Publications by authors named "Saadettin Kilickap"

127 Publications

The association between antibiotic use and survival in renal cell carcinoma patients treated with immunotherapy: a multi-center study.

Curr Probl Cancer 2021 Jun 5:100760. Epub 2021 Jun 5.

Department of Medical Oncology, Hacettepe University Oncology Hospital, Ankara, Turkey; Department of Medical Oncology, Istinye University Faculty of Medicine, Istanbul, Turkey.

Background: Immunotherapy improves overall survival (OS) in the second and later lines of renal cell carcinoma (RCC) treatment. Recent studies have suggested that antibiotic (ATB) use either shortly before or after the start of immunotherapy could lead to decreased OS. Herein, we evaluate the impact of ATB use on OS in RCC patients treated with nivolumab in a multi-center cohort from Turkey.

Methods: The data of 93 metastatic RCC patients treated with nivolumab in the second line or later were retrospectively collected from 6 oncology centers. Previous treatments, sites of metastases, International Metastatic RCC Database Consortium risk classification, and ATB use in the three months before (-3) or three months after (+3) the start of immunotherapy were recorded together with survival data. The association of clinical factors with OS and progression-free survival (PFS) was analyzed with univariate and multivariable analyses.

Results: The median age was 61 (interquartile range 54-67), and 76.3% of the patients were male. The median OS of the cohort was 23.75 ± 4.41, and the PFS was 8.44 ± 1.61 months. Thirty-one (33.3%) patients used ATBs in the 3 months before (-3) or 3 months after (+3) nivolumab initiation. In the multivariable analyses, ATB exposure (HR: 2.306, 95% confidence interval [CI]: 1.155-4.601, P = 0.018) and the presence of brain metastases at the baseline (HR: 2.608, 95% CI: 1.200-5.666, P = 0.015) had a statistically significant association with OS, while ATB exposure was the only statistically significant parameter associated with PFS (HR: 2.238, 95% CI: 1.284-3.900, P = 0.004).

Conclusion: In our study, patients with ATB exposure in the 3 months before or 3 months after the start of immunotherapy had shorter OS. Our findings further support meticulous risk-benefit assessments of prescribing ATBs for patients who are either receiving or are expected to receive immunotherapy.
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http://dx.doi.org/10.1016/j.currproblcancer.2021.100760DOI Listing
June 2021

Prognostic factors in patients with metastatic urothelial carcinoma who have treated with Atezolizumab.

Int J Clin Oncol 2021 Aug 23;26(8):1506-1513. Epub 2021 May 23.

Medical Oncology, Istanbul Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.

Background: Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies of patients with metastatic platinum-resistant urothelial carcinoma. However, the response rate of Atezolizumab was modest. In the current study, we evaluated the pretreatment prognostic factors for overall survival in patients with metastatic urothelial carcinoma who have progressed after first-line chemotherapy in the Expanded-Access Program of Atezolizumab.

Patients And Methods: In this study, we present a retrospective analysis of 113 patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy. Data of the patients was obtained from patient files and hospital records. Eligible patients included metastatic urothelial carcinoma patients treated with at least one course of ATZ. Univariate analysis was used to identify clinical and laboratory factors that significantly impact OS. Variables were retained for multivariate analysis if they had a statistical relationship with OS (p  < 0.1), and then included a final model of p  < 0.05.

Results: The median follow-up duration was 23.5 months. Of the patients, 98 (86.7%) were male and 13.3% were female. The median age was 65 years of age (37-86). In univariate analysis, primary tumor location in the upper tract, increasing absolute neutrophil count (ANC), increasing absolute lymphocyte count, neutrophil-to-lymphocyte ratio (NLR) > 3, liver metastases, baseline creatinine clearance less (GFR) than 60 ml/min, Eastern Cooperative Oncology Group (ECOG) performance status (1 ≥), and hemoglobin levels below 10 mg/dl were all the significantly associated with OS. Three of the five adverse prognostic factors according to the Bellmunt criteria were independent of short survival: liver metastases HR 3.105; 95% CI 1.673-5.761; p < (0.001), ECOG PS (1 ≥) HR 2.184; 95% CI 1.120-4.256; p = 0.022, and Hemoglobin level below 10 mg/dl HR 2.680; 95% CI 1.558-4.608; p < (0.001). In addition, NLR > 3 hazard ratio [HR] 2.092; 95% CI 1.031-4.243; p = 0.041 and GFR less than 60 ml/min HR 1.829; 95% CI 1.1-3.041; p = 0.02, maintained a significant association with OS in multivariate analysis.

Conclusions: This model confirms the Bellmunt model with the addition of NLR > 3 and GFR less than 60 ml/min and can be associated with clinical trials that use immunotherapy in patients with bladder cancer.
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http://dx.doi.org/10.1007/s10147-021-01936-6DOI Listing
August 2021

Efficacy and Safety of Trastuzumab Emtansine in Her2 Positive Metastatic Breast Cancer: Real-World Experience.

Cancer Invest 2021 Jul-Aug;39(6-7):473-481. Epub 2021 Jun 7.

Department of Medical Oncology, Selçuk University, Konya, Turkey.

Aim: The aim of this study is to evaluate the efficacy and toxicity of trastuzumab emtansine (T-DM1) in cases with metastatic breast cancer (mBC) in different lines of treatment.

Method: Retrospective analysis of T-DM1 results of human epidermal growth factor receptor 2 (Her2) positive 414 cases with mBC from 31 centers in Turkey.

Findings: Except 2, all of the cases were female with a median age of 47. T-DM1 had been used as second-line therapy in 37.7% of the cases and the median number of T-DM1 cycles was 9. Progression-free survival (PFS) and overall survival (OS) times were different according to the line of treatment. The median OS was found as 43, 41, 46, 23 and 17 months for 1st, 2nd, 3rd, 4th and 5th line, respectively ( = 0.032) while the median PFS was found as 37, 12, 8, 8 and 8 months, respectively ( = 0.0001). Treatment was well tolerated by the patients. The most common grade 3-4 adverse effects were thrombocytopenia (2.7%) and increased serum gamma-glutamyl transferase (2%).

Discussion: The best of our knowledge this is the largest real-life experience about the safety and efficacy of T-DM1 use in cases with mBC after progression of Her2 targeted treatment. This study suggests and supports that T-DM1 is more effective in earlier lines of treatment and is a reliable option for mBC.
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http://dx.doi.org/10.1080/07357907.2021.1933011DOI Listing
July 2021

The effect of the COVID-19 pandemic on routine adult vaccination in cancer patients.

