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Objective This study aimed to determine the prognostic role of baseline maximum standardized uptake value (SUVmax) obtained by pretreatment PET/CT and the change in SUVmax (ΔSUVmax [%]) in patients with axillary lymph node–positive breast cancer receiving neoadjuvant chemotherapy (NAC). Methods One hundred and eighty patients with baseline SUVmax and 121 patients with SUVmax measurement after treatment were evaluated in the study. The baseline SUVmax value of the breast (SUVmaxBI) and axilla (SUVmaxAI) and the change in the SUVmax of the breast (ΔSUVmaxB) and axilla (ΔSUVmaxA) were measured. The optimal cut-off value of SUVmax and ΔSUVmax were determined by ROC curve analysis. Disease-free survival (DFS) and overall survival (OS) were calculated using Kaplan–Meier curves. Results ΔSUVmaxB, pCRB, pCRA, and pCR parameters were found to be associated with relapse (P Conclusion The results showed that ΔSUVmaxB was an independent prognostic factor for relapse and mortality in patients with axillary lymph node–positive breast cancer who received NAC.

Resumen Objetivo En este estudio, se tuvo como objetivo determinar el papel pronostico del valor de captacion maximo estandarizado (SUVmax) basal obtenido por PET/TC antes del tratamiento, y el cambio en el SUVmax (ΔSUVmax [%]) en pacientes con cancer de mama con ganglios linfaticos axilares positivos en tratamiento con quimioterapia neoadyuvante (NAC). Metodos Se evaluaron en el estudio 180 pacientes con SUVmax basal y 121 pacientes con medicion de SUVmax despues del tratamiento. Se midieron el valor de SUVmax inicial de la mama (SUVmaxBI) y axila (SUVmaxAI), y el cambio en el SUVmax de la mama (ΔSUVmaxB) y axila (ΔSUVmaxA). El valor de corte optimo de SUVmax y ΔSUVmax se determino mediante el analisis de la curva ROC. La supervivencia libre de enfermedad (SSE) y la supervivencia global (SG) se calcularon mediante curvas de Kaplan-Meier. Resultados Se encontro que los parametros ΔSUVmaxB, pCRB, pCRA y pCR se asociaron con la recaida (p Conclusion Los resultados muestran que ΔSUVmaxB es un factor pronostico independiente de recaida y mortalidad en pacientes con cancer de mama con ganglios linfaticos axilares positivos que recibieron NAC.

Cancer patients are among patient groups most affected by the COVID-19 outbreak. During the COVID-19 pandemic, rearrangement of oncological services and adaptation to the pandemic process has become mandatory. In this review, we mentioned the changes in medical oncology practice and adaptive treatment modifications. COVID-19 infection will continue to affect and change the practice of oncology unless the COVID-19 outbreak ends.

Introduction: To investigate the clinical characteristics and outcomes of cancer patients with COVID-19 infections and evaluate the effect of hepatitis B immunization status on susceptibility to COVID-19 infection and mortality risk. Materials and methods: The records of 1,515 patients who presented to the Medical Oncology clinic between March 2020 and December 2020 were analysed retrospectively. The demographic and clinical characteristics and laboratory findings of cancer patients with (case group) and without (control group) COVID-19 infection were compared. Results: Of the 1,515 patients, 153 (10.1%) had been diagnosed with COVID-19, and the median age of cancer patients with COVID-19 infection was 53.9 (range; 18–82) years. The most common types of cancer were breast cancer (26.2%), gastrointestinal system cancers (22.3%), genitourinary-system cancers (16.5%) and lung cancer (15.5%). The presence of metastatic disease [hazard ratio (HR): 0.09, 95% CI (0.01–0.83), (p = 0.03)] and receipt of palliative chemotherapy in the cancer patients with COVID-19 infections [HR: 0.1, 95% CI (0.01–0.69), (p = 0.02)] were identified as prognostic factors in multivariate analysis as univariate analysis did not indicate palliative treatment as a prognostic factor. When the case group and control groups were compared in terms of hepatitis B immunization status (p = 0.24), no statistically significant difference was identified between the two groups. Furthermore, hepatitis B immunization status (p = 0.37) were not found to be associated with COVID-19-related mortality risk. Conclusion: Hepatitis B immunization status were not associated with the risk of COVID-19 transmission and mortality. The present study identified the presence of metastatic disease and palliative chemotherapy as negative and positive prognostic factors, respectively.

To investigate the status of thiol-disulphide homeostasis and ischemic-modified albumin and their association with clinicopathological parameters in breast cancer.A cross-sectional descriptive study.Department of Internal Medicine and Department of Medical Oncology, Dicle University, Turkey, from April to September 2021.Forty treatment-naive female patients diagnosed with breast cancer who presented to the Oncology Clinic of the hospital and 33 healthy women with no comorbidities were included. Serum levels of native thiol (NT), disulphide (Ds), total thiol (TT), IMA (ischemic modified albumin) at diagnosis and disulphide/native thiol (Ds/NT), disulphide/total thiol (Ds/TT), and the ratios of native thiol/total thiol (NT/TT) were analysed by the colorimetric method.Median age at diagnosis was 44 (29-70) years. The majority of patients had stage II-III disease (77.5%). Mean serum levels of TT were significantly lower in breast cancer patients (462.45 ± 100.2 μmol/L) compared to healthy controls (507.28 ± 75.72 μmol/L) (p=0.038). Mean serum levels of Ds were significantly lower in breast cancer patients (20.25 ± 5.94 μmol/L) compared to healthy controls (22.99 ± 3.56 μmol/L) (p=0.018). Meanwhile, mean IMA levels were significantly higher in breast cancer patients (0.81 ± 0.05 μmol/L) compared to healthy controls (0.73 ± 0.19 μmol/L) (p=0.016). NT and TT levels showed a moderate correlation with the percentage of fat mass and body mass index (BMI), and a weak correlation with age (p0.05). Univariate and multivariate analyses examining the association between thiol-disulphide levels and patient clinical characteristics demonstrated that NT and TT levels had a statistically significant relationship with body mass index and menopausal status (p0.05), with lower levels of NT and TT in postmenopausal patients and patients with high BMI.Decreased TT and Ds levels and increased IMA levels were determined in patients diagnosed with breast cancer compared to the healthy control group. Thiol-disulphide levels were observed to be associated with clinical characteristics such as menopausal status and BMI.Breast cancer, Thiol, Ischemic modified albumin.

