Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study.

<h4<Background</h4<Eribulin mesylate (E) is indicated for metastatic breast cancer patients previously treated with anthracycline and taxane. We argued that E could also benefit patients eligible for neoadjuvant chemotherapy.<h4<Methods</h4<Patients with primary triple negative breast cancer ≥2 cm received doxorubicin 60 mg/m2 and paclitaxel 200 mg/m2 x 4 cycles (AT) followed by E 1.4 mg/m2 x 4 cycles. Primary endpoint was pathological complete response (pCR) rate; secondary and explorative endpoints included clinical/metabolic response rates and safety, and biomarker analysis, respectively. Using a two-stage Simon design, 43 patients were to be included provided that 4 of 13 patients had achieved pCR in the first stage of the study.<h4<Results</h4<In stage I of the study 13 women were enrolled, median age 43 years, tumor size 2-5 cm in 9/13 (69%), positive nodal status in 8/13 (61%). Main grade 3 adverse event was neutropenia (related to AT and E in 4 and 2 cases, respectively). AT followed by E induced clinical complete + partial responses in 11/13 patients (85%), pCR in 3/13 (23%). Median measurements of maximum standardized uptake value (SUVmax) resulted 13, 3, and 1.9 at baseline, after AT and E, respectively. Complete metabolic response (CMR) occurred after AT and after E in 2 and 3 cases, respectively. Notably, 2 of the 5 (40%) patients with CMR achieved pCR at surgery. Immunostaining of paired pre-/post-treatment tumor specimens showed a reduction of β-catenin, CyclinD1, Zeb-1, and c-myc expression, in the absence of N-cadherin modulation. The study was interrupted at stage I due to the lack of the required patients with pCR.<h4<Conclusions</h4<Despite the early study closure, preoperative E following AT showed clinical and biological activity in triple negative breast cancer patients. Furthermore, the modulation of β-catenin pathway core proteins, supposedly outside the domain of epithelial-mesenchymal transition, claims for further investigation.<h4<Trial registration</h4<EU Clinical Trial Register, EudraCT number 2012-004956-12. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Serena Di Cosimo [verfasserIn] Nicla La Verde [verfasserIn] Anna Moretti [verfasserIn] Marina Elena Cazzaniga [verfasserIn] Daniele Generali [verfasserIn] Giulia Valeria Bianchi [verfasserIn] Luigi Mariani [verfasserIn] Valter Torri [verfasserIn] Flavio Crippa [verfasserIn] Biagio Paolini [verfasserIn] Gianfranco Scaperrotta [verfasserIn] Maria Carmen De Santis [verfasserIn] Massimo Di Nicola [verfasserIn] Giovanni Apolone [verfasserIn] Alessandro Gulino [verfasserIn] Claudio Tripodo [verfasserIn] Mario Paolo Colombo [verfasserIn] Secondo Folli [verfasserIn] Filippo de Braud [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2019

Übergeordnetes Werk:	In: PLoS ONE - Public Library of Science (PLoS), 2007, 14(2019), 8, p e0220644
Übergeordnetes Werk:	volume:14 ; year:2019 ; number:8, p e0220644

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1371/journal.pone.0220644

Katalog-ID:	DOAJ055011519

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520			\|a <h4<Background</h4<Eribulin mesylate (E) is indicated for metastatic breast cancer patients previously treated with anthracycline and taxane. We argued that E could also benefit patients eligible for neoadjuvant chemotherapy.<h4<Methods</h4<Patients with primary triple negative breast cancer ≥2 cm received doxorubicin 60 mg/m2 and paclitaxel 200 mg/m2 x 4 cycles (AT) followed by E 1.4 mg/m2 x 4 cycles. Primary endpoint was pathological complete response (pCR) rate; secondary and explorative endpoints included clinical/metabolic response rates and safety, and biomarker analysis, respectively. Using a two-stage Simon design, 43 patients were to be included provided that 4 of 13 patients had achieved pCR in the first stage of the study.<h4<Results</h4<In stage I of the study 13 women were enrolled, median age 43 years, tumor size 2-5 cm in 9/13 (69%), positive nodal status in 8/13 (61%). Main grade 3 adverse event was neutropenia (related to AT and E in 4 and 2 cases, respectively). AT followed by E induced clinical complete + partial responses in 11/13 patients (85%), pCR in 3/13 (23%). Median measurements of maximum standardized uptake value (SUVmax) resulted 13, 3, and 1.9 at baseline, after AT and E, respectively. Complete metabolic response (CMR) occurred after AT and after E in 2 and 3 cases, respectively. Notably, 2 of the 5 (40%) patients with CMR achieved pCR at surgery. Immunostaining of paired pre-/post-treatment tumor specimens showed a reduction of β-catenin, CyclinD1, Zeb-1, and c-myc expression, in the absence of N-cadherin modulation. The study was interrupted at stage I due to the lack of the required patients with pCR.<h4<Conclusions</h4<Despite the early study closure, preoperative E following AT showed clinical and biological activity in triple negative breast cancer patients. Furthermore, the modulation of β-catenin pathway core proteins, supposedly outside the domain of epithelial-mesenchymal transition, claims for further investigation.<h4<Trial registration</h4<EU Clinical Trial Register, EudraCT number 2012-004956-12.