Med Oncol 2021 04 23;38(6):62. Epub 2021 Apr 23.

Faculty of Medicine, Department of Medical Oncology, Hacettepe University, Ankara, Turkey.

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http://dx.doi.org/10.1007/s12032-021-01512-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8062818PMC
April 2021

The burden of polypharmacy and drug-drug interactions in older cancer patients treated with immunotherapy.

J Oncol Pharm Pract 2021 Apr 20:10781552211012038. Epub 2021 Apr 20.

Department of Medical Oncology, Hacettepe University Cancer Institute, Ankara, Turkey.

Introduction: Polypharmacy is a common problem in older cancer patients, although the data about polypharmacy and potentially inappropriate prescription practices is limited in patients treated with immune checkpoint inhibitors (ICIs). Therefore, we aimed to evaluate the polypharmacy frequency and drug-drug interactions in older cancer patients (≥65 years) treated with ICIs.

Methods: A total of 70 geriatric patients with advanced cancer were included. The polypharmacy was defined as regular use of 5 or more drugs. The START/STOPP Criteria Version 2 was used for the potentially inappropriate medications (PIM) and potential prescription omissions (PPO). The Medscape Drug Interaction Checker was used for potential drug-drug interactions.

Results: The patients had a median of 6 regular drugs, and polypharmacy was present in 77.1%. The polypharmacy risk was significantly increased in patients over 75 years of age (p = 0.028) and with opioid use (p = 0.048). The 50% of patients had category D or X interactions. Patients with higher Charlson Comorbidity Index had significantly increased risk for drug interactions (CCI ≤10 vs. >10, p = 0.017). The PIMs were present in 44.3% and the PPOs in 68.6% of the patients. While the overall survival and immune related adverse events were similar according to polypharmacy, in patients using seven or more drugs, the acute kidney injury risk was increased (HR: 4.667, p = 0.038).

Conclusion: In this study, we observed a high rate of polypharmacy and inappropriate prescription practices in ICI-treated patients. These issues pointed out the need for improved general medical care and attention for better comedication management in ICI-treated patients.
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http://dx.doi.org/10.1177/10781552211012038DOI Listing
April 2021

Poorer baseline performance status is associated with increased thromboembolism risk in metastatic cancer patients treated with immunotherapy.

Support Care Cancer 2021 Sep 11;29(9):5417-5423. Epub 2021 Mar 11.

Department of Medical Oncology, Hacettepe University Cancer Institute, 06100 Sıhhıye, Ankara, Turkey.

Purpose: Venous thromboembolism (VTE) is a significant cause of morbidity and mortality in cancer patients. However, the association of VTE with immunotherapy remains poorly defined. We therefore evaluated the frequency of VTE in patients receiving immunotherapy and tried to determine predisposing factors.

Methods: A total of 133 adult metastatic cancer patients treated with immunotherapy for any cancer between were included. Baseline demographics, ECOG performance status, type of tumors, and baseline blood count parameters were recorded. Possible predisposing factors were evaluated with univariate and multivariate analyses.

Results: The median age was 60 (interquartile range (IQR) 48-66) years, and the median follow-up was 10.1 (IQR 5.8-18.5) months. Renal cell carcinoma (26.3%) and melanoma (24.1%) were most common diagnoses. Fifteen patients (11.3%) had an episode of VTE. Most of the VTEs were diagnosed as pulmonary emboli (10/15; 67%). Eighty percent (12/15) of these VTE cases were detected incidentally. Patients with a baseline ECOG performance status of 1 or more (29.3% of patients) had a significantly increased risk of venous thrombosis (ECOG ≥1 vs. 0, HR: 3.023, 95% CI: 1.011-9.039, p=0.048). Other factors, including patient age, tumor type, body mass index, baseline thrombocyte, neutrophil, and lactate dehydrogenase levels were not significantly associated with VTE risk.

Conclusions: In this study, we observed VTE development in more than 10% of immunotherapy-treated patients and increased VTE risk in patients with poorer ECOG status. With the asymptomatic nature of VTEs in most cases, a high index of suspicion level for VTE is required in patients treated with immunotherapy.
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http://dx.doi.org/10.1007/s00520-021-06139-3DOI Listing
September 2021

Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial.

Lancet 2021 02;397(10274):592-604

Regeneron Pharmaceuticals, Tarrytown, New York, NY, USA.

Background: We aimed to examine cemiplimab, a programmed cell death 1 inhibitor, in the first-line treatment of advanced non-small-cell lung cancer with programmed cell death ligand 1 (PD-L1) of at least 50%.

Methods: In EMPOWER-Lung 1, a multicentre, open-label, global, phase 3 study, eligible patients recruited in 138 clinics from 24 countries (aged ≥18 years with histologically or cytologically confirmed advanced non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 0-1; never-smokers were ineligible) were randomly assigned (1:1) to cemiplimab 350 mg every 3 weeks or platinum-doublet chemotherapy. Crossover from chemotherapy to cemiplimab was allowed following disease progression. Primary endpoints were overall survival and progression-free survival per masked independent review committee. Primary endpoints were assessed in the intention-to-treat population and in a prespecified PD-L1 of at least 50% population (per US Food and Drug Administration request to the sponsor), which consisted of patients with PD-L1 of at least 50% per 22C3 assay done according to instructions for use. Adverse events were assessed in all patients who received at least one dose of the assigned treatment. This study is registered with ClinicalTrials.gov, NCT03088540 and is ongoing.

Findings: Between June 27, 2017 and Feb 27, 2020, 710 patients were randomly assigned (intention-to-treat population). In the PD-L1 of at least 50% population, which consisted of 563 patients, median overall survival was not reached (95% CI 17·9-not evaluable) with cemiplimab (n=283) versus 14·2 months (11·2-17·5) with chemotherapy (n=280; hazard ratio [HR] 0·57 [0·42-0·77]; p=0·0002). Median progression-free survival was 8·2 months (6·1-8·8) with cemiplimab versus 5·7 months (4·5-6·2) with chemotherapy (HR 0·54 [0·43-0·68]; p<0·0001). Significant improvements in overall survival and progression-free survival were also observed with cemiplimab in the intention-to-treat population despite a high crossover rate (74%). Grade 3-4 treatment-emergent adverse events occurred in 98 (28%) of 355 patients treated with cemiplimab and 135 (39%) of 342 patients treated with chemotherapy.

