Details

Autor(en) / Beteiligte

• Lang, I
• Inbar, M.J
• Kahán, Z
• Greil, R
• Beslija, S
• Stemmer, S.M
• Kaufman, B
• Zvirbule, Z
• Steger, G.G
• Messinger, D
• Brodowicz, T
• Zielinski, C

Titel

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

Ist Teil von

• European journal of cancer (1990), 2012-11, Vol.48 (17), p.3140-3149

Ort / Verlag

Kidlington: Elsevier Ltd

Erscheinungsjahr

2012

Quelle

MEDLINE

Beschreibungen/Notizen

• Abstract Background We 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 methods Patients 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. Results A 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. Conclusion These findings are in-line with safety data for bevacizumab plus paclitaxel or capecitabine, reported in previous phase III trials.