Risk Factors for Severe Neuropsychiatric Toxicity in Patients Receiving Interferon Alfa-2b and Low-Dose Cytarabine for Chronic Myelogenous Leukemia: Analysis of Cancer and Leukemia Group B 9013

2000 ◽  
Vol 18 (6) ◽  
pp. 1301-1308 ◽  
Author(s):  
Martee L. Hensley ◽  
Bercedis Peterson ◽  
Richard T. Silver ◽  
Richard A. Larson ◽  
Charles A. Schiffer ◽  
...  
Keyword(s):  
Risk Factors ◽  
Chronic Myelogenous Leukemia ◽  
Psychiatric Diagnosis ◽  
Interferon Alfa ◽  
Myelogenous Leukemia ◽  
Recombinant Interferon ◽  
History Of ◽  
Neuropsychiatric Toxicity ◽  
Group B ◽  
Leukemia Group

PURPOSE: Recombinant interferon alfa-2b (rIFNα2b) is a standard therapy for chronic myelogenous leukemia (CML). Severe neuropsychiatric toxicity has been described in patients receiving rIFNα2b, although the frequency of and the risk factors for developing this toxicity are not well described. The purpose of this study was to identify predictors for the development of severe neuropsychiatric toxicity in CML patients receiving rIFNα2b-based therapy. PATIENTS AND METHODS: From a prospective cohort of 91 Philadelphia chromosome–positive, previously untreated, chronic-phase CML patients treated on Cancer and Leukemia Group B (CALGB) 9013, a phase II trial of rIFNα2b plus cytarabine, the following were recorded at baseline: age, sex, race, pretreatment history of neurologic or psychiatric diagnosis, spleen size, blood counts, and peripheral blast count. Best response to treatment, rIFNα2b cumulative dose, dose duration, and dose-intensity were recorded during follow-up. Severe neuropsychiatric toxicity was defined as grade 3 or 4 events, according to CALGB expanded common toxicity criteria. Univariate and multivariate logistic regression analyses were used to identify variables that were associated with the development of severe neuropsychiatric toxicity. RESULTS: Severe neuropsychiatric toxicity developed in 22 patients (24.0%; 95% confidence interval [CI], 15.2% to 32.8%). Toxicity resolved after withdrawal of treatment in all patients. Five of six patients developed recurrence of symptoms with rechallenge. Twelve (63%) of 19 patients with a pretreatment neurologic or psychiatric diagnosis developed severe neuropsychiatric toxicity, as compared with 10 (14%) of 72 patients without a pretreatment neurologic or psychiatric diagnosis (P = .001), resulting in a relative risk of 4.55 (95% CI, 2.33 to 8.88) for developing severe neuropsychiatric toxicity. No other variables were independently associated with the development of neuropsychiatric toxicity. CONCLUSION: CML patients with a pretreatment history of a neurologic or psychiatric diagnosis are at significantly increased risk of developing severe neuropsychiatric toxicity during therapy with rIFNα2b plus cytarabine. Monitoring for neuropsychiatric symptoms and avoiding rechallenge are recommended measures for such patients receiving rIFNα2b-based therapy.

Treatment of chronic myelogenous leukemia with recombinant interferon alfa-2b

1987 ◽  
Vol 5 (S4) ◽  
Author(s):  
Norbert Niederle ◽  
Otto Kloke ◽  
Dieter May ◽  
Reinhard Becher ◽  
Rainhardt Osieka ◽  
...  
Keyword(s):  
Chronic Myelogenous Leukemia ◽  
Interferon Alfa ◽  
Myelogenous Leukemia ◽  
Recombinant Interferon

Treatment of Ph′-positive chronic myelogenous leukemia (CML) with recombinant interferon alfa-2b (INTRON A)

1988 ◽  
Vol 15 ◽  
pp. 21-26 ◽  
Author(s):  
G. Alimena ◽  
E. Morra ◽  
M. Lazzarino ◽  
A.M. Liberati ◽  
E. Montefusco ◽  
...  
Keyword(s):  
Chronic Myelogenous Leukemia ◽  
Interferon Alfa ◽  
Myelogenous Leukemia ◽  
Recombinant Interferon

Real world treatment patterns in chronic myeloid leukemia patients newly initiated on tyrosine kinase inhibitors in an U.S. integrated healthcare system

2017 ◽  
Vol 24 (4) ◽  
pp. 253-263
Author(s):  
Nazia Rashid ◽  
Han A Koh ◽  
Kathy J Lin ◽  
Brian Stwalley ◽  
Eugene Felber
Keyword(s):  
Chronic Myelogenous Leukemia ◽  
Index Date ◽  
Stem Cell Transplant ◽  
Study Time ◽  
Myelogenous Leukemia ◽  
Prior History ◽  
Cell Transplant ◽  
Time Period ◽  
History Of

