scholarly journals A randomized, double-blind, placebo-controlled study of B-cell lymphoma 2 homology 3 mimetic gossypol combined with docetaxel and cisplatin for advanced non-small cell lung cancer with high expression of apurinic/apyrimidinic endonuclease 1

2020 ◽  
Vol 38 (6) ◽  
pp. 1862-1871
Author(s):  
Yuxiao Wang ◽  
Xuemei Li ◽  
Liang Zhang ◽  
Mengxia Li ◽  
Nan Dai ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Response Rate ◽  
B Cell Lymphoma ◽  
Small Cell ◽  
Controlled Study ◽  
Control Group ◽  
Small Cell Lung ◽  
Experimental Group

Summary Background Overexpression of apurinic/apyrimidinic endonuclease 1 (APE1) is an important cause of poor chemotherapeutic efficacy in advanced non-small cell lung cancer (NSCLC) patients. Gossypol, a new inhibitor of APE1, in combination with docetaxel and cisplatin is believed to improve the efficacy of chemotherapy for advanced NSCLC with high APE1 expression. Methods Sixty-two patients were randomly assigned to two groups. Thirty-one patients in the experimental group received 75 mg/m2 docetaxel and 75 mg/m2 cisplatin on day 1 with gossypol administered at 20 mg once daily on days 1 to 14 every 21 days. The control group received placebo with the same docetaxel and cisplatin regimen. The primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), response rate, and toxicity. Results There were no significant differences in PFS and OS between the experimental group and the control group. The median PFS (mPFS) in the experimental and control groups was 7.43 and 4.9 months, respectively (HR = 0.54; p = 0.06), and the median OS (mOS) was 18.37 and 14.7 months, respectively (HR = 0.68; p = 0.27). No significant differences in response rate and serious adverse events were found between the groups. Conclusion The experimental group had a better mPFS and mOS than did the control group, though no significant difference was observed. Because the regimen of gossypol combined with docetaxel and cisplatin was well tolerated, future studies with larger sample sizes should be performed.

scholarly journals Carboplatin and Paclitaxel in Combination With Either Vorinostat or Placebo for First-Line Therapy of Advanced Non–Small-Cell Lung Cancer

2010 ◽  
Vol 28 (1) ◽  
pp. 56-62 ◽  
Author(s):  
Suresh S. Ramalingam ◽  
Michael L. Maitland ◽  
Paul Frankel ◽  
Athanassios E. Argiris ◽  
Marianna Koczywas ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Response Rate ◽  
Area Under The Curve ◽  
Progression Free Survival ◽  
Small Cell ◽  
Controlled Study ◽  
Small Cell Lung ◽  
Anticancer Effects

Purpose Vorinostat, a histone deacetylase inhibitor, exerts anticancer effects by both histone and nonhistone–mediated mechanisms. It also enhances the anticancer effects of platinum compounds and taxanes in non–small-cell lung cancer (NSCLC) cell lines. This phase II randomized, double-blinded, placebo-controlled study evaluated the efficacy of vorinostat in combination with carboplatin and paclitaxel in patients with advanced-stage NSCLC. Patients and Methods Patients with previously untreated stage IIIB (ie, wet) or IV NSCLC were randomly assigned (2:1) to carboplatin (area under the curve, 6 mg/mL × min) and paclitaxel (200 mg/m2 day 3) with either vorinostat (400 mg by mouth daily) or placebo. Vorinostat or placebo was given on days 1 through 14 of each 3-week cycle to a maximum of six cycles. The primary end point was comparison of the response rate. Results Ninety-four patients initiated protocol therapy. Baseline patient characteristics were similar between the two arms. The median number of cycles was four for both treatment arms. The confirmed response rate was 34% with vorinostat versus 12.5% with placebo (P = .02). There was a trend toward improvement in median progression-free survival (6.0 months v 4.1 months; P = .48) and overall survival (13.0 months v 9.7 months; P = .17) in the vorinostat arm. Grade 4 platelet toxicity was more common with vorinostat (18% v 3%; P < .05). Nausea, emesis, fatigue, dehydration, and hyponatremia also were more frequent with vorinostat. Conclusion Vorinostat enhances the efficacy of carboplatin and paclitaxel in patients with advanced NSCLC. HDAC inhibition is a promising therapeutic strategy for treatment of NSCLC.

