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    Biosimilar filgrastim in routine clinical practice: a single centre experience.

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    Introduction: The use of recombinant human granulocyte colony-stimulating factors (rh-G-CSF) has significantly increased the ability to maintain effective schedules and doses of chemotherapy regimens with severe medullary toxicity. However, despite numerous guidelines, the use of rh-G-CSFs in clinical practice is often suboptimal, occurring on a non-systematic case-by-case basis. The availability of biosimilar filgrastim at significantly reduced costs may allow more patients to benefit from growth factor support with comparable results to the originator filgrastim in terms of febrile neutropenia (FN) risk reduction. We performed a retrospective data analysis of 42 patients who underwent chemotherapy for advanced solid tumours and received primary prophylaxis with biosimilar filgrastim (Zarzio®). Methods: All hospital day patients with an expected risk of FN >20% based on their scheduled chemotherapy regimen received 3 days (days 2−4) primary prophylaxis with subcutaneous bolus injections of Zarzio® 300 μg. Patients with FN < 20% and poor bone marrow reserve or other severe co-morbidities and at high risk for infection also received primary prophylaxis. Blood tests were performed at the nadir and the day before the next cycle of treatment. Patients were usually asked to repeat each test in the same laboratory. The primary end-point was the efficacy and tolerability of primary prophylaxis with Zarzio® in terms of severe neutropenia and overall FN incidence and duration in unselected cancer patients in routine clinical practice. Treatment related toxicity (predominantly muscle-skeletal events) was evaluated through the NCI CTC 3.0. Results: We analysed data from 42 patients (male, n=14; female n=28) with advanced solid tumours (breast, n=15; endometrial/ovarian, n=7; non-small-cell lung, n=6; gastric, n=5; others, n=9) who received primary prophylaxis with Zarzio® for FN. Median age was 58 years (range: 26−82), with one-third of patients (n=14) aged ≥65 years. Median body weight was 68 kg (range 44−101). Eighteen patients received primary prophylaxis because of an FN risk >20% and 24 because of associated co-morbidities. A total of 185 chemotherapy cycles was administered (median 4.4 cycles/patient). Zarzio® was administered 538 times (median 12 administrations/patient). Severe neutropenia (ANC ≤ 1100 x 109/L) was recorded in 24/401 blood tests. None of the patients developed FN. Musculoskeletal event (arthralgia, myalgia, bone pain) after Zarzio® administration were as expected ; two patients reported cutaneous rash and one patient had hypotension. There were no significant differences between the elderly population (aged ≥65 years) and patients aged <65 years in terms of toxicity or severe neutropenic events (11 versus 13 events, OR: 0.57, 95% CI 0.24−1.31, p= 0.18). Conclusion: Our retrospective analysis in unselected patients confirmed the efficacy and safety profile of Zarzio® in routine clinical practice. No patients developed FN or had delayed treatment because of severe neutropenia. Elderly patients (33.3% of the study population) did not differ significantly from other patients in terms of treatment tolerability and efficacy

    ONE YEAR OF BIOSIMILAR FILGRASTIM IN ROUTINE CLINICAL PRACTICE

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    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 &gt;20% (n=21) or FN risk &lt; 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

    Going Beyond Counting First Authors in Author Co-citation Analysis

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    The present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed

    Variations on the Author

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    “Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship

    Appropriate Similarity Measures for Author Cocitation Analysis

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    We provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis

    Dispelling the Myths Behind First-author Citation Counts

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    We conducted a full-scale evaluative citation analysis study of scholars in the XML research field to explore just how different from each other author rankings resulting from different citation counting methods actually are, and to demonstrate the capability of emerging data and tools on the Web in supporting more realistic citation counting methods. Our results contest some common arguments for the continued use of first-author citation counts in the evaluation of scholars, such as high correlations between author rankings by first-author citation counts and other citation counting methods, and high costs of using more realistic citation counting methods that are not well-supported by the ISI databases. It is argued that increasingly available digital full text research papers make it possible for citation analysis studies to go beyond what the ISI databases have directly supported and to employ more sophisticated methods

    Author Index

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