Background: Around 20% of breast cancers (BC) are HER-2+. Trastuzumab (T) has dramatically change... more Background: Around 20% of breast cancers (BC) are HER-2+. Trastuzumab (T) has dramatically changed the outcome of HER-2+ BC patients (pts), both in early and in advanced settings. The combination of Pertuzumab (P) plus T and docetaxel, used as first-line treatment for HER-2+ metastatic BC (MBC) in the phase III CLEOPATRA study, significantly prolonged progression free survival (PFS) and overall survival (OS). In order to verify the results of the Cleopatra trial in unselected pts, we performed a multicenter, retrospective-prospective, observational study, in HER-2+ MBC pts candidate to receive first line therapy with P plus T plus taxanes. Methods: We analyze the outcome of all HER-2+ MBC pts treated with P+T and taxanes, as first line therapy since the availability of P in Italy (2013), at 13 general and university hospitals. Results: Until June 6th data from 217 HER-2+ MBC pts were recorded. Main pts' characteristics were: median age 54 y (28-80), median ECOG PS 0 (0-2), hormonal receptor positive 152 pts (70%), 60 pts (27.6%) received neo/adjuvant chemotherapy (CT) + T and 75 pts (34.5%) adjuvant endocrine therapy. Most common metastatic sites: bone 121 pts (55.7%), liver 85 pts (39.2%), lung 61 pts (28.1%), soft tissues 133 pts (61.3%); 8 pts had CNS involvement. Seventy-eight pts (35.9%) had bone and/or soft tissues disease only; 108 pts (49.7%) had metastatic disease on presentation. Median number of metastatic sites was 3 (1-8). 144 pts (66.3%) and 72 pts (33.2%) received docetaxel (D) and paclitaxel (P) respectively. Median number of CT cycles was 6 for both drugs (D range 1-13; P range 1-18). Up to now 23 pts are still on CT and 86 on maintenance; ORR in evaluated pts (189) is 80.9% (47 and 106 pts obtained CR and PR respectively), 11 pts experienced PD during CT; 113 pts (58.2%) received endocrine therapy during maintenance.Median PFS is 14.7+ months (0.3+ - 53.2+). Most common adverse events are reported in table 1 Table 1Adverse EventAll grades N (%)Grade 3-4 N (%)Leukopenia39 (18)10 (4.6)Neutropenia42 (19.3)16 (7.3)Anemia50 (23)2 (0.9)Febrile Neutropenia7 (3.2) Diarrhea103 (47.4)10 (4.6)Asthenia127 (58.5)5 (2.3)Peripheral Neuropathy80 (36.8)3 (1.3)Stomatitis67 (30.8)2 (0.9) Nail changes, nausea, alopecia, rash and arthro-myalgia were also reported. Three pts interrupted CT due to symptomatic drop of left ventricular ejection fraction (LVEF); 2 pts interrupted maintenance P due to rash and dyspnea respectively, 16 stopped P and T due to drop in LVEF, 1 due to occurrence of ALL and 1 refused to continue. Conclusions: Our preliminary results highlight the activity and safety of the combination of CT plus P and T in unselected HER-2+ MBC patients. The study is ongoing and updated results will be presented. Citation Format: Garrone O, D'Onofrio L, Blondeaux E, Bertolini I, Giarratano T, Beano A, Saggia C, Cazzaniga M, LaVerde N, Collovà E, Milani A, De Conciliis E, Coltelli L, Airoldi M, Del Mastro L, Cursano MC, Michelotti A, Vandone AM, Guarneri V, Donadio M, Riva F, Nuzzo A, Merlano MC. Moving from the CLEOPATRA study to real life: Preliminary results from the G.O.N.O. SUPER trial [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-21-29.