Purpose To evaluate treatment patterns in patients diagnosed with incident chronic myelogenous leukemia (CML) newly initiating therapy with imatinib, dasatinib, or nilotinib. Patients were followed to determine switching and discontinuation rates. Factors associated with switching or discontinuation from index TKI therapy, reasons for discontinuation based on electronic chart notes, and frequency of laboratory monitoring were assessed during the follow-up period. Methods A retrospective cohort study was conducted in chronic myelogenous leukemia patients aged ≥ 18 years who were identified from the Kaiser Permanente Southern California (KPSC) Cancer Registry database during the study time period of 1 January 2007 to 12 December 2013. The index date was defined as the date of the first TKI prescription (imatinib, dasatinib, or nilotinib) identified during the study time period with no prior history of TKI use within 12 months. Patients had to have continuous membership with drug benefit eligibility and no prior history of stem cell transplant (SCT) or other cancers during the 12 months prior to the index date. Baseline characteristics were identified during 12 months prior to the index date and outcomes were identified during the follow-up period after the index date. All patients were followed from index TKI therapy until end of study time period (12 December 2014), death, stem cell transplant, or disenrollment from the health plan unless one of the following occurred first: a patient switched their index therapy, or a patient discontinued their index therapy. Forward stepwise selection multivariable logistic regression models were used to evaluate factors associated with patients who continued therapy compared to those who switched or discontinued therapy with the index TKI. Chart notes were reviewed 30 days prior and 30 days post index TKI discontinuation to evaluate reasons for discontinuation. Molecular and cytogenetic testing frequency was also assessed during the follow-up period among the different patient groups. Results Two hundred sixteen patients were identified with incident chronic myelogenous leukemia and use of TKI therapy: 189 (87.5%) received imatinib, 19 (8.8%) received dasatinib, and 8 (3.7%) received nilotinib. The mean age on index date was 53 years and 63% were male; 103 patients (48%) continued on their index therapy, while 62 patients (28%) switched, and 51 patients (24%) discontinued.

scholarly journals Prevalence and the risk factors for the carriage of beta-haemolytic streptococci among women visiting a tertiary care hospital in South India

2021 ◽  
Vol 8 (4) ◽  
pp. 308-312
Author(s):  
Pendru Raghunath ◽  
LN Rao Sadanand
Keyword(s):  
Risk Factors ◽  
Teaching Hospital ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Latex Agglutination ◽  
Research Centre ◽  
Care Hospital ◽  
Microbiological Techniques ◽  
History Of ◽  
Group B

Streptococci are gram positive cocci arranged in chains and are part of normal flora of humans and animals. The present study is carried out to determine the prevalence and risk factors for the carriage of beta-haemolytic streptococci (BHS) among women visiting Dr. VRK Women’s Teaching Hospital & Research Centre, Hyderabad. Vaginal swabs were collected from 250 patients attending outpatient department (OPD) of Dr. VRK Women’s Teaching hospital. Swabs were inoculated onto 5% sheep blood agar plates and incubated for 24 h at 37°C in a candle jar. BHS isolates were phenotypically identified by standard microbiological techniques, all the isolates presumptively identified as BHS were tested for Bacitracin susceptibility. Sensitive isolates were presumptively identified as GAS and resistant isolates were identified as non-group A BHS (NGABHS). Presumptively identified GAS & NGABHS isolates were serogrouped by Lancefield grouping using a commercially available latex agglutination test. BHS were isolated from 12.4% of samples. As many as 12 BHS isolates were identified as GAS and 19 were identified as NGABHS. Ten of nineteen were identified as group B (GBS), 4 (12.9%) were identified as group C (GCS) and 5 (16.12%) were identified as group G (GGS). Among six clinical groups, the prevalence of GAS is highest i.e. 7.5% in female patients visiting Gynaecology OPD with history of white discharge. Prevalence of NGABHS was more among post insertion (18%) IUCD group compared to pre insertion (8%) IUCD group. GBS were isolated from 7% of samples from IUCD group and 4% of samples from prostitutes.This study reports the prevalence of BHS among women visiting a tertiary care hospital in Hyderabad. This study also identified certain risk factors such as IUCD usage and working as a FSW are associated with the increased prevalence of NGABHS especially GBS.