scholarly journals Effect of Sintilimab combined with Chemotherapy on Tumor Markers and Immune Function of advanced non-small cell lung cancer

2021 ◽  
Vol 37 (4) ◽  
Author(s):  
Xiaoyan Liang ◽  
Zhangfeng Wei
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Immune Function ◽  
Tumor Markers ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Control Group ◽  
Small Cell Lung ◽  
Serum Tumor Markers ◽  
Experimental Group

Objective: To evaluate the effect of sintilimab combined with chemotherapy on tumor markers and immune function in advanced non-small cell lung cancer. Methods: The study was conducted at Xi’an Medical University, China. The 120 patients with advanced NSCLC who were treated in our hospital from January 2016 to January 2020 were randomly divided into two groups, with 60 cases in each group. Patients in the control group received conventional GP chemotherapy, while those in the experimental group received intravenous injection of sindilimab on the basis of conventional GP chemotherapy. The changes of serum tumor markers CYFRA211, CEA, CA125 and T lymphocyte subsets CD3+, CD4+, CD8+, CD4+/CD8+ in the two groups prior to and after treatment were compared and analyzed. At the same time, the clinical efficacy at six months was compared between the two groups. Results: The serum tumor markers CYFRA211, CEA and CA125 in the two groups after treatment were lower than those before treatment, and the difference was statistically significant (P=0.00). Specifically, the above-mentioned markers in the experimental group decreased more significantly than those in the control group, and the difference was statistically significant (CYFRA211, CA125, p=0.00; CEA, p=0.01; the levels of CD3+ and CD4+ in the experimental group were higher than those in the control group after treatment, with statistical significance (CD3+, p=0.00; CD4+, p=0.01)). No significant change can be seen in CD8+ (p=0.14), and the level of CD4+/CD8+ in the experimental group was higher than that in the control group, with a significant difference (p=0.02). The complete remission rate (CR) was 22% in the experimental group and 8% in the control group (P=0.04), which was statistically significant. The progress rate (PD) of the experimental group was significantly lower than that of the control group, with statistical significance (p=0.02). The overall response rate (RR) of the experimental group was more advantageous than that of the control group, with a statistically significant difference (p=0.01). Conclusion: Compared with chemotherapy alone, significant therapeutic effects can be obtained in the treatment of advanced non-small cell lung cancer with sintilimab combined with chemotherapy. With this combination regimen, the level of serum tumor markers can be significantly reduced, the cellular immune function of patients can be improved, with the overall response rate of treatment increased, and the risk of progressive disease of patients reduced. doi: https://doi.org/10.12669/pjms.37.4.3820 How to cite this:Liang X, Wei Z. Effect of Sintilimab combined with Chemotherapy on Tumor Markers and Immune Function of advanced non-small cell lung cancer. Pak J Med Sci. 2021;37(4):---------. doi: https://doi.org/10.12669/pjms.37.4.3820 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

scholarly journals Observation on the Clinical Effect of Apatinib Combined with Chemotherapy in the Treatment of Advanced Non-Small Cell Lung Cancer

2021 ◽  
Vol 37 (4) ◽  
Author(s):  
Yu-jie Cui ◽  
Jia Liu ◽  
Miao-miao Liu ◽  
Hong-zhen Zhang
Keyword(s):  
Quality Of Life ◽  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Clinical Effect ◽  
Small Cell ◽  
Control Group ◽  
Small Cell Lung ◽  
Experimental Group

