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Background: We tried to understand the presence of any atherosclerotic background of cirrhosis in patients with sickle cell diseases (SCDs). Methods: The study was performed in the Hematology Service of the Mustafa Kemal University on SCDs patients between March 2007 and June 2012. Results: The study included 256 patients with SCDs (127 females). Their mean age was 29.3 years. Cirrhosis was detected in 5.8% (15) of the SCDs patients without any gender difference (6.2% of females versus 5.4% of males, p>0.05). There were 15 (5.8%) patients with chronic obstructive pulmonary disease with a highly significant male predominance (3.1% versus 8.5%, p0.05), and the mean ages were 31.0 and 26.8 years, respectively (p>0.05). Conclusion: Probably cirrhosis is a systemic inflammatory process prominently affecting the hepatic vasculature, and an eventual accelerated atheroscerotic process is the main underlying cause of characteristics of the disease. SCDs are accelerated systemic atherosclerotic processes, too, and the higher prevalence of cirrhosis in SCDs patients may indicate the underlying atherosclerotic background of cirrhosis. Key words: Atherosclerosis, metabolic syndrome, cirrhosis, sickle cell diseases

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

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 = 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., BayerBayer AG, This work was supported by Bayer. Bayer provided the study medication and collaborated with the authors to design the study. Bayer worked with the investigators on the collection, analysis and interpretation of the data, and on the preparation of this report. the authors made the final decision to submit the article for publication.

Soft tissue sarcomas (STS) are a heterogeneous group of rare mesenchymal neoplasms, accounting for

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

Summary Background Cytotoxic chemotherapy is generally ineffective in patients with hepatocellular carcinoma. We assessed the intravenous perfusion of doxorubicin-loaded nanoparticles in patients with hepatocellular carcinoma in whom previous sorafenib therapy had failed. Methods We did a multicentre, open-label, randomised, controlled phase 3 trial at 70 sites in 11 countries. Patients with hepatocellular carcinoma with one or more previous systemic therapies, including sorafenib, were randomly assigned to receive 30 mg/m2 doxorubicin-loaded nanoparticles (30 mg/m2 group), 20 mg/m2 doxorubicin-loaded nanoparticles (20 mg/m2 group), or standard care using a computer-generated randomisation list prepared by the funder and stratified by geographic region. Patients in the experimental groups received perfusion of the drug every 4 weeks and those in the control group received any systemic anticancer therapy (except sorafenib) as per investigator decision. The primary endpoint was overall survival in the intention-to-treat population. Safety was assessed in the population of patients who received at least one dose of their assigned treatment. This trial is registered with ClinicalTrials.gov , number NCT01655693 . Findings Between June 15, 2012, and Jan 27, 2017, 541 patients were screened, of whom 144 were excluded and 397 were randomly assigned to one of the groups (133 to the 30 mg/m2 group; 130 to the 20 mg/m2 group; and 134 to the control group). Median follow-up was 22·7 months (IQR 11·2–34·9). After pooling the doxorubicin groups for the efficacy analysis, median overall survival was 9·1 months (95% CI 8·1–10·4) in the pooled doxorubicin-loaded nanoparticles group and 9·0 months (7·1–11·8) in the control group (HR 1·00 [95% CI 0·78–1·28], two-sided p=0·99). 227 (94%) of 242 patients who received doxorubicin-loaded nanoparticles and 100 (75%) of 134 patients in the control group had at least one treatment-emergent adverse event. The most common drug-related grade 3 or 4 treatment-emergent adverse events were neutropenia (25 [10%] of 242 treated with doxorubicin-loaded nanoparticles and eight [6%] of 134 in the control group), asthenia (six [2%] and four [3%]), and thrombocytopenia (three [1%] and ten [7%]). Six (2%) patients treated with doxorubicin-loaded nanoparticles and one (1%) of those in the control group were deemed by investigators to have had a drug-related death. Serious adverse events occurred in 74 (31%) patients who received doxorubicin-loaded nanoparticles and 48 (36%) in the control group. Interpretation Doxorubicin-loaded nanoparticles did not improve overall survival for patients with hepatocellular carcinoma in whom previous sorafenib treatment had failed. Funding Onxeo.

WOS: 000404154000013, PubMed ID: 27812752, Background Currently, it is accepted that risk assessment of clinical stage I (CS I) nonseminomatous germ cell tumors (NSGCT) patient is mainly dependent on the presence of lymphovascular invasion (LVI). Initial active surveillance, adjuvant chemotherapy and retroperitoneal lymph node dissection (RPLND) are acceptable treatment options for these patients, but there is no uniform consensus. The purpose of this study was to compare outcomes of active surveillance with adjuvant chemotherapy. Methods A total of 201 patients with CS I NSGCT after orchiectomy were included. Outcomes of active surveillance and adjuvant chemotherapy were retrospectively analyzed. The prognostic significance of risk factors for survival and relapse was evaluated. Results Of the 201 patients, 110 (54.7%) received adjuvant chemotherapy, while the remaining 91 patients (45.3%) underwent surveillance. Relapses were significantly higher for patients underwent surveillance compared to adjuvant chemotherapy group (18.3 vs. 1.2%, p < 0.001). The 5-year relapse-free survival (RFS) rate for patients who were treated with adjuvant chemotherapy was significantly better than those of patients underwent surveillance (97.6 vs. 80.8%, respectively; p < 0.001). Univariate analysis showed that the presence of LVI (p = 0.01) and treatment option (p < 0.001) were prognostic factors for RFS and pT stage (p = 0.004) and invasion of rete testis (p = 0.004) and the presence of relapse (p < 0.001) were significant prognostic factors for OS. Multivariate analysis revealed that the treatment strategy was an independent prognostic factor for RFS (p < 0.001, HR 0.54). A logistic regression analysis demonstrated that treatment options (p = 0.031), embryonal carcinoma (EC) > 50% (p = 0.013) and tumor diameter (p = 0.016) were found to be independent factors for predicting relapse. Conclusion Our results indicate that adjuvant chemotherapy is associated with improved RFS compared with surveillance for CS I NSGCT patients. Moreover, the treatment strategy is an important prognostic indicator for RFS and a predictive factor for relapse. Although adjuvant chemotherapy seems to be a suitable treatment for patients with risk factors for relapse, surveillance is still preferred management option.

