Results of combined surgery, mSICS and cyclodialysis, in patients with glaucoma and cataract. Real-life experience, efficacy and safety

Dalbavancin is a lipoglycopeptide approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The aim of the study was to evaluate the efficacy and safety in all patients who received at least one administration of dalbavancin. Methods: We carried out a retrospective study of the use of dalbavancin in 55 patients at the Azienda Ospedaliera Ospedali Riuniti Umberto I (Ancona, Italy) from February 2017 to May 2020 and compared “on label” and “off label” use of dalbavancin in ABSSSI and non-ABSSSI. Results: A total of 55 patients were included in the study. The median age was 61 years; 51% had ABSSSI; 24% had prosthetic joint infections, and 14% had osteomyelitis. A total of 53% received a single 1500 mg infusion of dalbavancin, and 18% received a second dose 14 days later; 24% of patients received further doses at 14-day intervals. In 91% of cases, patients achieved clinical objectives with dalbavancin: 96% of patients with ABSSSI and 69% of those with prosthetic joint infections. Conclusions: Dalbavancin was shown to have an excellent tolerability profile and to be a highly successful therapeutic approach even in those cases treated “off-label”.

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The Impact of Clinical Features on Efficacy and Safety of the Combination of Ramucirumab and Paclitaxel for Metastatic Gastro-Oesophageal Junction/ Gastric Cancer: Data of a Real Life Experience in an Italian Institution

10.20944/preprints201804.0307.v1 ◽

2018 ◽

Author(s):

Emanuele Vita ◽

Antonia Strippoli ◽

Vincenzo Di Noia ◽

Carmela Di Dio ◽

Valeria Zurlo ◽

...

Keyword(s):

Nutritional Status ◽

Life Experience ◽

Real Life ◽

Progression Free Survival ◽

Phase Iii ◽

Vegf Receptor ◽

Efficacy And Safety ◽

Her2 Positive ◽

Cancer Data ◽

The Impact

The RAINBOW Phase III study established the efficacy of the combination of paclitaxel and ramucirumab, a monoclonal antibody targeting VEGF receptor-2 (VEGF-R2), as second-line therapy. We retrospectively analyzed the data of patients treated with ramucirumab plus paclitaxel at our Institution to evaluate the impact of clinical heterogeneous figures on the efficacy and safety of this combination paclitaxel/ramucirumab in a real- life cohort of patients. After a median follow-up of 10.74 months, the median progression-free survival (PFS) was 5.8 months (95% CI: 3.04 - 5,63). Disease control rate (DCR) was 61% and the median duration of response (DOR) was 5.8 months. Median overall survival (OS) was 8.3 months. A trend toward better outcome was observed in HER2 positive patients. In multivariate analysis, nutritional status (p = 0.0001) and number of metastatic sites (p = 0.0266) resulted significantly related with longer PFS. Our analysis confirmed the efficacy and safety of the combination of ramucirumab with paclitaxel also in the real-life practice and the median PFS is significantly longer than that reported for Western population in previous studies. Subgroup analysis confirms the key-role of nutritional status as prognostic factor and suggests a possible interaction between EGF and angiogenesis pathways that deserves further investigations.

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Real-Life Experience of Nivolumab in Heavily Pretreated Relapsed and Refractory Classical Hodgkin Lymphoma

Blood ◽

10.1182/blood.v128.22.3008.3008 ◽

2016 ◽

Vol 128 (22) ◽

pp. 3008-3008 ◽

Cited By ~ 2

Author(s):

Ohad Benjamini ◽

David Lavie ◽

Eldad J Dann ◽

Chava Perry ◽

Ory Rouvio ◽

...

Keyword(s):

