Apatinib Mesylate Research Articles

1928P Camrelizumab plus apatinib mesylate in patients with recurrent or metastatic poorly differentiated thyroid carcinoma (PDTC) /anaplastic thyroid carcinoma (ATC): A prospective, open-label, phase II study

1928P Camrelizumab plus apatinib mesylate in patients with recurrent or metastatic poorly differentiated thyroid carcinoma (PDTC) /anaplastic thyroid carcinoma (ATC): A prospective, open-label, phase II study

Effect of the combined use of docetaxel, cisplatin and apatinib mesylate on serum tumor markers and prognosis in advanced ovarian cancer patients

Effect of the combined use of docetaxel, cisplatin and apatinib mesylate on serum tumor markers and prognosis in advanced ovarian cancer patients

Retracted: Clinical Effect of Apatinib Mesylate Tablets Combined with Paclitaxel Concurrent Radiotherapy and Chemotherapy in the First-Line Treatment of Locally Advanced Nasopharyngeal Carcinoma.

[This retracts the article DOI: 10.1155/2022/6293816.].

Malignant gastrointestinal neuroectodermal tumor: a case report and literature review

Introduction and importance: A malignant gastrointestinal neuroectodermal tumor (GNET) is an extremely rare primary malignant mesenchymal tumor of the gastrointestinal tract characterized by EWSR1 gene rearrangement. An optimal systemic treatment strategy for advanced/recurrent GNET has not yet been identified. Case presentation: A 24-year-old male patient was hospitalized with abdominal pain and underwent two operations for a tumor in his small intestine. Immunohistochemistry (IHC) showed strong expression of S-100 protein and SOX 10. Fluorescence in situ hybridization analysis and next-generation sequencing analysis indicated that there were EWSR gene rearrangements and the presence of EWSR-ATP1 gene fusions, respectively. The diagnosis of GNET in the small intestine was confirmed by pathology. The young patient received the fifth-line of apatinib mesylate and the sixth-line of apatinib combined with temozolomide. The two apatinib-containing regimens showed stable disease and progression-free survival of 4.7 months and 3.1 months with single-agent apatinib or apatinib combined with temozolomide, respectively. Clinical discussion: To our best knowledge, this is the first report of malignant GNET treated with apatinib and temozolomide. Apatinib-containing regimens might has antineoplastic activity against GNET. The authors reviewed the relevant reports of previous GNET treatment, summarized the clinicopathological characteristics of GNET, and found that there are no reports of apatinib for backline treatment of GNET. Conclusion: Containing apatinib may provide an additional treatment option for patients with chemotherapy-resistant GNET tumors.

Low-dose apatinib in subjects with renal impairment: A pharmacokinetics study

ObjectiveIn patients with renal impairment, we studied apatinib and its major metabolites (M1–1, M1–2, M1–6, and M9–2) for pharmacokinetics. MethodsSubjects with different renal functions were given a single oral dose of apatinib mesylate tablets of 250 mg. Pharmacokinetic samples were collected at 1 hour before dosing,0.25, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, and 96 h after dosing. The pharmacokinetic parameters of apatinib and its major metabolites were calculated by noncompartmental analysis. ResultsComparing PK parameters of the mild or moderate renal impairment group with the healthy group: the geometric mean ratios of maximum observed drug concentration (Cmax), the area under the plasma drug concentration-time curve from time 0 to the final quantifiable time (AUC0-t), and the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0–inf) were all about one. No significant effect of mild and moderate renal impairment on apatinib pharmacokinetics was observed. Mild and moderate renal impairment was also not observed to have a significant effect on the pharmacokinetics of metabolites M1–1, M1–2, and M1–6. However, mild and moderate renal impairment had a certain increase in exposure to the metabolite M9–2. Considering that M9–2 has no inhibitory effect on protein tyrosine kinase, it has no clinical significance. In addition, the proportion of cumulative excretion of apatinib and its major metabolites was small and almost negligible in all three groups of subjects. ConclusionPatients with mild and moderate renal impairment do not need to adjust the dose of apatinib when using low dose (250 mg) apatinib.

Therapeutic effects and safety of apatinib mesylate on patients with gastric carcinoma peritoneal metastasis in SOX scheme.

