1.Phase III double-blind randomized placebo controlled trial of atezolizumab in combination with carboplatin and paclitaxel in women with advanced/recurrent endometrial carcinoma: the Asian cohort of the AtTEnd/ENGOT-EN7 trial
Kenichi HARANO ; Roldano FOSSATI ; Beatriz PARDO ; Francesca GALLI ; Emma HUDSON ; Yoland ANTILL ; Chulmin LEE ; Manuela RABAGLIO ; Florian HEITZ ; Vassiliki KOLOVETSIOU-KREINER ; Chyong-Huey LAI ; Elena BIAGIOLI ; Luis MANSO ; Shin NISHIO ; Karen ALLAN ; Yeh Chen LEE ; Sara UGGERI ; Andres REDONDO ; Satoshi NAKAGAWA ; Eunice AU ; Janine LOMBARD ; Angiolo GADDUCCI ; Kazuhiro TAKEHARA ; Edi Editta BALDINI ; Innocenza PALAIA ; Claudia CASANOVA ; Antonio ARDIZZOIA ; Alessandra BOLOGNA ; Maria-Pilar BARRETINA-GINESTA ; Nicoletta COLOMBO
Journal of Gynecologic Oncology 2025;36(4):e117-
Objective:
This post-hoc analysis of the AtTEnd trial explored differences in the prognostic characteristics and in the efficacy of atezolizumab between Asians and non-Asians.
Methods:
The role of Asian race was evaluated on progression-free survival (PFS) using Cox-models and on time to appearance of new lesions using Fine and Gray models.
Results:
From October 2018 to February 2022, 549 patients were randomized, of whom, 20.4% were Asian. Asians showed a better prognostic profile in terms of age, body mass index, Eastern Cooperative Oncology Group performance status, disease status and previous treatments. The prognostic impact of Asian race on PFS was confirmed in the placebo arm (adjusted hazard ratio [HR]=0.41; 95% confidence interval [CI]=0.24–0.70). In proficient mismatch repair (pMMR) tumors, the HRs for PFS comparing atezolizumab versus placebo were 0.82 (95% CI=0.63–1.05) in non-Asians, and 1.42 (95% CI=0.80–2.50) in Asians. In the pMMR population randomized to atezolizumab, the subdistribution HRs comparing Asians to non-Asians were 0.68 (95% CI=0.43–1.09) for progression with new lesions and 1.21 (95% CI=0.73–2.03) for progression without new lesions. Asians showed a higher occurrence of severe adverse events in atezolizumab compared to placebo arm (Asians: 82.1% vs. 64.3%, p=0.036; non-Asian: 63.3% vs. 63.6%, p=0.949).
Conclusion
Race seems to affect the safety of the addition of atezolizumab and, in pMMR tumors, also its efficacy. In the atezolizumab arm, Asian patients seem to have a lower cumulative incidence of new lesions when primary tumor regrowth was considered a competing risk, and a higher cumulative incidence of primary tumor regrowth when new lesions appearance was the competing risk.
2.Chondroblastoma’s Lung Metastases Treated with Denosumab in Pediatric Patient
Marco FOCACCIA ; Marco GAMBAROTTI ; Rossella HAKIM ; Anna PAIOLI ; Marilena CESARI ; Benedetta SPAZZOLI ; Paolo SPINNATO ; Davide DONATI ; Michele ROCCA ; Alessandra LONGHI
Cancer Research and Treatment 2021;53(1):279-282
Chondroblastoma is a rare benign chondrogenic tumor that occurs in skeletally immature patients between ages 10 and 20 years old. In literature are reported few cases of lung metastases, mainly occurred after surgery or local recurrences. There is no evidence on the pathogenesis of lung metastasis, as well as pulmonary disease course. Few treatments for metastases with aggressive behavior were based on chemotherapy regimen employed in other sarcoma with no results or not satisfying ones. Denosumab is approved for treatment of giant cell tumors and it is under investigation for other giant cell-rich bone tumors. Here, we report a case of a 16-year-old male chondroblastoma of the left humerus with bilateral lung metastases at presentation and progressing during follow-up, treated with denosumab for almost 2 years. We confirm that denosumab treatment can be effective in controlling chondroblastoma metastasis and it has been a safe procedure in an adolescent patient.
3.Testosterone Replacement Therapy: Long-Term Safety and Efficacy.
