scholarly journals Clinical Significance of Serum NEDD9 Levels in Patients with Pancreatic Cancer

Biomolecules ◽  
2018 ◽  
Vol 8 (4) ◽  
pp. 169 ◽  
Author(s):  
Cigdem Usul Afsar ◽  
Mehmet Karabulut ◽  
Senem Karabulut ◽  
Safiye Tokgoz Ozal ◽  
Murat Cikot ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Performance Status ◽  
Progression Free Survival ◽  
Serum Levels ◽  
Enzyme Linked Immunosorbent Assay ◽  
Control Group ◽  
Serum Samples ◽  
Baseline Serum ◽  
Free Survival ◽  
The Relationship

Introduction: Pancreatic cancer (PC) is a lethal malignancy. Various diagnostic, predictive, and prognostic biomarkers have been evaluated. This study was conducted to investigate the serum levels of neural precursor cell expressed developmentally downregulated protein 9 (NEDD9) in patients with PC and the relationship between tumor progression and known prognostic parameters. Materials and Methods: Serum samples were obtained on first admission before any treatment. Serum NEDD9 levels were determined using enzyme-linked immunosorbent assay (ELISA). Age- and sex-matched healthy controls were included in the analysis. Results: In a three year period, 32 patients with a pathologically-confirmed diagnosis of PC were enrolled in this study. The median age at diagnosis was 61 years, range 38 to 84 years; the majority of the patients in the group were men (n = 20, 62.5%). The tumor was located in the head of pancreas in 21 (65.6%) patients. Forty-one percent of 17 metastatic patients who received palliative CTx (chemotherapy) were CTx-responsive. The baseline serum NEDD9 levels were significantly higher in patients with PA than in the control group (p = 0.03). Median OS of the whole group were 27 ± 7.3 weeks. Alcohol intake, performance status, and LDH levels were found to be significant prognostic factors (p = 0.006, p < 0.001, and p < 0.001, respectively). However, serum NEDD9 levels had no significantly effect on progression free survival (PFS) and overall survival (OS) (p = 0.71 and p = 0.58, respectively). Conclusions: NEDD9 is identified as a secretory biomarker for PC but it has no prognostic role.

scholarly journals Evaluation of the Relationship between the Level of DHEA-S and Sex Hormones in Some Infertile Iraqi Men

2021 ◽  
Vol 8 (5) ◽  
pp. 130-136
Author(s):  
Khaled S. Abd ◽  
Adnan F. AL-Azzawie
Keyword(s):  
Sex Hormones ◽  
Seminal Fluid ◽  
Age Groups ◽  
Serum Levels ◽  
Dehydroepiandrosterone Sulfate ◽  
Enzyme Linked Immunosorbent Assay ◽  
Control Group ◽  
Infertile Men ◽  
The Relationship

This study aims to evaluate serum levels of the Dehydroepiandrosterone sulfate (DHEA-S) and its relationship with some sex hormones such as Follicle stimulating hormone (FSH), Luteinizing hormone (LH), prolactin and testosterone hormone and the infertility type in some infertile Iraqi men. Blood and seminal fluid samples from (60) idiopathic male infertile and (60) healthful individuals as a control group aged (18 to 60 year) were collected from private clinics. Serum hormones (DHEA-S, FSH, LH, prolactin and testosterone) were measurement using Enzyme Linked Immunosorbent Assay (ELISA). The levels of DHEA-S, FSH, LH and prolactin are significantly higher (P≤0.01) expect of the testosterone level was significantly decreased (P≤ 0.01) in the infertile men as compared with control group. High significant differences (P≤0.01) were recorded when comparing the hormonal levels (DHEA-S, FSH, LH, prolactin and testosterone) according to the age groups. There are significant differences (P≤ 0.01) in levels of (DHEA-S, FSH, LH, prolactin and testosterone) in the infertility period.  Smoker infertile men have high levels (P≤ 0.05) in the DHEA-S and LH while have low levels in the prolactin hormones compared with control. Patients with family history have shown significant differences (P≤0.05) in the levels of DHEA-S, FSH, LH and prolactin. In conclusion, this study revealed significantly increase in the DHEA-S levels in the infertile men and negative correlation between DHEA-S and FSH. Therefore, DHEA-S has important role in the diagnosis and follow up of the male infertility.