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700	0		\|a Daniele Generali \|e verfasserin \|4 aut
700	0		\|a Giulia Valeria Bianchi \|e verfasserin \|4 aut
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700	0		\|a Gianfranco Scaperrotta \|e verfasserin \|4 aut
700	0		\|a Maria Carmen De Santis \|e verfasserin \|4 aut
700	0		\|a Massimo Di Nicola \|e verfasserin \|4 aut
700	0		\|a Giovanni Apolone \|e verfasserin \|4 aut
700	0		\|a Alessandro Gulino \|e verfasserin \|4 aut
700	0		\|a Claudio Tripodo \|e verfasserin \|4 aut
700	0		\|a Mario Paolo Colombo \|e verfasserin \|4 aut
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allfields	10.1371/journal.pone.0220644 doi (DE-627)DOAJ055011519 (DE-599)DOAJa77adcf6e518472086e68d8757076fbf DE-627 ger DE-627 rakwb eng Serena Di Cosimo verfasserin aut Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study. 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Background</h4<Eribulin mesylate (E) is indicated for metastatic breast cancer patients previously treated with anthracycline and taxane. We argued that E could also benefit patients eligible for neoadjuvant chemotherapy.<h4<Methods</h4<Patients with primary triple negative breast cancer ≥2 cm received doxorubicin 60 mg/m2 and paclitaxel 200 mg/m2 x 4 cycles (AT) followed by E 1.4 mg/m2 x 4 cycles. Primary endpoint was pathological complete response (pCR) rate; secondary and explorative endpoints included clinical/metabolic response rates and safety, and biomarker analysis, respectively. Using a two-stage Simon design, 43 patients were to be included provided that 4 of 13 patients had achieved pCR in the first stage of the study.<h4<Results</h4<In stage I of the study 13 women were enrolled, median age 43 years, tumor size 2-5 cm in 9/13 (69%), positive nodal status in 8/13 (61%). Main grade 3 adverse event was neutropenia (related to AT and E in 4 and 2 cases, respectively). AT followed by E induced clinical complete + partial responses in 11/13 patients (85%), pCR in 3/13 (23%). Median measurements of maximum standardized uptake value (SUVmax) resulted 13, 3, and 1.9 at baseline, after AT and E, respectively. Complete metabolic response (CMR) occurred after AT and after E in 2 and 3 cases, respectively. Notably, 2 of the 5 (40%) patients with CMR achieved pCR at surgery. Immunostaining of paired pre-/post-treatment tumor specimens showed a reduction of β-catenin, CyclinD1, Zeb-1, and c-myc expression, in the absence of N-cadherin modulation. The study was interrupted at stage I due to the lack of the required patients with pCR.<h4<Conclusions</h4<Despite the early study closure, preoperative E following AT showed clinical and biological activity in triple negative breast cancer patients. Furthermore, the modulation of β-catenin pathway core proteins, supposedly outside the domain of epithelial-mesenchymal transition, claims for further investigation.<h4<Trial registration</h4<EU Clinical Trial Register, EudraCT number 2012-004956-12. Medicine R Science Q Nicla La Verde verfasserin aut Anna Moretti verfasserin aut Marina Elena Cazzaniga verfasserin aut Daniele Generali verfasserin aut Giulia Valeria Bianchi verfasserin aut Luigi Mariani verfasserin aut Valter Torri verfasserin aut Flavio Crippa verfasserin aut Biagio Paolini verfasserin aut Gianfranco Scaperrotta verfasserin aut Maria Carmen De Santis verfasserin aut Massimo Di Nicola verfasserin aut Giovanni Apolone verfasserin aut Alessandro Gulino verfasserin aut Claudio Tripodo verfasserin aut Mario Paolo Colombo verfasserin aut Secondo Folli verfasserin aut Filippo de Braud verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 14(2019), 8, p e0220644 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:14 year:2019 number:8, p e0220644 https://doi.org/10.1371/journal.pone.0220644 kostenfrei https://doaj.org/article/a77adcf6e518472086e68d8757076fbf kostenfrei https://doi.org/10.1371/journal.pone.0220644 kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2019 8, p e0220644