The aim of this study was to investigate the diagnostic values of serum tumor markers in gastric carcinoma peritoneal metastasis and the therapeutic efficacy as well as safety of apatinib mesylate combined with Geo+Oxaliplatin (SOX) scheme treatment in gastric carcinoma peritoneal metastasis. Sixty patients with gastric carcinoma peritoneal metastasis and 11 patients without gastric carcinoma peritoneal metastasis were selected as the research subjects. The levels of serum tumor markers [carcinoembryonic antigen (CEA), carbohydrate antigen (CA) 125, CA211, CA242, CA724, and CA19-9] and abdominal irrigating solution exosome [micro ribonucleic acid (miR)-21 and miR-320c] and the differences in their diagnostic values were compared and analyzed. The patients with gastric cancer peritoneal metastases are then divided into two groups, one for control (30 cases receiving just SOX scheme treatment) and the other for the experiment (30 cases receiving SOX scheme treatment plus apatinib mesylate). Besides, the differences in serum tumor marker level, therapeutic efficacy, overall survival (OS), complication rating, and Quality of Life Questionnaire-Core-30 (QLQ-C30) score among patients after treatment were compared. Demonstrated that serum carcinoembryonic antigen (CEA), carbohydrate antigen (CA) 125, CA211, CA242, CA724, and CA19-9 levels of patients in the transfer group were remarkably enhanced compared with those of patients in the non-transfer group, and the levels of abdominal irrigating solution exosome (miR-21 and miR-320c) were reduced compared with those in non-transfer group (p<0.05). The area under the curve (AUC) of the diagnosis of gastric carcinoma peritoneal metastasis by each index were 0.553, 0.880, 0.832, 0.619, 0.863, 0.651, 0.918, and 0.903, respectively. Patients in the experimental group's serum levels of CEA, CA125, CA211, CA242, CA724, and CA19-9 were noticeably lower after therapy compared to those in the control group, and their median OS was also noticeably longer (p<0.05). After treatment, the objective remission rate (ORR) and disease control rate (DCR) of the control group and experimental group amounted to 6.7% vs. 30.0% and 50.0% vs. 86.7%, respectively. ORR and DCR of the experimental group were notably higher (p<0.05). Between the patients in the control group and the experimental group, there were no glaring variations in the frequency of problems (hypertension, nausea, vomiting, bone marrow suppression, hand-foot syndrome, and leucopenia) (p>0.05). The cognitive function, emotional function, and life health scores of patients in the experimental group were significantly higher than those in the control group (p<0.05), which suggested that serum tumor markers and miR-21 as well as miR-320c showed high diagnostic efficiency in gastric carcinoma peritoneal metastasis. Apatinib mesylate combined with SOX scheme treatment was more effective in treating gastric carcinoma peritoneal metastasis and possessed the same safety as single SOX scheme treatment. Hence, it is worthy of clinical promotion.

Efficacy of apatinib on advanced ovarian cancer patients who failed first and second-line chemotherapy

Purpose: To investigate the efficacy and safety of apatinib in the treatment of advanced epithelial ovarian cancer (EOC) patients who failed first and second-line chemotherapy.&#x0D; Methods: The clinical data of 100 patients diagnosed with advanced ovarian cancer were retrospectively analyzed. They were divided into two groups, with 50 patients in each group. One group was treated with apatinib mesylate (Apatinib group), while the other group was treated with gemcitabine (Gemcitabine group). Clinical efficacy, adverse reactions, and quality-of-life scores were were assessed, while the survival status of patients was recorded during follow-up.&#x0D; Results: After treatment, the objective response rate (ORR) and disease control rate (DCR) were 24.0 % (12/50) and 70.0 % (35/50) in Apatinib group, and 12.0 % (6/50) and 52.0 % (26/50) in Gemcitabine group. In terms of adverse reactions, the incidence of hand-foot syndrome and hypertension were significantly higher in Apatinib group than in Gemcitabine group, but the incidence of nausea and vomiting, anemia, neutropenia, and thrombocytopenia were significantly lower in Apatinib group than in Gemcitabine group (p &lt; 0.05). Follow-up results revealed the median overall survival (OS) of patients to be 10.1 and 9.0 months, respectively, in Apatinib and Gemcitabine groups. Results of the log-rank test showed that OS in Apatinib group was significantly longer than that of Gemcitabine group.&#x0D; Conclusion: Apatinib demonstrates clear effectiveness and a superior safety profile than Gemcitabine in the management of patients with advanced ovarian cancer who did not respond effectively to multiple rounds of chemotherapy.

