scholarly journals Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) in Patients with Therapy-Related Myeloid Neoplasm: A Study from the Chronic Malignancies Working Party of the EBMT

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 45-45
Author(s):  
Marie Robin ◽  
Junfeng Wang ◽  
Linda Koster ◽  
Dietrich W. Beelen ◽  
Martin Bornhäuser ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Solid Tumor ◽  
Research Funding ◽  
Performance Status ◽  
Primary Cancer ◽  
Research Support ◽  
Karnofsky Score ◽  
Adjusted Risk ◽  
And Performance

Patients with t-MN have a poor prognosis with median overall survival < 1 year due to high risk features of the disease and refractoriness to chemotherapy. HSCT represents the only curative treatment. Outcome after HSCT has progressively improved over time with a last EBMT study showing a 2-year OS at 44% in patients with secondary leukemia (79% post MPN or MDS) (BBMT 2018: 1406). Previous large studies showed survival < 30% in patients transplanted for t-MN (Blood. 2010:1850; Haematologica 2009:542). We recently reported in patients transplanted for a leukemia arising from MDS, MPN and CMML that the primary disease impacts the outcome, particularly patients with a previous MPN had the worst outcome (BJH, 2019: 725). We report here outcome of patients who received HSCT for a t-MN (excluding post MDS, MPN and CMML) with the hypothesis that the primary cancer impacts the outcome. From EBMT registry, patients with MDS or AML occurring after a primary cancer who received a HSCT between 01/06 and 12/16 were included. OS and RFS were analyzed using Kaplan Meier curves and log-rank test, relapse and NRM were analyzed as competing risks with cumulative incidence curves and Gray's test. 2334 patients were identified. Primary cancers were CLL in 102, non-Hodgkin lymphoma (NHL) in 668, Hodgkin lymphoma (HL) in 235, plasma cell disease (PCD) in 111, breast cancer in 643 and other solid tumor (ST) in 575. 981 patients had MDS and 1353 had AML at time of transplantation. Performance status by Karnofsky score was 90 or higher in 1376 (59%) patients. 722 (31%) patients were transplanted from HLA matched sibling donor (SIB) and 843 (36%) received a myelo-ablative conditioning regimen (MAC). 1307 patients were in remission at time of transplantation: 29% of MDS and 76% of AML patients. Three-year OS and RFS were 34 and 32% respectively. OS was significantly better in patients with AML in CR (43%) than not in CR (21%). OS and DFS were impacted by the primary cancer: post NHL (30 and 27%), post HL (29 and 28%), post ST (34% for both), post breast cancer (41 and 37%), post CLL (34 and 31%) and post PCD (32 and 25%) (p<0.001). CR status at HSCT did not impact outcome in MDS patients (30%). Patients with normal cytogenetics (n=397) had a better OS than patients with abnormal cytogenetics (n=1036) (43% vs. 33%, p<0.001). OS was significantly better using SIB (38% vs 32%, p=0.05) and in patients with better Karnofsky score (38 vs. 28%, p<0.01). NRM was lower in patients with breast cancer (24% post breast cancer, 36% post NHL, 33% post HL, 29% post ST, 34% post CLL, 26% post PCD p<0.001). NRM was higher after non SIB (34% vs 23%, p<0.001) and after MAC (33 vs. 23%, p<0.001). Relapse rate was higher after RIC (33 vs. 28%, p=0.014) but was not influenced by the primary type of cancer. The multiple variables models includes age, regimen intensity, donor type, Karnofsky score, t-MN category (AML in CR, AML not in CR, MDS) and the primary type of cancer. Patients with HL (HR: 1.36, p=0.005) or NHL (HR: 1.31, p=0.001) had a higher adjusted risk for OS than patients with other primary diseases. Other risk factors for OS were t-MN type (AML not in CR, HR: 1.45, AML in CR, HR: 0.76, MDS = reference, p<0.001), type of donor (no SIB, HR: 1.20, p=0.004) and performance status (karnofsky < 90, HR: 1.34, p<0.001). Patients with HL (HR: 1.24, p=0.05) or NHL (HR: 1.21, p=0.01) had also a higher adjusted risk for DFS than patients with other diseases. Other risk factors for DFS were t-MN (AML not in CR, HR: 1.42, AML in CR: HR:0.76, p<0.001) and performance status (HR: 1.24, p<0.001). Adjusted post-HSCT t-MN relapse risk was not influenced by the primary cancer but was influenced by age (HR: 0.92, p=0.02), MAC (HR: 0.76, p=0.002), t-MN (AML not in CR, HR: 1.51, p<0.001; AML in CR, HR:0.74, p=0.03) and performance status (HR: 1.28, p=0.002). NRM risk was significantly higher in patients with NHL (HR: 1.52, p<0.001), HL (HR:1.58, p=0.007) and CLL (HR: 1.55, p=0.039) than in patients with primary solid tumor or PCD. Other risk factors for NRM were age (HR: 1.15, p=0.01), MAC (1.29, p=0.006), t-MN (AML in CR, HR: 0.76, p=0.005; AML not in CR, HR:1.29, p=0.05), performance status (HR: 1.22, p=0.03). Conclusion: A quarter to one third of patients with t-MN can be cured by HSCT which was influenced by type of t-MN and performance status. The type of primary cancer influenced also the outcome with lower mortality, especially NRM in patients with previous solid tumor or PCD as compared to patients with lymphoma. Disclosures Robin: Novartis Neovii: Research Funding. Beelen:Medac GmbH Wedel Germany: Consultancy, Honoraria. Kroeger:DKMS: Research Funding; Neovii: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Riemser: Research Funding; JAZZ: Honoraria; Sanofi-Aventis: Honoraria; Novartis: Honoraria, Research Funding; Medac: Honoraria. Platzbecker:Celgene: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Abbvie: Consultancy, Honoraria. Finke:Riemser: Honoraria, Other: research support, Speakers Bureau; Neovii: Honoraria, Other: research support, Speakers Bureau; Medac: Honoraria, Other: research support, Speakers Bureau. Blaise:Pierre Fabre medicaments: Honoraria; Molmed: Consultancy, Honoraria; Sanofi: Honoraria; Jazz Pharmaceuticals: Honoraria. Chevallier:Daiichi Sankyo: Honoraria; Incyte: Consultancy, Honoraria; Jazz Pharmaceuticals: Honoraria.

