Management of chemotherapy‐induced anemia (CIA) with biosimilar epoetin alfa (Binocrit) in patients with colorectal cancer (CC): An interim analysis of an ongoing French national observational study (The OncoBOS study).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 742-742
Author(s):  
Jean Philippe Metges ◽  
Jean-Pierre Crumbach ◽  
Daniela Petran ◽  
Vincent Boulanger ◽  
Otilia Stamerra ◽  
...  
Keyword(s):  
Iron Supplementation ◽  
Chemotherapeutic Agents ◽  
Routine Practice ◽  
Chemotherapy Treatment ◽  
Interventional Study ◽  
Time Points ◽  
Iv Iron ◽  
The Mean ◽  
Biosimilar Epoetin Alfa

742 Background: OncoBOS is a prospective, non-interventional study describing Binocrit use in routine practice in France in patients receiving chemotherapy treatment (CT) for solid tumors, lymphoma, or myeloma. This interim sub-analysis focuses on patients with CC, receiving usual chemotherapeutic agents. Methods: Patients ≥18 years with CC, CIA, and eligible for treatment with Binocrit were included in this analysis. Patients characteristics, data on CIA and its management, and predominant factors considered by the physician in prescribing Binocrit were recorded at baseline (BL), 3-4 weeks and 12 (±1) weeks later. Hemoglobin (Hb) outcomes assessed included the proportion of patients achieving a Hb increase ≥1 and ≥2 g/dL, and the mean Hb change from BL. Results: 96 patients with CC (51 males [53.1%], mean age 68.5 years) from 28 sites were recruited from September 2011 to April 2014. Mean and median BL Hb levels were 9.9 g/dL and 10 g/dL, respectively. The mean increase in Hb level was 1.2 g/dL after 1 month and 1.7 g/dL after 3 months (p<0.001 vs. BL) of Binocrit treatment. A Hb increase ≥1 g/dL was achieved by 56.8% of patients at week 3-4 and 77.6% at week 12; a Hb increase ≥2 g/dL was achieved by 17.9% and 47.4% of patients at the same time points. Patients received a median dose of 30,000 IU Binocrit once weekly. Four of the 96 patients (4.2%) required a dose increase. Transfusion rates remained low at 2.1% and 1.1% at week 3-4 and week 12, respectively. Oral and intravenous (IV) iron supplementation rates were low: oral iron was received by 4.2% and 4.7% of patients at week 3-4 and week 12, respectively; 15.6% and 9.3% of patients received IV supplementation at the same time points. Physicians considered quality of life (49%), fatigue (24%), and avoidance of blood transfusion (15.6%) as predominant factors in the rationale for CIA management. Over the treatment period, no treatment-related adverse reaction was recorded. Conclusions: This sub-analysis indicates that Binocrit, used in routine practice, is effective and well tolerated for the treatment of CIA in patients with CC, whatever CT received.

Management of chemotherapy‐induced anemia (CIA) with biosimilar epoetin alfa (Binocrit) in patients with pancreatic cancer (PC): An interim analysis of an ongoing French national observational study (The OncoBOS study).

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 479-479
Author(s):  
Jean Philippe Metges ◽  
Jérôme Desramé ◽  
Vincent Bourgeois ◽  
Otilia Stamerra ◽  
Jean-Loup Mouysset ◽  
...  
Keyword(s):  
Iron Supplementation ◽  
Adverse Reactions ◽  
Iron Status ◽  
Routine Practice ◽  
Chemotherapy Treatment ◽  
Time Points ◽  
Iv Iron ◽  
The Mean ◽  
Biosimilar Epoetin Alfa