Insight into intermolecular binding mechanism of apatinib mesylate and human alpha-1-acid glycoprotein: combined multi-spectroscopic approaches with in silico

Apatinib mesylate (APM), an oral tyrosine kinase inhibitor, has a good anti-tumor activity in the treatment of various cancers, particularly in advanced non-small cell lung cancer. In this study, the intermolecular binding mechanism between APM and human alpha-1-acid glycoprotein (HAG) was investigated by combining multi-spectroscopic approaches with in silico techniques. The findings revealed that APM gave rise to the fluorescence quenching of HAG by forming a ground-state complex between APM and HAG with a stoichiometric ratio of 1:1, and APM has a moderate affinity for HAG as the binding constant of APM and HAG of approximately 105 M−1, which was larger than the APM-HAG complex. The findings from thermodynamic parameter analysis indicated that the dominant driving forces for the formation of the APM-HAG complex were van der Waals forces, hydrogen bonding and hydrophobic interactions, which were also verified with site-probe studies and molecular docking. The findings from in silico study indicated that APM inserted into the opening of the hydrophobic cavity of HAG, leads to a slight conformational change in the HAG, which was verified by circular dichroism (CD) measurements, that was, the beta sheet level of HAG decreased. Additionally, the results of synchronous and 3D fluorescence spectroscopies confirmed the decline in hydrophobicity of the microenvironment around Trp and Tyr residues. Moreover, some common metal ions such as Cu2+, Mg2+, Fe3+, Ca2+, and Zn2+ could cause the alteration in the binding constant of APM with HAG, leading to the change in the efficacy of APM. It will be expected that these study findings are to provide useful information for further understanding pharmacokinetic and structural modifications of APM. Communicated by Ramaswamy H. Sarma

Retracted: Effects of Apatinib Mesylate Monotherapy on the Incidence of Adverse Reactions and Immune Function in Patients with Breast Cancer after Radical Mastectomy

Retracted: Effects of Apatinib Mesylate Monotherapy on the Incidence of Adverse Reactions and Immune Function in Patients with Breast Cancer after Radical Mastectomy

Efficacy and safety of apatinib in patients with recurrent or metastatic head and neck squamous cell carcinoma: a retrospective multi-center study

Apatinib is a novel antiangiogenic agent that targets vascular endothelial growth factor 2. The aim of our study was to explore the efficacy and safety of apatinib in the treatment of patients with recurrence or metastasis (R/M) inoperable head and neck squamous cell carcinoma (HNSCC). This multi-center retrospective study analyzed 53 cases of recurrent or metastatic inoperable HNSCC who had progressed or recurred after undergoing standard radiotherapy, chemotherapy, and immunotherapy treated with apatinib from March 2017 to August 2021. Patients continued apatinib until the time of disease progression or onset of intolerable adverse events. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), objective response rate (ORR), and disease control rate (DCR) and incidence of adverse events. Univariable and multivariable analyses were performed to determine prognostic factors. The main adverse events were counted, and the severity of the adverse reactions was evaluated. Fifty-three patients with recurrent or metastatic inoperable R/M HNSCC who had progressed or recurred after standard radiotherapy, chemotherapy, and immunotherapy were included. The ORR was 15.1%, and the DCR was 86.8%. The median PFS was 4.4 months (95% confidence interval [CI] 3.7–5.0 months) and the median OS was 6.6 months (95% CI 5.3–7.9 months). The number of apatinib lines was an influencing factor for both PFS and OS, and the Eastern Cooperative Oncology Group (ECOG) score, tumor differentiation, and apatinib duration were only the influencing factors for OS. Of these, only the ECOG score was an independent predictor of OS. The most common adverse reactions were hypertension (39.6%), hand-foot syndrome (32.1%), fatigue (32.1%), oral ulcers (28.3%), and nausea and vomiting (20.8%). Most adverse reactions were grade 1 or 2. Apatinib mesylate has good efficacy for recurrent/metastatic inoperable HNSCC as second-line and above-line treatment. ECOG score was an independent prognostic factors of OS in patients who were treated with apatinib. In addition, the adverse effects of apatinib mesylate were relatively mild.

