Early presence of antiangiogenesis-related adverse events as a potential biomarker of antitumor efficacy in patients with metastatic gastric cancer treated with apatinib.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4052-4052
Author(s):  
Xinyang Liu ◽  
Shukui Qin ◽  
Zhichao Wang ◽  
Jianming Xu ◽  
Jianping Xiong ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Clinical Outcomes ◽  
Progression Free Survival ◽  
Metastatic Gastric Cancer ◽  
Antitumor Efficacy ◽  
Sensitivity Analyses ◽  
Risk Scores ◽  
Potential Biomarker ◽  
Landmark Analyses

4052 Background: Reliable biomarkers of apatinib response in gastric cancer (GC) are lacking. We investigated the association between early presence of common adverse events (AEs) and clinical outcomes in metastatic GC patients. Methods: We conducted a retrospective cohort study using data on 269 apatinib-treated GC patients in two clinical trials. AEs were assessed at baseline until 28 days after the last dose of apatinib. Clinical outcomes were compared between patients with and without hypertension (HTN), proteinuria or hand and foot syndrome (HFS) in the first 4 weeks using Kaplan–Meier methods, Cox proportional hazard regression and logistic regression models. Landmark analyses were performed as sensitivity analyses. Predictive model and risk scores were analyzed to predict overall survival (OS). Results: Presence of AEs in the first 4 weeks was associated with prolonged median OS (169 vs. 103 days, log-rank p=0.0039; adjusted hazard ratio [HR] 0.64, 95% confidence interval [CI] 0.64-0.84, p=0.001), prolonged median progression-free survival (PFS, 87 vs. 62 days, log-rank p=0.0309; adjusted HR 0.69, 95%CI 0.53-0.91, p=0.007), and increased disease control rate (54.67% vs. 32.77%; adjusted odds ratio 2.67, p<0.001). Results remained significant in landmark analyses. An AE-based prediction model and subsequently derived scoring system showed high calibration and discrimination in predicting OS. Conclusions: Presence of HTN, proteinuria or HFS during the first cycle of apatinib treatment was a viable biomarker of antitumor efficacy in metastatic GC patients. [Table: see text]

MET amplification occurrence and prediction of unfavorable clinical outcomes in patients with recurrent/metastatic gastric cancer after chemotherapy.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15047-e15047 ◽  
Author(s):  
Yu-hong Li ◽  
Xin An ◽  
Fang Wang ◽  
Qiong Shao ◽  
Feng-Hua Wang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Protein Expression ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Performance Status ◽  
Progression Free Survival ◽  
Metastatic Gastric Cancer ◽  
Poor Performance Status ◽  
Met Amplification ◽  
Gastric Cancer Patients

e15047 Background: Several large studies have reported an extremely low incidence of MET gene amplification (GA) in patients with radically resected gastric cancer. The aim of our study was to evaluate the prevalence and prognostic role of MET GA and protein expression in recurrent/metastatic gastric cancer patients who received chemotherapy. Methods: This retrospective study included 232 recurrent/metastatic gastric cancer patients. MET GA and protein expression were evaluated by fluorescent in-situ hybridization (FISH) and immunohistochemistry (IHC), respectively.Results: MET GA and strong protein expression were observed in 8.3% and 9.6% of patients, respectively. MET IHC 3+ was significantly correlated with GA. Patients with MET GA more frequently had a poor performance status (P < 0.001) and poorly differentiate tumors (P = 0.015) than those without MET GA. Both MET GA and IHC 3+ expression were associated with substantially shorter median progression free survival (PFS) and overall survival (OS). The median OS and PFS for patients with MET GA positive vs. MET GA negative were 5.7 vs. 15.5 months (P < 0.001) and 3.6 vs. 6.9 months (P < 0.001), respectively.The median OS and PFS for patients with MET IHC 3+ vs. IHC (0 to 2+) were 6.3 vs. 15.1 months (P < 0.001) and 3.6 vs. 7.0 months (P < 0.001), respectively. Conclusions: In recurrent/metastatic gastric cancer, MET amplification and strong protein expression are not rare and significantly associated with unfavorable clinical outcomes.

scholarly journals Observational Study Comparing Efficacy and Safety Between Preoperative Neoadjuvant Concurrent Chemoradiotherapy and Chemotherapy for Patients with Unresectable Locally Advanced or Metastatic Gastric Cancer

