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Y. Song



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    JCHS - Joint IASLC - Chinese Society for Clinical Oncology - Chinese Alliance Against Lung Cancer Session (ID 239)

    • Event: WCLC 2015
    • Type: Joint Chinese/ English Session
    • Track: Other
    • Presentations: 1
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      JCHS.07 - First-Line Icotinib Versus Cisplatine/Pemetrexed plus Pemetrexed Maintenance in Advanced NSCLC Patients with EGFR Mutation (ID 3524)

      Y. Song

      • Abstract
      • Presentation
      • Slides

      Background:
      Clinical studies with anti-EGFR agents demonstrate that EGFR TKIs play critical roles in the treatment of non-small cell lung cancer, especially in patients with positive EGFR mutation. Icotinib is an oral, selective EGFR TKIs. Phase 3 study showed that icotinib is non-inferior to gefitinib in treating unselected or EGFR-mutated advanced NSCLC patients as second-line therapy but better safety profile, which provide a rationale to examine icotinib in first-line setting. The objective of this study is to evaluate progression-free survival (PFS), overall survival (OS) and safety of icotinib in chemotherapy naïve NSCLC patients with EGFR mutation.

      Methods:
      In this phase 3, open-label, randomized study (CONVINCE, NCT01719536), 285 patients (pathologically confirmed NSCLC, positive 19/21 EGFR mutation, treatment naive) will be 1:1 randomized to receive oral icotinib (125 mg, three times daily) or cisplatine (intravenous [IV], 75 mg/m2, day 1) plus pemetrexed (IV, 500 mg/m2, day 1), patients achieving disease control after 4-cycle chemotherapy continue to receive single pemetrexed (IV, 500 mg/m2, day 1) as maintenance therapy until progression. Randomization will be stratified by performance status (0-1/2), smoking status (smoker/non-smoker), disease stage (IIIB/IV), and mutation type (19/21). A total of 228 events would provide 90% power to detect an HR for PFS of 1 at 2-sided significance level of 0.05. Response will be reviewed by both investigator and independent data monitoring committee. Patient enrollment was completed in June 2014, and the results are expected in June, 2015.

      Results:
      Not applicable

      Conclusion:
      Not applicable.

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    MINI 23 - Lung Cancer Risk: Genetic Susceptibility and Airway Biology (ID 135)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Screening and Early Detection
    • Presentations: 1
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      MINI23.14 - Circulating Long Non-Coding RNA GAS5 Is a Novel Biomarkers for the Diagnosis of Non-Small Cell Lung Cancer (ID 2315)

      Y. Song

      • Abstract
      • Presentation
      • Slides

      Background:
      Long non-coding RNAs (lncRNAs) are new-founding RNAs which could regulate many biological processes. Our previous study shown that lncRNA-GAS5 was decreased in lung cancer tissue, which contributed to the proliferation and apoptosis of non-small lung cancer (NSCLC). GAS5 was also associated with the prognosis of lung cancer patients. However, the plasma samples were more easily available than the tissue sample in the clinic. And the expression of GAS5 in the plasma of NSCLC patients was unknown.

      Methods:
      90 patients with NSCLC and 33 health controls were included in our study. Blood samples were collected before surgery and therapy. We extracted the free RNA in the plasma and analyzed the expression of GAS5 with quantitative reverse transcription polymerase chain reaction (qRT-PCR). Suitable statistics methods were used to compare the plasma GAS5 levels between the NSCLC patients and health controls, preoperative and postoperative plasma samples. Receiver operating characteristic (ROC) analysis was used to evaluate the diagnostic sensitivity and specificity of plasma GAS5 in NSCLC.

      Results:
      The 2[-][△][CT ]of GAS5 in the plasma of NSCLC patients and health controls are 1.053774 and 3.019817, respectively. GAS5 in NSCLC plasma was down-regulated compared with health controls (P=0.001), which was significantly correlated with TMN stage (P=0.024). Furthermore, plasma GAS5 increased markedly on day 7 after surgery compared with preoperative levels in NSCLC patients (P=0.003). The CT values of preoperative and postoperative are 2.225909 and 1.050455, respectively. The area under the ROC curve of GAS5 was up to 0.832. The combination of the GAS5 and CEA could produce 0.909 area under the ROC curve in distinguishing NSCLC patients from control subjects (95% CI 0.857–0.962,p=0.000).These results indicated that lncRNA GAS5 may be a more precise biomarker in NSCLC.

