1,721,013 research outputs found
Safety and efficacy of T-DM1 in HER2 positive metastatic breast cancer patients: a real word experience.
Full text linkBackground: T-DM1 is an antibody–drug conjugate that combines the antitumor effects of trastuzumab with a cytotoxic antimicrotubule agent that is only released in HER-positive tumor cells. It has been approved for the treatment of patients with HER2 positive metastatic breast cancer (MBC) pre-treated with trastuzumab + taxanes or progressing while on adjuvant trastuzumab, after the pivotal phase III trial EMILIA. The aim of this study is to audit the real life experience with T-DM1 at the University Hospital of Modena.
Material and methods: All patients treated with T-DM1 in our Institution between May 2014 – February 2016 were retroprospectively collected. All patients registered at the time of analysis were evaluated for safety and efficacy. Treatment toxicities were graded according to CTCAE version 4.0. Efficacy was assessed as per clinical practice.
Results: Twenty-two patients have been treated with T-DM1. The median age was 58 years (range 38-77), 50% of them with ECOG 1-2. With regards to tumor characteristics, 72% were hormonal receptor positive BC and 82% of patients had visceral involvement at the beginning of T-DM1. All patients received previous trastuzumab and taxane, 50% received anthracycline-based therapy too. 27% of patients were pre-treated with at least three prior chemotherapy lines for MBC. Pertuzumab was previously administered to one patient, lapatinib to 8 patients. The median number of T-DM1 cycles was 9 (range 1-30), with 50% of patients receiving 5 or more courses. All patients were assessed for efficacy: 36% obtained PR and 18% SD as the best response. The clinical benefit rate (CR+PR+SD>6months) was 45%. The median PFS was 9.0 months (CI 2.8–20.8). Six patients (27%) out of 22 died. Mild grade transaminitis was the most common side effect observed in 50% of patients, followed by fatigue in 41% of patients, thrombocytopenia in 35% and diarrhea in 28%. No grade 3 adverse events were observed, although two hypersensitivity reactions were reported.
Conclusions: T-DM1 administered outside the context of a clinical trial is safe, well tolerated, and with reproducible efficacy, consistent with those published in the EMILIA and TH3RESA studies
Impact of gefitinib ('Iressa') treatment on the quality of life of patients with advanced non-small-cell lung cancer
Full text linkPurpose: Patients with advanced non-small-cell lung cancer (NSCLC) have a short life expectancy; therefore, in addition to increasing their survival, improving their quality of life (QoL) is also an important treatment goal. Methods: We evaluated the QoL of patients with advanced NSCLC who were unfit to receive chemotherapy, failed to respond or progress following prior chemotherapy, who received subsequent treatment with gefitinib ('Iressa') on a compassionate use basis, using a standard QoL questionnaire, (EORTC) QLQ-C30 and the related lung cancer-specific module QLQ-LC13. Results: Analysis of the functional scales showed a trend towards improvement for role, emotional and cognitive scales, while a substantial stability was seen for general QoL scale. Analysis of the symptoms scales of QLQ-C30, showed a trend towards improvement for fatigue, dyspnoea, insomnia, and constipation, after one month of therapy. Fifty-six of the 57 patients were considered evaluable for response. One patient evidenced a partial response (patient is still on response), 29 patients had stable disease for a median duration of 5 months (range 4-7 months), and 26 patients progressed. Conclusions: After treatment with Gefitinib, we observed maintenance of QoL in a group of patients with poor prognosis that would be expected to have a worsening QoL. Furthermore important symptoms like dyspnoea fatigue and pain in other parts, that usually afflict patients with NSCLC, showed a trend toward improvement after only one month of therapy
Clinical Prognosticators in Patients Treated with CDK 4/6 Inhibitors for Hormone Receptors Positive Advanced Breast Cancer
Full text linkBackground: CDK4/6 inhibitors are the new standard of care in hormonal receptors positive (HR+) advanced
breast cancer (ABC). Phase III trials demonstrated an improvement in survival outcomes in patients with combined
endocrine approach compared to endocrine therapy (ET) alone. The aim of this retrospective study was to assess
prognostic factors for clinical response to CDK4/6 inhibitors.
Methods: All patients receiving CDK4/6 inhibitors from September 2016 to July 2019 were registered in a database.
Data on tumor and patient’s characteristics as well as concomitant medications were collected. Survival data were
analyzed by Kaplan Meier curves and log rank test. Treatment toxicities were graded according to CTCAE v5. A
drug-drug interactions analysis among CDK 4/6 inhibitors and co-administered medications was performed too.
Results: 121 patients were included in the study: 49% of patients treated in 1st -line, 25% in 2nd -line and 26%
in 3rd –or further lines. 1st-line objective response rate (ORR) and clinical benefit rate (CBR) was 56% and 68%,
compared to 40% and 50% in 2nd-line and 31% and 47% in heavily pre-treated patients, respectively. Median PFS
according to line setting was: not reached in 1st-line, 17 months (95% CI 13-21) in 2nd-line and 7 months (95% CI
4-12) in 3rd or further lines. Negative prognostic factors in term of PFS were: previous chemotherapy for metastatic
disease (p=0.0001), visceral metastatic sites (p=0.002) and endocrine sensitivity (p=0.001). No association among
concomitant drugs administered and survival outcome was found. 94% of patients experienced neutropenia (G3-G4
60%) with 3% of febrile neutropenia. 71% of patients treated with Abemaciclib had diarrhea. Management of AE
included 63% of treatment delay, 44% of 1st dose reduction and 15% of 2nd dose reduction, all due to neutropenia.
No treatment discontinuation due to any toxicity was observed.
Conclusion: Data on efficacy and safety profile of CDK 4/6 inhibitors administered outside the context of a clinical
trial are consistent with those reported in Phase III trials. Previous chemotherapy for metastatic disease, visceral
metastatic site as well as previous endocrine sensitivity negatively affect CDK 4/6 inhibitors efficacy. Concomitant
medications did not affect survival outcome or safety profile
Going Beyond Counting First Authors in Author Co-citation Analysis
Full text linkThe 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
Full text link“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
Full text linkWe 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
Full text linkWe 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
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