scholarly journals Oral Capecitabine-Vinorelbine Is Associated with Longer Overall Survival When Compared to Single-Agent Capecitabine in Patients with Hormone Receptor-Positive Advanced Breast Cancer

Cancers ◽  
2020 ◽  
Vol 12 (3) ◽  
pp. 617
Author(s):  
Claudio Vernieri ◽  
Michele Prisciandaro ◽  
Federico Nichetti ◽  
Riccardo Lobefaro ◽  
Giorgia Peverelli ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Hormone Receptor ◽  
Single Agent ◽  
Multivariable Analysis ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Tolerability Profile ◽  
Good Tolerability ◽  
Hormone Receptor Positive

Background: Single-agent capecitabine (C) is a moderately effective chemotherapeutic compound in the treatment of patients with HER2-negative metastatic breast cancer (mBC). The capecitabine-vinorelbine (CV) combination is also used due to a good tolerability profile, but no studies have demonstrated its superiority over single-agent C. Methods: We conducted a retrospective analysis to compare overall response rate (ORR), progression-free survival (PFS), overall survival (OS) and incidence of adverse events (AEs) in patients with HER2-negative mBC treated with CV vs. single-agent C. Results: Out of 290 patients included in this study, 127 (43.8%) received single-agent C, while 163 (56.2%) patients were treated with CV. Median PFS was similar in patients treated with single-agent C or CV, while CV was associated with significantly longer OS in patients with hormone receptor-positive (HR+) BC. This OS advantage was confirmed at multivariable analysis also after propensity score-based matching of patients according to relevant clinical or tumor characteristics. When compared with single-agent C, CV was associated with higher incidence of G3/G4 and any-grade nausea/vomiting, diarrhea and increased transaminases. Conclusions: While prospective studies are needed to confirm our findings, the potential OS advantage of CV over single-agent C in HR+ mBC patients must be weighed against a significantly higher incidence of AEs.

A phase II trial of trabectedin (T) in patients with hormone receptor-positive, HER2-negative advanced breast cancer, according to xeroderma pigmentosum gene (XPG) expression.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS652-TPS652
Author(s):  
Ahmad Awada ◽  
Javier Cortes ◽  
Miguel Martin ◽  
Philippe Aftimos ◽  
Mafalda Oliveira ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Phase Ii ◽  
Primary Endpoint ◽  
Hormone Receptor ◽  
Single Agent ◽  
Progression Free Survival ◽  
Open Label ◽  
Hormone Receptor Positive ◽  
Metastatic Setting

TPS652 Background: Hormone receptor-positive, HER2-negative breast cancer (BC) is currently associated with 3-4 years overall survival in the metastatic setting and, after ≥2 relapses, therapeutic approaches are reduced. XPG expression is frequently modified in BC. T is a cytotoxic agent that forms a complex with the XPG, inducing cell apoptosis. As a single agent, T has shown anti-tumor activity in patients with poor prognosis BC, and a better response to T in BC patients with XPG RNA overexpression has been observed. Methods: This is an open-label, phase II study of T (1.3 mg/m2 in 3-hour intravenous infusion every 3 weeks) in patients with hormone receptor-positive, HER2-negative advanced BC, according to their primary tumor’s XPG expression. Primary endpoint: to evaluate the efficacy of T in terms of progression free survival rate at 4 months (PFS4) according to the patient’s XPG expression. Secondary endpoints: Comparison of PFS, overall response rate, duration of response, overall survival and safety profile in XPG-high and XPG-low patients. Assignment: BC patients who have previously received anthracyclins and/or taxanes and who progressed after 2-5 chemotherapy lines will be assigned according to their XPG expression from paraffin embedded tumor samples to stratum A (XPG-high [>3]) or to stratum B (XPG-low [≤3]) (threshold was selected from median XPG expression values observed in a previous trial). Statistical methods: A two-stage design was chosen: at a first stage 20 patients will be enrolled in each stratum. A futility analysis (O’Brien Fleming boundary) based on the primary endpoint (PFS4) will be conducted once 40 evaluable patients have been recruited. If ≥ 7 out of 20 patients achieve PFS4, recruitment will continue to a maximum sample size of 50 evaluable patients per stratum. If ≥ 22 out of 50 patients achieve PFS4, T will be considered active in this group (alpha error: 0.025, power: 80%). To date, 35 patients (16 XPG-high and 15 XPG-low) have been enrolled from three countries and five centers. Recruitment is ongoing.

scholarly journals Patterns of treatment and outcome of palbociclib plus endocrine therapy in hormone receptor-positive/HER2 receptor-negative metastatic breast cancer: a real-world multicentre Italian study

2021 ◽  
Vol 13 ◽  
pp. 175883592098765
Author(s):  
Raffaella Palumbo ◽  
Rosalba Torrisi ◽  
Federico Sottotetti ◽  
Daniele Presti ◽  
Anna Rita Gambaro ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Real World ◽  
Hormone Receptor ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Her2 Receptor ◽  
Treatment Line ◽  
Hormone Receptor Positive