Interpretation: Cemiplimab monotherapy significantly improved overall survival and progression-free survival compared with chemotherapy in patients with advanced non-small-cell lung cancer with PD-L1 of at least 50%, providing a potential new treatment option for this patient population.

Funding: Regeneron Pharmaceuticals and Sanofi.
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http://dx.doi.org/10.1016/S0140-6736(21)00228-2DOI Listing
February 2021

Trastuzumab ± Capecitabine Maintenance After the First-Line Treatment of HER2-Positive Advanced Gastric Cancer: Retrospective Observational Real-Life Data of Turkish Oncology Group.

J Gastrointest Cancer 2021 Feb 4. Epub 2021 Feb 4.

Faculty of Medicine, Department of Medical Oncology, Ankara University, Ankara, Turkey.

Purpose: In the ToGA trial for HER2-positive advanced gastric cancer, cisplatin plus fluoropyrimidine was given for 6 cycles; trastuzumab was given until disease progression. However, there is a lack of real-life data about trastuzumab maintenance after 6 cycle chemotherapy. This study aims to present real-life data of trastuzumab ± capecitabine maintenance after 6 cycles of platinum, fluoropyrimidine, and trastuzumab in non-progressive patients.

Methods: This is a retrospective multicenter study of the Turkish Oncology Group. A total of 35 HER2-positive, inoperable locally advanced, recurrent, or metastatic gastric adenocarcinoma patients being non-progressive at the end of 6 cycle chemotherapy and being given trastuzumab ± capecitabine as maintenance treatment were included from sixteen oncology centers. Baseline characteristics, objective tumor responses, progression free and overall survival data, and toxicities were determined.

Results: About 68% of the patients were given CF, and 32% were given FOLFOX with trastuzumab as the first-line treatment. The best response in 6 cycle chemotherapy was complete 8 (22%), partial 24 (68%), and stable disease 3 (8%). All patients had trastuzumab maintenance (median cycle 13; range 7-51), and 49% of the patients had capecitabine with trastuzumab (median capecitabine cycle 6; range 2-30). The median PFS of the patients was 12.0 months (95% CI 10.3-13.7), and median OS was 17.4 months (95% CI 15.2-19.5). There were 2 patients with grade 1 cardiotoxicity.

Conclusion: Trastuzumab maintenance ± capecitabine after 6 cycles of trastuzumab plus combined chemotherapy treatment revealed efficacy and safety in non-progressive HER2-positive advanced gastric cancer.
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http://dx.doi.org/10.1007/s12029-021-00594-1DOI Listing
February 2021

Comparison of respiratory muscle strength and endurance, maximal oxygen consumption, and fatigue in colorectal cancer survivors with healthy adults.

Support Care Cancer 2021 Jul 3;29(7):3903-3909. Epub 2021 Jan 3.

Department of Medical Oncology, Faculty of Medicine, Hacettepe University, Ankara, Turkey.

Purpose: This study aimed to evaluate respiratory muscle strength and endurance, maximal oxygen consumption, and fatigue of colorectal cancer (CRC) survivors and compare them with healthy individuals.

Methods: Demographic and clinical characteristics were recorded. Respiratory muscle strength (maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP)) was measured using an electronic mouth pressure device, and respiratory muscle endurance was assessed using a constant workload protocol with linear workload device. Peak oxygen consumption (VOpeak) was measured using the cardiopulmonary exercise test (CPET) with modified Bruce protocol. Fatigue was assessed using the Brief Fatigue Inventory (BFI).

Results: The patients had similar demographic characteristics (p > 0.05). MEP (cmHO and %predicted) were lower in the CRC group than in healthy controls (p < 0.05). MIP (cmHO and %predicted) and test duration did not differ between the groups (p > 0.05). VOpeak (ml/min and %predicted) and VOpeak/kg (%predicted) were significantly lower in the CRC group (p < 0.05). BFI score differed significantly in the CRC and control groups (p < 0.05).

Conclusion: Respiratory muscle strength, maximal exercise capacity, and fatigue are adversely affected in CRC survivors. Cancer treatment may cause loss of muscle strength and impair energy metabolism and oxygen transmission. These changes can result in decreased exercise capacity and respiratory muscle strength and increased fatigue. Studies examining the effects of different exercise training programs in CRC survivors are needed.
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http://dx.doi.org/10.1007/s00520-020-05963-3DOI Listing
July 2021

Clinical features and outcomes of COVID-19 in patients with solid tumors: Turkish National Registry Data.

Int J Cancer 2020 Dec 7. Epub 2020 Dec 7.

Department of Preventive Oncology, Hacettepe University Cancer Institute, Ankara, Turkey.

We present demographic, clinical, laboratory characteristics and outcomes of the patients with solid malignancies and novel coronavirus disease (COVID-19) collected from the National COVID-19 Registry of Turkey. A total of 1523 patients with a current or past diagnosis of solid tumors and diagnosed with COVID-19 (confirmed with PCR) between 11 March and 20 May 2020 were included. The primary outcome was 30-day mortality. Median age was 61 (range: 18-94), and 752 (49%) were male. The most common types of cancers were breast (19.8%), prostate (10.9%) and colorectal cancer (10.8%). 65% of the patients had at least one comorbidity. At least one COVID-19-directed therapy was given in 73% of the patients.. Hospitalization rate of the patients was 56.6% and intensive care unit admission rate was 11.4%. Seventy-seven (5.1%) patients died within 30 days of diagnosis. The first multivariate model which included only the demographic and clinical characteristics showed older age, male gender and presence of diabetes and receipt of cytotoxic therapy to be associated with increased 30-day mortality, while breast and prostate cancer diagnoses were associated with lower 30-day mortality. In the second set, we further included laboratory parameters. The presence of leukocytosis (OR 6.7, 95% CI 3.3-13.7, P < .001), lymphocytopenia (OR 3,1, 95% CI 1,6-6,1, P = .001) and thrombocytopenia (OR 3,4 95% CI 1,5-8,1, P = .005) were found to be associated with increased 30-day mortality. Relatively lower mortality compared to Western countries and China mainly results from differences in baseline risk factors but may also implicate the importance of intensive supportive care.
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http://dx.doi.org/10.1002/ijc.33426DOI Listing
December 2020

Combination of trastuzumab and taxane-containing intensified chemotherapy in first-line treatment of HER2-positive advanced gastric cancer.

