Efficacy and Safety of Apatinib Combined With S-1 in the Treatment of Advanced Gastric Cancer: a Meta-analysis

2021 ◽  
Author(s):  
Xu Zhang ◽  
Xiao-dong He ◽  
You-cheng Zhang ◽  
Ke-hu Yang ◽  
Jin-hui Tian ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Advanced Gastric Cancer ◽  
Objective Response Rate ◽  
Median Overall Survival ◽  
Adverse Reactions ◽  
Response Rate ◽  
Meta Analysis ◽  
Objective Response ◽  
Efficacy And Safety

Abstract Objective: To study the efficacy and safety of apatinib combined with S – 1 in the treatment of advanced gastric cancer, in order to provide more evidence based medical evidence for the clinic.Methods: Randomized controlled trials of apatinib combined with S – 1 (experimental group) versus S - 1 (controlg roup) in the treatment of advanced gastric cancer were collected by computer literature search in Chinese and English databases, for the deadlines of March 21, 2021. Two investigators independently screened the literature, extracted the data, and evaluated the quality of the literature using the Cochrane risk bias assessment tool. And the Meta – analysis was performed using Review Manager 5. 3 software almost.Results: A total of 20 articles were included, totaling 1,150 patients. Meta – analysis showed that the objective response rate [OR = 2.02, 95% CI (1.56, 2.63), P < 0.00001], disease control rate [OR = 3.10, 95% CI (2.30, 4.17), P < 0.00001], median overall survival [MD = 3.99, 95% CI (3.56, 4.43), P < 0.00001] of patients with apatinib combined with S – 1 group were higher than the S – 1 group, then the median progression – free survival had not significant differences [MD = 1.24, 95% CI (-1.19, 3.67), P = 0.32]. In the adverse reactions, only the incidence of hypertension [OR = 6.19, 95% CI (1.89, 20.23), P = 0.003] and the incidence of proteinuria [OR = 4.02, 95% CI (1.11, 14.62), P = 0.03] in the apatinib combined with S – 1 group were higher than the S – 1 group, and there was no significant difference in the other adverse reactions. In addition, the levels of IFN – γ and TNF – α in the apatinib combined with S – 1 group were higher than those in the S – 1 group, and the levels of IL - 10, IL – 4, TSGF, CA199 and CEA were lower than those of the S – 1 group.Conclusion: Current evidence suggests that apatinib combined with S - 1 can achieve higher objective response rate, disease control rate, median overall survival, less adverse reactions, and improve immune function, effectively reduce the level of tumor markers.

Efficacy and safety of localized concurrent chemoradiation therapy and sorafenib sequential therapy in advanced hepatocellular carcinoma: A prospective phase II trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15678-e15678
Author(s):  
Beom Kyung Kim ◽  
Do Young Kim ◽  
Hye Jin Choi ◽  
Seung-Hoon Beom ◽  
Hye Won Lee ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Objective Response Rate ◽  
Median Overall Survival ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Objective Response ◽  
Advanced Hepatocellular Carcinoma ◽  
Efficacy And Safety ◽  
Sorafenib Treatment

e15678 Background: Patients with advanced hepatocellular carcinoma (HCC) have a particularly poor prognosis of the median overall survival of less than 12 months. Even though sorafenib has been approved for treating advanced stage HCC, the unsatisfactory objective response rate still remain unresolved. In the current study, we aimed to evaluate the efficacy and safety of localized concurrent chemoradiotherapy (CCRT) followed by sequential sorafenib treatment for advanced hepatocellular carcinoma. Methods: This study is an ongoing, phase II trial. Patients with advanced HCC not amenable for curative treatments were eligible. In the course of radiotherapy for 5 weeks, hepatic arterial infusion of 5-fluorouracil (500mg/day) via implanted port was applied during the first 5 days and the last 5 days of radiotherapy. Four weeks after localized CCRT, sorafenib (400mg bid) was maintained. The primary endpoint was overall survival. Results: A total of 47 patients were enrolled. After the completion of localized CCRT, the objective response rate was 31.9%. During the overall treatment course, the objective response rate was 46.8% respectively. Overall, 7 patients (14.9%) underwent curative resection or transplantation after down-staging. The median overall survival was 18.4 months and the progression-free survival was 6.8 months. Adverse events were predictable and manageable with conservative care. Conclusions: Localized CCRT followed by sequential sorafenib treatment in patients with advanced HCC showed significant activity and good tolerability. Furthermore, such a treatment modality, when compared to the use of sorafenib alone, might provide the additional therapeutic benefit through initial tumor reduction, allowing curative treatment after down-staging in 14.9% of patients, Further randomized trial should be required to make the more robust evidence. Clinical trial information: NCT02425605.

