Purpose
We hypothesized different Overall Survival (OS) in metastatic breast cancer (MBC) after relapse vs de novo presentation.
Methods
We identified women in British Columbia with MBC diagnosed ...between 01/2001 and 12/2009. OS from MBC was calculated for relapsed vs de novo cohorts in 3 subgroups, based on hormone receptors (HR) and HER2 status. Age at MBC, disease-free interval (DFI), de novo vs relapsed, year of MBC diagnosis, and systemic treatment were entered into univariable and multivariable analyses.
Results
We identified 3645 pts with known HR of which 2796 had known HER2. Median follow-up was 91 months. Median OS was longer for de novo vs relapsed MBC: HR+/HER2- 34 versus 23 months (mos) (
p
< 0.0001), HR−/HER2- (TN) 11 versus 8 mos (
p
= 0.02), HER2+ 29 versus 15 mos (
p
< 0.0001). For TN disease, no variable independently discriminated a group with increased risk of death. For both the HR +/HER2- and the HER2 + groups, relapsed vs de novo status (HzR 1.4 95% CI 1.2–1.5;
p
< 0.0001, and HzR 1.6 95% CI 1.4–1.9;
p
< 0.0001, respectively) and age >50 (HzR 1.2 95% CI 1.1–1.4;
p
= 0.001 and HzR 1.3 95% CI 1.1–1.5;
p
= 0.01, respectively) were associated with increased risk of death on multivariable analysis.
Conclusion
These data provide information that may guide discussions about prognosis between physicians and patients with MBC. In addition, it highlights the importance of stratifying for initial stage at diagnosis in future MBC therapeutic trials.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OBVAL, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
•This ESMO Clinical Practice Guideline provides key recommendations and algorithms for managing metastatic breast cancer.•It covers diagnosis, staging, risk assessment, treatment, disease monitoring, ...palliative care and the patient perspective.•ESMO-MCBS and ESCAT scores are given to describe the levels of evidence for treatment choices.•The authors comprise an international expert group, with recommendations based on available evidence and expert opinion.•In clinical practice, all recommendations provided need to be discussed with patients in a shared decision-making approach.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Oral SERDs are a novel drug class that have been developed to counteract resistance due to ESR1 mutations. Several SERDs have emerged from phase 2 and 3 trials, with the FDA limiting approval for ...Elacestrant to patients with ESR1mt tumours despite PFS benefit in the overall population. However, questions remain on whether patients with ESR1wt tumours stand to benefit from oral SERDs.
Manuscripts and conference presentations of Randomised Controlled Trials were extracted after a systematic search of Embase, PubMed and Cochrane from inception until January 21,2023. RCTs investigating the efficacy of oral SERDs versus endocrine therapy for ER positive, HER2 negative advanced breast cancer, and which reported the Kaplan Meier (KM) curves of PFS in the overall and ESR1 mutant (ESR1mt) population were selected. A graphical reconstructive algorithm was applied to estimate time-to-event outcomes from reported KM curves in all overall and ESR1mt cohorts. A bipartite matching algorithm, KMSubtraction, was used to derive survival data for unreported (ESR1wt) subgroups. An individual patient data (IPD) meta-analysis was then pursued, pooling data by ESR1 mutation status in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Cochrane Guidelines for IPD.
The randomized clinical trials ACELERA, AMEERA-3, EMERALD and SERENA-2 were included, totalling 1290 patients. In the pooled analysis of the overall cohort, PFS benefit was observed with oral SERDs when compared with treatment of physicians choice (TPC) (HR 0.783, 95%CI 0.681-0.900, p<0.001). In the ESR1mt subgroup, oral SERDs demonstrated improved PFS (HR 0.557, 95%CI 0.440-0.705, p<0.001) compared to TPC. In the ESR1wt subgroup, oral SERDs demonstrated no significant PFS benefit (HR 0.944, 95%CI 0.783-1.138, p=0.543) when compared to TPC.
The results of this IPD meta-analysis suggests that PFS benefit in the overall population is mainly driven by the ESR1mt subgroup
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
•The mainstay of treatment for MBC is systemic therapy.•The role of locoregional surgery in MBC is controversial and worth exploring.•Locoregional surgery conferred significant OS and LRFS benefits ...in de novo MBC.•Surgery may serve as an alternative choice for selected patients.
We performed an updated meta-analysis to explore the value of locoregional surgery in de novo stage IV breast cancer patients.
