Prediction of early progression (EP) to CDKIs first line treatment in ER+/HER2- metastatic breast cancer (MBC) using machine learning.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13040-e13040
Author(s):  
Jose Manuel Jerez ◽  
Nuria Ribelles ◽  
Pablo Rodriguez-Brazzarola ◽  
Tamara Diaz Redondo ◽  
Begoña Jimenez Rodriguez ◽  
...  
Keyword(s):  
Machine Learning ◽  
Disease Progression ◽  
Metastatic Breast ◽  
True Positive Rate ◽  
Machine Learning Algorithms ◽  
Free Text ◽  
Line Treatment ◽  
First Line ◽  
True Negative ◽  
First Line Treatment

e13040 Background: The treatment of luminal MBC has undergone a substantial change with the use of cyclin dependent kinase 4/6 inhibitors (CDKIs). Nevertheless, there is not a clearly defined subgroup of patients who do not initially respond to CDKIs and show EP. Methods: MBC ER+/HER2- patients who have received at least one line of treatment were eligible. The event of interest was disease progression within 6 months of first line treatment according to the type of therapy administered. The first line treatments were categorized in chemotherapy (CT), hormonal therapy (HT), CT plus maintenance HT and HT plus CDKIs. Free text data from clinical visits registered in our Electronic Health Record were obtained until the date of first treatment in order to generate a feature vector composed of the word frequencies for each visit of every patient. Six different machine learning algorithms were evaluated to predict the event of interest and to obtain the risk of EP for every type of therapy. Area under the ROC curve (AUC), True Positive Rate (TPR) and True Negative Rate (TNR) were assessed using 10-fold cross validation. Results: 610 RE+/HER2- MBC treated between November 1991 and August 2019 were included. Median follow up for metastatic disease was 28 months. 17426 clinical visits were analyzed (per patient: range 1-173; median 30). 119 patients received CT as first line treatment, 311 HT, 117 CT plus maintenance HT and 63 HT plus CDKIs. There were 379 patients with disease progression, from which 126 were within 6 months from first line treatment (54 events with CT, 57 with HT, 4 with CT plus maintenance HT and 11 with HT plus CDKIs). The model that yields the best results was the GLMBoost algorithm: AUC 0.72 (95%CI 0.67-0.77), TPR 70.85% (95%CI 70.63%-71.06%), TNR 66.27% (95% 66.08%-66.46%). Conclusions: Our model based on unstructured data from real-world patients predicts EP and establishes the risk for each of the different types of treatment for MBC ER+/HER2-. Obviously an additional validation is needed, but a tool with these characteristics could help to select the best available treatment when that decision has to be made, avoiding those therapies that are probably not to be effective.

Non-pegylated doxorubicin plus capecitabine as first-line treatment in metastatic breast cancer

Oncoreview ◽  
2016 ◽  
Vol 6 (4) ◽  
pp. 0-0
Author(s):  
Piotr Plecka
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Adverse Events ◽  
Disease Progression ◽  
Metastatic Breast ◽  
Symptomatic Treatment ◽  
Line Treatment ◽  
Breast Cancer Patients ◽  
First Line ◽  
First Line Treatment

Purpose: To determine the toxicity and efficacy profile of non-pegylated doxorubicin in combination with capecitabine administered according to LipAX regimen. Materials and methods: The analysis included 5 female patients undergoing first-line treatment for metastatic breast cancer. Patients received non-pegylated doxorubicin intravenously and oral capecitabine at usual doses used for monotherapy, until disease progression or unacceptable toxicity. Results: Patients received a total of 26 complete treatment cycles according to LipAX regimen. During treatment, 15 toxicities occurred, including 7 adverse events with grade 3 severity. Only two haematological toxicities were observed, and the other 13 were of a non-haematological nature. Only one patient experienced no adverse events. Apart from symptomatic treatment, the capecitabine dose was reduced twice and the non-pegylated doxorubicin once. Positive clinical outcomes were observed in 4 patients, and disease progression was reported in the case of 1 patient in the course of the treatment. The median time to disease progression was 10.4 months, and the median overall survival was 34.2 months. During the 54-month follow-up, 4 of the patients died. The surviving patient continues treatment. Conclusions: Therapy according to the LipAX regimen was relatively well tolerated, however, since the majority of patients discontinued treatment due to adverse events, and not disease progression, an adequate reduction in the cytostatic doses should be considered. The use of the LipAX regimen may contribute to the achievement of long-term remission in some patients, a fact that encourages further studies on this form of therapy.