Apatinib in combination with S-1 as first-line treatment in patients with advanced gastric cancer: A phase II clinical trial.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 71-71
Author(s):  
Chuantao Zhang ◽  
Zimin Liu ◽  
Na Zhou ◽  
Jianli Zhang ◽  
Jingjuan Zhu ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Advanced Gastric Cancer ◽  
Objective Response Rate ◽  
Response Rate ◽  
Objective Response ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
First Line Treatment

71 Background: Apatinib is a standard therapy for advanced gastric cancer in third-line setting. However, the efficacy and safety of apatinib plus S-1 as first-line therapy is unknown. Here, we conducted a single center study to evaluate the efficacy and safety of it. Methods: In this phase II trial, chemotherapy-naive patients with advanced gastric cancer were enrolled between August 24, 2016 and Sept 25, 2017, at a single centers in P.R. China. The patients enrolled were assigned to S-1 plus apatinib, S-1 (40 mg m-2 depending on patient's body surface area) was given orally, twice daily for 2 consecutive weeks, followed by a 1-week rest period, and apatinib 500 mg was given once daily, every 3-week cycle. The primary endpoint was overall survival(OS). Secondary endpoints were progression-free survival(PFS), time to progress (TTP), objective response rate (ORR) and safety. On disease progression, patients had the option to receive single-agent apatinib every 3 weeks.This trial is registered with ClinicalTrials.gov , number NCT02525237. Results: Thirty eligible patients, median age 63 years (range 40-76) and median performance status 1 (ECOG 0-2) ,were enrolled, 9 patients have no evaluation or withdrew consent. Therefore, of the 21 patients the median PFS and TTP were 5.34±1.83 months [1.76–8.92] and 1.34±0.08 months[1.18–1.51], respectively. Additionally, one(4.76%) patient had a complete response, one (4.76%)patients had partial responses, 11 patients had stable disease, and 9 patients had progress of disease. The objective response rate(ORR)and the disease control rate(DCR) were 9.52%(2/21) and 57.14%(12/21),respectively. Until Sept 25.2017,the primary endpoint(OS) had not been reached. We recorded grade 3 or 4 adverse events including elevated bilirubin and/or transaminase, fatigue, abdominal pain, thrombocytopenia,et al. There were no treatment-related deaths. Conclusions: First-line chemotherapy with S-1 plus apatinib in patients with advanced gastric cancer did not reach its primary objective. However, it holds promise of becoming a standard first-line treatment for patients with advanced gastric cancer. Clinical trial information: NCT02525237.

Effects of adding necitumumab to first-line chemotherapy in patients with stage IV non-small-cell lung cancer: Meta-analysis

2019 ◽  
Vol 26 (6) ◽  
pp. 1331-1342
Author(s):  
Irena Ilic ◽  
Sandra Sipetic ◽  
Jovan Grujicic ◽  
Milena Ilic
Keyword(s):  
Overall Survival ◽  
Objective Response Rate ◽  
Advanced Nsclc ◽  
Response Rate ◽  
Meta Analysis ◽  
Objective Response ◽  
Stage Iv ◽  
Progression Free Survival ◽  
First Line ◽  
Free Survival

