Background: Immunosuppressive therapy is a known risk factor for hepatits B reactivation. The highest risk is reported in hematologic patients treated with anti-CD20 monoclonal antibodies, glucocorticoids and hematopoietic stem cell transplantation. Currently, treatment with tyrosine kinase inhibitors (TKIs) in the vast majority of chronic myeloid leukemia (CML) patients is life-long. Recently healthcare professionals were advised to test for hepatitis B infection before initializing therapy with TKIs and closely monitor HBV carriers. The risk is considered class effect with all TKIs and recommendations are based on case reports. Aim: The aim of the current study was to evaluate the risk of hepatitis B reactivation in patients with CML treated with TKIs. Methods: The records of patients with CML treated with TKIs from a single center were systematically reviewed for hepatitis B serology and serum biochemistry. Results: One hundred eighty one patients diagnosed with CML between the years 1983 and 2016 were evaluated. The median age at diagnosis was 49.7 years (range 18-89), 117/181 (65%) males, with median duration of follow up with TKI therapy of 5.3 years (range 0.4 to 33 years). Over a total of 1195 years of therapy with TKIs no cases of HBV reactivation were identified. Among 114 patients with hepatitis serology, 11 patients (10%) had evidence of prior resolved HBV infection (HBsAg negative/anti-HBc positive). Two of them had anti-HBs positive serology, one had negative PCR for HBV DNA and other two patients received lamivudine prophylaxis. Only one patient had HBsAg positive serology. None of the patients with positive hepatitis serology had clinical or biochemistry evidence of hepatitis B reactivation. The 67 patients without available hepatitis serology had normal liver transaminases at 6 months of TKI therapy and at last day of follow up, confirming that no overt hepatitis B reactivation occurred. Conclusions: We evaluated hepatitis B reactivation in a rather large cohort of CML patients, treated with TKIs. Although there were no cases of HBV reactivation during long term follow up, it should be emphasized that even a low incidence may exert a significant risk due to the long duration of treatment in a chronic disease with lifelong therapy. Our study infers that patients with serology of prior resolved HBV infection are at low risk for hepatitis B reactivation. Larger cohorts of patients with positive hepatitis B serology in a multicenter long term evaluation should be performed in order to address current recommendations for patients' safety and concerns. Disclosures No relevant conflicts of interest to declare.
Gemcitabine-based salvage therapy is considered an effective treatment for relapsed and refractory Non-Hodgkin’s lymphoma (NHL). We analyzed the outcome of 41 consecutive NHL patients treated with gemcitabine-based regimens between January 2007 and October 2015. Twenty-eight males and 13 females (median age 66.4 years) were included. The median follow-up from gemcitabine initiation was 7.3 months. Thirty patients (73%) had B-cell, and eleven (27%) had T-cell, lymphoma. All patients received a median of 2 prior regimens, of which at least 1 was anthracycline based. Twenty-eight patients (78%) received full-dose while 9 (22%) received reduced-dose regimens. The overall response rate was 37%, with 24% (n = 10) complete response, 12% (n = 5) partial response, and 63% (n = 22) progressive disease or stable disease. The median progression-free survival (PFS) was 47 days (range 12–1,318), the median overall survival (OS) was 1.9 years. Twenty patients (49%) died during follow-up. Grade 3–4 hematological toxicity was reported in 21 patients (51%). Relapsed vs. refractory disease, as well as a response to gemcitabine, predicted better PFS and OS. Use of a full-dose regimen predicted a better OS. Compared to previously published data, we observed less favorable outcomes. The administration of gemcitabine-based therapy as a salvage regimen for patients with relapsed or refractory NHL had limited success. Innovative therapies for these patients are an unmet need.
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