A phase II trial of trastuzumab (H) + capecitabine (X) as first-line treatment in patients (pts) with HER2-positive metastatic breast cancer (MBC)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 10615-10615 ◽  
Author(s):  
L. Xu ◽  
S. Song ◽  
J. Zhu ◽  
R. Luo ◽  
L. Li ◽  
...  
Keyword(s):  
Disease Progression ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Thoracic Wall ◽  
Line Treatment ◽  
First Line ◽  
Her2 Positive ◽  
Highly Active ◽  
Grade 3 ◽  
First Line Treatment

10615 Background: The addition of H to a taxane provides significant clinical benefit, including prolonged survival, in HER2-positive MBC. H adds little to the toxicity of taxanes alone. As monotherapy, X has consistently high activity and favorable safety. The addition of X to docetaxel extends survival in MBC. Preliminary data [Bangemann et al. 2000] indicated that the combination of H + X is effective and well-tolerated for intensively pretreated HER2-positive MBC (ORR 47%). The current study evaluated the efficacy and safety of H + X in first-line MBC. Methods: 72 pts of a planned population of 100 pts were enrolled between Mar03 and Dec05. All pts had measurable (WHO criteria), HER2-positive (IHC 3+ or IHC 2+/FISH positive) and untreated MBC, KPS ≥60, and adequate organ function. H was administered as a 4mg/kg loading dose followed by 2mg/kg i.v. weekly (until disease progression) and X 1250mg/m2 bid d1–14 q3w (max 6 cycles). The primary endpoint was progression-free survival (PFS). Results: Baseline characteristics: median age 49 years (range 27–74), median KPS 90 (range 60–100). Principal tumor sites: lymph nodes (49%), lung (33%), liver (28%), breast (14%), thoracic wall (9%), chest (9%), other (12%). Prior treatment: surgery (77%), radiotherapy (21%), and adjuvant chemotherapy (58%), including anthracycline (35%), paclitaxel (7%), docetaxel (7%) and other (21%). 43 pts are evaluable for safety and efficacy. The remaining 29 pts are being analyzed. 6 pts received 3 cycles of H + X; the other 37 pts completed 6 cycles of treatment. 16 pts received H monotherapy after completing 6 cycles of H + X. 3 pts discontinued H due to disease progression. The most common grade 1/2 adverse events (AEs) were HFS (14%), neutropenia (14%), SGOT abnormality (16%), and SGPT abnormality (14%). Grade 3 HFS occurred in 4 pts (10%) with grade 3 myelosuppression in 1 pt (2%). AEs were mild and resolved in all pts. The overall response rate was 63%, including 5 CRs and 22 PRs. At a median follow-up of 6 months, median PFS has not been reached. Conclusions: The combination of H and X is a highly active and well-tolerated regimen for first-line treatment of HER2-positive MBC. Updated data will be presented. No significant financial relationships to disclose.

The cost-effectiveness of atezolizumab in first-line for metastatic triple negative breast cancer is heavily linked to PD-L1 level

2021 ◽  
pp. 107815522110194
Author(s):  
Jacopo Giuliani ◽  
Beatrice Mantoan ◽  
Andrea Bonetti
Keyword(s):  
Breast Cancer ◽  
Triple Negative ◽  
Controlled Trial ◽  
Metastatic Breast ◽  
Cost Effective ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Pivotal Phase ◽  
First Line Treatment