Giovanni CORONA ; Alessandra SFORZA ; Mario MAGGI
The World Journal of Men's Health 2017;35(2):65-76
Recent position statements and guidelines have raised the distinction between a true and false, age-related hypogonadism (HG) or late-onset hypogonadism (LOH). The former is the consequence of congenital or acquired “organic” damage of the brain centers or of the testis. The latter is mainly secondary to age-related comorbidities and does not require testosterone (T) therapy (TTh). In addition, concerns related to cardiovascular (CV) safety have further increased the scepticism related to TTh. In this paper, we reviewed the available evidence supporting the efficacy of TTh in non-organic HG and its long term safety. A large amount of evidence has documented that sexual symptoms are the most specific correlates of T deficiency. TTh is able to improve all aspects of sexual function independent of the pathogenetic origin of the disease supporting the scientific demonstration that LOH does exist according to an “ex-juvantibus” criterion. Although the presence of metabolic derangements could mitigate the efficacy of TTh on erectile dysfunction, the positive effect of TTh on body composition and insulin sensitivity might counterbalance the lower efficacy. CV safety concerns related to TTh are essentially based on a limited number of observational and randomized controlled trials which present important methodological flaws. When HG is properly diagnosed and TTh correctly performed no CV and prostate risk have been documented.
Body Composition
;
Brain
;
Comorbidity
;
Erectile Dysfunction
;
Hypogonadism
;
Insulin Resistance
;
Male
;
Prostate
;
Testis
;
Testosterone*
4.Corrigendum: Testosterone Replacement Therapy and Cardiovascular Risk: A Review.
Giovanni CORONA ; Giulia RASTRELLI ; Elisa MASEROLI ; Alessandra SFORZA ; Mario MAGGI
The World Journal of Men's Health 2016;34(2):154-154
In published article by Corona G et al., an author's name was misspelled.
5.Testosterone Replacement Therapy and Cardiovascular Risk: A Review.
Giovanni CORONA G ; Giulia RASTRELLI ; Elisa MASEROLI ; Alessandra SFORZA ; Mario MAGGI
The World Journal of Men's Health 2015;33(3):130-142
Recent reports in the scientific and lay press have suggested that testosterone (T) replacement therapy (TRT) is likely to increase cardiovascular (CV) risk. In a final report released in 2015, the Food and Drug Administration (FDA) cautioned that prescribing T products is approved only for men who have low T levels due to primary or secondary hypogonadism resulting from problems within the testis, pituitary, or hypothalamus (e.g., genetic problems or damage from surgery, chemotherapy, or infection). In this report, the FDA emphasized that the benefits and safety of T medications have not been established for the treatment of low T levels due to aging, even if a man's symptoms seem to be related to low T. In this paper, we reviewed the available evidence on the association between TRT and CV risk. In particular, data from randomized controlled studies and information derived from observational and pharmacoepidemiological investigations were scrutinized. The data meta-analyzed here do not support any causal role between TRT and adverse CV events. This is especially true when hypogonadism is properly diagnosed and replacement therapy is correctly performed. Elevated hematocrit represents the most common adverse event related to TRT. Hence, it is important to monitor hematocrit at regular intervals in T-treated subjects in order to avoid potentially serious adverse events.
Aging
;
Drug Therapy
;
Hematocrit
;
Humans
;
Hypogonadism
;
Hypothalamus
;
Male
;
Mortality
;
Myocardial Infarction
;
Testis
;
Testosterone*
;
United States Food and Drug Administration
6.Role of 18F-FDG PET/CT in the Carcinoma of the Uterus: A Review of Literature.
Alessandra MUSTO ; Gaia GRASSETTO ; Maria Cristina MARZOLA ; Sotirios CHONDROGIANNIS ; Anna Margherita MAFFIONE ; Lucia RAMPIN ; David FUSTER ; Francesco GIAMMARILE ; Patrick M COLLETTI ; Domenico RUBELLO
Yonsei Medical Journal 2014;55(6):1467-1472
In the present review we reported the value of 18F-fluorodeoxyglucose (FDG) PET/CT in face of uterine cancer, in terms of sensitivity, specificity and accuracy. Moreover, we made a comparison with the other imaging techniques currently used to evacuate these tumors including contrast-enhanced CT, contrast enhanced-MRI and transvaginal ultrasonography. FDG PET/CT has been reported to be of particular value in detecting occult metastatic lesions, in prediction of response to treatment and as a pro-gnostic factor.