scholarly journals Correlation between IL-10 as Cancer Biomarker and Demographic Characteristics of Colorectal Cancer Patients

2021 ◽  
pp. 1-10
Author(s):  
Rahin Sh Hamad ◽  
Bushra H. Shnawa ◽  
Shereen J. Al-Ali
Keyword(s):  
Colorectal Cancer ◽  
Pearson Correlation ◽  
Serum Levels ◽  
Interleukin 10 ◽  
Enzyme Linked Immunosorbent Assay ◽  
Control Group ◽  
High Morbidity ◽  
Serum Samples ◽  
Cancer Pathogenesis ◽  
Colorectal Cancer Patients

Colorectal cancer (CRC) is classified as one of the most prevalent cancer types worldwide, with high morbidity and mortality rates. Patients of CRC have been shown to express a detectable cytokine in serum which contributes to cancer pathogenesis. Therefore, the serum interleukin 10 (IL-10) level in CRC patients was investigated in this study. Patients' medical records with CRC admitted to the Rizgary and Nanakali hospitals, Erbil, Iraq was analyzed as the study group compared to the healthy volunteers' control group. Seventy-one serum samples were collected, thirty-one from diagnosed CRC patients and forty from healthy controls. The concentrations of IL-10 in the sera were assessed by enzyme-linked immunosorbent assay (ELISA). The present finding showed that IL-10 Was significantly elevated in CRC patients' sera compared to the control group, suggesting confirmation of its usefulness for detecting CRC patients' prognosis. A non-significant Pearson correlation was detected between IL-10 serum levels and the CRC group's age, gender, and body mass index. Herein is the first study on the evaluation of IL-10 levels in CRC patients in Kurdistan, Iraq.

scholarly journals Clinical characteristics and blood/serum bound prognostic biomarkers in advanced pancreatic cancer treated with gemcitabine and nab-paclitaxel

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Hakon Blomstrand ◽  
Henrik Green ◽  
Mats Fredrikson ◽  
Emma Gränsmark ◽  
Bergthor Björnsson ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Regression Analysis ◽  
Serum Albumin ◽  
Blood Serum ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Older Age ◽  
Secondary Outcome ◽  
Baseline Serum ◽  
Free Survival

Abstract Background In recent years treatment options for advanced pancreatic cancer have markedly improved, and a combination regimen of gemcitabine and nab-paclitaxel is now considered standard of care in Sweden and elsewhere. Nevertheless, a majority of patients do not respond to treatment. In order to guide the individual patient to the most beneficial therapeutic strategy, simple and easily available prognostic and predictive markers are needed. Methods The potential prognostic value of a range of blood/serum parameters, patient-, and tumour characteristics was explored in a retrospective cohort of 75 patients treated with gemcitabine/nab-paclitaxel (Gem/NabP) for advanced pancreatic ductal adenocarcinoma (PDAC) in the South Eastern Region of Sweden. Primary outcome was overall survival (OS) while progression free survival (PFS) was the key secondary outcome. Result Univariable Cox regression analysis revealed that high baseline serum albumin (> 37 g/L) and older age (> 65) were positive prognostic markers for OS, and in multivariable regression analysis both parameters were confirmed to be independent prognostic variables (HR 0.48, p = 0.023 and HR = 0.47, p = 0.039,). Thrombocytopenia at any time during the treatment was an independent predictor for improved progression free survival (PFS) but not for OS (HR 0.49, p = 0.029, 0.54, p = 0.073), whereas thrombocytopenia developed under cycle 1 was neither related with OS nor PFS (HR 0.87, p = 0.384, HR 1.04, p = 0.771). Other parameters assessed (gender, tumour stage, ECOG performance status, myelosuppression, baseline serum CA19–9, and baseline serum bilirubin levels) were not significantly associated with survival. Conclusion Serum albumin at baseline is a prognostic factor with palliative Gem/NabP in advanced PDAC, and should be further assessed as a tool for risk stratification. Older age was associated with improved survival, which encourages further studies on the use of Gem/NabP in the elderly.

scholarly journals Clinical characteristics and blood/serum bound prognostic biomarkers in advanced pancreatic cancer treated with gemcitabine and nab-paclitaxel