Introduction Almost half of patients with non-small-cell lung cancer (NSCLC) are diagnosed at an advanced stage. Our aim was to assess the effects of adding necitumumab to chemotherapy in patients with stage IV NSCLC. Material and methods A comprehensive literature search was performed according to pre-specified inclusion and exclusion criteria. Data on overall survival, progression-free survival, objective response rate and adverse events were extracted. A meta-analysis was performed to obtain pooled hazard ratios (HR) and corresponding 95% confidence intervals (CI) for time-to-event data and pooled odds ratio (OR) with 95% CI for dichotomous outcomes. Results The meta-analysis included four randomized clinical trials with 2074 patients. The pooled results showed significant improvement for overall survival (HR = 0.87 (95% CI 0.79–0.95), p = 0.004) when necitumumab was added to chemotherapy in patients with advanced NSCLC. No statistically significant improvement was noted for progression-free survival and objective response rate (HR = 0.83 (95% CI 0.69–1.01), p = 0.06 and OR = 1.46 (95% CI 0.90–2.38), p = 0.13, respectively). Subgroup analysis showed that in patients with non-squamous NSCLC, there was no benefit in overall survival and objective response rate. Patients with advanced NSCLC who received necitumumab were at the highest odds of developing a skin rash (OR = 14.50 (95% CI 3.16–66.43), p = 0.0006) and hypomagnesaemia (OR = 2.77 (95% CI 2.23–3.45), p < 0.00001), while the OR for any grade ≥3 adverse event was 1.55 (95% CI 1.28–1.87, p < 0.00001). Conclusions The addition of necitumumab to standard chemotherapy in a first-line setting in patients with stage IV NSCLC results in a statistically significant improvement in overall survival, while the results were not significant for progression-free survival and objective response rate.

Efficacy of immunotherapy with PD-1 inhibitor in colorectal cancer: a meta-analysis

2020 ◽  
Vol 9 (18) ◽  
pp. 1285-1292
Author(s):  
Shengqi He ◽  
Dongqing Hu ◽  
Haixia Feng ◽  
Ye Xue ◽  
Jin Jin ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Survival Rate ◽  
Objective Response Rate ◽  
Response Rate ◽  
Meta Analysis ◽  
Objective Response ◽  
Progression Free Survival ◽  
Overall Survival Rate ◽  
Free Survival

Aim: PD-1 inhibitors have a leading role among immunotherapy while its efficacy on colorectal cancer (CRC) patients did not reach consensus and the small sample size remains as a limitation. Therefore, we undertook a meta-analysis on the effects of the monotherapy anti-PD-1 inhibitors in treating metastatic colorectal cancer (mCRC). Materials & methods: We searched databases to identify studies on efficacy of anti-PD-1 inhibitor on CRC. Objectives were objective response rate, progression-free survival rate, disease control rate and overall survival rate with their 95% CI. Results: The overall survival rate at 1-year was 64.2% (95% CI: 0.46–0.83). Disease control rate was 56.5% (CI: 0.27–0.86) and the objective response rate as 19.7% (CI: 0.08–0.32). The 1-year-progression-free survival rate was 38.4% (CI: 0.12–0.66). Sensitivity analysis and subgroup analysis were also conducted. Conclusion: The monotherapy anti-PD-1 inhibitors are effective in treating mCRC and could be a new option for dMMR mCRC patient in first-line treatment.

scholarly journals Comparative Efficacy of First-Line Immune-Based Combination Therapies in Metastatic Renal Cell Carcinoma: A Systematic Review and Network Meta-Analysis

Cancers ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1673 ◽  
Author(s):  
Reza Elaidi ◽  
Letuan Phan ◽  
Delphine Borchiellini ◽  
Philippe Barthelemy ◽  
Alain Ravaud ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Overall Survival ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Objective Response Rate ◽  
Response Rate ◽  
Meta Analysis ◽  
Objective Response ◽  
First Line