      Conclusion:
      We have demonstrated that GAS5 was decreased in NSCLC plasma expression and the plasma samples were more easily available than the tissue sample in the clinic. So GAS5 could be ideal biomarkers for the early diagnosis of NSCLC.

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    ORAL 17 - EGFR Mutant Lung Cancer (ID 116)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      ORAL17.01 - First-Line Icotinib Versus Cisplatine/Pemetrexed Plus Pemetrexed Maintenance in Advanced NSCLC Patients with EGFR Mutation (ID 742)

      Y. Song

      • Abstract
      • Presentation
      • Slides

      Background:
      Clinical studies with anti-EGFR agents demonstrate that EGFR TKIs play critical roles in the treatment of non-small cell lung cancer, especially in patients with positive EGFR mutation. Icotinib is an oral, selective EGFR TKIs. Phase 3 study showed that icotinib is non-inferior to gefitinib in treating unselected or EGFR-mutated advanced NSCLC patients as second-line therapy but better safety profile, which provide a rationale to examine icotinib in first-line setting. The objective of this study is to evaluate progression-free survival (PFS), overall survival (OS) and safety of icotinib in chemotherapy naïve NSCLC patients with EGFR mutation.

      Methods:
      In this phase 3, open-label, randomized study (CONVINCE, NCT01719536), 285 patients (pathologically confirmed NSCLC, positive 19/21 EGFR mutation, treatment naive) will be 1:1 randomized to receive oral icotinib (125 mg, three times daily) or cisplatine (intravenous [IV], 75 mg/m2, day 1) plus pemetrexed (IV, 500 mg/m2, day 1), patients achieving disease control after 4-cycle chemotherapy continue to receive single pemetrexed (IV, 500 mg/m2, day 1) as maintenance therapy until progression. Randomization will be stratified by performance status (0-1/2), smoking status (smoker/non-smoker), disease stage (IIIB/IV), and mutation type (19/21). A total of 228 events would provide 90% power to detect an HR for PFS of 1 at 2-sided significance level of 0.05. Response will be reviewed by both investigator and independent data monitoring committee using Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). Progression Between January, 2013 and August, 2014, 285 patients were randomized and treated at 18 centers from 13 cities in China. The data cut-off was planned at October, 2015 when 228 PFS events were observed in full analysis set (80% maturity). Final results were expected on December, 2015.

      Results:
      Not applicable

      Conclusion:
      Not applicable.

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    ORAL 32 - EGFR WT and MT Targeting (ID 144)

    • Event: WCLC 2015
    • Type: Oral Session
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 1
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      ORAL32.06 - Intercalating and Maintenance Use of Gefitinib plus Chemotherapy versus Chemotherapy Alone in Selected Advanced NSCLC: A Phase III Study (ID 2108)

      Y. Song

      • Abstract
      • Presentation
      • Slides

      Background:
      This study investigated whether intercalating and maintenance use of gefitinib with chemotherapy improves clinical outcomes versus chemotherapy alone in selected, chemotherapy-naive patients with advanced non-small cell lung cancer (NSCLC) after receiving two cycles of gemcitabine plus carboplatin with stable disease.

      Methods:
      We undertook an open-label, randomized, phase III trial at 14 centres in China. Non-smoking patients with previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutation status unknown (tissue not available) firstly received two cycles of gemcitabine (1,250 mg/m2 days 1 and 8) plus carboplatin (AUC=5, day 1). The patients with stable disease and Eastern Cooperative Oncology Group performance status of 0 or 1 were randomly assigned (1:1) to receive either gefitinib (250mg/d) on days 15 to 25 with a 4-week cycle of gemcitabine and carboplatin or a 4-week cycle of gemcitabine and carboplatin alone. A maximum of four cycles of chemotherapy was allowed in both arms after which time patients continued to receive gefitinib or observation until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS) and safety. The trial is registered at ClinicalTrials.gov, number NCT01404260, and has completed enrolment; patients are still in follow-up.

