Pretreatment Hemoglobin Level Research Articles

Weight loss induced by a hypocaloric diet with or without fish oil supplementation re-established iron and omega-3 fatty acid homeostasis in middle-aged women with obesity: A post-hoc analysis of a randomized controlled trial

ObjectiveMiddle-aged women with obesity are at increased risk of iron overload and iron disorder is known to disrupt n-3 polyunsaturated fatty acid homeostasis. We evaluated relationships between pretreatment hemoglobin and n-3 polyunsaturated fatty acid levels, and tested whether pretreatment hemoglobin contributed to inter-individual variability in weight loss with special focus on changes in body weight, iron and n-3 polyunsaturated fatty acid profiles. Study design117 middle and older aged women with obesity and more than two metabolic abnormalities were randomized to a 12-week hypocaloric diet without or with fish oil supplementation. Blood iron biomarker and erythrocyte membrane phospholipid profiles were evaluated. Main outcomeThe absolute change from baseline to week 12 in serum iron and erythrocyte n-3 polyunsaturated fatty acid levels according to pretreatment hemoglobin tertiles and fish oil supplementation. ResultsA Pearson correlation analysis showed that pretreatment hemoglobin levels were negatively correlated with linoleic acid (r = −0.231), α-linoleic acid (r = −0.279), and n-3 polyunsaturated fatty acid (r = −0.217) (all p < 0.05). Dietary weight loss markedly enhanced erythrocyte membrane lipids of linoleic acid, α-linoleic acid, and n-6 and n-3 polyunsaturated fatty acid only in those women with the highest pretreatment hemoglobin levels (tertile 3) (all p < 0.05). Fish oil supplementation increased bioavailable iron in women with moderate pretreatment hemoglobin levels (tertile 2) (p < 0.05) and, to a lesser extent, prevented a reduction in circulating iron in those with the lowest hemoglobin levels (tertile 1). ConclusionDietary weight loss is an effective treatment program to manage obesity-related iron and n-3 polyunsaturated fatty acid disorders, particularly for middle-aged women with obesity and iron overload.

Mean Rise in Hemoglobin After Intravenous Iron Therapy in Children with Iron Deficiency Anemia

Introduction: Iron deficiency anemia (IDA) is a significant public health issue in Pakistan, affecting up to 63% of children, as revealed by the Pakistan National Nutritional Survey 2018. While oral iron remains the primary choice, challenges in compliance have led to the consideration of intravenous (IV) iron therapy, particularly iron sucrose. The study discusses the safety and efficacy of IV iron therapy in Pakistani children and aims to broaden our understanding of treating IDA in resource-constrained regions. Aims &amp; Objectives: To determine the average hemoglobin (Hb) increase in iron-deficient-anemic children aged 01 to 12 years after treatment with intravenous iron sucrose. Place and Duration of Study: A quasi-experimental study was undertaken at Fauji Foundation Hospital in Rawalpindi, spanning from September 2021 to September 2022. Material &amp; Methods: The study focused on a cohort of pediatric patients aged between 1 and 12 years, all of whom were diagnosed with iron deficiency anemia and had previously encountered ineffective outcomes with oral iron therapy. In this investigation, the patients received treatment involving intravenous iron sucrose. Subsequently, their progress was diligently monitored after a period of 8 weeks. Improvement in hemoglobin level was assessed at the end of treatment to evaluate its efficacy.Data processing and statistical analysis were carried out using SPSS version 23,p-value of &lt;0.05 indicated statistical significance. Results: Out of 150 study cases, 96 (64.0 %) were male, while 54 (36.0 %) were female. The mean age of our study cases was 05 ± 2.3 years of these 150 study cases, 74 (49.3 %) belonged to rural areas, and 76 (50.7 %) belonged to urban areas. Poor socioeconomic status was noted in 97 (64.7 %), and 53 (35.3%) were middle-income. A family history of iron deficiency anaemia was recorded in 16 (10.7%). Iron deficiency due to dietary iron insufficiency was reported in 67 (44.7%), Total Parentral Nutrition (TPN) dependencywas seen in 61 (40.7%) and 22 (14.7%) had chronic gastritis. The mean baseline (pretreatment) haemoglobin level was 7.71 ± 0.63 g/dl, while the mean post-treatment haemoglobin level was 10.68 ± 0.60 g / dl (p = 0.001). Conclusion: After intravenous iron sucrose, we noted a significant rise in paediatric patients' hemoglobin levels, emphasizing its effectiveness and safety. Statistically, we found correlations with age, family history, and causes. Healthcare practitioners should consider injectable iron treatments for better results and reduced health issues in this group.

Blood Biomarkers and Risk of Venous Thromboembolism in Cancer Patients: A Systematic Review and Meta-Analysis