479 Background: OncoBOS is a prospective, non-interventional study describing Binocrit use in routine practice in France in patients receiving chemotherapy treatment (CT) for solid tumors, lymphoma or myeloma. This interim sub-analysis focuses on patients with PC. Methods: Patients ≥18 years with PC, CIA and eligible for treatment with Binocrit were included in this analysis. Patients characteristics, data on CIA and its management and predominant factors considered by the physician in prescribing Binocrit were recorded at baseline (BL), 3-4 weeks and 12 (± 1) weeks later. Hemoglobin (Hb) outcomes assessed included the proportion of patients achieving a Hb increase ≥1 and ≥2 g/dL, and the mean Hb change from BL. Results: 59 patients with PC (32 females (54.2%), mean age 68.3 years) from 22 sites were recruited from September 2011 to April 2014. Mean and median BL Hb levels were both 10 g/dL. The mean increase in Hb level was 1.1 g/dL after 1 month and 1.2 g/dL after 3 months (p<0.001 vs BL) of Binocrit treatment. A Hb increase ≥1 g/dL was achieved by 48.3% of patients at week 3-4 and 54.2% at week 12; a Hb increase ≥2 g/dL was achieved by 25.9% and 35.4% of patients at the same time points. Patients received a median dose of 30,000 IU Binocrit once weekly. Three of the 59 patients (5.1%) required a dose increase. Transfusion rates remained stable at 11.9% and 15.1% at week 3-4 and week 12, respectively. Oral and intravenous (IV) iron supplementation rates were low: oral iron was received by 1.7% and 0% of patients at week 3-4 and week 12, respectively; 20.3% and 13.2% of patients received IV supplementation at the same time points. Of note, iron status was assessed in only 11.9% of subjects at BL. Physicians considered quality of life (37.3%), fatigue (25.4%) and avoidance of blood transfusion (10.2%) as predominant factors in the rationale for CIA management. Over the treatment period, three treatment-related adverse reactions (non-serious) were recorded. Conclusions: This sub-analysis indicates that Binocrit, used in routine practice, is effective and well tolerated for the treatment of CIA in patients with PC.

Epoetin Beta (Neorecormon®) Treatment for Anemia of Patients with Non-Myeloid Hematological Malignancy under Chemotherapy: Results of a Large Prospective Cohort Study.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3777-3777
Author(s):  
Corinne Haïoun ◽  
Norbert Ifrah ◽  
Philippe Casassus ◽  
Bruno Audhuy ◽  
Malek Aoudjhane ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Iron Supplementation ◽  
Hematological Malignancy ◽  
Transferrin Saturation ◽  
Lymphocytic Leukemia ◽  
Routine Practice ◽  
Usual Practice ◽  
Epoetin Beta ◽  
The Mean

Abstract Background: The efficacy of epoetin beta (E) is well documented in clinical trials in anemic cancer patients (pts). This study was conducted to assess E use, efficacy, safety and effect on quality of life in cancer pts, in usual practice. Methods: This prospective, multicenter, longitudinal, observational French study assessed a 4-month follow-up of informed consent cancer pts (including both solid tumors (ST) and non-myeloid hematological malignancies (H)) treated with E for chemotherapy-related anemia. Data were collected between January 2005 and March 2006. We only present here the results of the H subgroup. Results: Among 2809 pts, 675 had an H including 325 non-Hodgkin lymphoma (NHL), 181 multiple myeloma (MM) and 80 chronic lymphocytic leukemia (CLL). 52% of pts received their first line of chemotherapy, 24% their second one. At inclusion, Hb levels were distributed as follows: &lt; 9 g/dl: 32%, [9–11[ g/dl, 56%, [11–13[ g/dl, 11%. At inclusion, endogenous erythropoietin rate was monitored for only 8% of pts, ferritin was available for 32%, transferrin saturation for 17% and reticulocytes for 24%. At initiation, pts received a median dose of 30000 U/week of E on a once weekly regimen schedule for 98% of pts. E was associated with iron supplementation in 20% of pts (1% IV). The mean Hb level increased from 10 g/dl [5 – 14] at baseline to 13 g/dl [7 – 17] in the entire cohort of H pts, from 10 g/dl [5 – 14] to 12 g/dl [7 – 16] in NHL pts, from 10 g/dl [6 – 13] to 13 g/dl [8 – 17] in MM pts and from 10 g/dl [6 – 13] to 13 g/dl [7 – 17] in CLL pts. Hb response rate (RR) was 56% (CI95: 51 – 61) in H pts, 53% (CI95: 46 – 60) in NHL pts, 57% (CI95: 48 – 66) in MM pts and 56% (CI95: 41 – 70) in CLL pts. 41% of patients were transfused at inclusion or during the study. Good performance status (PS≤1) (OR=1.6, CI95: 1.1–2.5), non platinum-based regimen (OR=2.4, CI95: 1.2–4.9) and iron supplementation (OR=2.6, CI95: 1.4–5.1) are identified both in univariate and multivariate analysis as predictive factors of Hb response. The mean of FACT score improved from 29 (CI95: 26–31) at initiation to 36 (CI95: 34–38) at the end of study (p&lt;0.0001). Thromboembolic events were reported in 2% of patients. Conclusion: These results confirm the efficacy and safety of epoetin beta in routine practice for anemic patients with a non-myeloid hematological malignancy receiving chemotherapy. Epoetin beta improves the quality of life measured by FACT score.

