Trastuzumab (H) treatment in patients (pts) with metastatic breast cancer (MBC): An observational retrospective study in four hospitals from Bogotá, Colombia (ONCOLGroup study)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e12016-e12016
Author(s):  
H. Carranza ◽  
A. F. Cardona ◽  
C. Vargas ◽  
J. M. Otero ◽  
J. O. Sánchez ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Retrospective Study ◽  
De Novo ◽  
Performance Status ◽  
Metastatic Breast ◽  
Chemotherapeutic Agents ◽  
First Line Therapy ◽  
Hormone Receptor Positive ◽  
Line Therapy ◽  
Her 2

e12016 Background: Breast cancer is the second most common cancer diagnosed in Colombian women, and approximately 26% of MBC are HER-2-positive in our population. The purpose of this study was to assess the characteristics and outcome of pts with HER-2-positive MBC treated with H-based therapy in Bogotá. Methods: This retrospective study included 119 pts treated between 2000 and 2007. Overall response rates (ORR), clinical benefit (CB), time to progression (TTP), and overall survival (OS) were estimated. Most common grade 2/3 toxicities are reported as well as variables that influenced survival. Results: Median age was 62 years (range, 37 to 75). Eighty-seven (73%) pts had recurrent disease and the rest had de novo MBC. Performance status was ≥70% in 114 pts, 66% had ≤2 metastatic sites, and 58% had hormone receptor positive disease. Previous adjuvant therapy before H included antracyclines in 68% and taxanes in 39% of the pts. H was part of the first-line therapy for MBC in 86.5% of the pts, leading to a 54% ORR in 103 evaluable pts. CB was 81% and median TTP was 6.1 months. (range, 1.2 to 26 mo). The most common toxicities in this setting included neutropenia ≥G3 (9%) and neuropathy ≥G3 (7%). H was given as part of second line therapy to 54 (45%) pts, but only 41 had evaluable disease. A 56% ORR was found in this subgroup, 85% CB and 4.7-month median of TTP. Grade ≥G3 hand-foot syndrome was the main toxicity (14%). Median OS after the diagnosis of MBC was 23 months (range, 1.6–93 mo), being longer for pts with HR-positive disease (p = 0.036), in pts with loco-regional relapse (p = 0.029), and in those older than 50 (p = 0.0025). Only two variables independently predicted OS: age (HR: 0.4, 95% CI: 0.35–0.93, p = 0.046) and HR status (HR: 0.7, 95% CI: 0.60–0.86, p = 0.040). Two pts (1.7%) had H-induced heart failure. Conclusions: H in combination with chemotherapeutic agents has been proved to be an effective and safe treatment for HER-2-positive MBC. The results from our series agreed with those reported in the medical literature and guarantee the regular use of H in Colombia. No significant financial relationships to disclose.

scholarly journals Lapatinib plus Letrozole as First‐Line Therapy for HER‐2 + Hormone Receptor–Positive Metastatic Breast Cancer

2010 ◽  
Vol 15 (2) ◽  
pp. 122-129 ◽  
Author(s):  
Lee S. Schwartzberg ◽  
Sandra X. Franco ◽  
Allison Florance ◽  
Lisa O'Rourke ◽  
Julie Maltzman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Hormone Receptor ◽  
Metastatic Breast ◽  
First Line ◽  
First Line Therapy ◽  
Hormone Receptor Positive ◽  
Line Therapy ◽  
Her 2

scholarly journals Lapatinib plus Letrozole as First‐Line Therapy for HER‐2 + Hormone Receptor–Positive Metastatic Breast Cancer

2010 ◽  
Vol 15 (3) ◽  
pp. 327-327
Author(s):  
Lee S. Schwarzberg ◽  
Sandra X. Franco ◽  
Allison Florance ◽  
Lisa O'Rourke ◽  
Julie Maltzman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Hormone Receptor ◽  
Metastatic Breast ◽  
First Line ◽  
First Line Therapy ◽  
Hormone Receptor Positive ◽  
Line Therapy ◽  
Her 2

Phase I/II study of letrozole and sorafenib as first-line therapy of hormone-receptor positive (HR+) metastatic breast cancer (MBC).