Tumori 2020 Nov 9:300891620969823. Epub 2020 Nov 9.

Department of Medical Oncology, Ankara University Faculty of Medicine, Ankara, Turkey.

Purpose: Taxane-containing combinations are recommended for the first-line therapy of advanced gastric cancer. It is not known which chemotherapy regimen is the best with trastuzumab for HER2-positive patients. The aim of this study was to compare taxane-containing intensified chemotherapy versus standard chemotherapy in combination with trastuzumab in the first-line treatment of HER2-positive advanced gastric adenocarcinoma.

Methods: This study is a retrospective multicenter study of the Turkish Oncology Group. A total of 130 HER2-positive patients with inoperable locally advanced, recurrent, or metastatic gastric adenocarcinoma being given chemotherapy plus trastuzumab as the first-line treatment were included from 16 different oncology centers. Trastuzumab combination with intensified chemotherapy including taxane or standard chemotherapy was compared in terms of progression-free survival (PFS), overall survival (OS), and toxicity.

Results: There were 108 patients in the standard and 22 patients in the intensified chemotherapy group. PFS of the standard and intensified group were 5.6 months (95% confidence interval [CI] 4.8-6.4) and 5.3 months (95% CI 2.6-8), respectively ( = 0.70). OS of the standard and intensified group were 11.1 months (95% CI 8.3-13.9) and 15.2 months (95% CI 12.7-17.7), respectively ( = 0.03). Repeated analysis excluding patients given any previous therapy revealed similar results. The intensified group had more fever and febrile neutropenia.

Conclusion: Trastuzumab combination with intensified chemotherapy provides better OS in first-line treatment of HER2-positive advanced gastric cancer. Further large-scale studies should be performed in HER2-positive patients.
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http://dx.doi.org/10.1177/0300891620969823DOI Listing
November 2020

Efficacy of regorafenib in the second-and third-line setting for patients with advanced hepatocellular carcinoma: A real life data of multicenter study from Turkey.

J BUON 2020 Jul-Aug;25(4):1897-1903

Department of Medical Oncology, Trakya University, Medicine Faculty, Edirne, Turkey.

Purpose: After failure of the first-line sorafenib treatment in advanced or metastatic stage hepatocellular carcinoma (HCC), regorafenib is one of the newly-approved targeted agents. We aimed to evaluate the efficacy of regorafenib in patients with advanced HCC treated in the second- or third-line setting.

Methods: In this retrospective and multicenter study, advanced HCC patients not eligible for local therapies, who received a second- or third-line regorafenib therapy after progression on the first-line sorafenib or sequential therapy with chemotherapy (CT) followed by sorafenib, were included.

Results: In the first-line setting, 28 (28.9%) patients received CT and 69 (71.1%) patients received sorafenib. There were 24 (24.7%) patients who were intolerant to sorafenib. Disease control rate (DCR) was 53.6% for all patients treated with regorafenib, 62.3% in patients who received regorafenib in the second-line, and 32.1% for those receiving regorafenib in the third-line (p=0.007). Median progression-free survival (PFS) and overall survival (OS) were 5.6 (range; 4.3-6.9) and 8.8 (range, 6.3-11.3) months for all patients treated with regorafenib vs. 7.1 months and 10.3 months for patients who received regorafenib in the second-line vs. 5.1 and 8.7 months for patients who received regorafenib in the third-line, respectively; however, there was no statistically significant difference (pPFS=0.22 and pOS=0.85).

Conclusion: Although receiving CT as a first-line therapy in advanced HCC patients did not affect the survival rates of subsequent regorafenib therapy, it might diminish the DCR of regorafenib.
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July 2021

Chemoimmunotherapy for the salvage treatment of Ewing sarcoma: A case report.

J Oncol Pharm Pract 2021 Jul 18;27(5):1281-1283. Epub 2020 Oct 18.

Department of Preventive Oncology, Hacettepe University Cancer Institute, Ankara, Turkey.

Introduction: Although, immune check-point inhibitors changed the course of many cancers, the outcomes in sarcomas were rather disappointing with less than 10% response rates. Ewing sarcoma is a poorly differentiated and aggressive tumor mostly seen in the children and adolescents. It's a distinct type of sarcoma with prominent chemosensitivity in the early stages. However, the relapsing disease has a poor prognosis with limited treatment options.

Case Report: Herein, we represent a case of relapsed Ewing sarcoma treated with multiple lines of chemotherapy. The patient had a very good response to salvage treatment with a combination of paclitaxel and nivolumab which lasted for twelve months after the cessation of treatment.

Discussion: We think that chemotherapy plus immunotherapy can be an option for Ewing sarcoma patients treated with multiple lines of chemotherapy.
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http://dx.doi.org/10.1177/1078155220965677DOI Listing
July 2021

Predictive biomarkers for immunotherapy efficacy in non-small-cell lung cancer: current status and future perspectives.

Biomark Med 2020 10 16;14(14):1383-1392. Epub 2020 Oct 16.

Department of Medical Oncology, Hacettepe University Cancer Institute, Ankara, Turkey.

In recent years, immune checkpoint inhibitors have rapidly changed treatment paradigms and have been pivotal for the treatment of advanced NSCLC patients. However, many patients don't respond to immunotherapy, and toxicities are a concern. Mounting evidence suggests that PD-L1 expression and tumor mutational burden are useful biomarkers in NSCLC and widely used in clinical practice. Given various limitations of PD-L1 and tumor mutational burden, many candidate biomarkers have emerged. From these biomarkers, peripheral blood-based biomarkers are promising options for the prediction of immunotherapy efficacy with ease of access, repeatability and low cost. This review provides an overview of recent developments on the biomarkers in immunotherapy efficacy together with comments on future perspectives.
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http://dx.doi.org/10.2217/bmm-2020-0310DOI Listing
October 2020

Perspectives, Knowledge, and Fears of Cancer Patients About COVID-19.

Front Oncol 2020 28;10:1553. Epub 2020 Aug 28.

Department of Medical Oncology, Hacettepe University Cancer Institute, Ankara, Turkey.