Management of Chemotherapy‐induced Anemia (CIA) with Biosimilar Epoetin Alfa (Binocrit®) in Patients with Multiple Myeloma (MM): An Interim Analysis of an Ongoing French National Observational Study (The OncoBOS study)

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4001-4001 ◽  
Author(s):  
Irina Voronina ◽  
Mario Ojeda-Urib ◽  
Charles Dauriac ◽  
Laurent Voillat ◽  
Camille Aubron-Olivier ◽  
...  
Keyword(s):  
Observational Study ◽  
Board Of Directors ◽  
Treatment Period ◽  
Iron Status ◽  
Routine Practice ◽  
Epoetin Alfa ◽  
Advisory Committees ◽  
Time Points ◽  
The Mean ◽  
Biosimilar Epoetin Alfa

Abstract Background: OncoBOS is a national, prospective, non-interventional, longitudinal, observational study describing biosimilar epoetin alfa (Binocrit®) use in routine practice in France in patients receiving chemotherapy treatment (CT) for solid tumors, lymphoma or myeloma. This sub-analysis focuses on the management of CIA in patients with MM. Patients and methods: Patients ≥18 years with MM, CIA and eligible for treatment with Binocrit® were included in this analysis. Patients characteristics, data on CIA and its management and predominant factors considered by the physician in prescribing Binocrit® were recorded at baseline, 3-4 weeks and 12 (± 1) weeks later. Hemoglobin (Hb) outcomes assessed included the proportion of patients achieving a Hb increase ≥1 and ≥2 g/dL, and the mean Hb change from baseline. Results: 99 patients with MM (mean age 71.1 years) from 20 sites were recruited from September 2011 to April 2014. 54.5% of subjects were male. Mean and median baseline Hb levels were 9.4 g/dL and 10 g/dL, respectively. The mean increase in Hb level was 1.1 g/dL after 1 month and 2.2 g/dL after 3 months (p<0.001 vs baseline) of Binocrit® treatment. A Hb increase ≥1 g/dL was achieved by 57.6% of patients at week 3-4 and 78.0% at week 12; a Hb increase ≥2 g/dL was achieved by 22.2% and 60.4% of patients at the same time points. Patients received a median dose of 30,000 IU Binocrit® once weekly. Four of the 99 patients (4.0%) required a dose increase; 3 of these patients had their dose doubled during the treatment period. Transfusion rates remained stable at 12.1% and 9.6% at week 3-4 and week 12, respectively. Oral and intravenous (IV) iron supplementation rates were low: oral iron was received by 1.0% and 2.2% of patients at week 3-4 and week 12, respectively; 1.0% and 1.1% of patients received IV supplementation at the same time points. Of note, these low rates could be explained by the fact that iron status (serum ferritin and transferrin saturation coefficient) was assessed in only 32.3% of subjects at baseline. Physicians considered quality of life (59.6%), fatigue (20.2%) and avoidance of blood transfusion (13.1%) as predominant factors in the rationale for anemia management and treatment. Over the treatment period, one treatment-related adverse reaction was recorded, which was not considered serious. Conclusion: This sub-analysis indicates that Binocrit®, used in routine practice, is effective and well tolerated for the treatment of CIA in patients with MM receiving CT. Disclosures Voronina: Sandoz: Investigator Other. Ojeda-Urib:Sandoz: Honoraria. Dauriac:Sandoz: Investigator Other. Voillat:Sandoz: Investigator Other. Aubron-Olivier:Sandoz: Employment. Fernet:Sandoz: Employment. Karlin:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sandoz: Honoraria, Membership on an entity's Board of Directors or advisory committees. Fitoussi:Sandoz: Honoraria.