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 531-531
Author(s):  
Antoinette R. Tan ◽  
Serena Tsan-Lai Wong ◽  
Robert D. Warren ◽  
Jennifer Eng-Wong ◽  
Minetta C. Liu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase I ◽  
Hormone Receptor ◽  
Metastatic Breast ◽  
First Line ◽  
First Line Therapy ◽  
Hormone Receptor Positive ◽  
Line Therapy

Retrospective analysis of ribociclib and letrozole as first-line therapy in patients with hormone receptor (HR) positive metastatic breast cancer (MBC) within a managed access program (MAP) in Turkey.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13055-e13055
Author(s):  
Gul Basaran ◽  
Umut Demirci ◽  
Fatih Yildiz ◽  
Irfan Cicin ◽  
Burak Yasin Aktas ◽  
...  
Keyword(s):  
Ovarian Function ◽  
De Novo ◽  
Metastatic Breast ◽  
Retrospective Chart Review ◽  
Qtc Interval ◽  
First Line ◽  
Ovarian Function Suppression ◽  
First Line Therapy ◽  
Line Therapy ◽  
Her 2

e13055 Background: The combination of ribociclib with ET significantly increased progression free survival (PFS) and OS compared with ET in first line treatment of HR positive HER2 negative MBC. We aimed to evaluate the efficacy and safety of ribociclib and letrozole within Turkish MAP in order to present clinical outcome with the real-world use of ribociclib, outside of clinical trial setting. Methods: Turkish MAP enabled access to ribociclib in combination with letrozole as first-line therapy for MBC patients with HR positive and Her-2 negative tumors. Adequate bone marrow reserve, a normal QTc interval, normal renal and liver functions were required for eligibility. Patients received 600 mg ribociclib once daily for 3 wks followed by 1wk off. A retrospective chart review of patient demographics, clinical and treatment characteristics have been performed. Results: Between July and November 2017, 178 patients were included from 47 institutions in Turkey. We report the results of first 101 patients analyzed. The median age was 53 years (33–81 years) and median follow up was 16 months. Forty-six patients had de novo disease, 78% patients were postmenopausal, 22% had ovarian function suppression. Thirty-six % patients had adjuvant chemotherapy, 49% received adjuvant ET. Forty % had visceral disease. Thirty patients had grade 3 neutropenia, 3 patients had febrile neutropenia, 5 patients have grade 2-3 elevation of liver function tests. There was no QT prolongation. Dose reduction to 400 mg was required for 16 patients. Four patients discontinued ribociclib due to toxicity, 22 patients due to progression, one patient refused treatment. Twelve patients had complete remission as their best response. Median PFS was 24.12 months (95%CI 22.2-26.2). None of the clinical and pathologic factors were significantly associated with prolonged PFS. Conclusions: The efficacy and toxicity of first-line ribociclib and letrozole within Turkish MAP is similar to the results from randomized clinical studies for patients with HR positive, Her-2 negative MBC.

scholarly journals Phase III, Double-Blind, Randomized Study Comparing Lapatinib Plus Paclitaxel With Placebo Plus Paclitaxel As First-Line Treatment for Metastatic Breast Cancer

2008 ◽  
Vol 26 (34) ◽  
pp. 5544-5552 ◽  
Author(s):  
Angelo Di Leo ◽  
Henry L. Gomez ◽  
Zeba Aziz ◽  
Zanete Zvirbule ◽  
Jose Bines ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Epidermal Growth Factor Receptor ◽  
Growth Factor Receptor ◽  
Metastatic Breast ◽  
Phase Iii ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Her 2 ◽  
Epidermal Growth

PurposeLapatinib, a dual tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR/ErbB1) and human epidermal growth factor receptor 2 (HER-2/ErbB2), is effective against HER-2–positive locally advanced or metastatic breast cancer (MBC). This phase III trial evaluated the efficacy of lapatinib in HER-2–negative and HER-2–uncharacterized MBC.Patients and MethodsWomen with MBC were randomly assigned to first-line therapy with paclitaxel 175 mg/m2every 3 weeks plus lapatinib 1,500 mg/d or placebo. A preplanned retrospective evaluation of HER-2 status was performed using fluorescence in situ hybridization and immunohistochemistry. The primary end point was time to progression (TTP); secondary end points were objective response rate (ORR), clinical benefit rate (CBR), event-free survival (EFS), and overall survival (OS).ResultsIn the intent-to-treat population (n = 579), there were no significant differences in TTP, EFS, or OS between treatment arms, although differences in ORR and CBR were noted. In 86 HER-2–positive patients (15%), treatment with paclitaxel-lapatinib resulted in statistically significant improvements in TTP, EFS, ORR, and CBR compared with paclitaxel-placebo. No differences between treatment groups were observed for any end point in HER-2–negative patients. The most common adverse events were alopecia, rash, and diarrhea. The incidence of diarrhea and rash was significantly higher in the paclitaxel-lapatinib arm. The rate of cardiac events was low, and no difference was observed between treatment arms.ConclusionPatients with HER-2–negative or HER-2–untested MBC did not benefit from the addition of lapatinib to paclitaxel. However, first-line therapy with paclitaxel-lapatinib significantly improved clinical outcomes in HER-2–positive patients. Prospective evaluation of the efficacy and safety of this combination is ongoing in early and metastatic HER-2–positive breast cancer patients.

scholarly journals Phase II Trial of a Novel Paclitaxel Schedule As Single-Agent, First-Line Therapy for HER-2/neu–Negative Metastatic Breast Cancer: A Community-Based Study

