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1.
Blood ; 140(4): 349-358, 2022 07 28.
Article in English | MEDLINE | ID: covidwho-1978749

ABSTRACT

CD19-directed chimeric antigen receptor (CAR) T cells have evolved as a new standard-of-care (SOC) treatment in patients with relapsed/refractory (r/r) large B-cell lymphoma (LBCL). Here, we report the first German real-world data on SOC CAR T-cell therapies with the aim to explore risk factors associated with outcomes. Patients who received SOC axicabtagene ciloleucel (axi-cel) or tisagenlecleucel (tisa-cel) for LBCL and were registered with the German Registry for Stem Cell Transplantation (DRST) were eligible. The main outcomes analyzed were toxicities, response, overall survival (OS), and progression-free survival (PFS). We report 356 patients who received axi-cel (n = 173) or tisa-cel (n = 183) between November 2018 and April 2021 at 21 German centers. Whereas the axi-cel and tisa-cel cohorts were comparable for age, sex, lactate dehydrogenase (LDH), international prognostic index (IPI), and pretreatment, the tisa-cel group comprised significantly more patients with poor performance status, ineligibility for ZUMA-1, and the need for bridging, respectively. With a median follow-up of 11 months, Kaplan-Meier estimates of OS, PFS, and nonrelapse mortality (NRM) 12 months after dosing were 52%, 30%, and 6%, respectively. While NRM was largely driven by infections subsequent to prolonged neutropenia and/or severe neurotoxicity and significantly higher with axi-cel, significant risk factors for PFS on the multivariate analysis included bridging failure, elevated LDH, age, and tisa-cel use. In conclusion, this study suggests that important outcome determinants of CD19-directed CAR T-cell treatment of LBCL in the real-world setting are bridging success, CAR-T product selection, LDH, and the absence of prolonged neutropenia and/or severe neurotoxicity. These findings may have implications for designing risk-adapted CAR T-cell therapy strategies.


Subject(s)
Lymphoma, Large B-Cell, Diffuse , Neutropenia , Antigens, CD19 , Germany/epidemiology , Humans , Immunotherapy, Adoptive/adverse effects , Lymphoma, Large B-Cell, Diffuse/pathology , Neutropenia/chemically induced
2.
Neuropsychopharmacol Rep ; 42(2): 238-240, 2022 06.
Article in English | MEDLINE | ID: covidwho-1680520

ABSTRACT

Clozapine is an atypical antipsychotic used for treatment-resistant schizophrenia and is known to cause serious side effects, such as leukopenia and neutropenia. We encountered the case of a 44-year-old female patient with a good response to clozapine, who experienced inflammatory reaction and cytopenia after coronavirus disease 2019 (COVID-19) vaccination. Soon after clozapine discontinuation, the inflammatory reaction resolved, and cell counts recovered. There are only a few reports on the interaction between clozapine and COVID-19 vaccine. Our findings suggest that caution is required when a patient who is receiving clozapine scheduled for COVID-19 vaccination, owing to the possibility of cytopenia. Moreover, blood tests and the measurement of clozapine concentration should be performed before and after the inoculation to ensure patient safety.


Subject(s)
COVID-19 , Clozapine , Neutropenia , Schizophrenia , Adult , COVID-19/drug therapy , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Clozapine/adverse effects , Female , Humans , Neutropenia/chemically induced , RNA, Messenger , Schizophrenia/drug therapy , Vaccination
3.
BMJ Case Rep ; 14(11)2021 Nov 30.
Article in English | MEDLINE | ID: covidwho-1546482

ABSTRACT

Neutropenia is a rare haematological complication of COVID-19 infection in immunocompetent patients. There is sparse literature on neutropenia in patients with COVID-19, except a few case reports. We encountered a similar case in an intensive care unit that developed severe neutropenia on day 24 of illness. Neutropenia resolved spontaneously on 4th day of its appearance. The patient was isolated and kept under close observation, antibiotics were upgraded and strict asepsis was maintained. Thus, we observed in a patient with no comorbidities and uncomplicated neutropenia that strict measures to prevent infection may suffice and the undue risk of hematopoietic therapy can be avoided. An expert opinion should always be sought in such cases as the presence of complications may require an aggressive approach.