scholarly journals Risk factors and prediction of second primary cancer in primary female non-metastatic breast cancer survivors

Aging ◽  
2020 ◽  
Vol 12 (19) ◽  
pp. 19628-19640
Author(s):  
Xiwen Qian ◽  
Huixun Jia ◽  
Yue Zhang ◽  
Bingqing Ma ◽  
Guoyou Qin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Metastatic Breast Cancer ◽  
Cancer Survivors ◽  
Breast Cancer Survivors ◽  
Metastatic Breast ◽  
Second Primary ◽  
Primary Cancer ◽  
Second Primary Cancer

Impact of Comorbidities and Prospective Functional Geriatric Assessment Tools (CF-GA) As an Aide to Understand Outcome, Therapy Tolerance, Side Effects and Clinical Trial Eligibility in Multiple Myeloma (MM) Patients (pts)

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 5616-5616
Author(s):  
Alexander Zober ◽  
Mandy Möller ◽  
Sandra-Maria Dold ◽  
Gabriele Ihorst ◽  
Stefanie Hieke ◽  
...  
Keyword(s):  
Risk Factors ◽  
Multiple Myeloma ◽  
Overall Survival ◽  
Research Funding ◽  
Performance Status ◽  
Geriatric Depression Scale ◽  
Depression Scale ◽  
Geriatric Depression ◽  
Timed Up And Go ◽  
Comorbidity Index