Coronavirus disease 2019 (COVID-19) is expected to significantly affect cancer patients due to adverse outcomes with COVID-19 and disruptions in cancer care. Another important point is the stress and anxiety burden of COVID-19, which could affect quality of life. Patient education is vital due to the vulnerability of the topic to disinformation. To determine the areas needing improvements in patient education, and coping with stress, the burden of the problem should be pictured. From this point, we aimed to assess the perspectives and fears of cancer patients about COVID-19 with resources of COVID-19 knowledge with a questionnaire. A total of 250 adult cancer patients applied to the outpatient chemotherapy unit of Hacettepe University Cancer Center between May 27, 2020, and June 9, 2020, invited to answer a questionnaire of 13 multiple-choice questions with a return rate of 78% (195/250). Most patients acquired their knowledge about COVID-19 from television (91.9%). Social media were the second most common source of knowledge (43.8%) with a predilection in younger patients, nonsmokers, targeted therapy- or immunotherapy-treated patients, and breast cancer patients (>65 vs. <65 years of age, = 0.057; nonsmoker vs. ever-smoker, = 0.036; targeted therapy and immunotherapy vs. chemotherapy, = 0.004; breast cancer vs. other cancers, = 0.019). The percentage of patients seeing the information about COVID-19 as adequate (38.9%) or inadequate (35.1%) was similar. More than 90% of the patients had a moderate to severe degree of COVID-19 fear. In addition, 27.6% of patients had false knowledge of glove using as a protective measure for COVID-19. More than half of the patients had another wrong knowledge as the need for the supplements for COVID-19 protection. A significant percentage of patients (84.7%) expected some level of disruption in oncological care with the expectation of a moderate-to-severe disruption was more common in the advanced-stage patients ( = 0.026). In our experience, most cancer patients had a significant degree of fear about both infecting COVID-19 and the disruption of cancer care by COVID-19. A significant amount of our patients had wrong information about the protection necessities, which denotes the need for better patient education about COVID-19.
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http://dx.doi.org/10.3389/fonc.2020.01553DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7493662PMC
August 2020

Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life Experiences.

Eur Urol Focus 2020 Sep 30. Epub 2020 Sep 30.

Medical Faculty, Ankara University, Ankara, Turkey.

Background: Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies in patients with locally advanced or metastatic platinum-resistant urothelial carcinoma.

Objective: To compare the real-life experience and data of clinical trials on ATZ treatment in metastatic urothelial carcinoma.

Design, Setting, And Participants: Patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy from an expanded access program were retrospectively studied. Data of patients were obtained from their files and hospital records. Safety was evaluated for patients treated with at least one cycle of ATZ.

Outcome Measurements And Statistical Analysis: The primary endpoint was objective response rate (ORR). The secondary endpoints are overall survival (OS), progression-free survival (PFS), duration of response, and safety profile of patients. Kaplan-Meier methods were used to calculate median follow-up and estimate PFS and OS.

Results And Limitations: Data of 115 enrolled patients were analyzed. Most of the patients (92.3%, n = 106) had received chemotherapy regimen only once prior to ATZ. The median follow-up duration was 23.5 mo. The complete response rate, partial response rate, and ORR were 8.7% (n = 10), 20.0% (n = 23), and 28.7% (n = 33), respectively. The median duration of response was 20.4 mo (95% confidence interval [CI], 6.47-28.8). Of the 33 patients who responded to treatment, 60% (n = 20) had an ongoing response at the time of the analysis. PFS and OS with ATZ were 3.8 mo (95% CI, 2.25-5.49) and 9.8 mo (95% CI, 6.7-12.9), respectively. All-cause and any-grade adverse events were observed in 113 (98%) patients. Of the patients, 64% experienced a treatment-related adverse event of any grade and 24 (21.2%) had a grade 3-4 treatment-related adverse event. Limitations of the study included its retrospective design, and determination of treatment response based on clinical notes and local radiographic studies.

Conclusions: In these real-life data, ATZ was effective and well tolerated in patients with metastatic urothelial carcinoma who have progressed with platinum-based first-line chemotherapy. ATZ is an effective and tolerable treatment for patients with locally advanced or metastatic platinum-resistant urothelial carcinoma in our study, similar to previously reported trials.

Patient Summary: Atezolizumab is effective and well-tolerated in patients with metastatic urothelial cancer who progressed with first-line chemotherapy, consistent with the outcomes of the previous clinical trials in this setting.
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http://dx.doi.org/10.1016/j.euf.2020.09.010DOI Listing
September 2020

Evaluation of emergency departments visits in patients treated with immune checkpoint inhibitors.

Support Care Cancer 2021 Apr 26;29(4):2029-2035. Epub 2020 Aug 26.

Department of Medical Oncology, Hacettepe University Cancer Institute, Ankara, Turkey.

Background: The emergency department (ED) is a crucial encounter point in cancer care. Yet, data on the causes of ED visits are limited in patients treated with immune checkpoint inhibitors (ICI). Therefore, we evaluated ED visits in patients treated with ICIs in attempt to determine the predisposing factors.

Methods: We performed a retrospective chart review on adult cancer patients treated with ICIs for any type of cancer in the Hacettepe University Cancer Center. The data on ED visits after the first dose of ICIs to 6 months after the last cycle of ICIs were collected.

Results: A total of 221 patients were included in the study. The mean age was 58.46 ± 13.87 years, and 65.6% of patients were males. Melanoma was the most common diagnosis (27.6%), followed by kidney and lung cancers. Eighty-three of these patients (37.6%) had at least one emergency department (ED) visit. Most of the ED visits were related to symptoms attributable to the disease burden itself, while immune-related adverse events comprised less than 10% of these visits. While baseline Eastern Cooperative Oncology Group performance status, age, polypharmacy, concomitant chemotherapy, eosinophilia, and lactate dehydrogenase levels did not significantly increase the risk, patients with regular opioid use and baseline neutrophilia (> 8000/mm) had a statistically significant increased risk of visiting the ED (p = 0.001 and 0.19, respectively). These two factors remained significant in the multivariate analyses.

Conclusion: In this study, almost 40% of ICI-treated patients had ED visits. Collaboration with other specialties like emergency medicine is vital for improving the care of patients receiving immunotherapy.
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http://dx.doi.org/10.1007/s00520-020-05702-8DOI Listing
April 2021

GLASS: Global Lorlatinib for ALK(+) and ROS1(+) retrospective Study: real world data of 123 NSCLC patients.

Lung Cancer 2020 10 27;148:48-54. Epub 2020 Jul 27.

Dokuz Eylul University Faculty of Medicine, Department of Medical Oncology, Izmir, Turkey.

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.
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http://dx.doi.org/10.1016/j.lungcan.2020.07.022DOI Listing
October 2020

Assessment of adherence to cancer-associated venous thromboembolism guideline and pharmacist's impact on anticoagulant therapy.

