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.
Background: The neutrophil-to-lymphocyte ratio (NLR) is a simple and inexpensive examination that is considered to show inflammation. In this study, which included a control group, the authors aimed ...to investigate if there was a relationship between glycaemic regulation parameters and NLR in patients with Type 2 diabetes mellitus.
Material and Methods: A total of 278 Type 2 diabetic patients were included in the study. An additional total of 148 healthy people were also included as a control group. NLR was calculated by dividing the absolute neutrophil number by the absolute lymphocyte number. The patients were divided into two groups: the good glycaemic control group (HbA1c ≤7.5%) and the poor glycaemic control group (HbA1c >7.5%). NLR was compared between the diabetic groups. In addition, NLR was compared with diabetic patients and control group.
Results: The NLR was statistically and significantly higher in the poor glycaemic control group compared to the good glycaemic control group (2.48 1.97–2.60 to 2.07 1.72–2.40, respectively; p=0.020). In addition, NLR was significantly higher in the patients than in the control group (2.30 2.04–2.49 to 2.01 1.85–2.18, respectively; p=0.002).
Conclusion: According to the authors’ knowledge, increased NLR may be associated with poor glycaemic control in Type 2 diabetic patients. NLR may be useful used as an easily measurable, noninvasive, available, and cost-effective parameter for the follow-up of diabetic patients.
Abstract Background SBAs are rarely seen tumors.Data regarding the use of chemotherapy together with bevacizumab in advanced SBA patients are lacking Materials and Methods The aim of this study is ...the evaluation of bevacizumab in advanced SBA. Twenty-eight patients from 5 centers with diagnosis of advanced SBA who received first-line treatments with modified FOLFOX6 (mFOLFOX6) and FOLFIRI chemotherapy regimens were involved in the study. All patients were divided into 2 groups; ones who received bevacizumab together with these chemotherapy regimens (Chemo+Bev group) and ones who did not receive bevacizumab (Chemo group) Results The median progression-free survival (PFS) and overall survival (OS) time of all population were 8.7 months and 16.9 months, respectively. Overall response rate (ORR) was 43.7% in Chemo group and 58.3% in Chemo+Bev group. Median PFSs in Chemo and Chemo+Bev groups were found to be 7.7 months and 9.6 months, respectively and median OS were 14.8 months and 18.5 months, respectively. There was not a significant difference between the groups in terms of ORR, PFS and OS Conclusion Although there was no significant difference in any of the outcomes, use of bevacizumab together with chemotherapy is a more effective treatment approach compared to chemotherapy alone and it does not cause an excess of significant toxicity.
Protein tyrosine kinase-7, a regulatory protein in the Wnt signaling pathway, was highly overexpressed in various cancer types and assumed to be related to prognosis.
The purpose of this study is to ...assess whether protein tyrosine kinase-7 expression status in curatively resected gastric carcinoma would independently identify patients with a high risk of recurrence and death.
Retrospective cohort study.
We included patients who were at least 18 years of age and diagnosed with gastric cancer. The exclusion criterion was a metastatic disease at the time of diagnosis or operation. Data on clinicopathological prognostic determinants and clinical courses, including the date of disease relapse and survival status, were collected with the use of medical records. Surgically removed tumor tissue specimens were examined by two independent pathologists at the pathology department of our institution. Protein tyrosine kinase-7 expression status was assessed with immunohistochemical processing and stratified on a scale ranging from 0 to +3 according to the extent of stained tumor cells. It was then further categorized into two groups, one being + (positive), including +1, +2, and +3 scores, another was-(negative), including-and +/− scores.
A total of 114 patients were analyzed. Protein tyrosine kinase-7 expression was present in 66.7% of the surgical tumor specimens. There was no statistically significant difference in almost all relevant parameters between the protein tyrosine kinase-7 positive and negative groups. The estimated median survival in the protein tyrosine kinase-7 positive group was significantly better than the protein tyrosine kinase-7 negative group (60 vs 22 months, p<0.001). Disease-free survival was found to be 55 months in the protein tyrosine kinase-7 positive group, whereas it was 21 months in the negative group (p=0.015). In the multivariate analysis, along with negative protein tyrosine kinase-7 expression, poor performance status, and advanced stage were significantly associated with the risk of death (p<0.001 for each).
Compared to patients with negative PTK-7 expression, patients with positive PTK-7 expression have better disease-free survival and overall survival rates. Efforts should be made to enhance this finding and translate it into clinical practice.
