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      Clinical Characteristics of Metastatic Prostate Cancer Patients Infected with COVID-19 in South Italy

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          Abstract

          Background

          To date, the clinical characteristics of coronavirus disease 19 (COVID-19)-infected urologic cancer patients are unknown.

          Methods

          We have analyzed all patients with prostate cancer undergoing hormonal or chemotherapy treatment and receiving telephone and in person pre-triage between March 1 and 27, 2020, at the Tortora Hospital, Pagani, Italy.

          Results

          Among 72 patients, 48 and 24 were hormone-sensitive (HS) and castration-resistant prostate cancer (CRPC), respectively; 0 HS and 2 (8.3%) CRPC ( p < 0.05) were positive for COVID-19. Both patients were receiving LHRH agonist therapy, and 1 patient was receiving enzalutamide. Urgent intensive care unit admission was required due to clinical worsening. Blood tests showed severe lymphopenia, anemia, and an increase in platelets. Retroviral therapy, antibiotics, heparin, and chloroquine were prescribed at the beginning. One patient also received tocilizumab as a salvage treatment. After 3 weeks of hospitalization, the patients were discharged from the hospital. Both patients suffered from an aggressive COVID-19 course due to concomitant comorbidities.

          Conclusions

          Investigating whether hormonal therapy, especially in advanced disease, acts as a protective factor or a risk factor during COVID-19 could be useful.

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          Most cited references 12

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          Advice Regarding Systemic Therapy in Patients with Urological Cancers During the COVID-19 Pandemic

          Take Home Message The risk/benefit ratio of a number of palliative and (neo)adjuvant treatments should be reconsidered during the COVID-19 pandemic. We provide treatment advice as a pragmatic perspective on the risk/benefit ratio in specific clinical scenarios.
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            Trajectories of Injectable Cancer Drug Costs After Launch in the United States

            Purpose Cancer drug prices at launch have increased in recent years. It is unclear how individual drug prices change over time after launch and what market determinants influence these changes. We measured the price trajectories of a cohort of cancer drugs after their launch into the US market and assessed the influence of market structure on price changes. Methods We studied the changes in mean monthly costs for a cohort of 24 patented, injectable anticancer drugs that were approved by the US Food and Drug Administration between 1996 and 2012. To account for discounts and rebates, we used the average sales prices published by the Centers for Medicare and Medicaid Services. Costs were adjusted to US general and health-related inflation rates. For each drug, we calculated the cumulative and annual drug cost changes. We then used a multivariable regression model to evaluate the association between market and cost changes over time. Results With a mean follow-up period of 8 years, the mean percent change in cost for all drugs was +25% (range, -14% to +96%). After adjusting for inflation, the mean cost change was +18% (range, -16% to +59%). Rituximab and trastuzumab followed a similar pattern in cost increases over time, and the inflation-adjusted monthly costs rose since approval by 49% and 44%, respectively. New supplemental US Food and Drug Administration approvals, new off-label indications, and new competitors did not influence the annual cost change rates. Conclusion Anticancer drug costs may change substantially after launch. Regardless of competition or supplemental indications, there is a steady increase in costs of patented anticancer agents over time. New regulations may be needed to prevent additional increases in drug costs after launch.
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              Is Open Access

              Apalutamide and overall survival in non-metastatic castration-resistant prostate cancer

              Abstract Background In the SPARTAN study, compared with placebo, apalutamide added to ongoing androgen deprivation therapy significantly prolonged metastasis-free survival (MFS) and time to symptomatic progression in patients with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). Overall survival (OS) results at the first interim analysis (IA1) were immature, with 104 of 427 (24%) events required for planned final OS analysis. Here, we report the results of a second pre-specified interim analysis (IA2). Methods One thousand two hundred and seven patients with nmCRPC were randomized 2 : 1 to apalutamide (240 mg daily) or placebo. The primary end point of the study was MFS. Subsequent therapy for metastatic CRPC was permitted. When the primary end point was met, the study was unblinded. Patients receiving placebo who had not yet developed metastases were offered open-label apalutamide. At IA2, pre-specified analysis of OS was undertaken, using a group-sequential testing procedure with O’Brien–Fleming-type alpha spending function. Safety and second progression-free survival (PFS2) were assessed. Results Median follow-up was 41 months. With 285 (67% of required) OS events, apalutamide was associated with an improved OS compared with placebo (HR 0.75; 95% CI 0.59–0.96; P = 0.0197), although the P-value did not cross the pre-specified O’Brien–Fleming boundary of 0.0121. Apalutamide improved PFS2 (HR 0.55; 95% CI 0.45–0.68). At IA2, 69% of placebo-treated and 40% of apalutamide-treated patients had received subsequent life-prolonging therapy for metastatic CRPC. No new safety signals were observed. Conclusion In patients with nmCRPC, apalutamide was associated with a 25% reduction in risk of death compared with placebo. This OS benefit was observed despite crossover of placebo-treated patients and higher rates of subsequent life-prolonging therapy for the placebo group.
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                Author and article information

                Journal
                Oncology
                Oncology
                OCL
                Oncology
                S. Karger AG (Allschwilerstrasse 10, P.O. Box · Postfach · Case postale, CH–4009, Basel, Switzerland · Schweiz · Suisse, Phone: +41 61 306 11 11, Fax: +41 61 306 12 34, karger@karger.com )
                0030-2414
                1423-0232
                22 June 2020
                : 1-5
                Affiliations
                aOncology Unit, “Andrea Tortora” Hospital, ASL Salerno, Pagani, Italy
                bDepartment of Medicine and Health Sciences “Vincenzo Tiberio”, University of Molise, Campobasso, Italy
                cDepartment of Neurosciences, Sciences of Reproduction and Odontostomatology, University of Naples Federico II, Naples, Italy
                dDepartment of Clinical Medicine and Surgery, University Federico II of Naples, Naples, Italy
                eUrology Division, Umberto I Hospital, Nocera Inferiore, Italy
                fInternational Agency for Research on Cancer, World Health Organization, Lyon, France
                Author notes
                *Giuseppe Di Lorenzo, Oncology Unit, “Andrea Tortora” Hospital, ASL Salerno, IT–84016 Pagani (Italy), direttoreuocpagani@ 123456gmail.com
                Article
                ocl-0001
                10.1159/000509434
                7360489
                32570240
                Copyright © 2020 by S. Karger AG, Basel

                This article is made available via the PMC Open Access Subset for unrestricted re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the COVID-19 pandemic or until permissions are revoked in writing. Upon expiration of these permissions, PMC is granted a perpetual license to make this article available via PMC and Europe PMC, consistent with existing copyright protections.

                Page count
                Tables: 2, References: 16, Pages: 5
                Categories
                Clinical Trial Note

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