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Eribulin in brain metastases of breast cancer: outcomes of the EBRAIM prospective observational trial.
Fabi, A, Terrenato, I, Vidiri, A, Villani, V, Tanzilli, A, Airoldi, M, Pedani, F, Magri, V, Palleschi, M, Donadio, M, et al
Future oncology (London, England). 2021;(26):3445-3456
Abstract
Background: Eribulin shows some activity in controlling brain metastasis in breast cancer. Methods: This observational, multicenter study evaluated brain disease control rates, survival and safety in patients with brain metastatic breast cancer treated with eribulin in clinical practice. Results: A total of 34 patients were enrolled (mean age 49 years, 91% with visceral metastases) and 29 were evaluable for brain disease. Fourteen achieved disease control and showed a longer time without progression: 10 months (95% CI: 2.3-17.7) versus 4 months (95% CI: 3.3-4.7) in the control group (p = 0.029). Patients with clinical benefits at 6 months had longer survival. Leukopenia and neutropenia were the most frequent grade 3-4 toxicities. Conclusion: Eribulin confirms its effectiveness in patients with brain metastatic breast cancer. Further studies on larger cohorts are needed to confirm the results.
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Indices of peripheral leukocytes predict longer overall survival in breast cancer patients on eribulin in Japan.
Takahashi, M, Inoue, K, Mukai, H, Yamanaka, T, Egawa, C, Miyoshi, Y, Sakata, Y, Muramoto, K, Ikezawa, H, Matsuoka, T, et al
Breast cancer (Tokyo, Japan). 2021;(4):945-955
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BACKGROUND It was reported that eribulin regulates the tumor microenvironment, including the immune system, by inducing vascular remodeling. Lymphocyte counts are a critical index of immune response in patients. The non-Asian, global EMBRACE study has suggested that baseline absolute lymphocyte count (ALC) may be a predictor of the survival benefit of eribulin in breast cancer patients. We examined whether the baseline ALC is a potential predictor of overall survival (OS) in Japanese patients with HER2-negative advanced breast cancer treated with eribulin. METHODS This was a post hoc analysis of data from a post-marketing observational study of eribulin in Japan. The OS by baseline ALC was estimated using the Kaplan-Meier method, with the cut-off value of 1500/μL for ALC. The OS by baseline neutrophil-to-lymphocyte ratio (NLR), a general prognostic index in breast cancer patients, was also estimated, with the cut-off value of 3. RESULTS The median OS was longer in patients with an ALC of ≥ 1500/μL than in those with an ALC of < 1500/μL (19.4 vs. 14.3 months; hazard ratio [HR]: 0.628; 95% confidence interval [CI]: 0.492, 0.801). Patients with an NLR of ≥ 3 showed shorter OS than those with an NLR of < 3 (13.2 vs. 18.8 months; HR: 1.552; 95% CI 1.254, 1.921), and NLR also separated OS in patients with an ALC of < 1500/μL. CONCLUSIONS Consistent with the findings of a previous study involving a non-Asian, Western population, our study suggested that baseline ALC may be a predictive factor for the survival benefit of eribulin in Japanese patients.
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Prognostic and predictive factors of eribulin in patients with heavily pre-treated metastatic breast cancer.
Chen, PH, Yeh, DC, Tung, HH, Lin, CY
Medicine. 2021;(47):e27859
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A predictive marker for efficacy of eribulin administered as different lines of treatment in metastatic breast cancer (MBC) has not been identified. We aimed to determine the predictive factors for efficacy of eribulin administered as different lines of treatment in MBC patients.This restrospective cohort study included 49 heavily pre-treated MBC patients who received either eribulin monotherapy or combination therapy with eribulin and anti-Her2 therapy. Associations between clinical response of eribulin-based treatment, time-to-treatment failure (TTF), and possible predictive markers were investigated.Patients' median age was 55 years; 65% were ER+; 43% were HER2+; and 16% were triple-negative. Median TTF was 5.23 months and longer in non-visceral metastases patients. Eastern Cooperative Oncology Group (ECOG) status was 0-1; eribulin as ≥2nd-line treatment; eribulin combined with dual blockades; lymphocyte-monocyte ratio (LMR) ≥3; and monocyte-lymphocyte ratio (MLR) <0.4. In patients with eribulin as >3rd-line treatment, univariate analysis showed that ECOG status was 0-1, and LMR ≥3 and MLR <0.4 were associated with a low risk of TTF. Multivariate analysis showed that ECOG status 0-1 was an independent protective factor. Leukopenia and neutropenia were the most common manageable adverse events.ECOG status is an independent predictor for TTF, while LMR and MLR may have an interactive effect with other biomarkers (e.g., ECOG status) to predict response in MBC patients receiving eribulin as ≥2nd-line treatment.