The optimal chemotherapy regimen for concurrent chemoradiation in locally advanced non-small cell lung cancer (NSCLC) remains unclear. Cisplatin-etoposide regimen related toxicity is high, weekly regimens have been investigating. We aimed to compare the efficacy and safety of different concurrent chemotherapy regimens in the context. A total of 225 patients with locally advanced, unresectable stage III NSCLC were included. Patients who were treated with weekly docetaxel-platin (DP), paclitaxel-platin (PP) and standard dose etoposide-platin (EP) chemotherapy regimens were selected and divided into groups for the comparison of toxicity, response rate, progression free survival (PFS), and overall survival (OS) times. There was a statistically significant difference between overall response rate of each treatment groups (DP: 96.1%, PP: 94% and EP: 76.7%, p

Results from studies in several cancers on single nucleotide polymorphisms (SNPs) suggest that DNA repair capacity may have prognostic implication for disease recurrence, survival, and responses to treatment. This study aimed to evaluate the potential prognostic value of SNPs as biomarkers in patients with metastatic non-small cell lung cancer (mNSCLC) treated with platinum. Analysis of SNPs from peripheral blood cells was performed by polymerase chain reaction. Excision repair cross-complementing group 1 (ERCC1)-Asn118Asn, excision repair cross-complementing group 2 (ERCC2)-Lys751Gln, X-ray repair cross-complementing group 1 (XRCC1)-Arg399Gln, and tumor protein 53 (TP53)-Arg72Pro polymorphisms were evaluated in conjunction with clinical and pathological parameters, and survival. The median progression-free survival (PFS) and overall survival (OS) of 145 patients were 5.1 months and 30.9 months, respectively. In the univariate analysis ERCC1 genotype, XRCC1 genotype, and Eastern Cooperative Oncology Group Performance Status (ECOG-PS) were significant parameters for OS. In the multivariate analysis ERCC1 genotype, XRCC1 genotype, and ECOG-PS retained their significance. The median OS was 45.2 months for the ERCC1 normal (CC) and heterozygote (CT) genotypes, and 25.5 months for the ERCC1 mutant (TT) genotype. The median OS was 31.4 months for the XRCC1 normal (AA) and heterozygote (AG) genotypes, and 23.1 months for the XRCC1 mutant (GG) genotype. The median OS was 30,7 months for ECOG-PS≤ 1 and 10.2 months for ECOG-PS≥ 2. ERCC1 and XRCC1 genotypes, and ECOG-PS independently predicted OS in mNSCLC patients. Additional studies are needed for the further evaluation of potential prognostic SNPs in mNSCLC. [Med-Science 2020; 9(1.000): 255-60]

Positive effects of exercise in cancer patients have been reported. To investigate whether intensity, duration, and timing of exercise affect disease relapse and mortality risk in patients with breast cancer (BC). Patients with local or locally advanced stages of BC between January 2018 and January 2020 were recruited in the study. Sociodemographic and clinicopathological characteristics of patients were recorded. Exercise evaluation was performed by preparing a questionnaire and asking the patients face-to-face questions in the outpatient clinic. Risk of relapse was 58% lower in patients who exercised than inactive patients (p = 0.004). Patients who exercised for 2 to 5 days per week had a 63% lower relapse risk than inactive patients (p = 0.010). Risk of relapse was 66% lower in the patients who exercised for less than 1 h or 3 metabolic equivalent of task (MET)-hours per week when compared to inactive patients (p = 0.037). Similarly, relapse risk was 62% lower in patients who exercised between 1 to 3 h or 3 to 8.9 MET-hours per week than inactive patients (p = 0.026). Mortality risk was lower in patients who exercised than patients who did not (p = 0.027). A significantly decreased mortality risk was found in both groups that included patients who exercised for 1 to 5 days per week and patients who exercised for less than 3 h or 9 MET-hours per week when compared to inactive patients. Exercise was associated with decreased relapse and mortality rates in patients with BC. Therefore, exercise should be recommended to BC patients as a significant component of the treatment.

Purpose: To compare the efficacy and toxicity of three different chemotherapy regimens used as first-line treatments in the real-life management of metastatic pancreatic cancer (mPC). Methods: A total of 218 patients diagnosed with mPC at the time of initial admission were included in this multicenter study. Gemcitabine (Gem, n=71), Gemcitabine-cisplatin (Gem-Cis, n=91) and FOLFIRINOX (FFX, n=56) treatments were compared in terms of efficacy and treatment-related toxicity. Results: Overall response rate was significantly higher in the FFX group (50.0%) than in the Gem (28.2%) and Gem-Cis (27.5%) groups (p=0.010).Median progression-free survival (8.4 vs. 4.6 and 5.5 months, respectively, pConclusion: In conclusion, our findings indicate that FFX regimen provides a significant advantage over the other treatment regimens in terms of response rates and survival. Treatment toxicity was more frequent but manageable with the FFX regimen.FFX seems to be a preferable regimen in the first-line treatment of the younger and fit patients diagnosed with mPC.

Objective: Breast cancer is the most common cancer in women. Mortality in breast cancer is associated with recurrence and metastases. The aim of this study was to determine the causes of local recurrence and metastasis in operated early stage breast cancer. Material and Methods: The files of the patients diagnosed with operated early stage breast cancer followed up at Dicle University Medical Faculty Medical Oncology Department between 2001-2010 were analyzed retrospectively. The group of patients with recurrence was referred to as the relapse-metastasis group and the other patients were called the remission group. Between these two groups, age, sex, tumor histology, size, presence of lymphovascular invasion, tumor grade molecular properties such as, ER, PR, HER, staging studies; time characteristics, surgical characteristics, time between surgery-chemotherapy and surgery-radiotherapy; The relapse-metastasis group and the remission group were compared in terms of chemotherapy. SPSS 22 was used for statistical analysis. p 1 month was 9.7% and 24% in the remission and relapse-metastasis group, respectively. In remission group 30.9%; relapse-metastasis group 47.7% of the patients had incomplete staging at the time of diagnosis. Conclusion: The factors determining the recurrence in patients with operated early stage breast cancer were tumor size, number of lymph node involvement, incomplete staging at the time of diagnosis, start chemotherapy later than 1 month.