Background: The CDK4/6 inhibitor palbociclib combined with endocrine therapy (ET) has proven to prolong progression-free survival (PFS) in women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (MBC). Few data are available regarding the efficacy of such a regimen outside the clinical trials. Patients and methods: This is a multicentre prospective real-world experience aimed at verifying the outcome of palbociclib plus ET in an unselected population of MBC patients. The primary aim was the clinical benefit rate (CBR); secondary aims were the median PFS, overall survival (OS) and safety. Patients received palbociclib plus letrozole 2.5 mg (cohort A) or fulvestrant 500 mg (cohort B). Results: In total, 191 patients (92 in cohort A, 99 in cohort B) were enrolled and treated, and 182 were evaluable for the analysis. Median age was 62 years (range 47–79); 54% had visceral involvement; 28% of patients had previously performed one treatment line (including chemotherapy and ET), 22.6% two lines and 15.9% three. An overall response rate of 34.6% was observed with 11 (6.0%) complete responses and 52 (28.6%) partial responses. Stable disease was achieved by 78 patients (42.9%) with an overall CBR of 59.8%. At a median follow-up of 24 months (range 6–32), median PFS was 13 months without significant differences between the cohorts. When analysed according to treatment line, PFS values were significantly prolonged when palbociclib-based therapy was administered as first-line treatment (14.0 months), to decrease progressively in second and subsequent lines (11.7 and 6.7 months, respectively). Median OS was 25 months, ranging from 28.0 months in 1st line to 18.0 and 13.0 months in 2nd and subsequent lines, respectively. Conclusions: Our data indicate that palbociclib plus ET is active and safe in HR+/HER2− MBC, also suggesting a better performance of the combinations in earlier treatment lines.

scholarly journals CDK4/6 inhibitors in breast cancer: beyond hormone receptor-positive HER2-negative disease

2018 ◽  
Vol 10 ◽  
pp. 175883591881834 ◽  
Author(s):  
Adriana Matutino ◽  
Carla Amaro ◽  
Sunil Verma
Keyword(s):  
Breast Cancer ◽  
Hormone Receptor ◽  
Growth Factor Receptor ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Breast Cancers ◽  
Cyclin Dependent Kinase ◽  
Her2 Positive ◽  
Hormone Receptor Positive ◽  
Epidermal Growth

The development of cyclin-dependent kinase (CDK) 4/6 inhibitors has been more prominent in hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancers, with a significant improvement in progression-free survival (PFS) in first and later lines of metastatic breast cancer (MBC) therapy. Preclinical evidence suggests that there is activity of CDK4/6 inhibitors in nonluminal cell lines. Here, we present a review of the current preclinical and clinical data on the use of CDK inhibitors in HER2-positive and triple-negative breast cancer (TNBC).

Progression-Free Survival for Real-World Use of Palbociclib in Hormone Receptor-Positive Metastatic Breast Cancer

2020 ◽  
Vol 20 (1) ◽  
pp. 33-40 ◽  
Author(s):  
Jonathan Wilkie ◽  
M. Alexandra Schickli ◽  
Michael J. Berger ◽  
Maryam Lustberg ◽  
Raquel Reinbolt ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Real World ◽  
Hormone Receptor ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Free Survival ◽  
Hormone Receptor Positive

scholarly journals Patterns of treatment and outcome with 500-mg fulvestrant in postmenopausal women with hormone receptor-positive/HER2-negative metastatic breast cancer: a real-life multicenter Italian experience

2019 ◽  
Vol 11 ◽  
pp. 175883591983386 ◽  
Author(s):  
Raffaella Palumbo ◽  
Federico Sottotetti ◽  
Erica Quaquarini ◽  
Anna Gambaro ◽  
Antonella Ferzi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Liver Metastasis ◽  
Hormone Receptor ◽  
De Novo ◽  
Large Population ◽  
Single Agent ◽  
Real Life ◽  
Metastatic Breast ◽  
Hormone Receptor Positive

Background: Fulvestrant 500 mg (F500) is the most active endocrine single agent in hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (MBC). Few data are available regarding the effectiveness of the drug in a real-world setting. Patients and methods: This prospective, multicenter cohort study aimed to describe the patterns of treatment and performance of F500 in a large population of unselected women with MBC, focusing on potential prognostic or predictive factors for disease outcome and response. The primary endpoints were progression-free survival (PFS) and clinical benefit rate. Results: From January 2011 to December 2015, 490 consecutive patients treated with F500 were enrolled. Overall, three different cohorts were identified and analyzed: the first received F500 after progression from previous chemotherapy (CT) or endocrine therapy; the second received the drug for de novo metastatic disease; and the third was treated as maintenance following disease stabilization or a response from a previous CT line. Median overall survival (OS) in the whole population was 26.8 months, ranging from 32.4 in first line to 22.0 and 13.7 months in second line and subsequent lines, respectively. Both the presence of liver metastasis and the treatment line were significantly associated with a worse PFS, while only the presence of liver metastasis maintained its predictive role for OS in multivariate analysis. Conclusions: The effectiveness of F500 was detected in patients treated both upon disease progression and as maintenance. The relevant endocrine sensitivity of 80% of patients included in the study could probably explain the good results observed in terms of outcome.