2006 ◽  
Vol 2 (6) ◽  
pp. 268-273
Author(s):  
David Loesch ◽  
Nicholas Robert ◽  
Stephen Jones ◽  
Maha Elkordy ◽  
Des Ilegbodu ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Response Rate ◽  
Group Performance ◽  
Single Agent ◽  
Metastatic Breast ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Her 2

Purpose To determine the response rate (RR), progression-free survival (PFS), and toxicity in patients with HER-2/neu–negative metastatic breast cancer treated with first-line paclitaxel in a de-escalating dosing schedule. Patients and Methods Between August 1999 and December 2000, 73 patients were enrolled. Paclitaxel was administered on day 1 (175 mg/m2) and on days 8 and 15 (80 mg/m2 each) in each 4-week cycle (1 week of rest). Doses were de-escalated with the aim of reducing toxicity. An Eastern Cooperative Oncology Group performance status of 0, 1, or 2 was found in 55%, 41%, and 4% of patients, respectively. Median age was 59 years (range, 38 to 84 years), and 86% of patients had received prior surgery; 60%, adjuvant chemotherapy; and 59%, radiation therapy. Results Based on an intention-to-treat analysis (N = 73), there were five patients with a complete response (6.8%), 16 with a partial response (21.9%), 17 with stable disease (23.3%), and 23 with progressive disease (31.5%) for an RR of 28.7%. Twelve patients (16.4%) were not assessable for response due to toxicity (seven patients, mainly neuropathy), withdrawal of consent (two patients), early death (two patients), or noncompliance (one patient). Median PFS was 6.5 months (range, < 1 to 36.1 months), median survival was 22.8 months (range, < 1 to 36.1 months), and median duration of response was 8.8 months (range, 3.0 to 31.8 months). Patients (n = 72) were evaluated for toxicity. Grade 3 to 4 treatment-related toxicities occurring in more than 5% of patients included neutropenia (22.2%), neuropathy (18.1%), fatigue (6.9%), and leukopenia (5.6%). Conclusion In a unique de-escalating schedule, this study of single-agent paclitaxel produced a response rate similar to other single-agent paclitaxel schedules, in first-line therapy for metastatic breast cancer, published in the literature. However, this schedule is not recommended for the therapy of metastatic breast cancer because of the higher rate of toxicity.

Presentation and treatment of HER2-positive metastatic breast cancer patients already treated with adjuvant trastuzumab.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 619-619
Author(s):  
Davis Yuri Torrejon ◽  
Serena Di Cosimo ◽  
Gessami Sanchez-Olle ◽  
Judith Balmaña ◽  
Meritxell Bellet ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Median Time ◽  
Metastatic Breast ◽  
Response To Treatment ◽  
First Line ◽  
Her2 Positive ◽  
Adjuvant Trastuzumab ◽  
First Line Therapy ◽  
Line Therapy ◽  
Her 2

619 Background: The introduction of trastuzumab in the clinical armamentarium has profoundly changed the natural history of HER2 positive breast cancer (BC). However, about 15% of patients with HER2 early BC treated with adjuvant trastuzumab continue to relapse. We aimed to analyze these patients with respect to clinical presentation and response to treatment. Methods: Data were retrieved from the institutional BC database of Vall d’Hebron. All the cases relapsing after exposure to adjuvant trastuzumab were analyzed. Change in expression of hormone-receptor (HR) and HER-2 status between primary tumour and corresponding local recurrence or distant metastasis was also evaluated Results: A total of 270 patients were identified. Twenty-six patients (9.6%) relapsed (Table). Overall median time from diagnosis to relapse was 27.1 months (24.1-30.1) being 29.1 months (14.3-44.1) in HR positive and 23.1 (9.9-36.2) in HR negative cases (p=0.037). Median time from last dose of trastuzumab to relapse was 7.6 (2.7-12.7) months, being 10.6 (0-27.9) and 3 months (0-7.6) in HR positive and negative cases, respectively (p=0.026). Sixteen patients have already progressed to first-line therapy with a median time to progression (TTP) of 7.4 months with no statistical difference among HR positive and HR negative (4.4 and 9.8 months, p=0.3). No difference was found in TTP to first line therapy among early (before 12 months) and delayed (after 12 months) progression on adjuvant trastuzumab. Among the 17 cases with primary tumor and matched metastatic biopsy, HER-2 negativization was detected in 2 cases; whereas a change in estrogen and progesterone receptors was seen in 17.6% and 29.4% of cases, respectively. Conclusions: Patients with HER2+/HR negative treated with adjuvant trastuzumab seems to have a significantly shorter time to relapse compared with the HER2+/HR+ tumors. In these patients biopsy of metastatic lesions might help to define the best treatment options. [Table: see text]

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