2019 ◽  
Author(s):  
Yung-Sung Yeh ◽  
Ming-Yii Huang ◽  
Cheng-Jen Ma ◽  
Ching-Wen Huang ◽  
Hsiang-Lin Tsai ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Outcomes ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Treatment Strategies ◽  
Progression Free Survival ◽  
Complete Response ◽  
Metastatic Gastric Cancer ◽  
Clinical Results ◽  
Treatment Modalities

Abstract Background: Dismal outcomes in patients with locally advanced or metastatic gastric cancer (GC) highlights the need for effective systemic neoadjuvant treatment strategies to improve clinical results. Neoadjuvant multimodality strategies vary widely. This study compared the efficacy, safety, and clinical outcomes of preoperative neoadjuvant CCRT and chemotherapy for such patients.Methods: Sixty-five patients with histologically confirmed locally advanced or metastatic GC following neoadjuvant CCRT or computed tomography (CT) were retrospectively enrolled between January 2010 and April 2019. Clinical outcomes included response, progression-free survival (PFS), and overall survival (OS), and toxicity was compared between the two groups.Results: Of the 65 patients, 18 (27.7%) were in the response group (2 patients with complete response and 16 with partial response) and 47 (72.3%) in the nonresponse group (29 patients with stable disease and 18 with progressive disease). Multivariate analysis revealed no independent response predictor between CCRT and CT groups (all P > 0.05). Furthermore, results revealed no statistical differences in toxicity between the two groups (all P > 0.05). With a follow-up median of 12 months (ranging 6–48 months), 12-month OS and PFS were 39.7% and 20.4% in the CCRT group and 30.3% and 13.2% in the chemotherapy group, respectively. The median OS and PFS were 14.0 months (95% CI 9.661–18.339) and 9.0 months (95% CI 6.805–11.195) in the CCRT group and 10.0 months (95% CI 6.523–13.477) and 8.0 months (95% CI 6.927–9.073) in the CT group, respectively. Both OS (P = 0.011) and PFS (P = 0.008) in patients with CCRT were significantly better than those in patients with chemotherapy alone. Conclusions: Neoadjuvant CCRT achieved more favorable OS and PFS than did neoadjuvant chemotherapy alone, without significant increases of toxicity in patients. However, prospective randomized trials comparing treatment modalities are necessary to confirm potential advantages of preoperative neoadjuvant CCRT.

scholarly journals Observational Study Comparing Efficacy and Safety Between Preoperative Neoadjuvant Concurrent Chemoradiotherapy and Chemotherapy for Patients with Unresectable Locally Advanced or Metastatic Gastric Cancer

2020 ◽  
Author(s):  
Yung-Sung Yeh ◽  
Ming-Yii Huang ◽  
Cheng-Jen Ma ◽  
Ching-Wen Huang ◽  
Hsiang-Lin Tsai ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Outcomes ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Treatment Strategies ◽  
Progression Free Survival ◽  
Complete Response ◽  
Metastatic Gastric Cancer ◽  
Clinical Results ◽  
Treatment Modalities

Abstract Background Dismal outcomes in patients with locally advanced or metastatic gastric cancer (GC) highlights the need for effective systemic neoadjuvant treatment strategies to improve clinical results. Neoadjuvant multimodality strategies vary widely. This study compared the efficacy, safety, and clinical outcomes of preoperative neoadjuvant CCRT and chemotherapy for such patients. Methods Sixty-five patients with histologically confirmed locally advanced or metastatic GC following neoadjuvant CCRT or computed tomography (CT) were retrospectively enrolled between January 2010 and April 2019. Clinical outcomes included response, progression-free survival (PFS), and overall survival (OS), and toxicity was compared between the two groups. Results Of the 65 patients, 18 (27.7%) were in the response group (2 patients with complete response and 16 with partial response) and 47 (72.3%) in the nonresponse group (29 patients with stable disease and 18 with progressive disease). Multivariate analysis revealed no independent response predictor between CCRT and CT groups (all P > 0.05). Furthermore, results revealed no statistical differences in toxicity between the two groups (all P > 0.05). With a follow-up median of 12 months (ranging 6–48 months), 12-month OS and PFS were 39.7% and 20.4% in the CCRT group and 30.3% and 13.2% in the chemotherapy group, respectively. The median OS and PFS were 14.0 months (95% CI 9.661–18.339) and 9.0 months (95% CI 6.805–11.195) in the CCRT group and 10.0 months (95% CI 6.523–13.477) and 8.0 months (95% CI 6.927–9.073) in the CT group, respectively. Both OS (P = 0.011) and PFS (P = 0.008) in patients with CCRT were significantly better than those in patients with chemotherapy alone. Conclusions Neoadjuvant CCRT achieved more favorable OS and PFS than did neoadjuvant chemotherapy alone, without significant increases of toxicity in patients. However, prospective randomized trials comparing treatment modalities are necessary to confirm potential advantages of preoperative neoadjuvant CCRT.

