Tumor Volume Is a Better Prognostic Factor than Greatest Tumor Diameter in Operated Stage I-III Non-Small-Cell Lung Cancer.

INTRODUCTION: The aim of this study was to investigate the prognostic impact of tumor volume (TV, recorded from surgical specimens) on patients with stage I-III non-small-cell lung cancer (NSCLC) after complete resection. MATERIALS AND METHODS: A total of 129 patients with stage I-III NSCLC diagnosed and underwent curative resection from 2007 to 2014 in our center were included in the study. Their clinico-pathological factors were retrospectively reviewed. Overall survival (OS) and disease-free survival (DFS) analyses were performed with the Kaplan-Meier method and Cox's hazard model. According to the ROC analysis, patients were divided into 2 groups (Group 1: 58 patients <30.3 cm3 and Group 2: 71 patients ≥30.3 cm3) and the OS and DFS values were compared. RESULTS: Median TVs and greatest tumor diameter were 12 cm3 (0.1-30) / 3 cm (0.4-6.5) in Group 1 and 98 cm3 (30.6-1521) / 6 cm (3.5-21) in Group 2. Median OS was 53 (5-177) months in Group 1 and 38 (2-200) months in Group 2 (P < .001). DFS was similar in both group (28 [1-140] vs. 24 [1-155] months, Introduction P = .489). Kaplan-Meier curves showed significantly higher OS rates in Group 1 than Group 2 (P = .04). In multivariable analysis (TV, tumor T stage, tumor N stage, receiving adjuvant radiotherapy) showed that TV (HR: 0.293, 95% CI: 0.121-0.707, P = .006) and tumor N stage (HR: 0.013, 95% CI: 0.001-0.191, P = .02) were independent factors associated with OS. CONCLUSION: Tumor volume, not considered in the routine TNM classification, may improve prediction accuracy of overall OS in operated Stage I-III NSCLC.

An Online Distance Tracker for Verification of Robotic Systems' Safety.

This paper presents an efficient method for minimum distance calculation between a robot and its environment and the implementation framework as a tool for the verification of robotic systems' safety. Collision is the most fundamental safety problem in robotic systems. Therefore, robotic system software must be verified to ensure that there are no risks of collision during development and implementation. The online distance tracker (ODT) is intended to provide minimum distances between the robots and their environments for verification of system software to inspect whether it causes a collision risk. The proposed method employs the representations of the robot and its environment with cylinders and an occupancy map. Furthermore, the bounding box approach improves the performance of the minimum distance calculation regarding computational cost. Finally, the method is applied to a realistically simulated twin of the ROKOS, which is an automated robotic inspection cell for quality control of automotive body-in-white and is actively used in the bus manufacturing industry. The simulation results demonstrate the feasibility and effectiveness of the proposed method.

Prediction of the proximate analysis parameters of refuse-derived fuel based on deep learning approach.

Determination of proximate characteristics can be achieved using conventional analyses methods that require a certain amount of time. In cement factories, refuse-derived fuel (RDF) is continuously fed to a kiln by a conveyor belt, so even if an inappropriate proximate characteristic is determined, it would be too late to prevent the feeding of RDF to the kiln. To overcome this problem, there is a need for instant measurement of the proximate characteristics (moisture, volatile matter, ash) that enables the feeding to be stopped. In such cases, the deep learning (DL) is a useful method based on the prediction of proximate characteristics. Therefore, in this study, the aim is to estimate the mentioned parameters developed by near-infrared spectroscopy (NIR) combined with deep learning models. For this purpose, the spectrographic measurements taken from RDF samples with an NIR spectrometer, and the results of proximate analysis in a laboratory, were used together as a dataset. A fully convolutional neural network (FCNN) and ResNet were used as a network, and they were trained using images of RDF samples and proximate analysis values. The FCNN model was more successful in prediction studies. According to the FCNN model, the results show that the models in the study can predict the moisture, ash, and volatile matter content of RDF with satisfactory R2 values between 0.979, 0.983, and 0.952.

Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer: PRECONNECT Turkey.

Background: The efficacy and safety of trifluridine/tipiracil (FTD/TPI) for third-line treatment of metastatic colorectal cancer have been demonstrated. The authors present the Turkish post hoc analysis of the PRECONNECT study. Methods: An international, multicenter, single-arm, open-label, phase IIIb trial evaluating FTD/TPI in patients with ≥2 previous lines of chemotherapy for metastatic colorectal cancer was conducted. The primary end point was safety. Results: In this Turkish cohort (n = 100; eight centers), the most frequent treatment-emergent adverse event was neutropenia (48%). Median progression-free survival was 3.0 months; disease control rate was 36%; quality of life remained stable. Conclusion: Outcomes with FTD/TPI in Turkey are consistent with previous studies and confirm the efficacy and safety of FTD/TPI treatment in the third-line setting. Clinical Trial Registration: NCT03306394 (ClinicalTrials.gov).

Implementation of an early warning system with hyperspectral imaging combined with deep learning model for chlorine in refuse derived fuels.

Chlorine content is one of the most important parameters in Refuse Derived Fuels (RDFs) used as a fuel in cement kilns. The main problem with the use of RDF is that chlorine in the waste weakens the cement, increases the risk of corrosion in the kiln and forms toxic gas emissions. Alternative fuels containing high amounts of chlorine, such as plastic waste should be used in limited quantities with the quality of the kiln used and the cement being should be preserved by preparing the appropriate RDF mixture. Analyses conducted on the samples taken before the RDF is given to the furnace are time consuming and costly. Therefore, in this study, the aim is to present a more efficient solution to classify by using chlorine analysis results with hyperspectral imaging and a deep learning model study. For this purpose, a model was created using validated laboratory results and spectral data from samples, the model was tested on a prototype conveyor belt, and was implemented using an online early warning system for high chlorine concentrations. The chlorine content of the RDF samples used in the study ranged from 0.10% to 1.41%, with an average of 0.27%. According to the results, the accuracy, precision, Recall and F1 Score related to the early warning system were found to be 0.8909, 0.8889, 0.8889, 0.8889, respectively. In addition, chlorine measurements were performed at 200, 500 and 1000 mm/s belt speeds and accuracy values of 78.39%, 76.35% and 69.94 %, respectively were obtained.

Prognostic and Predictive Significance of PD-L1 Expression in Non-Small Cell Lung Cancer Patients: A Single-Center Experience.

OBJECTIVE: To investigate the prognostic and predictive value of PD-L1 expression in operated non-small cell lung cancer (NSCLC) patients and to analyze its relationship with clinicopathological factors. MATERIAL AND METHOD: A total of 90 patients with operable NSCLC were included in this retrospective single center study. Tumor blocks of patients were stained immunohistochemically with PD-L1 polyclonal antibody. When evaluated immunohistochemically and statistically, patients with tumor staining percentage of ≥5%, those with +2 and +3 membranous staining intensity, and those with ≥50% H-Score were considered positive. The relationship between PD-L1 expression status and clinicopathological features in addition to the prognostic effect of PD-L1 on survival were statistically analyzed. RESULTS: The frequency of PD-L1 expression was 37%, 15% and 5% according to the staining percentage, staining intensity, and the H-Score, respectively. There was no significant relationship between PD-L1 expression and age, gender, smoking, tumor stage and histological subtype (p > 0.05). However, PD-L1 expression was relatively higher in patients < 65 years of age, men, smokers, patients with advanced tumor stage, and squamous cell subtype. Based on the analysis of the H-Score, no significant difference was noted regarding disease-free survival time between PD-L1 positive and PD-L1 negative patients (median 20 [95% CI 1.2-38.7] months vs. median 27 [95% CI 17.5-36] months, p=0.208). However, overall survival time was significantly shorter in PD-L1 positive compared to PD-L1 negative patients (median 24 months [95% CI 9.9-38] vs. median 48 months [95% CI 33.6-62.3], p=0.049). CONCLUSION: In patients with high PD-L1 expression, the biological behavior of the cancer was more aggressive, and the life expectancy was shorter. PD-L1 expression seems to be a poor prognostic marker in NSCLC patients.

