Preoperative Carboplatin–Paclitaxel–Bevacizumab in Triple-Negative Breast Cancer

Final Results of the Phase II Ca.Pa.Be Study

Valentina Guarneri, Maria Vittoria Dieci, Giancarlo Bisagni, Corrado Boni, Katia Cagossi, Fabio Puglisi, Annarita Pecchi, Federico Piacentini, Pier Franco Conte

Research output: Contribution to journalArticle

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Abstract

Purpose: The phase II Ca.Pa.Be trial evaluated preoperative carboplatin–paclitaxel in combination with bevacizumab in triple-negative breast cancer patients with previously untreated stage II–III disease. The primary aim was the assessment of the rate of pathologic complete response (pCR). Secondary aims included safety, breast-conserving surgery rate, and early response assessment with dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). Methods: Patients with hormone receptor-negative, HER-2-negative stage II–III breast cancer were eligible. Treatment included paclitaxel 80 mg/mq + carboplatin area under the curve (AUC) 2 on days 1, 8, and 15, combined with bevacizumab 10 mg/kg on days 1 and 15 each 28 days, for 5 courses. At baseline, patients underwent breast DCE-MRI, followed by a single dose of bevacizumab 5 mg/kg (day −6). DCE-MRI was repeated before the initiation of chemotherapy. Results: Forty-four patients were enrolled. Forty-three patients underwent surgery, and 22 (50 %) received breast-conserving surgery (conversion rate from mastectomy indication at baseline, 34.4 %). A pCR in breast and axillary lymph nodes occurred in 22 patients (50 %). Bevacizumab-associated adverse events (AEs) were mild: G1–2 hypertension and bleeding occurred in 6 (13.6 %) and 12 (27 %) patients, respectively. No G4 nonhematologic AEs were recorded. More frequent G3 AEs were liver function test abnormalities (6.8 %), and diarrhea and fatigue (4.5 % each). The only G3–4 hematologic toxicity was neutropenia (G3, 25 %; G4, 9 %). Early assessed DCE-MRI response parameters failed to predict pCR. Conclusions: The neoadjuvant anthracycline-free combination of weekly paclitaxel and carboplatin plus bevacizumab is active and safe in triple-negative breast cancer, and the rate of pCR is comparable to that observed with more intensive carboplatin- and bevacizumab-containing regimens. Further investigation is warranted.

Original languageEnglish
Pages (from-to)2881-2887
Number of pages7
JournalAnnals of Surgical Oncology
Volume22
Issue number9
DOIs
Publication statusPublished - Jan 9 2015

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Triple Negative Breast Neoplasms
Carboplatin
Magnetic Resonance Imaging
Segmental Mastectomy
Paclitaxel
Breast
Liver Function Tests
Anthracyclines
Mastectomy
Neutropenia
Area Under Curve
Fatigue
Bevacizumab
Diarrhea
Lymph Nodes
Hormones
Breast Neoplasms
Hemorrhage
Hypertension
Safety

ASJC Scopus subject areas

  • Surgery
  • Oncology

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Preoperative Carboplatin–Paclitaxel–Bevacizumab in Triple-Negative Breast Cancer : Final Results of the Phase II Ca.Pa.Be Study. / Guarneri, Valentina; Dieci, Maria Vittoria; Bisagni, Giancarlo; Boni, Corrado; Cagossi, Katia; Puglisi, Fabio; Pecchi, Annarita; Piacentini, Federico; Conte, Pier Franco.

In: Annals of Surgical Oncology, Vol. 22, No. 9, 09.01.2015, p. 2881-2887.