Subject(s)
COVID-19 , Neutropenia , Anti-Bacterial Agents/therapeutic use , Humans , Intensive Care Units , Neutropenia/chemically induced , Neutropenia/drug therapy , SARS-CoV-2
4.
Cancer Discov ; 11(10): 2430-2435, 2021 10.
Article in English | MEDLINE | ID: covidwho-1472319

ABSTRACT

We had previously reported short-term efficacy, immunogenicity, and safety of the BNT162b2 vaccine among cancer patients with solid tumors. We aimed to evaluate these outcomes at six months postvaccination. The study cohort comprised patients who were on treatment during vaccination and throughout six months postvaccination. Serologic tests were performed after second vaccination and six months afterward. An age-matched cohort of health care workers served as controls. Documentation of COVID-19 infection, blood tests, and imaging studies during the study period was reviewed. Participants included 154 patients and 135 controls. Six months postvaccination, 122 (79%) patients were seropositive compared with 114 (84%) controls (P = 0.32). Serology titer dramatically decreased in a similar manner in both cohorts. No COVID-19 cases were documented in controls, and one case occurred in patient cohort. All previously reported adverse effects resolved. Taken together, the pattern of immunogenicity, efficacy, and safety of BNT162b2 in patients with cancer with solid tumors at six months postvaccination resembles that of the general population. SIGNIFICANCE: Evidence regarding efficacy and safety of COVID-19 vaccines in patients with cancer indicate a favorable short-term profile. Immunomodulation due to anticancer treatments may affect immunity and immunogenicity of patients with cancer to the BNT162b2 vaccine over time. Our study sheds light on these long-term outcomes and portrays a trend that resembles the general population.This article is highlighted in the In This Issue feature, p. 2355.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/pharmacology , Neoplasms , Adult , Aged , Aged, 80 and over , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/immunology , Health Personnel , Humans , Male , Middle Aged , Neoplasms/drug therapy , Neutropenia/chemically induced , Thrombocytopenia/chemically induced , Time-to-Treatment , Vaccination
5.
Cancer Discov ; 11(10): 2430-2435, 2021 10.
Article in English | MEDLINE | ID: covidwho-1394287

ABSTRACT

We had previously reported short-term efficacy, immunogenicity, and safety of the BNT162b2 vaccine among cancer patients with solid tumors. We aimed to evaluate these outcomes at six months postvaccination. The study cohort comprised patients who were on treatment during vaccination and throughout six months postvaccination. Serologic tests were performed after second vaccination and six months afterward. An age-matched cohort of health care workers served as controls. Documentation of COVID-19 infection, blood tests, and imaging studies during the study period was reviewed. Participants included 154 patients and 135 controls. Six months postvaccination, 122 (79%) patients were seropositive compared with 114 (84%) controls (P = 0.32). Serology titer dramatically decreased in a similar manner in both cohorts. No COVID-19 cases were documented in controls, and one case occurred in patient cohort. All previously reported adverse effects resolved. Taken together, the pattern of immunogenicity, efficacy, and safety of BNT162b2 in patients with cancer with solid tumors at six months postvaccination resembles that of the general population. SIGNIFICANCE: Evidence regarding efficacy and safety of COVID-19 vaccines in patients with cancer indicate a favorable short-term profile. Immunomodulation due to anticancer treatments may affect immunity and immunogenicity of patients with cancer to the BNT162b2 vaccine over time. Our study sheds light on these long-term outcomes and portrays a trend that resembles the general population.This article is highlighted in the In This Issue feature, p. 2355.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/pharmacology , Neoplasms , Adult , Aged , Aged, 80 and over , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/immunology , Health Personnel , Humans , Male , Middle Aged , Neoplasms/drug therapy , Neutropenia/chemically induced , Thrombocytopenia/chemically induced , Time-to-Treatment , Vaccination
7.
BMJ Case Rep ; 14(5)2021 May 12.
Article in English | MEDLINE | ID: covidwho-1226744

ABSTRACT

A novel coronaravirus, identified as SARS-CoV-2, spread throughout the world in 2020. The COVID-19 pandemic has led to many discoveries and clinical manifestations. A young patient is presented with new, self-resolving neutropenia presenting weeks after a prolonged hospital stay for COVID-19 pneumonia. Workup included analysis for underlying infection, nutritional abnormalities, malignancy, medication and toxin exposure, all of which were negative. From 2020 to the present, few reports have described neutropenia associated with a recent COVID-19 infection. In particular, no reports have described a delayed presentation of neutropenia. The authors would like to propose that the significant inflammatory response associated with COVID-19 is likely what led to this patient's postviral neutropenia. Furthermore, in young healthy patients, bone marrow biopsy may be deferred and a watchful-waiting approach may be taken to assess for neutropenia resolution.