A literature search was conducted to identify randomized controlled trials comparing primary tumor resection with systemic therapy in de novo stage IV breast cancer. The hazard ratio (HR) of overall survival (OS), local relapse-free survival (LRFS), and distant relapse-free survival (DRFS) were estimated and pooled.
Six studies were eligible, including a total of 1368 patients. Both OS (HR = 0.86; 95 %CI: 0.77–0.96; p = 0.01; I2 = 45 %) and LRFS (HR = 0.35; 95 %CI: 0.20–0.62; p = 0.0003; I2 = 83 %) were significantly improved with locoregional surgery compared with systemic therapy alone. There was no significant difference in terms of DRFS (HR = 0.96; 95 %CI: 0.41–2.22; p = 0.92; I2 = 86 %). The OS benefit was more pronounced in hormone receptor-positive patients (HR = 0.79; p = 0.003) and HER2-negative patients (HR = 0.80; p = 0.003).
This study demonstrated that locoregional surgery conferred significant OS and LRFS benefits in de novo stage IV breast cancer patients and may serve as an alternative choice for selected patients.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background
Limited data exist describing real‐world treatment of de novo and recurrent HER2‐positive metastatic breast cancer (MBC).
Materials and Methods
The Systemic Therapies for HER2‐Positive ...Metastatic Breast Cancer Study (SystHERs) was a fully enrolled (2012–2016), observational, prospective registry of patients with HER2‐positive MBC. Patients aged ≥18 years and ≤6 months from HER2‐positive MBC diagnosis were treated and assessed per their physician's standard practice. The primary endpoint was to characterize treatment patterns by de novo versus recurrent MBC status, compared descriptively. Secondary endpoints included patient characteristics, progression‐free and overall survival (PFS and OS, by Kaplan‐Meier method; hazard ratio HR and 95% confidence interval CI by Cox regression), and patient‐reported outcomes.
Results
Among 977 eligible patients, 49.8% (n = 487) had de novo and 50.2% (n = 490) had recurrent disease. A higher proportion of de novo patients had hormone receptor–negative disease (34.9% vs. 24.9%), bone metastasis (57.1% vs. 45.9%), and/or liver metastasis (41.9% vs. 33.1%), and a lower proportion had central nervous system metastasis (4.3% vs. 13.5%). De novo patients received first‐line regimens containing chemotherapy (89.7%), trastuzumab (95.7%), and pertuzumab (77.8%) more commonly than recurrent patients (80.0%, 85.9%, and 68.6%, respectively). De novo patients had longer median PFS (17.7 vs. 11.9 months; HR, 0.69; 95% CI, 0.59–0.80; p < .0001) and OS (not estimable vs. 44.5 months; HR, 0.55; 95% CI, 0.44–0.69; p < .0001).
Conclusion
Patients with de novo versus recurrent HER2‐positive MBC exhibit different disease characteristics and survival durations, suggesting these groups have distinct outcomes. These differences may affect future clinical trial design. Clinical trial identification number. NCT01615068 (clinicaltrials.gov).
Implications for Practice
SystHERs was an observational registry of patients with HER2‐positive metastatic breast cancer (MBC), which is a large, modern, real‐world data set for this population and, thereby, provides a unique opportunity to study patients with de novo and recurrent HER2‐positive MBC. In SystHERs, patients with de novo disease had different baseline demographics and disease characteristics, had superior clinical outcomes, and more commonly received first‐line chemotherapy and/or trastuzumab versus those with recurrent disease. Data from this and other studies suggest that de novo and recurrent MBC have distinct outcomes, which may have implications for disease management strategies and future clinical study design.
The SystHERs breast cancer study was a fully enrolled, prospective registry study that explored contemporary treatment patterns and outcomes in patients with HER2‐positive metastatic breast cancer (MBC), resulting in one of the largest real‐world datasets for this population and providing a unique opportunity to assess patients with de novo and recurrent HER2‐positive MBC. This article reports baseline characteristics, treatment patterns, patient‐reported outcomes, and clinical outcomes in these patient subsets.
The European Breast Cancer Council (EBCC) traditionally identifies controversies or major deficiencies in the management of patients with breast cancer and selects a multidisciplinary expert team to ...collaborate in setting crucial principles and recommendations to improve breast cancer care. The 2024 EBCC manifesto focuses on disparities in the care of patients with metastatic breast cancer. There are several reasons for existing disparities both between and within countries. Our recommendations aim to address the stigma of metastatic disease, which has led to significant disparities in access to innovative care regardless of the gross national income of a country. These recommendations are for different stakeholders to promote the care of patients with metastatic breast cancer across Europe and worldwide.
