ONE YEAR OF BIOSIMILAR FILGRASTIM IN ROUTINE CLINICAL PRACTICE

Objectives: The use of biosimilar filgrastim has been debated for the limited experience at the time of the approval. We performed a retrospective data analysis of 52 patients who underwent and completed a chemotherapy line for advanced solid tumour and received primary (n=46) or secondary (n=6) prophylaxis with biosimilar filgrastim (Zarzio®). Methods: All hospital day patients with an expected risk of FN >20% (n=21) or FN risk < 20% at high risk for infection (n=25), received 3 days (days 2−4) primary prophylaxis with subcutaneous bolus injections of Zarzio® 300 μg/die. Uneligible patients who developed severe neutropenia after the first cycle, received secondary prophylaxis. Blood tests were performed at the nadir and the day before chemotherapy. The primary end-point was to evaluate the efficacy and tolerability of Zarzio® in terms of severe neutropenia or overall FN incidence and duration. Results: Our retrospective data analysis involved 52 patients (median age 59.2 years) with fifteen aged ≥65 years and median body weight of 70 kg who received a total of 243 chemotherapy cycles (median 4.6 cycles/patient) and 651 Zarzio® administrations (median 12.5 administrations/patient). Severe neutropenia was recorded in 29/452 blood tests. None of the patients developed FN. Two patients received prophylactic antibiotics for severe neutropenia. None of the patients delayed the treatment for bone marrow toxicity. Conclusion: Our data confirmed the efficacy and safety of Zarzio® in routine clinical practice. The use of a three days schedule is actually under debate; longer schedule (5 up to 10 days) could improve the outcome

Matrix-Producing Carcinoma of the Breast: A Case Report

Matrix-producing breast cancer (MPC) is a subtype of metaplastic carcinoma of the breast. It is a very rare tumor, which constitutes less than 1% of all malignant mammary tumors. The origin of this tumor is still unclear: there are molecular studies that suggest an origin from myoepithelial cells, whereas other studies underline the neoplastic transformation of a multipotent stem cell. Even the differential diagnosis of MPC and other breast neoplasms (phyllodes tumors and real sarcomas of the breast) is not always easy. In the literature, a certain chemoresistance has been demonstrated, and a standard treatment of this tumor does not exist at this time. We report the case of a 44-year-old, premenopausal, female patient with a 6-cm breast lump. Neither imaging nor fine needle aspiration biopsy was crucial in achieving a diagnosis. The patient underwent a simple mastectomy. In consideration of the negative lymph node status, the patient was not subjected to radiotherapy or adjuvant chemotherapy. Moreover, since the receptor status was negative, hormone therapy was not necessary. The patient has been disease free for 4 years now

A preliminary study on the importance of normalization methods in Infrared Micro-Spectroscopy for biomedical applications

Fourier transformed infrared (FT-IR) micro spectroscopy has become a reliable, non-destructive and automatic tool to analyze the chemical differences in biological samples associated with healthy or diseased states for diagnostic or biomedical research purpose. To extract useful information from the huge number of spectra usually recorded, statistical multivariate analysis is applied and careful data pre-treatment to reduce or eliminate possible sources of error is necessary. In this regard, a quantitative criterion to evaluate the performance of different methods applied in the most sensitive pre-processing step, normalization, is proposed here. This could constitute a promising approach for validating the significance of chemical variations in complex samples of biomedical interest

Isochemotopic response: the first case on a scar

A 65-year-old male patient affected by adenocarcinoma of the lung received systemic chemotherapy. The regimen chosen by the oncologists was an association of both classic chemoterapeutic drugs and target therapy, specifically cisplatin, paclitaxel and pembrolizumab. Fifty-three years prior, the patient had underwent surgery for a non-specified thyroid carcinoma and, as a consequence of this, had a scar in the anterior region of the neck. The patient’s history was also positive for type 2 diabetes, in treatment with metformin, and a precedent cholecystectomy. During the third infusion of the expected chemotherapeutic protocol, the patient developed an acute inflammatory reaction upon the scar area. Upon clinical examination, it appeared erythematous, edematous and there was a mild temperature increase and an increased stiffness detectable upon palpation. The patient also complained of mild discomfort and referred that the last therapeutic cycle had been associated with weakness, diarrhea and fever that had resolved spontaneously within 24 hours from the infusion. Routine blood analysis were normal. Considering the history, there was a clear link between the therapy and the reaction. We defined this as “isochemotopic”

