RESUMEN
Polatuzumab vedotin (Pola) is an approved therapy in combination with rituximab and bendamustine for relapsed or refractory diffuse large B-cell lymphoma (RR-DLBCL) based on positive results of the landmark phase II randomised G029365 trial. However, trial results for many approved novel therapies in RR-DLBCL have not been replicated in routine care cohorts, as RR-DLBCL patient populations are heterogeneous and trial eligibility is increasingly restrictive. We evaluated outcomes from pola ± bendamustine and rituximab in patients with RR-DLBCL enrolled in a compassionate access program with no alternative treatment options identified via the Australasian Lymphoma and Related Diseases Registry according to their eligibility for the original phase II published study. Of 58 eligible patients, 74% met the criteria deeming them ineligible for the G029365 original study at the time of pola's commencement. Median progression-free survival and overall survival in our cohort were 2.3 and 3.5 months, respectively. In contrast to the landmark trial cohort, more of our patients ceased therapy prior to completion, the majority due to progressive disease and only 8/58 received any subsequent treatment. Dismal outcomes in this Australian real-world population demonstrate trial eligibility is challenging to meet, and newer treatments can be difficult to deliver in routine care. Clinically applicable results from therapeutic studies require trial cohorts to reflect representative clinical populations wherever possible, and more research is required to address the benefit of novel agents in the increasing majority who are ineligible for modern studies.
RESUMEN
Background: Immune thrombocytopenia (ITP) has been reported following COVID-19 vaccination. After index case fatalities, there was concern among patients both with and without a prior history of ITP in Australia. Objectives: To describe treatment outcomes of ITP after COVID-19 vaccination and compare relapsed vs historical pre-COVID-19 ITP cohorts. Methods: We collected ITP cases in Australia within 6 weeks of receiving any COVID-19 vaccination as part of primary vaccination (up to October 17, 2021). Second, we reviewed platelet charts in a historical ITP cohort to determine whether platelet variability was distinct from relapsed ITP after vaccination. Results: We report on 50 patients (37 de novo, 13 relapsed ITP) vaccinated from March 22, 2021, to October 17, 2021. Although there was 1 fatality, bleeding was otherwise mostly minor: (70% WHO bleeding grade <2). De novo ITP was more likely after AstraZeneca ChAdOx1 nCoV-19 (89%) than Pfizer BNT162b2 (11%). Most patients responded quickly (median, 4 days; complete response, 40 of 45 [89%]). In the historical cohort, only 6 of 47 patients exhibited platelet variability (>50% decrease and platelets <100 × 109/L), but median platelet nadir was significantly higher than vaccination relapse (27 vs 6 × 109/L, P =.005). Conclusion: ITP was more frequently reported after AstraZeneca ChAdOx1 nCoV-19 than Pfizer BNT162b2 vaccination. Standard ITP treatments remain highly effective for de novo and relapsed ITP (96%). Although thrombocytopenia can be severe after vaccination, bleeding is usually mild. Despite some sampling bias, our data do not support a change in treatment strategies for patients with ITP after vaccination.
RESUMEN
BACKGROUND AND OBJECTIVES: Transfusion-associated circulatory overload is a leading cause of transfusion-related adverse events. The frequency and risks for transfusion-associated circulatory overload in ambulatory haematology patients are not known. MATERIALS AND METHODS: A retrospective cohort analysis of ambulatory patients transfused in a tertiary haematology centre, using medical records and an electronic transfusion database, was undertaken between January and December 2014. Variables studied included age, gender, diagnosis, heart failure, kidney disease and details of transfusions. Transfusion-associated circulatory overload was defined according to proposed International Society of Blood Transfusion criteria. Patients with clinical evidence of hypervolaemia, not meeting the TACO definition and/or who were prescribed otherwise unscheduled diuretic agent, were collectively deemed to be at 'risk of clinically significant hypervolaemia' (ROCSH). RESULTS: In the study period, 93 ambulatory patients (male = 49, female = 44, mean age = 75·89 ± 11·37 years) attended 715 transfusion encounters, totalling 1536 packed red cell units. No cases of TACO occurred whilst 'ROCSH' events occurred in 57/715 (8%) of transfusion encounters. In a univariate model, age was significantly associated with 'ROCSH', odds ratio = 1·05 (P = 0·017 95%, CI 1·01-1·09) and no factors were significant on multivariate analysis. CONCLUSIONS: Transfusion-associated circulatory overload occurs infrequently haematology patients receiving ambulatory blood transfusions. To our knowledge, this is the first study to report on occurrence and risk factors for circulatory overload in ambulatory transfusions. This study provides vital baseline data for future prospective studies on this important aspect of haemovigilance.