      Results:
      From June 2011 to August 2014, 219 patients with stable disease were randomized to intercalating and maintenance use of gefitinib with chemotherapy (n=109) or chemotherapy alone (n=110). The number of PFS events is 84 cases for the gefitinib plus chemotherapy group and 93 cases for the chemotherapy alone group. PFS was significantly longer in the patients receiving gefitinib and chemotherapy than in those receiving chemotherapy alone (median 10.0 vs 4.4 months, respectively; hazard ratio 0.475, 95% CI 0.349-0.646; p<0.0001). The median follow-up duration for OS is 24.5 months; OS of maturity 34.7% was not statistically different between these two arms (32.2 vs 32.5 months, respectively; hazard ratio 1.01, 95% CI 0.64-1.58; p=0.97). The addition of gefitinib to chemotherapy was well tolerated, with no increase in haematologic toxicity and no treatment-related interstitial lung disease.

      Conclusion:
      Intercalating and maintenance use of gefitinib with gemcitabine/carboplatin led to a significant improvement in PFS versus gemcitabine/carboplatin alone for Chinese nonsmoking patients with advanced pulmonary adenocarcinoma (EGFR mutation status unknown) who had previously achieved stable disease after receiving two cycles of gemcitabine/carboplatin; immature OS was not statistically different.

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    P1.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 233)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Biology, Pathology, and Molecular Testing
    • Presentations: 1
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      P1.04-087 - The Role and Mechanism of Twist1 in Non-Small Cell Lung Cancer Pathogenesis (ID 1215)

      Y. Song

      • Abstract
      • Slides

      Background:
      Metastasis is a multistep process and the main cause of disease failure and mortality in lung cancer patients. Twist1 is a highly conserved developmental gene involved in embryogenesis that could be reactivated in cancers promoting both malignant conversion and cancer progression through epithelial-mesenchymal transition (EMT). The aim of this study was to investigate the role and mechanism of Twist1 in the pathogenesis of lung cancer.

      Methods:
      We examined a series of surgical lung cancer samples from Chinese patients (n=75) and showed that Twist1 expression was linked to lymph node status (P<0.05). To validate that Twist1 is a driver of EMT in non-small cell lung cancer (NSCLC), we used two human lung cancer cell lines (H1650 and H1975, EGFR mutation) and demonstrated that Twist1 was associated with cell growth and mobility.

      Results:
      Overexpression of Twist1 increased cell growth, mobility, and a decrease of Twist1 by shRNA technology reversed the phenomenon. Twist1 promoted the tumor growth in vivo and induced the expression changes of many genes by tumor gene RNA array. Twist1 significantly down-regulated p4EBP1 expression in H1650 cells and up-regulated p4EBP1 in H1975 cells by qRT-PCR and western blot assay.

      Conclusion:
      Collectively, both our in vivo and in vitro findings support that Twist1 in promoting lung cancer by upregulation p4EBP1, which are needed to further study the role of Twist1in NSCLC

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    P2.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 234)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Biology, Pathology, and Molecular Testing
    • Presentations: 1
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      P2.04-031 - EGFR Mutation Associated with Histologic Subtype According to the IASLC/ATS/ERS Adenocarcinoma Classification: A Meta-Analysis (ID 1137)

      Y. Song

      • Abstract
      • Slides

      Background:
      In 2011, the International Association for the Study of Lung Cancer, American Thoracic Society and European Respiratory Society (IASLC/ATS/ERS) proposed the new lung adenocarcinoma histologic classification. The purpose of this meta-analysis is to determine the relationship between EGFR mutation states and different predominant histologic subtypes.