Patients with cancer have an increased risk of venous thromboembolism (VTE). Currently, several VTE risk prediction tools have been developed to identify candidates for primary VTE thromboprophylaxis. However, the availability of reliable and highly discriminatory prediction models for VTE risk assessment in cancer patients is limited, warranting further improvement of VTE risk stratification strategies. The implementation of biomarkers in risk assessment models might lead to refined VTE risk prediction, but it remains to be more comprehensively investigated. In this systematic review and meta-analysis, we aimed to evaluate and summarize all candidate biomarkers and their association with cancer-associated VTE. We conducted an electronic search in Medline, EMBASE and Cochrane central databases for studies that evaluated biomarkers in adult patients with cancer from inception to September 26 th 2022. We included observational and interventional studies reporting on subsequent VTE occurring after a cancer diagnosis. The baseline or index event of the biomarker measurements had to be definitively and uniformly applied to all enrolled patients. Two reviewers independently screened titles, abstracts and full-text articles for inclusion. Median differences (for continuous measures) and Odds Ratios (OR) (for dichotomous cut-off measures) with 95% confidence intervals (95% CI) were estimated and pooled using random-effects models. We assessed each studies risk of bias using the Quality in Prognostic Studies (QUIPS) risk of bias tool. Our search identified 4274 studies that were screened for inclusion (Figure 1). Following the screening, 109 studies (with 520 biomarker measurements) met the inclusion criteria and were included in the systematic review. Of these, 51 studies (with 174 biomarker measurements) were included in the meta-analysis. The majority of the studies were cohort studies (n=47; 32 prospective and 15 retrospective), while the other 4 studies were nested case-control studies. Eighteen studies had a study population of mixed cancer types and the remaining studies had a study population of specific cancer types, including: lung (n=6), gynecologic (n=5), breast (n=3), stomach (n=3), lymphoma (n=2), myeloma (n=2), ovarian (n=2), pancreas (n=2), brain (n=1), colorectal (n=1), gastrointestinal (n=1), genitourinary (n=1), gynecologic or breast (n=1), head and neck (n=1), liver (n=1), and prostate (n=1). We calculated the median difference and 95% CI for 23 different biomarkers. Cancer patients who experienced subsequent VTE events had significantly higher pre-treatment factor VIII activity, peak thrombin, platelet count and prothrombin fragment F1+2 levels compared to patients who did not experience VTE events (Table 1). Pre-treatment d-dimer levels were also higher in cancer patients who developed VTE, however, considerable heterogeneity was observed (Table 1). Contrastingly, pre-treatment hemoglobin, lag time - thrombin generation, prothrombin time and time to peak thrombin levels were significantly lower in those experiencing VTE events compared to patients who did not experience any events (Table 1). D-dimer levels on day-1 after cancer surgery were reported in two studies which, when pooled, revealed that cancer patients with subsequent VTE had higher d-dimer levels post-operatively compared to those with no events (Table 1). Moreover, pre-treatment hemoglobin levels 100 g/L was significantly associated with future VTE risk [OR: 1.42 (95%CI: 1.03-1.97), I 2=0%, n=11] while neutrophil lymphocyte ratio 3 was associated, yet insignificant [OR: 1.60 (95%CI: 0.99-2.60), I 2=43%, n=4]. Pre-treatment platelet count 350 x 10 9/L and white blood count levels 11 x 10 9/L were not significantly associated with future VTE risk [OR: 0.84 (95%CI: 0.66-1.06), I 2=0%, n=9 and 1.32 (0.86-2.03), I 2=56%, n=8, respectively]. From the 51 studies included in the meta-analyses, 27 studies had a low risk of bias, 19 studies had a moderate risk of bias and 5 studies had a high risk of bias. In conclusion, nine blood biomarkers were found to be significantly associated with VTE in cancer patients. Their utility as predictors of VTE in thrombotic risk assessment models may help in optimising VTE prediction and should be further explored in future studies.

Effect of Baseline Hemoglobin Level on Prognosis in Nasopharyngeal Cancer Patients Receiving Chemoradiotherapy

Objective: To explore retrospectively how pretreatment hemoglobin levels affected the prognosis of patients with nasopharyngeal cancer receiving chemoradiotherapy. Methods: Clinical data of 97 nasopharyngeal cancer patients who received definitive chemoradiotherapy between 2000 and 2022 were analyzed. We accepted the cut-off value of hemoglobin as 11.0g/dL. Results: In general, 13 (13%) of patients were Hb≤11g/dL, while 84 (86%) was Hb&gt;11g/dL. Median survival times were 76 (95%CI 19-132) months and 205 (95%CI 157-252) months for Hb≤11g/dL and Hb&gt;11g/dL patients, respectively. 1, 2, 3 and 5 year survival rates were 67.7%, 67.7%, 67.7% and 58% for Hb≤11g/dL and 90.3%, 83.6.2%, 75.2% and 66.1% for Hb&gt;11g/dL patients, respectively, and this difference show no statistical significance (p=0.254). When we evaluated patients according to WHO criteria for anemia (hemoglobin &lt;12g/dL (female) or &lt;13g/dL (male)), the median survival time was 220 (95%CI 190-255) months for non-anemic patients whereas it was 76 (95%CI 0-157) months for anemic patients. 1, 2, 3 and 5 year survival rates were 92.5%, 87.6%, 78.8% and 68.9% for non-anemic and 75%, 67.5%, 63.7% and 55.8% for anemic patients, respectively. There was statistically significant difference between the two groups (p=0.013). Conclusion: In our study, although Hb&lt;11g/dl before chemoradiotherapy did not show a statistically significant difference in nasopharyngeal cancer patients, the median overall survival of 76 months in Hb≤11g/dL patients and 205 months for Hb&gt;11g/dL patients. However, pretreatment anemia according to WHO criteria, and Hb≤11 g/dL in male patients were found to be independent adverse prognostic factors.

Personalized [177Lu]Lutetium-PSMA Therapy for Patients with Pre-Treated Castration-Resistant Prostate Cancer: A Single Institution Experience from a Comprehensive Cancer Centre.