Abstract Introduction: Cancer pts present with a highly heterogeneous health status and treatment choices are often numerous. Therefore, careful assessment of individuals' condition is highly relevant. In order to define best possible and tolerable treatment options, novel parameters and metrics for non-disease variables are needed. Albeit impairment in the Karnofsky Performance Status (KPS), Activities of Daily Living (IADL or ADL) and quality of life (QoL) are predictive for outcome in cancer and MM pts, the prognostic variables within a defined and prospectively assessed battery of established functional tests have rarely been delineated nor have their combination with disease-related risk factors or molecular markers been meticulously assessed. Their prognostic value for functional decline and overall survival (OS) has also not been tested and validated prospectively. Methods: We performed this comorbidity and functional geriatric assessment (CF-GA) in consecutive MM pts treated at our center according to our institutional Comprehensive Cancer Center pathway. The GA was prospectively obtained prior to initiation of anti-myeloma treatment and reflected pts' baseline health status rather than being confounded by toxicities induced by therapy. This CF-GA included the IADL, ADL, Timed Up and Go-Test, malnutrition, pain, rating of fitness, SF12-QoL and geriatric depression scale. Moreover, established comorbidity (CM) scores: ß2MG/eGFR (Eur J Haematol. 2009;83:519-27), Kaplan Feinstein (KF), Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI), Charlson Comorbidity Index (CCI) and initial Freiburg Comorbidity Index (iFCI) vs. revised FCI (rFCI) were assessed. This CF-GA was performed as one screening tool to assess pt fitness as well as to predict survival and toxicities in elderly myeloma pts. Results: Characteristics of 131 pts, currently included in this CF-GA, were typical for tertiary centers with a median age of 63 years (40-83), all with symptomatic disease. Their median hemoglobin was 10.8g/dl (7.6-14.7), the eGFR 68ml/min/1.73qm (7-136), the ß2-MG 4.4mg/l (0.8-38.4) and BM infiltration 40% (3-90). The baseline frailty assessment revealed a median KPS of 80% (40-100). The fitness score scaled both by physicians and patients was 4 vs. 3 (1-6), demonstrating that physicians overestimate pts' performance status and objective tests to verify this are essential. Median functional results for the IADL were 5 (1-8), for the ADL 4 (2-6), for pain 2 (0-10), for malnutrition 4 (0-14) and for cognitive deficiency via Mini Mental State Examination 28 (16-30). The median geriatric depression scale was 3 (0-13) and Timed Up and Go-Test 10 (4-30). Median CM scores were substantially different with an iFCI of 0 (0-3), ß2MG/eGFR of 1 (0-2), KF of 1 (0-3), HCT-CI of 2 (0-8), rFCI of 4 (0-9) and CCI of 7 (0-12). Highly valuable CF-GA-tools seem currently the IADL, Timed Up and Go-Test and rFCI. Since CF-GA is a time and man-power consuming procedure, we have presently completed a web account that allows the straightforward assessment of the rFCI for MM pts (https://rfci-score.org). This permits to perform this score in only 1-2 minutes. Moreover, we continue to perform this prospective assessment in more MM pts at our center and within a multicentre approach within the German Study Group Multiple Myeloma(DSMM) and will thereby also assess whether these function deficits and tests change over time. Prior scores to define fit, intermediate and frail pts (Blood. 2015;125:2068-74) will be compared with our risk group definitions and their predictive power for progression free survival, overall survival, side effects, therapy termination/discontinuation and early mortality will be evaluated. Adverse risk groups will allow to test and validate the most significant predictors of survival outcomes. Conclusions: Our CF-GA and rFCI contain easily assessable and reliable tests, which are of value to further test for their discriminative character in MM pts. Moreover, most predictive CF-CA tools need to be determined in prospective multicentre cohorts and need to be included in future clinical trials. We advocate our CF-GA and rFCI to foresee treatment toxicity, facilitate treatment decisions and guide personalized therapies. Timely identification and management of risk factors in MM pts are important considerations in the daily care of older and frail cancer pts, specifically those with MM. Disclosures Zober: Deutsche Krebshilfe: Other: grant. Knop:Celgene Corporation: Consultancy. Einsele:Amgen/Onyx: Consultancy, Honoraria, Speakers Bureau; Novartis: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau. Engelhardt:Deutsch Krebshilfe: Other: grant.

Gynecologic Cancers: Cervical, Uterine, and Ovarian Cancers

2016 ◽  
pp. 667-672
Author(s):  
Andrea E. Wahner Hendrickson
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Unknown Primary ◽  
Primary Cancer ◽  
Histologic Diagnosis ◽  
Carcinoma Of Unknown Primary ◽  
Ovarian Cancers ◽  
Primary Origin ◽  
Symptoms And Signs ◽  
Unknown Primary Origin

Carcinoma of unknown primary origin (CUP) describes a metastatic disease for which the primary cancer cannot be identified. Of all invasive malignancies, 2% to 6% are CUP. The most common tumor associated with CUP is adenocarcinoma. Squamous cell carcinoma and undifferentiated neoplasms make up a smaller portion of CUP. When a pathologic diagnosis is established, additional evaluation should be tailored according to the patient’s risk factors (eg, smoking and breast cancer risk), symptoms and signs, sites of metastasis, and the histologic diagnosis.

scholarly journals Factors influencing length of survival in ambulatory palliative care - a cross sectional study based on secondary data

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Johannes Just ◽  
Marie-Therese Schmitz ◽  
Ulrich Grabenhorst ◽  
Thomas Joist ◽  
Kirsten Horn ◽  
...  
Keyword(s):  
Palliative Care ◽  
Survival Time ◽  
Performance Status ◽  
Secondary Data ◽  
Cross Sectional Study ◽  
Sectional Study ◽  
Karnofsky Score ◽  
Cross Sectional ◽  
And Performance ◽  
Clinical Records

Abstract Background Quality of life and patient self-determination are key elements in successful palliative care. To achieve these goals, a robust prediction of the remaining survival time is useful as it can provide patients and their relatives with information for individual goal setting including appropriate priorities. The Aim of our study was to assess factors that influence survival after enrollment into ambulatory palliative care. Methods In this cross-sectional, multicenter study (n = 14 study centers) clinical records of all palliative care patients who were treated in 2017 were extracted and underwent statistical analysis. The main outcome criterion was the association of survival time with clinical characteristics such as age, type of disease, symptoms and performance status. Results A total of 6282 cases were evaluated. Median time of survival was 26 days (95 % CI: 25–27 days). The strongest association for an increased hazard ratio was found for the following characteristics: moderate/severe weakness (aHR: 1.91; 95 % CI: 1.27–2.86) Karnofsky score 10–30 (aHR: 1.80; 95 % CI: 1.67–1.95), and age > 85 (aHR: 1.50; 95 % CI: 1.37–1.64). Surprisingly, type of disease (cancer vs. non-cancer) was not associated with a change in survival time (aHR: 1.03; 95 % CI: 0.96–1.10). Conclusions In this cross-sectional study, the most relevant predictor for a short survival time in specialized ambulatory palliative care was the performance status while type of disease was irrelevant to survival.