      Methods:
      We carried out a comprehensive search for published articles from 2011 to February, 2015, using the PubMed, EMBASE databases and Cochrane Library. The main key words used for search were : IASLC/ATS/ERS, new lung adenocarcinoma classification, EGFR. By searching the databases and further checking the reference lists of the publications, we obtained the initial articles. Next, we performed the preliminary screening through reading the titles and abstracts and excluded the obviously irrelevant articles. Then, we downloaded the full texts and read these articles intensively, excluding articles not giving the detailed data for meta-analysis. We extracted information from all eligible studies as follows: author, publish year, region, total cases, mean age, number of a certain histologic subtype, number of EGFR mutation in certain histologic subtype, total number of other histologic subtypes, total number of EGFR mutation in other histologic subtypes. This meta-analysis was completed using the Stata software (version 11.0; StataCorp LP, College Station, TX, USA). Detailed numbers in each included study were pooled to evaluate the association between EGFR mutation and histologic subtype. A random-effect model was used to calculate the pooled relative risks (RRs), 95% confidence interval (95%CI), and P values. Two-sided P values less than 0.05(P<0.05) were considered statistically significant.

      Results:
      The micropapillary predominant subtype was found to be tended with EGFR mutation (RR=1.37, 95%CI=1.08-1.74, p=0.011). On the contrary, the solid predominant subtype has a low EGFR mutation frequency (RR=0.74, 95%CI=0.59-0.93, p=0.009). Obvious correlation with EGFR mutation states is not found among other histologic subtypes.

      Conclusion:
      Taken together, the new IASLC/ATS/ERS lung adenocarcinoma classification is a very useful predictor of EGFR mutation frequency, the micropapillary predominant subtype has higher EGFR mutation frequency, on the contrary, the solid predominant subtype with lower frequency.

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    P2.06 - Poster Session/ Screening and Early Detection (ID 219)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Screening and Early Detection
    • Presentations: 1
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      P2.06-006 - Diagnostic Accuracy of CT-Guided Transthoracic Needle Biopsy for Solitary Pulmonary Nodules (ID 1478)

      Y. Song

      • Abstract
      • Slides

      Background:
      To evaluate the diagnostic accuracy of computed tomography (CT)-guided percutaneous lung biopsy for solitary pulmonary nodules.

      Methods:
      Three hundred and eleven patients (211 males and 100 females), with a mean age of 59.6 years (range, 19–87 years), who were diagnosed with solitary pulmonary nodules and underwent CT-guided percutaneous transthoracic needle biopsy between January 2008 and January 2014 were reviewed.

      Results:
      All patients were confirmed by surgery or the clinical course. The overall diagnostic accuracy and incidence of complications were calculated, and the factors influencing these were statistically evaluated and compared. Specimens were successfully obtained from all 311 patients. A total of 217 and 94 cases were found to be malignant and benign lesions, respectively, by biopsy. Two hundred and twenty-five (72.3%) carcinomas, 78 (25.1%) benign lesions, and 8 (2.6%) inconclusive lesions were confirmed by surgery and the clinical course. The diagnostic accuracy, sensitivity, and specificity of CT-guided percutaneous transthoracic needle biopsy were 92.9%, 95.3%, and 95.7%, respectively. The incidences of pneumothorax and self-limiting bleeding were 17.7% and 11.6%, respectively.

      Conclusion:
      Taking account of all evidence, CT-guided percutaneous lung biopsy for solitary pulmonary nodules is an irreplaceable, efficient, and safe diagnostic method associated with few complications.

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    P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Treatment of Advanced Diseases - NSCLC
    • Presentations: 3
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      P3.01-050 - A Interim Analysis of Randomized Phase III Trial of Nedaplatin or Cisplatin Combined with Docetaxel as First-Line Treatment for Advanced ASQC (ID 1225)

      Y. Song

      • Abstract
      • Slides

      Background:
      Cisplatin combined with docetaxel is one of the stand treatment in advanced squamous cell carcinoma(ASQC) of the lung. Nedaplatin combined with docetaxel has demonstrated potent activity in ASQC in phase II study. But until now there is no randomized phase III study comparing these 2 chemotherapy regimens. The aim of this study was to evaluate and compare the efficacy and safety between the combination chemotherapy of nedaplatin or cisplatin plus docetaxel in patients with ASQC.