Purpose Triple-negative breast cancer (TNBC) represents a subtype of breast cancer which lacks th... more Purpose Triple-negative breast cancer (TNBC) represents a subtype of breast cancer which lacks the expression of oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (HER2): TNBC accounts for approximately 20% of newly diagnosed breast cancers and is associated with younger age at diagnosis, greater recurrence risk and shorter survival time. Therapeutic options are very scarce. Aim of the present analysis is to provide further insights into the clinical activity of metronomic chemotherapy (mCHT), in a real-life setting. Methods We used data included in the VICTOR-6 study for the present analysis. VICTOR-6 is an Italian multicentre retrospective cohort study, which collected data of metastatic breast cancer (MBC) patients who have received mCHT between 2011 and 2016. Amongst the 584 patients included in the study, 97 were triple negative. In 40.2% of the TNBC patients, mCHT was the first chemotherapy treatment, whereas 32.9% had received 2 ...
e12561 Background: Metastatic breast cancer (MBC) is an incurable disease. The main goals of trea... more e12561 Background: Metastatic breast cancer (MBC) is an incurable disease. The main goals of treatment are palliation, symptoms control, preserving QoL and prolonging survival. New drugs have contributed to ameliorate the outcome of MBC patients (pts) by increasing response rates (RR) progression free survival (PFS) and, in some setting, overall survival (OS). Taxanes are the most effective drugs in the management of MBC. Nab-Paclitaxel (Nab-P), a solvent-free albumin-bound taxane with high tumor retention, showed antitumor efficacy, and limited toxicity in MBC pts. Aim of the present study is to evaluate the activity and safety of Nab-P in clinical practice. Methods: MANTEL is a retrospective, multicenter, observational study, designed to collect biological and clinical data of MBC treated with Nab-P, from its availability in Italy. Objectives of the study are PFS, correlation between response and tumor biological characteristics and safety. Results: Up to date 137 cases were colle...
e12552 Background: mCHT is the minimum biologically effective dose of a chemotherapeutic agent, g... more e12552 Background: mCHT is the minimum biologically effective dose of a chemotherapeutic agent, given at regular dosing regimen with no prolonged drug free interval, that leads to anti-tumor activity. Old regimens included Cyclophosphamide-Methotrexate (CM), whereas in the last years new regimens, such as Vinorelbine (VRL) and Capecitabine (CAPE)-based have been developed. Aim of this observational retrospective ongoing study is to describe the use of mCHT in ABC pts across 5 years and the clinical characteristics of the pts together with efficacy of old (CM-like) vs new (VRL/CAPE-based) metronomic regimens in terms of response and disease control. Methods: We retrospectively identified from clinical records those HER2-ve ABC pts who have received any kind of mCHT in the years 2011-2015, alone, or in combination with a non-metronomic drug. Standard statistical approaches were used for describing the sample characteristics. Logistic and non proportional hazard analysis were used to i...
e12510 Background: Approximately 20% of breast cancers (BC) are HER-2+. Trastuzumab (T) has subst... more e12510 Background: Approximately 20% of breast cancers (BC) are HER-2+. Trastuzumab (T) has substantially improved the outcome, both in early and in advanced settings, in HER-2+BC. Pertuzumab (P), combined with T and taxanes, ameliorated progression free survival (PFS) and overall survival (OS) in the phase III CLEOPATRA study. In order to verify the results of the trial in unselected patients (pts), we performed a multicenter, retrospective-prospective, observational study, in HER-2+ metastatic BC (MBC) pts. Methods: We analyze the outcome of all HER-2+ MBC pts treated with P+T and taxanes, as first line therapy since the availability of P in Italy, at 11 general and university hospitals. Results: Up to February 1stdata from 103 HER-2+ MBC pts were recorded. Main pts’ characteristics were: median (M) age 52 y (28-78), m ECOG PS 0 (0-2), ER/PgR positive 68 pts (66%). Most common metastatic sites: liver 51 pts (49.5%), bone 64 pts (62.1%), lung 26 pts (25.2%). Thirty pts (29.1%) had ...