scholarly journals Impact of Sars-CoV2 Infection on 491 Hematological Patients: The Ecovidehe Multicenter Study

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 5-6
Author(s):  
Cristina De Ramón ◽  
Jose Angel Hernandez-Rivas ◽  
Jose Antonio Rodríguez García ◽  
Enrique M. Ocio ◽  
María Teresa Gómez-Casares ◽  
...  
Keyword(s):  
Risk Factors ◽  
Mortality Rate ◽  
Hospital Admission ◽  
Board Of Directors ◽  
Research Funding ◽  
Performance Status ◽  
Biological Data ◽  
Advisory Committees ◽  
Hematological Diseases ◽  
Hematological Patients

INTRODUCTION Coronavirus disease 2019 (COVID-19) caused by SARS-CoV2 virus is thought to be more severe in patients with prior hematological diseases. There is evidence suggesting that hematological patients are particularly vulnerable and have a higher risk of developing severe events, with higher mortality rate than general population. However, the available data are limited, and prognostic factors at admission still remain unclear. With this background, our aims were to analyze the impact of hematological diseases and their therapy on the COVID-19 severity and to identify clinical and biological risk factors to predict the outcome in these patients. METHODS We carried out a multicenter retrospective observational study with data collection from 19 Spanish centers. A total of 491 patients with hematological diseases who developed COVID-19 (HEMATOCOVID patients) from March 8th to June 9th were included in the study. Clinical and biological data were collected at the time of emergency room assistance or hospital admission. For statistical analysis, chi-square test and Mann-Whitney U-test were used to identify differences between groups. The effects of multiple predictor variables on COVID-19 outcomes were assessed by logistic binary regression. RESULTS The geographic distribution of the studied HEMATOCOVID patients was similar to the national geographic spread of the COVID-19 (Figure 1). Most patients (94,3%) were confirmed cases of COVID-19 with a positive result on SARS-CoV2 RT-PCR on a nasopharyngeal swab or serologic testing, and 15% were nosocomial infections. The mean age was 71 years with 57% males, and 70% had at least one associated comorbidity. The most frequent hematological diseases among COVID-19 patients were Lymphoid Malignancies (53,8%), and 51,7% of patients were on active treatment. Most common symptoms were fever (59%), cough (54%) and dyspnea (46%), with associated pneumonia in 70% of cases. Hospital admission was required in 89% of patients and 6,3% were admitted to intensive care units. Mortality rate was about 36%. Non-survival patients were older and had a higher Charlson comorbidity index and ECOG performance status. Furthermore, patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), and those with an active or progressive hematological disease at the diagnosis of COVID-19 had higher mortality. Patients who had undergone hematopoietic stem cell transplantation (autologous, allogeneic, and both) had better outcomes. Other factors such as low lymphocyte and platelets counts, or high lactate dehydrogenase (LDH), C-reactive protein (CRP) and procalcitonin values were also associated with poorer outcomes (Table 1). In addition, COVID-19 therapy had no impact on survival, except for corticosteroids, that correlated with a negative impact (p < 0,001) probably because they were not administrated to patients with less severe COVID-19. Multivariate regression analysis showed the following risk factors for death: age >70 years, ECOG ≥2, absolute lymphocyte count ≤0.6·109/L, platelet count ≤40·109/L, high LDH (higher than upper normal limit) and CRP >11 mg/dL (Table 2). CONCLUSIONS SARS-CoV2 infection causes more severe disease and higher mortality rates in hematological patients, especially those with AML/MDS or active/progression status disease. In addition, advanced age, co-morbidities, poor performance status, low lymphocyte and platelet counts and high LDH and CRP at admission are associated with poorer survival. This worse disease evolution could be explained by the immunosuppression state induced by underlying disease and treatments received. These particular features should be taken into account for a population that is highly exposed to SARS-CoV2 contagion due to high number of hospital visits for treatment. Disclosures Hernandez-Rivas: Janssen: Membership on an entity's Board of Directors or advisory committees; Abbvie: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees; Celgene/BMS: Membership on an entity's Board of Directors or advisory committees; Rovi: Membership on an entity's Board of Directors or advisory committees. Ocio:MDS: Honoraria; Asofarma: Honoraria; Takeda: Honoraria; GSK: Consultancy; Celgene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Speakers Bureau; Amgen: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Secura-Bio: Consultancy; Oncopeptides: Consultancy. López Jiménez:Gilead: Research Funding, Speakers Bureau; Janssen: Research Funding, Speakers Bureau; Roche: Research Funding, Speakers Bureau; MSD: Speakers Bureau; Takeda: Speakers Bureau; Abbvie: Research Funding, Speakers Bureau. Córdoba:Takeda Farmacéutica España S.A.: Speakers Bureau; Janssen: Honoraria, Other: travel and accommodation; Abbvie: Honoraria, Other: travel and accommodation; Roche: Honoraria, Other: travel and accommodation; Gilead: Honoraria, Other: travel and accommodation. Moraleda:Takeda: Consultancy, Other: Travel Expenses; Sandoz: Consultancy, Other: Travel Expenses; Novartis: Consultancy, Other: Travel Expenses; Gilead: Consultancy, Other: Travel Expenses; Jazz Pharmaceuticals: Consultancy, Research Funding. Garcia-Sanz:Takeda: Consultancy, Research Funding; Pharmacyclics: Honoraria; Novartis: Honoraria; Janssen: Honoraria, Research Funding; Incyte: Research Funding; Gilead: Honoraria, Research Funding; BMS: Honoraria; Amgen: Membership on an entity's Board of Directors or advisory committees.

