A high percentage of discontinuations due to adverse events and voluntary withdrawal was found, particularly early during treatment. Patients who may therapeutically benefit from this regimen, particularly naïve subjects, should be identified, and interventions to improve adherence and optimize recovery parameters should be implemented.
Almost a quarter of the patients discontinued treatment with tenofovir during the study. The main cause for this was adverse effects. No association was found between any abnormal basal analytical parameter and a greater probability of discontinuing treatment.
Background Eribulin’s clinical benefit remains unclear; so, studies analyzing its effectiveness in routine clinical practice are interesting. Patients and methods This is a multicenter, retrospective study including patients with human epidermal growth factor receptor-2-negative metastatic breast cancer which assesses effectiveness and safety of eribulin. Results A total of 140 women were included, with a median age of 57 years. The median overall survival and progression-free survival were 8.8 (95% confidence interval: 6.1–11.4) and 2.8 months (95% confidence interval: 2.5–3.1), respectively. For patients with hormonal receptor expression, a significantly longer progression-free survival was observed: 3.4 (95%confidence interval: 2.3–4.5) versus triple negative: 2.0 (95%confidence interval: 1.7–2.3) months, p = 0.003. Also, those who had received capecitabine prior to eribulin had a higher median overall survival than those who had not received it (9.5 months, 95% confidence interval: 6.6–12.5 vs. 4.8 months, 95% confidence interval: 3.4–6.2; p = 0.001). When only triple-negative patients were included, median overall survival was 6.5 (95% confidence interval: 0.1–16.2) for those who had received previous capecitabine versus 4.3 (95% confidence interval: 2.8–5.8) months for patients who had not received it; p =0.006. The safety profile of eribulin was adequate. Conclusion Effectiveness of eribulin in a real-life human epidermal growth factor receptor-2--negative population is lower than that observed in clinical trials. Its benefit seems to be higher in patients with hormonal receptor expression and patients who had received capecitabine prior to eribulin. The safety profile of eribulin is adequate.
Background
Clinical trials of atezolizumab for locally advanced or metastatic urothelial bladder cancer (mUBC) report controversial efficacy data. Moreover, real-world evidence regarding this use is limited.
Aim
We aimed to evaluate the effectiveness of atezolizumab in a real-world population with mUBC, to explore the effectiveness in relation to certain poor prognostic criteria such as performance status by Eastern Oncology Cooperative Group (ECOG), hemoglobin levels, and liver metastases, and to determine the safety profile of atezolizumab.
Methods
This multicenter, retrospective real-world study included previously treated mUBC patients who received atezolizumab. The primary endpoint was overall survival (OS). Furthermore, progression-free survival (PFS), the best response reached, and safety data were analyzed. A descriptive analysis was performed, while OS and PFS were estimated using the Kaplan-Meier method.
Results
185 patients (84.9% men, median age 69 years) were included. Median PFS was 4.8 months [95% confidence interval (CI) 3.6-6.0], and median OS was 20.0 months (95% CI 11.8–28.5), with an objective response rate of 28.1%. OS was higher for patients with ECOG 0–1 [24.5 months (95% CI 14.5–34.6) vs 5.2 (95% CI 4.4-6.0), p = 0.004]; and for patients without liver metastases [25.4 months (95% CI 16.2–34.6) vs 6.4 months (95% CI 4.0-8.1), p = 0.006]. Regarding hemoglobin levels, no survival differences were detected. Adverse events were reported in 55.1% of patients.
Conclusion
In a real-world population with previously treated mUBC, atezolizumab appears to provide a clinically relevant benefit, which is even greater for patients with ECOG 0–1 and those without liver metastases, maintaining an acceptable safety profile.
Introduction Hypogammaglobulinemia after front-line immunochemotherapy for follicular lymphoma is a poorly studied adverse event that could be related to the appearance of severe and/or recurrent non-neutropenic infections which could affect the quality of life of the patients, even motivating a need of long-term replacement therapy with human immunoglobulins. Methods Observational, retrospective study aiming to estimate the incidence of hypogammaglobulinemia, as well as its severity and clinical consequences, and to explore possible predictive factors for its development. Specific immunoglobulin deficiencies were also studied. Results 76.5% of patients had hypogammaglobulinemia during or after front-line treatment, mostly grade 1-2; with 38.8% patients who developed clinically relevant infections and 20% patients requiring human immunoglobulins replacement therapy. A high-risk FLIPI score was identified as a risk factor for hypogammaglobulinemia (ods ratio: 4.51; 95% confidence interval: 1.29–15.68; p < 0.001) and basal gamma globulin level as a protective factor (odds ratio: 0.92; 95% confidence interval: 0.988–0.996; p = 0.018). Any type of immunochemotherapy regimen was associated with different risks of hypogammaglobulinemia in our study. Conclusions Hypogammaglobulinemia appears in a high percentage of patients with follicular lymphoma in a real-world population, identifying a high-risk FLIPI score as a risk factor for its development and basal gamma globulins as a protective factor.
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