Background: Around 20% of breast cancers (BC) are HER-2+. Trastuzumab (T) has dramatically change... more Background: Around 20% of breast cancers (BC) are HER-2+. Trastuzumab (T) has dramatically changed the outcome of HER-2+ BC patients (pts), both in early and in advanced settings. The combination of Pertuzumab (P) plus T and docetaxel, used as first-line treatment for HER-2+ metastatic BC (MBC) in the phase III CLEOPATRA study, significantly prolonged progression free survival (PFS) and overall survival (OS). In order to verify the results of the Cleopatra trial in unselected pts, we performed a multicenter, retrospective-prospective, observational study, in HER-2+ MBC pts candidate to receive first line therapy with P plus T plus taxanes. Methods: We analyze the outcome of all HER-2+ MBC pts treated with P+T and taxanes, as first line therapy since the availability of P in Italy (2013), at 13 general and university hospitals. Results: Until June 6th data from 217 HER-2+ MBC pts were recorded. Main pts' characteristics were: median age 54 y (28-80), median ECOG PS 0 (0-2), hormonal receptor positive 152 pts (70%), 60 pts (27.6%) received neo/adjuvant chemotherapy (CT) + T and 75 pts (34.5%) adjuvant endocrine therapy. Most common metastatic sites: bone 121 pts (55.7%), liver 85 pts (39.2%), lung 61 pts (28.1%), soft tissues 133 pts (61.3%); 8 pts had CNS involvement. Seventy-eight pts (35.9%) had bone and/or soft tissues disease only; 108 pts (49.7%) had metastatic disease on presentation. Median number of metastatic sites was 3 (1-8). 144 pts (66.3%) and 72 pts (33.2%) received docetaxel (D) and paclitaxel (P) respectively. Median number of CT cycles was 6 for both drugs (D range 1-13; P range 1-18). Up to now 23 pts are still on CT and 86 on maintenance; ORR in evaluated pts (189) is 80.9% (47 and 106 pts obtained CR and PR respectively), 11 pts experienced PD during CT; 113 pts (58.2%) received endocrine therapy during maintenance.Median PFS is 14.7+ months (0.3+ - 53.2+). Most common adverse events are reported in table 1 Table 1Adverse EventAll grades N (%)Grade 3-4 N (%)Leukopenia39 (18)10 (4.6)Neutropenia42 (19.3)16 (7.3)Anemia50 (23)2 (0.9)Febrile Neutropenia7 (3.2) Diarrhea103 (47.4)10 (4.6)Asthenia127 (58.5)5 (2.3)Peripheral Neuropathy80 (36.8)3 (1.3)Stomatitis67 (30.8)2 (0.9) Nail changes, nausea, alopecia, rash and arthro-myalgia were also reported. Three pts interrupted CT due to symptomatic drop of left ventricular ejection fraction (LVEF); 2 pts interrupted maintenance P due to rash and dyspnea respectively, 16 stopped P and T due to drop in LVEF, 1 due to occurrence of ALL and 1 refused to continue. Conclusions: Our preliminary results highlight the activity and safety of the combination of CT plus P and T in unselected HER-2+ MBC patients. The study is ongoing and updated results will be presented. Citation Format: Garrone O, D'Onofrio L, Blondeaux E, Bertolini I, Giarratano T, Beano A, Saggia C, Cazzaniga M, LaVerde N, Collovà E, Milani A, De Conciliis E, Coltelli L, Airoldi M, Del Mastro L, Cursano MC, Michelotti A, Vandone AM, Guarneri V, Donadio M, Riva F, Nuzzo A, Merlano MC. Moving from the CLEOPATRA study to real life: Preliminary results from the G.O.N.O. SUPER trial [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-21-29.