Comparison of efficacy and safety of three different drugs combined with radiotherapy in the treatment of patients with advanced pancreatic cancer

Purpose: To investigate the clinical efficacy and safety of three different drugs combined with radiotherapy, viz, apatinib mesylate combined radiotherapy (group A), gemcitabine combined oxaliplatin (group B), and Huachansu capsules combined radiotherapy (group C)] in advanced pancreatic cancer patients.&#x0D; Methods: A total of 174 patients with advanced pancreatic cancer treated in Yantai Qishan Hospital, Yantai, China from June 2015 to December 2016 were randomly and evenly divided into groups A, B, and C. The incidence of adverse reactions during treatment, immune reaction, efficacy, quality of life, and survival were compared among the three groups after four courses of treatment.&#x0D; Results: Compared with groups B and C, the incidence of nausea and vomiting was higher in group A (p &lt; 0.05), but the incidence of other adverse events was not significantly different (p &gt; 0.05). Group A showed higher response rate and disease control rate, higher CD4+, CD4+/CD8+ levels and QOL scores, as well as lower CD8+ level in peripheral blood after treatment than groups B and C (p &lt; 0.05). Group A also exhibited longer median OS and median PFS, and higher 2-year survival than groups B and C (p &lt; 0.05).&#x0D; Conclusion: Among the three different drug treatments combined with radiotherapy, apatinib mesylate combined radiotherapy enhanced efficacy and quality of life, and lengthen the survival time of advanced pancreatic cancer patients. However, additional clinical trials are required to validate these findings.

Clinical Effect of Apatinib Mesylate Tablets Combined with Paclitaxel Concurrent Radiotherapy and Chemotherapy in the First-Line Treatment of Locally Advanced Nasopharyngeal Carcinoma.

Objective To explore the clinical efficacy and safety of apatinib combined with paclitaxel in the first-line treatment of locally advanced nasopharyngeal carcinoma. Methods From March 2016 to June 2018, 114 patients with locally advanced nasopharyngeal carcinoma who received first-line treatment in our hospital were selected as the patient group, and those who received apatinib combined with paclitaxel concurrent radiotherapy and chemotherapy were selected as the research group (n = 54), while those who received paclitaxel concurrent radiotherapy and chemotherapy were selected as the control group (n = 60). Sixty healthy individuals in our hospital were recruited in the same period as the healthy group. The clinical effective rate, adverse reactions, 2-year overall survival rate (OS), 2-year progression-free survival rate (PFS), and quality of life were compared between the two groups, and the expression of miR-655 in the serum of each group was tested by RT-qPCR. Results The total clinical effective rate of the research group was higher than that of the control group, and the 2-year OS and PFS of the research group were also higher than those of the control group (P < 0.05). Both groups of patients could tolerate the treatment, but the incidence of hypertension and proteinuria in the research group was higher than that in the control group (P < 0.05). The expression of miR-655 in the serum of patients was lower than that of the healthy group (P < 0.05). After treatment, miR-655 in serum increased in both the groups and miR-655 in the research group was higher than that in the control group (P < 0.05). The 2-year survival rate of OS and PFS in patients with low expression of miR-655 was significantly lower than that in patients with high expression of miR-655 (P < 0.05). Conclusion Apatinib combined with paclitaxel concurrent radiotherapy and chemotherapy is effective and well-tolerated in the treatment of locally advanced nasopharyngeal carcinoma, which improves the quality of life of patients and can be popularized in clinical practice. In addition, the increase of miR-655 may be a target for treating nasopharyngeal carcinoma.

Effects of Apatinib Mesylate Monotherapy on the Incidence of Adverse Reactions and Immune Function in Patients with Breast Cancer after Radical Mastectomy.

Objective To assess the effects of monotherapy with apatinib mesylate on the incidence of adverse events and immune function in breast cancer patients after a radical mastectomy. Methods Between December 2018 and August 2020, 90 patients with breast cancer scheduled for a radical mastectomy in People's Liberation Army Navy 971 Hospital were randomly recruited and assigned at a ratio of 1 : 1 to receive either conventional treatment (conventional group) or apatinib mesylate after radical mastectomy (study group). The primary endpoint was disease control rate (DCR), and the secondary endpoints were adverse events and the immune function of the patients. Results Monotherapy with apatinib mesylate was associated with a higher DCR (86.67%) versus conventional postoperative treatment (42.23%). All patients in the study group had documented adverse events, including 2 (4.45%) cases of headache, 3 (6.67%) cases of dizziness, 9 (20.00%) cases of hypertension, 6 (13.34%) cases of hand-foot syndrome, 3 (6.67%) cases of thrombocytopenia, 1 (2.23%) case of tinnitus, 7 (15.56%) cases of fatigue, 2 (4.45%) cases of anemia, 2 (4.45%) cases of oral pain, and 10 (22.23%) cases of leukopenia. There were 23 cases of intermittent discontinuation due to adverse events during treatment, 15 cases of dose reduction, and 3 cases of discontinuation due to adverse events. The difference in preoperative and postoperative T-cell subsets and natural killer (NK) cells between the two groups did not come up to the statistical standard (P > 0.05). Monotherapy with apatinib mesylate resulted in significantly lower levels of CD4+, CD4+/CD8+, and NK cells and higher CD8+ levels versus conventional treatment at 1 week and 4 weeks postoperatively (P < 0.05). Conclusion Apatinib mesylate monotherapy after radical mastectomy yields a high DCR, a lower incidence of adverse events, and improved immune recovery. Clinical trials are, however, required prior to clinical promotion.