Diagnostic and prognostic utilities of multimarkers approach using procalcitonin, B-type natriuretic peptide, and neutrophil gelatinase-associated lipocalin in critically ill patients with suspected sepsis

BACKGROUND: We investigated the diagnostic and prognostic utilities of procalcitonin (PCT), B-type natriuretic peptide (BNP), and neutrophil gelatinase-associated lipocalin (NGAL) in critically ill patients with suspected sepsis, for whom sepsis was diagnosed clinically or based on PCT concentrations. METHODS: PCT, BNP, and NGAL concentrations were measured in 340 patients and were followed up in 109 patients. All studied biomarkers were analyzed according to the diagnosis, severity, and clinical outcomes of sepsis. RESULTS: Clinical sepsis and PCT-based sepsis showed poor agreement (kappa = 0.2475). BNP and NGAL showed significant differences between the two groups of PCT-based sepsis (P = 0.0001 and P < 0.0001), although there was no difference between the two groups of clinical sepsis. BNP and NGAL were significantly different according to the PCT staging and sepsis-related organ failure assessment subscores (P < 0.0001, all). BNP and PCT concentrations were significantly higher in the non-survivors than in the survivors (P = 0.0002) and showed an equal ability to predict in-hospital mortality (P = 0.0001). In the survivors, the follow-up NGAL and PCT concentrations were significantly lower than the initial values (148.7 ng/mL vs. 214.5 ng/mL, P < 0.0001; 0.61 ng/mL vs. 5.56 ng/mL, P = 0.0012). CONCLUSIONS: PCT-based sepsis diagnosis seems to be more reliable and discriminating than clinical sepsis diagnosis. Multimarker approach using PCT, BNP, and NGAL would be useful for the diagnosis, staging, and prognosis prediction in the critically ill patients with suspected sepsis

Diagnostic and prognostic utilities of multimarkers approach using procalcitonin, B-type natriuretic peptide, and neutrophil gelatinase-associated lipocalin in critically ill patients with suspected sepsis

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.Abstract Background We investigated the diagnostic and prognostic utilities of procalcitonin (PCT), B-type natriuretic peptide (BNP), and neutrophil gelatinase-associated lipocalin (NGAL) in critically ill patients with suspected sepsis, for whom sepsis was diagnosed clinically or based on PCT concentrations. Methods PCT, BNP, and NGAL concentrations were measured in 340 patients and were followed up in 109 patients. All studied biomarkers were analyzed according to the diagnosis, severity, and clinical outcomes of sepsis. Results Clinical sepsis and PCT-based sepsis showed poor agreement (kappa = 0.2475). BNP and NGAL showed significant differences between the two groups of PCT-based sepsis (P = 0.0001 and P < 0.0001), although there was no difference between the two groups of clinical sepsis. BNP and NGAL were significantly different according to the PCT staging and sepsis-related organ failure assessment subscores (P < 0.0001, all). BNP and PCT concentrations were significantly higher in the non-survivors than in the survivors (P = 0.0002) and showed an equal ability to predict in-hospital mortality (P = 0.0001). In the survivors, the follow-up NGAL and PCT concentrations were significantly lower than the initial values (148.7 ng/mL vs. 214.5 ng/mL, P < 0.0001; 0.61 ng/mL vs. 5.56 ng/mL, P = 0.0012). Conclusions PCT-based sepsis diagnosis seems to be more reliable and discriminating than clinical sepsis diagnosis. Multimarker approach using PCT, BNP, and NGAL would be useful for the diagnosis, staging, and prognosis prediction in the critically ill patients with suspected sepsis