The aim of this retrospective study was to compare the different treatment options of patients with advanced biliary tract carcinoma (BTC) who were treated with platinum-gemcitabine (CG) or platinum-5-fluorouracil (CF) or 5-Fluorouracil-oxaliplatin-irinotecan (FOLFIRINOX) chemotherapy. We included the patients with advanced BTC who were registered at the Department of Oncology in Gaziantep University between January 2008 and January 2016. The following data were analyzed: disease control rate (DCR), progression free survival (PFS) of first and second-line of chemotherapy, and overall survival (OS). Kaplan–Meier method and Log-rank test was used to compare two survival curves, and hazard regression model was used to evaluate risk factors for PFS. Ninety-two patients were recruited. 53 (57.6 %), 27 (29.3 %), and 12 (13 %) patients received CG, CF, and FOLFIRINOX regimen as first-line chemotherapy, respectively. Median PFS and DCR of CG group were 22 weeks and 56.6 %, and these were 12 weeks and 44.4 % for CF group, and 9 weeks and 41.7 % for FOLFIRINOX group. Median OS of CG, CF, and FOLFIRINOX groups was 28, 21,and 23.5 weeks, respectively (p = 0.497). Second-line PFS of fluoropyrimidine-based chemotherapy group and gemcitabine-based chemotherapy group was 12 vs. 14 weeks (p = 0.988). Second-line PFS of FOLFIRINOX was 20 weeks, whereas it was 14 weeks for other fuoropyrimidine-based chemotherapies (p = 0.190). This was the first study evaluating the FOLFIRINOX regimen in BTC. Cisplatin-gemcitabine therapy still provides better survival in BCT. However, FOLFIRINOX can be an option in the second-line treatment of BTC patients who are eligible for chemotherapy.

Purpose The aim of this study is to clarify the relationship between recurrence risk of breast cancer and methylenetetrahydrofolate reductase (MTHFR) C677T polymorphisms.

Background Interindividual variability of pharmacogenetics may account for unpredictable neurotoxicities of taxanes.

Background BOLERO-2 phase III trial established the efficacy of everolimus (EVE) plus exemestane (EXE) for the treatment of postmenopausal patients with hormone receptor (HR)-positive, HER2-negative, advanced breast cancer (aBC). However, in this study only a minority ( Methods EVEREXES is an open-label phase IIIb, single arm, multi-center trial, which from March 2013 to October 2014 enrolled 232 post-menopausal, HR-positive and HER2-negative, aBC patients previously treated with aromatase inhibitors, across 13 countries in Asia Pacific, Middle East, North and South Africa, with a significant majority of patients being of Asian ethnicity (196, 84.5%). Its primary objective was to investigate the safety and tolerability profile of EVE+EXE. Secondary objectives were the evaluation of efficacy (assessed by PFS, ORR, and CBR based on RECIST 1.1 criteria) and change in ECOG performance status. Results At data cut off of 31st of January 2015, at a median follow up of 11.7 months, median PFS for the ITT population was 9.5 months [9.2-11.6 months], based on local assessment, with the observation of 1 (0.4%) CR and 35 (15.4%) PR. Regarding safety and tolerability, a majority (81.1%) of grade (G) 1/2 adverse events (AEs) was reported. In particular, the following pattern was observed in terms of % of patients who developed G1/G2/G3 mTOR-inhibition induced AEs: stomatitis (36.1, 13.7, 10.6), rash (21.6/6.2/0), fatigue (10.6, 4.4, 2.2), hyperglycemia (6.2, 11.5, 7.0), weight decrease (7.5, 7, 0.9), pneumonitis (5.7, 7, 0.9). No Grade 4 AEs related to EVE+EXE treatment were observed, with exception of one case of non infectious pneumonitis (0.4%). Median dose intensity of everolimus was 9.2 mg/day. Conclusions Efficacy and safety results from EVEREXES trial further confirm the role of EVE+EXE for the treatment of HR+/Her2- advanced BC patients in Eastern countries. Results were consistent with data previously reported in BOLERO-2 trial. Citation Format: Im Y-H, Uslu R, Lee KS, Nagarkar R, Sohn J, Sevinc A, Altundag K, Chang Y-C, Abdel-Razeq H, Im S-A, Jeong J, Park HY, Arpornwirat W, Bastick P, Le TH, Ocak Arikan O, Xue HL, Canatar A, Valenti R, Kim S-B. Clinical effectiveness of everolimus and exemestane in advanced breast cancer patients from Asia and Africa: First efficacy and updated safety results from the phase IIIb EVEREXES study. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-13-09.

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.

WOS: 000427407200003, PubMed ID: 29551901, Introduction: The introduction of targeted therapies in renal cell carcinoma has significantly improved its prognosis and treatment outcomes in recent years. Such treatment options are targeted therapies of the vascular endothelial growth factor (VEGF) pathway and the mammalian target of the rapamycin pathway. With the use of tyrosine kinase inhibitors (TKIs) and mammalian target of the rapamycin inhibitors, overall survival has increased up to 2 years. In Turkey, due to applicable reimbursement conditions for patients with metastatic renal cell carcinoma (mRCC), interferon use is mandated as a first-line treatment, thus providing information on the use of everolimus only after initial interferon and second-line VEGF-targeted treatments such as VEGF-TKI. Patients and methods: To provide a first real-life data set in Turkey, we conducted a prospective, non-interventional, observational study and assessed the efficacy and safety of everolimus after two lines of treatment including interferon. A total of 100 patients with histologically confirmed mRCC were enrolled in the study from 11 centers between June 2012 and March 2014 (70 males and 30 females). Efficacy was assessed on the basis of progression-free survival and overall survival; safety of everolimus was assessed on the basis of adverse event occurrence. Results: The study results showed that the median progression-free survival with everolimus treatment was 8.1 months (95% CI: 5.1-11.1) and the median overall survival was 17.6 months (95% CI: 10.1-25.1), thus indicating a better overall response based on survival durations than those from the randomized Phase III REnal Cell cancer treatment with Oral RAD001 given Daily study results (4.9 and 14.8 months, respectively). Conclusion: The study showed that everolimus treatment is a safe and effective treatment option in the treatment of mRCC after VEGF-TKI, with an acceptable safety and tolerability profile in real-life settings.

Prostate cancer is one of the frequently seen types of cancers in men. The most frequent histological type of prostate cancer is the acinar adenocarcinoma. Mucin-producing urothelial-type adenocarcinoma of the prostate is a very rare subtype. The mucin-producing urothelial-type adenocarcinoma of the prostate has microscopic similarities with colon and bladder adenocarcinoma. It has a more aggressive clinical course and does not respond to androgen deprivation therapy. A 77-year-old male patient diagnosed with mucinous prostate cancer was presented in the current case report.

Background: Biliary tract cancers are rare, and surgical resection is the standard treatment at early stages. However, reports on the benefits of adjuvant treatment following surgical resection are conflicting. This study aimed to evaluate the factors affecting survival and adjuvant treatments in patients with surgically treated biliary tract cancers. Materials and Methods: Patient clinical features, adjuvant treatments, and efficacy and prognostic factor data were evaluated. Survival analyses were performed using SPSS 15.0. Results: The median overall survival was 30.7 months (95% confidence interval [CI], 18.4-42.9 months). Median survival was 19 months (95% CI, 6-33) for patients treated with fluorouracil based chemotherapy and 53 months (95% CI, 33.2-78.8) with gemcitabine based chemotherapy (p=0.033). On univariate analysis, poor prognostic factors for survival were galbladder localization, perineural invasion, hepatic invasion, a lack of adjuvant chemoradiotherapy treatment, and a lack of lymph node dissection. On multivariate analysis, perineural invasion was a poor prognostic factor (p=0.008). Conclusions: Biliary tract cancers generally have poor prognoses. The main factors affecting survival are tumour localization, perineural invasion, hepatic invasion, adjuvant chemoradiotherapy, and lymph node dissection. Gemcitabine-based adjuvant chemotherapy is more effective than 5-fluorouracil-based chemotherapy.

