Treatment Of Chinese Patients Research Articles

Role of irisin in Chinese patients with hypothyroidism: an interventional study.

ObjectiveIrisin is a myokine that greatly affects energy expenditure and systemic metabolism. While thyroid hormone is likely associated with irisin, a direct relationship remains to be fully elucidated. This study aimed to investigate plasma irisin levels in Chinese patients with hypothyroidism.MethodsA total of 155 subjects were divided into the hypothyroidism group or the control group. Fifty-seven patients in the hypothyroidism group received levothyroxine treatment. Baseline irisin levels were measured in the two groups and post-treatment levels were measured in the hypothyroidism group.ResultsIrisin levels were significantly lower in the hypothyroidism group than in the control group. In the hypothyroidism group, irisin levels were positively associated with free triiodothyronine and free thyroxine levels, and negatively associated with thyrotropin levels. In the hypothyroidism group, irisin levels were significantly increased after levothyroxine treatment. Multiple linear regression models showed that total cholesterol and free thyroxine levels were the only significant predictors of serum irisin levels.ConclusionsIrisin levels are decreased in patients with hypothyroidism. Our results suggest that decreased irisin levels are directly associated with reduced thyroid hormone levels. These values may be restored after levothyroxine treatment in Chinese patients with hypothyroidism.

Tislelizumab in combination with chemotherapy for the treatment of Chinese patients (pts) with esophageal squamous cell carcinoma (ESCC): Results from one cohort of an ongoing phase 2 study.

14 Background: Tislelizumab, a humanized IgG4 mAb with high affinity and specificity for PD-1, is specifically engineered to minimize binding to FcγR on macrophages, thereby abrogating antibody-dependent phagocytosis, a potential mechanism of T-cell clearance and resistance to anti-PD-1 therapy. This phase 2 study assessed the safety and tolerability of tislelizumab combined with chemotherapy as first-line therapy in pts with gastric cancer and ESCC; the results of the ESCC cohort are presented here. Methods: Chinese pts with inoperable, locally advanced ESCC were treated with tislelizumab (200 mg IV Q3W), cisplatin (80 mg/m² IV Q3W for up to six cycles), and fluorouracil (800 mg/m²/d, days 1-5 IV Q3W for up to six cycles). Safety/tolerability of the combination regimen was assessed by monitoring adverse events (AEs) per NCI-CTCAE v4.03 criteria. Results: As of 13 June 2018, 15 pts (median age, 61 yrs; male/female, 14/1) were enrolled. The median treatment duration was 108 days (range 21-201). The mean (Q1, Q3) dose intensity was 0.92 (0.91, 0.97) for tislelizumab, 0.91 (0.90, 0.98) for cisplatin, and 0.78 (0.72, 0.97) for 5-FU. Among 15 pts, AEs occurring in > 2 pts reported to be related to chemotherapy and/or tislelizumab are detailed in the table. One pt experienced grade 5 hepatic dysfunction (possibly from progressive disease and underlying hepatitis) which was possibly related to study treatment, according to the investigator. Four pts discontinued study treatment due to AEs (grade 3 tracheal fistula, grade 3 lung infection, grade 2 pneumonitis, and grade 3 increase in aspartate aminotransferase). The antitumor activity data remain unmatured and may be updated later. Conclusions: Tislelizumab combined with chemotherapy was generally well tolerated in pts with advanced ESCC. Clinical trial information: NCT03469557. [Table: see text]

Primary Clinical Evaluation of Photodynamic Therapy With Oral Leukoplakia in Chinese Patients.

Background: Photodynamic therapy (PDT) has demonstrated promising results in the treatment of oral leukoplakia. This study evaluated the clinical efficacy and side effects of PDT in the treatment of Chinese patients with oral leukoplakia.Methods: Twenty-nine patients with oral leukoplakia were enrolled in this study, including patients with both homogenous and non-homogenous lesions and various dysplastic tissues. All patients received PDT using a 632 nm laser at 500 mW/cm2 power density at a dosage of 90–180 J/cm2 and with aminolevulinic acid (ALA) used as a photosensitizer. A fixing and restricting complex as well as high laser power density for PDT in oral cavity was applied.Results: An overall response rate of 86.2% was achieved in this study, including 55.2% complete remission and 31.0% partial remission. The only adverse events observed in subjects were transient local ulcer and pain. It is observed the PDT utilizing ALA showed strong effectiveness in patients with moderate to severe dysplasia, as less treatment time per cm2 of lesion is required.Conclusion: Topic ALA-PDT is effective to treat oral leukoplakia, especially for that with the presence of dysplasia. A fixing and restricting complex as well as high laser power density for PDT in oral cavity should be considered as an optimal choice.