Is SUVmax of 18F-FDG PET/CT Predictive Factor for Malignancy in Gastrointestinal Tract?

BACKGROUND: Increasing use of 18F-FDG PET/CT in cancer patients, has led to more common detection of 18F- FDG uptake in the gastrointestinal tract (GIT). AIMS: The objective of this study was to assess 18F-FDG uptake in incidental and known GIT malignancy. METHODS: A total of 6500 patients followed-up in a single and tertiary center between January 2010 and September 2016 were retrospectively reviewed. Of 2850 patients assessed with 18FDG-PET/CT, known GIT malignancy and 18F-FDG uptake cases during follow-up were included in the study. RESULTS: Of 658 patients with 18F-FDG uptake, 150 patients who underwent endoscopy were included in the study. Seventy-seven of these patients had known GIT malignancy and 73 had incidental 18F-FDG uptake. Among these 73 patients; 7 (9.6%) had malignancy, 20 (27,2%) adenoma and 24 (32.9%) inflammation that were confirmed. Endoscopy was normal in 22 (30.2%) patients. One hundred forty-three (95.3%) patients had focal and 7 (4.7%) had diffuse uptake. While no malignancy was detected in patients with diffuse uptake, 58.7% (84/143) of the patients with focal uptake presented malignancy. Mean the standardized uptake value (SUV) max values were found as 15.0 ± 10.6 (range, 3.8-56.5) in malignant disease, 10.2 ± 4.3 (range, 2.4-19.7) in adenoma, 7.3 ± 3.6 (range, 3.6-18.7) in inflammation, and 9.8 ± 4.2 (range, 3.8-19.9) in normal endoscopy groups (p < 0.001, rho = 0.378). CONCLUSION: Although this study demonstrated high probability of malignant disease with increased 18F-FDG uptake in the GIT, it would be a more appropriate approach to confirm all patients with 18F-FDG uptake through endoscopy as SUVmax values vary in a wide range.

Efficacy of trastuzumab and potential risk factors on survival in patients with HER2-positive metastatic gastric cancer.

Aim: To evaluate the efficacy of trastuzumab and potential risk factors on survival in patients with HER2-positive metastatic gastric cancer. Methods: We retrospectively included 138 patients who were given trastuzumab-based chemotherapy as first-line treatment and analyzed the relationship between clinical response rates and maintenance treatment status and survival outcomes. Results: In the whole group, the median progression-free survival and overall survival were 10.2 and 16 months, respectively. Clinical response was obtained in 79% of patients. The median overall survival was 16.9 months in follow-up group and 19.0 months in the maintenance group in patients with clinical response. Continuation of maintenance trastuzumab created a significant survival advantage (p = 0.021). Eastern Cooperative Oncology Group performance status 2 (hazard ratio [HR]: 2.02), grade 3 (HR: 1.78) and more than four metastatic lesions (HR: 1.67) were determined as risk factors for death. Conclusion: We recommend the continuation of maintenance trastuzumab in patients with clinical response, but those with identified risk factors may not benefit from treatment because life expectancy may be low.

Gastric cancer has a poor prognosis despite available treatments. Inclusive studies are still needed with real-life data. Our research retrospectively evaluated the efficacy of trastuzumab and potential risk factors on survival in patients with HER2-positive metastatic gastric cancer who received trastuzumab-based chemotherapy as first-line therapy. In total, 138 patients were included in this study. Clinical response to trastuzumab-based chemotherapy was obtained in 79% of the patients. We also divided the patients who had a clinical response into two groups according to whether they received maintenance therapy. In the present study, trastuzumab administration had compatible survival outcomes with recent studies. Continuation of trastuzumab maintenance treatment provided a survival advantage in patients with clinical response. We suppose that maintenance trastuzumab may be recommended in patients with clinical responses to the first-line treatment. Furthermore, Eastern Cooperative Oncology Group Performance Status 2, grade 3 and having more than four metastatic lesions were determined as risk factors for death. Therefore, although we recommend maintenance of trastuzumab in patients with clinical response, those with identified risk factors may not benefit from treatment.