Objectives: To evaluate the clinical effect of apatinib combined with chemotherapy in the treatment of advanced non-small cell lung cancer (NSCLC). Methods: Eighty patients with advanced NSCLC treated in Hebei General Hospital from January 2017 to July 2020 were randomly divided into two groups: the experimental group and the control group, each with 40 cases. Patients in the control group were treated with conventional paclitaxel combined with cisplatin chemotherapy, while patients in the experimental group were treated with apatinib mesylate tablets based on the treatment of the control group. After treatment, tumor efficacy evaluation was conducted on all patients every two cycles, and the therapeutic effect, adverse drug reactions, improvement of quality-of-life scores prior to and after treatment, and changes of indicators such as tumor markers carcinoembryonic antigen (CEA) and carbohydrate antigen 153(CA153) were compared and analyzed between the two groups.  Results: The total effective rate of the experimental group was 67.5%, which was significantly better than the 45% of the control group (p=0.04); The incidence of adverse drug reactions in the experimental group was 25%, while that in the control group was 37.5%, with no significant difference (p=0.23); Moreover, the improvement rate of quality of life scores in the experimental group was significantly higher than that in the control group (p=0.03), and the levels of CEA and CA153 in the experimental group were significantly lower after treatment than those in the control group, with a statistically significant difference (p=0.01). Conclusion: Apatinib combined with conventional chemotherapy is effective in the treatment of advanced non-small cell lung cancer, the quality of life can be significantly improved, tumor markers can be significantly reduced, and adverse reactions will not be significantly increased. doi: https://doi.org/10.12669/pjms.37.4.4066 How to cite this:Cui Y, Liu J, Liu M, Zhang H. Observation on the Clinical Effect of Apatinib Combined with Chemotherapy in the Treatment of Advanced Non-Small Cell Lung Cancer. Pak J Med Sci. 2021;37(4):---------.   doi: https://doi.org/10.12669/pjms.37.4.4066 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

scholarly journals The morbidity and mortality of non-small cell lung cancer in low risk areas of the COVID-19

2020 ◽  
Author(s):  
Minhao Yu ◽  
Yalin Cheng
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cancer Progression ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Low Risk ◽  
Control Group ◽  
Small Cell Lung ◽  
Risk Areas ◽  
Experimental Group

Abstract Objective: To analyze the morbidity and mortality of non-small cell lung cancer and evaluate treatment strategies for non-small cell lung cancer patients in low-risk areas of the COVID-19.Materials and methods: We selected patients in the hospital in Sichuan Science City Hospital from September 2019 to February 2020 as research subjects and divided them into experimental and control groups. The evaluation of treatment strategy was based on morbidity and mortality.Results: There were 9010 patients hospitalized. The total morbidity was 0.699%, which was 0.504% in the control group and 0.991% in the experimental group (P=0.024). The total mortality was 0.887 /103, which was 0.840/103 in the control group (4/4764) and 0.942/103 in the experimental group (P=0.998). The patients discontinued therapy or follow-up and cancer progression in the experimental group was significantly higher than that in the control group (P＜0.001, =0.007). Most of the discontinued and progressive cancer patients were elderly and in late stage.Conclusion: The morbidity of NSCLC during the COVID-19 pandemic was significantly high. The mortality in the experimental group was slightly higher than that in the control group, while the difference in cancer progression was significant. It is practicable to perform surgery for early-stage NSCLC patients and undesirable to suspend treatment for late-stage patients in low-risk areas.

scholarly journals Therapeutic effects of Kanglaite injection combined with chemotherapy on advanced non-small cell lung cancer (NSCLC).

2018 ◽  
Vol 2 (4) ◽  
Author(s):  
Zhaoji Luan
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Late Stage ◽  
Effective Rate ◽  
Small Cell ◽  
Control Group ◽  
Small Cell Lung ◽  
Total Treatment ◽  
Experimental Group

AbstractObjective: To study the therapeutic effect of Kanglaite injection combined with chemotherapy in the treatment of late stage non-small cell lung cancer (NSCLC), and also to observe the effect of the combination treatment on immune function. Methodology: 92 patients with advaned stage of non-small cell lung cancer who admitted to First Hospital of ZiBo city hospital from May 2017 to October 2018 were randomly divided into experimental group and control group, with 46 cases respectively. The control group was treated with chemotherapy only while the experimental group was treated with Kanglaite injection combined with chemotherapy which was the basic treatment for patients, and the total treatment effective rate, adverse reaction rate and immune index of the treatments on two groups were compared. Result: The total treatment effective rate of the experimental group was 80.43%, which was significantly higher than that of the control group, which was 63.04%. The incidence of adverse reactions in the experimental group was 36.96%, which was lower than that of the control group (78.26%). The immune indexes of the experimental group (CD3+, CD4+, IgG, IgA) were better than that of the control group, respectively. The differences between the two groups were statistically significant (P<0.05).Conclusion: During the chemotherapy of late stage or advanced non-small cell lung cancer, the addition use of Kanglaite injection has a significant effect on improving tumor control and reducing the side effects of chemotherapy, and helps to improve the immune function of patients, thus it is worth promoting.