Efficacy and safety of ranibizumab 0.5 mg in Chinese patients with visual impairment due to diabetic macular edema: results from the 12-month REFINE study

PurposeTo demonstrate the efficacy and safety of ranibizumab 0.5 mg pro re nata (PRN) versus laser photocoagulation for the treatment of Chinese patients with visual impairment due to diabetic macular edema (DME).MethodsREFINE was a phase III, 12-month, double-masked, multicenter, laser-controlled study in patients (aged ≥ 18 years) with DME. Patients were randomized 4:1 to receive either ranibizumab 0.5 mg or laser dosing regimen. Efficacy was evaluated as mean average change in best-corrected visual acuity (BCVA) from Months 1 to 12 versus baseline (primary endpoint), anatomical outcomes, treatment exposure, and safety were also assessed.ResultsRanibizumab was statistically superior (p < 0.001) to laser treatment, with a mean average BCVA gain of 6.8 letters (ranibizumab) over 12 months versus 1.1 letters (laser). At Month 12, mean BCVA gain was 7.8 letters (ranibizumab) and 2.5 letters (laser) from baseline. Patients in the ranibizumab arm received a mean number of 7.9 intravitreal injections, whereas those in the laser arm received a mean of 2.1 treatments. There were no new safety signals.ConclusionRanibizumab 0.5 mg PRN demonstrated a statistically significant and clinically meaningful treatment effect versus laser and was well tolerated in Chinese patients with visual impairment due to DME over 12 months.

Association of mononucleotide polymorphisms of angiotensinogen gene at promoter region with antihypertensive response to angiotensin receptor blockers in hypertensive Chinese.

Introduction:This study aimed to investigate whether mononucleotide polymorphisms of the angiotensinogen gene at promoter were associated with the blood-pressure-lowering response to telmisartan treatment.Materials and methods:After a two-week single-blind placebo run-in period, 148 patients with mild-to-moderate primary hypertension received monotherapy with 80 mg/day of telmisartan and then were followed up for eight weeks. The -6A/G and -20A/C polymorphisms of the angiotensinogen gene at promoter were determined through polymerase chain reaction and restriction fragment length polymorphsim analysis. The relationship between these polymorphisms and changes in blood pressure was observed and evaluated after eight weeks of treatment.Results:There were no significant differences between -6A/G, -20A/C polymorphisms of the angiotensinogen gene and blood pressure reductions after treatment, p>0.05.Conclusion:It is suggested that angiotensinogen-6 A/G and angiotensinogen-20 A/C polymorphisms were not associated with the antihypertensive response to telmisartan treatment in Chinese patients with hypertension.

A real-world study of paritaprevir/ritonavir-ombitasvir combined with dasabuvir in the treatment of genotype 1b chronic hepatitis C

Objective: To recognize the efficacy and safety of paritaprevir/ritonavir-ombitasvir combined with dasabuvir (OBV/PTV/RTV+DSV) in the treatment of genotype 1b chronic hepatitis C. Methods: Patients with genotype 1b chronic hepatitis C who were admitted to the People's Hospital of Henan Province, Huashan Hospital of Shanghai and the Fifth Medical Center of the General Hospital of the People's Liberation Army of China between November 2017 to August 2018 were enlisted. All patients received OBV/PTV/RTV+DSV antiviral therapy. HCV RNA levels were measured at baseline, weeks 1, 2, 3, 4, 8, 12, and 24, then 12 weeks, and 24 weeks after completion of treatment; patients' comorbidity, concomitant medications, and clinical adverse events were recorded. Results: 108 patients were enrolled in the study, with an average age of 49.1 years, 44 patients were male (40.8%), 96.3% (104/108) were newly diagnosed, and four patients had previous treatment history, of whom three were treated with IFN and one with IFN + DAA. Ninety-eight cases completed 12 weeks treatment and 89 cases were in follow up for 12 weeks, after discontinuation of the drug. Overall, 89 cases (100%) achieved SVR12.One patient treated with PR and DAA had HCV RNA level of 869175 IU/mL at 4 weeks of treatment, which was significantly higher than the baseline HCV RNA level (301776IU/ML), and was judged as failure of treatment; and follow-up was discontinued. Of all enrolled patients, 19 (17.6%) had underlying diseases and 15 (13.9%) had combined medications. During treatment, adverse events (AE) occurred in 11 patients (10.1%). The main adverse events were pruritus and elevated bilirubin. Conclusion: Combined antiviral therapy (OBV/PTV/RTV+DSV) of 12 weeks are highly effective with good safety profile in the treatment of Chinese patients with genotype 1b chronic hepatitis C.