Antiemesis Clinical Practice Guidelines in Oncology

2004 ◽  
Vol 2 (5) ◽  
pp. 470 ◽  
Keyword(s):  
Functional Ability ◽  
Performance Status ◽  
Wound Dehiscence ◽  
Chemotherapeutic Agents ◽  
Nausea And Vomiting ◽  
Nutrient Depletion ◽  
Chemotherapy Treatment ◽  
Anticancer Treatment ◽  
Recent Version

Chemotherapy-induced nausea and vomiting (emesis) can significantly affect a patient's quality of life, leading to poor adherence with further chemotherapy treatment. In addition, nausea and vomiting can result in metabolic imbalances, degeneration of self-care and functional ability, nutrient depletion, anorexia, decline of the patient's performance status and mental status, wound dehiscence, esophageal tears, and withdrawal from potentially useful or curative anticancer treatment. The incidence and severity of nausea and/or vomiting in patients receiving chemotherapy are affected by numerous factors, including (1) the specific chemotherapeutic agents used, (2) dosage, (3) the schedule and route of administration, and (4) individual patient variability. Approximately 70% to 80% of all cancer patients receiving chemotherapy experience emesis, and 10% to 44% experience anticipatory emesis. For the most recent version of the guidelines, please visit NCCN.org

scholarly journals Flupirtine in the Management of Taxane-induced Pain in Cancer Patients

2021 ◽  
Vol 0 ◽  
pp. 1-4
Author(s):  
Anusha Paul ◽  
M. Abdul Razak ◽  
Ameya Binoy ◽  
Padma Uma Devi ◽  
Keechilat Pavithran
Keyword(s):  
Quality Of Life ◽  
Liver Toxicity ◽  
Opioid Analgesic ◽  
Opioid Analgesics ◽  
Brief Pain Inventory ◽  
Chemotherapeutic Agents ◽  
Medical Practitioners ◽  
The Mean

Objectives: Paclitaxel and docetaxel are two commonly used chemotherapeutic agents in the treatment of various types of cancers. However, debilitating taxane-induced arthralgia and myalgia are among the most common adverse reactions associated with taxanes, which has greatly influenced medical practitioners. Most of the mild and moderate analgesics were found to be less effective in the management of taxane induced pain. So we used flupirtine, a non-opioid analgesic, in the treatment of taxane-induced pain. Materials and Methods: In this study, we analysed the baseline pain score and follow-up data of 60 patients receiving a taxane-based chemotherapy regimen. Baseline data of these study populations experiencing significant taxane-induced pain were compared with follow-up data after treating them with analgesic flupirtine (200 mg/day). The baseline and follow-up data representing pain were assessed with the help of the Visual Analogue Scale (VAS), and the quality of life was determined using the Brief Pain Inventory (BPI) scale questionnaire. Results: The mean baseline and follow-up VAS score was compared using paired sample t-test, which showed a significant reduction in taxane-induced pain after treatment with flupirtine (P < 0.001). Similarly, the mean BPI score representing the quality of life before and after treatment with flupirtine was compared, and a notable improvement in quality of life was seen after treatment with flupirtine. The mean and follow-up data of aspartate aminotransferase and alanine aminotransferase levels of patients were also compared to assess the adverse drug reaction profile of the drug, and the analyzed data was found to be statistically insignificant (no significant liver toxicity) which indicates that drug can be used effectively for a period of <2 weeks. Conclusion: We believe that flupirtine can be used as an effective analgesic in dire situations where patients require opioid analgesics for the management of taxane-induced pain, provided that the drug is given for <2 weeks to avoid drug-related hepatotoxicity.

scholarly journals Management of anaemia in oncohaematological patients treated with biosimilar epoetin alfa: results of an Italian observational, retrospective study

2016 ◽  
Vol 9 (1) ◽  
pp. 22-32 ◽  
Author(s):  
Giovanni Rosti ◽  
Mario Petrini ◽  
Alberto Bosi ◽  
Piero Galieni ◽  
Daniele Bernardi ◽  
...  
Keyword(s):  
Solid Tumour ◽  
Solid Tumours ◽  
Routine Practice ◽  
Blood Transfusions ◽  
Haematological Malignancies ◽  
The European Union ◽  
Epoetin Alfa ◽  
Symptomatic Anaemia ◽  
Biosimilar Epoetin Alfa