2020 ◽  
Author(s):  
Hakon Blomstrand ◽  
Henrik Green ◽  
Mats Fredriksson ◽  
Emma Gränsmark ◽  
Bergthor Björnsson ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Regression Analysis ◽  
Serum Albumin ◽  
Blood Serum ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Secondary Outcome ◽  
Baseline Serum ◽  
Free Survival ◽  
High Age

Abstract Background In recent years treatment options for advanced pancreatic cancer has markedly improved, and a combination regimen of gemcitabine and nab-paclitaxel is now considered standard of care in Sweden and elsewhere. Nevertheless, a majority of patients do not respond to treatment. In order to guide the individual patient to the most beneficial therapeutic strategy, simple and easily available prognostic and predictive markers are needed. Methods The potential prognostic value of a range of blood/serum parameters, patient-, and tumour characteristics was explored in a retrospective cohort of 75 patients treated with gemcitabine/nab-paclitaxel (Gem/NabP) for advanced pancreatic ductal adenocarcinoma (PDA) in the South Eastern Region of Sweden. Primary outcome was overall survival while progression free survival was the key secondary outcome. Result Univariable Cox regression analysis revealed that high baseline serum albumin (> 37 g/L) and high age (>65) were positive prognostic markers for OS, and in multivariable regression analysis both parameters were confirmed to be independent prognostic variables (HR 0.48, p =0.023 and HR=0.47, p =0.039,). Thrombocytopenia at any time during the treatment was an independent predictor for improved progression free survival (PFS) but not for OS (HR 0.49, p =0.029 and 0.54, p =0.073), whereas thrombocytopenia developed under cycle 1 was neither related with OS nor PFS (HR 0.87 p =0.384 and HR 1.04, p =0.771). Other parameters assessed (gender, tumour stage, ECOG performance status, myelosuppression, baseline serum CA19-9, and baseline serum bilirubin levels) were not significantly associated with survival. Conclusion Serum albumin at baseline is a prognostic factor with palliative Gem/NabP in advanced PDA, and should be further assessed as a tool for risk stratification. High age was associated with improved survival, which encourages further studies on the use of Gem/NabP in the elderly.

scholarly journals Multiple Myeloma Patients with Lenalidomide-Associated Skin Rash Have a Favorable Prognosis

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 4532-4532 ◽  
Author(s):  
Ayumi Kojima ◽  
Yuka Tanaka ◽  
Yuta Kimura ◽  
Daisuke Tsuchimoto ◽  
Rina Etani ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Skin Rash ◽  
Research Funding ◽  
Kinase Inhibitors ◽  
Performance Status ◽  
Progression Free Survival ◽  
Rank Test ◽  
Free Survival ◽  
The Relationship

Abstract Background: Lenalidomide, one of the immunomodulatory drugs, is an important component of treatment for multiple myeloma. Lenalidomide inhibits the proliferation of tumor cells via antiangiogenesis, induces apoptosis and acts directly on the immune system and tumor microenvironment. Immunomodulatory effects of lenalidomide notably stimulate the production of cytokines and activation of T-cells and natural killer cells. Skin rash is a frequent adverse event of lenalidomide. Some studies have shown a correlation between the efficacy of anti-cancer agents such as tyrosine kinase inhibitors and the development of skin rash. However, the relationship between the development of lenalidomide-associated skin rash and its efficacy is unclear. We conducted a retrospective survey to clarify whether development of skin rash correlates with the efficacy of lenalidomide. Materials and Methods: All patients with multiple myeloma who received lenalidomide at 9 hospitals in Japan from July 2009 to December 2015 were serially registered. The chart review was performed for all identified patients to obtain the following information; age, sex, performance status at the initiation of lenalidomide, International Staging System (ISS) classification, prior chemotherapy regimen, tumor response, development of skin rash and clinical outcomes. A log-rank test was used to assess the relationship between the presence of skin rash and survival. A two-sided p < 0.05 was considered statistically significant. This study received approval from the appropriate ethics committees. Results: We identified 215 patients (92 women and 123 men), with a median age was 69 years (range, 39-86 years). Types of myeloma were as follows: 139 patients of IgG, 43 of IgA, and 29 of Bence-Jones protein. ISS was available for 204 patients, and of these, 63, 73, and 68 patients were classified as ISS stage I, II, and III, respectively. The median number of prior therapies was 2 (range, 0-6); 161 (74.9%) and 46 patients (21.4%) had previously received bortezomib and thalidomide, respectively. Fifty patients (23.3%) had undergone previous autologous stem cell transplantation. Sixty-five patients (30.2%) developed a skin rash after lenalidomide initiation, and the median time to onset of skin rash was 12 days. The patients with and without skin rash were similar with respect to age, type of myeloma, and ISS. The median follow-up of survivors was 28.9 months (range, 1.7-80.3 months). The progression-free survival and overall survival were better in patients who had skin rash than in those who did not (p = 0.009 and p = 0.033, respectively) (Figures A and B). Conclusions: In this study, the progression-free survival and overall survival among patients with skin rash during lenalidomide therapy was significantly superior to the patients without skin rash. Lenalidomide-associeated skin rash in patients with multiple myeloma may be a predictive factor of their clinical outcome. Figure Figure. Disclosures Nagai: Takeda: Honoraria, Research Funding; Janssen: Research Funding; Mundipharma KK: Research Funding.