Loss of T790M mutation is associated with early progression to osimertinib in Chinese patients with advanced NSCLC who are harboring EGFR T790M

BackgroundOsimertinib demonstrates superior efficacy in patients with non-small cell lung cancer (NSCLC) who acquired EGFR T790M mutation as resistant mechanism to upfront EGFR tyrosine kinase inhibitors (TKIs). Not all the T790M-positive tumors are homogeneously sensitive to osimertinib, however, and the duration of response often varies. Previous studies suggest that loss of T790 M at osimertinib resistance is correlated with shortened survival benefit of osimertinib. The aim of this study is to investigate the prevalence of T790 M loss after progression to osimertinib in Chinese patients with NSCLC harboring EGFR T790 M mutation and to compare their clinical outcomes and characteristics when stratified by T790 M mutational status at osimertinib resistance. Patients and methodsAll patients with a secondary T790 M mutation after progression to prior-line EGFR TKIs and received single-agent osimertinib were reviewed. The patients who were reassessed for T790 M mutation post-osimertinib resistance were included in final analysis. Detailed clinicopathologic characteristics and response data were collected. ResultsOf the patients with confirmed T790 M mutation as acquired resistance to early-generation EGFR TKIs and subsequently received single-agent osimertinib, 84 patients experienced clinical progression after osimertinib treatment and were eligible for analysis. Among them, 31 patients underwent repeated T790 M mutation testing on osimertinib resistance. Sixteen patients had maintained T790 M mutation, whereas 15 patients lost T790 M at resistance. Loss of T790 M at resistance was remarkably correlated with shorter duration of response to osimertinib (P = 0.0005). Furthermore, the overall survival after osimertinib treatment was also decreased in T790M-loss group (P=0.021). The objective response rates were comparable between T790M-maintain and T790M-loss group (31.3% and 26.7%, respectively). In multivariate analysis, loss of T790M remained statistically associated with early progression to osimertinib. ConclusionLoss of T790 M mutation at resistance was correlated with early progression and overall survival in response to osimertinib treatment in Chinese patients with NSCLC harboring acquired T790 M mutation.

Analysis of Efficacy and Prognostic Factors of CLAG Treatment in Chinese Patients with Refractory or Relapsed Acute Myeloid Leukemia

Background/Aims: The aim of this work was to investigate the efficacy and predictive factors of CLAG treatment in refractory or relapsed (R/R) acute myeloid leukemia (AML) patients. Methods: Sixty-seven R/R AML patients were enrolled in this prospective cohort study and treated by a CLAG regimen: 5 mg/m²/day cladribine (days 1–5), 2 g/m²/day cytarabine (days 1–5), and 300 μg/day filgrastim (days 0–5). The median follow-up duration was 10 months. Results: A total of 57 out of 67 patients were evaluable for remission after CLAG therapy, of whom 57.9% achieved a complete remission (CR) and the overall remission rate was 77.2%. The median overall survival (OS) was 10.0 months, with a 1-year OS of 40.3 ± 6.0% and 3-year OS of 16.7 ± 5.7%. CR at first induction after the initial diagnosis was associated with a favorable CR. Age above 60 years, high risk stratification, second or higher salvage therapy, and bone marrow (BM) blasts ≥42.1% were correlated with an unfavorable CR. Secondary disease, age ≥60 years, high risk stratification, and second or higher salvage therapy were associated with worse OS. Patients developed thrombocytopenia (41, 61%), febrile neutropenia (37, 55%), leukopenia (33, 49%), neutropenia (18, 27%), and anemia (9, 13%). Conclusion: CLAG was effective and well tolerated for R/R AML. BM blasts ≥42.1%, age ≥60 years, high risk stratification, and second or higher salvage therapy were independent factors for a poor prognosis.