Verification and validation of an automated robot inspection cell for automotive body-in-white: a use case for the VALU3S ECSEL project.

Verification and validation (V&V) of systems, and system of systems, in an industrial context has never been as important as today. The recent developments in automated cyber-physical systems, digital twin environments, and Industry 4.0 applications require effective and comprehensive V&V mechanisms. Verification and Validation of Automated Systems' Safety and Security (VALU3S), a Horizon 2020 Electronic Components and Systems for European Leadership Joint Undertaking (ECSEL-JU) project started in May 2020, aims to create and evaluate a multi-domain V&V framework that facilitates evaluation of automated systems from component level to system level, with the aim of reducing the time and effort needed to evaluate these systems. VALU3S focuses on V&V for the requirements of safety, cybersecurity, and privacy (SCP). This paper mainly focuses on the elaboration of one of the 13 use cases of VALU3S to identify the SCP issues in an automated robot inspection cell that is being actively used for the quality control assessment of automotive body-in-white. The joint study here embarks on a collaborative approach that puts the V&V methods and workflows for the robotic arms safety trajectory planning and execution, fault injection techniques, cyber-physical security vulnerability assessment, anomaly detection, and SCP countermeasures required for remote control and inspection. The paper also presents cross-links with ECSEL-JU goals and the current advancements in the market and scientific and technological state-of-play.

Tyrosine kinase inhibitors in the treatment of metastatic renal cell cancer patients with early cytokine intolerance: TURCOS, a Turkish national, prospective observational study.

OBJECTIVE: Cytokines have been the mainstay of treatment in metastatic renal cell cancer (mRCC) for decades before the introduction of tyrosine kinase inhibitors (TKIs), which dramatically changed the therapeutic landscape in these patients. This observational study was designed to evaluate use of TKIs in the treatment of cytokine-intolerant mRCC patients. METHODS: A total of 151 cytokine-intolerant mRCC patients who were treated with TKIs (sunitinib, pazopanib and sorafenib) were enrolled in this prospective, non-interventional, multi-center observational study at 16 oncology centers across Turkey. Mean (SD) age was 61.3 (11.1) years and 74.8% were males. Data on duration of TKI treatment was the primary outcome measure. Additionally, overall response rate (ORR), progression free survival (PFS), overall survival (OS) and safety data were recorded. RESULTS: Median duration of treatment was 8.2 months at a median follow up of 17.9 months. ORR and disease control rate were 12.5% and 70.8%, respectively. Median PFS and OS were 7.5 months (95%CI: 6.4-10.4) and 27.3 months (95%CI: 17.6-27.3) with no significant difference among three TKI agents in terms of treatment duration, ORR, PFS and OS. The most common adverse events excluding progression-which was the protocol requirement were diarrhea (13.6%), asthenia (13.6%) and hand-foot syndrome (12.6%). Dose modifications were required in 30.5% of the patients and 15% discontinued TKIs because of toxicity. CONCLUSIONS: Our findings confirm the efficacy and safety profile of TKIs in the first-line treatment of mRCC patients intolerant to cytokine treatment. There was no significant difference among three TKI agents in terms of treatment duration, ORR, PFS and OS.Trial registration: TURCOS ClinicalTrials.gov Identifier: NCT01585974. Registered April 25, 2012.

COVID-19 Pandemic and the Global Perspective of Turkish Thoracic Society.