Three drug combinations, ipilimumab-nivolumab (Ipi-Nivo), pembrolizumab-axitinib (Pembro-Axi), and avelumab-axitinib (Ave-Axi), have received regulatory approval in the USA and Europe for the treatment of metastatic renal cell carcinoma with clear cell component (mRCC). However, no head-to-head comparison data are available to identify the best option. Therefore, we aimed to compare these new treatments in a first-line setting. We conducted a systematic search in PubMed, the Cochrane Library, and clinicaltrials.gov for any randomized controlled trials of treatment-naïve patients with mRCC, from January 2015 to October 2019. The process was performed according to PRISMA guidelines. We performed a Bayesian network meta-analysis with two different approaches, a contrast-based model comparing HRs and ORs between studies and arm-based using parametric modeling. The outcomes for the analysis were overall survival, progression-free survival (PFS), and objective response rate. Our search identified 3 published phase 3 randomized clinical trials (2835 patients). In the contrast-based model, Ave-Axi (SUCRA = 83%) and Pembro-Axi (SUCRA = 80%) exhibited the best ranking probabilities for PFS. For overall survival (OS), Pembro-Axi (SUCRA = 96%) was the most preferable option against Ave-Axi and Ipi-Nivo. Objective response rate analysis showed Ave-Axi as the best (SUCRA: 94%) and Pembro-Axi as the second best option. In the parametric models, the risk of progression was comparable for Ave-Axi and Ipi-Nivo, whereas Pembro-Axi exhibited a lower risk during the first 6 months of treatment and a higher risk afterwards. Furthermore, Pembro-Axi exhibited a net advantage in terms of OS over the two other regimens, while Ave-Axi was the least preferable option. Overall evidence suggests that pembrolizumab plus axitinib seems to have a slight advantage over the other two combinations.

scholarly journals Efficacy and Safety of Oncolytic Viruses in Randomized Controlled Trials: A Systematic Review and Meta-Analysis

Cancers ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1416 ◽  
Author(s):  
Zengbin Li ◽  
Zeju Jiang ◽  
Yingxuan Zhang ◽  
Xiaotian Huang ◽  
Qiong Liu
Keyword(s):  
Randomized Controlled Trials ◽  
Objective Response Rate ◽  
Response Rate ◽  
Meta Analysis ◽  
Objective Response ◽  
Oncolytic Viruses ◽  
Oncolytic Virotherapy ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled

Oncolytic virotherapy is a promising antitumor therapeutic strategy. It is based on the ability of viruses to selectively kill cancer cells and induce host antitumor immune responses. However, the clinical outcomes of oncolytic viruses (OVs) vary widely. Therefore, we performed a meta-analysis to illustrate the efficacy and safety of oncolytic viruses. The Cochrane Library, PubMed, and EMBASE databases were searched for randomized controlled trials (RCTs) published up to 31 January 2020. The data for objective response rate (ORR), overall survival (OS), progression-free survival (PFS), and adverse events (AEs) were independently extracted by two investigators from 11 studies that met the inclusion criteria. In subgroup analyses, the objective response rate benefit was observed in patients treated with oncolytic DNA viruses (odds ratio (OR) = 4.05; 95% confidence interval (CI): 1.96–8.33; p = 0.0002), but not in those treated with oncolytic RNA viruses (OR = 1.00, 95% CI: 0.66–1.52, p = 0.99). Moreover, the intratumoral injection arm yielded a statistically significant improvement (OR = 4.05, 95% CI: 1.96–8.33, p = 0.0002), but no such improvement was observed for the intravenous injection arm (OR = 1.00, 95% CI: 0.66–1.52, p = 0.99). Among the five OVs investigated in RCTs, only talimogene laherparepvec (T-VEC) effectively prolonged the OS of patients (hazard ratio (HR), 0.79; 95% CI: 0.63–0.99; p = 0.04). None of the oncolytic virotherapies improved the PFS (HR = 1.00, 95% CI: 0.85–1.19, p = 0.96). Notably, the pooled rate of severe AEs (grade ≥3) was higher for the oncolytic virotherapy group (39%) compared with the control group (27%) (risk difference (RD), 12%; risk ratio (RR), 1.44; 95% CI: 1.17–1.78; p = 0.0006). This review offers a reference for fundamental research and clinical treatment of oncolytic viruses. Further randomized controlled trials are needed to verify these results.