A single-center experience with methotrexate in the treatment of Chinese Crohn's disease patients.

Methotrexate (MTX) can be used as an alternative for patients with Crohn's disease (CD) who are intolerant of thiopurine. This retrospective study aimed to provide some clues about MTX treatment in Chinese patients with CD. Medical records of 27 adult patients with CD who were treated with MTX between 2012 and 2017 at Renji Hospital were reviewed. MTX was administered at 15 mg or 20 mg intramuscularly once per week. The remission and response rates and adverse reactions of MTX were recorded and analyzed. Thirteen (48.1%) of the patients achieved remission for more than 12 months, whereas four (14.8%) responded clinically. Eight (29.6%) patients discontinued MTX due to adverse events. The mean age of those who maintained remission was significantly younger than that of those who did not ([35.62 ± 10.99] years vs. [45.43 ± 11.93] years, P < 0.05). The pretreatment C-reactive protein (CRP) level was higher in the group who maintained remission than that in those who did not ([17.20 ± 17.26] mg/L vs. [6.98 ± 5.66] mg/L, P < 0.05). MTX is effective and relatively safe for patients at doses of 15 mg/week or 20 mg/week and may be an alternative therapy for patients who are intolerant of thiopurine. Elderly patients with CD and patients with normal pretreatment CRP level may have a reduced response to MTX.

Afatinib vs erlotinib for second-line treatment of Chinese patients with advanced squamous cell carcinoma of the lung.

BackgroundThe global Phase III LUX-Lung 8 trial (ClinicalTrials.gov: NCT01523587) identified significant improvements in progression-free survival (PFS), overall survival (OS), and patient-reported outcomes (PROs) with second-line afatinib vs erlotinib in patients with advanced squamous cell carcinoma (SCC) of the lung.Materials and methodsWe conducted a post hoc analysis of data for patients in LUX-Lung 8 from mainland China (n=67). Compared with erlotinib, afatinib reduced the risk of disease progression or death (PFS) in the Chinese subgroup by 30% (HR=0.70; 95% CI: 0.38–1.27).ResultsThe risk of death was reduced by 31% (HR=0.69; 95% CI: 0.39–1.21). The proportion of Chinese patients with improvements in PROs also favored afatinib vs erlotinib (global health status/quality of life [QoL], 52.8% vs 29.6%, P=0.072; dyspnea, 47% vs 26%, P=0.091; “dyspnea walked”, 44% vs 15%, P=0.017; QoL rate, 53% vs 26%, P=0.037).DiscussionWhile this analysis was not powered to demonstrate differences compared to the overall trial population (OTP), and there were some differences in baseline characteristics (eg, the proportion of patients aged ≥65 years old), the benefits of afatinib treatment in Chinese patients with SCC of the lung appeared to be at least comparable to that observed in LUX-Lung 8. As with the OTP, the most common adverse events (AEs) with afatinib in the Chinese subgroup were diarrhea and rash/acne, and the incidence and type of the most frequently occurring AEs were similar.ConclusionThe results suggest that afatinib represents a feasible treatment option for Chinese patients with advanced SCC of the lung following progression on platinum-based chemotherapy.

A gender-specific association of the polymorphism Ile197Met in the kininogen 1 gene with plasma irbesartan concentrations in Chinese patients with essential hypertension.

This study was conducted to explore interactions in the association of the kininogen (KNG1) Ile197Met polymorphism and gender with plasma concentrations of irbesartan in Chinese patients with essential hypertension. A total of 1100 subjects with essential hypertension received a daily oral dose of 150 mg irbesartan for twenty-eight consecutive days. High-performance liquid chromatography-fluorescence (HPLC) was used to detect plasma irbesartan concentrations on day 28. The KNG1 Ile197Met gene polymorphism was determined using high-throughput TaqMan technology. The frequency distribution of KNG1 Ile197Met genotype conformed to the Hardy-Weinberg equilibrium. After 28 days of treatment, patients with the GG genotype had significantly lower irbesartan concentrations (P = 0.033) compared to homozygous TT genotype carriers. After stratifying by gender, male G allele carriers had significantly lower irbesartan concentrations (GG, P = 0.015; TG, P = 0.015, respectively) relative to TT genotype after adjusting for age, region, body mass index (BMI), smoking, and alcohol consumption. However, there was no significant difference in female subjects. A further test for a multiplicative interaction between the KNG1 Ile197Met polymorphism and gender in association with ln-plasma irbesartan concentrations in a multiple linear regression model was also significant (P for interaction = 0.033). This is the first study to suggest that gender may influence the association of the Ile197Met variant of KNG1 with ln-plasma irbesartan concentration. This finding may indicate that the interaction of gender and the KNG1 Ile197Met gene polymorphism can influence plasma trough irbesartan concentrations, which may contribute to a better development of personalized hypertensive treatment in Chinese patients.