Castration resistant prostate cancer (CRPC) is characterized by an aggressive biological behavior with a relatively short survival time, especially in progressive tumors pretreated with new hormonal agents and taxane chemotherapy. [177Lu]-Lutetium-PSMA (Lu-PSMA) treatment has proven efficacy in these patients. However, around 30% of the CRPC patients do not benefit from Lu-PSMA treatment, and little is known about predictive factors for treatment success if Lu-PSMA is offered in an individualized approach based on clinical and laboratory features. In this monocentric retrospective study, 86 CRPC patients receiving Lu-PSMA treatment were evaluated. The focus of the study was to describe clinical factors at baseline and during early treatment that are related to overall survival (OS). In addition, PSMA PET/CT-, PSA-response, and safety and tolerability (CTCAE adverse event reporting) were assessed. Efficacy endpoints were calculated using stratified Kaplan-Meier methods and Cox regression models. Mean applied dose was 17.7 GBq (mean 5.3 ± 1.1 GBq per cycle) with an average of 3.6 (range 1-8) therapy cycles. Patients were followed up for a mean of 12.4 months (range 1-39). The median OS was 15 months (95% CI 12.8-17.2). The best overall response rate in patients assessed with PSMA PET/CT and PSA response was 27.9%, and 50.0% had at least stable disease. Nine patients had a ≥grade 3 adverse event with anemia being the most frequent adverse event. Positive predictors for prolonged OS from baseline parameters were pre-treatment hemoglobin level of ≥10 g/dL and a lower PSA values at treatment start, while the presence of visceral or liver metastases were not significantly associated with worse prognoses in this cohort. With careful patient selection, an individualized Lu-PSMA treatment approach is feasible and patients with dose-limiting factors or visceral metastases should be included in prospective trials.

Impact of hemoglobin on survival of young women with cervical cancer treated with concurrent chemoradiotherapy.

e17529 Background: Cervical cancer is a global public health problem, with higher impact in many low-income and middle income countries. In Peru, cervical cancer is the leading cause of cancer deaths among women. The aim of this study is to investigate the prognostic factors affecting long-term survival in locally advanced cervical cancer young patients treated with concurrent chemoradiotherapy. Methods: This is a retrospective study of young women with locally advanced cervical cancer who underwent radiotherapy with concurrent platinum-based chemotherapy at the national cancer peruvian institute (INEN), from 2008 to 2012. The clinicopathological factors of all patients were collected. To explore the relationship between factors and prognosis, survival rates were estimated by the Kaplan–Meier method. Results: A total of 192 patients under 35 years old . Among all patients, 167 were diagnosed with SCC, 19 with AC, and 5 with ASC. Most of the patients were IIB and IIIB FIGO stage, 69% and 22% respectively. 38 cases had no metastatic lymph nodes and 42 cases were diagnosed of lymph node metastases, of which 30 were positive for pelvic lymph nodes only, and 12 were positive for para-aortic lymph nodes. We obtained pretreatment hemoglobin levels for all patients and found a median of 111 g/L, also we calculated the Prognostic nutritional index (PNI) with a median of 41.87 that correlates with a moderate to severe malnutrition in patients prior treatment. Response to chemoradiotherapy was not available in 13 patients, 136 achieved complete response, 30 patients with persistent disease and 12 with disease progression. Estimated median OS of all patients was 114.1 months [101.8-126.4] and median DFS was 112.3 months [98.9-125.7]. Exploratory analysis was performed to determine potential prognostic factors, only hemoglobin ≤ 100 g/L was statistically significant (p = 0.007). Conclusions: In young patients undergoing chemoradiation for cervical carcinoma, the hemoglobin prior treatment is prognostically significant.

Predictive factors and prognosis of immune checkpoint inhibitor-related pneumonitis in non-small cell lung cancer patients.

To investigate the influencing factors and prognosis of immune checkpoint inhibitor-related pneumonitis (CIP) in advanced non-small cell lung cancer (NSCLC) patients during or after receiving immune checkpoint inhibitors(ICIs). The clinical and laboratory indicator data of 222 advanced NSCLC patients treated with PD-1/PD-L1 inhibitors at the First Affiliated Hospital of Zhengzhou University between December 2017 and November 2021 were collected retrospectively. The patients were divided into a CIP group (n=41) and a non-CIP group (n=181) according to whether they developed CIP or not before the end of follow-up. Logistic regression was used to evaluate risk factors of CIP, and Kaplan‒Meier curves were used to describe the overall survival (OS) of different groups. The log-rank test was used to compare the survival of different groups. There were 41 patients who developed CIP, and the incidence rate of CIP was 18.5%. Univariate and multivariate logistic regression analyses showed that low pretreatment hemoglobin (HB) and albumin (ALB) levels were independent risk factors for CIP. Univariate analysis suggested that history of chest radiotherapy was related to the incidence of CIP. The median OS of the CIP group and non-CIP were 15.63 months and 30.50 months (HR:2.167; 95%CI: 1.355-3.463, P<0.05), respectively. Univariate and multivariate COX analyses suggested that a high neutrophil-to-lymphocyte ratio (NLR) level, a low ALB level and the development of CIP were independent prognostic factors for worse OS of advanced NSCLC patients treated with ICIs. Additionally, the early-onset and high-grade CIP were related to shorter OS in the subgroup. Lower pretreatment HB and ALB levels were independent risk factors for CIP. A high NLR level, a low ALB level and the development of CIP were independent risk factors for the prognosis of advanced NSCLC patients treated with ICIs.

Pretreatment Hemoglobin Levels and Platelet-to-Lymphocyte Ratio Predict Survival Benefit from Pembrolizumab in Advanced Urothelial Carcinoma.

Several prognostic risk factors have been recognized when using cisplatin-based conventional chemotherapy for the treatment of advanced urothelial carcinoma (UC); these include performance status (PS), liver metastasis, hemoglobin (Hb) levels, time from prior chemotherapy (TFPC), and other systemic inflammation scores including neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR). However, the benefit of these indicators for predicting outcome of immune checkpoint inhibitors is not fully understood. Here, we investigated the predictive value of the indicators in patients who received pembrolizumab for the treatment of advanced UC. Seventy-five patients who received pembrolizumab treatment for advanced UC were included. The Karnofsky PS, liver metastasis, hemoglobin levels, TFPC, NLR, and PLR were analyzed, and their relationship with overall survival (OS) was determined. All factors were highlighted as significant prognostic indicators for OS in the univariate proportional regression analysis (p<0.05 for each). Multivariate analysis revealed that Karnofsky PS and liver metastasis were independent prognostic indicators for OS (p<0.01) but were applicable only for a small number of patients. Notably, the combined analysis with low Hb levels and high PLR was significantly associated with OS in patients who could gain less benefit from pembrolizumab at a median of 6.6 [95% confidence interval (CI)=4.2-9.0] versus 15.1 (95% CI=12.4-17.8) months (p=0.002). The combination of Hb levels and PLR may be a broadly applicable indicator for the outcome of pembrolizumab as second-line chemotherapy in patients with advanced UC.

