PP-8-2 First line tamoxifen for invasive hormonal sensitive non metastatic breast carcinomas in young postmenopausal patients

Abstract Purpose Metronomic chemotherapy (MCT) is an increasingly used treatment option in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced/metastatic breast cancer (MBC) after failure of endocrine-based therapies. Methods VinoMetro was a multicentre, open-label, single-arm, phase II study of metronomic oral vinorelbine (VRL; 30 mg/day) as a first-line chemotherapy (CT) in patients with HR+/HER2− MBC after endocrine failure. The primary endpoint was the clinical benefit rate (CBR) at 24 weeks. Results Between January 2017 and April 2019, nine patients were enrolled. The CBR was 22.2% (90% confidence interval [CI] 4.1–55.0), p = 0.211. The median progression-free survival (PFS) was 12.0 weeks (95% CI 11.3–12.7). Grade 3–4 adverse events (AEs) occurred in 22.2% of patients. One patient died of febrile neutropenia. Conclusion VinoMetro (AGO-B-046) was closed early after nine patients and occurrence of one grade 5 toxicity in agreement with the lead institutional review board (IRB). Metronomic dosing of oral VRL in HR+/HER2− MBC as first-line CT after failure of endocrine therapies showed only limited benefit in this population. Trial registration number and date of registration ClinicalTrials.gov Identifier: NCT03007992; December 15, 2016.

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Physical Activity, Weight, and Outcomes in Patients Receiving Chemotherapy for Metastatic Breast Cancer (C40502/Alliance)

JNCI Cancer Spectrum ◽

10.1093/jncics/pkab025 ◽

2021 ◽

Author(s):

Jennifer A Ligibel ◽

Luke Huebner ◽

Hope S Rugo ◽

Harold J Burstein ◽

Debra L Toppmeyer ◽

...

Keyword(s):

Breast Cancer ◽

Physical Activity ◽

Body Mass Index ◽

Metastatic Breast Cancer ◽

Body Mass ◽

Hormone Receptor ◽

Metastatic Breast ◽

Hazard Ratio ◽

First Line ◽

Risk Of Cancer

Abstract Background Obesity and inactivity are associated with increased risk of cancer related- and overall mortality in breast cancer, but there are few data in metastatic disease. Methods CALGB 40502 was a randomized trial of first-line taxane-based chemotherapy for patients with metastatic breast cancer. Height and weight were collected at enrollment. After 299 patients enrolled, the study was amended to assess recreational physical activity (PA) at enrollment using the Nurses’ Health Study Exercise Questionnaire. Associations with progression-free survival (PFS) and overall survival (OS) were evaluated using stratified Cox modeling (strata included hormone receptor status, prior taxane, bevacizumab use, and treatment arm). Results 799 patients were enrolled and at the time of data lock, median follow-up was 60 months. At enrollment, median age was 56.7 years, 73.1% of participants had hormone receptor-positive cancers, 42.6% had obesity, and 47.6% engaged in less than 3 metabolic equivalents of task (MET)-hours of PA/week (<1 hour of moderate PA). Neither baseline body mass index nor PA was statistically significantly associated with PFS or OS, although there was a marginally statistically significant increase in PFS (hazard ratio = 0.83, 95% confidence interval [CI] = 0.79, 1.02; p = .08) and OS (hazard ratio = 0.81, 95% CI = 0.65, 1.02; p = .07) in patients who reported PA greater than 9 MET-hours/week vs 0–9 MET-hours/week. Conclusions In a trial of first-line chemotherapy for metastatic breast cancer, rates of obesity and inactivity were high. There was no statistically significant relationship between body mass index and outcomes. More information is needed regarding the relationship between PA and outcomes.

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

Journal of Oncology Pharmacy Practice ◽

10.1177/10781552211019462 ◽

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.

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