P1.01-112 Osimertinib vs Standard of Care (SoC) EGFR-TKI as First-Line Treatment in Chinese Patients With EGFRm Advanced NSCLC

P1.01-112 Osimertinib vs Standard of Care (SoC) EGFR-TKI as First-Line Treatment in Chinese Patients With EGFRm Advanced NSCLC

P1.04-36 Tislelizumab Combined With Chemotherapy as First-Line Treatment in Chinese Patients With Advanced Lung Cancer

P1.04-36 Tislelizumab Combined With Chemotherapy as First-Line Treatment in Chinese Patients With Advanced Lung Cancer

Cost-effectiveness analysis of ribotype-guided fecal microbiota transplantation in Chinese patients with severe Clostridium difficile infection.

BackgroundClostridium difficile infection (CDI) caused by ribotype 002 strain is associated with poor outcomes in Chinese patients. Fecal microbiota transplantation (FMT) is an effective but costly treatment for CDI. We aimed to examine potential cost-effectiveness of ribotype-guided FMT in Chinese patients with severe CDI.MethodsA decision-analytic model was designed to simulate outcomes of ribotype 002-guided FMT versus vancomycin treatment in Chinese patients with severe CDI in the hospital setting. Outcome measures included mortality rate; direct medical cost; and quality-adjusted life year (QALY) loss for CDI. Sensitivity analysis was performed to examine robustness of base-case results.ResultsComparing to vancomycin treatment, ribotype-guided FMT group reduced mortality (11.6% versus 17.1%), cost (USD8,807 versus USD9,790), and saved 0.472 QALYs in base-case analysis. One-way sensitivity analysis found the ribotype-guided FMT group to remain cost-effective when patient acceptance rate of FMT was >0.6% and ribotype 002 prevalence was >0.07%. In probabilistic sensitivity analysis, ribotype-guided FMT gained higher QALYs at 100% of simulations with mean QALY gain of 0.405 QALYs (95%CI: 0.400–0.410; p<0.001). The ribotype-guided group was less costly in 97.9% of time, and mean cost-saving was USA679 (95%CI: 670–688; p<0.001).ConclusionsIn the present model, ribotype-guided FMT appears to be a potential option to save QALYs and cost when comparing with vancomycin. The cost-effectiveness of ribotype-guided FMT is subject to the patient acceptance to FMT and prevalence of ribotype 002.

Effect of EGFR C797S/G mutation on osimertinib resistance in Chinese patients with non-small-cell lung cancer.

e21171Background: To identify the optimal targets mutated genes after resistant to osimertinib treatment in Chinese patients with non-small-cell lung cancer. Methods: Study patients were all advanc...

Vorolanib (CM082), everolimus, and the combination in patients with pretreated metastatic renal cell carcinoma (CONCEPT study): A randomized, phase 2/3, double-blind, multi-center trial.