scholarly journals Network meta-analysis of nivolumab plus ipilimumab in the second-line setting for advanced hepatocellular carcinoma

2021 ◽  
Author(s):  
Neehar D Parikh ◽  
Alexander Marshall ◽  
Keith A Betts ◽  
Jinlin Song ◽  
Jing Zhao ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Objective Response Rate ◽  
Response Rate ◽  
Meta Analysis ◽  
Objective Response ◽  
Credible Interval ◽  
Hazard Ratio ◽  
Advanced Hepatocellular Carcinoma ◽  
Second Line

Aims: To compare the efficacy of nivolumab 1 mg/kg + ipilimumab 3 mg/kg with regorafenib 160 mg, cabozantinib 60 mg and nivolumab 3 mg/kg monotherapy for second-line treatment of advanced hepatocellular carcinoma. Materials & methods: Indirect comparison using network meta-analysis and propensity score weighting. Results: Nivolumab 1 mg/kg + ipilimumab 3 mg/kg had significantly higher objective response rate (median 31.2% [95% credible interval: 19.6–44.5%]) than cabozantinib (4.2% [2.0–6.5%]) and regorafenib (4.8% [1.1–8.3%]), and significantly longer overall survival (cabozantinib: hazard ratio: 0.46 [95% credible interval: 0.27–0.79]; regorafenib: 0.56 [0.32–0.97]). Nivolumab 1 mg/kg + ipilimumab 3 mg/kg had significantly better objective response rate (difference 21.0% [4.5–37.5%]) and overall survival (hazard ratio: 0.58 [0.35–0.96]) than nivolumab monotherapy. Conclusion: Nivolumab 1 mg/kg + ipilimumab 3 mg/kg had a superior efficacy versus cabozantinib 60 mg, regorafenib 160 mg and nivolumab 3 mg/kg monotherapy as second-line therapy for advanced hepatocellular carcinoma.

scholarly journals Efficacy and Safety of Xiao Ai Ping Injection Combined with Chemotherapy in Advanced Gastric Cancer: A Systematic Review and Meta-Analysis

2019 ◽  
Vol 2019 ◽  
pp. 1-12
Author(s):  
Kerui Wu ◽  
Zehao Zhu ◽  
Yaxing He ◽  
Lanlin Huang ◽  
Xia Yan ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Liver Damage ◽  
Combination Treatment ◽  
Karnofsky Performance Status ◽  
Meta Analysis ◽  
Objective Response ◽  
Efficacy And Safety ◽  
Improvement Rate ◽  
Hand Foot Syndrome