It has been more than 3 months now since the first case of COVID-19 was reported in Turkey. Globally, the number of confirmed cases and deaths reached 9,653,048 and 491,128 respectively, as reported by 216 countries by June 27, 2020. Turkey had 1,396 new cases, 194,511 total cases, and 5,065 deaths by the same date. From the first case until today, the Turkish Thoracic Society (TTS) has been very proactive in educating doctors, increasing public awareness, undertaking academic studies, and assisting with public health policies. In the present report, social, academic, and management perspectives of the pandemic are presented under appropriate subtitles. During this critical public health crisis, TTS has once again demonstrated its readiness and constructive stance by supporting public health, healthcare workers, and the environment. This review summarizes the perspective of TTS on each aspect of the COVID-19 pandemic and casts light on its contributions.

Prognostic Significance of Tumor Tissue NeuGcGM3 Ganglioside Expression in Patients Receiving Racotumomab Immunotherapy.

Expression of N-glycolyl GM3 (NeuGcGM3) ganglioside was detected in the tumor specimens of patients who were on Racotumomab anti-idiotype vaccine maintenance treatment, and prognostic significance as a biomarker was investigated. No statistically significant association was observed in the multivariate analysis between overall survival and tissue NeuGcGM3 IHC levels. Although numerically there was a difference favoring less intense IHC for better prognosis, this did not reach statistical power. However, there was a strong correlation between Racotumomab doses and overall survival (OS). Mean OS of the patient with more than 10 Racotumomab application was significantly longer than the patient who had less than 10 injections (70.7 months vs. 31.1 months, p < 0.001). We propose that, regardless of staining intensity, the presence of NeuGcGM3 in patient tissues might be an indicator of benefit in Racotumomab treatment.

Quality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine+nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study.

BACKGROUND: Combination of gemcitabine and nab-paclitaxel has superior clinical efficacy than gemcitabine alone. Nevertheless, health-related quality of life. (QoL) associated with this combination therapy when administered at first-line in advanced pancreatic adenocarcinoma is unknown. METHODS: A total of 125 patients were randomized to combination therapy (1000 mg/m2 gemcitabine + 125 mg/m2 nab-paclitaxel) and single-agent gemcitabine (1000 mg/m2) arms to take treatment weekly for 7 of 8 weeks, and following 3 of 4 weeks, until progression or severe toxicity. Primary endpoints were three-months of definitive deterioration free percent of patients, and QoL. RESULTS: Overall QoL analyses showed that 34 and 58.3% of cases in gemcitabine and gemcitabine+nab-P arms had no deterioration in 3rd month QoL scores (p = 0.018). These proportions were 27.3 and 36.6% in 6th month assessments, respectively (p = 0.357). Median overall survivals in combination and single-agent arms were 9.92 months and 5.95 months, respectively (HR: 0.64, 95% CI: 0.42-0.86, p = 0.038). Median progression free survivals in these treatment arms were 6.28 and 3.22 months, respectively (HR: 0.58, 95% CI: 0.39-0.87, p = 0.008). Median time-to-deterioration were 5.36 vs 3.68 months, and objective response rates were 37.1% vs 23.7% (p = 0.009), respectively in combination and single-agent arms. CONCLUSIONS: Combination therapy with gemcitabine + nab-paclitaxel had better overall and progression-free survival than gemcitabine alone. Also, combination therapy showed increased response rate without toxicity or deteriorated QoL. Combination treatment with gemcitabine and nab-paclitaxel may provide significant benefit for advanced pancreatic cancer. TRIAL REGISTRATION: This study has been registered in ClinicalTrials.gov as NCT03807999 on January 8, 2019 (retrospectively registered).

Safety and efficacy of regorafenib in patients with treatment-refractory metastatic colorectal cancer in Turkey: the single-arm, open-label REGARD study.