Purpose Triple-negative breast cancer (TNBC) represents a subtype of breast cancer which lacks th... more Purpose Triple-negative breast cancer (TNBC) represents a subtype of breast cancer which lacks the expression of oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (HER2): TNBC accounts for approximately 20% of newly diagnosed breast cancers and is associated with younger age at diagnosis, greater recurrence risk and shorter survival time. Therapeutic options are very scarce. Aim of the present analysis is to provide further insights into the clinical activity of metronomic chemotherapy (mCHT), in a real-life setting. Methods We used data included in the VICTOR-6 study for the present analysis. VICTOR-6 is an Italian multicentre retrospective cohort study, which collected data of metastatic breast cancer (MBC) patients who have received mCHT between 2011 and 2016. Amongst the 584 patients included in the study, 97 were triple negative. In 40.2% of the TNBC patients, mCHT was the first chemotherapy treatment, whereas 32.9% had received 2 ...
e12561 Background: Metastatic breast cancer (MBC) is an incurable disease. The main goals of trea... more e12561 Background: Metastatic breast cancer (MBC) is an incurable disease. The main goals of treatment are palliation, symptoms control, preserving QoL and prolonging survival. New drugs have contributed to ameliorate the outcome of MBC patients (pts) by increasing response rates (RR) progression free survival (PFS) and, in some setting, overall survival (OS). Taxanes are the most effective drugs in the management of MBC. Nab-Paclitaxel (Nab-P), a solvent-free albumin-bound taxane with high tumor retention, showed antitumor efficacy, and limited toxicity in MBC pts. Aim of the present study is to evaluate the activity and safety of Nab-P in clinical practice. Methods: MANTEL is a retrospective, multicenter, observational study, designed to collect biological and clinical data of MBC treated with Nab-P, from its availability in Italy. Objectives of the study are PFS, correlation between response and tumor biological characteristics and safety. Results: Up to date 137 cases were colle...
e12552 Background: mCHT is the minimum biologically effective dose of a chemotherapeutic agent, g... more e12552 Background: mCHT is the minimum biologically effective dose of a chemotherapeutic agent, given at regular dosing regimen with no prolonged drug free interval, that leads to anti-tumor activity. Old regimens included Cyclophosphamide-Methotrexate (CM), whereas in the last years new regimens, such as Vinorelbine (VRL) and Capecitabine (CAPE)-based have been developed. Aim of this observational retrospective ongoing study is to describe the use of mCHT in ABC pts across 5 years and the clinical characteristics of the pts together with efficacy of old (CM-like) vs new (VRL/CAPE-based) metronomic regimens in terms of response and disease control. Methods: We retrospectively identified from clinical records those HER2-ve ABC pts who have received any kind of mCHT in the years 2011-2015, alone, or in combination with a non-metronomic drug. Standard statistical approaches were used for describing the sample characteristics. Logistic and non proportional hazard analysis were used to i...
e12510 Background: Approximately 20% of breast cancers (BC) are HER-2+. Trastuzumab (T) has subst... more e12510 Background: Approximately 20% of breast cancers (BC) are HER-2+. Trastuzumab (T) has substantially improved the outcome, both in early and in advanced settings, in HER-2+BC. Pertuzumab (P), combined with T and taxanes, ameliorated progression free survival (PFS) and overall survival (OS) in the phase III CLEOPATRA study. In order to verify the results of the trial in unselected patients (pts), we performed a multicenter, retrospective-prospective, observational study, in HER-2+ metastatic BC (MBC) pts. Methods: We analyze the outcome of all HER-2+ MBC pts treated with P+T and taxanes, as first line therapy since the availability of P in Italy, at 11 general and university hospitals. Results: Up to February 1stdata from 103 HER-2+ MBC pts were recorded. Main pts’ characteristics were: median (M) age 52 y (28-78), m ECOG PS 0 (0-2), ER/PgR positive 68 pts (66%). Most common metastatic sites: liver 51 pts (49.5%), bone 64 pts (62.1%), lung 26 pts (25.2%). Thirty pts (29.1%) had ...
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