scholarly journals A Risk Prediction Model for Severe Chemotherapy-Induced Anemia in Breast Cancer Patients

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2399-2399 ◽  
Author(s):  
Chun Chao ◽  
Lanfang Xu ◽  
Leila Family ◽  
Hairong Xu
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Prediction Model ◽  
Risk Prediction ◽  
Research Funding ◽  
Risk Prediction Model ◽  
Breast Cancer Patients ◽  
Training Set ◽  
Final Model ◽  
Validation Set

Abstract Introduction: Chemotherapy induced anemia (CIA) is associated with an array of symptoms that can negatively impact patients' quality of life. The incidence and severity of CIA vary significantly depending on the cancer type and chemotherapy regimen administered. Several patient characteristics, such as age, gender, renal function and pre-treatment hemoglobin (Hb) and albumin level have also been reported to be associated with the risk of CIA. However, a comprehensive risk prediction model for CIA is lacking. Here we sought to develop a risk prediction model for severe CIA (Hb<8 g/dl) in breast cancer patients that accounts for detailed chemotherapy regimens and novel risk factors for anemia. Methods: Women diagnosed with incident breast cancer at age 18 and older between 2000-2012 at Kaiser Permanente Southern California (KPSC)and initiated myelosuppressivechemotherapy before June 30, 2013 were included. Women who did not have any hemoglobin measurement prior or during the course of chemotherapy were excluded. Those who had the following conditions prior to chemotherapy were also excluded: less than 12 months KPSC membership, anemia, transfusion, radiation therapy or bone marrow transplant. Potential predictors considered included established CIA risk factors, such as patient demographic characteristics, cancer stage at diagnosis, chemotherapy regimens, and laboratory measurements (Table 1). In addition, several novel risk factors were also evaluated for their ability to predict severe CIA; these included recent cancer surgery and radiation therapy, chronic comorbidities (Table 1) and mediation use (Table 1).All data were collected from KPSC's electronic health records. The cohort was randomly split into a training set (50%) and a validation set (50%). Logistic regression was used to develop the risk prediction model for severe CIA. Predictors that showed a crude association with severe CIA with an odds ratio > 1.5 or <0.67 (i.e., 1/1.5) or a p-value <0.10 in the training set were included for predictive model selection. A stepwise model selection method was used with a p-value cut-off at 0.05. The model performance of the selected final model was evaluated in the validation set usingHosmer-Lemeshow goodness of fit test and the area underthe receiver operating characteristiccurve (AUC). Results: A total of 11,291 breast cancer patients were included in the study. The mean age at diagnosis was 55 years. The majority of the patients were of non-Hispanic white race/ethnicity (57%). Of these, 3.0% developed severe CIA during chemotherapy. The following factors were positively associated with risk of developing severe anemia in the crude analyses and were thus included for model selection: age >65, advanced stages, length of KPSC membership, time between cancer diagnosis to chemotherapy, prior radiation therapy, vascular disease, renal disease, hypertension, osteoarthritis, use of steroids, use of diuretics, use of calcium channel blockers, use of statins, chemotherapy regimens, prior surgery, anti-coagulant use, calendar periods, and baseline ALP, HCT, HGB, lymphocyte count, MCH, MCV, ANC, platelet, RBC, RDW, WBC and GFR (calculated from creatinine). The final model included age, stage, chemotherapy regimen, corticosteroid use, and baseline Hb, MCV and GFR. The odds ratio and 95% confidence interval estimates of variables in the final model in the training set and the validation set are both shown in Table 2. This prediction model achieved an AUC of 0.76 in the validation set, and passed the goodness-of-fit test (test statistics was 0.17). Conclusion: The risk prediction model incorporating traditional and novel CIA risk factors appeared to perform well and may assist clinicians to increase surveillance for patients at high risk of severe CIA during chemotherapy. Disclosures Chao: Amgen Inc.: Research Funding. Xu:Amgen Inc.: Research Funding. Family:Amgen Inc.: Research Funding. Xu:Amgen Inc.: Research Funding.

