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Richard S. Finn Hope S. Rugo Karen A. Gelmon Massimo Cristofanilli Marco Colleoni Sherene Loi Patrick Schnell Dongrui R. Lu Kathy Puyana Theall Ave Mori Eric Gauthier Eustratios Bananis Nicholas C. Turner Véronique Diéras 《The oncologist》2021,26(5):e749-e755
BackgroundPrevious studies demonstrated the tolerability of palbociclib plus endocrine therapy (ET). This analysis evaluated safety based on more recent cutoff dates and a longer palbociclib treatment exposure.Patients and MethodsData were pooled from three randomized studies of patients with hormone receptor‐positive/human epidermal growth factor receptor 2‐negative (HR+/HER2−) advanced breast cancer (ABC), including postmenopausal women who had not received prior systemic treatment for advanced disease (PALOMA‐1/‐2) and pre‐ and postmenopausal women who had progressed on prior ET (PALOMA‐3).ResultsUpdated cutoff dates were December 21, 2017 (PALOMA‐1), May 31, 2017 (PALOMA‐2), and April 13, 2018 (PALOMA‐3). Total person‐years of treatment exposure were 1,421.6 with palbociclib plus ET (n = 872) and 528.4 with ET (n = 471). Any‐grade neutropenia and infections were more frequent with palbociclib plus ET (82.1% and 59.2%, respectively) than with ET (5.1% and 39.5%). The hazard ratios were 1.6 (p = .0995) for grade 3/4 infections, 1.8 (p = .4358) for grade 3/4 viral infections, 1.4 (p = .0001) for infections, and 30.8 (p < .0001) for neutropenia. Febrile neutropenia was reported in 1.4% of patients receiving palbociclib plus ET. Cumulative incidence of all‐grade hematologic adverse events in both arms peaked during the first year of treatment and plateaued over the 5 subsequent years. Interstitial lung disease was reported in 13 patients receiving palbociclib plus ET and 3 receiving ET.ConclusionThis 5‐year, long‐term analysis demonstrated that palbociclib plus ET has a consistent and stable safety profile and is a safe treatment for patients with HR+/HER2− ABC.Implications for PracticeSeveral treatments for patients with breast cancer are associated with long‐term or latent adverse events. This long‐term, 5‐year analysis demonstrated that palbociclib plus endocrine therapy has a consistent and stable safety profile without cumulative or delayed toxicities. These results further support palbociclib plus endocrine therapy as a safe and manageable treatment in clinical practice for patients with hormone receptor‐positive/human epidermal growth factor receptor 2‐negative advanced breast cancer. 相似文献
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Papadimitriou DK Pitoulias GA Papaziogas BT Tachtsi MD Kalaitzis ED 《Surgery today》2007,37(4):298-304
Purpose The aim of this study was to evaluate the effects of the intraluminal intestinal administration of oxygenated perfluorocarbon,
during experimental acute intestinal ischemia, on the acid–base blood status and the cardiopulmonary parameters.
Methods Thirty-six rabbits were separated into three groups: (a) Control group (ischemia alone), (b) PFC-O2 group (ischemia plus infusion of oxygenated F-Decalin in intraluminal intestinal administration), and (c) PFC group (ischemia
plus infusion of nonoxygenated F-Decalin in intraluminal intestinal administration). An equal number of the animals was then
subjected to 8 h of intestinal ischemia by ligation of the superior mesenteric artery (subgroups 1), the mesenteric vein (subgroups
2) or both vessels (subgroups 3). At 0, 2, 4, 6, and 8 h arterial blood samples were taken for acid–base status tests and
the vital signs (heart and respiratory rate, pressure of inferior vena cava, and systolic arterial pressure) were noted. The
statistical analysis was performed by the nonparametric Kruskal–Wallis test.
Results There were no significant differences in any of the studied parameters (pH, base excess, respiratory gases, pressure of inferior
vena cava, systolic arterial pressure, heart and respiratory rate) between animals of the same group and subgroup. In addition,
the differences among Control and PFC groups and their equal subgroups were not significant. On the other hand, the measurements
of the PFC-O2 animals showed significant differences at 4, 6, and 8 h of ischemia (P < 0.05) in comparison with those from the Control and PFC groups.