scholarly journals Observational Study Comparing Efficacy and Safety between Neoadjuvant Concurrent Chemoradiotherapy and Chemotherapy for Patients with Unresectable Locally Advanced or Metastatic Gastric Cancer

2020 ◽  
Vol 2020 ◽  
pp. 1-10 ◽  
Author(s):  
Yung-Sung Yeh ◽  
Ming-Yii Huang ◽  
Cheng-Jen Ma ◽  
Ching-Wen Huang ◽  
Hsiang-Lin Tsai ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Outcomes ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Treatment Strategies ◽  
Progression Free Survival ◽  
Complete Response ◽  
Metastatic Gastric Cancer ◽  
Treatment Modalities ◽  
Chemotherapy Group

Objective. Dismal outcomes in patients with locally advanced or metastatic gastric cancer (GC) highlight the need for effective systemic neoadjuvant treatment strategies to improve clinical results. Neoadjuvant multimodality strategies vary widely. This study compared the efficacy, safety, and clinical outcomes of neoadjuvant CCRT and chemotherapy for such patients. Materials and Methods. Sixty-five patients with histologically confirmed locally advanced or metastatic GC following neoadjuvant CCRT or computed tomography (CT) were retrospectively enrolled between January 2010 and April 2019. Clinical outcomes included response, progression-free survival (PFS), and overall survival (OS), and toxicity was compared between the two groups. Results. Of the 65 patients, 18 (27.7%) were in the response group (2 patients with a complete response and 16 with a partial response) and 47 (72.3%) in the nonresponse group (29 patients with a stable disease and 18 with a progressive disease). Multivariate analysis revealed no independent response predictor between CCRT and chemotherapy groups (all P>0.05). Furthermore, results revealed no statistical differences in toxicity between the two groups (all P>0.05). With a follow-up median of 12 months (ranging 6–48 months), 12-month OS and PFS were 39.7% and 20.4% in the CCRT group and 30.3% and 13.2% in the chemotherapy group, respectively. The median OS and PFS were 14.0 months (95% CI 9.661–18.339) and 9.0 months (95% CI 6.805–11.195) in the CCRT group and 10.0 months (95% CI 6.523–13.477) and 8.0 months (95% CI 6.927–9.073) in the chemotherapy group, respectively. Both OS (P=0.011) and PFS (P=0.008) in patients with CCRT were significantly better than those in patients with chemotherapy alone. Conclusion. Neoadjuvant CCRT achieved more favorable OS and PFS than did neoadjuvant chemotherapy alone, without significant increases of toxicity in patients. However, prospective randomized trials comparing treatment modalities are necessary to confirm the potential advantages of neoadjuvant CCRT.

scholarly journals Impact of single-heterozygous UGT1A1 on the clinical outcomes of irinotecan monotherapy after fluoropyrimidine and platinum-based combination therapy for gastric cancer: a multicenter retrospective study

2020 ◽  
Vol 25 (10) ◽  
pp. 1800-1806
Author(s):  
Shintaro Nakano ◽  
Satoshi Yuki ◽  
Yasuyuki Kawamoto ◽  
Hiroshi Nakatsumi ◽  
Takayuki Ando ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adverse Events ◽  
Clinical Outcomes ◽  
Progression Free Survival ◽  
Hematological Toxicity ◽  
Free Survival ◽  
Significant Difference ◽  
Sh Group ◽  
Grade 3 ◽  
Toxicity Criteria