Support Care Cancer 2021 Mar 10;29(3):1699-1709. Epub 2020 Aug 10.

Hacettepe Cancer Institute, Hacettepe University, Ankara, Turkey.

Purpose: Cancer-associated venous thromboembolism (VTE) can cause many unfavorable health outcomes. Many institutions have published guidelines, but implementation of these guidelines in cancer clinics is still under investigation. This study aimed to evaluate the guideline adherence and identify potential gaps between the recommendations and their implications in clinics.

Methods: A prospective study was conducted between September and December 2018 at oncology inpatient and ambulatory settings. The guideline adherence rate was assessed for inpatients during hospital stay by using 8 criteria developed based on the National Comprehensive Cancer Network (NCCN) Guideline on Cancer Associated Venous Thromboembolic Disease Version 1.2018. Guideline-based recommendations were proposed to the consultant physician in case of non-adherence. Khorana risk scores were calculated for each patient at outpatient clinics. In cases where the score was found to be ≥ 3, the consultant physician was informed.

Results: A total of 100 inpatients and 200 ambulatory patients were included in the study. The guideline adherence rates ranged between 59 and 100% for 5 out of 8 pre-defined criteria, whereas the rate for others remained at 0-1%. A significant increase was observed in the adherence rates for initiation of prophylaxis at admission and determination of correct dose of an anticoagulant after recommendations being implemented (p < 0.001, McNemar test). Eleven patients were identified as at high-risk of VTE at ambulatory setting; however, an initiation of an anticoagulant was not considered by the consultant physicians.

Conclusion: There are potential problems in implementation of guideline recommendations, which leads to low adherence rate. Therefore, liason with pharmacists and consultants for individual risk assessment and monitoring of patients will help to increase guideline adherence rates.
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http://dx.doi.org/10.1007/s00520-020-05669-6DOI Listing
March 2021

Survey of the Impact of COVID-19 on Oncologists' Decision Making in Cancer.

JCO Glob Oncol 2020 08;6:1248-1257

Department of Medical Oncology, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.

Purpose: To understand readiness measures taken by oncologists to protect patients and health care workers from the novel coronavirus (COVID-19) and how their clinical decision making was influenced by the pandemic.

Methods: An online survey was conducted between March 24 and April 29, 2020.

Results: A total of 343 oncologists from 28 countries participated. The median age was 43 years (range, 29-68 years), and the majority were male (62%). At the time of the survey, nearly all participants self-reported an outbreak in their country (99.7%). Personal protective equipment was available to all participants, of which surgical mask was the most common (n = 308; 90%). Telemedicine, in the form of phone or video encounters, was common and implemented by 80% (n = 273). Testing patients with cancer for COVID-19 via reverse transcriptase polymerase chain reaction before systemic treatment was not routinely implemented: 58% reported no routine testing, 39% performed testing in selected patients, and 3% performed systematic testing in all patients. The most significant factors influencing an oncologist's decision making regarding choice of systemic therapy included patient age and comorbidities (81% and 92%, respectively). Although hormonal treatments and tyrosine kinase inhibitors were considered to be relatively safe, cytotoxic chemotherapy and immune therapies were perceived as being less safe or unsafe by participants. The vast majority of participants stated that during the pandemic they would use less chemotherapy, immune checkpoint inhibitors, and steroids. Although treatment in neoadjuvant, adjuvant, and first-line metastatic disease was less affected, most of the participants stated that they would be more hesitant to recommend second- or third-line therapies in metastatic disease.

Conclusion: Decision making by oncologists has been significantly influenced by the ongoing COVID-19 pandemic.
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http://dx.doi.org/10.1200/GO.20.00300DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7456315PMC
August 2020

The Impact of Everolimus and Radiation Therapy on Pulmonary Fibrosis.

Medicina (Kaunas) 2020 Jul 13;56(7). Epub 2020 Jul 13.

Department of Radiation Oncology, Medicine Faculty, Acibadem University, 34457 Istanbul, Turkey.

Everolimus (EVE) is a mammalian target of the rapamycin (mTOR) inhibitor that is widely used in cancer patients. Pulmonary toxicity, usually manifesting as interstitial pneumonitis, is a serious adverse effect of this drug. Radiation therapy, which is often administered in conjunction with chemotherapy for synergistic effects, also causes pulmonary fibrosis. In view of pulmonary damage development in these two forms of cancer treatment, we have examined the effect of EVE administration individually, in combination with radiation given in varying sequences, and its relation to the extent of pulmonary damage. We performed an experimental study in albino rats, which were randomized into five groups: (1) control group, (2) EVE alone, (3) EVE 22 h after radiation, (4) EVE 2 h after irradiation, and (5) only radiation. Sixteen weeks after thoracic irradiation, rat lung tissue samples were examined under light microscopy, and the extent of pulmonary damage was estimated. After this, we calculated median fibrosis scores in each group. The highest fibrosis score was noted in Group 4. Among the five groups, the control group had a significantly lower median fibrosis score compared to the others. When the median fibrosis score of the group that received concurrent EVE with radiation therapy (RT) (Group 4) was compared with that of the control group, the difference was statistically significant ( = 0.0022). However, no significant differences were achieved among the study groups that received EVE only or RT only, whether concurrently or sequentially ( > 0.05). EVE is an effective treatment option for the management of several malignancies and is often combined with other therapies, such as radiation, for a more efficient response. However, an increased risk of pulmonary fibrosis should also be anticipated when these two modalities are combined, as they both can cause pulmonary damage, especially when administered concurrently.
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http://dx.doi.org/10.3390/medicina56070348DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7404687PMC
July 2020

COVID-19 pandemic: changes in cancer admissions.

BMJ Support Palliat Care 2020 Jul 14. Epub 2020 Jul 14.

Department of Medical Oncology, Cancer Institute, Hacettepe University, Ankara, Turkey.

Background: COVID-19 pandemic could create a collateral damage to cancer care denoting disruptions in care due to a significant burden on healthcare and resource allocations. Herein, we evaluate the early changes in the inpatient and outpatient oncology clinics to take a snapshot of this collateral damage at Hacettepe University Cancer Institute.

Methods: Patients applying the outpatient clinic and outpatient palliative care (OPC) clinic for the first time and patients admitted to inpatient wards in the first 30 days after the first case of COVID-19 in Turkey were evaluated. These data were compared with data from the same time frame in the previous 3 years.