Conclusion We conclude that the intraluminal intestinal administration of oxygenated perfluorocarbons may thus be a useful adjunctive
therapy in the treatment of patients with acute mesenteric ischemia. 相似文献
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Meletis Rozis Eustratios Papadelis Andreas Mavrogenis Spyridon Koufos Vasilios Polyzois Spyros Pneumaticos 《The Journal of foot and ankle surgery》2017,56(6):1263-1268
Malignant peripheral nerve sheath tumors are rare soft tissue tumors accounting for 3% to 10% of all soft tissue tumors. They are strongly related to neurofibromatosis type 1, an autosomal dominant disease, and are characterized by aggressive biologic behavior, high local recurrence rates, and frequent metastases. Although the major nerves of the lower extremities are a common location of these tumors, scarce cases have been reported of malignant peripheral nerve sheath tumors involving the interdigital nerves of the foot. We report the case of a patient with non-neurofibromatosis type 1 and a recurrent malignant peripheral nerve sheath tumor of the first interdigital nerve of the foot treated successfully with limb salvage surgery with wide resection margins and reconstruction with an autogenous fibula graft. 相似文献
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Georgalas I Ladas I Tservakis I Taliantzis S Gotzaridis E Papaconstantinou D Koutsandrea C 《Cutaneous and ocular toxicology》2011,30(4):251-262
Since their introduction by Chang et al. in 1987, perfluorocarbon liquids (PFCLs) have become a useful tool in vitreoretinal surgery. They are synthetic compounds with carbon-fluorine chemical chains that have specific physico-chemical properties, which make them valuable for the intraoperative management of the retina by simplifying vitreoretinal surgical maneuvers in a variety of settings. These maneuvers include retinal detachments associated with proliferative vitreous retinopathy, following penetrating trauma, giant retinal tears, dislocated lenses or lens implants and complications from proliferative diabetic vitreoretinopathy. Purified PFCLs are generally considered to be biologically inert. Despite the stability of PFCLs during vitreoretinal surgery, several studies have indicated that these compounds may be associated with toxicity in ocular tissues. The purpose of this review is to report the use and toxicity of PFCLs in vitreoretinal surgery and to present the latest perspectives on modified PFCLs (hydrofluorocarbon liquids (HFCLs) and HFCL-oligomers). 相似文献
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Vibeke Strand Eun Bong Lee Yusuf Yazici Ara Dikranian Bethanie Wilkinson Liza Takiya Chuanbo Zang Eustratios Bananis Martin J. Bergman 《Clinical rheumatology》2018,37(8):2043-2053
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. We evaluated the relationship between disease activity, according to Routine Assessment of Patient Index Data 3 (RAPID3) after 6-month treatment with tofacitinib, and long-term outcomes at 24 months. This was a post hoc analysis of two 24-month, phase 3, randomized controlled trials in methotrexate (MTX)-naïve (ORAL Start [NCT01039688]) or MTX-inadequate responder patients (ORAL Scan [NCT00847613]) receiving tofacitinib 5 or 10 mg twice daily (BID) as monotherapy or with background MTX. RAPID3 scores were calculated at baseline, month (M)6, and M24, and defined as remission (≤?3), low (LDA; >?3–≤?6), moderate (MDA; >?6–≤?12), or high disease activity (HDA; >?12). Clinical Disease Activity Index (CDAI), Health Assessment Questionnaire-Disability Index (HAQ-DI) scores, and radiographic non-progression (modified Total Sharp Scores ≤?0) at M24 were evaluated by M6 RAPID3 response. Among patients receiving tofacitinib 5 or 10 mg BID, respectively, 42.2 and 51.5% (ORAL Start) and 29.8 and 39.0% (ORAL Scan) achieved RAPID3 remission/LDA at M6. Most patients maintained/improved RAPID3 responses at M24. A higher proportion of patients in RAPID3 remission/LDA versus MDA/HDA at M6 achieved CDAI remission, reported normative HAQ-DI scores (<?0.5), and achieved both normative HAQ-DI scores and radiographic non-progression at M24. Patients achieving RAPID3 remission/LDA after 6-month treatment with tofacitinib 5 or 10 mg BID have improved long-term outcomes versus patients with MDA/HDA. These findings support the use of RAPID3 to monitor longer-term disease activity in conjunction with physician-assessed measures. 相似文献