Pharmaceutical Care for Patients Undergoing S-1 Plus Cisplatin Therapy for Unresectable Recurrent Gastric Cancer

2013 ◽  
Vol 26 (4) ◽  
pp. 409-414 ◽  
Author(s):  
Michio Kimura ◽  
Eiseki Usami ◽  
Tomoaki Yoshimura ◽  
Tadashi Yasuda ◽  
Yuji Kaneoka ◽  
...  
Keyword(s):  
Risk Factors ◽  
Gastric Cancer ◽  
Adverse Events ◽  
Nutritional Support ◽  
Performance Status ◽  
Recurrent Gastric Cancer ◽  
Grade 3 ◽  
And Performance ◽  
Treatment Dosage ◽  
Cisplatin Therapy

We examined the adverse gastrointestinal events associated with tegafur/gimeracil/oteracil potassium (S-1) plus cisplatin therapy for unresectable recurrent gastric cancer and risk factors for discontinuing therapy due to adverse events. A total of 65 subjects who had received S-1 plus cisplatin therapy for gastric cancer at Ogaki Municipal Hospital were examined. We found that the risk factors for discontinuation of the therapy due to adverse events were serum albumin (Alb) level less than 3.5 g/dL (odds ratio [OR]: 321.14, P = .0015), creatinine clearance (CrCl) rate less than 78 mL/min (OR: 35.23, P = .0123), and performance status (PS) more than 1 (OR:12.62, P = .0243). Moreover, grade 3 or 4 nonhematological toxicities (including malaise and anorexia) were significantly higher in subjects with Alb less than 3.5 g/dL and CrCl less than 78 mL/min ( P < .01). In conclusion, we should pay attention to the safety and continuity of S-1 plus cisplatin therapy in cases where the Alb level is <3.5 g/dL, CrCl level is <78 mL/min, and PS level is >1. Pharmacists should consider reducing the treatment dosage and providing nutritional support in such cases.

scholarly journals BMI Is Not Associated with Toxicity to High Dose Methotrexate: A Single Institution Retrospective Study of 147 Patients

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 42-42
Author(s):  
Shakthi Bhaskar ◽  
Priyanka Pullarkat ◽  
Fei Wan ◽  
Sara Butler ◽  
Neha Mehta-Shah
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Acute Kidney Injury ◽  
Research Funding ◽  
Cell Lymphoma ◽  
Kidney Injury ◽  
High Dose ◽  
High Dose Methotrexate ◽  
Dose Methotrexate ◽  
Washington University

