Safety results from a phase III study (TURANDOT trial by CECOG) of first-line bevacizumab in combination with capecitabine or paclitaxel for HER-2-negative locally recurrent or metastatic breast cancer |
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| Affiliation: | 1. Division of Medical Oncology and Haematology, Bras Family Drug Development Program, Princess Margaret Cancer Centre, Toronto, Ontario, Canada;2. Kliniken-Essen-Mitte, AGO, Essen, Germany;3. The Royal Melbourne Hospital, Parkville, Australia;4. Gynecologic Cancer InterGroup (GCIG), Kingston, Ontario, Canada;5. Clinical Trials Unit, MITO Istituto Nazionale dei Tumori — Fondazione G Pascale, Napoli, Italy;6. Hôpital Hôtel-Dieu, Arcagy-GINECO, Paris, France;7. Université Paris Descartes, AP-HP, Paris, France;1. Department of Medicine, University of Alberta, Edmonton, Alberta, Canada;2. Department of Medicine, University of Calgary, Calgary, Alberta, Canada;3. Division of Hematology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada;4. Division of Hematology and Bone Marrow Transplantation, Department of Medicine, University of Calgary, Calgary, Alberta, Canada |
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| Abstract: | BackgroundWe report safety data from a randomised, phase III study (CECOG/BC.1.3.005) evaluating first-line bevacizumab plus paclitaxel or capecitabine for locally recurrent or metastatic breast cancer.Patients and methodsPatients aged ⩾18 years with human epidermal growth factor receptor-2-negative breast adenocarcinoma were randomised to Arm A: bevacizumab 10 mg/kg days 1 and 15; paclitaxel 90 mg/m2 days 1, 8, and 15, every 4 weeks; or Arm B: bevacizumab 15 mg/kg day 1; capecitabine 1000 mg/m2 b.i.d., days 1–14, every 3 weeks, until disease progression, unacceptable toxicity or consent withdrawal.ResultsA post hoc interim safety analysis included 561 patients (Arm A: 284, Arm B: 277). The regimens demonstrated similar frequencies of all-grade and serious adverse events (SAEs), but different safety profiles. Treatment-related events occurred in 85.2% (Arm A) and 78.0% (Arm B) of patients. Fatigue was most common in Arm A (30.6% versus 23.5% Arm B), and hand–foot syndrome (HFS) most common in Arm B (49.5% versus 2.5% Arm A). Diarrhoea (Arm A: 0.4%, Arm B: 1.4%) and pulmonary embolism (Arm A: 0.7%, Arm B: 1.1%) were the most frequently reported SAEs.ConclusionThese findings are in-line with safety data for bevacizumab plus paclitaxel or capecitabine, reported in previous phase III trials. |
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