Background: Many patients with solid tumours or nonmyeloid haematopoietic tumours develop symptomatic anaemia, which has a major impact on quality of life (QoL). The efficacy of erythropoiesis-stimulating agents (ESAs) in improving QoL and reducing blood transfusions has been widely demonstrated. Binocrit® (biosimilar epoetin alfa) is an ESA indicated in the European Union for treating chemotherapy-induced anaemia. The aim of this study was to investigate the effect of Binocrit® on haemoglobin (Hb) levels in anaemic cancer patients in Italian clinical practice. Methods: The ANEMONE study was a national, longitudinal, retrospective, multicentre observational study. Patients had to be 18 years or older, with a solid tumour or non-Hodgkin’s lymphoma, Hodgkin’s disease or multiple myeloma, receiving chemotherapy, and treated with Binocrit® to manage chemotherapy-induced anaemia. The primary outcomes were the proportion of patients with a Hb increase ⩾1 g/dl during the first 4 weeks and with a Hb increase ⩾2 g/dl during the first 12 weeks. Results: A total of 245 patients were enrolled and 215 patients were evaluable for statistical analysis. In the first 4 weeks, 49.3% of patients showed an increase in Hb of ⩾1 g/dl: 45.5% in patients with solid tumours and 52.1% in patients with haematological malignancies. In the first 12 weeks, 51.6% of patients showed an increase in Hb of ⩾2 g/dl (48.4% solid tumours, 54.2% haematological diseases). Treatment with Binocrit® was well tolerated. Conclusions: These results confirm the effectiveness and safety of Binocrit® for chemotherapy-induced anaemia in routine practice in patients with solid tumours, lymphoma and myeloma.

scholarly journals P186 Prevalence and management of anaemia in Greek patients with inflammatory bowel disease: a multicentre real-life cohort study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S231-S232
Author(s):  
K Karmiris ◽  
K Fotinogiannopoulou ◽  
M Velegraki ◽  
E Koureta ◽  
G Axiaris ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Iron Supplementation ◽  
Point Prevalence ◽  
World Health ◽  
History Of ◽  
Iv Iron ◽  
Inflammatory Bowel

Abstract Background Anaemia is a common extra intestinal manifestation of inflammatory bowel disease (IBD) that plays an important role in patients’ quality of life. The aim of our study was to evaluate the prevalence of anaemia and its current management in referral IBD centres in Greece. Methods We performed a retrospective analysis of demographic, clinical, laboratory and IBD-related treatment data as well as data concerning the type of anaemia and its treatment in IBD patients registered in 10 Greek tertiary referral centres. Consecutive patients (the last seen) having at least two follow-up visits with available to retrieve relevant laboratory results were included. Anaemia was defined by the World Health Organization criteria. Patients with co-morbidities related to anaemia were excluded. Results A total of 751 IBD patients have been registered so far and their demographic and clinical characteristics are presented in Table 1. The point prevalence of anaemia at inclusion was 26.8 % (201 patients), whereas the overall prevalence of history of anaemia was 38.7% (291 patients). The prevalence of anaemia was numerically higher in CD (41.1 %, n = 186) than in ulcerative colitis (35.2 %, n = 105) but the difference was not statistically significant (p = 0.13). Persistent anaemia (anaemia in all measurements) was found in 40 (13.7%) and recurrent anemia in 102 (35.1%) patients, whereas 54 (18.5 %) had a history of anaemia before IBD diagnosis. IBD patients with anaemia at entry had higher activity (HBI, SCCAI and CRP) and lower quality of life (SIBDQ) scores than patients without anaemia (for all comparisons p &lt; 0.05). Among the 291 patients with anaemia iron supplementation was administered in 239 (82.3%); oral iron in 52 (17.9%) and iv iron in 205 (70.4%). Vitamin B12 and folate were administered in 54 and 107 patients, respectively. Conclusion The point prevalence of anaemia in Greek IBD patients is 26.8%. Almost half of the patients with anaemia present recurrent or persistent anaemia. The presence of anaemia is associated with active disease and lower quality of life. The vast majority of patients received iron supplementation mainly in the form of iv iron.