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: 000392824000012, PubMed ID: 27768606, The objectives of this study were to compare progression-free survival (PFS) with somatostatin analog (SSA) versus chemotherapy (CTx) in first-line therapy and to determine the patient group in which these treatments were more effective in neuroendocrine tumors (NETs) with a Ki-67 index of 20% or less. Patients who received SSA or CTx and had unresectable locally advanced and metastatic NETs with a Ki-67 index of 20% or less were retrospectively selected from 13 centers in the Turkish database between 2000 and 2015. One hundred and sixty-five patients were enrolled. The median age was 56 years and the male-to-female ratio was 1.09. Seventy-four (45%) patients were of grade 1 NET and 91 (55%) were of grade 2. SSA was given to 104 patients, whereas 61 were treated with CTx. The objective response rate after SSA was 15.4%; another 73.1% had stable disease. The objective response rate after CTx was 36.1%, and 40.9% had stable disease (P = 0.008). The median PFS in SSA patients was 21 months (95% confidence interval: 12.4-29.6), and 8 months for CTx (95% confidence interval: 5.5-10.6) (P < 0.001). There was no significant difference between PFS of receiving SSA and CTx in pancreatic neuroendocrine tumor (PNET) patients; however, the PFS of receiving SSA was longer in non-PNET patients (P < 0.001). SSA was better treatment in advanced NET patients with a Ki-67 index of less than 5%, having a primary resected and a performance status of 0 (P < 0.05). SSA may be preferred over CTx in advanced NET patients with low-to-intermediate grade. Copyright (C) 2017 Wolters Kluwer Health, Inc. All rights reserved.

BACKGROUND: ExteNET showed that 1 year of neratinib, an irreversible pan-HER tyrosine kinase inhibitor, significantly improves 2-year invasive disease-free survival after trastuzumab-based adjuvant therapy in women with HER2-positive breast cancer. We report updated efficacy outcomes from a protocol-defined 5-year follow-up sensitivity analysis and long-term toxicity findings. METHODS: In this ongoing randomised, double-blind, placebo-controlled, phase 3 trial, eligible women aged 18 years or older (≥20 years in Japan) with stage 1-3c (modified to stage 2-3c in February, 2010) operable breast cancer, who had completed neoadjuvant and adjuvant chemotherapy plus trastuzumab with no evidence of disease recurrence or metastatic disease at study entry. Patients who were eligible patients were randomly assigned (1:1) via permuted blocks stratified according to hormone receptor status (hormone receptor-positive vs hormone receptor-negative), nodal status (0 vs 1-3 vs or ≥4 positive nodes), and trastuzumab adjuvant regimen (given sequentially vs concurrently with chemotherapy), then implemented centrally via an interactive voice and web-response system, to receive 1 year of oral neratinib 240 mg/day or matching placebo. Treatment was given continuously for 1 year, unless disease recurrence or new breast cancer, intolerable adverse events, or consent withdrawal occurred. Patients, investigators, and trial funder were masked to treatment allocation. The predefined endpoint of the 5-year analysis was invasive disease-free survival, analysed by intention to treat. ExteNET is registered with ClinicalTrials.gov, number NCT00878709, and is closed to new participants. FINDINGS: Between July 9, 2009, and Oct 24, 2011, 2840 eligible women with early HER2-positive breast cancer were recruited from community-based and academic institutions in 40 countries and randomly assigned to receive neratinib (n=1420) or placebo (n=1420). After a median follow-up of 5·2 years (IQR 2·1-5·3), patients in the neratinib group had significantly fewer invasive disease-free survival events than those in the placebo group (116 vs 163 events; stratified hazard ratio 0·73, 95% CI 0·57-0·92, p=0·0083). The 5-year invasive disease-free survival was 90·2% (95% CI 88·3-91·8) in the neratinib group and 87·7% (85·7-89·4) in the placebo group. Without diarrhoea prophylaxis, the most common grade 3-4 adverse events in the neratinib group, compared with the placebo group, were diarrhoea (561 [40%] grade 3 and one [BACKGROUND: ExteNET showed that 1 year of neratinib, an irreversible pan-HER tyrosine kinase inhibitor, significantly improves 2-year invasive disease-free survival after trastuzumab-based adjuvant therapy in women with HER2-positive breast cancer. We report updated efficacy outcomes from a protocol-defined 5-year follow-up sensitivity analysis and long-term toxicity findings.METHODS: In this ongoing randomised, double-blind, placebo-controlled, phase 3 trial, eligible women aged 18 years or older (≥20 years in Japan) with stage 1-3c (modified to stage 2-3c in February, 2010) operable breast cancer, who had completed neoadjuvant and adjuvant chemotherapy plus trastuzumab with no evidence of disease recurrence or metastatic disease at study entry. Patients who were eligible patients were randomly assigned (1:1) via permuted blocks stratified according to hormone receptor status (hormone receptor-positive vs hormone receptor-negative), nodal status (0 vs 1-3 vs or ≥4 positive nodes), and trastuzumab adjuvant regimen (given sequentially vs concurrently with chemotherapy), then implemented centrally via an interactive voice and web-response system, to receive 1 year of oral neratinib 240 mg/day or matching placebo. Treatment was given continuously for 1 year, unless disease recurrence or new breast cancer, intolerable adverse events, or consent withdrawal occurred. Patients, investigators, and trial funder were masked to treatment allocation. The predefined endpoint of the 5-year analysis was invasive disease-free survival, analysed by intention to treat. ExteNET is registered with ClinicalTrials.gov, number NCT00878709, and is closed to new participants.FINDINGS: Between July 9, 2009, and Oct 24, 2011, 2840 eligible women with early HER2-positive breast cancer were recruited from community-based and academic institutions in 40 countries and randomly assigned to receive neratinib (n=1420) or placebo (n=1420). After a median follow-up of 5·2 years (IQR 2·1-5·3), patients in the neratinib group had significantly fewer invasive disease-free survival events than those in the placebo group (116 vs 163 events; stratified hazard ratio 0·73, 95% CI 0·57-0·92, p=0·0083). The 5-year invasive disease-free survival was 90·2% (95% CI 88·3-91·8) in the neratinib group and 87·7% (85·7-89·4) in the placebo group. Without diarrhoea prophylaxis, the most common grade 3-4 adverse events in the neratinib group, compared with the placebo group, were diarrhoea (561 [40%] grade 3 and one [INTERPRETATION: At the 5-year follow-up, 1 year of extended adjuvant therapy with neratinib, administered after chemotherapy and trastuzumab, significantly reduced the proportion of clinically relevant breast cancer relapses-ie, those that might lead to death, such as distant and locoregional relapses outside the preserved breast-without increasing the risk of long-term toxicity. An analysis of overall survival is planned after 248 events.FUNDING: Wyeth, Pfizer, and Puma Biotechnology.

