BackgroundThe independent prognostic impact of diabetes mellitus (DM) and prediabetes mellitus (pre‐DM) on survival outcomes in patients with chronic heart failure has been investigated in observational registries and randomized, clinical trials, but the results have been often inconclusive or conflicting. We examined the independent prognostic impact of DM and pre‐DM on survival outcomes in the GISSI‐HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca‐Heart Failure) trial.Methods and ResultsWe assessed the risk of all‐cause death and the composite of all‐cause death or cardiovascular hospitalization over a median follow‐up period of 3.9 years among the 6935 chronic heart failure participants of the GISSI‐HF trial, who were stratified by presence of DM (n=2852), pre‐DM (n=2013), and non‐DM (n=2070) at baseline. Compared with non‐DM patients, those with DM had remarkably higher incidence rates of all‐cause death (34.5% versus 24.6%) and the composite end point (63.6% versus 54.7%). Conversely, both event rates were similar between non‐DM patients and those with pre‐DM. Cox regression analysis showed that DM, but not pre‐DM, was associated with an increased risk of all‐cause death (adjusted hazard ratio, 1.43; 95% CI, 1.28–1.60) and of the composite end point (adjusted hazard ratio, 1.23; 95% CI, 1.13–1.32), independently of established risk factors. In the DM subgroup, higher hemoglobin A1c was also independently associated with increased risk of both study outcomes (all‐cause death: adjusted hazard ratio, 1.21; 95% CI, 1.02–1.43; and composite end point: adjusted hazard ratio, 1.14; 95% CI, 1.01–1.29, respectively).ConclusionsPresence of DM was independently associated with poor long‐term survival outcomes in patients with chronic heart failure.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00336336.
Elderly EOC patients can receive an adequate treatment, but patients who are older than 75 years can be undertreated, if not adequately selected. The pretreatment assessment of frailty through mFI could be suggested in the surgical and medical management.
Epithelial ovarian cancer is the sixth most common cancer among women worldwide and the first cause of death among gynecological malignancies. Most of the patients present recurrent disease and unfortunately cannot be cured. The unsatisfactory results obtained with salvage chemotherapy have elicited investigators to search for novel biological agents capable of achieving a better control of the disease. In the setting of homologous recombination deficiency, the DNA errors that occur cannot be accurately repaired, and the treatment with poly(ADP-ribose) polymerase (PARP) inhibition results in definitive cell death in a process called synthetic lethality. As a result of two positive clinical trials, Olaparib was approved in 2014 by U.S. Food and Drug Administration and European Medicines Agency as the first-in-class PARP inhibitor. Olaparib is effective and well tolerated in homologous recombination deficient patients. Several studies with Olaparib have been conducted in the recurrent setting either as maintenance in platinum-responsive patients or as a single agent. Ongoing trials are focused on the use of olaparib as maintenance in the first-line ovarian cancer setting alone or in combination with antiangiogenic agents. Future perspectives will probably investigate the association of olaparib with novel agents as check-point inhibitors and PI3K-AKT inhibitors. The PARP inhibitor era is just at the beginning.
Recurrence is a common event in endothelial ovarian cancer (EOC) patients, and the choice of the most appropriate treatment is driven by the platinum-free interval, molecular characteristics of the disease such as BRCA mutational status, previous treatments and toxicity. Areas covered: This review focuses on the main hematologic and non-hematologic toxicities correlated with the use of licensed antiangiogenic agents and PARP inhibitors in recurrent platinum-sensitive EOC, providing recommendations for their management. Expert opinion: The clinical research over the next years will be focused on a more precise characterization of molecular pathways underlying tumorigenesis of the five ovarian tumors, to improve the decision-making process in these rare diseases. For this purpose, new study designs and international collaborations will become mandatory. Immunotherapy, antiangiogenic agents and PARP inhibitors will be combined to build a treatment strategy algorithm which will allow patients to receive all the available treatment option, in the more appropriate sequence.