Efficacy and Safety of Apatinib in Advanced Hepatocellular Carcinoma: A Multicenter Real World Retrospective Study.

Background and Purpose: Apatinib is a novel antiangiogenic agent that can target vascular endothelial cell growth factor 2. The aim of our study was to evaluate the efficacy and safety of apatinib mesylate in the treatment of advanced hepatocellular carcinoma (HCC) in the real world. Methods: We retrospectively analyzed 178 patients with advanced HCC who had been treated with apatinib mesylate from January 2017 to March 2020. The primary outcome indexes were progression-free survival (PFS) and overall survival (OS), and the secondary outcome indexes were overall response rate (ORR), disease control rate (DCR), and incidence of treatment-related adverse reactions. Results: Univariate analysis showed that patients with third-line treatment (p <0.001), alpha fetoprotein (AFP) ≥400 ng/ml (p <0.05), distant metastasis (p <0.05), portal vein tumor thrombus (PVTT) (p <0.05), and apatinib monotherapy (p <0.001) had shorter survival. Multivariate analysis confirmed that third-line drugs, PVTT, and combination therapy were independent prognostic factors for PFS in all patients. Univariate analysis showed that Eastern Cooperative Oncology Group (ECOG) scores (p <0.05), line of apatinib (p <0.001), AFP (p <0.001), tumor progression (p <0.05), PVTT (p <0.05), and combination therapy (p <0.001) may impact the OS. Multivariate analysis proved that AFP, PVTT, and combination therapy were independent prognostic factors for OS. The most common adverse reactions were secondary hypertension (29.21%), symptoms of fatigue (16.85%), hand and foot syndrome (16.29%), vomiting (14.04%), liver dysfunction (6.18%), and proteinuria (6.74%). Most of the adverse reactions were Grade 1 or 2. Conclusion: Apatinib mesylate is an effective treatment for advanced HCC, and its adverse reactions are relatively mild. Line of apatinib, PVTT, AFP level, and combination therapy were independent prognostic factors for patients with advanced HCC who were treated with apatinib.

Clinical study of apatinib mesylate combined with paclitaxel injection and cisplatin injection in the treatment of non-small cell lung cancer.

article: Clinical study of apatinib mesylate combined with paclitaxel injection and cisplatin injection in the treatment of non-small cell lung cancer - Minerva Surgery 2022 Mar 10 - Minerva Medica - Journals

A single-arm, prospective study of apatinib mesylate plus pemetrexed in patients of advanced non-squamous non-small cell lung cancer after failure of previous chemotherapy.

BackgroundThe outcomes of advanced non-small cell lung cancer (NSCLC) patients after first- or second-line therapy are still discouraging due to a lack of effective treatment strategies. As a novel oral anti-angiogenesis drug, apatinib, approved by the National Medical Products Administration of China only for advanced gastric cancer, has been increasingly used in off-label treatment across various cancer types in recent years, especially advanced NSCLC. It has shown strong anti-tumor efficacy and acceptable safety.MethodsThis prospective study (NCT02974933) was conducted in patients with advanced NSCLC, who had suffered disease progression from the first- or second-line treatment, in Hubei Cancer Hospital. Eligible patients were enrolled and administrated with apatinib mesylate (500 mg qd) in combination with pemetrexed (500 mg/m2, every 4 weeks). The primary endpoint was progression-free survival (PFS).ResultsFrom September 2016 to September 2019, a total of 21 advanced NSCLC patients were enrolled in Hubei Cancer Hospital. As of January 2021, treatment was discontinued in all patients, with 1 still in follow-up. There were 7/21 (33.3%) patients who achieved objective response. The median PFS and median overall survival (OS) were 7.0 months (95% CI: 6.15–7.85 months) and 13.0 months (95% CI: 7.39–18.6 months), respectively. Toxicities were tolerable or could be clinically managed. The most common grade 3–4 adverse events (AEs) were hypertension (14.3%, 3/21), hand-foot syndrome (4.7%, 1/21), and proteinuria (4.7%, 1/21). Hematological toxicities were moderate, with rare occurrences of grade 3/4 toxicities. During the period of treatment, there was no occurrence of treatment-related death.ConclusionsApatinib plus pemetrexed demonstrated promising efficacy and a high level of safety profile in previously heavily-treated NSCLC patients. More definitive studies on the combination of apatinib and pemetrexed are warranted