Results: The mean number of daily new patient applications to the outpatient clinic (9.87±3.87 vs 6.43±4.03, p<0.001) and OPC clinic (3.87±1.49 vs 1.13±1.46, p<0.001) was significantly reduced compared with the previous years. While the number of inpatient admissions was similar for a month frame, the median duration of hospitalisation was significantly reduced. The frequency of hospitalisations for chemotherapy was higher than in previous years (p<0.001). By comparison, the rate of hospitalisations for palliative care (p=0.028) or elective interventional procedures (p=0.001) was significantly reduced.

Conclusion: In our experience, almost all domains of care were affected during the pandemic other than patients' systemic treatments. There were significant drops in the numbers of newly diagnosed patients, patients having interventional procedures and palliative care services, and these problems should be the focus points for the risk mitigation efforts for prevention of care disruptions.
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http://dx.doi.org/10.1136/bmjspcare-2020-002468DOI Listing
July 2020

Clinical impact of Ga-DOTATATE PET-CT imaging in patients with medullary thyroid cancer.

Ann Nucl Med 2020 Sep 29;34(9):663-674. Epub 2020 Jun 29.

Department of Head and Neck Surgery, Faculty of Medicine, Hacettepe University, Ankara, Turkey.

Purpose: Medullary thyroid cancer (MTC) arises from neuroendocrine C cells of the thyroid. There is no single diagnostic imaging method that can reveal all MTC recurrences or metastases. Ga-DOTATATE is an alternative PET radiotracer that showed acceptable efficacy in the detection of MTC. In this study, we aimed to reveal the clinical efficacy and impact of this radiotracer on the management of patients with MTC.

Methods: The Ga-DOTATATE PET-CT records of 38 patients with confirmed MTC were included in the study. The demographic data, clinical indication for the scan, previous therapies, and tumor marker levels were recorded. The site and SUVmax of the lesions were also noted. A consensus was reached on the additional value of Ga-DOTATATE PET-CT, and sites with discordant results on conventional imaging (CI). Finally, changes in management after the scan were evaluated.

Results: Ga-DOTATATE PET-CT outperformed CI in 14/38 (37%) patients. In these 14 patients, metastatic lymph nodes were detected in 8, bone metastases in 4, and both bone and lymph nodes metastases in 2 patients. In 16/38 (42%) patients, Ga-DOTATATE PET-CT performed equally well as CI. In 5/38 (13%) patients, CI outperformed PET-CT. Most of the patients (4/5) in this group had hepatic metastases. Ga-DOTATATE PET-CT positivity was also correlated with tumor marker expression [median calcitonin; PET-positive: 743 ± 5439 vs PET-negative: 45 ± 17 (p:0.012), median CEA; PET-positive: 41 ± 162 vs PET-negative: 2.6 ± 1.4 (p:0.015)]. Ga-DOTATATE PET-CT changed the clinical management of 13/38 (34%) patients. The information provided by PET-CT resulted in neck surgery in 5/13 patients, external radiotherapy in 3/13 and both in one patient. Four of these thirteen patients were found to be eligible for peptide receptor radionuclide therapy.

Conclusion:  Ga-DOTATATE is an essential part of the work-up for patients with MTC. This modality outperformed CI in 14/38 (37%) patients and changed the clinical management in 13/38 (34%) patients. Prospective randomized studies with image-guided therapy decisions are needed to further reveal the impact of PET imaging in patients with MTC.
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http://dx.doi.org/10.1007/s12149-020-01494-3DOI Listing
September 2020

Factors affecting the response to Y-90 microsphere therapy in the cholangiocarcinoma patients.

Radiol Med 2021 Feb 27;126(2):323-333. Epub 2020 Jun 27.

Department of Nuclear Medicine, Faculty of Medicine, Hacettepe University, 06100, Sıhhiye, Ankara, Turkey.

Objective: The aim of this study was to assess the early therapy response in patients with unresectable CCA who received Y-90 microsphere therapy for CCA and define the factors related to therapy response.

Materials And Methods: Data of 19 patients [extrahepatic (n: 6) and intrahepatic (n: 13)] who received 24 sessions of Y-90 microsphere therapy [glass (n: 13) and resin (n: 11)] were retrospectively evaluated. Tumor load, tumor size, therapy response evaluation by RECIST1.1 criteria (n: 13), tumor lesion glycolysis (TLG), metabolic tumor volume (MTV), and metabolic therapy responses were evaluated (n: 8) using PERCIST1.0 criteria.

Results: No significant relation was found between therapy response and tumor localization, treated liver lobe, type of Y90 microspheres, the presence of previous therapies, perfusion pattern on hepatic artery perfusion scintigraphy, or patient demographics. The mean overall survival (OS) was 11.9 ± 2.3 months and was similar after both resin and glass Y90 microspheres; however, it was longer RECIST responders (p: 0.005). MTV and TLG values significantly decreased after therapy, and ΔMTV (- 45.4% ± 12.1) was found to be positively correlated with OS. No statistical difference was found between iCCA and eCCA, in terms of OS and response to therapy. Although not quantitatively displayed, better-perfused areas on HAPS images had a better metabolic response and less perfused areas were prone to local recurrences.

Conclusions: Both resin and glass microsphere therapy can be applied safely to iCCA and eCCA patients. Early therapy response can be evaluated with both RECIST and PERCIST criteria. Both anatomical and metabolic therapy response evaluations give complementary information.
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http://dx.doi.org/10.1007/s11547-020-01240-9DOI Listing
February 2021

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

BMC Cancer 2020 Mar 30;20(1):259. Epub 2020 Mar 30.

Hacettepe University Cancer Institute, Ankara, Turkey.

Background: Combination of gemcitabine and nab-paclitaxel has superior clinical efficacy than gemcitabine alone. Nevertheless, health-related quality of life. (QoL) associated with this combination therapy when administered at first-line in advanced pancreatic adenocarcinoma is unknown.

Methods: A total of 125 patients were randomized to combination therapy (1000 mg/m2 gemcitabine + 125 mg/m2 nab-paclitaxel) and single-agent gemcitabine (1000 mg/m2) arms to take treatment weekly for 7 of 8 weeks, and following 3 of 4 weeks, until progression or severe toxicity. Primary endpoints were three-months of definitive deterioration free percent of patients, and QoL.