Nowadays, the optimal management of patients with cervical cancers measuring 2–4 cm desiring to maintain fertility is still uncertain. In this systematic review, we assessed the reliability of neoadjuvant chemotherapy (NACT) prior to fertility-sparing (FS) surgery in International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB2 cervical cancer, in terms of pathologic response, oncological and obstetric outcomes. The review of the literature was performed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data, using MEDLINE and PubMed, were searched for from 1 January 2005 up to 1 December 2020. We identified 20 articles and 114 women with IB2 disease, possible candidates for NACT prior to FS surgery. However, uterine conservation was achieved only in 76.7% of them. Patients reached optimal pathological response to NACT in 60.9% of cases and a TIP (cisplatin, ifosfamide and paclitaxel) regime was related to the best response. Suboptimal response to NACT appeared to be an independent negative prognostic factor. Up to 9.2% of patients recurred with a median 7.4-months DFS, and 4.6% of patients died of disease. Fifty percent of women tried to conceive after treatment and NACT prior to conization appeared to be the most promising alternative to upfront radical trachelectomy in terms of obstetric outcomes. In conclusion, NACT prior to FS surgery is an option, but the literature about this issue is still weak and FS should be carefully discussed with patients.
Results support the need to reorganize the clinical pathway of patients with OC in the Piedmont Region and the need for better adherence to current guidelines.
The management of gynaecological cancers in elderly women and high-risk patients is an even more relevant issue, because the increase in longevity and comorbidities. The assumption of frailty based on age alone may lead to inadequate and inappropriate treatment and frailty assessment is recommended. The aim of this study was to assess if Vulnerable Elders Survey-13 (VES-13), as indicator of frailty, can predict the toxicity of chemotherapy in gynaecological cancers.VES-13 was administered to patients aged ≥ 70 years with ovarian, endometrial and cervical cancers who underwent chemotherapy from 2010 to 2016.Eighty-four patients aged ≥ 70 years (mean age 74.6) were included, 36 patients (42.9%) resulted vulnerable (score ≥ 3). Thrombocytopenia and anaemia were more prevalent in the vulnerable subjects (81.3% versus 18.7%, P = .0005, and 81.8% versus 18.2%, P = .005, respectively), while neutropenia was similar between the 2 groups. Vulnerable women had higher risk of non-haematological toxicities. Most of the patients (77.4%) completed chemotherapy, but dose reductions and discontinuations were more common in the vulnerable group (66.7% versus 33.3%, P = .07 and 68.4% versus 31.6%, P = .01, respectively).To our knowledge, this is the first study to evaluate VES-13 exclusively in elderly women with gynaecological cancers. VES-13 may be useful to stratify this category of patients according to vulnerability in order to identify women at risk of toxicity and to prevent complications induced by chemotherapy.
Aims: To investigate the frequency of and predictive factors for hypersensitivity reactions (HR) to taxanes and platinum salts in a cohort of patients treated for pelvic gynecologic malignancies. Methods: The medical records of all patients with gynecologic pelvic neoplasms treated with chemotherapy at the Department of Gynecologic Oncology, AO Mauriziano Umberto I of Turin, from September 2007 through August 2008, were retrospectively reviewed. Two multivariate models, regarding carboplatin and taxane chemotherapy, respectively, were performed to evaluate the potential predictive value of various clinical features. Results: The incidence of HR was 14% (22/157). Multivariate models showed that menopausal women had a significantly lower probability of HR (OR 0.12, CI 0.02–1.13, p = 0.06 for the carboplatin model and OR 0.05, CI 0.01–0.63, p = 0.02 for the taxane model) while a history of systemic hypersensitivity was associated with a higher but non-significant risk of HR (OR 2.64, CI 0.78–8.95, p = 0.11, for the carboplatin model and OR 3.42, CI 0.94–12.45, p = 0.06, for the taxane model). Conclusion: We confirmed a history of hypersensitivity as a risk factor for HR. Other larger cohorts should be analyzed: we need to find new predictive factors in order to select women who should be submitted to experimental prophylactic strategies.
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