Background: Colorectal cancer (CRC) is a rare disease amongst children and adolescents. Previous studies have reported a number of differences between children/adolescents, young adults, and adult patients with CRC. However, none of these studies compared these age groups according to their clinicopathologic and prognostic characteristics. In the current study, we compare these three age groups. Methods:A total of 173 (1.1% of 15,654 patients) young CRC patients (≤25 years) were included in the study. As a control group, 237 adult CRC patients (>25 years) were also included. Patients were divided into three age groups: child/adolescent (10–19 years), young adult (20–25 years), and adult (>25 years). Results: Statistical differences amongst the three groups in terms of gender (p = 0.446), family history (p = 0.578), symptoms of presentation (p = 0.306), and interval between initiation of symptoms and diagnosis (p = 0.710) could not be demonstrated. Whilst abdominal pain (p < 0.001) and vomiting (p = 0.002) were less common in young adults than in other groups, rectal bleeding and changes in bowel habits were relatively less common in adolescents than in other groups. Rectal localisation (p = 0.035), mucinous adenocarcinoma (p < 0.001), and a poorly differentiated histologic subtype (p < 0.001) were less common in the adult group than in other groups. The percentage of patients with metastasis and sites of metastasis (e.g., peritoneum and lung) differed between groups. The median overall survival was 32.6 months in the adolescent group, 57.8 months in the young adult group and was not reached in the adult group (p = 0.022). The median event-free survival of the adolescent, young adult, and adult groups was 29.0, 29.9, and 61.6 months, respectively (p = 0.003). Conclusions: CRC patients of different age groups present different clinicopathologic and prognostic characteristics. Clinicians should be aware of and manage the disease according to these differences.

WOS:000621799100001 PMID: 33631986 Aim: To assess the efficacy and tolerability of the first-line treatment options for hormone-refractory prostate cancer patients with visceral metastases. Materials and methods: The records of 191 patients diagnosed with hormone-refractory prostate cancer with visceral metastases were analyzed retrospectively. Results: Docetaxel was administered to 61.2% (n = 117), abiraterone to 14.2% (n = 27) and enzalutamide to 9.4% (n = 18) as the first-line treatment. The median survival of the patients receiving docetaxel, abiraterone and enzalutamide as the first-line treatment during the hormone-refractory period was 15 (95% Cl: 12.9-17) months, 6 (95% Cl: 1.8-10.1) months and 11 (95% Cl: 0.9-23.1) months (p = 0.038), respectively. Conclusion: The present study established a statistically significant difference in favor of docetaxel in terms of overall survival and progression-free survival. Lay abstract The optimal therapeutic option for castration-resistant prostate cancer (CRPC) patients with visceral metastases is unknown. We assessed the efficacy and tolerability of the first-line treatment options for CRPC patients with visceral metastasis. One hundred ninety-one patients diagnosed with CRPC with visceral metastases were included in the study. The present study established a statistically significant difference in favor of docetaxel in terms of overall survival and progression-free survival between first-line docetaxel, abiraterone and enzalutamide treatments in CRPC patients with visceral metastases. For patients who cannot undergo chemotherapy, enzalutamide, among novel androgen pathway inhibitors, may be the most appropriate option, given its numerical, although statistically insignificant, difference in overall survival and its fewer side effects compared with abiraterone.

WOS:000617829700001 PMID: 33586012 Purpose We aim to compare the efficiency and toxicity of three different 5-fluorouracil (5-FU) administration types in 5-FU, leucovorin, and oxaliplatin (FOLFOX) combination treatment for adjuvant therapy in colorectal cancer (CRC). Methods Five hundred and seventy patients with stage III colorectal carcinoma who received different FOLFOX regimens after curative resection were included. Patients were divided into three groups as FOLFOX-4, modified FOLFOX-6 (mFOLFOX-6), and mFOLFOX-4 for comparison of toxicity and disease-free survival (DFS) and overall survival (OS) times. Results Three-year DFS rates for FOLFOX-4, mFOLFOX-6, and mFOLFOX-4 groups were 65%, 72%, and 72%, respectively. Five-year OS rates for FOLFOX-4, mFOLFOX-6, and mFOLFOX-4 groups were 69%, 75%, and 67%, respectively. There was no statistically significant difference between the three treatment groups in terms of DFS and OS (p = 0.079, and p = 0.147, respectively). Among grade 1-2 adverse events (AE), thrombocytopenia, neuropathy, and stomatitis were more common in the mFOLFOX-6-treated group. The frequency of grade 1-2 nausea and vomiting were similar in mFOLFOX-6 (36.3% and 24%, respectively) and mFOLFOX-4 (32.4% and 24.7%, respectively) groups but were higher than that in the FOLFOX-4 (19.5% and 11.3%, respectively) group. Among the most common grade 3-4 AE, neutropenia (53.4%, 9%, and 13.5%, respectively) and diarrhea (10.5%, 2.2%, and 2.4, respectively) were more common in FOLFOX-4. The rate of anemia and febrile neutropenia was similar in treatment groups (p = 0.063, and p = 0.210, respectively). Conclusion In the adjuvant treatment of stage III CRC patients, three different 5-FU administration types in FOLFOX combination treatment can be used with similar efficiency and manageable toxicity.

WOS:000639298200012 PMID: 33315727 Objective The aim of this study was to determine the role of 18F-FDG PET/CT in predicting pathological response among patients diagnosed with local or locally advanced breast cancer and receiving neoadjuvant chemotherapy (NAC). Methods Basal SUVmax value were analyzed in 212 patients and 142 of these patients had posttreatment SUVmax value. Overall pathological complete response (pCR(C)) was defined as no evidence of residual invasive cancer in breast (pCR(B)) and axilla (pCR(A)). Basal SUVmax value of the breast (SUVmax(B)I) and axilla (SUVmax(A)I) and change in SUVmax of the breast (Delta SUVmax(B)) and axilla (Delta SUVmax(A)) were measured. The optimal cutoff value of SUVmax and Delta SUVmax were determined by receiver operating characteristic curve analysis. Results The number of patients with pCR(B) was 85 (40.1%), pCR(A) was 76 (42.5%) and pCR(C) was 70 (33%). In the artificial neural network-based analysis the Delta SUVmax(B) (100%) was the most important variable for predicting pCR(B). Delta SUVmax(A) (100%) was the most important variable in estimation of pCR(A). When pCR(C) was evaluated, the highest relation was found with Delta SUVmax(B). When the Delta SUVmax(B) cutoff value for pCR(B) and pCR(C) accepted as