      Methods:
      This is a multicentre, open-label, randomized, phase III study in China (NCT02088515). Chemo-naive stage IIIB/IV squamous NSCLC with Eastern Cooperative Oncology Group performance status 0/1 were randomized (1:1) to four cycles of nedaplatin (80 mg/m[2]) plus docetaxel(75 mg/m[2]) or cisplatin(75 mg/m[2]) plus docetaxel (75 mg/m[2]) . The primary endpoint was progression-free survival (PFS). Secondary end points were overall survival (OS), overall response rate (ORR), disease control rate (DCR) and quality of life.

      Results:
      From December 2013 to January 2015, 117 patients were accrued: nedaplatin plus docetaxel (n = 57) and cisplatin plus docetaxel (n = 60). The objective response rates were 27% and 31% and the disease control rate were 78.92 % and 82.67% in nedaplatin and cisplatin groups, respectively. There is no significance difference in nausea / vomiting(21% vs 30%) , diarrhea(3% vs 5%), liver dysfunction(12% vs 15%), neutropenia(60% vs 65%), thrombocytopenia(10% vs 12%), anemia(8% vs 7%) between the 2 arms. The renal dysfunction incidence is higher in the cisplatin group(3% vs 0%). Although there is no 3/4 grade toxicities difference between 2 arms including nausea / vomiting(0% vs 0%) , diarrhea(0% vs 1%), liver dysfunction(0% vs 0%), renal dysfunction(0% vs 0%) , neutropenia(4% vs 3%), thrombocytopenia(0% vs 0%), anemia(0% vs 0%) . This is an interim analysis and we haven't got the data of survival and quality of life.

      Conclusion:
      There is no ORR difference between the group of nedaplatin plus docetaxel and cisplatin plus docetaxel. But the toxicity of nedaplatin regiment is less toxicities, especially in renal toxicity,as first-line treatment for patients with advanced squamous NSCLC

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      P3.01-051 - Biomarker Analyses from a Phase II Trial of Nab-Paclitaxel/Carboplatin vs Emcitabine/Carboplatin in Advanced Squamous Cell Lung Cancer (ID 2846)

      Y. Song

      • Abstract
      • Slides

      Background:
      The administration of nab-paclitaxel/carboplatin (nab-PC) as first-line therapy in patients with advanced non-small-cell lung cancer (NSCLC) was efficacious and resulted in a significantly improved objective overall response rate (ORR) versus solvent-based PC in a phase Ⅲ trial. However, our phase Ⅱ trial (NCT01236716; CTONG1002), which compared the efficacy and safety of first-line nab-PC with gemcitabine/carboplatin (GC) in advanced squamous cell carcinoma of the lung, only showed a marginally improved ORR caused by first-line nab-PC. Meanwhile, the matricellular glycoprotein SPARC (secreted protein acidic and rich in cysteine) and caveolin-1 are potential biomarkers for advanced NSCLC patients receiving nab-PC. Therefore, we retrospectively aimed to explore their predictive and prognostic value using immunohistochemistry (IHC).

      Methods:
      From November 2010 to June 2013, 127 untreated patients with locally advanced and metastatic squamous cell carcinoma of the lung were randomly assigned 1:1 to receive first-line nab-PC (nab-P, 135 mg/m[2], d1, d8, q3w; C, AUC = 5, d1, q3w ) or GC (G, 1,250 mg/m[2], d1, d8, q3w; C, AUC = 5, d1, q3w). There were 110 patients evaluable for ORR (nab-PC, 54; GC, 56), 119 evaluable for survival (nab-PC, 57; GC, 62) respectively. However, there were 72 patients with sufficient tissue for IHC of both SPARC and caveolin-1 proteins. Different cut-off values of IHC scoring systems were used to explore predictive and prognostic role of both biomarkers.

