Background:In real-world practice, eribulin mesylate provides significant survival benefit, with a manageable safety profile in heavily pretreated patients with metastatic breast cancer (MBC).Methods:In this prospective, open-label, multicentre, observational study we evaluated the effectiveness and tolerability of eribulin as third-line treatment in a homogeneous population. The primary endpoints were the safety profile and response in metastatic sites; secondary endpoints included the response in different subtypes, overall response rate (ORR), progression-free survival (PFS) and overall survival (OS).Results:From 2013 to 2016, 118 women were treated in 21 Sicilian institutions; the median age was 58 years (range 29–79), with 69% of patients under 65. The median cycles of eribulin were 5.5 (range 1–26). The most common adverse event was neutropenia (9.3%, 3 cases of grade 3, 4 of grade 4); only 1 case of QT prolongation was reported. Eribulin was effective in controlling metastatic disease in all sites, and it achieved the highest ORR in brain (16%) and liver (14.9%). Median OS was 31.8 months (95% CI 27.9–34.4) and median PFS 5.5 months (95% CI 4.2–6.6). PFS was 5.2 months (95% CI 2.8–8.4) in patients with triple-negative subtype. Median PFS was longer in patients over 65 years (6.1 months, 95% CI 4.4–8.3). In patients who had visceral metastases PFS was 5.5 months (95% CI 95% 3.5–6.6) and OS 33.9 months (95% CI 29.8–40.8).Conclusions:Eribulin as third-line treatment shows an acceptable safety profile and a substantial antitumour activity in the treatment of MBC, even in elderly patients and in those with visceral disease.
Objective There are few real-world setting studies focused on apremilast effectiveness (i.e., retention rate) in psoriatic arthritis (PsA). The main aim of this retrospective observational study is the assessment of apremilast 3-year retention rate in real-world PsA patients. Moreover, the secondary objective is to report the reasons of apremilast discontinuation and the factors related to treatment persistence. Methods In fifteen Italian rheumatological referral centers, all PsA consecutive patients who received apremilast were enrolled. Anamnestic data, treatment history, and PsA disease activity (DAPSA) at baseline were recorded. The Kaplan-Meier curve and the Cox analysis computed the apremilast retention rate and treatment persistence-related risk factors. A p-value < 0.05 was considered statistically significant. ResultsThe 356 enrolled patients (median age 60 [interquartile range IQR 52-67] yrs; male prevalence 42.7%) median observation period was 17 [IQR 7-34] months (7218 patients-months). The apremilast retention rate at 12, 24, and 36 months was, respectively, 85.6%, 73.6%, and 61.8%. The main discontinuation reasons were secondary inefficacy (34% of interruptions), gastro-intestinal intolerance (24%), and primary inefficacy (19%). Age and oligo-articular phenotype were related to treatment persistence (respectively hazard ratio 0.98 IQR 0.96-0.99; p = 0.048 and 0.54 IQR 0.31-0.95; p = 0.03). Conclusion Almost three-fifths of PsA patients receiving apremilast were still in treatment after 3 years. This study confirmed its effectiveness and safety profile. Apremilast appears as a good treatment choice in all oligo-articular PsA patients and in those ones burdened by relevant comorbidities. Key Points• Apremilast retention rates in this real-life cohort and trials are comparable.• The oligo-articular phenotype is associated with long-lasting treatment (i.e., 3 years).• No different or more prevalent adverse events were observed.
Background: The Agenzia Italiana del Farmaco (AIFA) Determination 809/2015 sets all the requirements that clinical units and laboratories must meet in order to conduct phase I studies. Requirements include buildings, equipment, personnel, emergency management, as well as quality requirements defined in a set of standard operating procedures. Methods: In September 2018, the Italian Association of Medical Oncology working group, Clinical Research Coordinator, created an anonymous survey addressed to 51 medical directors of oncologic/hematologic clinical phase I units and all medical directors of generic and transversal units located in Italy and listed at the AIFA website. Results: Questionnaires from 24 institutions were collected, 9 previously inspected by competent authorities. All surveyed structures are certified to conduct profit studies and 1 is authorized to include healthy volunteers; 15 units implemented a Clinical Trial Quality Team in order to conduct nonprofit studies. At the time of data collection, a total of 398 proposals for phase I trials have been received, more than 50% coming from 3 institutes. A total of 144 phase I studies were active, with a median of 2.5 (Q1–Q3=0–6) studies for each center and asymmetric distribution of proposals. Conclusion: The considerable number of proposals received from the interviewed centers indicates that Italy plays an important role in the international pharmaceutical scene, despite bureaucratic procedures that threaten exclusion from decision-making. The AIFA Determination will be an important opportunity to acquire a competitive working approach.
We are currently witnessing an increase in procedural and managerial complexities within the field of clinical research, which require greater human and infrastructural resources as well as imply the need for a greater skill set and expertise on the part of professionals. Within this frame of reference clinical trial units and clinical research coordinators play a vital role in the design and conduct of clinical trials in Italy. There is a current recruitment and retention crisis for this specialist role due to a complex set of factors, most likely to have come to a head due to the lack of recognition at the Italian institutional level, that lead to precarious work contracts, lack of identity, and excessive turnover at experimental sites. This article, led by the Italian Group of Clinical Research Coordinator (GIDMcrc), presents some of the issues and ways in which national stakeholders may be able to address this.
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