Pre-chemoradiotherapy low hemoglobin levels indicate increased osteoradionecrosis risk in locally advanced nasopharyngeal cancer patients.

We aimed to determine whether pretreatment hemoglobin (Hb) levels can predict the risk of osteoradionecrosis (ORN) in patients receiving concurrent chemoradiotherapy (CCRT) for locally advanced nasopharyngeal carcinoma (LA-NPC). ORN cases were identified from the records of LA-NPCs who had oral exams before and after CCRT. All Hb measurements were obtained on the first day of treatment. Receiving operating characteristic curve analysis was used to determine the relationship between Hb levels and ORN rates. The relationship between pretreatment Hb levels and ORN rates served as the primary endpoint, and secondary endpoints included the discovery of additional potential ORN risk factors. Among the 263 eligible LA-NPCs, we identified 8.7% ORN cases. The ideal cutoff Hb before CCRT was 10.6g/dL. It was revealed that HPR ≤ 10.6 group had a significantly higher ORN rate (32.5% vs. 1.5% for Hb > 10.6; P < 0.001). The mandibular V59.8 ≥ 36% Gy, pre-CCRT ≥ 4 tooth extractions, the presence of post-CCRT tooth extractions, and the time of post-CCRT tooth extractions > 8months were the other factors associated with significantly increased ORN rates (P < 0.05 for each). Low pre-CCRT Hb levels appeared to be independently linked to significantly higher ORN rates. Pretreatment Hb levels may be used to establish preventive measures and predict ORN.

Characteristics of Submucous Myomas and the Risk of Anemia.

Background and Objectives: Uterine fibroids still represent the most common indication for hysterectomy for benign pathologies. In the United States, more than 479,000 hysterectomies are performed annually, 46.6% for myomas and 47.7% in women aged from 18 to 44 years. By applying appropriateness criteria to this procedure, it has been estimated that overuse ranges from 16 to 70%. One of the main reasons that induce patients and gynecologists to consider hysterectomy is represented by severe anemia. Materials and Methods: This is a retrospective cohort study of 202 patients with uterine fibroids diagnosed by transvaginal ultrasound who underwent a hysteroscopic procedure. Myoma grade, size, location, and number were assessed by transvaginal scan and office hysteroscopy and correlated to the pre-treatment hemoglobin level. Results: Univariate analysis showed that anemia does not have a statistically significant association with myoma number and with age considered as a numerical predictor. In the patients with myoma type 0, there is a possibility of 81% having anemia regardless of menorrhagia. On the contrary, in patients with myoma type 1 or type 2, the possibility of having anemia varies according to the presence or absence of menorrhagia. If there is menorrhagia, the risk of moderate anemia is only present for myomas &gt;60 mm. Conclusions: The results of this study may contribute to defining objective criteria for the management of submucous myomas and anemia. Our data suggest that submucosal myomas type 0 &gt;10 mm should always be treated, putting patients at risk for anemia. Myomas type 2 and 3 should be treated for the risk of anemia in the presence of menorrhagia episodes or if &gt; of 60 mm. Adequate management of anemia and myomas could reduce the rate of unnecessary hysterectomies.

Outcomes and prognostic factors in patients with locally advanced cervical cancer treated with concurrent chemoradiotherapy

BackgroundTo investigate the prognostic factors affecting long-term survival in locally advanced cervical cancer (LACC) patients treated with concurrent chemoradiotherapy (CCRT).MethodsWe retrospectively analyzed 192 naive LACC (stage IIB–IVA) patients who underwent intensity-modulated radiotherapy (IMRT) with concurrent platinum-based chemotherapy in Xiangya Hospital from January 2014 to June 2017. The clinicopathological factors of all patients were collected. To explore the relationship between factors and prognosis, survival rates were estimated by the Kaplan–Meier method. Univariate and multivariate Cox proportional hazards models were used to evaluate the effect of various factors on overall survival (OS) and progression-free survival (PFS). The nomogram and calibration curves were generated on the basis of survival analysis.ResultsThe median follow-up time was 39.5 months. There-year rates of OS and PFS were 89.1% and 82.8%. LACC patients with non-squamous cell carcinoma [NSCC, including adenocarcinoma or adenosquamous carcinoma (AC/ASC)], advanced stage (IIIA-IVA), initially positive lymph node (pelvic or para-aortic lymph node, PLN/PALN), and a lower pretreatment hemoglobin (HGB) level (< 126 g/L) had lower survival rates. In univariate analysis, patients with NSCC, advanced stage, PLN or PALN metastasis had worse OS. Patients with NSCC, advanced stage, PLN or PALN metastasis, and a lower pretreatment HGB level had worse PFS. In multivariate analysis, NSCC and PALN metastasis were independent prognostic parameters of OS. NSCC, PALN metastasis and a lower pretreatment HGB level were independent prognostic parameters of PFS.ConclusionsNSCC and PALN metastasis were poor prognostic factors of OS and PFS, a lower pretreatment HGB level was an independent prognostic factor of PFS in LACC patients treated with CCRT.