Abstract Background It is unclear whether the UGT1A1 status, single heterozygous (SH) or wild type (WT), is associated with the efficacy and toxicity of irinotecan monotherapy in advanced gastric cancer (AGC). We investigated the association between clinical outcomes (efficacy and safety) and UGT1A1 status in patients who received irinotecan monotherapy. Methods We evaluated AGC patients who received irinotecan monotherapy between January 2011 and December 2017. Efficacy was assessed according to overall survival (OS) and progression-free survival (PFS). Toxicity was graded using the Common Toxicity Criteria for Adverse Events (version 4.0). Results A total of 100 patients were evaluated (62 and 38 patients with UGT1A1 WT and SH, respectively). In the WT and SH groups, the irinotecan dose was reduced in 19 (30.6%) and 18 (47.2%) patients (p = 0.135), respectively; treatment was delayed due to adverse events (AEs) in 19 (30.6%) and 13 (34.2%) patients (p = 0.826), respectively; the median PFS was 3.15 and 3.25 months (HR, 0.734; 95% CI 0.465–1.158; p = 0.184), respectively; and the median OS was 10.4 and 7.26 months (HR, 1.137; 95% CI 0.752–1.721; p = 0.543), respectively. Severe hematological AEs (Grade ≥ 3) were significantly more frequent in the SH group than in the WT group (63% vs. 36%; p = 0.008), while severe non-hematological AEs was not significantly different (16.0% vs. 6.5%; p = 0.173). Conclusion There was no significant difference in the efficacy of irinotecan monotherapy between UGT1A1 WT and UGT1A1 SH, but UGT1A1 SH was associated with a high frequency of severe hematological toxicity.

scholarly journals HIFU for the treatment of gastric cancer with liver metastases with unsuitable indications for hepatectomy and radiofrequency ablation: a prospective and propensity score-matched study

BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Bin Zhou ◽  
Ning He ◽  
Jiaze Hong ◽  
Tong Yang ◽  
Derry Minyao Ng ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Radiofrequency Ablation ◽  
Propensity Score ◽  
Adverse Events ◽  
Liver Metastases ◽  
Hepatic Metastasis ◽  
Focused Ultrasound ◽  
Progression Free Survival ◽  
High Intensity Focused Ultrasound ◽  
Entire Cohort

Abstract Background The purpose of this study was to explore the efficacy and safety of high intensity focused ultrasound (HIFU) in gastric cancer with liver metastasis (GCLM) patients who were contraindicated for either hepatectomy or radiofrequency ablation (RFA). Methods This is a prospective, observational study on GCLM patients with 1–3 liver metastases. The primary gastric lesions were thoroughly resected and any case that exhibited extra-hepatic metastasis was excluded. A 1:2:2 propensity score-matching analysis was performed using a logistic regression model on the HIFU group, best supportive care (BSC) group, and palliative chemotherapy (PC) group. The primary endpoints include progression-free survival (PFS) and overall survival (OS). Results Forty patients were finally included, there were 8 cases in HIFU group, 16 cases in BSC group, and 16 cases in PC group. The median follow-up time for the entire cohort was 10 months. The median PFS was 16.5 months in HIFU group, 2 months in BSC group, and 5 months in PC group. The median OS was 27.5 months in the HIFU group, 7 months in the BSC group, and 11.5 months in the PC group. Additionally, no grade 3 or higher adverse events occurred in the HIFU group. Conclusion The results of this study showed that HIFU treatment could improve the long-term prognosis of GCLM patients without a significant increase in the occurrence of adverse events. Compared with PC and BSC, HIFU is the preferred treatment option when GCLM patients without extra-hepatic metastasis are unable to undergo either surgery or RFA.

637 Immune-related adverse events (irAEs) may indicate a favorable prognosis in metastatic renal cell carcinoma (mRCC) patients treated with immune checkpoint inhibitors (ICI)

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A672-A673
Author(s):  
Dylan Martini ◽  
Sean Evans ◽  
Subir Goyal ◽  
Yuan Liu ◽  
T Anders Olsen ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Adverse Events ◽  
Clinical Outcomes ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Progression Free Survival ◽  
Free Survival ◽  
Kaplan Meier ◽  
Emory University

