•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.
Purpose
To investigate the efficacy of metformin (M) plus chemotherapy versus chemotherapy alone in metastatic breast cancer (MBC).
Methods
Non-diabetic women with HER2-negative MBC were randomized ...to receive non-pegylated liposomal doxorubicin (NPLD) 60 mg/m
2
+ cyclophosphamide (C) 600 mg/m
2
× 8 cycles Q21 days plus M 2000 mg/day (arm A) versus NPLD/C (arm B). The primary endpoint was progression-free survival (PFS).
Results
One-hundred-twenty-two patients were evaluable for PFS. At a median follow-up of 39.6 months (interquartile range IQR 24.6–50.7 months), 112 PFS events and 71 deaths have been registered. Median PFS was 9.4 months (95% CI 7.8–10.4) in arm A and 9.9 (95% CI 7.4–11.5) in arm B (
P
= 0.651). In patients with HOMA index < 2.5, median PFS was 10.4 months (95% CI 9.6–11.7) versus 8.5 (95% CI 5.8–9.7) in those with HOMA index ≥ 2.5 (
P
= 0.034). Grade 3/4 neutropenia was the most common toxicity, occurring in 54.4% of arm A patients and 72.3% of the arm B group (
P
= 0.019). M induced diarrhea (G2) was observed in 8.8% of patients in Arm A. The effect of M was similar in patients with HOMA index < 2.5 and ≥ 2.5, for PFS and OS.
Conclusions
The MYME trial failed to provide evidence in support of an anticancer activity of M in combination with first line CT in MBC. A significantly shorter PFS was observed in insulin-resistant patients (HOMA ≥ 2.5). Noteworthy, M had a significant effect on CT induced severe neutropenia. Further development of M in combination with CT in the setting of MBC is not warranted.
Axillary web syndrome (AWS) is a complication of surgical procedures in breast cancer (BC) patients. This condition with poorly understood incidence and etiology is characterized by the locoregional ...development of scar tissue, leading to subcutaneous cording, motion impairment and pain. The early identification of patients at risk for AWS would improve their clinical management. Here, we sought to characterize the prevalence of and the risk factors associated with AWS in BC women after surgery.
All patients with BC that underwent axillary surgery referred to an Outpatient Service for Oncological Rehabilitation were retrospectively collected. These women were assessed two weeks after the surgical procedure for their clinicopathologic features, type of therapeutic interventions, and AWS presence, laterality, pain, localization, cords type, and number of cords.
Altogether, 177 patients (mean aged 60.65 ± 12.26 years) were included and divided into two groups: AWSPOS (n=52; 29.4%) and AWSNEG (n=125; 70.6%). Patients with tumor N ≥1 (OR=3.7; p<0.001), subjected to mastectomy, axillary lymph node dissection (ALND) and chemotherapy showed significant correlations with AWS onset (p<0.05). The range of shoulder motion limitation (OR=11.2; p<0.001) and the presence of breast cancer related lymphedema (OR=3.5; p=0.020) were associated with AWS.
Mastectomy, ALND, chemotherapy, low staging tumors, shoulder range of motion limitations, and BCRL represent risk factors for AWS onset. Realizing new strategies for assessing the individual risk of AWS is a crucial clinical need to improve the health-related quality of life of BC survivors.
There are no specific guidelines regarding best treatment for focal, distant metastasis in ependymoma in the context of a well-controlled primary site. A combination using maximal safe resection and ...adjuvant radiotherapy is usually advised. As wound healing might be hindered by repeated radiotherapy, and delay future radiation treatment if needed, there is a growing interest in less invasive surgeries to reduce post-operative pain and wound healing complications. Those approaches have been extensively used and studied in adult but never in the pediatric population. Here, we present a pediatric case of a 12-year-old boy known for a posterior fossa ependymoma completely resected 18 months earlier who presented with a dual lumbosacral intradural ependymoma metastasis. A single-stage complete resection was achieved using a fixed tubular retractor with no complication. Post-operative course was favorable with rapid healing and discharge, minimal post-operative pain, and a rapid return to normal activities. Re-irradiation could be performed 2 weeks later without any problem. To our knowledge, this is the first report of the use of minimally invasive techniques to achieve complete resection of dual intradural metastasis of an ependymoma in the pediatric population. We demonstrate its feasibility and safety as well as its advantages.
18F-fluoroestradiol (FES) positron emission tomography (PET)/computed tomography (CT) is considered an accurate diagnostic tool to determine whole-body endocrine responsiveness. In the endocrine ...therapy (ET)-FES trial, we evaluated 18F-FES PET/CT as a predictive tool in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2−) metastatic breast cancer (MBC).
Eligible patients underwent an 18F-FES PET/CT at baseline. Patients with standardized uptake value (SUV) ≥ 2 received single-agent ET until progressive disease; patients with SUV < 2 were randomized to single-agent ET (arm A) or chemotherapy (ChT) (arm B). The primary objective was to compare the activity of first-line ET versus ChT in patients with 18F-FES SUV < 2.
Overall, 147 patients were enrolled; 117 presented with 18F-FES SUV ≥ 2 and received ET; 30 patients with SUV < 2 were randomized to ET or ChT. After a median follow-up of 62.4 months, 104 patients (73.2%) had disease progression and 53 died (37.3%). Median progression-free survival (PFS) was 12.4 months 95% confidence interval (CI) 3.1-59.6 months in patients with SUV < 2 randomized to arm A versus 23.0 months (95% CI 7.7-30.0 months) in arm B, hazard (HR) = 0.71, 95% CI 0.3-1.7 months; median PFS was 18.0 months (95% CI 11.2-23.1 months) in patients with SUV ≥ 2 treated with ET. Median overall survival (OS) was 28.2 months (95% CI 14.2 months-not estimable) in patients with SUV < 2 randomized to ET (arm A) versus 52.8 months (95% CI 16.2 months-not estimable) in arm B (ChT). Median OS was not reached in patients with SUV ≥ 2. 60-month OS rate was 41.6% (95% CI 10.4% to 71.1%) in arm A, 42.0% (95% CI 14.0% to 68.2%) in arm B, and 59.6% (95% CI 48.6% to 69.0%) in patients with SUV ≥ 2. In patients with SUV ≥ 2, 60-month OS rate was 72.6% if treated with aromatase inhibitors (AIs) versus 40.6% in case of fulvestrant or tamoxifen (P < 0.005).
The ET-FES trial demonstrated that ER+/HER2− MBC patients are a heterogeneous population, with different levels of endocrine responsiveness based on 18F-FES CT/PET SUV.
•18F-FES PET/CT may be used as a predictive tool of efficacy of ET to assess overall endocrine sensitivity.•Endocrine-sensitive patients (SUVmax ≥ 2) treated with single-agent ET have a prolonged OS.•In endocrine-sensitive patients, PFS and OS related to the use of AI were significantly higher than ER-directed agents.•18F-FES PET/CT can be used as a valid alternative to biopsy.
The objective was to compare L4/5 range of motions of fusion constructs using anchored cages. Twelve human cadaveric spine were tested in intact condition, and divided into TLIF and PLIF groups. ...Testing consisted in applying pure moments in flexion-extension, lateral bending and axial rotation. The computation of intersegmental motion was assessed using 3 D biplanar radiographs. In TLIF group, the addition of contralateral transfacet decreased flexion-extension motion (39%; p = 0.036) but without difference with the ipsilateral pedicle screw construction (53%; p = 0.2). In PLIF group, the addition of interspinous anchor reduced flexion-extension motion (12%; p = 0.036) but without difference with the bilateral pedicle screw construction (17%; p = 0.8).
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