Defining the optimal threshold and prognostic utility of pre-treatment hemoglobin level as a biomarker for survival outcomes in head and neck cancer patients receiving chemoradiation

ObjectivesWe sought to define the optimal threshold for anemia in North American head and neck cancer patients and evaluate its role as a prognostic biomarker. Materials and MethodsA single-institution database was queried for patients with head and neck cancer who underwent chemoradiation from January 2005 to April 2021. An optimal threshold of hemoglobin (Hgb) level was defined based on maximum log-rank test statistic. Cox multivariable analysis (MVA), Kaplan-Meier, and propensity score matching were performed to evaluate treatment outcomes. ResultsA total of 496 patients were identified. Threshold for Hgb was determined to be 11.4 for both overall survival (OS) and progression-free survival (PFS). Low Hgb was associated with worse OS (adjusted hazards ratio [aHR] 2.41, 95 % confidence interval [CI] 1.53–3.80, p < 0.001) and PFS (aHR 2.01, 95 % CI 1.30–3.11, p = 0.002). Similar findings were observed among 39 matched pairs for OS (5-year OS 22.3 % vs 49.0 %; HR 2.22, 95 % CI 1.23–4.03, p = 0.008) and PFS (5-year PFS 24.3 % vs 39.1 %; HR 1.78, 95 % CI 1.02–3.12, p = 0.04). Among those with HPV-negative tumors, low Hgb was associated with worse OS (aHR 13.90, 95 % CI 4.66–41.44, p < 0.001) and PFS (aHR 5.24, 95 % CI 2.09–13.18, p < 0.001). However, among those with HPV-positive tumors, low Hgb was not associated with both OS (aHR 1.75, 95 % CI 0.60–5.09, p = 0.31) and PFS (aHR 1.13, 95 % CI 0.41–3.14, p = 0.82). Conclusion and relevanceLow Hgb below 11.4 was an independent adverse prognostic factor for worse survival. It was also prognostic among patients with HPV-negative tumors, but not for HPV-positive tumors.

Association of pre-treatment hemoglobin levels with survival outcomes among Indian women with triple negative breast cancer.

e12549 Background: Prevalence of Triple Negative Breast Cancer (TNBC), which has utterly poor prognosis and higher recurrence rate, is high among Indian women ranging from 20-43% across different regions of India. Previous studies from other countries have shown that pretreatment hemoglobin and hematocrit values influence treatment outcomes among breast cancer patients. Recent 2019-2020 National Family Health Survey (NFHS) of India reported that 66.4% of women suffer from anemia. This study examined the association of pre-treatment hemoglobin levels with survival outcomes among Indian women with TNBC. Methods: We retrospectively analyzed the medical records of 435 women registered at our institute with a diagnosis of TNBC between the years 2013-2021. Pre-treatment hemoglobin levels i.e. either before the start of neoadjuvant chemotherapy (NACT) or prior to surgery among those who received adjuvant chemotherapy were retrieved from the medical records along with clinical and tumor characteristics. Primary outcomes were relapse free survival (RFS) and overall survivals (OS). Cox-regression and Kaplan-Meier survival analysis were used to examine the association of pre-treatment anemia with survival outcomes in these patients. Results: Fifty-one percent (n=221) of the 435 TNBC patients in our study cohort had pretreatment hemoglobin level of &lt;12.0 g/dL (based on the World Health Organization criteria). 278 patients received NACT and pathological complete response (pCR) rates were similar in anemic (31.5%) and non-anemic groups (30.1%). When adjusted for clinical and other hematological parameters, anemia was not associated with pCR. Median follow-up of the study cohort was 22.9 months (Range: 2.6 to 92.7 months). Pre-treatment anemia was significantly associated with poor RFS when adjusted for clinical and hematological parameters [adjusted Hazard ratio (aHR) (95%CI): 1.53 (1.02-2.31)]. Median RFS was 52.5 months among the anemic group and was not reached in non-anemic group. Effect of anemia on RFS did not vary by age category or menopausal status. However, the effect of anemia on OS varied significantly by menopausal status. Menopausal women with anemia at time of diagnosis had significantly higher hazard of death compared to menopausal women without anemia [aHR (95%CI): 5.0 (1.15-21.66)] and this association was not observed in pre-menopausal women [aHR (95%CI): 0.53 (0.19-1.44)]. Conclusions: Pretreatment hemoglobin level of &lt;12g/dL was associated with poor survival outcomes among Indian women with TNBC and the effect of anemia on overall survival of these patients varied by menopausal status. Evaluation of hemoglobin levels during chemotherapy, pre-post surgery, and at various stages of follow-up is needed to determine the independent association of hemoglobin level trajectories with treatment outcomes and long-term survival among these TNBC patients.

Optimal Threshold of Pre-Treatment Hemoglobin Level as a Prognostic Biomarker for Survival Outcome in Patients with Head and Neck Cancer in the Era of Human Papillomavirus

<h3>Purpose/Objective(s)</h3> Recent systematic reviews suggested that hemoglobin (Hgb) level may play a role as biomarker for survival outcome among patients with head and neck cancer. However, the optimal threshold for anemia and its role in a current human papillomavirus (HPV) era remain unclear. To address this knowledge gap, we performed an observational cohort study to investigate pre-treatment Hgb and its association with survival outcomes in patients with head and neck cancer treated with radiation therapy. <h3>Materials/Methods</h3> A single-institution, retrospective database was queried for patients with non-metastatic head and neck cancer who underwent radiation therapy from January 2005 to April 2021. Pre-radiation Hgb was evaluated as a continuous variable using restricted cubic splines (RCS), and the model-derived threshold was used to stratify patients into low and high Hgb. Cox multivariable analysis (MVA) and Kaplan-Meier method were used to analyze overall survival (OS) and disease-specific survival (DSS). Logistic MVA was performed to identify variables associated with low Hgb level. Propensity score matching was used to construct matched pairs. A subgroup analysis was also performed among patients with available HPV data. <h3>Results</h3> Among a total of 753 patients, median follow up was 29.7 months (interquartile range 17.8-57.8). Cox MVA based on RCS showed a threshold of Hgb at 12.96, with worsening survival in a continuous fashion without plateau as Hgb decreases. Low Hgb was associated with worse OS (aHR 1.55, 95% CI 1.17-2.05, p=0.002) and DSS (aHR 1.79, 95% CI 1.28-2.51, p<0.001). Similar findings were observed in 178 matched pairs (OS: HR 1.47, 95% CI 1.05-2.06, p=0.03; DSS: HR 1.82, 95% CI 1.19-2.78, p=0.006). On logistic MVA, patients were more likely to have low Hgb if they were female, had a higher T staging, underwent induction chemotherapy or surgery prior to radiation therapy, and had feeding tubes placed. They were less likely to have low Hgb if they had a good performance status and HPV-associated head and neck cancer. Among 466 patients with available HPV data, low Hgb was associated with DSS (aHR 1.84, 95% CI 1.30-2.61, p<0.001), but not OS (aHR 1.32, 95% CI 0.89-1.95, p=0.16). <h3>Conclusion</h3> In this study, low Hgb was associated with worse survival outcomes even among those with available HPV data. Patients with significant primary disease burden, feeding tube placement, and poor performance status who underwent either induction chemotherapy or surgery were more likely to have low Hgb. Further studies would be warranted to investigate the role of Hgb to identify patients early with poor prognosis and tailor treatments based on their risk factors.