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Application of polyetheretherketone cages through minimally invasive oblique retroperitoneal approach for the treatment of lumbar polymicrobial spondylodiscitis: A STROBE-compliant retrospective study with 7 cases.
Luo, W, Zhu, Y, Zhao, ZH, Ou, YS
Medicine. 2020;(17):e18594
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Despite the plethora of evidence in support of the use of structural osseous autograft in lumbar spondylodiscitis, attention has recently been turned to the addition of synthetic materials such as polyetheretherketone (PEEK) to restore anterior vertebral column support.From January 2015 to April 2017, 7 patients with lumbar polymicrobial spondylodiscitis were surgically treated with a minimally invasive oblique retroperitoneal approach to the infected focus. The patients underwent a standard lateral minimally invasive oblique retroperitoneal approach using direct lateral interbody fusion system. The PEEK cages were loaded with autologous bone graft. All the patients underwent posterior fixation with percutaneous pedicle screw instrumentation. Lumbar function was measured using Oswestry Disability Index, and pain was measured with visual analog scale. Fusion and subsidence were also recorded.The study included 5 female and 2 male patients. The median age was 58.9 years. The duration of follow-up was 31.8 ± 6.1 months (range: 24-47). All patients recovered from the infection without relapse within 24-month follow-up. Visual analog scale significantly declined from 7.57 ± 0.53 before surgery to 1.57 ± 0.53 at 12-month follow-up. Mean Oswestry Disability Index decreased from 72.14 ± 6.82 before surgery to 22.28 ± 2.13 after surgery. All patients had solid fusion at 2-year follow-up. Fusion occurred at 6 to 15 months (mean 9.8 months).The specific use of PEEK cages in lumbar polymicrobial spondylodiscitis suggests reliable outcome in terms of clinical and imaging outcomes in our limited cases.
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PEEK versus metal cages in posterior lumbar interbody fusion: a clinical and radiological comparative study.
Cuzzocrea, F, Ivone, A, Jannelli, E, Fioruzzi, A, Ferranti, E, Vanelli, R, Benazzo, F
Musculoskeletal surgery. 2019;(3):237-241
Abstract
BACKGROUND Low back pain and sciatica represent a common disabling condition with a significant impact on the social, working and economic lives of patients. Transforaminal lumbar interbody fusion (TLIF) is a surgical procedure used in degenerative spine conditions. Several types of cages were used in the TLIF procedure. PURPOSE To determine whether there is a difference in terms of symptomatology improvement, return to daily activities and fusion rate between metal cages and polyetheretherketone (PEEK) cages. METHODS We have retrospectively reviewed 40 patients who have undergone TLIF from October 2015 to May 2016. All patients were clinically evaluated with questionnaires and were assessed with CT scan and standing X-ray films of the full-length spine. RESULTS We found no significant functional differences in the two groups. At 1-year follow-up, osteolysis was present in 50% of cases of the PEEK cages and in 10% cases of the metal cages. The degree of fusion at 1 year was evaluated as complete in 40% cases of the metal cages and 15% cases of the PEEK cages. CONCLUSIONS We have found a better fusion rate and prevalence of fusion in the group treated with metal cages, reflecting the well-known osteoinductive properties of titanium and tantalum.
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Real-life activity of eribulin mesylate among metastatic breast cancer patients in the multicenter national observational ESME program.