The present analysis was conducted to assess the pharmacological costs of atezolizumab as first-line treatment in triple negative metastatic breast cancer (mBC). Pivotal phase III randomized controlled trial (RCT) was considered. Nine hundred and two patients were included. Differences in costs between the 2 arms (atezolizumab plus nabpaclitaxel versus placebo plus nab-paclitaxel) was 17 398 €, with a cost of 7564 €per month of OS-gain in the overall population and 2485 €per month of OS-gain in PD-L1-positive (≥1) population. Combining pharmacological costs of drugs with the measure of efficacy represented by the OS, atezolizumab could be considered cost-effective in first-line treatment for triple-negative mBC only in PD-L1-positive population, but a reduction of costs is mandatory.

Exemestane and Chemotherapy as First-line Treatment of Metastatic Breast Cancer: Results of a Phase II Study

2010 ◽  
Vol 10 (4) ◽  
pp. 313-317 ◽  
Author(s):  
Juan de la Haba-Rodriguez ◽  
Rosario González Mancha ◽  
Gumersindo Pérez Manga ◽  
Enrique Aranda Aguilar ◽  
José Manuel Baena Cañada ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Metastatic Breast ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

First-line treatment with a cyclin-dependent kinase 4/6 inhibitor combined with an aromatase inhibitor for hormone receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer: Population-based outcomes for patients treated in Alberta, Canada.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13020-e13020
Author(s):  
Carla Pires Amaro ◽  
Atul Batra ◽  
Sasha M. Lupichuk
Keyword(s):  
Hormonal Therapy ◽  
Growth Factor Receptor ◽  
Metastatic Breast ◽  
Population Based ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Hormone Receptor Positive ◽  
Targeted Agent ◽  
First Line Treatment

e13020 Background: Cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with an aromatase inhibitor (AI) has emerged as the standard first line treatment in patients with hormone receptor positive, human epidermal growth factor receptor-2 (HER-2) negative metastatic breast cancer (MBC). In this analysis, we describe population-based outcomes for first-line treatment with a CDK4/6i combined with an AI. Methods: All patients who were prescribed CDK4/6i + AI from January 2016 through June 2019 in a large Canadian province were included. Descriptive statistics were used to summarize patient demographics, tumor and treatment characteristics. Survival distributions were estimated using the Kaplan-Meier method. Multivariate analysis (MVA) using a Cox proportional hazards model was constructed to examine associations between potentially prognostic clinical variables and progression free survival (PFS). Results: A total of 316 patients were included. Median age was 61 years (interquartile range, 53-70 years), 82% were postmenopausal women, 39% had de novo MBC, and 48% had non-visceral disease. Palbociclib was prescribed in 94% of patients and the remaining patients received ribociclib. The CDK4/6i was dose-reduced upfront or during treatment in 47%. While 70% of the patients discontinued treatment due to progression, 30% stopped due to toxicity/patient preference/physician recommendation. With a median follow-up of 28.1 months, the median PFS was 37.9 months (95% CI, 26.7-NR). In the MVA, PR-negative tumour (HR, 2.37; 95% CI, 1.45-3.88; P = 0.001) and dose reduction of the CDK4/6i (HR, 1.51; 95% CI, 1.06-2.16; P = 0.022) predicted worse PFS. Median overall survival (OS) was not reached. The 30-month and 36-month OS rates were 74% and 68%, respectively. Of patients who progressed (n = 131), 89% received second-line treatment (chemotherapy in 46%, single agent hormonal therapy in 35%, hormonal therapy plus a targeted agent in 15%, and other in 4%). Median time to progression on second line chemotherapy was 9.0 (5.8-17.6) months and second line hormonal therapy +/- targeted agent was 4.0 (3.4-8.6) months (P = 0.012). Conclusions: The real-world outcomes of first-line use of CDK4/6i and AI are encouraging. PR negative tumors and dose reduction appear to be negative prognostic markers. CDK4/6i + AI as first-line treatment for HR-positive, HER2-negative MBC in Alberta is justified based on favorable PFS and early OS outcomes.

Sign in / Sign up

Export Citation Format

Share Document