OBJECTIVES: Regorafenib improved overall survival in patients with metastatic colorectal cancer (mCRC) refractory to standard therapies in two randomised, phase III trials, but has not been evaluated in Turkey. REGARD evaluated the safety and efficacy of regorafenib in Turkish patients with treatment-refractory mCRC. DESIGN: Open-label, single-arm, phase IIIb study conducted between July 2013 and April 2015. SETTING: 11 tertiary centres in Turkey. PARTICIPANTS: Eligible patients were adults with mCRC who had disease progression within 3 months after receiving their last dose of approved standard therapies and who had an Eastern Cooperative Oncology Group performance status ≤1. Patients were excluded if they had previously received regorafenib. Of 139 patients screened, 100 were treated and completed the study, and all 100 were analysed. Fifty-eight per cent were male. INTERVENTIONS: Patients received oral regorafenib, 160 mg once daily, for the first 3 weeks of each 4-week cycle until disease progression, death or unacceptable toxicity. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint was safety, assessed by incidence of treatment-emergent adverse events (TEAEs). Progression-free survival (PFS) per investigator was the primary efficacy endpoint. There were no secondary endpoints. RESULTS: The median treatment duration was 2.5 months (range 0.1 to 20.6). Ninety-six per cent of patients had at least one TEAE and 77% had a grade ≥3 TEAE. The most common grade ≥3 regorafenib-related TEAEs were hypophosphataemia (11%), fatigue (8%), hyperbilirubinaemia (6%), hand-foot skin reaction (5%), hypertension (5%), anorexia (5%) and increased alanine aminotransferase (5%). TEAEs led to dose reduction in 30% of patients. Regorafenib-related TEAEs led to treatment discontinuation in 17% of patients. Median PFS was 3.1 months (95% CI 2.9 to 3.8). CONCLUSION: The regorafenib safety profile and PFS in REGARD were consistent with the results of previous trials of regorafenib in mCRC. Regorafenib is an option for patients in Turkey with treatment-refractory mCRC. TRIAL REGISTRATION NUMBER: NCT01853319, ClinicalTrials.gov.

Efficacy of second-line targeted agents in kras wild metastatic colorectal cancer patients who received prior targeted agent: First anti-epidermal growth factor receptor or vascular endothelial growth factor in right and left colon?

INTRODUCTION: We aimed to investigate the impact of first biological agents on second-line biological agents in kras wild-type metastatic colon patients in right and left colon. PATIENTS AND METHODS: The patients received anti-EGFR compared with anti-VEGF in right and left colon separately according to progression-free survival and overall survival in second line. RESULTS: A total of 84 patients were included in the study. In left colon, progression-free survival and overall survival were 9 and 14 months for anti-EGFR and 9 and 16 months for anti-VEGF in the second line. In right colon, progression-free survival and overall survival were 5 and 9 months for anti-EGFR and 4 and 6 months for anti-VEGF in the second line. CONCLUSIONS: Progression-free survival was higher in patients who received bevacizumab first followed by anti-EGFR than reverse sequencing in right colon. Overall survival was similar between two groups.

Impact of neutrophil-lymphocyte and platelet-lymphocyte ratio on antiEGFR and bevacizumab efficacy in metastatic colorectal cancer.

PURPOSE: The purpose of this study was to determine the influence of the neutrophil-lymphocyte ratio (NLR) and the platelet-lymphocyte ratio (PLR) on antiEGFR and bevacizumab efficacy in metastatic colorectal cancer patients. METHODS: All metastatic colorectal cancer patients who had received chemotherapy and biological agents as first-line treatment at Erciyes University Hospital were retrospectively reviewed. NLR and PLR were each divided into two groups, as high and low. The NLR high group was compared with the low group and the PLR high group was compared with the low group in patients in terms of progression-free survival (PFS) and overall survival (OS), separately. Cox regression and the Kaplan Meier method were used. RESULTS: One hundred and thirty (58%) of the patients had received bevacizumab and 94 (42%) had received antiEGFR therapy (cetuximab or panitumumab). In the bevacizumab group, PFS was 9 months in the NLR high group and 11 months in the NLR low group (p=0.013). OS was 23 months in the NLR high group and 27 months in the NLR low group (p=0.734). There was no statistically significant OS difference in patients who had received antiEGFR therapy according to NLR. There was no statistically significant PFS difference in patients who received bevacizumab according to PLR. In the antiEGFR group, PFS was 9 months (95% CI, 8.07-13.55) in the PLR high group and 18 months (95% CI, 12.02-18.68) in the PLR low group, with statistically significant difference (p=0.040). There was no statistically significant OS difference in patients who had received antiEGFR therapy according to PLR. CONCLUSIONS: NLR and PLR are important inflammatory markers. In patients who had received bevacizumab, PFS was longer in the NLR low group than in the high group. In patients who had received antiEGFR, PFS was longer in the PLR low group than in the high group.