Background: High-dose methotrexate (HD-MTX) with leucovorin rescue is frequently used in the treatment of various lymphomas, breast cancer, and sarcomas and remains an important therapy for lymphoma with CNS involvement. Despite its efficacy, HD-MTX can carry considerable toxicity which can lead to prolonged hospital stays, invasive therapies, and delays/discontinuation of a potentially curative treatments. Previous studies have shown that advanced age, male sex, use of proton pump inhibitors and impaired creatinine clearance are associated with higher rates of MTX toxicity (May et al 2014). However, the impact of body mass index (BMI) on the risk of toxicity with HD-MTX has not previously been reported. We performed a retrospective analysis of all patients at Washington University in St. Louis who were treated with HD-MTX to evaluate the relationship between BMI and risk of toxicity. Methods: Consecutively treated adult patients at Washington University in St. Louis who were treated with HD-MTX (&gt;1,000mg/m2) for any malignancy (excluding leukemia) from 2005-2011 were identified via our pharmacy database. Baseline patient data was collected via retrospective review of the medical record including age, sex, diagnosis, methotrexate dose received, baseline renal and liver function tests, evidence for HD-MTX toxicity, concomitant medications. HD-MTX toxicity was defined as by delayed methotrexate clearance, acute kidney injury, liver function abnormalities, mucositis, or acute kidney injury, disease status and survival. Delayed methotrexate clearance was defined as serum methotrexate level of greater than 15umol/L at 24 hours, greater than 1.5umol/L at 48 hours, or greater than 0.15umol/L at 72 hours based on prior studies (May et al 2014). Results: 147 patients were included who received a total of 496 cycles of methotrexate (58 CNS lymphoma, 26 DLBCL, 11 T-cell lymphoma, 12 Burkitt's lymphoma, 2 mantle cell lymphoma, 27 sarcoma, 10 breast cancer, 1 other). 2 patients with B-ALL were excluded. The median age was 50 years (range 19-80) with 14 patients who were ≥70 years. Patients each received a median of 2.5 cycles of HD-MTX (range 1-12) at doses of ≤3.5g/m2 (n=248) and &gt;3.5g/m2 (n=248). The total incidence of HD-MTX toxicity in this cohort was 52.4% (260/496 administrations) and did not differ between those who received doses ≤3.5g/m2 (n=248) or &gt;3.5g/m2 (n=248) (OR: 0.875, 95% CI: 0.61-1.25). Median OS was not impacted by presence or absence of MTX toxicity (66 mo vs 84 mo p=0.78). Patients who experienced toxicity had longer clearance than those who did not (5.8 days vs 3.1 days, p=&lt;0.001). Use of proton pump inhibitors was associated with a higher risk of MTX toxicity (OR 1.8, 95% CI: 1.25-2.6). Use of concomitant antibiotics (OR 1.024, 95% CI: 067-1.6) and age &gt;70 (OR 0.64, 95% CI: 0.185-2.2) were not independent risk factors for HD-MTX toxicity. The median BMI of patients was 25.3 (range 14.7-44.9). 6.1%, 40.8%, 27.2%, and 25.9% had BMIs of underweight (&lt;18.5), normal (18.5-25), overweight (25-30), obese (&gt;30) respectively. We used the restricted cubic spline smoothing method to model the functional form of the association between BMI and MTX toxicity. We found that there is no significant association between BMI and MTX toxicity (p=0.898). The 95% confidence bands contain a flat line such that there is no associated change in the probability of having a MTX toxicity event for any given change in BMI. When comparing patients who had normal BMI or underweight compared to those who had BMIs above normal, there was no significant difference in the rate of methotrexate toxicity. Conclusions: In this cohort of patients treated with HD-MTX, we found that BMI is not a risk factor in the development of toxicity. Our analysis also suggests that a single incidence of HD-MTX toxicity does not significantly impact patient survival, which is similar with previous findings (May, Leukemia & Lymphoma 2013). Determining potential risk factors for HD-MTX toxicity will allow clinicians to be better prepared to manage complications and tailor treatment regimens based on individual patient characteristics. Disclosures Mehta-Shah: Genetech: Research Funding; Karyopharm Therapeutics: Consultancy; Bristol Myers-Squibb: Research Funding; C4 Therapeutics: Consultancy; Celgene: Research Funding; Innate Pharmaceuticals: Research Funding; Kyowa Kirin: Consultancy; Verastem: Research Funding.

scholarly journals Venous and Arterial Thrombosis Following Abemaciclib Therapy for Metastatic Breast Cancer

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4063-4063
Author(s):  
Nathan Watson ◽  
Seth A Wander ◽  
Hanny Al-Samkari
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Metastatic Breast Cancer ◽  
Brain Metastases ◽  
Risk Score ◽  
Real World ◽  
Arterial Thrombosis ◽  
Research Funding ◽  
Metastatic Breast