scholarly journals Megakaryocyte Potentiating Factor as a Predictive Biomarker for Therapies Against Malignant Mesothelioma

2018 ◽  
pp. 1-16 ◽  
Author(s):  
Liang Cao ◽  
Yunkai Yu ◽  
Anish Thomas ◽  
Jingli Zhang ◽  
Masanori Onda ◽  
...  
Keyword(s):  
Overall Survival ◽  
Malignant Mesothelioma ◽  
Targeted Therapies ◽  
Progression Free Survival ◽  
Predictive Biomarker ◽  
Serum Samples ◽  
Baseline Serum ◽  
Free Survival ◽  
Serial Serum ◽  
Systemic Therapies

Purpose Effective biomarkers for malignant mesothelioma (MM) are needed for clinical management and the development of mesothelin-targeted therapies. We evaluated serum megakaryocyte potentiating factor (MPF) as a biomarker predictive of treatment outcome in patients with MM and for developing mesothelin-targeted therapies. Materials and Methods Serial serum samples from patients with MM in two clinical trials of an antimesothelin immunotoxin were tested with our clinically validated MPF assay. Correlative studies were performed to determine the test effectiveness in treatment monitoring and outcome prediction. MPF was further evaluated for an association with response to an antimesothelin therapy and for disease monitoring. Results There was a significant reduction of serum MPF in patients with elevated baseline and radiologic response, with an average change from −52% to −78% after one to six cycles. Using a −50% change as the cutoff, patients with MM with positive MPF response had significantly improved progression-free survival ( P < .001), with the median extended from 1.9 to 11.3 months. These patients with MPF response further exhibited improved overall survival (P = .004), with the median extended from 8.8 to 22.3 months. In patients with refractory MM, there was an association between elevated pretreatment serum MPF and radiologic response to an antimesothelin therapy (P = .033). Furthermore, in these response patients, serum MPF was monitored between 32.2 and 63.8 months and was found to reflect treatment response and disease progression. Conclusion At a cutoff of −50% change after receiving systemic therapies, a reduction in MPF was associated with improved clinical outcome, both progression-free survival and overall survival. An elevated baseline serum MPF was associated with a response to an antimesothelin therapy in patients with refractory MM; however, this finding needs to be confirmed in another study.

Exploratory analysis of multiprotein serum predictors at baseline of progression-free survival of ipilimumab or ipilimumab and nivolumab in the Checkmate-069 study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9571-9571
Author(s):  
Krisztian Homicsko ◽  
Michel A. Cuendet ◽  
Agata Mlynska ◽  
Bianca Moura ◽  
Christine Horak ◽  
...  
Keyword(s):  
Serum Protein ◽  
Checkpoint Inhibitors ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Exploratory Analysis ◽  
Protein Markers ◽  
Protein Biomarkers ◽  
Serum Samples ◽  
Baseline Serum ◽  
Free Survival