WOS:000717544600006 PMID: 34366407 Introduction The present study investigates the role of Ga-68-PSMA PET/CT-derived whole-body metabolic and volumetric parameters in the prediction of treatment response and prognosis among metastatic hormone-refractory prostate cancer patients undergoing second-generation androgen receptor axis-targeted therapy (abiraterone or enzalutamide). Materials and methods This retrospective study included 44 metastatic hormone-refractory prostate cancer patients undergoing Ga-68-PSMA PET/CT, including 29 enzalutamide-treated and 15 abiraterone-treated patients. Results Of the 44 patients included in the study, 29 received enzalutamide and 15 received abiraterone. During treatment, the changes in PET parameters were correlated with the PSA (biochemical) response. More specifically, a positive correlation was noted between PSA response and percent change in TLP (Delta TLP) response, and there was concordance between the results (r = 0.652, k = 0.42, P < 0.001). Baseline PSA (P =0.05), high MTVw (P = 0.005), the increase in Delta PSA (P = 0.036), Delta TLP (P = 0.039) and percent change in MTV (Delta MTV) (P = 0.049) values were identified as factors associated with mortality risk.Multivariate analysis showed that PSA1 [odds ratio (OR): 1.005, 95% confidence interval (CI) 1.002-1.008, P = 0.004], Delta PSA (OR: 14.7, 95% CI 1.50-143.7, P = 0.02) and MTVw1 (OR: 11.4, 95% CI 1.11-116, 6, P = 0.04) were independent prognostic factors associated with mortality risk. Conclusion A statistically significant concordance and correlation was noted between Ga-68-PSMA PET/CT-derived whole-body metabolic parameters (Delta TLP and Delta MTV) and Delta PSA. In addition, the baseline PSA, Delta PSA, Delta TLP, Delta MTV and TMTV were identified as predictive factors for mortality risk.

[No Abstract Available], Amgen Ilac Tic Ltd Sti, Turkey

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.

BackgroundCombination 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.MethodsA total of 125 patients were randomized to combination therapy (1000mg/m2 gemcitabine +125mg/m2 nab-paclitaxel) and single-agent gemcitabine (1000mg/m2) arms to take treatment weekly for 7 of 8weeks, and following 3 of 4weeks, until progression or severe toxicity. Primary endpoints were three-months of definitive deterioration free percent of patients, and QoL.ResultsOverall 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 6(th) month assessments, respectively (p=0.357). Median overall survivals in combination and single-agent arms were 9.92months and 5.95months, 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 3.22months, respectively (HR: 0.58, 95% CI: 0.39-0.87, p=0.008). Median time-to-deterioration were 5.36 vs 3.68months, and objective response rates were 37.1% vs 23.7% (p=0.009), respectively in combination and single-agent arms.ConclusionsCombination 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 registrationThis study has been registered in ClinicalTrials.gov as NCT03807999 on January 8, 2019 (retrospectively registered)., Celgene [aaaa] Funding Source: Medline; onkoloji arastirmalari dernegi [aaa] Funding Source: Medline; hacettepe onkoloji dernegi [wwww] Funding Source: Medline; Turk Kanser Arastirma ve Savas Kurumu Dernegi [awe] Funding Source: Medline; Turk Tibbi Onkoloji Dernegi (TR) [wwww] Funding Source: Medline

Lorlatinib is a third-generation tyrosine-kinases inhibitor (TKI) targeting ALK/ROS1 fusions. the FDA has approved lorlatinib for TKI-pretreated ALK(+) NSCLC, while its approval for ROS1( + ) is still pending. Here we present the largest real-world data of NSCLC patients harboring ALK/ROS1 rearrangements treated with lorlatinib. Methods: 123 patients were enrolled retrospectively (data cut-off 1/1/2019). Lorlatinib was administered through an early access program for patients with no other available therapy. Outcome and response were defined by each investigator upon RECIST 1.1 criteria. Results: 106 ALK(+) and 17 ROS1(+) patients recruited from 8 different countries. the ALK( + ) cohort included 50 % males, 73 % never-smokers and 68 % with brain metastases. Extracranial (EC) and intracranial (IC) response rates (RR) were 60 % and 62 %, with disease control rates (DCR) of 91 % and 88 % respectively. Mean duration of therapy (DoT) was 23.9 +/- 1.6 months and median overall survival (mOS) was 89.1 +/- 19.6 months. ROS1 cohort enrolled 53 % males, 65 % never-smokers and 65 % had brain metastases. EC and IC RR were 62 % and 67 % with DCR of 92 % and 78 % respectively. Median DoT was 18.1 +/- 2.5 months and mOS of 90.3 +/- 24.4 months. OS and DoT in both cohorts were not significantly correlated with line of therapy nor other parameters. the most common adverse events of any grade were peripheral edema (48 %), hyperlipidemia (47 %), weight gain (25 %) and fatigue (30 %). CNS adverse events such as cognitive effect of grade 1-2 were reported in 18 % of patients. Conclusion: Lorlatinib shows outstanding EC/IC efficacy in ALK/ROS1(+) NSCLC. the observed mOS of 89 +/- 19 months in ALK(+) NSCLC supports previous reports, while mOS from of 90 +/- 24 months is unprecedented for ROS1( + ) NSCLC., PfizerPfizer [IIS 53234545], We grateful to Pfizer for the funding of the grant IIS 53234545.

WOS:000614471900004 Background and Aims: Cancer patients are admitted to intensive care units (ICU) due to primary diseases, treatment-related conditions or comorbid diseases. Acute kidney injury (AKI) and infections appear to be factors affecting mortality and morbidity in ICU follow-up. Therefore, in our study, we investigated the effect of AKI and inflammation-based parameters on mortality in cancer patients admitted to the ICU. Materials and Methods: In this study, 386 patients diagnosed with malignancy hospitalized between 2010 and 2014 in Dicle University Medical Faculty Internal Medicine ICU were included. The study was designed retrospectively. The demographic characteristics and clinical information of the patients were obtained from the files. Subsequently, patients were classified as non-survivors (group 1) and survivors (group 2). Both groups were compared in terms of the presence and stage of AKI by KDIGO definition, neutrophil / lymphocyte ratio (NLR) and platelet / lymphocyte ratio (PLR). Results: Creatinine, CRP, neutrophil counts were found to be significantly higher and albumin, hemoglobin, platelet and lymphocyte counts were found to be lower in group 1 (n=276) compared to group 2 (n=110). Length of ICU was longer in group 2 patients. There was a positive correlation between mortality and KDIGO stages and NLR. Mortality rate was increased 1.9 fold in KDIGO stage 1, 2.3 fold in stage 2, 2.4 fold in stage 3 and 1.5 fold if NLR>5. There was no statistically significant relationship between PLR and mortality. Conclusion: The presence of AKI and elevated inflammation-based parameters were associated with mortality in oncologic patients admitted to the ICU.

