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.
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.
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