9571 Background: Checkpoint inhibitors have revolutionized the treatment of stage IV melanoma patients. Selection of patients for PD-1 monotherapy or CTLA4/PD1 combination remains an important challenge. We set out to perform a discovery study of pretreatment serum protein biomarkers to identify predictors of progression free survival (PFS) for ipilimumab (IPI) or ipilimumab/nivolumab (IPI/NIVO). Methods: We performed an exploratory analysis of baseline serum samples from 135 treatment-naive patients with metastatic melanoma included in the randomized phase II clinical trial, CheckMate 069 (NCT01927419). We used the RayBiotech 440 human cytokine array and evaluated the relationship of serum protein levels with 44 clinical parameters. R, Prism 7.0 and TensorFlow were used for analyses. Results: We focused on correlation of serum protein markers with PFS as a predictor of long-term benefit. In the IPI arm (n = 46), high FGF4 correlated with worse PFS outcome (p = 0.0012). However, FGF4 levels alone were unable to select responsive vs. non-responsive patients. In contrast, a set of three markers consisting of FGF4 ( < 760pg/ml), CCL15 ( > 2.7 ng/ml), and TACE ( > 600pg/ml) separated non-progressing versus progressing patients. Moreover a small group of FGF4-high patients who were concomitantly TIM-3-low also had longer PFS (combined of both: p = 0.0004, HRlogrank: 0.07, 95% CI: 0.03279 to 0.1533). The same markers did not discriminate between IPI/NIVO patients (p = 0.467, HR: 15). In the IPI/NIVO arm, three different markers could select patients. Patients either with low CCL2 ( < 72 pg/ml) or alternatively with high CCL2 combined with high PDGF-AA ( > 8.2 ng/ml) and low GASP-1 ( < 1.3 ng/ml) had longer PFS (p < 0.0001, HR: 0.115, 95% CI: 0.03848 to 0.3408). Conversely, these markers did not predict benefit for IPI-monotherapy. Conclusions: In this study we identified protein signatures in baseline serum that correlate with PFS for therapies with IPI or IPI/NIVO. The markers were exclusive for IPI or IPI/NIVO but not for both. Additional research is warranted to substantiate these results and evaluate the possibility of incorporating into clinical practice.

scholarly journals Clinical characteristics and blood/serum bound prognostic biomarkers in advanced pancreatic cancer treated with gemcitabine and nab-paclitaxel

2020 ◽  
Author(s):  
Hakon Blomstrand ◽  
Henrik Green ◽  
Mats Fredriksson ◽  
Emma Gränsmark ◽  
Bergthor Björnsson ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Regression Analysis ◽  
Serum Albumin ◽  
Blood Serum ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Older Age ◽  
Baseline Serum ◽  
Free Survival ◽  
Cox Regression Analysis

Abstract Background: In recent years treatment options for advanced pancreatic cancer has markedly improved, and a combination regimen of gemcitabine and nab-paclitaxel is now considered standard of care in Sweden and elsewhere. Nevertheless, a majority of patients do not respond to treatment. In order to guide the individual patient to the most beneficial therapeutic strategy, simple and easily available prognostic and predictive markers are needed. Methods: The potential prognostic value of a range of blood/serum parameters, patient-, and tumour characteristics was explored in a retrospective cohort of 75 patients treated with gemcitabine/nab-paclitaxel (Gem/NabP) for advanced pancreatic ductal adenocarcinoma (PDAC) in the South Eastern Region of Sweden. Primary outcome was overall survival while progression free survival was the key secondary outcome.Result: Univariable Cox regression analysis revealed that high baseline serum albumin (> 37 g/L) and older age (>65) were positive prognostic markers for OS, and in multivariable regression analysis both parameters were confirmed to be independent prognostic variables (HR 0.48, p=0.023 and HR=0.47, p=0.039,). Thrombocytopenia at any time during the treatment was an independent predictor for improved progression free survival (PFS) but not for OS (HR 0.49, p=0.029, 0.54, p=0.073), whereas thrombocytopenia developed under cycle 1 was neither related with OS nor PFS (HR 0.87, p=0.384, HR 1.04, p=0.771). Other parameters assessed (gender, tumour stage, ECOG performance status, myelosuppression, baseline serum CA19-9, and baseline serum bilirubin levels) were not significantly associated with survival. Conclusion: Serum albumin at baseline is a prognostic factor with palliative Gem/NabP in advanced PDAC, and should be further assessed as a tool for risk stratification. Older age was associated with improved survival, which encourages further studies on the use of Gem/NabP in the elderly.