spelling	10.1371/journal.pone.0220644 doi (DE-627)DOAJ055011519 (DE-599)DOAJa77adcf6e518472086e68d8757076fbf DE-627 ger DE-627 rakwb eng Serena Di Cosimo verfasserin aut Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study. 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Background</h4<Eribulin mesylate (E) is indicated for metastatic breast cancer patients previously treated with anthracycline and taxane. We argued that E could also benefit patients eligible for neoadjuvant chemotherapy.<h4<Methods</h4<Patients with primary triple negative breast cancer ≥2 cm received doxorubicin 60 mg/m2 and paclitaxel 200 mg/m2 x 4 cycles (AT) followed by E 1.4 mg/m2 x 4 cycles. Primary endpoint was pathological complete response (pCR) rate; secondary and explorative endpoints included clinical/metabolic response rates and safety, and biomarker analysis, respectively. Using a two-stage Simon design, 43 patients were to be included provided that 4 of 13 patients had achieved pCR in the first stage of the study.<h4<Results</h4<In stage I of the study 13 women were enrolled, median age 43 years, tumor size 2-5 cm in 9/13 (69%), positive nodal status in 8/13 (61%). Main grade 3 adverse event was neutropenia (related to AT and E in 4 and 2 cases, respectively). AT followed by E induced clinical complete + partial responses in 11/13 patients (85%), pCR in 3/13 (23%). Median measurements of maximum standardized uptake value (SUVmax) resulted 13, 3, and 1.9 at baseline, after AT and E, respectively. Complete metabolic response (CMR) occurred after AT and after E in 2 and 3 cases, respectively. Notably, 2 of the 5 (40%) patients with CMR achieved pCR at surgery. Immunostaining of paired pre-/post-treatment tumor specimens showed a reduction of β-catenin, CyclinD1, Zeb-1, and c-myc expression, in the absence of N-cadherin modulation. The study was interrupted at stage I due to the lack of the required patients with pCR.<h4<Conclusions</h4<Despite the early study closure, preoperative E following AT showed clinical and biological activity in triple negative breast cancer patients. Furthermore, the modulation of β-catenin pathway core proteins, supposedly outside the domain of epithelial-mesenchymal transition, claims for further investigation.<h4<Trial registration</h4<EU Clinical Trial Register, EudraCT number 2012-004956-12. Medicine R Science Q Nicla La Verde verfasserin aut Anna Moretti verfasserin aut Marina Elena Cazzaniga verfasserin aut Daniele Generali verfasserin aut Giulia Valeria Bianchi verfasserin aut Luigi Mariani verfasserin aut Valter Torri verfasserin aut Flavio Crippa verfasserin aut Biagio Paolini verfasserin aut Gianfranco Scaperrotta verfasserin aut Maria Carmen De Santis verfasserin aut Massimo Di Nicola verfasserin aut Giovanni Apolone verfasserin aut Alessandro Gulino verfasserin aut Claudio Tripodo verfasserin aut Mario Paolo Colombo verfasserin aut Secondo Folli verfasserin aut Filippo de Braud verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 14(2019), 8, p e0220644 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:14 year:2019 number:8, p e0220644 https://doi.org/10.1371/journal.pone.0220644 kostenfrei https://doaj.org/article/a77adcf6e518472086e68d8757076fbf kostenfrei https://doi.org/10.1371/journal.pone.0220644 kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2019 8, p e0220644
allfields_unstemmed	10.1371/journal.pone.0220644 doi (DE-627)DOAJ055011519 (DE-599)DOAJa77adcf6e518472086e68d8757076fbf DE-627 ger DE-627 rakwb eng Serena Di Cosimo verfasserin aut Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study. 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Background</h4<Eribulin mesylate (E) is indicated for metastatic breast cancer patients previously treated with anthracycline and taxane. We argued that E could also benefit patients eligible for neoadjuvant chemotherapy.<h4<Methods</h4<Patients with primary triple negative breast cancer ≥2 cm received doxorubicin 60 mg/m2 and paclitaxel 200 mg/m2 x 4 cycles (AT) followed by E 1.4 mg/m2 x 4 cycles. Primary endpoint was pathological complete response (pCR) rate; secondary and explorative endpoints included clinical/metabolic response rates and safety, and biomarker analysis, respectively. Using a two-stage Simon design, 43 patients were to be included provided that 4 of 13 patients had achieved pCR in the first stage of the study.