This study aimed to analyze prognostic factors for survival and the reliability and the effectiveness of eribulin therapy in metastatic breast cancer (MBC) patients.A total of 80 patients treated with eribulin in 12 medical oncology centers in Turkey between 2013-2017 were retrospectively evaluated. Sixteen potential prognostic variables were assessed for analysis.The patients had received a median of 5 prior chemotherapy regimens and a median of 3 eribulin cycles for MBC. Median progression-free survival (PFS) was 5.5 months (95% Cl: 4.1-7.8) and median overall survival (OS) was 11 months (95 % Cl: 6-15). Multivariate analysis showed that eribulin treatment line was shown to have independent prognostic significance for PFS. PFS difference was demostrated in patients who received 3 chemotherapy lines for advanced disease compared to those who had more than 3 chemotherapy lines [median PFS; 3 lines: 8.6 months (6.2-11) and ˃3 lines: 4.6 months (3.7-4.6) p=0.00]. The clinical benefit rate (CBR) was 52.5 and 35% in patients treated with three lines and with ˃3 previous chemotherapeutic regimens. Most common toxicities were neutropenia (62.5%), fatigue (52.5%), alopecia (50%) and nausea (37.5%).Eribulin treatment line was identified as indepedent prognostic factor for PFS in MBC patients.

Patients and Methods:We performed a retrospective cohort study of 207 operated breast cancer women treated with doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) for adjuvant setting between 2007 and 2016. Patients' demographic features, toxicities, fat mass, body mass index (BMI) and body surface area (BSA) were evaluated in their charts. Patients were evaluated according to fat mass (high ≥35% vs. low Results:Median age was 46 (23-82) and 61.8% of the patients (n=128) were premenopausal. Median fat mass, BSA, and BMI level was 37 (10-55), 1.75 (1.3-2.27) and 29.4 (16-54.7), respectively. Grade ≥3 toxicity was observed in 68 patients (%32.9). Although, in univariate analyses [table 1] there are no differences in terms of grade ≥3 toxicity according to BMI (in obese and nonobese patients, 34.8% vs. 31.4%, respectively, p=0.589), and BSA (in patients with m2 ≥1.73 vs. m2 35, OR (odds ratio): 2.341 %95CI:0.39-5.27, p=0.040] was affect grade ≥3 toxicity, while BMI [30; OR:0.876 %95 CI=0.392-1.959, p=0.748], BSA [1.73 m2, OR:0.956, %95CI:0.450-2.034, p=0.908], age [50, OR:2.171, %95CI:0.338-13.956, P= 0.414], menopausal status [premenopausal vs. postmenopausal, OR:4.374, %95CI:0.661-28.964, p=0,126], stage [1,2 vs 3, OR:0.535, %95CI:0.279-1.024, p=0.059] and histologic subtype [ductal vs. others; OR:2.010 %95 CI=0.368-2.010, p:0.729] was not. Grade ≥3 toxicity according to BMI, BSA, and fat massMethodGrade ≥3 toxicityP valueBMI (obese vs nonobese)34.8% vs. 31.4%0.589BSA (≥1.73 vs. m2 Multivariate analayses for grade ≥ 3 tocicityParametersOdds Ratio%95 Confidence IntervalP valueFat mass (≥35% vs. 35%)2.3410.39-5.270.040BMI (≥30 vs. < 30)0.8760.392-1.9590.748BSA (1.73)0.9560.450-2.0340.908Age (≥50 vs. Discussion:BSA-based dosing has been widely adopted in oncology as a means of safely administering cytotoxic drugs. In our study demonstrated that fat mass is most valuable than BSA and BMI for evaluation to grade ≥3 toxicity for breast cancer patients treated with AC in the adjuvant setting. Citation Format: Kaplan MA, Kavak H, Urakci Z, Nas N, Oruç Z, Yerlikaya H, Akdeniz N, Isikdogan A. Is fat mass more effective than body mass index (BMI) to predict toxicity in early breast cancer patients treated with doxorubicin and cyclophosphamide? [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-14-04.

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, Video abstract

Aim of the study : Vascular endothelial growth factor (VEGF) is one of the parameters that has been studied in differential diagnosis of malignant fluids. This study is aimed at evaluate applicability of serum, fluid VEGF level and fluid to serum VEGF ratio in the diagnosis of malignant pleural mesothelioma (MPM). Material and methods : The patients with pleural effusion over age of 18, between 2011 and 2015 were included in the study. They were divided into three groups: group 1 – mesothelioma patients; group 2 – other malignancies; and group 3 – benign aetiologies. Group 1 and 2 were termed as the malignant group. Fluid, serum VEGF levels, and the ratio of fluid/serum VEGF level were studied to evaluate the fluid/serum VEGF ratio in all groups. Results : Twenty cases with mesothelioma, 44 cases with other malignancies, and 20 cases with benign aetiologies were included in this study. No statistically significant difference was found according to serum VEGF levels for all groups, (group 1: 437 ±324 pg/ml, group 2: 354 ±223 pg/ml, group 3: 373 ±217 pg/ml, p = 0.836), while fluid VEGF levels showed a statistically significant difference (group 1: 3359 ±700 pg/ml, group 2: 2175 ±435 pg/ml, group 3: 1092 ±435 pg/ml, p = 0.041). The ratio of fluid to serum VEGF levels showed a difference, at the significance limit, between the malignant (group 1 and group 2) and benign (group 3) groups (8.83 ±1.29 vs. 4.57 ±1.07, p = 0.059) but showed a statistically significant difference between the mesothelioma and benign groups (12.11 ±1.68 vs. 4.57 ±1.07, p = 0.044). Conclusions : The VEGF fluid/serum ratio may be an applicable parameter in the differential diagnosis of malignant fluids, especially MPM.