scholarly journals Effect of Systemic Corticosteroid Therapy on the Efficacy and Safety of Nivolumab in the Treatment of Non-Small-Cell Lung Cancer

2021 ◽  
Vol 28 ◽  
pp. 107327482098579
Author(s):  
Kengo Umehara ◽  
Kaori Yama ◽  
Keisuke Goto ◽  
Azusa Wakamoto ◽  
Tae Hatsuyama ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Survival Time ◽  
Cell Lung Cancer ◽  
Objective Response ◽  
Small Cell ◽  
Control Group ◽  
Small Cell Lung ◽  
Corticosteroid Administration

Introduction: Corticosteroids are used to treat immune-related adverse events (irAEs) associated with nivolumab. However, patients with non-small-cell lung cancer who are administered corticosteroids before the initiation of nivolumab treatment are commonly excluded from clinical trials. The appropriate timing for corticosteroid administration in relation to nivolumab treatment, effects of corticosteroids on the efficacy of nivolumab, and resulting adverse events are not clearly understood. In this study, the effects of differences in the timing of corticosteroid administration on nivolumab efficacy and the resulting adverse events were examined. Methods: A retrospective study was conducted with 109 patients who were treated with nivolumab at Sapporo Minami-Sanjo Hospital between December 2015 and March 2018. Results: Of the 109 patients treated with nivolumab, 12 patients were administered corticosteroids before the first cycle of nivolumab (pre-CS), and 33 patients were administered corticosteroids after the first cycle of nivolumab (post-CS). These 2 groups were compared with the control group comprising 64 patients who were not administered corticosteroids (non-CS). The objective response rate in the post-CS group was significantly higher than that in the non-CS group, and the disease control rate in the pre-CS group was significantly lower than that in the non-CS group. The overall survival time and progression-free survival time in the pre-CS group were significantly shorter than those observed in the non-CS group; however, these did not differ from those in the post-CS group. Conclusions: These results suggest that corticosteroids administered to patients with non-small-cell lung cancer after initiation of nivolumab treatment did not affect the disease prognosis. Thus, corticosteroids can be administered immediately for rapid treatment of irAEs.

Efficacy and safety of recombinant human endostatin during peri-radiotherapy period in advanced non-small-cell lung cancer

2022 ◽  
Author(s):  
Jianbo Zhu ◽  
Guangpeng Chen ◽  
Kai Niu ◽  
Yongdong Feng ◽  
Lijiao Xie ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Radiation Pneumonitis ◽  
Small Cell ◽  
Hazard Ratio ◽  
Control Group ◽  
Efficacy And Safety ◽  
Small Cell Lung ◽  
Recombinant Human Endostatin

Background: This study aimed to retrospectively investigate the efficacy and safety of recombinant human endostatin (Rh-endostatin) combined with radiotherapy in advanced non-small-cell lung cancer (NSCLC). Methods: Patients with unresectable stage III and IV NSCLC who treated with radiotherapy were enrolled. Patients who received Rh-endostatin infusion throughout the whole peri-radiotherapy period formed the Endostar group, and those who received no Rh-endostatin infusion were the control group. Results: The median progression-free survival was 8.0 and 4.4 months (hazard ratio: 0.53; 95% CI: 0.32–0.90; p = 0.019) and median overall survival was 40.0 and 13.1 months (hazard ratio: 0.53; 95% CI: 0.28–0.98; p = 0.045) for the Endostar and control groups, respectively. The Endostar group exhibited a numerically lower rate of radiation pneumonitis relapse, radiation pneumonitis death and pulmonary fibrosis. Conclusion: Rh-endostatin infusion throughout the peri-radiotherapy period enhanced radiosensitivity and showed better survival outcomes and a tendency toward fewer radiation-related pulmonary events in patients with NSCLC.