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Karen A. Gelmon Massimo Cristofanilli Hope S. Rugo Angela M. DeMichele Anil A. Joy Aurelio Castrellon Bethany Sleckman Ave Mori Kathy Puyana Theall Dongrui R. Lu Xin Huang Eustratios Bananis Richard S. Finn Dennis J. Slamon 《The breast journal》2020,26(3):368-375
Palbociclib is a cyclin‐dependent kinase 4/6 inhibitor indicated for treatment of hormone receptor‐positive/human epidermal growth factor receptor 2‐negative advanced breast cancer in combination with endocrine therapy. We investigated the efficacy and safety of palbociclib in patients enrolled in North America during two‐phase 3 trials: PALOMA‐2 (n = 267, data cutoff: May 31, 2017) and PALOMA‐3 (n = 240, data cutoffs: April 13, 2018, for overall survival, October 23, 2015, for all other outcomes). In PALOMA‐2, treatment‐naïve postmenopausal patients with advanced breast cancer were randomized 2:1 to palbociclib (125 mg/d; 3 weeks on/1 week off [3/1]) plus letrozole (2.5 mg/d, continuous) or placebo plus letrozole. In PALOMA‐3, patients who progressed on prior endocrine therapy were randomized 2:1 to palbociclib (125 mg/d; 3/1) plus fulvestrant (500 mg, per standard of care) or placebo plus fulvestrant; pre/perimenopausal patients received ovarian suppression with goserelin. Palbociclib plus endocrine therapy prolonged median progression‐free survival vs placebo plus endocrine therapy in North American patients (PALOMA‐2: 25.4 vs 13.7 months, hazard ratio, 0.54 [95% CI, 0.40–0.74], P < .0001; PALOMA‐3: 9.9 vs 3.5 months, hazard ratio, 0.52 [95% CI, 0.38–0.72], P < .0001). Objective response and clinical benefit response rates were greater with palbociclib vs placebo in North American patients in both trials. While overall survival data are not yet mature for PALOMA‐2, median overall survival was increased in PALOMA‐3 (32.0 vs 24.7 months, hazard ratio, 0.75 [95% CI, 0.53–1.04]), though this did not reach statistical significance (P = .0869). Safety profiles in North American patients were similar to those of the overall populations; neutropenia was the most common treatment‐emergent adverse event. No new safety signals were observed. In summary, palbociclib plus endocrine therapy is an effective treatment option for North American women with hormone receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer. 相似文献
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Nemanja Damjanov Waleed Al Shehhi Feng Huang Sameer Kotak Ruben Burgos-Vargas Khalid Shirazy Eustratios Bananis Annette Szumski Lyndon J. Q. Llamado Ehab Mahgoub 《Rheumatology international》2016,36(5):643-651
Despite the demonstrated efficacy of etanercept for the treatment of ankylosing spondylitis (AS), sulfasalazine is often prescribed, especially in countries with limited access to biologic agents. The objective of this subset analysis of the ASCEND trial was to compare the efficacy of etanercept and sulfasalazine in treating patients with AS from Asia, Eastern/Central Europe, and Latin America. A total of 287 patients, 190 receiving etanercept 50 mg once weekly and 97 receiving sulfasalazine 3 g daily, from eight countries were included in this subset analysis. Differences in disease activity and patient-reported outcomes assessing health-related quality-of-life (HRQoL) parameters in response to treatment were analyzed using the Cochran–Mantel–Haenszel test for categorical efficacy endpoints and analysis of covariance model for continuous variables. At week 16, a significantly greater proportion of patients receiving etanercept achieved ASAS20 (79.0 %) compared with patients receiving sulfasalazine (61.9 %; p = 0.002). At week 16, treatment with etanercept also resulted in significantly better responses than sulfasalazine for ASAS40 (64.7 vs. 35.1 %; p < 0.001), ASAS5/6 (48.1 vs. 26.3 %; p < 0.001), proportion of patients achieving 50 % response in Bath AS Disease Activity Index (65.8 vs. 42.3 %; p < 0.001), partial remission (35.3 vs. 17.5 %; p = 0.002), and all HRQoL parameters. Both treatments were well tolerated. Etanercept was significantly more effective than sulfasalazine in the treatment of patients with AS from Asia, Central/Eastern Europe, and Latin America. 相似文献
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