Unita Operativa Sperimentazioni Cliniche Oncologia

Napoli, Italy

Unita Operativa Sperimentazioni Cliniche Oncologia

Napoli, Italy
SEARCH FILTERS
Time filter
Source Type

Di Lorenzo G.,University of Naples Federico II | Sonpavde G.,University of Alabama at Birmingham | Pond G.,McMaster University | Lucarelli G.,University of Bari | And 12 more authors.
European Urology Focus | Year: 2017

Background: Although statin use has been associated with favorable effects in various solid malignancies, no conclusive evidence is available at present. Statins are safe and inexpensive, and may synergize with novel antiandrogen agents abiraterone via pharmacokinetic interactions and decrease substrate availability for de novo androgen biosynthesis. Objective: To determine whether statin use affects survival in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone. Design, setting, and participants: Medical records of patients with documented mCRPC between September 2011 and August 2016 were reviewed at multiple participating centers. This research was conducted in ten institutions, including both referral centers and local hospitals. A total of 187 patients receiving abiraterone for mCRPC between September 2011 and August 2016 were eligible for inclusion in this retrospective study. Outcome measurements and statistical analysis: Patients were assessed for overall survival (OS), statin use at the time of treatment initiation, prostate-specific antigen (PSA) variations, and other variables of interest. Univariable and multivariable analysis was used to explore the association of variables of interest with OS and PSA declines. Results and limitations: Statin use was a significant prognostic factor for longer OS in univariable (hazard ratio [HR] 0.51, 95% confidence interval [CI] 0.37-0.72; p <. 0.001) and multivariable analysis (HR 0.40, 95% CI 0.27-0.59; p <. 0.001) and was significantly associated with PSA declines (>50% decline at 12 wk: 72.1% in statin users vs 38.5% in non-users; p <. 0.001). Conclusions: Our study suggests a prognostic impact of statin use in patients receiving abiraterone for mCRPC. The mechanism of this interaction warrants elucidation, but may include enhancement of the antitumor activity of abiraterone as well as cardioprotective effects. Patient summary: We assessed the effects of statin use in patients with advanced prostate cancer receiving abiraterone. Patients treated with a statin plus abiraterone appeared to live longer than those treated with abiraterone only. Since no negative drug-drug interaction is known and statins are widely used and inexpensive, further studies assessing the use of abiraterone plus statins are warranted. Patients with advanced prostate cancer receiving a statin plus abiraterone appeared to live longer than those treated with abiraterone only. Since no negative drug-drug interaction is known and statins are widely used and inexpensive, further prospective studies are warranted. © 2017.


Rossetti S.,Instituto Nazionale Tumori Fondazione G Pascale Irccs | D'Aniello C.,Ospedali dei Colli Monaldi Contugno CTO | Iovane G.,Instituto Nazionale Tumori Fondazione G Pascale Irccs | Scagliarini S.,Unita Operativa Sperimentazioni Cliniche Oncologia | And 9 more authors.
Frontiers in Pharmacology | Year: 2017

In metastatic renal cell carcinoma, complete response to first-line antiangiogenic agents is rare and resistance to therapy often develops. Protocols for sequential treatment with angiogenesis and mTOR inhibitors are under evaluation to improve outcomes. In this observational, real-world study, patients received a first-line therapy with pazopanib until discontinuation for disease progression or toxicity, then a second-line with everolimus. Primary endpoints were overall survival (OS) for sequence, progression free survival (PFS) for each agent, and safety. Thirty-one patients were included in the analysis: 73.3% of patients underwent nephrectomy before treatment, 25.8% had at least three comorbidities. At the beginning of therapy, the median age was 68 years, with more than 60% of patients older than 65 years. The median OS for sequence was 26.5 months (95% CI 17.4-nc); median PFS was 10.6 months (95% CI 6.3-12.1) with pazopanib and 5.3 months (95% CI 3.8-6.7) with everolimus. The median persistence in pazopanib therapy was 8.1 months (Interquartile Range IQR 5.3-12.7), with 31% of patients who required dose reduction, while persistence in everolimus was 4.4 months (IQR 3.4-6.5). Sequence was well tolerated with a different profile of adverse events for each agent. These data confirmed that pazopanib was effective, even in reduced dosing, and well tolerated and suggested that everolimus may represent an opportunity to continue a therapy when patients cannot further tolerate angiogenesis inhibitors or develop a resistance. © 2017 Rossetti, D'Aniello, Iovane, Scagliarini, Laterza, De Vita, Savastano, Cartenì, Porricelli, Berretta, Pisconti, Facchini and Cavaliere.


Bosso D.,University of Naples Federico II | Pagliuca M.,University of Naples Federico II | Sonpavde G.,University of Alabama at Birmingham | Pond G.,McMaster University | And 16 more authors.
Medicine (United States) | Year: 2017

Rationale: PSA responses have been associated with a survival benefit in patients treated with enzalutamide in retrospective analyses. Patient concerns: However the prognostic value of PSA declines in highly pretreated patients receiving enzalutamide remains to be defined. Diagnoses and interventations: Medical records of patients with documented mCRPC treated with enzalutamide between September 2011 and August 2016 were reviewed at multiple participating centers and assessed for overall survival (OS), PSA variations, and other variables of interest. Univariable and multivariable analyses were conducted. Outcomes: A total of 129 patients received enzalutamide. PSA response rates (>50% PSA declines) were 58/119 (48.7%), 58/115 (50.4%), 54/110 (49.1%), and 47/91 (51.7%) at weeks 4, 8, 12, and 16, respectively. Having a PSA response was a statistically significant prognostic factor of improved OS at 8 and 12 weeks in univariable analysis, whereas it was significant at 12 weeks in the multivariable analysis. Patients treated with enzalutamide had a median OS of 7.8 months. Lessons: Our study supports the prognostic value of PSA declines in heavily treated patients receiving enzalutamide. © Copyright 2017 the Author(s). Published by Wolters Kluwer Health, Inc.

Loading Unita Operativa Sperimentazioni Cliniche Oncologia collaborators
Loading Unita Operativa Sperimentazioni Cliniche Oncologia collaborators