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.

Tulay Kus, Gokmen Aktas, Alper Sevinc, Mehmet Emin Kalender, Celaletdin Camci Department of Internal Medicine, Division of Medical Oncology, Gaziantep University, Gaziantep, Turkey Abstract: Erlotinib, an epidermal growth factor receptor and tyrosine kinase inhibitor, is a targeted drug that was approved for the treatment of non-small-cell lung cancers and pancreatic cancers. Targeted tyrosine kinase inhibitors are known to have cardiotoxic effects. However, erlotinib does not have a statistically proven effect of increasing acute cardiovascular event (ACE) risk. Preclinical studies showed that beta agonist stimulation among rats that were administered erlotinib led to cardiovascular damage. Thus, there would be an aggregate effect of erlotinib on ACE, although it is not thought to be a cardiotoxic drug itself. In this paper, we present two non-small-cell lung cancer cases that developed ACE under erlotinib treatment. Keywords: erlotinib, lung cancer, myocardial infarction, EGFR

Amac: Bu calismada primer akciger kanserli hastalarda agrinin ozellikleri degerlendirildi. Ca­lis­ma­pla­ni:­Ocak 2004 Ocak 2009 tarihleri arasinda Gaziantep Universitesi Tip Fakultesi Algoloji klinigine basvuran 216 primer akciger kanserli hastanin (184 erkek, 32 kadin; ort. yas 63 yil; dagilim 30-85 yil) verileri retrospektif olarak degerlendirildi. Kanserle iliskili agrinin baslangici, yeri ve dogasi degerlendirildi. Bul gu lar: Agri sirt, omuz, ust karin, sakroiliyak eklem ve bacaklarda yerlesmis idi. Calisma grubunda, agri 154 hastada (%71.3) akciger disi metastaz, 62 hastada (%28.7) ise akcigerdeki primer tumorden kaynaklanmakta idi. Yuz bes hastada (%48.6) noropatik agri, 61 hastada (%28.2) ise viseral agri vardi. Viseral ve noropatik agrinin ortalama baslama zamani sirasiyla 2 ve 12 hafta idi. Tibbi tedavi hastalarin %68.5’de etkili bulundu. Ancak hastalarin %31.5’de tibbi tedaviye ek olarak santral ve periferik bloklar ile agri kontrol edildi. So­nuc:­Calisma bulgularimiz, noropatik agrinin calisma grubunda daha sik goruldugunu ve agrinin tum hastalarda tibbi veya girisimsel yontemler ile kontrol altina alindigini gosterdi. Anah tar soz cuk ler: Kanser; girisimsel yontemler; agri yonetimi; akciger. Background:­This study aims to evaluate characteristics of pain in primary lung cancer patients. Methods: Between January 2004 and January 2009, data of 216 patients with primary lung cancer (184 males, 32 females, mean age 63 years; range 30 to 85 years) who were admitted to Gaziantep University, Faculty of Medicine, Algology Outpatient Clinic were retrospectively analyzed. The onset, localization and nature of cancerrelated pain were evaluated. Results:­Pain was localized in the back, shoulders, upper abdomen, sacroiliac joint and legs. Pain originated from non-pulmonary metastasis in 154 patients (71.3%) and primary lung cancer in 62 patients (28.7%) in the study group. One hundred five (48.6%) patients had neuropathic pain, while 61 patients had visceral pain (28.2%). The mean onset of visceral and neuropathic pain was 2 and 12 weeks, respectively. Medical treatment was found to be effective in 68.5% patients. However, pain was controlled with central or peripheral block in addition to medical treatment in 31.5% patients. Conclusion:­ Our study results showed that neuropathic pain was more frequent in the population and pain was controlled with medical or interventional methods in all patients.

Substantial advancements have been made in the treatment of metastatic malignant melanoma, for which therapeutic options were quite limited until recently, with the elucidation of molecular pathways that play role in the development and progression of the disease. Although remarkable improvement has been achieved in survival rates with these advancements, a satisfactory response rate could not be obtained or high response rates could not be maintained. In this paper, therapeutic options for metastatic melanoma, particularly ipilimumab and vemurafenib that are also in use in our country, were summarized.

Gokmen Aktas,1 Tulay Kus,1 Mehmet Emin Kalender,1 Alper Sevinc,1 Celaletdin Camci,1 Seval Kul2 1Division of Medical Oncology, Department of Internal Medicine, School of Medicine, Gaziantep Oncology Hospital, Gaziantep University, Gaziantep, Turkey; 2Department of Biostatistics, School of Medicine, Gaziantep University, Gaziantep, Turkey Purpose: The number of patients who make it to receive third-line chemotherapy is increasing owing to the improvements in adverse-event management of chemotherapy for small-cell lung cancer (SCLC). Sequencing of optimal treatment for SCLC is still a challenge for oncologists. In this paper, we aim to present a different approach to the treatment of SCLC.Methods: Between January 2008 and July 2014, all patients diagnosed with extensive-stage SCLC and treated with third-line chemotherapy at Gaziantep University Oncology Hospital were analyzed retrospectively. Disease control rates and progression-free survival (PFS) for first-, second-, and third-line chemotherapy, and overall survival (OS) were recorded. Survival analysis was calculated by using Kaplan–Meier method.Results: A total of 255 SCLC patients were screened, and 25 of those patients who received third-line chemotherapy were included in this study. Median age was 57±10.131 years (range:39–74 years). Disease control rates at first-, second-, and third-line chemotherapy were 92%, 68%, and 44%, respectively. Fourteen patients received irinotecan followed by topotecan, and eleven patients received topotecan followed by irinotecan. Second-line median PFS was statistically better in patients treated with irinotecan at second-line compared with those treated with topotecan (21 vs 12 weeks, P=0.018). Comparison of third-line median PFS of the two groups was not statistically significant (14 vs 12 weeks, P=0.986). Median OS was not statistically significant in patients who received irinotecan followed by topotecan vs those who received topotecan followed by irinotecan (18 vs 14 months, P=0.112).Conclusion: Sequential monotherapy with topotecan and irinotecan provides a considerable contribution to OS, and second-line irinotecan showed a better PFS, despite a similar OS, compared with topotecan. Keywords: small-cell lung cancer, irinotecan, topotecan, third-line chemotherapy

A 46-year-old man was diagnosed with brain metastasis after a two-year history of melanoma. Paliative radiotherapy was administered followed by dacarbazine, temozolamide, ipilimumab, stereotactic radiosurgery, ipilimumab reinduction and finally vemurafenib, to which the patient showed objective responses. The patient received vemurafenib for four months and died after progresive disease. Long-term follow-ups after surgery have been reported in the literature. However, in patients with unresectable metastases, outcomes are mostly detrimental. The present patient survived for 40 months after brain metastasis. The unusually long survival observed in the present case indicates the sequential effectiveness of radiotherapy, chemotherapy, ipilimumab, stereotactic radiosurgery and vemurafenib.