Jacot, W, Heudel, PE, Fraisse, J, Gourgou, S, Guiu, S, Dalenc, F, Pistilli, B, Campone, M, Levy, C, Debled, M, et al
International journal of cancer. 2019;(12):3359-3369
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Eribulin mesylate (EM) was recently approved for metastatic breast cancer (MBC) chemotherapy (CT) in late lines by the FDA, with debated results in second line. We evaluated outcomes in breast cancer patients receiving EM as second, third and fourth line in a national real-life cohort of 16,703 consecutive MBC patients initiating their first metastatic therapeutic line between 2008 and 2014. Primary and secondary objectives were overall survival (OS) and progression-free survival (PFS). An imbalance was seen for HER2+ tumors and concomitant anti-HER2 targeted therapies use, we thus performed a subanalysis in HER2- patients. PFS and OS were significantly better in EM patients in third and fourth lines, compared to "Other chemotherapies" patients (PFS: 4.14 vs. 3.02 months, p = 0.0010; 3.61 vs. 2.53 months, p = 0.0102, third and fourth-line; OS: 11.27 vs. 7.65 months, p = 0.0001; 10.91 vs. 5.95 months, p < 0.0001, third and fourth-line). No significant difference was reported in second-line (PFS: 5.06 vs. 4.14 months, p = 0.1171; OS: 13.99 vs. 11.66 months, p = 0.151). Among HER2- patients, a significant difference was seen for all lines, including 2nd-line (PFS: 4.57 vs. 3.91 months, p = 0.0379; OS: 14.98 vs. 10.51 months, p = 0.0113). In this large real-world database, HER2-negative MBC patients receiving EM in second or later CT line presented significantly better PFS and OS. This difference disappeared in second line in the overall population, probably because of the imbalance in HER2-targeted treatments use. Our results mirror those of the published randomized trials. The effect of anti-HER2 therapies addition in this setting still needs to be defined.
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Titanium and polyether ether ketone (PEEK) patient-specific sub-periosteal implants: two novel approaches for rehabilitation of the severely atrophic anterior maxillary ridge.
Mounir, M, Atef, M, Abou-Elfetouh, A, Hakam, MM
International journal of oral and maxillofacial surgery. 2018;(5):658-664
Abstract
The aim of this study was to assess two new protocols for single-stage rehabilitation of the severely atrophic maxillary ridge using customized porous titanium or polyether ether ketone (PEEK) sub-periosteal implants. Ten patients with a severely atrophic anterior maxillary alveolar ridge were divided randomly into two groups (five patients in each) to receive customized sub-periosteal implants fabricated via CAD/CAM technology: group 1, porous titanium implants; group 2, PEEK implants. Prosthetic loading with fixed acrylic bridges was performed 1 month postoperative. The implants were followed-up for 12 months and evaluated for the presence of any sign of radiographic bone resorption, mobility, infection, prosthetic fracture, or implant exposure. The immediate postoperative period was uneventful except for one case complicated by wound dehiscence in group 1. At 12 months, all implants were functionally stable and the patients were comfortable with the prostheses. No signs of radiographic bone resorption, mobility, infection, or prosthetic fracture were observed. Within the limitations of this study, the application of customized porous titanium and PEEK sub-periosteal implants produced through CAD/CAM technology appears to be an acceptable method for single-stage prosthetic rehabilitation of the severely atrophic edentulous anterior maxilla. This study was awarded the best case study at the academy of osseintegration annual meeting 2017, Orlando, Florida.
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Safety and effectiveness of eribulin in Japanese patients with locally advanced or metastatic breast cancer: a post-marketing observational study.
Watanabe, J, Ito, Y, Ohsumi, S, Mizutani, M, Tashiro, H, Sakurai, K, Takahashi, M, Saito, T, Tsurutani, J, Mukai, H, et al
Investigational new drugs. 2017;(6):791-799
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Abstract
Background This large-scale study was conducted to evaluate the safety and effectiveness of eribulin for the treatment of inoperable or recurrent breast cancer in real-world settings in Japan. Methods Between July and December 2011, eligible patients with inoperable or recurrent breast cancer receiving eribulin for the first time were centrally registered and observed for 1 year. Eribulin was administered intravenously (1.4 mg/m2) on days 1 and 8 of every 3-week cycle. The primary endpoint was the frequency and intensity of adverse drug reactions (ADRs). Secondary endpoints included overall response rate (ORR) and time to treatment failure (TTF). Results Of 968 patients registered at 325 institutions, 951 and 671 were included in the safety and effectiveness analyses, respectively. In the safety population, ADRs were observed in 841 patients (88.4%). The most common (≥15% incidence) were neutropenia (66.6%), leukopenia (62.4%), lymphopenia (18.4%), and peripheral neuropathy (16.8%). The most common grade ≥ 3 ADRs (>5% incidence) were neutropenia (59.8%), leukopenia (50.5%), lymphopenia (16.1%), and febrile neutropenia (7.7%). In the effectiveness population, ORR was 16.5% (95% confidence interval: 13.7, 19.4). The median TTF was 127 days (95% confidence interval: 120, 134). Conclusions The safety and effectiveness profile of eribulin was consistent with prior studies. Eribulin had a favorable risk-benefit balance when used in real-world clinical settings.