The prognostic value of the change in neutrophil-to-lymphocyte ratio during first-line palliative chemotherapy in patients with metastatic gastric cancer: A retrospective study.

PURPOSE: Metastatic gastric cancer (mGC) is linked with worse prognosis, and tools are needed for predicting disease course and chemotherapy response. The value of the change in the neutrophil-to-lymphocyte ratio (NLR) during first-line palliative chemotherapy on the outcomes in patients with mGC is not fully explained. This study aimed to investigate the importance of changes in NLR in predicting disease course and chemotherapy response in mGC. METHODS: We retrospectively reviewed 194 patients diagnosed with mGC between August 2005 and November 2016. The NLR was assessed before and after chemotherapy to evaluate its relationship with survival. According to threshold values determined by receiver operating characteristics (ROC) analysis, the NLR was divided into two groups with <2.6 and ≥2.6. RESULTS: Elevated prechemotherapy NLR was significantly correlated with worse overall survival (OS) on univariate analysis (p=0.01). On multivariate analysis, elevated prechemotherapy NLR (HR 1.43, p=0.036) was an independent prognostic element for worse OS, but not for progression-free survival (PFS). Constantly elevated NLR or an increase in NLR after chemotherapy was correlated with poor OS, PFS and chemotherapy response. In the multivariate analysis, constantly elevated NLR was identified to be independent predictor of reduced OS and PFS. CONCLUSION: NLR change during chemotherapy is a better index than prechemotherapy NLR for predicting survival in patients with mCG.

Biweekly cisplatin and gemcitabine with two different doses in non small cell lung cancer patients: A retrospective singlecenter experience.

PURPOSE: Non-small-cell lung cancer (NSCLC) constitutes 80-85% of all lung cancers. Patients with advanced-stage NSCLC may benefit from chemotherapy. Gemcitabine and cisplatin is a well-established therapy for this malignancy. Recently, biweekly administration is becoming more acceptable, but the most effective and tolerable dose remains unclear. The purpose of this study was to compare the toxicity and efficacy of 1000 mg/m2 gemcitabine (GEM 1000) and 1500 mg/m2 gemcitabine (GEM 1500) in combination with 50 mg/m2 cisplatin. METHODS: Gemcitabine was administered at a dose of 1000 or 1500 mg/m2 with cisplatin administered at a dose of 50 mg/m2 on day 1. The treatment was repeated every 2 weeks for a total of 4 courses. Response rates, progression-free survival (PFS), overall survival (OS) and toxicities were assessed. RESULTS: 114 patients with IIIB and IV stages of NSCLC were included. Seventy two patients (63%) received GEM 1000 and 42 (37%) received GEM 1500. The overall reponse rate (ORR), PFS and OS were 24%, 6 months and 13 months respectively in the GEM 1000 group and 36%, 6 months and 15 months in the GEM 1500 group, respectively. Grade 3-4 neutropenia and thrombocytopenia were observed in 4% of the GEM 1000 group and 9% of the GEM 1500 group (p=0.41). CONCLUSION: Biweekly administration of GEM 1000 and 1500 is a well tolerated regimen. Although the GEM 1000 group showed a lower response rate than the GEM 1500 group, PFS and OS were similar.

