph Rochlitz, Martin Bigler, Roger von Moos, Jürg Bernhard, Klazien Matter-Walstra, Andreas Wicki, Khalil Zaman, Sandro Anchisi, Marc Küng, Kyung-Jae Na, Daniela Bärtschi, Markus Borner, Tamara Rordorf, Daniel Rauch, Andreas Müller, Thomas Ruhstaller, Marcus Vetter, Andreas Trojan, Ursula Hasler-Strub, Richard Cathomas, Ralph Winterhalder, on behalf of the Swiss Group for Clinical Cancer Research (SAKK) |
Abstract |
Adding bevacizumab to chemotherapy improves response rates and progression-free survival (PFS) in metastatic breast cancer (mBC). We aimed to demonstrate decreased toxicity with metronomic chemotherapy/bevacizumab compared with paclitaxel/bevacizumab. This multicenter, randomized phase III trial compared bevacizumab with either paclitaxel (arm A) or daily oral capecitabine-cyclophosphamide (arm B) as first-line treatment in patients with HER2-negative advanced breast cancer. The primary endpoint was the incidence of selected grade 3-5 adverse events (AE) including: febrile neutropenia, infection, sensory/motor neuropathy, and mucositis. Secondary endpoints included objective response rate, disease control rate, PFS, overall survival (OS), quality of life (QoL), and pharmacoeconomics. The study was registered prospectively with ClinicalTrials.gov, number NCT01131195 on May 25, 2010. Between September 2010 and December 2012, 147 patients were included at 22 centers. The incidence of primary endpoint-defining AEs was similar in arm A (25 % [18/71]; 95 % CI 15-35 %) and arm B (24 % [16/68]; 95 % CI 13-34 %; P = 0.96). Objective response rates were 58 % (42/73; 95 % CI 0.46-0.69) and 50 % (37/74; 95 % CI 0.39-0.61) in arms A and B, respectively (P = 0.45). Median PFS was 10.3 months (95 % CI 8.7-11.3) in arm A and 8.5 months (95 % CI 6.5-11.9) in arm B (P = 0.90). Other secondary efficacy endpoints were not significantly different between study arms. The only statistically significant differences in QoL were less hair loss and less numbness in arm B. Treatment costs between the two arms were equivalent. This trial failed to meet its primary endpoint of a reduced rate of prespecified grade 3-5 AEs with metronomic bevacizumab, cyclophosphamide and capecitabine. |
X Demographics
Geographical breakdown
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Unknown | 1 | 100% |
Demographic breakdown
Type | Count | As % |
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Science communicators (journalists, bloggers, editors) | 1 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 91 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Master | 15 | 16% |
Student > Ph. D. Student | 10 | 11% |
Other | 8 | 9% |
Student > Bachelor | 7 | 8% |
Researcher | 6 | 7% |
Other | 13 | 14% |
Unknown | 32 | 35% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 23 | 25% |
Pharmacology, Toxicology and Pharmaceutical Science | 9 | 10% |
Nursing and Health Professions | 7 | 8% |
Biochemistry, Genetics and Molecular Biology | 4 | 4% |
Psychology | 3 | 3% |
Other | 7 | 8% |
Unknown | 38 | 42% |