Clinical curative effect of neoadjuvant chemotherapy combined with immunotherapy and its impact on immunological function and the expression of ER, PR, HER-2 & SATB1 in HER-2-Positive breast cancer patients.

Objective:To evaluate the clinical curative effect of neoadjuvant chemotherapy combined with immunotherapy and its impact on immunological function and the expression of ER, PR, HER-2 and SATB1 in HER-2-positive breast cancer patients.Methods:The subjects of study were 80 patients with HER-2-positive breast cancer. Enrolled patients were randomly divided into two groups, with 40 cases in each group at The Fourth Affiliated Hospital of Hebei Medical University from March 2018 from March 2021. Patients in the control group were provided with neoadjuvant chemotherapy using TAC regimen merely; while those in the study group received oral administration of Apatinib Mesylate (500mg/d; three weeks a cycle) on the basis of the TAC regimen. Further comparative analysis was performed focusing on the therapeutic effect and adverse drug reaction rate of the two groups; levels of CD3+, CD4+, CD8+ and CD4+/CD8+ of T lymphocyte subsets in the two groups before and after treatment; as well as the expressions of ER, PR, HER-2 and SATB1 in the two groups before and after treatment.Results:The total response rate was 77.5% and 55% in the study group and the control group, respectively, with an obviously better outcome in the former group than that in the latter group (p=0.03). Meanwhile, the incidence of adverse reactions was 40% in the study group and 45% in the control group, without statistical difference (p=0.65). There were statistically significant differences that the levels of CD3+, CD4+, and CD4+/CD8+ in the study group were significantly higher when compared with those in the control group after treatment (CD3+, p=0.00; CD4+, p=0.02; CD4+/CD8+, p=0.00); while no evident change was observed in the level of CD8+ (p=0.88). After treatment, the positive expression rates of ER, HER-2 and SATB1 were remarkably lower in the study group than those in the control group, showing statistically significant differences (ER, HER-2, p=0.03; SATB1, p=0.02). However, there was no statistically significant difference in the positive expression rate of PR between the study group and the control group (P=0.80).Conclusions:Neoadjuvant chemotherapy combined with immunotherapy has significant effect on the treatment of HER-2-positive breast cancer patients. It can result in the significant enhancement of T lymphocyte function, obvious improvement in the negative converse rates of ER, HER-2 and SATB1, and no evident increase in the adverse drug reactions. The proposed therapeutic approach is safe, effective, and have certain clinical value.

823TiP Fluzoparide combined with apatinib mesylate in the treatment of platinum resistant recurrent ovarian cancer: A single arm, single center, prospective clinical study

Ovarian cancer is one of the most common malignant tumors in female genital organs. The incidence rate is third highest and its mortality is the highest. In the treatment of ovarian cancer, 70% of patients will still relapse after chemotherapy, of which, about 25% isplatinum resistant relapse, which seriously affects the quality of life and prognosis of patients. At present, platinum-resistant ovarian cancer treatment is still a difficult problem. BRCA gene mutation is closely related to the occurrence and development of ovarian cancer.