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.
The treatment of gastroesophageal junction tumors remains controversial due to confusion on whether they should be considered as primary esophageal or as gastric tumors. The incidence of these tumors ...with poor prognosis has increased, thus creating scientific interest on gastroesophageal cancers. Esophagogastric cancers are classified according to their location by Siewert, and the treatment of each type varies. We evaluated the prognostic factors and differences in clinicopathologic factors of patients with gastroesophageal junction tumor, who have been treated and followed-up in our clinics.
We retrospectively analyzed 187 patients with gastroesophageal junction tumors who have been operated and treated in the Oncology Department between 2005 and 2014. The chi-square test was used to evaluate differences in clinicopathologic factors among Siewert groups I, II and III. Prognostic factors were analyzed by univariate and multivariate analysis.
The median age of our patients was 62 years, and approximately 70% was male. Nineteen patients (10.2%) had Siewert I tumors, 40 (21.4%) II, and the remaining 128 (64.4%) had Siewert III tumors. Siewert III tumors were at more advanced pathologic and T stages. Preoperative chemoradiotherapy was mostly applied to Siewert group I patients. There was no difference between the 3 groups in terms of recurrence. While the median overall survival and 2-year overall survival rate were 26.6 months and 39.6%, the median disease free survival and disease free survival rates were 16.5 months and 30.1%, respectively. The N stage, pathologic stage, vascular invasion, lymphatic invasion, perineural invasion, surgical margin, and grade were associated with both overall survival and disease free survival, while pathologic stage and presence of recurrence were significant factors for overall survival. The median disease free survival for Siewert III tumors was 20 months, 11.3 month for Siewert I tumors, and 14 months for Siewert II tumors, but the finding was not statistically significant (p=0.08).
Although gastroesophageal junction tumors were grouped according to their location and they exerted different clinicopathologic properties, their prognosis was similar.
Objective
The diagnostic value of Carbon-14 urea breath test (C-14 UBT) in the detection of Helicobacter pylori (H. pylori) infection in non-operated patients has been proved. However, the efficacy ...of C-14 UBT in patients with partial gastric resection (PGR) has not been evaluated yet. Herein, the results of the C-14 UBT and H. pylori stool antigen test (HpSAT) in this patient group were compared with the endoscopic findings.
Methods
Multi-breath samples C-14 UBT and HpSAT were performed in all patients on the same day. Histology was used as a gold standard for testing C-14 UBT and HpSAT diagnostic efficacies.
Results
30 patients (mean age: 54.6 ± 11 year) with PGR were included. The sensitivity and specificity of standard C-14 UBT were 29 and 100 %, respectively. When breath samples were collected at 20th min, and >35 CPM was selected as radioactivity threshold, the sensitivity raised to 86 % without any loss of specificity. The specificity and sensitivity of the HpSAT were 71 and 96 %, respectively.
Conclusions
The sensitivity of the standard C-14 UBT was very poor for patients with PGR, and results of HpSAT were superior in this population. Certain modifications are needed if C-14 UBT is to be used in PGR patients.
Abstract Background Although studies have investigated whether a routine follow-up should be performed after a gastrectomy, no consensus has been reached on the significance of the follow-up or the ...optimal surveillance protocol. In the present study, we evaluated the significance of the presence or absence of symptoms in the detection of recurrences after curative gastrectomy for gastric cancer. Methods We retrospectively analyzed 173 patients with recurrent gastric cancer who underwent radical gastrectomy. We evaluated the prognostic significance of the presence of cancer-related symptoms at the diagnosis of recurrence, and the relationship between the presence of symptoms and other clinicopathological factors. Results We detected a symptomatic recurrence in 42.2% of patients. The presence of symptoms were significantly correlated with tumor size, pT stage, pN stage, pathologic stage, and short disease-free interval (<12 mo). The median disease-free survival (DFS), post-recurrence survival (PRS), and overall survival (OS) times for patients with asymptomatic recurrence were significantly longer than those of patients with symptomatic recurrence (disease-free survival was corrected as DFS, 11.1 versus 9.3 mo, P < 0.001; PRS, 4.9 versus 3.1 mo, P = 0.02; OS, 18.3 versus 12.3 mo, P = 0.001, respectively). Multivariate analysis showed that the presence of cancer-related symptoms ( P = 0.033; hazard ratio HR, 0.81) was an independent prognostic factor for PRS, as were short disease-free intervals ( P < 0.001; HR, 2.42), age ( P = 0.02; HR, 1.53), and the presence of chemotherapy in recurrence ( P = 0.001; HR, 0.49). In addition, multivariate analysis indicated that the presence of symptoms, short disease-free interval, and age were also independent prognostic indicators for OS. Conclusions Our results demonstrate that symptomatic recurrence is an important prognostic factor for PRS of patients with gastric cancer after a curative gastrectomy. The presence of symptomatic recurrence may be a new and beneficial prognostic marker to evaluate biologic aggressiveness, which is an important determinant of survival at the time of recurrence diagnosis during a follow-up for gastric cancer.