BCR Rearrangement–Negative Chronic Myelogenous Leukemia Revisited

2001 ◽  
Vol 19 (11) ◽  
pp. 2915-2926 ◽  
Author(s):  
Razelle Kurzrock ◽  
Carlos E. Bueso-Ramos ◽  
Hagop Kantarjian ◽  
Emil Freireich ◽  
Susan L. Tucker ◽  
...  
Keyword(s):  
Chronic Myelogenous Leukemia ◽  
Blast Crisis ◽  
Chronic Phase ◽  
Interferon Alfa ◽  
Myelogenous Leukemia ◽  
Disease Evolution ◽  
Number Of Patients ◽  
Significant Difference ◽  
Atypical Cml ◽  
Peripheral Blood Smears

PURPOSE: To document the characteristics of patients with major breakpoint cluster region (M-bcr) rearrangement–negative chronic myelogenous leukemia (CML). PATIENTS AND METHODS: The hematopathologist, who was blinded to patients’ molecular status, reviewed the referral bone marrows and peripheral-blood smears from 26 patients with Philadelphia (Ph) translocation–negative CML who lacked Bcr rearrangement (and other evidence of a Bcr-Abl anomaly) and 14 patients (controls) with chronic-phase Ph-positive CML. Clinical data was ascertained by chart review. RESULTS: Among the 26 M-bcr rearrangement–negative CML patients, three pathologic subtypes emerged: (1) patients indistinguishable from classic CML (n = 9), (2) patients with atypical CML (n = 8), and (3) patients with chronic neutrophilic leukemia (n = 9). Among the 14 patients with Ph-positive CML who were included in the blinded review, 13 were classified as classic CML, and one was classified as atypical CML. The only statistically significant difference between M-bcr rearrangement–negative subgroups was in the proportion of patients having karyotypic abnormalities, an observation common only in patients with atypical CML (P = 0.008). However, the small number of patients in each subgroup limited our ability to differentiate between them. Interferon alfa induced complete hematologic remission in five of 14 patients; four of these remissions lasted more than 5 years. Only one of 26 patients developed blast crisis. The median survival of the 26 patients was 37 months. CONCLUSION: Patients with M-bcr rearrangement–negative CML fall into three morphologic subgroups. Disease evolution does not generally involve blastic transformation. Instead, patients show progressive organomegaly, leukocytosis, anemia, and thrombocytosis. Some patients in each subgroup can respond to interferon alfa.

Early treatment decisions with interferon-alfa therapy in early chronic-phase chronic myelogenous leukemia.

1998 ◽  
Vol 16 (3) ◽  
pp. 882-889 ◽  
Author(s):  
S Sacchi ◽  
H M Kantarjian ◽  
T L Smith ◽  
S O'Brien ◽  
S Pierce ◽  
...  
Keyword(s):  
Chronic Myelogenous Leukemia ◽  
Univariate Analysis ◽  
Group Analysis ◽  
Philadelphia Chromosome ◽  
Chronic Phase ◽  
Cytogenetic Response ◽  
Interferon Alfa ◽  
Myelogenous Leukemia ◽  
Costal Margin ◽  
Hematologic Response

PURPOSE To determine, in patients with Philadelphia chromosome (Ph)-positive chronic myelogenous leukemia (CML) on interferon alfa (IFNalpha), whether combining pretreatment characteristics and early response profiles would distinguish patients with differential benefits that would allow better decisions on subsequent therapy. PATIENTS AND METHODS A total of 274 patients treated from 1982 through 1990 with IFNalpha regimens were analyzed. A second group of 137 patients treated with IFNalpha and low-dose cytarabine (ara-C) between 1990 and 1994 was later used to confirm the guidelines derived from the original study group analysis. Patients' pretreatment factors and response to IFNalpha therapy at 3, 6, and 12 months were analyzed in relation to subsequent achievement of major cytogenetic response. After univariate analysis of prognostic factors, a multivariate analysis selected, at 6 months, independent pretreatment factors that added to the response status in predicting subsequent outcome. The results were then applied at the 3- and 12-month periods and confirmed in the subsequent population. RESULTS Response to IFNalpha therapy at 3, 6, and 12 months was a significant predictor of later major cytogenetic response. The presence of splenomegaly > or = 5 cm below the costal margin (BCM) or thrombocytosis > or = 700 x 10(9)/L pretreatment added significant independent prediction to response. At 6 months, patients with a partial hematologic response (PHR) or resistant disease had a less than 10% chance of achieving a later major cytogenetic response, as were those in complete hematologic response (CHR) and who had pretreatment splenomegaly and thrombocytosis. Applying the model at 3 months showed that only patients with < or = PHR and pretreatment splenomegaly or thrombocytosis at 3 months had such a low major cytogenetic response rate. Finally, at 12 months, patients with CHR still had a 15% to 25% chance of having a major cytogenetic response later if they did not have pretreatment splenomegaly and thrombocytosis. CONCLUSION This analysis allows better selection of patients with Ph-positive CML on IFNalpha therapy for continuation of IFNalpha versus changing therapy early in the course of CML. For treatment programs that choose to change patients to other investigational therapies (eg, intensive chemotherapy and/or autologous stem-cell transplantation [SCT]), baseline outcome expectations are provided for patients continued on IFNalpha therapy, against which the results of new approaches can be compared.

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