To compare anti-EGFR and anti-VEGF agents in patients with K-RAS wild-type metastatic colorectal cancer (mCRC) with regards to tumor location.450 patients diagnosed with mCRC, who applied to our center were included in this retrospective study. Of 450 patients, 303 underwent K-RAS mutation tests, assessed as having right-sided or left-sided mCRC and grouped according to localization of right and left colon. Sixty-five Patients with K-RAS wild-type mCRC, who were treated with first line anti-EGFR or anti-VEGF containing combination therapies of fluorouracil with leucovorin and either irinotecan or oxaliplatin were compared.393 (87%) out of 450 mCRC patients had left-sided colon cancers, and 57(13%) had right-side colon cancers. K-RAS analysis was performed in 303 of 450 patients with mCRC, 186 (61.4%) patients had K-RAS wild-type and 117 (38,6%) had K-RAS mutant. Median survival for right-sided cancers was 23.3 months and 29.4 months for left-sided cancers (p=0.309). Median progression-free survival (PFS) was 10.4 months (95% CI 7.3-13.4) in the anti-EGFR containing regimens group and 9.7 months (8.2-11.1) in the anti-VEGF containing regimens group (p=0.037); however, median overall survival (OS) was 18.4 months (95% CI 11.7-25.1) in the anti-EGFR containing regimens group and 19.3 months (95% CI 15.7-22.9) in the anti-VEGF containing regimens group (p=0.635).Addition of anti-EGFR in left sided K-RAS wild-type mCRC regarding PFS was beneficial, however there was no difference in terms of OS.

To analyze the reliability and the effectiveness of chemotherapy and prognostic factors for survival in patients with HER2 (human epidermal growth receptor 2) negative early-stage breast cancer treated with adjuvant sequential anthracycline-based chemotherapy and paclitaxel.This analysis retrospectively evaluated the medical records of 756 HER2 negative early-stage breast cancer patients who received adjuvant sequential anthracycline-based chemotherapy and weekly paclitaxel in 15 medical oncology centers in Turkey between 2008-2015. Estrogen receptor (ER), progesterone receptor (PR),HER2,age,tumor size and grade,nodal status,perineural and lymphatic invasion,disease-free survival (DFS) and overall survival (OS) were analyzed.The median patient age was 50 years (22-82). Median follow up period was 46 months (13-82). The rates of recurrence and death detected in this period were 14.8% and 7.4%, respectively. Median OS and PFS were not reached in this period. Five-year DFS and OS rates were 87% and 89%, respectively. Age (OR:0.35,95%Cl 0.12-0.96, p=0.04), PR status (OR:0.44,95%Cl 0.18-1, p=0.05), lymphatic invasion (OR:2.6,95%Cl 0.97-7.4, p=0.05) were independent prognostic factors. Most common grade 3-4 toxicities were fatigue (6.7%), neutropenia (1.7%) and nausea (1.3%). Neutropenic fever developed in 1.8% of the patients and peripheral neuropathy in 16.9%. Dose reduction was necessary for 10% of the patients due to grade 3-4 toxicity, whereas postponement of chemotherapy was necessary for 7% of the patients.This multicentric retrospective study confirmed that sequential adjuvant therapy with anthracycline-based chemotherapy and paclitaxel for HER2 negative breast cancer is an effective and reliable regimen.

Objective: The prognostic value of tumor location in patients with metastatic colorectal cancer (mCRC) was reported by recent analyses in RAS wild-type patients. However, there is no enough specific data regarding prognostic value of primary tumor location in RAS mutated mCRC patients. We aimed to find if there is any relation between tumor prognosis and primary tumor location in patients with RAS mutated mCRC. Method: This retrospective study included 57 patients with mCRC who were diagnosed and treated in our hospital between January 2011 and December 2017. Characteristics features of the patients were obtained from our institution patient medical records. Patients were included to the present study if KRAS or NRAS mutation was detected in tumor tissues.Results: Twenty-nine (50.9%) of patients were female and the median age of all patients was 52 (18-80) years. Forty (70.2%) of 57 patients were defined as left side (LS) and 17 (29.8%) of patients were located in the right side (RS). As first line systemic treatment, twenty-five (43.9%) patients had received oxaliplatin-based chemotherapy while 32 (56.1%) patients had received irinotecan-based chemotherapy. Tumor sidedness did not affect on progression-free survival (PFS) (mPFS, 10.9 months for LS vs 8.1 months for RS, p=0.400) and overall survival (OS) (mOS, 20.9 months for LS vs 20.8 months for RS, p=0.930).The patients who had oxaliplatin based chemotherapy regimens showed better OS rate than irinotecan based regimens (28.7months vs16.3 months, p=0.017, respectively). Conclusion: Our study results support the thought that claims the sidedness of primary CRC in metastatic setting does not have effect on PFS and OS in patients with RAS mutant mCRC. However, our findings also underline the necessity of studies with larger patient populations and subgroup analyzes to evaluate potential prognostic and molecular features to determine the standart approach to this specific subgroup of the disease. Amaç: RAS wild metastatik kolorektak kanser (KRK) tanılı hastalarda tümör lokalizasyonun prognostik önemi hakkında çok sayıda çalışma bildirilmiştir. Ancak RAS mutant hastalar ile ilgili yeterli sayıda çalışma bulunmamaktadır. Bu çalışmada RAS mutant metastatik KRK tanılı hastalarda tümör yerleşim yerinin prognostik önemini belirlemeyi amaçladık. Yöntemler: Bu retrospektif çalışmaya hastanemizde 2011 ve 2017 yılları arasında tanı alan RAS mutant metastatik KRK tanılı 57 hasta dahil edildi. Hasta özellikleri hastane kayıt sistemindeki verilerden elde edildi. KRAS veya NRAS mutasyonu saptanan hastalar dahil edildi. Bulgular: Hastalardan 29 ’u (%50,9) kadın olup ortanca yaş 52 (18-80) idi. Primer tümör, hastaların 40’ında (%70,2) sol kolon ve 17’sinde (%29,8) sağ kolonda yerleşim göstermekteydi. Yirmi beş (%43,9) hasta oxaliplatin temelli ve 32 (%56,1) hasta da irinotekan temelli kemoterapi almıştı. Primer tümör lokalizasyonuna göre progresyonsuz sağkalım (PSK) ve genel sağkalım (GSK) süreleri arasında istatiksel anlamlı fark saptanmadı (PSK sol kolonda 10.9 ay, sağ kolonda 8.1 ay, p=0.400 ve GSK sol kolonda 20.9 ay, sağ kolonda 20.8 ay, p=0.930). Oxaliplatin temelli tedavi alan hastaların irinotekan temelli tedavi alanlara göre GSK ’larının daha iyi olduğu görüldü (28.7 ay,16.3 ay, sırası ile p=0.017). Sonuç: Çalışmamızda metastatik KRK hastalarında primer tümör yerleşim yerine göre guruplar arasında PSK ve GSK açısından fark saptanmadı. Ancak, bulgularımız bu hasta alt gurubu için standart yaklaşımın belirlenmesi için daha büyük hasta popülasyonları ve alt grup analizleri ile potansiyel prognostik ve moleküler özelliklerin değerlendirildiği çalışmalara olan ihtiyacın altını çizmektedir.