<h4<Results</h4<In stage I of the study 13 women were enrolled, median age 43 years, tumor size 2-5 cm in 9/13 (69%), positive nodal status in 8/13 (61%). Main grade 3 adverse event was neutropenia (related to AT and E in 4 and 2 cases, respectively). AT followed by E induced clinical complete + partial responses in 11/13 patients (85%), pCR in 3/13 (23%). Median measurements of maximum standardized uptake value (SUVmax) resulted 13, 3, and 1.9 at baseline, after AT and E, respectively. Complete metabolic response (CMR) occurred after AT and after E in 2 and 3 cases, respectively. Notably, 2 of the 5 (40%) patients with CMR achieved pCR at surgery. Immunostaining of paired pre-/post-treatment tumor specimens showed a reduction of β-catenin, CyclinD1, Zeb-1, and c-myc expression, in the absence of N-cadherin modulation. The study was interrupted at stage I due to the lack of the required patients with pCR.<h4<Conclusions</h4<Despite the early study closure, preoperative E following AT showed clinical and biological activity in triple negative breast cancer patients. Furthermore, the modulation of β-catenin pathway core proteins, supposedly outside the domain of epithelial-mesenchymal transition, claims for further investigation.<h4<Trial registration</h4<EU Clinical Trial Register, EudraCT number 2012-004956-12. Medicine R Science Q Nicla La Verde verfasserin aut Anna Moretti verfasserin aut Marina Elena Cazzaniga verfasserin aut Daniele Generali verfasserin aut Giulia Valeria Bianchi verfasserin aut Luigi Mariani verfasserin aut Valter Torri verfasserin aut Flavio Crippa verfasserin aut Biagio Paolini verfasserin aut Gianfranco Scaperrotta verfasserin aut Maria Carmen De Santis verfasserin aut Massimo Di Nicola verfasserin aut Giovanni Apolone verfasserin aut Alessandro Gulino verfasserin aut Claudio Tripodo verfasserin aut Mario Paolo Colombo verfasserin aut Secondo Folli verfasserin aut Filippo de Braud verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 14(2019), 8, p e0220644 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:14 year:2019 number:8, p e0220644 https://doi.org/10.1371/journal.pone.0220644 kostenfrei https://doaj.org/article/a77adcf6e518472086e68d8757076fbf kostenfrei https://doi.org/10.1371/journal.pone.0220644 kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2019 8, p e0220644
allfieldsGer	10.1371/journal.pone.0220644 doi (DE-627)DOAJ055011519 (DE-599)DOAJa77adcf6e518472086e68d8757076fbf DE-627 ger DE-627 rakwb eng Serena Di Cosimo verfasserin aut Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study. 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Background</h4<Eribulin mesylate (E) is indicated for metastatic breast cancer patients previously treated with anthracycline and taxane. We argued that E could also benefit patients eligible for neoadjuvant chemotherapy.<h4<Methods</h4<Patients with primary triple negative breast cancer ≥2 cm received doxorubicin 60 mg/m2 and paclitaxel 200 mg/m2 x 4 cycles (AT) followed by E 1.4 mg/m2 x 4 cycles. Primary endpoint was pathological complete response (pCR) rate; secondary and explorative endpoints included clinical/metabolic response rates and safety, and biomarker analysis, respectively. Using a two-stage Simon design, 43 patients were to be included provided that 4 of 13 patients had achieved pCR in the first stage of the study.<h4<Results</h4<In stage I of the study 13 women were enrolled, median age 43 years, tumor size 2-5 cm in 9/13 (69%), positive nodal status in 8/13 (61%). Main grade 3 adverse event was neutropenia (related to AT and E in 4 and 2 cases, respectively). AT followed by E induced clinical complete + partial responses in 11/13 patients (85%), pCR in 3/13 (23%). Median measurements of maximum standardized uptake value (SUVmax) resulted 13, 3, and 1.9 at baseline, after AT and E, respectively. Complete metabolic response (CMR) occurred after AT and after E in 2 and 3 cases, respectively. Notably, 2 of the 5 (40%) patients with CMR achieved pCR at surgery. Immunostaining of paired pre-/post-treatment tumor specimens showed a reduction of β-catenin, CyclinD1, Zeb-1, and c-myc expression, in the absence of N-cadherin modulation. The study was interrupted at stage I due to the lack of the required patients with pCR.