Sunitinib is an oral multitargeted tyrosine kinase inhibitor that was newly approved by the FDA for the treatment of renal cell carcinoma and imatinib-resistant gastrointestinal stromal tumors. Although generally well tolerated, common side effects of sunitinib have been reported, with an important and well-recognized example being hypothyroidism. Although the exact mechanism of sunitinib-induced hypothyroidism is unclear, some authors have suggested sunitinib might induce hypothyroidism by the blockade of iodine uptake, destructive thyroiditis and inhibition of peroxidase activity. In these studies autoimmune-mediated hypothyroidism could not be demonstrated as an etiological factor. We herein report the case of a 71-year-old woman diagnosed as metastatic renal cell carcinoma with severe autoimmune hypothyroidism associated with sunitinib after 10 months of treatment. To the best of our knowledge, this is the first report that shows sunitinib may induce autoimmune thyroiditis. Further clinical and experimental studies with larger patient groups are required to verify the findings of the present study. Routine monitoring of thyroid autoantibodies including antithyroglobulin and antithyroid peroxidase antibodies and thyroid ultrasonography are recommended during the treatment of sunitinib-induced hypothyroidism.

Patients with advanced non-small cell lung cancer (NSCLC) generally require second-line treatment although their prognosis is poor. In this multicenter study, we aimed to detect the characteristics related to patients and disease that can predict the response to second-line treatments in advanced NSCLC. Data of 904 patients who have progressed after receiving first-line platinum-based chemotherapy in 11 centers with the diagnosis of stage IIIB and IV NSCLC and who were evaluated for second-line treatment were retrospectively analyzed. The role of different factors in determining the benefit of second-line treatment was analyzed. Median age of patients was 57 years (range 19-86). Docetaxel was the most commonly used (20.9 %, n = 189) single agent, while gemcitabine-platinum was the most commonly used (6.7 %, n = 61) combination chemotherapy regimen in second-line setting. According to survival analysis, median progression-free survival after first-line treatment (PFS2) was 3.5 months (standard error (SE) 0.2; 95 % confidence interval (CI), 3.2-3.9), median overall survival (OS) was 6.7 months (SE 0.3; 95 % CI, 6.0-7.3). In multivariate analysis, independent factors affecting PFS2 were found to be hemoglobin (Hb) level over 12 g/dl and treatment-free interval (TFI) longer than 3 months (p = 0.006 and 0.003, respectively). Similarly, in OS analysis, Hb level over 12 g/dl and time elapsed after the first-line treatment that is longer than 3 months were found to be independent prognostic factors (p = 0.0001 and 0.045, respectively). In light of these findings, determining and using the parameters for which the treatment will be beneficial prior to second-line treatment can increase success rate.

Background: Patient compliance with long-term use of adjuvant AI treatment is a multidimensional problem. EM may improve patients’ treatment compliance, and understanding the reasons for non-compliance may aid the design of future interventions aimed at improving patients’ compliance. Methods: This 2-year, global observational study (NCT00681122) recruited 2,758 patients in 18 countries to investigate whether EM could influence patients’ motivation and behaviour, and improve treatment compliance. A total of 352 patients from 23 centres were randomised 1:1 to Group A: Standard Therapy or Group B: Standard Therapy + EM in the Turkey arm of the CARIATIDE study. Group B patients received regular EM with a range of information on breast cancer-related topics. The primary study endpoint was compliance rate for the adjuvant AI medication and secondary endpoints were persistence rate after 1 and 2 years, and reasons for and time to treatment discontinuation of AI. Specialised questionnaires were used to evaluate patients’ compliance and behaviour (EORTC-INPATSAT-32, OPTIMA-X, GHQ-12, FACT-ES, compliance questionnaire and EM feedback in Group B). Study accrual was completed in March 2009. Results: Preliminary, investigator-assessed analysis at 1 year: data did not show statistical difference for compliance rates and compliance with initial AI in groups A and B (91% vs. 89% and 85% vs. 82%, respectively). Persistence rates were also similar (91% vs. 90%). Treatment discontinuation rates were 15% in Group A and 19% in Group B at 1 year; discontinuation was mainly attributed to lost to follow up (46% in Group A and 55% in Group B). AI medication discontinuation was the third most common reason for discontinuation in Group A (15%) and Group B (9%). Total scores of Subject Mental Well-being evaluated by GHQ-12 were 2.8±3.4 in Group A and 2.5±3.2 in Group B at baseline and were determined to be 1.5±2.5 and 2.0±2.8 at the end of the first year in Group A and B, respectively. Summary scores obtained for EORTC INPATSAT-32 for subj ects were 71.0±21.8 and 72.6±20.4 at baseline while 76.6±18.6 and 78.5±18.3 at the end of the first year in Group A and B, respectively. Total scores obtained for FACT-ES scale were 128.4±23.6 and 126.6±23.6 at the end of the first year in Group A and B, respectively. Summary scores obtained for Medication Adherence Profile OPTIMA-X were 70.5±14.9 and 72.6±13.5 in the baseline while 75.1±12.4 and 74.2±11.5 at the end of the first year in Group A and B, respectively. Discussion: At 1 year, CARIATIDE data showed that the provision of EM did not improve patients’ compliance. Compliance with initial AI, compliance with AI and persistence with therapy rates at 1 year did not show statistically significant differences between treatment arms. Specialised questionnaires did not reveal differences between the two groups. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-08-02.

Background. Platinum, antracyline, and fluoropyrimidine combination chemotherapy has been widely used as a first-line treatment for advanced gastric cancer (AGC). In the present study, we determined the efficacy and the safety of docetaxel and oral etoposide as second-line combination chemotherapy after failure of commonly used combination regimens in AGC. Methods. Patients with histologically proven gastric cancer and measurable metastatic disease received docetaxel 75 mg/m2 as a 1-h intravenous infusion on day 1, and oral etoposide 50 mg/m2 once daily on days 1—5, every 3 weeks until disease progression or unacceptable toxicities. Results. Between June 2006 and September 2008, 32 patients, of median age 60 years (range 32—77 years) were included in the study. Overall response rate was 9.4% and 31.3% of patients achieved a stable disease. Median progression-free survival was 3 months (95% CI, 2.5—3.5). Median overall survival was 6 months (95% CI, 3.8—8.2) with 16.9% 1-year survival rate. Grade 3—4 toxicities included neutropenia (28.8%), febrile neutropenia (18.8%), thrombocytopenia (3.1%), nausea and vomiting (15.6%), diarrhea (9.4%), and mucositis (6.2%). Conclusion. Docetaxel and oral etoposide combination was moderately effective and safe in appropriately selected AGC patients after failure of platinum- and fluoropyrimidine-based combination regimens. J Oncol Pharm Practice (2010) 16: 173—178.