Sequential treatment with pazopanib (PAZO) followed by nivolumab (NIVO) in patients with advanced or metastatic renal cell carcinoma (mRCC): Third interim results of the non-interventional study PAZOREAL.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4574-4574
Author(s):  
Martin Boegemann ◽  
Jens Bedke ◽  
Martin Schostak ◽  
Christiane Hering-Schubert ◽  
Manfred Welslau ◽  
...  
Keyword(s):  
Real World ◽  
Randomized Clinical Trials ◽  
Hypertensive Crisis ◽  
Routine Practice ◽  
Interventional Study ◽  
Real World Evidence ◽  
Grade 3 ◽  
Selection Of

4574 Background: Randomized clinical trials for the implementation of new therapies include only a selection of patients that are later treated with these new options. Thus, real-world evidence is urgently needed not only to monitor the translation of treatment approaches into routine practice but also to improve cancer treatment and survivorship care on a broader scale. Methods: PAZOREAL is a prospective, multicenter, non-interventional study to evaluate effectiveness [primary time on drug (TD)], tolerability, safety, and quality of life (QoL) in patients (pts) with mRCC, treated with 1st L PAZO followed by 2nd L NIVO or everolimus (EVE). Results: Between Dec. 2015 and Sep. 2017, 421 pts were enrolled and 402 pts started 1st L PAZO treatment (Tx), 127 and 5 pts received NIVO and EVE as 2nd L Tx, resp., 56 entered follow-up. At time of data-cut (08 Nov 2018) median TD was 6.6 months (95%CI 6.0-7.9) for 1st L PAZO and 4.1 months (95%CI 3.2-5.8) for 2nd L NIVO (all pts), 8.1 months (95% CI 6.6-9.5) for PAZO and 3.2 (2.7-6.5) for NIVO Tx for trial eligible pts (39.1% of 402 pts). Median TD for pts with or without prior nephrectomy was 7.6 vs 4.5 months, resp. The clinical benefit rate of 1st L PAZO was 58.2 % (95% CI 53.3-62.9) based on investigator assessment. Median OS of PAZO was 29.5 months (95%CI 23.6-NA) for all pts, 28.2 months (95% CI 22.2-NA) for NIVO in 2nd L. The most commonly reported AEs for PAZO Tx were diarrhea (35%), nausea (20.3%) and fatigue (17.5%). Most common PAZO-related grade 3/4 adverse events were hypertension (5%), hypertensive crisis (2.3%) and GGT increase (1.8%). QoL evaluated by EQ-5D-5L remained stable over different Tx lines. Conclusions: The interim results of the PAZOREAL study confirm a favorable overall survival in pts with mRCC treated with 1st L PAZO in a real-world setting, good benefit-risk profile of PAZO and sustained QoL monitored over several treatment lines. In Germany NIVO as 2nd L Tx is commonly applied after 1st L Tx with PAZO.

scholarly journals Protocol and Baseline Data of a Multicentre Prospective Double-Blinded Randomized Study of Intravenous Iron on Functional Status in Patients with Chronic Kidney Disease

2020 ◽  
Vol 51 (6) ◽  
pp. 493-500
Author(s):  
Sunil Bhandari ◽  
Victoria Allgar ◽  
Archie Lamplugh ◽  
Iain C. Macdougall ◽  
Philip A. Kalra
Keyword(s):  
Exercise Capacity ◽  
Heart Function ◽  
Well Being ◽  
Iron Treatment ◽  
Iv Iron ◽  
The Mean ◽  
Double Blinded ◽  
And Function ◽  
Minute Walk