A first-in-human study of mirzotamab clezutoclax as monotherapy and in combination with taxane therapy in relapsed/refractory solid tumors: Dose escalation results.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3015-3015
Author(s):  
Anthony W. Tolcher ◽  
Benedito A. Carneiro ◽  
Afshin Dowlati ◽  
Albiruni Ryan Abdul Razak ◽  
Young Kwang Chae ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Solid Tumors ◽  
Cell Lung Cancer ◽  
Dose Escalation ◽  
Lymphocyte Count ◽  
B Cell Lymphoma ◽  
Small Cell ◽  
Small Cell Lung ◽  
Grade 3

3015 Background: Mirzotamab clezutoclax (ABBV-155) is a first-in-class antibody drug conjugate comprised of a BCL-XL (B-cell lymphoma - extra long) inhibitor, solubilizing linker, and a monoclonal anti-B7H3 antibody. Methods: Patients (pts) with relapsed and/or refractory (R/R) solid tumors were administered mirzotamab clezutoclax with or without paclitaxel. Dose escalation of mirzotamab clezutoclax was guided by Bayesian continual reassessment. Primary outcomes were to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). Secondary outcomes: safety, pharmacokinetics, and overall response rate per RECIST v1.1. Results: As of November 6, 2020, 31 pts received mirzotamab clezutoclax monotherapy (monoTx) and 28 pts received combination therapy with paclitaxel (comboTx). Overall demographics: median age 62 years (range 25–79); 61% female; 86% white; 24% ECOG 0, 76% ECOG 1; 51% had > 3 prior systemic therapies. The median duration of mirzotamab clezutoclax exposure was 3 cycles (range 1–14) for monoTx and 5 cycles (range 1–14) for comboTx. There were no dose limiting toxicities (DLT) reported with monoTx. In comboTx, 2 pts experienced a DLT: Grade 4 neutrophil count decreased and Grade 3 lymphocyte count decreased considered related to paclitaxel. 97% of all pts had adverse events (AEs). The most common AEs (in ≥20% of pts) overall were fatigue (39%), nausea (25%), diarrhea and arthralgia (22% each), vomiting and hypokalemia (20% each). AEs in ≥5 pts related to mirzotamab cleuzutoclax were fatigue (27%), diarrhea (12%), and nausea (9%). Related Grade 3/4 AEs overall (in > 1 patient) included anemia, lymphocyte count decreased, fatigue, and diarrhea (3% each). One patient on monoTx experienced a fatal cardiac arrest. No fatal AEs occurred on comboTx. Responses were observed with comboTx as shown in the Table. Conclusions: Mirzotamab clezutoclax as monotherapy and with paclitaxel demonstrates a tolerable safety profile (MTD not reached) with anti-tumor activity in R/R solid tumors. Further investigation in prospectively-selected B7H3 positive tumors as monoTx in pts with R/R small cell lung cancer and with paclitaxel in pts with R/R breast cancer and docetaxel in pts with R/R non-small cell lung cancer in the dose expansion phase is ongoing. Clinical trial information: NCT03595059. [Table: see text]

scholarly journals miRNA-486 and miRNA-499 in human plasma evaluate the clinical stages of lung cancer and play a role as a tumor suppressor in lung tumorigeneisis not pathogenesis

2016 ◽  
Vol 11 (1) ◽  
pp. 264 ◽  
Author(s):  
Youchao Jia ◽  
Aimin Zang ◽  
Yanguang Feng ◽  
Xiao-Fang Li ◽  
Ke Zhang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cancer Patients ◽  
Cell Lung Cancer ◽  
Statistical Significance ◽  
Small Cell ◽  
Expression Level ◽  
Control Group ◽  
Small Cell Lung ◽  
Lung Cancer Patients

<p class="Abstract">It was aimed to explore the expression level of miRNA-486 and miRNA-499 in the plasma of lung cancer patients and analysis their differences in expre-ssion. The expression level of both miRNA-486 and miRNA-499 in the plasma of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) were lower than that of the control group (p&lt;0.05) and the decrease was more obvious in NSCLC. Compare with the miRNA-499，expression quantity in NSCLC patients plasma. There was statistical significance difference (p&lt;0.05) between III～Ⅳstage and I～II stage. The expression quantity of miRNA in plasma of patients with extensive-stage SCLC was lower than that of patients with limited-stage SCLC (p&lt;0.05). The sensitivity and specificity of plasms miRNA-486 respectively were 88.5% and 83.3%. The expression of miRNA-499 and miRNA-486 in lung cancer patients were up-regulated, and might be closely related to the occurrence and prognosis of lung cancer, and might be used as potential screening and prognosis index for lung cancer.</p><p> </p>

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