The aim of the study was to evaluate the efficacy and tolerability of gemcitabine and uracil-tegafur (LIFT) combination in patients with advanced pancreatic carcinoma, retrospectively. Thirty-one patients, including 27 with metastatic disease, were treated with gemcitabine at a dose of 1000 Mg/m(2) in 30 minutes on days 1 and 8, and oral UFT 300 mg/m(2) on days 1-14, as the first-line regimen in advanced stage. The cycle was repeated every 21 days. A total of 116 cycles of chemotherapy were administered, with a median of 3 cycles per patient (range 1-13). The objective response rate was observed in 6 (19.3%) patients with 1 (3.2%) complete response, and 5 (16.1%) partial responses. The median response duration was 4 (range, 3-14) months. Eight (25.8%) patients had a standard deviation of more than 3 months. Median overall survival was 8 months (95% Cl, 6-10 months) and median time to progression was 4.2 months (95% Cl, 1-6 months). This combination was generally well tolerated. There were no life-threatening side effects. Most common toxicities were of hematologic and gastrointestinal nature. In conclusion, this regimen was well tolerated and seemed to have a moderate activity in the palliative treatment of advanced pancreatic carcinoma.

Ovarian cancer remains one of the most lethal of all gynecologic malignancies, accounting for more deaths than cervical and uterine cancer combined. Advanced ovarian cancer is a chemosensitive tumor and most patients initially respond to platinum-based combination chemotherapy with response rates of about 70%, including a high proportion of complete responses. However, despite aggressive surgery and chemotherapy, more than 80% of patients will relapse and will then be treated with second line chemotherapy with objective responses in about 20% of patients and even lower percentages of complete responses. We observed a 42-months of complete response with administration of 1-[2-tetrahydrofuryl]-5-fluorouracil mixed with uracil (UFT) in patient with platinium refractory ovarian cancer. We report a complete remission of platinium refractory epitelial ovarian cancer with UFT monotherapy that was not reported previously.

Oxaliplatin and taxane-induced neurosensory toxicity is dose-limiting and mostly presents with acute symptoms that affect the activities of daily living and overall quality of life. The objective of the present study is to assess the relief of acute neuropathy with venlafaxine treatment during the chemotherapy period. In this retrospective case–control study, from January 2010 to February 2015, patients who experienced treatment with oxaliplatin and taxane-induced acute neurotoxicity were evaluated according to the NCI-CTCAE v. 4.03 grading scale. Neurotoxicity was evaluated using a numeric rating scale (NRS) for pain intensity and experienced relief under the treatment of venlafaxine and using a neuropathic pain symptom inventory scale (NPSI) for the style of complaints. Patients who were diagnosed as mildly depressed according to the HOST anxiety and depression scale and who had grade 1 to 3 sensory neurotoxicity based on the NCI-CTCAE v. 4.03 grading scale, and who also reported ≥4/10 on a NRS were eligible. The primary end point was the rate of more than 75 % symptomatic relief under venlafaxine treatment. Two hundred six patients were included (82 % female, median age: 52.7 years). Most patients had breast, gynecologic, and colon cancer (93.4 %). Ninety-one patients who received venlafaxine and 115 patients as the control group were assessed for neurotoxicity every 3 weeks. Based on the NRS, a rate of more than 75 % symptomatic relief was 53.5, 58.3, and45.2 % in venlafaxine arm versus 0, 0, and 0 % in the control arm in the first, second, and third visits, respectively. Side-effects of venlafaxine (n = 7) were grade 1–2 nausea/vomiting (3.2 %) and asthenia/somnolence (3.2 %) without grade 3–4 events. Venlafaxine has a significant clinical activity against taxane-oxaliplatin-induced acute neurosensory toxicity.

The purpose of this study was to determine whether the presence of diabetes mellitus (DM) influences the incidence and severity of peripheral sensory neuropathy (PSN) in patients using taxane therapy.A retrospective single-center analysis was conducted: Patients with PSN at baseline were excluded. The incidence of PSN was evaluated retrospectively in patient subgroups who received taxane arm and taxane-plus-platinum-agents combination arm with or without known DM at baseline.Three hundred seventy-four patients were enrolled in this study, 81 (21.6%) of patients had DM at baseline. The incidence of grade 1 PSN (non-DM/DM) in patients receiving taxane-based chemotherapy was 33.4/25.9% and more than grade 2 PSN (non-DM/DM) was 15/34.6%. The rate of neuropathy of non-diabetic patients was 48.8%, while the rate of diabetic patients was 52.8 and 75% in DM duration below 5 years and above 5 years group, respectively.This retrospective analysis indicates that taxane-based therapy in DM patients whose disease duration is above 5 years appears to affect the incidence and severity of PSN without known baseline neuropathy. The probability of PSN with taxane-based therapy was similar in DM duration below 5 years and non-DM patients.

Background and Aim: Breast cancer is the most common type of cancer amongst women today. The aim of this study was to examine the association between complementary and alternative medicine (CAM) and the quality of life (QoL), anxiety and depression and demographic characteristics of women with breast cancer. Materials and Methods: QoL was measured by the European Organization for Treatment and Research of Cancer quality of life core questionnaire (QLQ-C30, version 3.0) and anxiety and depression was measured by the hospital anxiety and depression scale. Results: In total, 122 patients with breast cancer were enrolled in the study and 50% (n = 61) of them reported that they were using CAM. The most commonly used CAM methods were stinging nettle (57%) and prayer and spiritual healing (49%). No relationship was found between the use of CAM and the patient's age, time to diagnosis, cancer stage, chemotherapy use, smoking and residence. However, the analyses showed a positive association between CAM and role functioning (P = 0.014) and financial difficulties (P = 0.011); and a negative association between CAM and emotional functioning (P = 0.033). Conclusions: Based on the previous studies, 20-83.3% of breast cancer patients among different countries and cultures used CAM. Our results suggested that the use of CAM among women is quite popular, but they showed no correlation between CAM usage and anxiety and depression. In addition, CAM usage was more common in breast cancer patients with a poor emotional and financial status.

PubMedID: 24338610 Background: Optimal duration of adjuvant trastuzumab in early breast cancer is an unresolved issue. In this observational study, we compared the outcome of 9 weeks and 1 year adjuvant trastuzumab in early breast cancer patients in Turkey. Methods: Records of 680 patients with HER2-positive early breast cancer who received adjuvant trastuzumab plus chemotherapy were obtained and patients were followed up to compare the disease-free survival (DFS) outcome of 9 weeks versus 1 year trastuzumab. Results: Nine weeks and 1 year trastuzumab was given to 202 (29.7 %) and 478 (70.3 %) patients, respectively. There was a significantly lower rate of patients with negative lymph nodes in the 9-week trastuzumab group. At median 3 years of follow-up from the date of starting trastuzumab, the DFS rates were 88.6 and 85.6 %, respectively (p = 0.670). When adjusted for all the prognostic factors that were significant on univariate analysis, again there was no significant difference in DFS between the groups (HR 0.675; 95 % CI 0.370–1.231; p = 0.200). Cardiac toxicity defined as a ?15 % decrease in LVEF was significantly higher in the 1-year trastuzumab group (1.88 % versus none for 1-year and 9-week trastuzumab groups, respectively; p = 0.050). Conclusion: The results of this observational study suggest that DFS outcome of 9 weeks of adjuvant trastuzumab may be comparable to 1 year adjuvant trastuzumab: this needs confirmation by randomized trials. © 2013, The Japanese Breast Cancer Society.