      Results:
      The last follow-up was on January 16, 2015. Considering treatment, when the maximum rank method was used for cut-off values, median progression-free survival (PFS) was 7.5 (95%CI: 2.4~12.6) months in higher SPARC-expression arm and 4.3 (95%CI: 2.2~6.3) months in lower SPARC-expression arm for patients treated with GC, HR=0.43 (95%CI: 0.19~0.94), p = 0.030; Median overall survival (OS) was 20.0 (95%CI: 14.7~25.3) months in lower SPARC-expression arm and 10.1 (95%CI: 6.2~14.0) months in higher SPARC-expression arm for patients treated with nab-PC, HR=2.41 (95%CI: 1.08~5.40), p = 0.027. When average method was used for cut-off values, median OS was 18.2 (95%CI: 9.6~26.8) months in lower SPARC-expression arm and 8.4 (95%CI: 5.1~11.7) months in higher SPARC-expression arm for patients treated with nab-PC, HR=2.46 (95%CI: 1.07~5.65), p = 0.029. Regardless of treatment, when the maximum rank method was used for cut-off values, median OS was 14.5 (95%CI: 6.8~22.1) months in lower SPARC-expression arm and 8.4 (95%CI: 5.3~11.5) months in higher SPARC-expression arm, HR=0.47 (95%CI: 0.27~0.83), p = 0.007. When average method was used for cut-off values, median OS was 14.4 (95%CI: 9.2~19.5) months in lower SPARC-expression arm and 8.4 (95%CI: 5.4~11.4) months in higher SPARC-expression arm, HR=0.48 (95%CI: 0.27~0.87), p = 0.013. ORR was not correlated with expression of SPARC, p>0.05. However, there were no significant differences in ORR, PFS and OS between higher and lower caveolin-1 expression arms, p>0.05.

      Conclusion:
      SPARC expression could be a negative prognostic factor for OS of patients with advanced squamous cell carcinoma of the lung, but was not a predictive factor for ORR and PFS, except for patients treated with GC. However, caveolin-1 expression had neither predictive nor prognostic value.

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      P3.01-076 - Efficacy and Safety of Recombinant Human Tumor Necrosis Factor Application for the Treatment of Malignant Pleural Effusion Caused by Lung Cancer (ID 1148)

      Y. Song

      • Abstract
      • Slides

      Background:
      Malignant pleural effusion (MPE) is mainly caused by metastatic pleural cancer and defines malignant tumors with a poor prognosis. To achieve sufficient control of MPE and to minimize invasive interventions are the primary goals of the treating physicians. Recombinant human mutant tumor necrosis factor-alpha (rhu-TNF) has been used in the treatment of MPE. The aim of our research study, which included a total of 102 patients with MPE caused by lung cancer, was retrospectively to evaluate efficacy and safety of rhu-TNF application via ultrasound-guided chest tube for the treatment of MPE. Malignant pleural effusion (MPE) is mainly caused by metastatic pleural cancer and defines malignant tumors with a poor prognosis. To achieve sufficient control of MPE and to minimize invasive interventions are the primary goals of the treating physicians. Recombinant human mutant tumor necrosis factor-alpha (rhu-TNF) has been used in the treatment of MPE. The aim of our research study, which included a total of 102 patients with MPE caused by lung cancer, was retrospectively to evaluate efficacy and safety of rhu-TNF application via ultrasound-guided chest tube for the treatment of MPE.

      Methods:
      Rhu-TNF was administered as a single dose to 102 patients, and dexamethasone (Dmx, 5 mg) was administered 30 min before rhu-TNF in 35 patients in order to prevent side effects. The primary endpoint was the efficacy of the Rhu-TNF treatment (disease response rate) and side effects (pain, fever and flu-like symptoms) evaluated four weeks after instillation.

      Results:
      The disease response rate of Rhu-TNF treatment in 102 patients was 81.37%. Side effects included 13 (12.75%) patients complaining about flu-like symptoms, 15 (14.71%) with fever/chill, and 14 (13.73%) with chest pain. A significantly higher efficacy was observed for the treatment with three versus two million units rhu-TNF (= 0.036), while the adverse effects were similar. Although application of Dmx before the intra-pleural instillation of rhu-TNF reduced the incidence of adverse events, no significant differences were found.

      Conclusion:
      In conclusion, our study shows that intra-pleural instillation of rhu-TNF in MPE patients achieves sufficient control of MPE and minimizes invasive interventions.

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