Adverse Events ◽

Hodgkin Lymphoma ◽

Clinical Studies ◽

Life Experience ◽

Real Life ◽

Brentuximab Vedotin ◽

Efficacy And Safety ◽

Classical Hodgkin Lymphoma ◽

Post Transplantation ◽

Heavily Pretreated

Abstract Background: The fully human IgG4 anti-PD-1 monoclonal antibody, nivolumab, has shown to be highly efficacious in relapsed and refractory (RR) classical Hodgkin lymphoma (cHL). Initial results of a single-arm nivolumab monotherapy in heavily pretreated young adults with RR cHL, previously treated with autologous hematopoetic stem cell transplantation (autoSCT) and brentuximab vedotin are promising. However, demonstrating similar results in real-life experience in patients not on Pharma clinical studies are of major clinical importance. Aim: The aim of the current study was to evaluate the efficacy and safety of nivolumab in previously heavily pretreated patients with RR cHL not on Pharma clinical studies. Methods: The records of patients with RR cHL who were treated with nivolumab in seven medical centers were reviewed. The regimen consisted of nivolumab 3 mg/kg once every 2 weeks until disease progression or unacceptable toxicity. Results: Between May 2015 and April 2016, 30 patients with RR cHL received nivolumab monotherapy. The median age was 35 years (range: 21 to 88). Patients were extremely heavily pretreated with median of 6 prior therapies (range: 3 to 11); 73% of them received ≥ 5 lines of therapy. Specifically, 29/30 (97%) received ABVD, 7/30 (23%) escBEACOPP, 20/30 (67%) gemcitabine based regimens, 30/30 (100%) brentuximab vedotin, 8/30 (27%) bendamustine, 3/30 (10%) lenalidomide, 28/30 (93%) other combinations of chemotherapy and 22/30 (73%) radiotherapy. Twenty patients (67%) previously underwent autoHSCT and 4/30 (13%) allogeneic transplantation (alloSCT), two before and two after receiving nivolumab. Median number of nivolumab doses received was 8 (range 1 to 29). Twenty three patients (77%) are still on treatment. Seven patients (23%) discontinued therapy due to disease progression 3/30 (10%), adverse events 2/30 (7%) and referral to alloSCT 2/30 (7%). Overall response rate among 25 evaluable patients was 76%, complete response (CR) - 7/25 (28%), partial response - 12/25 (48%), stable disease - 3/25 (12%) and only 3/25 (12%) progressed, one of them with cHL type of Richter's transformation. Two patients underwent alloSCT in remission following nivolumab treatment. One patient was transplanted from a matched sibling donor and the second patient from a T replete haploidentical donor with post transplantation cyclophosphamide as anti-graft versus host disease prophylaxis. Both patients are in CR, ten and three months post transplantation, respectively. The median overall survival (OS) and progression free survival (PFS) for the cohort were not reached (Figure 1). At 24 weeks the PFS was 74%. Adverse events reported in 9/30 patients (30%) were usually mild. Severe nivolumab related adverse events in 3/30 (10%) included immune related pneumonitis, myelitis and uveitis. No treatment related death occurred. Conclusions: The check point inhibitor nivolumab is a novel therapy for RR cHL patients, previously with unmet need following relapse or refractory to autoHSCT and brentuximab vedotin. Our real life experience confirms and highlights the efficacy and safety of nivolumab in very heavily pretreated young and elderly patients with cHL eligible as well as ineligible for autologous HSCT. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

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Efficacy and safety of IFN-free antiviral therapy in patients with HCV recurrence after liver transplantation: real-life experience from Austria

Zeitschrift für Gastroenterologie ◽

10.1055/s-0035-1551752 ◽

2015 ◽

Vol 53 (05) ◽

Cited By ~ 1

Author(s):

S Beinhardt ◽

C Freissmuth ◽

R Al-Zoairy ◽

K Kozbial ◽

S Hamethner ◽

...

Keyword(s):

Liver Transplantation ◽

Antiviral Therapy ◽

Life Experience ◽

Real Life ◽

Efficacy And Safety

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Efficacy And Safety Of Pcsk9 Inhibitors: The Real-Life Experience Of The Lipid Clinic In Modena, Italy

Atherosclerosis ◽

10.1016/j.atherosclerosis.2019.06.608 ◽

2019 ◽

Vol 287 ◽

pp. e200

Author(s):

S. Lugari ◽

F. Nascimbeni ◽

A. Mondelli ◽

S. Bursi ◽

G. Onfiani ◽

...

Keyword(s):

Life Experience ◽

Real Life ◽

Efficacy And Safety ◽

Pcsk9 Inhibitors ◽

The Real ◽

Lipid Clinic

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Mucoactive Agents in the Therapy of Upper Respiratory Airways Infections: Fair to Describe Them Just as Mucoactive?

Clinical Medicine Insights Ear Nose and Throat ◽

10.1177/1179550618821930 ◽

2019 ◽

Vol 12 ◽

pp. 117955061882193 ◽

Cited By ~ 3

Author(s):

Francesco Scaglione ◽

Orlando Petrini

Keyword(s):

Clinical Trials ◽

Life Experience ◽

Real Life ◽

Symptomatic Treatment ◽

Comparable Efficacy ◽

Efficacy And Safety ◽

Important Place ◽

Upper Respiratory ◽

Randomised Controlled ◽

Tract Infections

Background: Upper and lower respiratory tract infections are common conditions for which medical advice is sought, and their management relies on the use of prescription and over-the-counter (OTC) medicines. Ambroxol, bromhexine, carbocysteine, erdosteine, N-acetyl cysteine (NAC), and sobrerol are mucoactive agents for which clinical trials have been conducted, have been awarded well-established status by regulatory authorities, and are available as OTC or prescription products. Objective: To briefly review the evidence-based efficacy and safety of these substances in the therapy of upper respiratory airways infections. Methods: We conducted searches in MEDLINE and other databases for clinical trials and reviews done on the efficacy and safety of ambroxol, bromhexine, carbocysteine, erdosteine, NAC, and sobrerol. Results: Clinical trials have shown that these mucolytics have an important place in the relief of cough symptoms by easing the elimination of mucus. All drugs have shown comparable efficacy in the symptomatic treatment of productive cough, with some shared characteristics and some specific features. Conclusions and relevance: All mucolytics reviewed have a good safety profile, although some precautions should be taken when using ambroxol and bromhexine, and the use of NAC and carbocysteine should be monitored in special patient groups. Overall, however, the available evidence from randomised, controlled, and observational trials, as well as pragmatic, real-life experience, suggests that these products are useful in the therapy of upper respiratory airways infections, including bronchitis, sinusitis, and rhinosinusitis.

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