Mustafa Benekli,1 Suayib Yalcin,2 Metin Ozkan,3 Emin Tamer Elkiran,4 Alper Sevinc,5 Devrim Cabuk,6 Hasan Senol Coskun,7 Berna Oksuzoglu,8 Banu Bayar,9 Akif Akbulat,9 Ahmet Ozet1 On behalf of Turkish Thyroid Cancer Study Group 1Department of Medical Oncology, Gazi University Faculty of Medicine, Ankara, 2Department of Medical Oncology, Hacettepe University Faculty of Medicine, Ankara, 3Department of Medical Oncology, Erciyes University Faculty of Medicine, Kayseri, 4Department of Medical Oncology, Inonu University Faculty of Medicine, Malatya, 5Department of Medical Oncology, Gaziantep University Faculty of Medicine, Gaziantep, 6Department of Medical Oncology, Kocaeli University Faculty of Medicine, Kocaeli, 7Department of Medical Oncology, Akdeniz University Faculty of Medicine, Antalya, 8Department of Medical Oncology, Ankara Oncology Training and Research Hospital, Ankara, 9Ministry of Health of Turkey, General Directorate of Pharmaceuticals and Medical Devices, Ankara, Turkey Background: Antivascular endothelial growth factor tyrosine kinase inhibitors have been used recently in the treatment of advanced differentiated thyroid cancer (DTC) and medullary thyroid cancer (MTC). Off-label sorafenib is used in Turkey with special permission by the Ministry of Health for this indication. Patients and methods: Patients with advanced DTC and MTC were retrospectively identified from the Turkish Ministry of Health database. Data on these patients were prospectively collected before permission is granted to use sorafenib. Results: Thirty patients with complete data were analyzed: 14 DTC (papillary number [n] =10; follicular n=4) and 16 MTC. The median age of the patients was 57 years (range: 28–79 years), and there were 18 males and 12 females. All DTC patients were iodine refractory and had received a median three doses of radioactive iodine (range: 1–7 doses). Sorafenib was used for a median of 12 months (range: 1–49 months). The overall response rate was 20%, all partial responses, with no complete response. The overall response rate was 14% in DTC and 25% in MTC patients. The median progression-free survival (PFS) was 17.1 months (95% confidence interval [CI]: 7.3–26.8) and overall survival (OS) was not reached. The 2-year PFS and OS were 39% and 68%, respectively. DTC and MTC patients had similar survival outcomes: median PFS of 21.3 months (95% CI: 5.8–36.7) versus 14.5 months (95% CI: 3.7–25.2), respectively (P=0.36), with the median OS not reached in either group (P=0.17). Tumor marker levels did not have any prognostic or predictive role. The toxicity profile was similar to that of other sorafenib trials. Conclusion: Sorafenib is an effective and well-tolerated treatment in advanced thyroid cancers. Keywords: advanced thyroid cancer, sorafenib, overall survival

In this study, we investigated the rate of human epidermal growth factor receptor 2 (HER2) overexpression in gastric (GC) and gastroesophageal junction cancers (GEJCs) and the relationship with HER2 expression and clinical, pathological parameters and prognosis. Surgery or biopsy specimen of 598 (436 males, 162 females) patients with GC or GEJC was evaluated for the presence of HER2 overexpression by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) methods. HER2 IHC scores were as follows: 418 (69.9 %) IHC 0, 58 (9.7 %) IHC 1+, 50 (8.4 %) IHC 2+, 72 (12 %) IHC 3+. Among 50 patients with IHC 2+, 18 (38.2 %) were FISH positive, and 29 (61.7 %) were FISH negative for HER2 amplification. Patients were regarded as HER2 positive in case of IHC 3+ disease or IHC 2+ disease with a positive FISH test result for HER2 amplification. In the primary analysis population, 90 (15 %) were considered HER2 positive. HER2 positivity was higher in intestinal GC compared to diffuse GC (16.9 vs 6.6 %, p = 0.014). HER2 positivity was significantly higher in well and moderately differentiated tumors than poorly differentiated tumors (p

Granulocytic sarcoma (GS) is an extramedullary tumor composed of immature cells of the granulocytic series known to occur in patients with myelodysplastic syndrome, chronic myelogenous leukemia, or acute myelogenous leukemia (AML). Involvement of the gastrointestinal tract is relatively rare in GS. We present an extremely rare case of GS of the colon and liver infiltration in a 60-year-old male patient with AML presenting with jaundice and hematochezia and review the literature. It should be kept in mind that hematochezia may be due to colonic involvement of GS besides thrombocytopenia which is usually encountered in patients with AML.

Lapatinib is the first dual tyrosine kinase inhibitor of human epidermal growth factor receptor type 2 (HER2/neu) and epidermal growth factor receptor (EGFR). The present study evaluated the efficacy and tolerability of the combination of lapatinib and capecitabine in patients with metastatic breast cancer (MBC) who progressed after therapy with trastuzumab, a taxane and/or anthracycline. A total of 203 patients with a median age of 48 years (range: 25-82 years) were evaluated retrospectively in 11 centres between September 2007 and May 2011. All the patients had HER2-positive MBC progressing after trastuzumab and chemotherapy including an anthracycline and/or taxane. All patients were treated with the combination of lapatinib (1250 mg/day, continuously) and capecitabine (2000 mg/m(2) on days 1 through 14 of a 21-day cycle). Data on demographics, clinical outcome, and toxicity were collected for descriptive analyses. The median follow-up was 10.7 months (range: 1-40 months). An overall response rate (ORR) of 33.4% was achieved including 7 complete responses (CR, 3.4%), 61 partial responses (PR, 30.0%), and 44 stable disease (37.9%). Clinical benefit rate of 71.3% was achieved. Median progression-free survival (PFS) was 7 months (95% CI: 6-10 months), with a median overall survival (OS) of 15 months (95% CI: 12-18 months). The most common side effects were hand-foot syndrome (46.8%), nausea (42.3%), fatigue (42.2%), anorexia (38.5%), diarrhea (31.5%), and rash (29.6%). Grade 3-4 toxicities were identified as hand foot syndrome (7.9%), diarrhea (6.9%), fatigue (5.9%), and rash (5.4%). There were no symptomatic cardiac events. Lapatinib and capecitabine combination therapy is effective and well tolerated in patients with MBC who had progressive disease after trastuzumab, taxane, and/or anthracycline therapy, as evidenced by this retrospective evaluation. Toxicity was mild to moderate with low grade 3-4 toxicity.

e20051 Background: Mucosal melanoma is a rare disease that is clearly distinct from cutaneous melanoma in clinical course and prognosis. We aim to evaluate patients with mucosal melanoma of differe...