TPS4605 Background: VEGF and mTOR pathways play key role in the development of renal cell carcinoma (RCC), the combination of agents targeting both VEGF- and mTOR-mediated pathways have been investigated with distinct results. Vorolanib (CM082) is a potent and selective inhibitor of VEGFR and PDGFR. Previous phase 1 study (NCT02577458) found that the combination of vorolanib 200 mg plus everolimus 5mg was associated with manageable toxicity consistent with individual agents and no new safety signals, antitumor activities was also seen in 35.7% patients with RCC patients who progressed on at least one VEGFR TKI therapy. Based on these findings, we conducted the CONCEPT study, a randomized, phase 2/3, double-bind, multicenter trial to assess vorolanib, everolimus, or their combination as second-line treatment in Chinese patients with metastatic RCC. Methods: Patients with cytologically or histologically confirmed RCC who had disease progression after one prior VEGFR TKI were eligible for participation in the study. They will be randomized by 1:1:1 ratio to receive matching placebo plus vorolanib or everolimus, or the combination. Randomization was stratified according to the MSKCC risk scores. The sample size was specified assuming a hazard ratio (HR) of 0.60, equating to an expected 6.5 months for everolimus and 10.5 months for vorolanib with or without everolimus. To provide 80% power at a two-sided 5% significance level, and an estimated 20% dropout rate, a total of 390 patients are required. This study is registered as NCT03095040. Progression: This study in conducted in 35 centers in China, so far 32 centers have been activated. Recruitment was started since March 10, 2017, and a total of 101 patients were randomized currently. Clinical trial information: NCT03095040.

PCN32 - Comparison of Video-Assisted Thoracic Surgery Segmentectomy (VATS-S) Versus Video-Assisted Thoracic Surgery Lobectomy (VATS-L) for Stage I Non-Small Cell Lung Cancer (NSCLC-I) in Chinese Patients: A Systemic Review and Meta-Analysis

VATS-S is a newly introduced surgical technique in the treatment of stage I NSCLC. However, owing to small sample sizes of relevant clinical studies, there is no conclusive evidence of the relative benefit between the outcomes of VATS-S and VATS-L in Chinese patients. This meta-analysis offers the first robust comparative assessment of the safety and clinical outcomes of VATS-S versus VATS-L in Chinese patients with NSCLC-I. A thorough search of major electronic databases was conducted to identify surgical studies on Chinese patients with NSCLC-I till September 2017. Random-effects meta-analysis was used to estimate risk ratios (RRs, 95% CI) and mean differences (MD, 95% CI) for dichotomous and continuous variables, respectively. The main outcomes and measures were operating room time (ORT), intraoperative blood loss (BL), number of lymph nodes resected (LNRN), total volume of chest tube drainage postoperatively (TVCTD), chest tube duration (CTD), length of stay (LOS), post-operative complications (POC), overall cancer recurrence rate (ORR), local cancer recurrence rate (LRR) and distal cancer recurrence rate (DRR). 7 studies, with 762 NSCLC-I patients (229 VATS-S, 533 VATS-L), were included. Patient characteristic baselines were matched between 2 groups, including age (p=0.22), gender (p=0.67) and comorbidity rate (p=0.37). The average follow-up time was 10.2 to 27 months. VATS-S group was associated with a reduction in TVCTD by 224.42 ml (MD:-224.42, 95%CI (-345.06, -103.79), p=0.0003); a reduction of CTD by 0.73 days (-1.42, -0.03; p=0.04); and a reduction of LOS by 0.58 days (-1.04, -0.11; p=0.02). There was no significant difference between the groups in BL, LNRN, POC, ORT, ORR, LRR, and DRR. VATS-S is a less invasive surgical technique which is associated with less chest tube drainage volume, shorter chest tube duration, and shorter length of stay compared to VATS-L in the treatment of Chinese patients with stage I NSCLC.

Apatinib: A Review in Advanced Gastric Cancer and Other Advanced Cancers.

Apatinib [Aitan® (brand name in China)], also known as rivoceranib, is a novel, small molecule, selective vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor and is the second anti-angiogenic drug to be approved in China for the treatment of advanced or metastatic gastric cancer. This article summarizes the pharmacological properties of apatinib and reviews its clinical use in chemotherapy-experienced patients with advanced gastric adenocarcinoma, including gastroesophageal adenocarcinoma (GEA), or with other advanced cancers such as non-small cell lung cancer (NSCLC), breast cancer, gynaecological cancers, hepatocellular carcinoma (HCC), thyroid cancer and sarcomas. As third- or subsequent-line therapy, oral apatinib significantly prolonged median progression-free survival (PFS) and overall survival (OS) compared with placebo and had a manageable safety profile in Chinese patients with advanced or metastatic gastric cancer or GEA participating in randomized, double-blind, multicentre, phase 2 and 3 trials. More limited evidence also supports it use as subsequent-line treatment in Chinese patients with other advanced or metastatic solid tumours, including NSCLC, breast cancer and HCC. Further clinical experience and long-term pharmacovigilance data are required to more definitively establish the efficacy and safety profile of apatinib, including its use in combination with other chemotherapy agents and its role in the management of other types of advanced or metastatic solid tumours. In the meantime, given its convenient administration regimen and the limited treatment options and poor prognosis for patients with advanced or metastatic solid tumours, apatinib is an important, emerging treatment option for adult patients with advanced gastric adenocarcinoma or GEA who have progressed or relapsed after chemotherapy.