<h4<Conclusions</h4<Despite the early study closure, preoperative E following AT showed clinical and biological activity in triple negative breast cancer patients. Furthermore, the modulation of β-catenin pathway core proteins, supposedly outside the domain of epithelial-mesenchymal transition, claims for further investigation.<h4<Trial registration</h4<EU Clinical Trial Register, EudraCT number 2012-004956-12. Medicine R Science Q Nicla La Verde verfasserin aut Anna Moretti verfasserin aut Marina Elena Cazzaniga verfasserin aut Daniele Generali verfasserin aut Giulia Valeria Bianchi verfasserin aut Luigi Mariani verfasserin aut Valter Torri verfasserin aut Flavio Crippa verfasserin aut Biagio Paolini verfasserin aut Gianfranco Scaperrotta verfasserin aut Maria Carmen De Santis verfasserin aut Massimo Di Nicola verfasserin aut Giovanni Apolone verfasserin aut Alessandro Gulino verfasserin aut Claudio Tripodo verfasserin aut Mario Paolo Colombo verfasserin aut Secondo Folli verfasserin aut Filippo de Braud verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 14(2019), 8, p e0220644 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:14 year:2019 number:8, p e0220644 https://doi.org/10.1371/journal.pone.0220644 kostenfrei https://doaj.org/article/a77adcf6e518472086e68d8757076fbf kostenfrei https://doi.org/10.1371/journal.pone.0220644 kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2019 8, p e0220644
allfieldsSound	10.1371/journal.pone.0220644 doi (DE-627)DOAJ055011519 (DE-599)DOAJa77adcf6e518472086e68d8757076fbf DE-627 ger DE-627 rakwb eng Serena Di Cosimo verfasserin aut Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study. 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <h4<Background</h4<Eribulin mesylate (E) is indicated for metastatic breast cancer patients previously treated with anthracycline and taxane. We argued that E could also benefit patients eligible for neoadjuvant chemotherapy.<h4<Methods</h4<Patients with primary triple negative breast cancer ≥2 cm received doxorubicin 60 mg/m2 and paclitaxel 200 mg/m2 x 4 cycles (AT) followed by E 1.4 mg/m2 x 4 cycles. Primary endpoint was pathological complete response (pCR) rate; secondary and explorative endpoints included clinical/metabolic response rates and safety, and biomarker analysis, respectively. Using a two-stage Simon design, 43 patients were to be included provided that 4 of 13 patients had achieved pCR in the first stage of the study.<h4<Results</h4<In stage I of the study 13 women were enrolled, median age 43 years, tumor size 2-5 cm in 9/13 (69%), positive nodal status in 8/13 (61%). Main grade 3 adverse event was neutropenia (related to AT and E in 4 and 2 cases, respectively). AT followed by E induced clinical complete + partial responses in 11/13 patients (85%), pCR in 3/13 (23%). Median measurements of maximum standardized uptake value (SUVmax) resulted 13, 3, and 1.9 at baseline, after AT and E, respectively. Complete metabolic response (CMR) occurred after AT and after E in 2 and 3 cases, respectively. Notably, 2 of the 5 (40%) patients with CMR achieved pCR at surgery. Immunostaining of paired pre-/post-treatment tumor specimens showed a reduction of β-catenin, CyclinD1, Zeb-1, and c-myc expression, in the absence of N-cadherin modulation. The study was interrupted at stage I due to the lack of the required patients with pCR.<h4<Conclusions</h4<Despite the early study closure, preoperative E following AT showed clinical and biological activity in triple negative breast cancer patients. Furthermore, the modulation of β-catenin pathway core proteins, supposedly outside the domain of epithelial-mesenchymal transition, claims for further investigation.