BackgroundImmune checkpoint inhibitors (ICI) have become an increasingly utilized treatment in metastatic renal cell carcinoma (mRCC). Although they have a favorable toxicity profile, immune-related adverse events (irAEs) can have a significant impact on patients‘ quality of life. It is not well understood whether irAEs are associated with improved clinical outcomes. We investigated the relationship between irAEs and clinical outcomes in mRCC patients treated with ICI.MethodsWe performed a retrospective study of 200 patients with mRCC who received ICI at Winship Cancer Institute of Emory University from 2015–2020. Clinical outcomes were measured by overall survival (OS), progression-free survival (PFS), and clinical benefit (CB). OS and PFS were calculated from ICI-initiation to date of death and radiographic or clinical progression, respectively. CB was defined as a best radiographic response of complete response (CR), partial response (PR), or stable disease (SD) for >6 months per response evaluation criteria in solid tumors (RECIST) version 1.1. Toxicity data was collected from clinic notes and laboratory values. The association with OS and PFS was modeled by Cox proportional hazards model. Kaplan-Meier curves were created for survival estimates.ResultsMost patients were males (71%), and 78% had clear-cell RCC (ccRCC). Most patients (58%) received anti-PD-1 monotherapy. The majority were international mRCC database consortium (IMDC) intermediate (57%) or poor-risk (26%). Anti-PD-1 monotherapy was the most common (58%) treatment regimen and most patients received ICI as first (38%) or second-line (42%) treatment. One-third of patients (33%) experienced an irAE, with the most common being endocrine (13%), gastrointestinal (11%), and dermatologic (10%). Patients who experienced irAEs had significantly longer OS (HR: 0.52, 95% CI: 0.32–0.87, p=0.013), higher chance of CB (OR: 2.10, 95% CI: 1.11–4.00, p=0.023) and showed a trend towards longer PFS (HR: 0.71, 95% CI: 0.49–1.02, p=0.065) in MVA (table 1). Patients who had thyroid irAEs had significantly longer OS, PFS, and higher chance of CB in MVA (table 1). The objective response rate was higher for patients who experienced irAEs (34% vs. 18%). Patients who experienced irAEs had significantly longer median OS (44.5 vs. 18.2 months, p=0.005) and PFS (7.5 vs 3.6 months, p=0.0028) compared to patients who did not (figure 1).Abstract 637 Table 1MVA* of association between irAEs and clinical outcomesAbstract 637 Figure 1Kaplan-Meier curves of association between immune-related adverse events (irAEs) and overall survival (OS, top panel) and progression-free survival (PFS, bottom panel)ConclusionsWe showed that mRCC patients who experienced irAEs, particularly thyroid irAEs, had improved clinical outcomes. This suggests that irAEs may be prognostic of favorable outcomes in mRCC patients treated with ICI. Larger, prospective studies are needed to validate these findings.AcknowledgementsResearch reported in this publication was supported in part by the Breen Foundation and the Biostatistics Shared Resource of Winship Cancer Institute of Emory University and NIH/NCI under award number P30CA138292. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.Trial RegistrationNot applicableEthics ApprovalThis retrospective study was approved by the Emory University Institutional Review Board.ConsentNot applicableReferencesNot applicable

scholarly journals The Prognostic Model of Pre-Treatment Complete Blood Count (CBC) for Recurrence in Early Cervical Cancer

2020 ◽  
Vol 9 (9) ◽  
pp. 2960
Author(s):  
Joseph J. Noh ◽  
Myong Cheol Lim ◽  
Moon-Hong Kim ◽  
Yun Hwan Kim ◽  
Eun Seop Song ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Clinical Outcomes ◽  
Predictive Factors ◽  
Blood Count ◽  
Complete Blood Count ◽  
Early Stage ◽  
Risk Scores ◽  
Potential Biomarker ◽  
Pre Treatment ◽  
Early Cervical Cancer

The aim of the present study was to investigate the prognostic role of the pre-treatment complete blood count (CBC) profile as a predictive marker of survival, recurrence, and death in early stage squamous cell carcinoma and adenocarcinoma of the cervix. The pre-treatment CBC profiles of the patients from nine tertiary medical centers in South Korea who were treated surgically for early stage cervical cancer were reviewed. Statistical models by the Akaike’s information criterion (AIC) were developed using CBC profiles to calculate individuals’ risk scores for clinical outcomes. A total of 1443 patients were included in the study and the median follow-up was 63.7 months with a range of 3–183 months. Univariate analyses identified the components of CBC that were significantly related to clinical outcomes including white blood cell (WBC), hemoglobin, neutrophil, and platelet levels. The models developed using CBC profiles and the conventional clinical predictive factors provided individuals’ risk scores that were significantly better in predicting clinical outcomes than the models using the conventional clinical predictive factors alone. Pre-treatment CBC profiles including WBC, hemoglobin, neutrophil, lymphocyte, and platelet levels were found to be a potential biomarker for survival prognosis in early cervical cancer.

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