Tolloid-like 1 gene variant rs17047200, pretreatment FIB-4, ALBI and PALBI scores as predictors of hepatocellular carcinoma occurrence after directly acting antivirals.

Identifying persons at increased risk of developing hepatocellular carcinoma (HCC) after exposure to directly acting antivirals (DAAs) is of utmost importance. Our aim was to identify the predictors of de novo HCC occurrence among cirrhotic patients after hepatitis C virus (HCV) treatment using DAAs. 529 cirrhotic patients who initiated treatment for HCV using DAAs were followed up for 2 years from the end of treatment for development of HCC. Pretreatment clinical and laboratory data were assessed as possible predictors for HCC occurrence. Genotyping for tolloid-like 1 gene (TLL1) variant rs17047200 was assessed in all patients who developed HCC and in the matched control group. Pretreatment bilirubin, FIB-4 and platelet-albumin-bilirubin (PALBI) scores were significantly higher among those who developed HCC than those who did not develop HCC during the 2-year follow-up period while hemoglobin level was significantly lower. ROC curve analysis revealed that at a cut-off ≥ 3.07, pretreatment FIB-4 had a sensitivity of 76.5%, and negative predictive value (NPV) of 92%. At a cut-off ≥ -2.5, pretreatment PALBI score had a sensitivity of 82.4%, and NPV of 93.2%. Regarding genotyping for TLL1 rs17047200 there were no statistically significant differences between those who developed HCC during follow-up and the matched control group. TLL1 rs17047200 genotyping is not helpful in predicting HCC occurrence after DAAs. On the other hand, lower pretreatment hemoglobin level and higher pretreatment bilirubin, FIB-4 and PALBI scores are associated with higher risk of HCC development after DAAs.

Efficacy and Safety of Ferric Derisomaltose/Iron Isomaltoside in Patients with Inflammatory Bowel Disease: A Systematic Review

BackgroundAnemia in inflammatory bowel disease (IBD) presents as a common extraintestinal manifestation resulting in many complications. This condition is often missed or underrated, anemia is secondary to blood loss or defective absorption of iron which can result in a combination of iron deficiency anemia (IDA) or anemia of chronic disease (ACD). The management is iron replacement therapy which improves the quality of life in these patients. Due to the constraints in the use of oral iron, parenteral preparations are more used in IBD patients. Commonly used iron sucrose and ferric carboxymaltose are often associated with side effects leading to poor compliance. Our study explores data about ferric derisomaltose also known as iron isomaltoside (IIM), a recently approved IV iron preparation. The FDA approved this drug in 2020 for patients with poor compliance with other iron preparations. We explored the efficacy and safety data of ferric derisomaltose in adult patients with IBD.Material/MethodsA literature search was performed using the following databases: PubMed, Cochrane, Embase, Clinical trials.gov, and Web of Science. The search was completed without using any filter and we used the MeSH Terms for “anemia”, “iron deficiency anemia”, “inflammatory bowel disease”, and “ferric compounds”. A total of 1590 articles were screened, and we finally selected 2 trials and 2 observational studies. We followed the PRISMA guidelines for literature search and selection of studies. Case reports, preclinical trials, meta-analyses, and review articles were excluded. Trial and observational studies related to IBD were included.ResultsIn total, 294 patients with anemia in inflammatory bowel disease received ferric derisomaltose intravenously as a single dose between 500 mg to 2000 mg. All patients were >18 years of age. The mean pre-treatment hemoglobin (Hb) level varied from 10.0 g/dL to 12.3 g/dL. The mean serum ferritin ranged from 19.6 µg/L to 57 µg/L and the mean transferrin saturation (TSAT) ranged from 8.8% to 18.5%. J. Stein et al investigated the effectiveness and safety of IIM in routine practical care of IDA in IBD patients. Dahlerup et al (NCT01599702) compared single dose IIM with multiple dosages of IIM in IBD patients. The remaining two studies investigated the effectiveness and safety of high dose IIM in patients with IBD. Results are summarized in Table 1.Efficacy:The increase in hemoglobin ranged from 0.6 g/dl to 2.9 g/dl from baseline while the increase in serum ferritin ranged between 102 µg /L to 250 µg /L and transferrin saturation increased in the range of 15.0%-23.7% in 10 to 52 weeks post iron isomaltoside (IIM) therapy. All markers of iron deficiency anemia showed significant improvement. In the observational study by J. Stein et al, the hemoglobin increased from a mean of 10.7 g/dl to 13.1 g/dl, serum ferritin increased from 57 µg /L to 146 µg /L, and TSAT from 8.8% to 23.7% at 16 weeks. Dahlerup et al demonstrated a Hb increase of >2 g/dl in 75% of patients at 10 weeks. According to W. Reinisch et al (NCT 01410435), there was a mean increase in serum ferritin from 32 µg /L to 102 µg /L and a decrease in TSAT from the baseline, but this decrease was not statistically significant.Safety:Adverse events were noted in 8 (3.6%) patients. Out of the 8 patients, 4 (<2%) were serious adverse events such as perianal abscess, miliary tuberculosis, nephrolithiasis, and worsening of ulcerative colitis, which may not be related to the study drug. The other 4 (1.8%) had life-threatening events, anaphylaxis being the most common. All four patients recovered. The most common mild adverse events reported were hypersensitivity reaction (HSR) seen in 3 patients. 2 patients discontinued due to mild HSR. There were no reports of death due to side effects of the drug.ConclusionFerric derisomaltose has demonstrated a substantial increment in iron parameters in anemia in patients with IBD. This was measured in terms of hemoglobin response, serum ferritin, and transferrin saturation. Greater Hb response was achieved irrespective of concomitant treatment with steroids and anti-TGF-ß.The adverse events were mild, and patients recovered showing high compliance. Since the average duration of follow-up in our study was 21 weeks, long-term follow-up is limited for this drug, we need further studies to assess the need for maintenance therapy. [Display omitted] DisclosuresAnwer: GlaxoSmithKline: Research Funding; BMS / Celgene: Honoraria, Research Funding; Janssen pharmaceutical: Honoraria, Research Funding; Allogene Therapeutics: Research Funding.