We aimed to investigate the prognostic significance of neutrophil, lymphocyte, platelet, mean platelet value (MPV), platelet-lymphocyte ratio (PLR) and neutrophil–lymphocyte ratio (NLR) in patients ...with locally advanced gastric cancer (LAGC). One hundred sixty-eight patients with LAGC who had been followed-up between 2004 and 2008 were included in present study. The results of hematological (platelet, lymphocyte, neutrophil and MPV) and biochemical (uric acid and LDH) parameters were evaluated before treatment. NLR was divided into two groups as <2.56 and ≥2.57 and PLR was also divided into two groups as ≤160 and >160. Platelet counts and lymphocyte counts were also divided into two groups; ≤300.000/mm3 and >300.000/mm3, and <1,500/mm3 and ≥1,500/mm3, respectively. Results were evaluated with Kaplan–Meier and Long-rank tests. The mean age of patients at diagnosis was 60.1 ± 12.1 and 114 of patients (67.8%) were male. For 168 patients, 48 months overall survival (OS) rate was 45.2% and the median OS was 39 months (range 33–44). In patients whose PLR was less than 160 (
n
= 54), the median OS was 45 months (range 38–52) and also for cases whose PRL was greater than 160 (
n
= 114), the median OS was 27 months (range 22–32) (
p
= 0.006). While for fifty patients whose lymphocyte counts were less than 1,500, the median OS was 27 months (range 21–33), in cases with high lymphocyte counts (≥1,500) (
n
= 118), it was 41 months (range 35–48) (
p
= 0.03). The median OS was 41 (range 34–48) and 30 (range 23–37) months in two platelets groups, respectively (
p
= 0.24). However, in the patients whose NLR was less than 2.56 (
n
= 107), median OS was better than with cases whose NLR was greater than or equal to 2.56 (42 vs. 27 months). Routine peripheral blood counts may be useful prognostic factor for evaluating the accuracy of risk stratification in patients with radically resected gastric cancer Our results need to be confirmed by study including larger sample size in future.
To evaluate the efficacy of bevacizumab a monoclonal, antivascular endothelial growth factor antibody in combination with cytotoxic chemotherapy in Turkish patients with recurrent and metastatic ...cervical cancer.
Data of 64 patients with metastatic or recurrent cervical cancer, receiving bevacizumab with first-line cisplatin or carboplatin and paclitaxel chemotherapy between 2013 and 2017 were retrospectively evaluated.
The mean age of the patients was 49 years (range, 28-68), the median follow-up time was 12 months (range, 2-53), the median progression-free survival (PFS) was eight months, and the median overall survival (OS) was 23 months. All 64 patients received a median of 6 (range, 1-12) bevacizumab and 6 (range, 2-12) chemotherapy cycles. The chemotherapy regimens used with bevacizumab were cisplatin and paclitaxel in 31 (48%) and carboplatin and paclitaxel in 33 (52%) patients. The survival in patients treated with bevacizumab and cisplatin plus paclitaxel was better-particularly in patients with no previous cisplatin-based radiosensitizer therapy-than those treated with carboplatin, paclitaxel, and bevacizumab (p=0.023). The bevacizumab dose was 7.5 mg/kg in 30 patients (47%) and 15 mg/kg in 34 patients (53%) every 21 days. No significant difference was reported in the OS and the PFS between the two groups. While the most common all-grades adverse events were nausea, neutropenia, anemia, and peripheral sensory neuropathy, the most common grade ≥3 adverse events were neutropenia, anemia, and peripheral sensory neuropathy.
Adding bevacizumab to platinum and paclitaxel chemotherapy in a case of metastatic or recurrent cervical cancer is an effective and tolerable treatment for Turkish patients.