50th Annual Meeting of the American-Society-of-Clinical-Oncology -- MAY 30-JUN 03, 2014 -- Chicago, IL, WOS: 000358613200846, …, Amer Soc Clin Oncol

e12518 Background: Breast cancer (BC) is the most common cancer in women in Turkey. Studies investigating the epidemiology of BC in Turkey are retrospective case series providing limited informatio...

e15176 Background: Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal neoplasm of the gastrointestinal tract. We aimed to survey the approximate incidence, clinicopathological ...

e11542 Background: Breast cancer is the most common cancer in women. Approximately 60% of breast cancer are hormone receptor positive. The goal of this study is to evaluate the possible factors affecting the survival of patients treated with gonadotropin-releasing hormone (GnRH). Methods: Demographic characteristics, treatment modalities, overall survival and the possible factors affecting the survival a total of 539 premenoposal breast cancer patients from 16 different centers in Turkey analysed retrospectively. Results: Median age was 36±6.3 (19-53). The median tumour size was 2.5±1.8 (0.5-13) cm. Estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2) positivity rates were 92.0%, 90.4% 31.4% respectively. Histology of the tumors were as follows; invasive ductal carcinoma in 85.3%, invasive lobular carcinoma in 4.6%, mixed in 4.6%, and other subtypes in 5.3%. T staging were T1, T2, T3, T4 in 25.8%, 49.9%, 13.4%, 1,7% respectively. Lymph node involvement was in...

WOS: 000329829200052, PubMed: 24377556, Background: Non-epithelial malignant ovarian tumors and clear cell carcinomas, Brenner tumors, transitional cell tumors, and carcinoid tumors of the ovary are rare ovarian tumors (ROTs). In this study, our aim was to determine the clinicopathological features of ROT patients and prognostic factors associated with survival. Materials and Methods: A total of 167 patients with ROT who underwent initial surgery were retrospectively analyzed. Prognostic factors that may influence the survival of patients were evaluated by univariate and multivariate analyses. Results: Of 167 patients, 75 (44.9%) were diagnosed with germ-cell tumors (GCT) and 68 (40.7%) with sex cord-stromal tumors (SCST); the remaining 24 had other rare ovarian histologies. Significant differences were found between ROT groups with respect to age at diagnosis, tumor localization, initial surgery type, tumor size, tumor grade, and FIGO stage. Three-year progression-free survival (PFS) rates and median PFS intervals for patients with other ROT were worse than those of patients with GCT and SCST (41.8% vs 79.6% vs 77.1% and 30.2 vs 72 vs 150 months, respectively; p=0.01). Moreover, the 3-year overall survival (OS) rates and median OS times for patients with both GCT and SCST were better as compared to patients with other ROT, but these differences were not statistically significant (87.7% vs 88.8% vs 73.9% and 170 vs 122 vs 91 months, respectively; p=0.20). In the univariate analysis, tumor localization (p

Background: There is no standard treatment for patients with colorectal cancer (CRC) progressing after irinotecan and oxaliplatin treatment. Here we aimed to retrospectively evaluate the efficacy and tolerability of raltitrexed in combination with oral 5-fluoropyrimidine (uracil tegafur-UFT) or mitomycin C as salvage therapy in mCRC patients. Materials and Methods: A total of 62 patients who had received raltitrexed combined with UFT or mitomycin C were identified between December 2008 and June 2013. They were given raltitrexed 2.6 mg/m(2) (max 5 mg) i.v. on day 1 in combination with either oral UFT 500 mg/day on days 1-14 every 3 weeks (group A) or mitomycin C 6 mg/m(2) i.v. on day every 3 weeks (group B). Results: Forty-two patients (67.7%) were in group A and 20 (32.2%) in group B. In 15 patients (24%) grade 3/4 toxicity was observed, resulting in dose reduction, and in 13 patients (20.9%) dose delay was necessary. The median progression free survival (PFS) was 3 months (95% CI 2.65-3.34) and median overall survival (OS) was 6 months (95% CI 2.09-9.90) in the whole group. Median PFS was 3 months (95% CI 2.60-3.39) in group A vs 3 months (95% CI 1.64-4.35) in group B (p=0.90). Median OS was 6 months (95% CI 2.47-9.53) in group A vs 12 months (95% CI 2.83-21.1) in group B (p=0.46). Conclusions: The combination of raltitrexed with UFT or mitomycin C seem to be a salvage therapy option due to safety profile and moderate clinical activity in heavily-pretreated mCRC patients.

Gastric cancer is one of most common types of cancers. Metastatic gastric cancer has a poor prognosis and is accepted as incurable at this stage. Treatment of metastatic gastric cancer did not progress substantially until new targeted agents have come out. Recently published ToGA trial showed promising results in HER2 overexpressing metastatic gastric cancer. In this case we present a case with an excellent complete response with anti-HER2 treatment. Most importantly, we wanted to emphasize (1) the importance of early determination of HER2 overexpression, and (2) to draw attention of anti-HER2 agents in the first line treatment even in patients with a poor performance status.

WOS: 000351058400056, PubMed ID: 25556478, Background: XELOX plus bevacizumab (XELOX-Bev) and FOLFIRI plus Bevacizumab (FOLFIRI - Bev) treatments are an effective strategies patients with metastatic colorectal cancer (mCRC). The aim of this study was to compare efficacy of first-line XELOX-Bev treatment vs FOLFIRI-Bev treatment for mCRC. Materials and Methods: A total of 409 patients with mCRC who received chemotherapy were included and divided into 2 groups. Group 1 (n=298) received XELOX-Bev and Group 2 (n=111) FOLFIRI-Bev. Comparisons were made in terms of overall (OS) and progression-free (PFS) survival, response rate (RR), and grade 3-4 toxicity. Results: Median follow-up was 11 months in Group 1 and 15 months for Group 2. Complete remission was observed in 29 (9.7%) and 2 (1.8%) patients, partial remission in 139 (46.6%) and 27 (24.5%), stable disease in 88 (29.5%) and 49 (44.1%) and progressive disease in 42 (14.1%) and 33 (30.0%) patients in Group 1 and 2, respectively. Median OS was 25 months (range 2-57 months, 95% CI; 22.2-27.7) for Group 1 and 20 months (range 1-67 months, 95% CI; 16.8-23.1) for Group 2 (p=0.036). Median PFS was 9.6 months (range 2-36 months, 95% CI; 8.8-10.4) for Group 1 and 9 months (range 1-44 months, 95% CI; 7.4-10.5) for Group 2 (p=0.019). Objective RR was 56.4% in Group 1 and 26.1% in Group 2 (p