•This manifesto strives for equal access to innovation for people in Europe with mBC.•To redress inequity it is critical to know how many people are living with mBC.•A priority is to overturn the stigma of living with mBC.•All patients deserve access to high-quality multidisciplinary information and care.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Metastatic oral malignancies have been reported in the mandible, tongue, and gingiva. Breast cancer oral metastasis usually presents as a benign oral lesion clinically. At histology, it shares ...several features with metastatic carcinoma. Immunohistochemistry (IHC) can be useful in the differential diagnosis. The clinical presentation consisted of swelling in the upper front tooth region in a 35-year-old woman. The lesion was excised under local anaesthesia and underwent histological and immunohistochemical examination to rule out any malignancy. Histological findings, Pan CK positivity suggesting the epithelial origin and the absence of reactivity to Oestrogen Receptor (ER), Progesterone Receptor (PR), Human Epidermal Growth Factor Receptor-2 (HER2) indicated metastatic triple negative breast carcinoma. The histological diagnosis of metastatic breast carcinoma can be confirmed by IHC. The current case report illustrates the necessity of including a panel of IHC markers in confirming the diagnosis of metastatic lesions in oral cavity. By utilising such panels, one can expedite the prognosis and prevent delay in diagnosis.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Approximately 0.5 million people worldwide die from metastatic breast cancer (mBC) every year. This manuscript provides an overview on the status of mBC in several regions of the world, highlighting ...the gaps in care, resources, and support available for patients with mBC. Primary research was conducted in 2015 and 2016, comprising four global qualitative and quantitative surveys of approximately 15,000 individuals in 34 countries. Secondary research was conducted using literature reviews of peer-reviewed publications, patient survey reports, and media or online articles. There have been modest improvements in mBC outcomes over the past decade. Patients are not provided with adequate information about mBC. There is a need for open discussion with patients and caregivers about realistic goals; however, physicians are not trained in communicating with patients about their disease. Maintaining patients' quality of life is a crucial goal; however, this has not improved, and in some cases, may have declined in the past decade. Public awareness and understanding of mBC is limited, with damaging consequences for patients and caregivers. Issues affecting employment remain relevant to patients with mBC and their caregivers. Globally, mBC is associated with a substantial economic burden. Relationships with caregivers are crucial to patients with mBC, and caregiver support needs are often overlooked. A strong and united global effort among healthcare professionals, including clinicians, oncologists, pharmaceutical manufacturers, payers, and policy makers, and with advocates, families, and patients, is necessary to improve the outcome and quality of life for patients with mBC.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
To characterize the clinical and pathological features and survival of patients with human epidermal growth factor receptor 2 (HER2)-low breast cancer in China.
The China National Cancer Center ...database was used to identify 1,433 metastatic breast cancer patients with HER2-negative disease diagnosed between 2005 and 2015. Clinicopathological features, survival, and prognosis information were extracted. Overall survival (OS) was estimated using the Kaplan-Meier method and compared using the log-rank test. Prognostic factors associated with OS were analyzed using Cox regression model with 95% confidence interval (95% CI).
There were 618 (43.1%) and 815 (56.9%) HER2-low and HER2-zero tumors out of 1,433 tumors, respectively. The proportion of hormone receptor (HR)-positive tumors was significantly higher in HER2-low tumors than in those with HER2-zero tumors (77.8% vs. 69.2%,
< 0.001). Patients with HER2-low tumors survived significantly longer than those with HER2-zero tumors in the overall population (48.5 months vs. 43.0 months,
= 0.004) and HR-positive subgroup (54.9 months vs. 48.1 months,
= 0.011), but not in the HR-negative subgroup (29.5 months vs. 29.9 months,
= 0.718). Multivariate regression analysis revealed that HER2-low tumors were independently associated with increased OS in HER2-negative population (HR: 0.85, 95% CI: 0.73-0.98,
= 0.026).
Our findings demonstrate that HER2-low tumors could be identified as a more distinct clinical entity from HER2-zero tumors, especially for the HR-positive subgroup. A more complex molecular landscape of HER2-low breast cancer might exist, and more precise diagnostic algorithms for HER2 testing could be investigated, thus offering new therapeutic targets for breast cancer treatment.
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