A novel biomarker panel examining response to adjuvant pancreatic cancer therapy in RTOG 9704.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 176-176 ◽  
Author(s):  
Gregory M. Heestand ◽  
James Don Murphy ◽  
Jennifer Moughan ◽  
William Regine ◽  
Jia Luo ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Disease Free Survival ◽  
High Sensitivity ◽  
Serum Levels ◽  
Proximity Ligation Assay ◽  
P Value ◽  
Serum Samples ◽  
Multivariate Statistical ◽  
Baseline Serum ◽  
Clinical Endpoints

176 Background: RTOG 9704 was an adjuvant pancreatic adenocarcinoma trial. Patients with resected stage I-III disease were randomized to receive 5-FU vs. gemcitabine (GEM) chemotherapy pre and post 5-FU chemoradiation. Prior to adjuvant therapy, patients had baseline serum samples drawn and archived for future study. Methods: To better understand the biology of pancreatic cancer, investigators involved with this project have evaluated numerous proteins of interest via literature review and gene expression data. By using the multiplex capabilities and high sensitivity detection of the proximity ligation assay (PLA), a probe panel was built from commercially available antibodies capable of quantifying 42 key proteins from 24 uL of patient serum. To determine if any of these proteins corresponded with survival or predicted response, the baseline serum specimens were obtained for assay with our PLA panel. Clinical endpoints were overall (OS) and disease-free survival (DFS). Univariate and multivariate statistical techniques were used. Using a Bonferroni correction, a p-value of <0.0012 was considered statistically significant. Results: Of the 451 eligible patients, 213 had samples available for study – 112 (53%) in the 5-FU arm and 101 (47%) in the GEM arm. As expected, decreased levels of CEA and CA 19-9 were prognostic for improved OS in all patients. Low levels of matrix metalloproteinase-7 (MMP-7) predicted an OS benefit from adjuvant GEM, but not 5-FU. Conclusions: PLA is a powerful tool for identifying potential biomarkers from archived, small volume serum samples. These data suggest that pancreatic cancer patients with low MMP-7 serum levels were most likely to benefit from adjuvant GEM. Supported by RTOG grants U10 CA21661, CCOP grant U10 CA37422, and RTOG Biospecimen Resource grant U24 CA114734 from the National Cancer Institute. [Table: see text]

Efficacy of anlotinib in advanced soft tissue sarcoma by age, gender, and ECOG performance status.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e23562-e23562
Author(s):  
Zhiwei Fang ◽  
Yang Yao ◽  
Jianqiang Cai ◽  
Yihebali Chi ◽  
Shusen Wang ◽  
...  
Keyword(s):  
Performance Status ◽  
Single Agent ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Ecog Performance Status ◽  
Free Survival ◽  
Cautious Interpretation ◽  
Ecog Ps ◽  
The Relationship ◽  
Clinical Trial Information

e23562 Background: ALTER0203 was a randomized phase IIB trial (NCT02449343) that demonstrated single-agent activity of anlotinib in advanced STS (aSTS). The primary endpoint progression-free survival (PFS) was met and presented as an oral presentation in 2018 ASCO. We evaluated the relationship between age, gender and ECOG performance status. Methods: Median PFS was analyzed in subgroups of age (≤40 y; > 40 y), gender (male; female) and ECOG performance status score (0; 1). All analyses were exploratory and required cautious interpretation. Results: A total of 158 patients received anlotinib in the ALTER0203 study. 79 patients (50.0%) were > 40 y. Median PFS was longer in patients of age > 40 y than ≤40 y (7.43 vs 5.43 months, P = 0.40). In patients receiving anlotinib, 76 patients (48.1%) were female and median PFS was longer in female than male (9.80 vs 4.43 months, P = 0.002). All enrolled patients had a Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 107 patients (67.7%) were with poor PS (ECOG PS = 1). The median PFS was longer in PS of 1(8.43 vs 4.73, P = 0.53) than PS of 0. Conclusions: In patients receiving anlotinib, longer mPFS was observed in patients of age > 40 y, ECOG PS = 1 and female. Clinical trial information: NCT02449343 .

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