CalliSpheres drug-eluting beads versus lipiodol transarterial chemoembolization in the treatment of hepatocellular carcinoma: a short-term efficacy and safety study

BackgroundThe present study aimed to evaluate the short-term efficacy and safety of drug-eluting beads transarterial chemoembolization (DEB-TACE) with CalliSpheres Beads loaded with doxorubicin (DOX) in the treatment of Chinese patients with hepatocellular carcinoma (HCC) compared to conventional TACE (cTACE).MethodsA total of 54 patients with HCC treated by TACE from June 2016 to February 2017 were retrospectively analyzed. These included 24 cases in the DEB-TACE group and 30 cases in the cTACE group. The clinical efficacy, tumor recurrence rate, and complications were compared between the two groups. Furthermore, liver function tests and alpha-feto protein levels were compared between the two groups before and at 1 week and 1 month after interventional treatment.ResultsThere were no significant differences in baseline characteristics (p > 0.05). Tumor response rates and disease control rates in the DEB-TACE group were significantly higher than those in the cTACE group at 3 and 6 months after treatment (p < 0.05). Recurrence rates at 6 months were significantly higher for cTACE compared to DEB-TACE (43.3 vs. 16.7%; p = 0.036). At 1 month, the AFP level in the DEB-TACE group was significantly lower than that in the cTACE group (p = 0.008). At the end of follow-up, four cases in the DEB-TACE group and two cases in the cTACE group were treated with salvage surgery after downstaging the disease. Liver function of both groups improved at 1 month. However, alanine aminotransferase, aspartate aminotransferase, and total bilirubin levels in the DEB-TACE group were better than those in the cTACE group (p < 0.05). The incidence of DOX-related complications in the DEB-TACE group was significantly lower than in the cTACE group (p < 0.05).ConclusionThe short-term efficacy of DEB-TACE is better, and the complication rates are lower compared to cTACE in the treatment of Chinese patients with HCC. However, long-term clinical efficacy and survival benefit should be analyzed in future studies.

Ledipasvir/sofosbuvir for treatment-naive and treatment-experienced Chinese patients with genotype 1 HCV: an open-label, phase 3b study

BackgroundChronic hepatitis C virus (HCV) infection is a significant medical burden in China, affecting more than 10 million persons. In clinical trials and real-world settings, treatment with ledipasvir/sofosbuvir in patients with genotype 1 HCV infection resulted in high sustained virologic response rates. Ledipasvir/sofosbuvir may provide a highly effective, short-duration, single-tablet regimen for Chinese patients with HCV infection.MethodsChinese patients with genotype 1 HCV infection who were HCV treatment naive or treatment experienced, without cirrhosis or with compensated cirrhosis, were treated with open-label ledipasvir/sofosbuvir for 12 weeks. The primary efficacy endpoint was sustained virologic response 12 weeks after completing treatment (SVR12). For treatment-naive patients, SVR12 was compared to a historical rate of 57%. The primary safety endpoint was adverse events leading to permanent discontinuation of study drug; serious adverse events were also evaluated. The presence of resistance-associated substitutions (RASs) was evaluated by viral sequencing.ResultsAll 206 enrolled patients achieved SVR12 (100%; 95% CI 98–100%), including 106 treatment-naive patients (100%; 95% CI 97–100%), which was superior to a historical SVR rate of 57% (p < 0.001). All patients with baseline NS5A and NS5B RASs (14 and 1% of patients, respectively) achieved SVR12. The most common adverse events were viral upper respiratory tract infection (17%), upper respiratory tract infection (14%), and cough (6%). There were no discontinuations due to adverse events; and no treatment-related serious adverse events were reported.ConclusionLedipasvir/sofosbuvir is a well tolerated and highly effective treatment for Chinese patients with genotype 1 HCV, regardless of prior treatment experience, cirrhosis status, or the presence of pretreatment RASs.