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

• Published in: European journal of cancer (1990) Vol. 48; no. 17; pp. 3140 - 3149
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 01.11.2012; Elsevier
• Subjects: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Bevacizumab; Biological and medical sciences; Breast Neoplasms - chemistry; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Capecitabine; Deoxycytidine - administration & dosage; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Fluorouracil - analogs & derivatives; Hematology, Oncology and Palliative Medicine; Humans; Medical sciences; Metastatic breast cancer; Middle Aged; Neoplasm Metastasis - drug therapy; Neoplasm Recurrence, Local - drug therapy; Paclitaxel; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Pharmacology. Drug treatments; Prospective Studies; Receptor, ErbB-2 - analysis; Tumors; Metastatic breast cancer; Capecitabine; Paclitaxel; Bevacizumab; Antineoplastic agent; Phase III trial; Relapse; Breast disease; erbB2 Gene; Monoclonal antibody; Metastasis; Cancerology; Taxane derivatives; Advanced stage; Antiangiogenic agent; Antimitotic; Pyrimidine nucleoside; Protooncogene; Drug combination; Fluoropyrimidine derivatives; Breast cancer; Malignant tumor; Prodrug; Human Epidermal growth factor Receptor 2; First line treatment; Mammary gland diseases; Chemotherapy; Treatment; Vascular endothelium growth factor; C-Onc gene; Cancer
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2012.04.022

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.