WOS: 000473357300009, PubMed ID: 31312795, Objective: Breast cancer is a heterogenous disease, and genetic profiling helps to individualize adjuvant treatment. The Oncotype DX is a validated test to predict benefit of adjuvant systemic treatment. The aims of this study are to determine the costs of chemotherapy in government hospitals in Turkey and evaluate the cost-effectiveness of the Oncotype DX from the national insurance perspective. Materials and Methods: A Markov model was developed to make long term projections of distant recurrence, survival, quality adjusted life expectancy, and direct costs for patients with ER+, HER2-, node-negative or up to 3 node-positive early stage breast cancer. Turkish decision impact study patient data were captured for model reference. In that study, ten academic centers across Turkey participated in a prospective trial. Of 165 patients with pT1-3, pN0-N1mic, ER-positive, and HER-2 negative tumors, 57% had low recurrence score (RS), 35% had intermediate RS, and 8% had high RS, respectively. The overall rate of change in chemotherapy treatment decisions following Oncotype DX was 33%. Results: The cost of adjuvant chemotherapy in public hospitals was estimated at $3.649, and Oncotype Dx test was $5.141. Based on the cost-effectiveness analysis, Oncotype DX testing was estimated to improve life expectancy (+0.86 years) and quality-adjusted life expectancy (+0.68 QALYs) versus standard care. The incremental cost-effectiveness ratio (ICERs) of Oncotype DX was estimated to be $7207.9 per QALY gained and $5720.6 per LY gained versus current clinical practice. Conclusion: As Oncotype DX was found both cost-effective and life-saving from a national perspective, the test should be introduced to standard care in patients with ER+, HER-2 negative early-stage breast cancer in Turkey.

Introduction and purpose: Educational status and the living environment are closely related to the survival rates of patients with head and neck cancer. In this study we evaluate the effects of educational status and the living environment on the survival of patients with head and neck cancer. Materials and methods: Patients with head and neck tumors that show squamous cell histological properties were included in the study. Cases had been followed up in Dicle University Medical Faculty Medical Oncology clinic between January 2006 and June 2013. Data was collected retrospectively from the medical records of the patients. Classical parameters, which are considered to affect the prognosis, such as age, gender, stage, tumor localization and performance status, were investigated, in addition to educational status and the living environment. Results: The study comprised 171 cases. The rate of metastatic disease was determined to be higher in illiterate patients, when compared to ones with at least an elementary school or higher education (12.7% and 8.1%, respectively; p = 0.012). Similarly, patients living in rural areas showed higher rates of metastatic disease, when compared to those living in cities (16.3% and 8.0%, respectively; p = 0.146). It was determined that the educational status (median overall survival in the cases with elementary school or higher education 21.5 months; in cases that cannot read or write, it is 10.3 months; p = 0.001) and the environment being lived (median overall survival in cases living in cities 17.6 months; in cases living in rural areas it is 9.0 months; p = 0.014) affect survival in the patients with head and neck cancer. In the multivariate analysis; age (>60 vs

Introduction and objective The present study aimed to evaluate the association between tumor Standard Uptake Value (SUVmax) values obtained by PET/CT, and survival in patients with locally advanced or metastatic squamous cell head and neck cancer. Method The present study included 38 patients with locally advanced or metastatic squamous cell head and neck cancer, who were staged using PET/CT at diagnosis. PET/CT imaging findings were evaluated retrospectively. The effect of SUVmax value by PET/CT on overall survival was analyzed. Results The most common tumor localization was laryngeal cancer among 38 patients included in the study (n = 25, 65.8%). The study group consisted of mostly male patients (n = 33, 86.8%), and the median age was 58 (range: 24–77). The median SUVmax value was 11 (range: 3–58). Median survival was 32.7 months in patients with SUVmax ≤11 compared to 16.5 months in patients with SUVmax >11 (p = 0.019).

Nodal (N) status and molecular subtypes are well-known prognostic factors for breast cancer patients. The aim of the present study was to evaluate whether there was a prognostic role of molecular subtypes for pN3a breast cancer patients in the modern therapeutic era. The present study retrospectively evaluated a total of 521 breast cancer patients who had 10 or more metastatic lymph nodes and received adjuvant systemic therapy at the Oncology Department of four different centers in Turkey between 2000–2015. Patients were divided into four molecular subtypes by immunohistochemical staining. There were no significant differences in relapse rates according to the molecular subtypes (P=0.07). The five year disease free survival rate was 62% for the whole study population, 67% for Luminal A tumors, 53% for Luminal B tumors, 64% for human epidermal growth factor receptor 2-positive tumors and 56% for triple negative tumors. Luminal A patients had a better progression free survival when compared with Luminal B (P=0.026) and triple negative (P=0.07) patients. pT stage (P

346 Background: Although clinical efficacy of gemcitabine in combination with nabpaclitaxel has been shown to be superior to single agent gemcitabine in a randomize phase 3 trial, data are lacking on the quality of life of this combination regimen as first-line therapy in patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma. Methods: We randomly assigned 125 patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1 to receive gemcitabine, 1000 mg/m2 plus nabpaclitaxel 125 mg/m2 or gemcitabine at a dose of 1000 mg per square meter weekly for 7 of 8 weeks and then weekly for 3 of 4 weeks. Treatment continued until disease progression or unacceptable toxicity. The primary end point was 3-months deterioration-free rate (percentage of patients free from definitive deterioration) and quality of life of patients. Results: The median overall survival was 9.92 months in the gemcitabine plus nabpaclitaxel group as compared with 5.95 months in the gemcitabine group (hazard ratio for death, 0.642, 95% confidence interval, 0.422 to 0.866; p < 0.038). Median progression-free survival was 6.28 months in the combination group and 3.22 months in the gemcitabine group (hazard ratio for disease progression, 0.582; 95% CI, 0.391 to 0.866; p < 0.008). The objective response rate was 37.1% in the combination group versus 23.7% in the gemcitabine group (p < 0.009). Median time to deterioration was 3.68 months in the gemcitabine arm versus 5.36 months in the combination arm. More data on quality of life will be presented. Conclusions: As compared with gemcitabine, gemcitabine plus nabpaclitaxel was associated with an overall and progressive free survival advantage, with increased response rate, without increasing toxicity and deterioration of quality of life. Gemcitabine and nabpaclitaxel combination regimen with this form is a preferable option for the treatment of patients with advanced pancreatic cancer Clinical trial information: EudraCT: 2013-004180-32.