Xiao Ai Ping injection (XAPI), extracted from the Chinese herbal medicine Marsdenia tenacissima, is widely used in the adjuvant treatment of tumors in China. The present study aimed to evaluate the efficacy and safety of XAPI combined with chemotherapy for treating patients with advanced gastric cancer. Seven databases were searched for relevant studies published up to October 1, 2018, and Review Manager 5.3 software and Stata 12.0 software were used for meta-analysis. Fourteen studies, representing 1097 enrolled patients, were included in our analysis. Compared with chemotherapy alone, combination treatment with XAPI and the XELOX regimen (capecitabine plus oxaliplatin) was found to improve the objective response rate (ORR) [RR=1.36; 95%CI (1.10, 1.70); P=0.006], disease control rate (DCR) [RR=1.15; 95% CI (1.04, 1.28); P=0.010], and Karnofsky Performance Status (KPS) improvement rate [RR=1.51; 95%CI (1.14, 2.00); P=0.004] and to reduce the incidence of leukopenia [RR=0.68; 95%CI (0.55,0.84); P=0.0005], liver damage [RR=0.59; 95% CI (0.37, 0.92); P=0.02], renal impairment [RR=0.39; 95% CI (0.18, 0.85); P=0.02], and hand-foot syndrome [RR=0.56; 95%CI (0.35,0.90); P=0.02]. However, median progression-free survival (PFS), 1-year survival rate, and median overall survival (OS) were not extended by XAPI plus XELOX. Combination treatment with XAPI and the SOX regimen (tegafur plus oxaliplatin) did not improve ORR or DCR, but it did enhance the KPS improvement rate [RR=1.73; 95%CI (1.23,2.43); P=0.002] and reduce the incidence of nausea and vomiting [RR=0.66; 95% CI (0.50, 0.88); P=0.004]. XAPI in combination with the FOLFOX regimen (fluorouracil/calcium folinate/oxaliplatin) enhanced only the KPS improvement rate [RR=1.68; 95%CI (1.18,2.39); P=0.004] and had no significant effect on ORR or DCR or the incidence of adverse events. A single study reported that XAPI combined with the CPT-11 regimen (irinotecan) was superior to chemotherapy alone with respect to DCR and also reduced the incidence of leukopenia, liver damage, and hand-foot syndrome during chemotherapy, while prolonging PFS. Finally, one study reported that XAPI combined with the TP regimen (palitaxel plus cisplatin) improved ORR and KPS improvement rate to a greater extent than TP alone. Although the present review has some limitations, the findings suggest that XAPI combined with chemotherapy may represent a beneficial treatment strategy, particularly the combination of XAPI and XELOX.

The role of modified FOLFIRINOX regimen in unresectable advanced pancreatic cancer: A retrospective clinical study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15709-e15709
Author(s):  
Yuan Qian ◽  
Song Zheng ◽  
Changku Jia
Keyword(s):  
Pancreatic Cancer ◽  
Overall Survival ◽  
Adverse Events ◽  
Objective Response Rate ◽  
Median Overall Survival ◽  
Response Rate ◽  
Objective Response ◽  
Advanced Pancreatic Cancer ◽  
The United States ◽  
Grade 3

e15709 Background:Pancreatic cancer was the fourth leading cause of death from cancer in the United States in 2015, with a 5-year survival rate only 6%.More than 85% of patients has an unresectable disease at diagnosis for most patients remain asymptomatic. This population including locally advanced pancreatic cancer (LAPC) and metastatic pancreatic cancer (MPC). Gemcitabine has been the standard treatment option for these patients for more than a decade, with a median overall survival nearly 6 months. In 2011, the phase 3 randomised controlled trial(PRODIGE 4/ACCORD 11) reported that FOLFIRINOX regimen had a significantly improved OS,PFS and a predominant ORR in patients with metastatic disease.FOLFIRINOX, as an encouraging regimen, its actual higher adverse events rate in clinical practice should not be underestimated, especially the grade 3/4 neutropenia and sensory neuropathy. The aim of our study is to explore whether a modified FOLFIRINOX regimen with the decrements of oxaliplatin and irinotecan had maintained efficacy and decreased grade 3/4 adverse events rate for the advanced pancreatic cancer. Methods:Retrospectively collected data of all patients carrying a diagnosis of advanced pancreatic cancer at the department of medical oncology, Hangzhou First People’s Hospital and Hangzhou cancer hospital between January 2014 and September 2016.The endpoint were overall survival, objective response rate and grade 3/ 4 adverse events. Results:Among 21 patients who received median 5(1-12) cycles modified FOLFIRINOX regimen,15 of total patients received this regimen for more than 4 cycles (71.4%). The median overall survival of MPC patients in this study is 12.6 months (95% CI, 6.2 months to 19 months). The objective response rate was 42.9%, with partial remission in 9 cases, stable disease in 8 cases and progression disease in 4 cases. Totally 8 patients had grade 3/4 adverse events, the most frequent were neutropenia (14.3%), neuropathy (14.3%) and diarrhea (9.5%). No chemotherapy-related death occurred. Conclusions:mFOLFIRINOX regimen in this study has maintained efficacy for its high objective response rate and an improved safety profile in patients with advanced pancreatic cancer.

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