<h4<Trial registration</h4<EU Clinical Trial Register, EudraCT number 2012-004956-12. Medicine R Science Q Nicla La Verde verfasserin aut Anna Moretti verfasserin aut Marina Elena Cazzaniga verfasserin aut Daniele Generali verfasserin aut Giulia Valeria Bianchi verfasserin aut Luigi Mariani verfasserin aut Valter Torri verfasserin aut Flavio Crippa verfasserin aut Biagio Paolini verfasserin aut Gianfranco Scaperrotta verfasserin aut Maria Carmen De Santis verfasserin aut Massimo Di Nicola verfasserin aut Giovanni Apolone verfasserin aut Alessandro Gulino verfasserin aut Claudio Tripodo verfasserin aut Mario Paolo Colombo verfasserin aut Secondo Folli verfasserin aut Filippo de Braud verfasserin aut In PLoS ONE Public Library of Science (PLoS), 2007 14(2019), 8, p e0220644 (DE-627)523574592 (DE-600)2267670-3 19326203 nnns volume:14 year:2019 number:8, p e0220644 https://doi.org/10.1371/journal.pone.0220644 kostenfrei https://doaj.org/article/a77adcf6e518472086e68d8757076fbf kostenfrei https://doi.org/10.1371/journal.pone.0220644 kostenfrei https://doaj.org/toc/1932-6203 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_34 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 14 2019 8, p e0220644
language	English
source	In PLoS ONE 14(2019), 8, p e0220644 volume:14 year:2019 number:8, p e0220644
sourceStr	In PLoS ONE 14(2019), 8, p e0220644 volume:14 year:2019 number:8, p e0220644
format_phy_str_mv	Article
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topic_facet	Medicine R Science Q
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container_title	PLoS ONE
authorswithroles_txt_mv	Serena Di Cosimo @@aut@@ Nicla La Verde @@aut@@ Anna Moretti @@aut@@ Marina Elena Cazzaniga @@aut@@ Daniele Generali @@aut@@ Giulia Valeria Bianchi @@aut@@ Luigi Mariani @@aut@@ Valter Torri @@aut@@ Flavio Crippa @@aut@@ Biagio Paolini @@aut@@ Gianfranco Scaperrotta @@aut@@ Maria Carmen De Santis @@aut@@ Massimo Di Nicola @@aut@@ Giovanni Apolone @@aut@@ Alessandro Gulino @@aut@@ Claudio Tripodo @@aut@@ Mario Paolo Colombo @@aut@@ Secondo Folli @@aut@@ Filippo de Braud @@aut@@
publishDateDaySort_date	2019-01-01T00:00:00Z
hierarchy_top_id	523574592
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We argued that E could also benefit patients eligible for neoadjuvant chemotherapy.<h4<Methods</h4<Patients with primary triple negative breast cancer ≥2 cm received doxorubicin 60 mg/m2 and paclitaxel 200 mg/m2 x 4 cycles (AT) followed by E 1.4 mg/m2 x 4 cycles. Primary endpoint was pathological complete response (pCR) rate; secondary and explorative endpoints included clinical/metabolic response rates and safety, and biomarker analysis, respectively. Using a two-stage Simon design, 43 patients were to be included provided that 4 of 13 patients had achieved pCR in the first stage of the study.<h4<Results</h4<In stage I of the study 13 women were enrolled, median age 43 years, tumor size 2-5 cm in 9/13 (69%), positive nodal status in 8/13 (61%). Main grade 3 adverse event was neutropenia (related to AT and E in 4 and 2 cases, respectively). AT followed by E induced clinical complete + partial responses in 11/13 patients (85%), pCR in 3/13 (23%). Median measurements of maximum standardized uptake value (SUVmax) resulted 13, 3, and 1.9 at baseline, after AT and E, respectively. Complete metabolic response (CMR) occurred after AT and after E in 2 and 3 cases, respectively. Notably, 2 of the 5 (40%) patients with CMR achieved pCR at surgery. Immunostaining of paired pre-/post-treatment tumor specimens showed a reduction of β-catenin, CyclinD1, Zeb-1, and c-myc expression, in the absence of N-cadherin modulation. The study was interrupted at stage I due to the lack of the required patients with pCR.<h4<Conclusions</h4<Despite the early study closure, preoperative E following AT showed clinical and biological activity in triple negative breast cancer patients. 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author	Serena Di Cosimo
spellingShingle	Serena Di Cosimo misc Medicine misc R misc Science misc Q Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study.