Prediction of clinical efficacy by plasma concentration of apatinib in patients with solid tumor.

e15000 Background: To explore the correlation between plasma concentration of apatinib and clinical efficacy. Methods: 42 patients were enrolled. Plasma specimens of all patients were collected. At 7:40 am, fasting blood was drawn as plasma trough concentration (Ctrough). At 8 am, apatinib mesylate (APA-M, 250mg qd) was orally administrated. At 11 am, venous blood was drawn as plasma peak concentration (Cpeak). Each patient has Ctrough and Cpeak samples. A total of 84 plasma samples were obtained. The concentration of APA-M in plasma was determined by UPLC-MS/MS. Results: 1) 42 patients were evaluable. Treatment response was assessed by RECIST1.1. 2 patients achieved complete response (CR), 16 partial response (PR), 12 stable disease (SD) (tumor shrinks), 5 SD (tumor enlargement), 7 progressive disease (PD). Objective response rate (ORR) was 42.9% (18/42) and disease control rate (DCR) was 83.3% (35/42). 2) On day 1 and 456 after oral APA-M from different patients, median trough concentration (Ctrough median) was 264.38 ng/ml (1.18 ng/ml-918 ng/ml), and median peak concentration (Cpeak median) was 543.61 ng/ml (71.11 ng/ml-1609.4 ng/ml), respectively. 3) The Ctrough median in patients with CR, PR and SD (tumor shrinks) was significantly higher than that SD (tumor enlargement) and PD ( P＜0.05). There was significantly difference between CR and PR with SD (tumor shrinks) ( P＜0.05). But there was no significantly difference between CR and PR ( P＞0.05). (Table) 4) The Cpeak median in patients with CR, PR, SD (tumor enlargement) and PD was significantly higher than that SD (tumor shrinks) ( P＜0.05). But there was no significantly difference between CR and PR with SD (tumor enlargement) ( P＞0.05). (Table). Conclusions: The plasma Ctrough of Apatinib can predict the clinical efficacy of patients with solid tumor. Perspective clinical studies with adequate sample size are required to validate our results. [Table: see text]

Camrelizumab plus apatinib combined with TACE and cryoablation in the first-line treatment of advanced hepatocellular carcinoma.

TPS4160 Background: Hepatocellular carcinoma (HCC) is a common cancer in the world, a leading cause of cancer-related death, and especially in China. Most of the HCC patients are diagnosed at an advanced stage and require a multidisciplinary approach. The IMbrave 50 trial has reported the successful efficacy of atezolizumab and bevacizumab combination therapy in advanced hepatocellular carcinoma, which indicate the potential efficacy of combination of immunotherapy and antiangiogenesis therapy in HCC patients. In some studies, the combinatorial approaches with immunotherapy and liver directed therapies such as transarterial chemoembolization (TACE), radiofrequency ablation (RFA), microwave ablation (MWA), and cryoablation are explored. Most combined interventional therapies reveal their enormous advantages as compared with any single therapeutic regimen alone, which may result from the immunologic enhancement effect of the multimodel therapy. In this study, we evaluated the efficacy and safety of combined therapy with camrelizumab plus apatinib mesylate and TACE plus cryoablation in patients with advanced HCC. Methods: This study was an open-label, single-arm, single centre, phase 2 trial in patients who were diagnosed with advanced HCC. Patients who meet the following criterias will be enrolled: (1) 18 - 75 years old; (2) Child-Pugh classification A or B(≤7);(3) Barcelona Clinic Liver Cancer stage B or C, or China liver cancer staging (CNLC) stage IIb̃IIIa; (4) Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0–1; (5) no history of previous systematic treatment; (6) expected life expectancy of more than 12 weeks; (7) adequate organs function. The key exclusion criteria were history of active autoimmune disease, or concurrent medical use of immunosuppressive medications or immunosuppressive doses of systemic corticosteroids. Eligible patients received camrelizumab 200 mg intravenously every 2 weeks and apatinib 250 mg orally once per day continuously in a treatment cycle of 4 weeks, treatment continued until 1 year or development of unacceptable toxicity or progression of disease. TACE was administrated at the first treatment cycles on day 1or 2, the chemotherapy regimens included 100-150mg oxaliplatin, 750-1000mg fluorouracil, or 30-50 mg lobaplatin, raltitrexed 2-4mg, and epirubicin 40-80 mg. Two or three weeks after the TACE, percutaneous cryoablation was performed under CT guidance. TACE and cryoablation was given as combination therapy and the periods were assessed by the investigator. The primary endpoint is objective response rate (complete or partial response according to mRECIST) and Progression-Free-Survival (Time ranges from random to the first occurrence of disease progression or death from any cause). This trial is registered with Chinese Clinical Trials Registry, ChiCTR2100043044, and is ongoing. Clinical trial information: ChiCTR2100043044.