Title: Efficacy and Safety of Ferric Derisomaltose for Treatment of Anemia in Chronic Kidney Disease Patients: A Systematic Review

BackgroundAnemia in chronic kidney disease (CKD) patients develop primarily due to iron and erythropoietin deficiency, factors contributing to this include uremia induced inhibition of erythropoiesis, shortened red cell survival and nutritional deficiency. Erythropoietin stimulating agents (ESA) used in CKD increases iron demand for the production of new red blood cells (RBCs). Oral iron does not provide a reliable route to meet the demand of the iron required and poses the risk of side effects. The intravenous formulation provides the fastest route, although multiple intravenous formulations are available they require multiple dosing and still carry a risk of an adverse event. Ferric derisomaltose/iron isomaltoside (IIM) is an intravenous formulation of iron recently approved by the Food and drug administration (FDA) for patients intolerant to oral iron and non-dialysis dependent CKD patients. FDI is administered in high dose usually in a single administration. In this systematic review, we evaluated the published literature for the efficacy and safety of ferric derisomaltose in both dialysis-dependent and dialysis independent patients.Material/MethodsA literature search was done using the following databases: PubMed, Cochrane, Embase, Clinical trials.gov, and Web of Science. The search was completed without using any filter and we used the Mesh Terms for “anemia”, “iron deficiency anemia” “chronic kidney disease” and “ferric compounds”. Total of 316 which were further screened and we included 2 trials, and 2 prospective studies. Case reports, preclinical trials, meta-analyses, and review articles were excluded. We followed the PRISMA guidelines for literature search and selection of studies. We only included the trial studies that were completed. We excluded the studies that did not report efficacy and safety.ResultsIn total, amongst the four studies, 1558 CKD patients received ferric derisomaltose in a single dose. Patients in all stages of CKD were studied but most patients were between stages I to stage III CKD, stage IV and V(dialysis-dependent) were studied by Kalra et al (2020). A single dose of 1000 mg/dl of IIM, was administered intravenously. The mean pre-treatment haemoglobin level varied from 9.6g/dl to 10.6 g/dl. The mean serum ferritin ranged from 82.4 µg/L to 161.9 µg/L and the mean transferrin saturation ranged in patients from 15.8% to 18.51%. IIM receiving patients were compared with iron sucrose receiving patients by Bhandari et al, and oral iron by Kalra et al (2015). The remaining two studies compared single IIM with multiple IIM dosages. The results are summarised in the table below.Efficacy: The increase in haemoglobin ranged between 0.9 g/dL to 6.58 g/dL from baseline measured at 8 weeks. At the same time, serum ferritin showed an increase in baseline serum ferritin from 104 µg/L to 277 µg/L and transferrin saturation (TSAT) increased in the range of 5.3%-11.4 %. All markers of iron deficiency showed significant improvement. It achieved a greater Hb response irrespective of ESA treatment in both haemodialysis dependent and non-dependent patients. In the comparison group by Bhandari et al, iron sucrose receiving patients also had similar efficacy as IIM. On the other hand, those receiving oral iron in the study by Kalra et al (2015) had much poorer efficacy as compared to IIMSafety: Severe adverse effect was seen in a total of 10 (0.6%) patients who developed hypersensitivity reaction, acute myocardial infarction and injection site-related adverse effects with hypersensitivity being the most common. 15 (0.9%) patients discontinued the treatment. 21 (1.3%) died, and the death was attributed to end-stage renal disease.ConclusionFerric derisomaltose is an effective parenteral iron therapy to treat iron deficiency when compared to oral iron therapy, however, its efficacy is very similar to other parenteral iron formulations. In terms of safety, being used as a single dose it relatively has lesser adverse events but can seldom lead to discontinuation of the drug. This drug can be recommended for iron therapy especially considering single-dose administration but more studies need to be carried out in comparison to other parenteral formulations to further clarify its efficacy in dialysis-dependent CKD patients. [Display omitted] DisclosuresAnwer: BMS / Celgene: Honoraria, Research Funding; GlaxoSmithKline: Research Funding; Janssen pharmaceutical: Honoraria, Research Funding; Allogene Therapeutics: Research Funding.

Anemia is a Prognostic Factor for Overall Survival Rate in Patients with Non-Small Cell Lung Cancer Treated with Stereotactic Body Radiation Therapy.

