FLUDARABINE, CYCLOPHOSPHAMIDE AND RITUXIMAB (FCR) IN THE TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL): UNIVERSITY HOSPITAL CENTRE ZAGREB EXPERIENCE

U kliničkim je studijama kombinacija fludarabina, ciklofosfamida i rituksimaba (FCR) pokazala odlične rezultate u liječenju bolesnika s kroničnom limfocitnom leukemijom (KLL) i postala zlatni standard u prvoj liniji liječenja takvih bolesnika bez znatnijih komorbiditeta. Cilj rada bio je ispitati terapijsku djelotvornost, toksičnost i provedivost ovog protokola u svakodnevnoj kliničkoj praksi. Retrospektivno su analizirani tijek i ishodi liječenja 43-oje bolesnika s KLL-om sa Zavoda za hematologiju Klinike za unutarnje bolesti Kliničkoga bolničkog centra Zagreb. Shema primjene rituksimaba razlikovala se od one u kliničkim studijama; primjenjivan je infuzijski u dozi od 375 mg/m2 u svim ciklusima, u ukupno osam doza u prvoj, odnosno šest u kasnijim linijama liječenja. Na liječenje je odgovorilo 95% bolesnika, a 83% postignulo je kompletnu remisiju. Trogodišnje preživljenje i preživljenje bez progresije bolesti u prvoj liniji liječenja (29 bolesnika) bilo je 90 i 80%, a u kasnijim linijama 86 i 62%. Teške neutropenije zabilježene su u 46% bolesnika, a teške infekcije u 9% bolesnika. Ishodi liječenja i toksični profil u svakodnevnome kliničkom radu usporedivi su s onima iz kliničkih studijaIn clinical trials the combination of fludarabine, cyclophosphamide and rituximab (FCR) demonstrated superior results and became the gold standard for first-line treatment of fit patients with chronic lymphocytic leukemia (CLL). The aim of this study was to evaluate the efficacy, toxicity and feasibility of this protocol in everyday clinical practice. We ­retrospectively analyzed the outcomes of 43 CLL patients treated at the Division of Haematology, Department of Internal Medicine, University Hospital Centre Zagreb. The dosing of rituximab differed from that in clinical trials, we administered 375mg/m2 of rituximab per cycle, in previously untreated patients for eight and in relapsed/refractory patients for six cycles. The response rate was 95% with 83% of complete remissions. Twenty–nine patients received FCR as a front–line therapy; three-year overall and progression–free survival were 90% and 80%, respectively. In relapsed/refractory disease three–year overall and progression–free survival were 86% and 62%, respectively. Severe neutropenias occurred in 46% and serious infections in 9% of patients. According to these results, the toxicity profile and treatment outcomes in everyday routine clinical practice are similar to those reported in clinical trials

Fludarabin, ciklofosfamid i rituksimab (FCR) u liječenju bolesnika s kroničnom limfocitnom leukemijom (KLL): iskustvo Kliničkoga bolničkog centra Zagreb [Fludarabine, cyclophosphamide and rituximab (FCR) in the treatment of chronic lymphocytic leukemia (CLL): University Hospital Centre Zagreb experience]

In clinical trials the combination of fludarabine, cyclophosphamide and rituximab (FCR) demonstrated superior results and became the gold standard for first-line treatment of fit patients with chronic lymphocytic leukemia (CLL). The aim of this study was to evaluate the efficacy, toxicity and feasibility of this protocol in everyday clinical practice. We ­retrospectively analyzed the outcomes of 43 CLL patients treated at the Division of Haematology, Department of Internal Medicine, University Hospital Centre Zagreb. The dosing of rituximab differed from that in clinical trials, we administered 375mg/m2 of rituximab per cycle, in previously untreated patients for eight and in relapsed/refractory patients for six cycles. The response rate was 95% with 83% of complete remissions. Twenty–nine patients received FCR as a front–line therapy; three-year overall and progression–free survival were 90% and 80%, respectively. In relapsed/refractory disease three–year overall and progression–free survival were 86% and 62%, respectively. Severe neutropenias occurred in 46% and serious infections in 9% of patients. According to these results, the toxicity profile and treatment outcomes in everyday routine clinical practice are similar to those reported in clinical trials

Non-Myelofibrosis Chronic Myeloproliferative Neoplasm Patients Show Better Seroconversion Rates after SARS-CoV-2 Vaccination Compared to Other Hematologic Diseases: A Multicentric Prospective Study of KroHem

Disease- and treatment-mediated immunodeficiency might render SARS-CoV-2 vaccines less effective in patients with hematologic diseases. We performed a prospective non-interventional study to evaluate humoral response after one and two doses of mRNA-1273, BNT162b2, or ChAdOx1 nCoV-19 vaccine in 118 patients with different malignant or non-malignant hematologic diseases from three Croatian treatment centers. An electrochemiluminescent assay was used to measure total anti-SARS-CoV-2 S-RBD antibody titers. After one vaccine dose, 20/66 (33%) achieved seropositivity with a median antibody titer of 6.1 U/mL. The response rate (58/90, 64.4%) and median antibody titer (>250 U/mL) were higher after two doses. Seropositivity varied with diagnosis (overall p 67 years, non-Hodgkin’s lymphoma, active treatment, and anti-CD20 monoclonal antibody therapy increased the likelihood of no vaccine response, while hematopoietic stem cell recipients were more likely to respond. Age and anti-CD20 monoclonal antibody therapy remained associated with no response in a multivariable model. Patients with the hematologic disease have attenuated responses to SARS-CoV-2 vaccines, and significant variations in different disease subgroups warrant an individualized approach