Research output: Contribution to journalArticle

Guarneri, Valentina ; Dieci, Maria Vittoria ; Bisagni, Giancarlo ; Boni, Corrado ; Cagossi, Katia ; Puglisi, Fabio ; Pecchi, Annarita ; Piacentini, Federico ; Conte, Pier Franco. / Preoperative Carboplatin–Paclitaxel–Bevacizumab in Triple-Negative Breast Cancer : Final Results of the Phase II Ca.Pa.Be Study. In: Annals of Surgical Oncology. 2015 ; Vol. 22, No. 9. pp. 2881-2887.
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abstract = "Purpose: The phase II Ca.Pa.Be trial evaluated preoperative carboplatin–paclitaxel in combination with bevacizumab in triple-negative breast cancer patients with previously untreated stage II–III disease. The primary aim was the assessment of the rate of pathologic complete response (pCR). Secondary aims included safety, breast-conserving surgery rate, and early response assessment with dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). Methods: Patients with hormone receptor-negative, HER-2-negative stage II–III breast cancer were eligible. Treatment included paclitaxel 80 mg/mq + carboplatin area under the curve (AUC) 2 on days 1, 8, and 15, combined with bevacizumab 10 mg/kg on days 1 and 15 each 28 days, for 5 courses. At baseline, patients underwent breast DCE-MRI, followed by a single dose of bevacizumab 5 mg/kg (day −6). DCE-MRI was repeated before the initiation of chemotherapy. Results: Forty-four patients were enrolled. Forty-three patients underwent surgery, and 22 (50 {\%}) received breast-conserving surgery (conversion rate from mastectomy indication at baseline, 34.4 {\%}). A pCR in breast and axillary lymph nodes occurred in 22 patients (50 {\%}). Bevacizumab-associated adverse events (AEs) were mild: G1–2 hypertension and bleeding occurred in 6 (13.6 {\%}) and 12 (27 {\%}) patients, respectively. No G4 nonhematologic AEs were recorded. More frequent G3 AEs were liver function test abnormalities (6.8 {\%}), and diarrhea and fatigue (4.5 {\%} each). The only G3–4 hematologic toxicity was neutropenia (G3, 25 {\%}; G4, 9 {\%}). Early assessed DCE-MRI response parameters failed to predict pCR. Conclusions: The neoadjuvant anthracycline-free combination of weekly paclitaxel and carboplatin plus bevacizumab is active and safe in triple-negative breast cancer, and the rate of pCR is comparable to that observed with more intensive carboplatin- and bevacizumab-containing regimens. Further investigation is warranted.",
author = "Valentina Guarneri and Dieci, {Maria Vittoria} and Giancarlo Bisagni and Corrado Boni and Katia Cagossi and Fabio Puglisi and Annarita Pecchi and Federico Piacentini and Conte, {Pier Franco}",
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AU - Dieci, Maria Vittoria

AU - Bisagni, Giancarlo

AU - Boni, Corrado

AU - Cagossi, Katia

AU - Puglisi, Fabio

AU - Pecchi, Annarita

AU - Piacentini, Federico

AU - Conte, Pier Franco

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N2 - Purpose: The phase II Ca.Pa.Be trial evaluated preoperative carboplatin–paclitaxel in combination with bevacizumab in triple-negative breast cancer patients with previously untreated stage II–III disease. The primary aim was the assessment of the rate of pathologic complete response (pCR). Secondary aims included safety, breast-conserving surgery rate, and early response assessment with dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). Methods: Patients with hormone receptor-negative, HER-2-negative stage II–III breast cancer were eligible. Treatment included paclitaxel 80 mg/mq + carboplatin area under the curve (AUC) 2 on days 1, 8, and 15, combined with bevacizumab 10 mg/kg on days 1 and 15 each 28 days, for 5 courses. At baseline, patients underwent breast DCE-MRI, followed by a single dose of bevacizumab 5 mg/kg (day −6). DCE-MRI was repeated before the initiation of chemotherapy. Results: Forty-four patients were enrolled. Forty-three patients underwent surgery, and 22 (50 %) received breast-conserving surgery (conversion rate from mastectomy indication at baseline, 34.4 %). A pCR in breast and axillary lymph nodes occurred in 22 patients (50 %). Bevacizumab-associated adverse events (AEs) were mild: G1–2 hypertension and bleeding occurred in 6 (13.6 %) and 12 (27 %) patients, respectively. No G4 nonhematologic AEs were recorded. More frequent G3 AEs were liver function test abnormalities (6.8 %), and diarrhea and fatigue (4.5 % each). The only G3–4 hematologic toxicity was neutropenia (G3, 25 %; G4, 9 %). Early assessed DCE-MRI response parameters failed to predict pCR. Conclusions: The neoadjuvant anthracycline-free combination of weekly paclitaxel and carboplatin plus bevacizumab is active and safe in triple-negative breast cancer, and the rate of pCR is comparable to that observed with more intensive carboplatin- and bevacizumab-containing regimens. Further investigation is warranted.

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