Abstract Introduction: Over the past several years, inhibitors of cyclin-dependent kinases 4 and 6 (CDK 4/6) have revolutionized the treatment of hormone receptor (HR)-positive breast cancer. However, evidence suggests an increased risk of venous thromboembolism (VTE) with use of these agents. Recent studies additionally suggest higher VTE rates in real-world populations receiving palbociclib as compared with the highly selected population of published clinical trials. Such study in real-world patients has not been performed for abemaciclib, a newer CDK 4/6 inhibitor with unique pharmacokinetic and pharmacodynamic properties. This study evaluated rates and predictors of thrombosis in patients receiving abemaciclib for metastatic breast cancer. Methods: We conducted a multicenter observational cohort study of patients with metastatic breast cancer receiving abemaciclib at 5 affiliated hospitals. A research patient data repository was queried to identify all patients receiving abemaciclib and manual chart review was used to extract all data. Patient demographics, concurrent medications, labs, Khorana risk score, tumor characteristics, and relevant venous and arterial thrombotic risk factors (including age, BMI, prior thrombosis, recent surgery, hereditary thrombophilia, systemic inflammatory diseases, presence of brain metastases, hypertension, hyperlipidemia, diabetes mellitus, atrial fibrillation, heart failure, and atherosclerosis) were collected for all patients. The primary endpoint was thrombosis during abemaciclib treatment or within 30 days of discontinuation. Multivariable logistic models assessed predictors of VTE and a multivariable Cox proportional hazards model was used to compare mortality in patients developing VTE with those who did not. Data are presented as median (IQR) or number (%). Results: Patient Cohort and Thrombosis Risk Factors. 364 patients were included in the analysis. 360 (98.9%) patients were female, with median (interquartile range) age of 61 (53-71) years. 320 (88.7%) were post-menopausal and 291 (79.9%) were concurrently on endocrine therapy (of which 19 (5.2%) were on tamoxifen). At the time of abemaciclib initiation, 51 (14.0%) were receiving long-term anticoagulation and 47 (12.9%) were receiving aspirin. Khorana scores were between 0-3 with 339 (93.1%) patients having a score of 0 or 1. 267 (73.4%) and 46 (12.6%) were diagnosed with invasive ductal and lobular carcinoma, respectfully. Brain metastases were present in 71 (19.5%) patients. Venous and arterial thrombosis risk factors for this cohort are highlighted in TABLE 1. The median duration of abemaciclib therapy was 5.5 (2.8-13.0) months and median duration of follow-up was 12.7 (6.2-22.1) months. Thrombotic Events. 27 patients (7.4%) developed one or more thrombotic event (17 VTE, 9 arterial thrombosis, 1 both). Events are described in TABLE 2. Risk Factors for VTE. In a multivariable logistic model including age, race, BMI, receipt of long-term anticoagulation, receipt of aspirin, brain metastases, Khorana risk score, receipt of tamoxifen, prior VTE, systemic autoimmune disease, and known thrombophilia, HER2 positivity was predictive of VTE during or after abemaciclib treatment (odds ratio 5.20, 95% CI 1.29-20.93, P=0.020). Association of VTE with Mortality. In a multivariable Cox model controlling for age, race, HER2 status, receipt of long-term anticoagulation, receipt of aspirin, brain metastases, Khorana risk score, receipt of tamoxifen, prior VTE, systemic autoimmune disease, and known thrombophilia, patients developing VTE during abemaciclib therapy had a significantly higher risk of death (hazard ratio, 2.04, 95% CI, 1.03-4.01, P=0.040), FIGURE 1. Median survival in patients developing a VTE vs. those who did not was 9.6 months vs. 25.8 months, respectively. Conclusions: In this study, we provide the first real-world data describing risk of venous and arterial thrombosis in a large cohort of patients with metastatic breast cancer treated with the CDK 4/6 inhibitor abemaciclib. As the role of abemaciclib continues to expand both within and beyond the metastatic disease setting, understanding the VTE risk of this agent has become critical. Thrombosis occurred in 7.4%, and in multivariable models controlling for relevant covariates, HER2 positivity predicted for development of VTE, and patients developing VTE had an approximate 2-fold risk of mortality. Figure 1 Figure 1. Disclosures Al-Samkari: Moderna: Consultancy; Amgen: Research Funding; Novartis: Consultancy; Rigel: Consultancy; Argenx: Consultancy; Dova/Sobi: Consultancy, Research Funding; Agios: Consultancy, Research Funding.

scholarly journals Assessment of Knowledge, Attitude, and Performance of Women Referring to Kashan and Aran-O-Bidgol Comprehensive Health Centers Toward Symptoms and Risk Factors for Breast Cancer in 2020

2021 ◽  
Vol 13 (4) ◽  
Author(s):  
Mohammadreza Khani ◽  
Mahdiyeh Mohammadzadeh ◽  
Ghasem Yadegarfar
Keyword(s):  
Breast Cancer ◽  
Risk Factors ◽  
Early Diagnosis ◽  
Health Centers ◽  
Breast Self Examination ◽  
Increased Risk ◽  
Comprehensive Health ◽  
Level Of Knowledge ◽  
And Performance ◽  
Self Examination

Background: Breast cancer (BC) is one of the most common cancers in women. Among factors reducing BC mortality, referring to health centers for early diagnosis is important. The level of knowledge, attitude, and performance of women toward BC risk factors has a major contribution in deciding to refer to a health center for early diagnosis. Objectives: The present study aimed to assess the level of knowledge, attitude, and performance of women referring to Kashan and Aran-O-Bidgol comprehensive health centers toward breast cancer risk factors. Methods: This cross-sectional study was conducted on 820 women aged 30 years and above in 2020 using a standard questionnaire, including sections of sociodemographic and existence risk factors, 20 items for women's awareness of the signs and symptoms of BC, risk factors, and breast self-examination, 10 items for attitude measurement, and 5 items for performance measurement. Data analysis was administered by SPSS using relative frequency and Chi-square tests. Results: Data of 776 (94.6%) participants were included in the analysis. The majority of participants had a moderate level of knowledge (66.4%) and attitude (76.6%) towards BC. For performance, about 44% of the participants had no breast self-examination during the last year. The results showed a significant association between marital status and education level with knowledge and attitude; employment with knowledge; age and income with attitude and performance (P < 0.05). Conclusions: Given the low level of knowledge, attitude, and performance of old aged and low educated women, as well as the increased risk of the disease in the elderly, it is necessary to provide educational interventions to this high-risk group.

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