Biosimilar filgrastim vs filgrastim: a multicenter nationwide observational bioequivalence study in patients with chemotherapy-induced neutropenia.

BACKGROUND: We studied the comparative effectiveness of biosimilar filgrastim vs original filgrastim in patients with chemotherapy-induced neutropenia. PATIENTS AND METHODS: This multicenter, observational study was conducted at 14 centers. The study included 337 patients experiencing neutropenia under chemotherapy. Patients were given either filgrastim 30 MIU or 48 MIU (Neupogen®) or biosimilar filgrastim 30 MIU (Leucostim®). Data regarding age, chemotherapeutic agents used, number of chemotherapy courses, previous diagnosis of neutropenia, neutrophil count of patients after treatment, medications used for the treatment of neutropenia, and duration of neutropenia were collected. Time to absolute neutrophil count (ANC) recovery was the primary efficacy measure. RESULTS: Ambulatory and hospitalized patients comprised 11.3% and 45.1% of the enrolled patients, respectively, and a previous diagnosis of neutropenia was reported in 49.3% of the patients, as well. Neutropenia occurred in 13.7% (n=41), 45.5% (n=136), 27.4% (n=82), 11.4% (n=34), and 2.0% (n=6) of the patients during the first, second, third, fourth, and fifth cycles of chemotherapy, respectively. While the mean neutrophil count was 0.53±0.48 before treatment, a significant increase to 2.44±0.66 was observed after treatment (p=0.0001). While 90.3% of patients had a neutrophil count <1.49 before treatment, all patients had a neutrophil count ≥1.50 after treatment. Neutropenia resolved within ≤4 days of filgrastim therapy in 60.1%, 56.7%, and 52.6% of the patients receiving biosimilar filgrastim 30 MIU, original filgrastim 30 MIU, and original filgrastim 48 MIU, respectively. However, there was no significant difference between the three arms (p=0.468). Similarly, time to ANC recovery was comparable between the treatment arms (p=0.332). CONCLUSION: The results indicate that original filgrastim and biosimilar filgrastim have comparable efficacy in treating neutropenia. Biosimilar filgrastim provides a valuable alternative; however, there is need for further studies comparing the two products in different patient subpopulations.

Effectiveness and Safety of LMWH Treatment in Patients With Cancer Diagnosed With Non-High-Risk Venous Thromboembolism: Turkish Observational Study (TREBECA).

We compared the efficacy and safety of low-molecular-weight heparins (LMWHs) in patients with cancer who are at low risk of venous thromboembolism (VTE). Patients were treated by medical oncologists in Turkey at 15 sites, where they were enrolled and followed up for a period of 12 months. Due to the study design, there was no specific treatment protocol for LMWH. Primary end points were efficacy and the time to change in VTE status. Of the included 250 patients, 239 (95.6%), 176 (70.4%), 130 (52.0%), and 91 (36.4%) completed their day 15, month 3, month 6, and month 12 visits, respectively. Number of patients treated with enoxaparin, bemiparin, and tinzaparin were 133, 112, and 5, respectively. Anticoagulant therapy provoked thrombus resolution in 1.2% and 12.7% of patients using enoxaparin and bemiparin, respectively ( P = .004). Thrombus resolution was observed in 81 more patients at month 3 visit. This ratio was 35 (40.2%) of 87 and 46 (54.1%) of 85 patients administered enoxaparin and bemiparin at the third visit, respectively ( P = .038). Thrombus resolution was observed in 21 more patients during month 6 visit. This ratio was 5 (7.7%) of 65 and 15 (23.4%) of 64 patients administered enoxaparin and bemiparin at the fourth visit, respectively ( P = .022). The LMWH was discontinued in only 2 patients due to gastrointestinal bleeding. This pioneering study shows bemiparin is more effective than enoxaparin in thrombosis resolution and has a similar tolerability profile.