Background: Iron deficiency (ID) is common in patients with chronic kidney disease (CKD) due to an inadequate dietary intake of iron, poor absorption from the gut and increased iron losses. In addition to preventing anaemia, iron is important for normal heart function, being involved in processes that generate a necessary continuous energy supply. Treatment with intravenous (IV) iron has been suggested to lead to improvement in heart function and well-being in people with ID and CKD. In the Iron and the Heart Study, we hypothesized that IV iron treatment will primarily improve exercise capacity and may secondarily impact the feeling of well-being in comparison to placebo over 3 months in non-anaemic CKD patients who have ID. Methods: This was a prospective double-blinded explorative randomized, multi-centre study designed to compare the effects of IV iron supplementation and placebo in iron-deficient but not anaemic patients with established CKD stages 3b-5 on functional status, and in addition cardiac structure and function. The study included 54 adults with serum ferritin (SF) <100 µg/L and/or transferrin saturation <20%, randomized in a 1:1 ratio to 1,000 mg IV ferric derisomaltose or placebo. Following randomization, participants underwent baseline assessments and then received IV iron or placebo infusion. Each participant was followed up at months 1 and 3. At each visit, patients underwent clinical review, measurements of hematinics and haemoglobin (Hb), and assessments of physical function and well-being. The primary outcome was exercise capacity using the 6-minute walk test. Secondary objectives included effects on hematinic profiles and Hb concentration, changes in myocardial parameters assessed with speckle tracking echocardiography and change in patients’ quality of life. Results: Between October 2016 and April 2018, 55 from 326 individuals from 3 UK centres attended screening and were randomized. The mean (SD) age was 59.6 (11.7) years, 26 (48%) patients were male, the majority were Caucasians (42; 78%), and 32 (59%) were non-smokers. The mean (SD) body mass index was 30.3 (6.5); SF was 66.3 (44.1) µg/L, TS was 20.1 (7.4) % and Hb was 128.7 (10.1) g/L at randomization for the whole group. Mean (SD) serum creatinine was 186.7 (58.6) µmol/L, estimated glomerular filtration rate was 31.1 (9.6) mL/min/1.73 m2 and urinary albumin and protein/creatinine ratios 60.9 (133.3) and 83.8 (128.4) mg/mmol respectively. The mean (SD) C-reactive protein was 5.0 (4.4) mg/L and the mean (SD) 6-minute walk distance at baseline was 401.2 (120.2) m. Conclusion: The Iron and the Heart Trial will provide important information on the short-term effects of IV iron treatment in CKD patients with ID without anaemia on measures of exercise capacity, quality of life and mechanistic data on myocardial structure and function. Trial Registration: European Clinical Trials Database (No. 2014-004133-6; REC no. 14/YH/1209; Sponsor ref. R1766).

scholarly journals Prevalence of cognitive impairment following chemotherapy treatment for breast cancer: A systematic review and meta-analysis

2021 ◽  
Author(s):  
Alexandra L Whittaker ◽  
Rebecca P George ◽  
Lucy O’Malley
Keyword(s):  
Breast Cancer ◽  
Cognitive Impairment ◽  
Neuropsychological Tests ◽  
Negative Impact ◽  
Self Report ◽  
Screening Tools ◽  
Low Grade ◽  
Chemotherapy Treatment ◽  
Time Points

AbstractBreast cancer survival rates have markedly improved. Consequently, survivorship issues have received increased attention. One common sequela of treatment is chemotherapy- induced cognitive impairment (CICI). CICI causes a range of impairments that can have a significant negative impact on quality of life. Knowledge of the prevalence of this condition is required to inform survivorship plans, and ensure adequate resource allocation and support is available for sufferers.ObjectiveTo estimate the prevalence of cognitive impairment following chemotherapy treatment for breast cancer.MethodsMedline, Scopus, CINAHL and PSYCHInfo were searched for eligible studies which included prevalence data on CICI, as ascertained though the use of self-report, or neuropsychological tests. Methodological quality of included studies was assessed. Findings were synthesised narratively, with meta-analyses being used to calculate pooled prevalence when impairment was assessed by neuropsychological tests.Results and discussionThe review included 52 studies. Time-points considered ranged from the chemotherapy treatment period to greater than 10 years after treatment cessation. Summary prevalence figures (across time-points) using self-report, short cognitive screening tools and neuropsychological test batteries were 44%, 16% and 21-34% respectively (very low GRADE evidence).ConclusionSynthesised findings demonstrate that 1 in 3 breast cancer survivors may have clinically significant cognitive impairment. Prevalence is higher when self-report based on patient experience is considered. This review highlights a number of study design issues that may have contributed to the low certainty rating of the evidence. Future studies should take a more consistent approach to the criteria used to assess impairment. Larger studies are urgently needed.Summary of Findings Table

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