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topic_title	Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study
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title	Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study.
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title_full	Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study
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author_browse	Serena Di Cosimo Nicla La Verde Anna Moretti Marina Elena Cazzaniga Daniele Generali Giulia Valeria Bianchi Luigi Mariani Valter Torri Flavio Crippa Biagio Paolini Gianfranco Scaperrotta Maria Carmen De Santis Massimo Di Nicola Giovanni Apolone Alessandro Gulino Claudio Tripodo Mario Paolo Colombo Secondo Folli Filippo de Braud
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doi_str_mv	10.1371/journal.pone.0220644
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title_sort	neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: results from the hope study
title_auth	Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study.
abstract	<h4<Background</h4<Eribulin mesylate (E) is indicated for metastatic breast cancer patients previously treated with anthracycline and taxane. We argued that E could also benefit patients eligible for neoadjuvant chemotherapy.<h4<Methods</h4<Patients with primary triple negative breast cancer ≥2 cm received doxorubicin 60 mg/m2 and paclitaxel 200 mg/m2 x 4 cycles (AT) followed by E 1.4 mg/m2 x 4 cycles. Primary endpoint was pathological complete response (pCR) rate; secondary and explorative endpoints included clinical/metabolic response rates and safety, and biomarker analysis, respectively. Using a two-stage Simon design, 43 patients were to be included provided that 4 of 13 patients had achieved pCR in the first stage of the study.<h4<Results</h4<In stage I of the study 13 women were enrolled, median age 43 years, tumor size 2-5 cm in 9/13 (69%), positive nodal status in 8/13 (61%). Main grade 3 adverse event was neutropenia (related to AT and E in 4 and 2 cases, respectively). AT followed by E induced clinical complete + partial responses in 11/13 patients (85%), pCR in 3/13 (23%). Median measurements of maximum standardized uptake value (SUVmax) resulted 13, 3, and 1.9 at baseline, after AT and E, respectively. Complete metabolic response (CMR) occurred after AT and after E in 2 and 3 cases, respectively. Notably, 2 of the 5 (40%) patients with CMR achieved pCR at surgery. Immunostaining of paired pre-/post-treatment tumor specimens showed a reduction of β-catenin, CyclinD1, Zeb-1, and c-myc expression, in the absence of N-cadherin modulation. The study was interrupted at stage I due to the lack of the required patients with pCR.<h4<Conclusions</h4<Despite the early study closure, preoperative E following AT showed clinical and biological activity in triple negative breast cancer patients. Furthermore, the modulation of β-catenin pathway core proteins, supposedly outside the domain of epithelial-mesenchymal transition, claims for further investigation.<h4<Trial registration</h4<EU Clinical Trial Register, EudraCT number 2012-004956-12.
abstractGer	<h4<Background</h4<Eribulin mesylate (E) is indicated for metastatic breast cancer patients previously treated with anthracycline and taxane. We argued that E could also benefit patients eligible for neoadjuvant chemotherapy.<h4<Methods</h4<Patients with primary triple negative breast cancer ≥2 cm received doxorubicin 60 mg/m2 and paclitaxel 200 mg/m2 x 4 cycles (AT) followed by E 1.4 mg/m2 x 4 cycles. Primary endpoint was pathological complete response (pCR) rate; secondary and explorative endpoints included clinical/metabolic response rates and safety, and biomarker analysis, respectively. Using a two-stage Simon design, 43 patients were to be included provided that 4 of 13 patients had achieved pCR in the first stage of the study.<h4<Results</h4<In stage I of the study 13 women were enrolled, median age 43 years, tumor size 2-5 cm in 9/13 (69%), positive nodal status in 8/13 (61%). Main grade 3 adverse event was neutropenia (related to AT and E in 4 and 2 cases, respectively). AT followed by E induced clinical complete + partial responses in 11/13 patients (85%), pCR in 3/13 (23%). Median measurements of maximum standardized uptake value (SUVmax) resulted 13, 3, and 1.9 at baseline, after AT and E, respectively. Complete metabolic response (CMR) occurred after AT and after E in 2 and 3 cases, respectively. Notably, 2 of the 5 (40%) patients with CMR achieved pCR at surgery. Immunostaining of paired pre-/post-treatment tumor specimens showed a reduction of β-catenin, CyclinD1, Zeb-1, and c-myc expression, in the absence of N-cadherin modulation. The study was interrupted at stage I due to the lack of the required patients with pCR.<h4<Conclusions</h4<Despite the early study closure, preoperative E following AT showed clinical and biological activity in triple negative breast cancer patients. Furthermore, the modulation of β-catenin pathway core proteins, supposedly outside the domain of epithelial-mesenchymal transition, claims for further investigation.<h4<Trial registration</h4<EU Clinical Trial Register, EudraCT number 2012-004956-12.