PurposeAnemia has been associated with poor prognosis in patients with cancer across several cancer types. It has been identified as a prognostic factor in patients with non-small cell lung cancer (NSCLC) who have undergone surgery or chemoradiotherapy. However, there are only a few reports that have evaluated the prognostic significance of anemia in patients with NSCLC undergoing stereotactic body radiation therapy (SBRT).Patients and MethodsA total of 77 patients were enrolled in this study. The pretreatment hemoglobin (Hb) levels, within 2 weeks before SBRT, were available for all patients. The median age of the participants (56 men, 21 women) was 80 (range, 50–90) years. The median Hb level was 12.8 (range, 7.8–18.3) g/dL. The median follow-up period was 24 (range, 1–87) months.ResultsLocal recurrence was observed in 8 (10.4%) cases during the follow-up period. The 1- and 2-year local control (LC) rates were 94.8% and 86.4%, respectively. Seventeen (22.1%) patients died during the follow-up period. The 1- and 2-year overall survival (OS) rates were 93.1% and 85.2%, respectively. Univariate analysis identified anemia and body mass index as significant prognostic factors for predicting OS. On multivariate analysis, anemia was confirmed to be the only significant factor (p = 0.02469).ConclusionOur data suggest that anemia is a prognostic factor for predicting the OS rate in patients with early-stage NSCLC treated with SBRT.

The Prognostic Value of Pre-treatment Hemoglobin (Hb) in Patients With Advanced or Metastatic Gastric Cancer Treated With Immunotherapy.

BackgroundBiomarkers such as prevailing PD-L1 expression and TMB have been proposed as a way of predicting the outcome of immunotherapy in patients with advanced gastric cancer (AGC) and metastatic gastric cancer (MGC). Our study aims to investigate whether there is a link between pretreatment hemoglobin (Hb) levels and survival to immunotherapy in patients with AGC and MGC.MethodsWe retrospectively reviewed patients with AGC or MGC treated at the oncology department of the Chinese PLA general hospital receiving PD-1 inhibitor. The Propensity Score Matching (PSM) (1:1) was performed to balance potential baseline confounding factors. Progression-free survival (PFS) and overall survival (OS) was analyzed among different Hb level (normal Hb group and decreased Hb group). Objective response rate (ORR), disease control rate (DCR) were also analyzed. Univariate analysis and multivariate analysis were performed further to validate the prognostic value of Hb level.ResultsWe included 137 patients with AGC and MGC who received PD-1 inhibitors (including Pembrolizumab, Nivolumab, Sintilimab, Toripalimab) in this study. After PSM matching, there were no significant differences between the two groups for baseline characteristics. Within the matched cohort, the median PFS was 7.8 months in the normal Hb level group and 4.3 months in the decreased Hb group (HR 95% CI 0.5(0.31, 0.81), P=0.004). The OS was 14.4 months with normal Hb level as compared with 8.2 months with decreased Hb level(HR 95% CI 0.59(0.37, 0.94), P=0.024). The ORR was 40.7% and DCR was 83.0% in the normal Hb group, while the ORR was 25.5% and DCR was 85.1% in the decreased Hb group. No significant differences were found in the ORR and DCR between the two groups (P=0.127, P=0.779). Univariate analysis and multivariate analysis showed that Hb level was only independent predictor for PFS and baseline Hb level was significant prognostic factor influencing the OS. Only when patients had normal Hb level, anti-pd-1 monotherapy or combined with chemotherapy was superior to anti-pd-1 plus anti-angiogenic therapy with respect to PFS (10.3 m vs 2.8 m, HR 95% CI 0.37(0.15, 0.95), P=0.031) and OS(15 m vs 5.7 m, HR 95% CI 0.21 (0.08, 0.58), P=0.001).ConclusionsOur study have demonstrated that pretreatment Hb level was an independent prognostic biomarker in term of PFS and OS with immunotherapy for AGC and MGC patients. Correction of anemia for GC patients as immunotherapy would be a strategy to improve the survival. More data was warranted to further influence this finding.

The importance of hemoglobin levels before and during chemoradiotherapy in locally advanced carcinoma cervix

Purpose: Carcinoma cervix forms a major burden among malignancies in women in India. Anemia is very common among Indian women and a high proportion of carcinoma cervix patients present with anemia. Previous studies show that hemoglobin level may be considered as a prognostic factor in carcinoma cervix. It has been observed that anemia is associated with diminished radiocurability in patients with carcinoma of the cervix. However, the therapeutic benefit of the measures to correct anemia remains debatable. The objective of this study was to evaluate the association of hemoglobin concentrations and its correction by blood transfusions before and during treatment and the response to chemoradiation. Materials and Methods: Fifty patients with histologically proven squamous cell carcinoma of the cervix (Stage II to IV) from December 2018 to May 2020 were taken up for this study. Patients received definitive chemoradiation of 50 Gy in 25 fractions, 2 Gy/fraction, 5 fractions per week, along with-weekly injection cisplatin/carboplatin, followed by brachytherapy. All patients had their pretreatment hemoglobin levels measured at the first consultation. The effects of hemoglobin concentrations at presentation and during therapy on the clinical response to radiotherapy were studied. Blood transfusions and the time point when transfusions were given were recorded. Results: Eighteen patients received packed red blood cell transfusion before the start of radiation therapy and 9 patients received packed cell transfusion during radiation therapy. Out of the 18 patients who received transfusion before RT, 3 patients had complete response. Out of the 9 patients who received transfusion during radiation, 4 had complete response. The presence of anemia had a significant impact on the response rate. Pretreatment anemia was associated with poor response and local control among patients who underwent chemoradiotherapy for cervical cancer. Conclusion: Pretreatment hemoglobin and hemoglobin levels during radiation therapy were prognostic factors for local control, in addition to stage and histology, which might have independently predicted the outcome.