Subject(s)
COVID-19 , Neoplasms , Neutropenia , Humans , Neutropenia/chemically induced , Neutropenia/drug therapy , Pandemics , SARS-CoV-2
8.
BMJ Case Rep ; 14(3)2021 Mar 22.
Article in English | MEDLINE | ID: covidwho-1186263

ABSTRACT

A 61-year-old man was transferred to our facility from an outside hospital due to refractory neutropaenia of unknown aetiology. The patient presented to the referring hospital with a 5-day history of worsening diarrhoea and abdominal pain. Initial lab results at presentation showed severe neutropaenia with an absolute neutrophil count of 0. Investigations included a bone marrow biopsy which showed slightly hypocellular marrow with near absence of granulocytic precursors. A CT without contrast showed evidence of chronic pancreatitis and acute colitis. The patient's neutropaenia persisted despite granulocyte colony-stimulating factor therapy. The patient was, thus, transferred to our facility for a higher level of care. At our facility, the patient had rapid correction of neutropaenia after discontinuation of pancrelipase therapy. The patient's abdominal pain and diarrhoea also improved while off pancrelipase. Neutropaenia has completely resolved 6 weeks after discharge without any further therapy.


Subject(s)
Neutropenia , Pancrelipase , Granulocyte Colony-Stimulating Factor , Granulocytes , Humans , Leukocyte Count , Male , Middle Aged , Neutropenia/chemically induced
9.
J Psychiatry Neurosci ; 46(2): E232-E237, 2021 03 11.
Article in English | MEDLINE | ID: covidwho-1127808

ABSTRACT

Background: Monitoring of white cell counts during clozapine treatment leads to cessation of therapy if levels fall below predetermined values. Reductions in white cell counts, driven by lower levels of lymphocytes, have been observed with coronavirus disease 2019 (COVID-19). Neutropenia during COVID-19 has not been reported. We present data for 56 patients who were taking clozapine and had COVID-19. Methods: We included patients who were taking clozapine at the time they tested positive for COVID-19. We compared absolute neutrophil counts, lymphocyte counts and white cell counts between baseline and the first week of infection, and baseline and the second week of infection. Results: We observed reductions in absolute neutrophil counts (p = 0.005), lymphocyte counts (p = 0.003) and white cell counts (p < 0.001) between baseline and the first 7 days of COVID-19. All cell counts had returned to baseline levels by days 8 to 14. Six patients experienced neutropenia (absolute neutrophil counts < 2.0 × 109/L) and of those, 4 underwent mandatory cessation of clozapine. For 3 patients, clozapine treatment had been established for more than 6 months with no previous neutropenia, neutrophil levels returned to baseline within 2 weeks and no further neutropenia was observed on restarting treatment. Limitations: This was a retrospective chart review; larger cohorts are required. Clozapine plasma levels were largely not measured by clinicians. Conclusion: These data strongly suggest that mild neutropenia in the acute phase of COVID-19 in patients who are well established on clozapine is more likely to be a consequence of the virus than of clozapine treatment.


Subject(s)
Antipsychotic Agents/adverse effects , COVID-19/complications , Clozapine/adverse effects , Neutropenia/etiology , Psychotic Disorders/drug therapy , Schizophrenia/drug therapy , Adult , Aged , Aged, 80 and over , Antipsychotic Agents/therapeutic use , COVID-19/blood , Clozapine/therapeutic use , Female , Humans , Leukocyte Count , Leukopenia/etiology , Lymphocyte Count , Lymphopenia/etiology , Male , Middle Aged , Neutropenia/chemically induced , Neutrophils , Retrospective Studies , SARS-CoV-2 , Young Adult
10.
Br J Clin Pharmacol ; 87(7): 2902-2906, 2021 07.
Article in English | MEDLINE | ID: covidwho-979671

ABSTRACT

Metamizole is commonly used as analgesic and antipyretic drug. The use of metamizole is prohibited in several countries due to its rare side effect of neutropenia and even agranulocytosis. Among the many symptoms of COVID-19, fever and diffuse pain predominant and therefore it can be assumed that metamizole may be widely used in the current epidemic period. So far, there have been no reports on the safety of metamizole in COVID-19 patients. We describe a series of 3 patients who developed severe neutropenia under metamizole treatment, raising a concern of a possible increased risk of this side effect among COVID-19 patients.


Subject(s)
COVID-19 , Neutropenia , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Dipyrone/adverse effects , Humans , Neutropenia/chemically induced , Neutropenia/epidemiology , SARS-CoV-2
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