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Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer
In
PIK3CA
-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer, inavolisib plus palbociclib–fulvestrant led to significantly longer progression-free survival than placebo plus palbociclib–fulvestrant.
Journal Article
Vepdegestrant, a PROTAC Estrogen Receptor Degrader, in Advanced Breast Cancer
Vepdegestrant is an oral proteolysis-targeting chimera (PROTAC) estrogen receptor (ER) degrader that directly harnesses the ubiquitin-proteasome system.
In this phase 3, open-label, randomized trial, we enrolled patients with ER-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer who had received one previous line of cyclin-dependent kinase 4 and 6 inhibitor therapy plus one line of endocrine therapy (and up to one additional line of endocrine therapy). Patients were randomly assigned in a 1:1 ratio to receive vepdegestrant at a dose of 200 mg orally once every day of each 28-day cycle or fulvestrant at a dose of 500 mg, administered intramuscularly, on day 1 and day 15 of cycle 1 and on day 1 of subsequent cycles, with randomization stratified according to
-mutation status and presence or absence of visceral disease. The primary end point was progression-free survival as assessed by blinded independent central review among the patients with
mutations and among all the patients who underwent randomization. Progression-free survival was estimated with Kaplan-Meier methods and hazard ratios with a stratified Cox proportional-hazards model.
A total of 624 patients underwent randomization; 313 were assigned to receive vepdegestrant, and 311 to receive fulvestrant. Among the 270 patients with
mutations, the median progression-free survival was 5.0 months (95% confidence interval [CI], 3.7 to 7.4) with vepdegestrant and 2.1 months (95% CI, 1.9 to 3.5) with fulvestrant (hazard ratio, 0.58 [95% CI, 0.43 to 0.78]; P<0.001). Among all the patients, the median progression-free survival was 3.8 months (95% CI, 3.7 to 5.3) with vepdegestrant and 3.6 months (95% CI, 2.6 to 4.0) with fulvestrant (hazard ratio, 0.83 [95% CI, 0.69 to 1.01]; P = 0.07). Adverse events of grade 3 or higher occurred in 23.4% of the patients in the vepdegestrant group and in 17.6% of the patients in the fulvestrant group. Adverse events led to treatment discontinuation in 2.9% and 0.7% of the patients, respectively.
Among patients with ER-positive, HER2-negative advanced breast cancer, vepdegestrant was associated with significantly longer progression-free survival than fulvestrant in the subgroup with
mutations but not in the full patient population. (Funded by Pfizer and Arvinas Estrogen Receptor; VERITAC-2 ClinicalTrials.gov number, NCT05654623.).
Journal Article
Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer
In patients with
PIK3CA
-mutated advanced breast cancer, inavolisib added to palbociclib–fulvestrant led to a significant overall survival benefit, with a higher incidence of certain toxic effects than placebo.
Journal Article
The eight mountains : a novel
\"For fans of Elena Ferrante, Fredrik Backman, and Paulo Coelho comes the international sensation about the friendship between two young Italian boys from different backgrounds and how their incredibly strong connection evolves, changes, and challenges them throughout their lives. Pietro is a lonely boy living in Milan. With his parents becoming more distant each day, the only thing the family shares is their love for the Dolomites, the mountains that hug the northeastern border of Italy. While on vacation at the foot of the mountains, Pietro meets Bruno, an adventurous, spirited local boy. Together they spend many summers exploring the mountain's meadows and peaks and discover the similarities and differences in their lives, their backgrounds, and their futures. The two boys come to find the true meaning of friendship and camaraderie, even as their divergent paths in life-- Bruno's in the mountains, Pietro's in cosmopolitan cities across the world--test the strength and meaning of their connection. A modern Italian masterpiece, The Eight Mountains is a lyrical coming-of-age story about the power of male friendships and the enduring bond between fathers and sons. \"There are no more universal themes than those of the landscape, friendship, and becoming adults, and Cognetti's writing becomes classical (and elegant) to best tell this story\"-- Provided by publisher.
Book
The spectrum of renal involvement in male patients with infertility related to excretory-system abnormalities: phenotypes, genotypes, and genetic counseling
Background
While reproductive technologies are increasingly used worldwide, epidemiologic, clinical and genetic data regarding infertile men with combined genital tract and renal abnormalities remain scarce, preventing adequate genetic counseling.
Methods
In a cohort-based study, we assessed the prevalence (1995–2014) and the clinical characteristics of renal disorders in infertile males with genital tract malformation. In a subset of 34 patients, we performed a detailed phenotype analysis of renal and genital tract disorders.
Results
Among the 180 patients with congenital uni- or bilateral absence of vas deferens (CU/BAVD), 45 (25 %) had a renal malformation. We also identified 14 infertile men with combined seminal vesicle (SV) and renal malformation but no CU/BAVD. Among the 34 patients with detailed clinical description, renal disease was unknown before the assessment of the infertility in 27 (79.4 %), and 7 (20.6 %) had chronic renal failure. Four main renal phenotypes were observed: solitary kidney (47 %); autosomal-dominant polycystic kidney disease (ADPKD, 0.6 %); uni- or bilateral hypoplastic kidneys (20.6 %); and a complex renal phenotype associated with a mutation of the
HNF1B
gene (5.8 %). Absence of SV and azoospermia were significantly associated with the presence of a solitary kidney, while dilatation of SV and necroasthenozoospermia were suggestive of ADPKD.
Conclusion
A dominantly inherited renal disease (ADPKD or
HNF1B
-related nephropathy) is frequent in males with infertility and combined renal and genital tract abnormalities (26 %). A systematic renal screening should be proposed in infertile males with CU/BAVD or SV disorders.
Journal Article