Carcinoma/*pathology
;
Female
;
Fluorodeoxyglucose F18/*diagnostic use
;
Humans
;
*Magnetic Resonance Imaging
;
Neoplasm Staging
;
Positron-Emission Tomography/*methods
;
Predictive Value of Tests
;
Sensitivity and Specificity
;
Tomography, X-Ray Computed/*methods
;
Uterine Neoplasms/*pathology
;
Uterus
7.Risks and Benefits of Late Onset Hypogonadism Treatment: An Expert Opinion.
Giovanni CORONA ; Linda VIGNOZZI ; Alessandra SFORZA ; Mario MAGGI
The World Journal of Men's Health 2013;31(2):103-125
Late-onset hypogonadism (LOH) is a syndromic condition that has a well-recognized association with sexual and reproductive failure. LOH is frequently associated with chronic conditions including cardiovascular diseases (CVD), obesity, osteoporosis, HIV infection, renal failure, and obstructive pulmonary diseases. Despite this evidence, in patients with these conditions, LOH is still only rarely investigated and testosterone replacement therapy (TRT) rarely considered. In this paper, we critically reviewed the available evidence on LOH treatment focusing on possible risks and benefits. Medical therapy of LOH should be individualized depending on the etiology of the disease and the patient's expectations. The fear of prostate cancer and the risk of erythrocytosis probably represent the main limitations of TRT in aging men. However, TRT in healthy older men in near physiological doses does not appear to incur serious adverse events, although regular monitoring of prostate-specific antigen and hematocrit levels is required. Available evidence also suggests that TRT might ameliorate central obesity and glycometabolic control in patients with metabolic syndrome and type 2 diabetes. In addition, TRT has been associated with an increase in bone mineral density in men with osteoporosis, with an improvement in lean body mass in subjects with human immunodeficiency virus infection or chronic obstructive pulmonary disease, as well as with peripheral oxygenation in patients with chronic kidney diseases. Despite this evidence, however, it should be recognized that the results of these trials were heterogeneous and limited by small sample sizes. Hence, further research is required regarding the long-term benefits and adverse effects of TRT in LOH.
Aging
;
Bone Density
;
Cardiovascular Diseases
;
Diabetes Mellitus
;
Erectile Dysfunction
;
Hematocrit
;
HIV
;
HIV Infections
;
Humans
;
Hypogonadism
;
Lung Diseases, Obstructive
;
Male
;
Obesity
;
Obesity, Abdominal
;
Osteoporosis
;
Polycythemia
;
Prostate
;
Prostate-Specific Antigen
;
Prostatic Neoplasms
;
Pulmonary Disease, Chronic Obstructive
;
Renal Insufficiency
;
Renal Insufficiency, Chronic
;
Testosterone
8.Biceps femoris muscle transposition for treatment of cranial cruciate ligament rupture in small breed dogs.
Roberto TAMBURRO ; Stefania PINNA ; Anna Maria TRIBUIANI ; Alessandra PANACEA ; Fabio CARLI ; Antonio VENTURINI
Journal of Veterinary Science 2012;13(1):93-98
The purpose of this study was to evaluate a new extracapsular surgical technique for the treatment of cranial cruciate ligament rupture in small breed dogs. Nine small breed dogs (seven females and two males) weighing < or = 15 kg were treated with biceps femoris muscle transposition (BFT). The duration of the BFT procedure was 20 min. Each patient underwent a standard clinical protocol and a questionnaire for the owners. Follow-up (at 1, 3, and 12 months postoperative) confirmed significant improvement in all patients, especially at 1 month postoperatively (p < 0.01) and again after complete stifle joint assessment at 3 months postoperatively. After 12 months, only two patients showed a slight increase in osteoarthritis. According to our results, BFT is a simple extracapsular surgical technique that can be used for the treatment of cranial cruciate ligament rupture in small breed dogs.
Animals
;
Anterior Cruciate Ligament/*injuries/*surgery
;
Dog Diseases/*surgery
;
Dogs
;
Female
;
Male
;
Muscle, Skeletal/*transplantation
;
Questionnaires
;
Rupture/veterinary
;
Stifle/*surgery

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