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

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

Research output: Contribution to journalArticle

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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/m 2 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.

Original languageEnglish
Pages (from-to)3140-3149
Number of pages10
JournalEuropean Journal of Cancer
Volume48
Issue number17
DOIs
Publication statusPublished - Nov 2012

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Paclitaxel
Arm
Breast Neoplasms
Safety
Bevacizumab
Capecitabine
Hand-Foot Syndrome
Pulmonary Embolism
Fatigue
Disease Progression
Diarrhea
Adenocarcinoma
Breast

Keywords

  • Bevacizumab
  • Capecitabine
  • Metastatic breast cancer
  • Paclitaxel

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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. / Láng, 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.

In: European Journal of Cancer, Vol. 48, No. 17, 11.2012, p. 3140-3149.

Research output: Contribution to journalArticle

Láng, 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. / 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. In: European Journal of Cancer. 2012 ; Vol. 48, No. 17. pp. 3140-3149.
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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/m 2 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.",
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T1 - 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

AU - Láng, I.

AU - Inbar, M. J.

AU - Kahán, Z.

AU - Greil, R.

AU - Beslija, S.

AU - Stemmer, S. M.

AU - Kaufman, B.

AU - Zvirbule, Z.

AU - Steger, G. G.

AU - Messinger, D.

AU - Brodowicz, T.

AU - Zielinski, C.

PY - 2012/11

Y1 - 2012/11

N2 - 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/m 2 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.

AB - 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/m 2 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.

KW - Bevacizumab

KW - Capecitabine

KW - Metastatic breast cancer

KW - Paclitaxel

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