Phase II randomized trial of toremifene 120 mg compared with exemestane 25 mg after prior nonsteroidal aromatase inhibitor in postmenopausal women with hormone receptor-positive breast cancer.

2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 105-105 ◽  
Author(s):  
Hirotaka Iwase ◽  
Yutaka Yamamoto ◽  
Takashi Ishikawa ◽  
Yasuo Hozumi ◽  
Masahiko Ikeda ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hormone Receptor ◽  
Objective Response ◽  
Metastatic Breast ◽  
Postmenopausal Breast Cancer ◽  
Comparative Trial ◽  
Progression Free Survival ◽  
Hazard Ratio ◽  
High Dose ◽  
Hormone Receptor Positive

105 Background: The non-steroidal aromatase inhibitors (nsAIs) have been mainly employed as adjuvant therapy or as early recurrent treatment for postmenopausal breast cancer with hormone receptor-positive tumor. When its treatment fails, it is unclear which endocrine therapy including selective estrogen receptor modulator (SERM), steroidal AI (sAI), or fulvestrant is the most appropriate. Methods: Open labeled multicenter randomized comparative trial of high-dose toremifene for nsAI resistant breast cancer compared to exmestane (Hi-FAIR ex; registry number UMIN000001841) was performed from Nov 2008 to Oct 2011. Toremifene 120 mg (TOR120) or exemestane 25mg (EXE) was administered once daily. The primary end point was clinical benefit rate (CBR). The secondary end points were objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and toxicity. Results: A total of 91 women were randomly assigned to TOR120 (n=46) or EXE (n=45). Two of 46 cases allocated for TOR120 refused this trial before the administration. There was no difference of patients’ characteristics between both groups. In the analysis as of median 16.9 months for an observation period, TOR120 were superior to EXE in CBR (47.5% vs. 26.7%; p=0.046) and in PFS (Hazard ratio; 0.62, 95% CI; 0.38-0.99, p=0.047). There was, however, no statistical differences in ORR (11.6% vs. 2.2%; p=0.065) and in OS (hazard ratio; 0.57, 95% CI; 0.24-1.34, p=0.19). Both treatments were well-tolerated, with no severe adverse events, although 3 of 44 women treated by TOR120 were stopped in a couple of weeks because of nausea and general fatigue which were thought to be early endocrine-related symptoms. Conclusions: Our data suggested that toremifene 120mg, as a following therapy for postmenopausal metastatic breast cancer who have failed non-steroidal AI treatment, could be potentially useful than steroidal AI.

Improved survival supports primary endocrine therapy in patients with hormone receptor positive/ HER-2 negative metastatic breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13034-e13034
Author(s):  
Robert Shenk ◽  
Lifen Cao ◽  
Jonathan T. Bliggenstorfer ◽  
James Michael Martin ◽  
Megan E. Miller
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Metastatic Breast Cancer ◽  
Endocrine Therapy ◽  
Systemic Therapy ◽  
Hormone Receptor ◽  
Survival Benefit ◽  
Metastatic Breast ◽  
Hormone Receptor Positive ◽  
Primary Endocrine Therapy

e13034 Background: Current ASCO guidelines recommend endocrine therapy as preferred primary treatment for hormone receptor positive (HR+) metastatic breast cancer (MBC). We assessed survival outcomes of HR+/HER2- MBC patients undergoing endocrine therapy with and without chemotherapy. Methods: The National Cancer Database was queried 2004-2016 for patients with de novo HR+/HER2- MBC. Exclusion criteria were treatment with surgery or radiation at the primary site and missing oncologic and follow up data. Overall survival was compared between systemic treatment groups using multivariable cox proportional hazards regression modes. Results: 19,317 patients met inclusion criteria, among whom 2,360 (12%) received no systemic therapy, 2,617 (14%) received chemotherapy only, 10,078 (52%) received endocrine therapy only and 4,262 (22%) received both chemotherapy and endocrine therapy. Patients treated with chemotherapy only more frequently had lung (38%, p<0.001) or liver (36%, p<0.001) metastasis while those undergoing endocrine therapy only presented primarily with bone metastasis (82%, p<0.001). Patients with multiple metastatic sites more often received endocrine therapy alone than combined therapy (44 vs. 25%, p<0.001). Median overall survival was similar after combination therapy and endocrine therapy, and poorest after chemotherapy alone (33.1 vs 31.4 vs 19.8 months, p<0.001). After controlling for patient, facility, and tumor characteristics, endocrine therapy alone provided superior survival benefit to chemotherapy only, though combination systemic therapy resulted in the greatest overall survival (p<0.001). Conclusions: Primary endocrine therapy provided significant survival benefit over chemotherapy alone for HR+/HER2- MBC. Though combination systemic therapy may be warranted in progressive disease, our results align with recommendations for endocrine therapy as first line treatment for HR+/HER2- MBC. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document