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.

e21656 Background: Venous thromboembolism (VTE) is one of the most important causes of death in cancer patients, with VTE risk being 4-7 times higher among these patients compared to normal population. TREBECA is an observational study on cancer outpatients with low risk VTE treated with LMWH. Methods: Patients were treated by medical oncologists in Turkey at 15 sites, where they were enrolled and followed-up for a period of 12 months. Each center used their own treatment protocol. Primary endpoints were efficacy and the time to a change inVTE status (dissolution of thrombosis). The doses of LMWHs have been calculated according to patients’ body weights based on the dosage scheme and administered subcutaneously once or twice daily. Results: Data for 250 patients who met the study inclusion criteria were examined and analyzed. Of the included patients; 239 patients (95.6%) completed their Day 15 visit, 176 (70.4%) completed their Month 3 visit, 130 (52.0%) completed their Month 6 visit, and 91 (36.4%) completed the entire study. The mean age of the patients was 60.2 ± 13.7, while 53.2% (n = 133) of the patients were women. Colorectal (21.2%), lung (16.8%) and breast (14.8%) cancers were the most common forms of cancer. One hundred thirty-three patients were treated with enoxaparin, 112 patients were treated with bemiparin and 5 patients were treated with tinzaparin. Bemiparin resulted thrombosis resolution in more patients than enoxaparin, during day 15, month 3 and month 6 visits (table 1; p < 0.05). Conclusions: The observation that bemiparin is more effective in resolution of thrombosis was noteworthy. Thrombosis could not be effectively treated within the first 15 days in a significant number of patients, but could effectively be treated in most patients by Month 3. We can conclude that a treatment of at least 3 months is appropriate for cancer patients, even among those who are at low risk for venous thromboembolism. [Table: see text]

WOS: 000397930400218 … Genekor The study was supported by a grant provided by Genekor.

Aim To assess the safety and tolerability of adjuvant subcutaneous trastuzumab (Herceptin ® SC, H SC), delivered from an H SC Vial via hand-held syringe (Cohort A) or single-use injection device (Cohort B), with or without chemotherapy, for human epidermal growth factor receptor 2 (HER2)-positive stage I to IIIC early breast cancer (EBC) in the phase III SafeHer study (NCT01566721). Methods Patients received 600 mg fixed-dose H SC every 3 weeks for 18 cycles. The chemotherapy partner was at the investigators' discretion (H SC monotherapy was limited to ≤10% of the population). Data from the first H SC dose until 28 days (plus a 5-day window) after the last dose are presented. Results are descriptive. Results In the overall population, 2282/2573 patients (88.7%) experienced adverse events (AEs). Of the above, 128 (5.0%) patients experienced AEs leading to study drug discontinuation; 596 (23.2%) experienced grade ≥ 3 AEs and 326 (12.7%) experienced serious AEs. Grade ≥ 3 cardiac disorders were reported in 24 patients (0.9%), including congestive heart failure in eight (0.3%). As expected, the AE rates varied according to the timing of chemotherapy in both cohorts, with higher rates in concurrent versus sequential chemotherapy subgroups. In the concurrent chemotherapy subgroup, AEs were more common during the actual period of concurrent chemotherapy compared with the period when patients did not receive concurrent chemotherapy. Conclusion SafeHer confirms the safety and tolerability of the H SC 600 mg fixed dose for 1 year (every 3 weeks for 18 cycles) as adjuvant therapy with concurrent or sequential chemotherapy for HER2-positive EBC. These primary analysis results are consistent with the known safety profile for intravenous H and H SC.

Aim of the study: Gastrointestinal lymphoma is the most common type of extranodal lymphoma and commonly involved site is the stomach. We have compared the superiority between treatment modalities for primary gastric lymphoma and we want to investigate efficacy of rituximab in gastric lymphoma. Material and methods: Between April 2002 and December 2011, 146 patients with a histologically confirmed primary gastric lymphoma, initially diagnosed at eight different Cancer Centers within Turkey were evaluated retrospectively. According to the treatment modality, the patients were divided into chemotherapy (CT) alone, chemotherapy and radiotherapy (CRT), surgery and chemotherapy (SCT), surgery along with chemotherapy and radiotherapy (SCRT), and surgery (S) alone groups. Results: Median follow-up period was 25.5 months. The 5-year EFS (event free survival) and OS (overall survival) rates for the patients were 55% and 62.3% respectively. In Log rank analysis of OS and EFS, we have identified levels of albumin and hemoglobine, IPI score, stage at diagnosis as factors influencing survival. In multivariate analysis of OS and EFS, only albumin and stage at diagnosis were factors independently contributing to survival. There was no statistically significant difference in terms of survival between different treatment modalities (p = 0.707 in EFS and p = 0.124 in OS). In analysis of patients treated with chemotherapy alone, there was no a statistically significant difference in terms of EFS and OS between chemotherapy regimens with or without rituximab in localized and advanced stage groups (p = 0.264 and p = 0.639). There was no statistical difference in survival rate (EFS and OS) between surgical or non-surgical treatment modalities for localized/advanced stage gastric lymphoma groups (p = 0.519 / p = 0.165). Conclusions: There are several treatment options due to similar results in different treatment modalities. Also benefit of rituximab treatment in gastric lymphoma is still a controversial subject. Additional prospective trials are definitely required in order to clarify use of rituximab in treatment of extranodal gastric lymphoma.

Background: It has been demonstrated that there are a lot of different prognostic factors which are worthy of consideration whereas diabetes mellitus (DM) has not been clearly or consistently identified as a prognostic value in advanced non-small cell lung cancer (NSCLC). The aim of this study was to investigate the prognostic significance of the characteristics of patients in advanced NSCLC. Specifically, we investigated the impact of DM for progression-free survival (PFS) and overall survival (OS) in patients receiving first-line platinum-based doublets chemotherapy. Methods: We retrospectively reviewed 442 patients with advanced NSCLC. DM and other potential prognostic variables were chosen for analysis in this study. Univariate and multivariate analyses were conducted to identify prognostic factors associated with survival. Result: The results of univariate analysis for OS were identified as having prognostic significance: performance status (pÂ