abstract_unstemmed	<h4<Background</h4<Eribulin mesylate (E) is indicated for metastatic breast cancer patients previously treated with anthracycline and taxane. We argued that E could also benefit patients eligible for neoadjuvant chemotherapy.<h4<Methods</h4<Patients with primary triple negative breast cancer ≥2 cm received doxorubicin 60 mg/m2 and paclitaxel 200 mg/m2 x 4 cycles (AT) followed by E 1.4 mg/m2 x 4 cycles. Primary endpoint was pathological complete response (pCR) rate; secondary and explorative endpoints included clinical/metabolic response rates and safety, and biomarker analysis, respectively. Using a two-stage Simon design, 43 patients were to be included provided that 4 of 13 patients had achieved pCR in the first stage of the study.<h4<Results</h4<In stage I of the study 13 women were enrolled, median age 43 years, tumor size 2-5 cm in 9/13 (69%), positive nodal status in 8/13 (61%). Main grade 3 adverse event was neutropenia (related to AT and E in 4 and 2 cases, respectively). AT followed by E induced clinical complete + partial responses in 11/13 patients (85%), pCR in 3/13 (23%). Median measurements of maximum standardized uptake value (SUVmax) resulted 13, 3, and 1.9 at baseline, after AT and E, respectively. Complete metabolic response (CMR) occurred after AT and after E in 2 and 3 cases, respectively. Notably, 2 of the 5 (40%) patients with CMR achieved pCR at surgery. Immunostaining of paired pre-/post-treatment tumor specimens showed a reduction of β-catenin, CyclinD1, Zeb-1, and c-myc expression, in the absence of N-cadherin modulation. The study was interrupted at stage I due to the lack of the required patients with pCR.<h4<Conclusions</h4<Despite the early study closure, preoperative E following AT showed clinical and biological activity in triple negative breast cancer patients. Furthermore, the modulation of β-catenin pathway core proteins, supposedly outside the domain of epithelial-mesenchymal transition, claims for further investigation.<h4<Trial registration</h4<EU Clinical Trial Register, EudraCT number 2012-004956-12.
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container_issue	8, p e0220644
title_short	Neoadjuvant eribulin mesylate following anthracycline and taxane in triple negative breast cancer: Results from the HOPE study.
url	https://doi.org/10.1371/journal.pone.0220644 https://doaj.org/article/a77adcf6e518472086e68d8757076fbf https://doaj.org/toc/1932-6203
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author2	Nicla La Verde Anna Moretti Marina Elena Cazzaniga Daniele Generali Giulia Valeria Bianchi Luigi Mariani Valter Torri Flavio Crippa Biagio Paolini Gianfranco Scaperrotta Maria Carmen De Santis Massimo Di Nicola Giovanni Apolone Alessandro Gulino Claudio Tripodo Mario Paolo Colombo Secondo Folli Filippo de Braud
author2Str	Nicla La Verde Anna Moretti Marina Elena Cazzaniga Daniele Generali Giulia Valeria Bianchi Luigi Mariani Valter Torri Flavio Crippa Biagio Paolini Gianfranco Scaperrotta Maria Carmen De Santis Massimo Di Nicola Giovanni Apolone Alessandro Gulino Claudio Tripodo Mario Paolo Colombo Secondo Folli Filippo de Braud
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doi_str	10.1371/journal.pone.0220644
up_date	2024-07-04T01:27:51.943Z
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