Results: Overall QoL analyses showed that 34 and 58.3% of cases in gemcitabine and gemcitabine+nab-P arms had no deterioration in 3rd month QoL scores (p = 0.018). These proportions were 27.3 and 36.6% in 6 month assessments, respectively (p = 0.357). Median overall survivals in combination and single-agent arms were 9.92 months and 5.95 months, respectively (HR: 0.64, 95% CI: 0.42-0.86, p = 0.038). Median progression free survivals in these treatment arms were 6.28 and 3.22 months, respectively (HR: 0.58, 95% CI: 0.39-0.87, p = 0.008). Median time-to-deterioration were 5.36 vs 3.68 months, and objective response rates were 37.1% vs 23.7% (p = 0.009), respectively in combination and single-agent arms.

Conclusions: Combination therapy with gemcitabine + nab-paclitaxel had better overall and progression-free survival than gemcitabine alone. Also, combination therapy showed increased response rate without toxicity or deteriorated QoL. Combination treatment with gemcitabine and nab-paclitaxel may provide significant benefit for advanced pancreatic cancer.

Trial Registration: This study has been registered in ClinicalTrials.gov as NCT03807999 on January 8, 2019 (retrospectively registered).
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http://dx.doi.org/10.1186/s12885-020-06758-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7106641PMC
March 2020

Prognostic value of the 2017 World Health Organization Classification System for gastric neuroendocrine tumors: A single-center experience.

Turk J Gastroenterol 2020 02;31(2):91-98

Department of Medical Oncology, Hacettepe University Cancer Institute, Ankara, Turkey.

Background/aims: Gastric neuroendocrine tumors (G-NETs) are rare tumors, but their incidence is gradually increasing. Despite the existence of many classification systems, determining prognosis and planning treatment in patients with G-NETs remains a clinical challenge. In this study, the prognostic value of the World Health Organization (WHO) 2017 grading system and the effect of surgery on survival in low grade neuroendocrine tumors were investigated.

Materials And Methods: G-NETs who were diagnosed between January 2000 and May 2017 were included in the study. Patients' demographic characteristics, treatment details, and survival data were obtained from medical charts. Pathological samples were re-classified according to the WHO 2017 grading system.

Results: Of the total 94 evaluated patients, 50 (53.2%) were classified with G1 NETs, 37(39.4%) with G2 NETs, 4(4.2%) with well-differentiated G3 NETs, and the remaining 3 patients with poorly differentiated G3 neuroendocrine carcinoma (NEC). The median follow-up time was 83.2 months. There was a statistically significant difference in 5-year progression free survival (PFS) between G1 tumors (100%) and G2 tumors (76%) (p<0.001). However, there was no statistically significant deference in 5-year overall survival rate (OS) for G1 (97%) and G2 (82%) tumors (p=0.141). When G2 and G1 NETs were compared according to their surgical approach, radical surgery was more frequently performed in patients with G2 tumors (p<0.001). However, radical surgery did not improve PFS in G1 and G2 NETs.

Conclusion: The WHO 2017 NET classification system may have low prognostic value for determining the prognosis of patients with G1 and G2 tumors. Radical surgery for G1 and G2 NETs did not improve PFS in our study.
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http://dx.doi.org/10.5152/tjg.2020.18919DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7062132PMC
February 2020

Neutrophil-lymphocyte ratio as a prognostic factor for survival in patients with advanced renal cell carcinoma (Turkish Oncology Group Study).

J Oncol Pharm Pract 2020 Oct 13;26(7):1583-1589. Epub 2020 Feb 13.

Medical Oncology Department, Ankara University School of Medicine, Ankara, Turkey.

Background: To describe the prognostic value of neutrophil-lymphocyte ratio and its effect on survival in in patients with advanced renal cell carcinoma.

Methods: We retrospectively analyzed 331 patients. The cut-off value of neutrophil-lymphocyte ratio was specified as "3" which is mostly close-and also clinically easily applicable-to the median neutrophil-lymphocyte ratio level of our study group. High group is identified as neutrophil-lymphocyte ratio >3 (n = 160) and low group is identified as neutrophil-lymphocyte ratio ≤3 (n = 163).

Results: A total of 331 (with 211 male and 120 female) patients were enrolled to study. The median age of the patients was 58. The International Metastatic RCC Database Consortium risk score is calculated for the 72.8% (n = 241) of the study group and among these patients, favorable, intermediate, and poor risk rates were 22, 45.2, and 32.8%. The total usage of tyrosine kinase inhibitors reached 78% of the patients. The median overall survival was 32 months versus 11 months in the neutrophil-lymphocyte ratio low and high groups, respectively (HR: 0.49 (95% CI 0.37-0.65), p < 0.001).

Conclusion: In conclusion, the pre-treatment value of elevated neutrophil-lymphocyte ratio might be a predictor of poor overall survival in advanced renal cell carcinoma patients.
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http://dx.doi.org/10.1177/1078155219900908DOI Listing
October 2020

The relationship between prognostic nutritional index and treatment response in patients with metastatic renal cell cancer.

J Oncol Pharm Pract 2020 Jul 25;26(5):1110-1116. Epub 2019 Oct 25.

Faculty of Medicine, Medical Oncology Department, Ankara University Ankara, Turkey.

Introduction And Aim: To investigate the effect of the prognostic nutritional index on treatment response and survival in patients with metastatic renal cell cancer.

Methods: We retrospectively analyzed the treatment modalities; the demographic, clinical and pathological features of 396 patients with RCC and prognostic nutritional index. Based on the median value, patients were grouped as having low and high prognostic nutritional index values. Kaplan-Meier method was used for survival analysis, and Cox-regression analysis was used for multivariate analysis.

Results: The median overall survival was 39 months (95% CI 26.1-51.8), 28 months (95% CI 17.9-38) and 7 months (95% CI 4.7-9.2) in patients with favorable, intermediate and poor International Metastatic Renal Cell Carcinoma Database Consortium risk group, respectively. The difference between the groups was statistically significant (p < 0001). Overall survival was 11 months (95% CI 7.5-14.5) in the low-prognostic nutritional index (prognostic nutritional index ≤38.5) group, and 41 months (95% CI 30.5-51.4) in the high prognostic nutritional index (prognostic nutritional index >38.5) group (p < 0.001). In Cox regression analysis, Eastern Cooperative Oncology Group performance score (HR: 2.5), time to systemic treatment (HR: 1.7) and prognostic nutritional index (HR: 1.8) were associated with overall survival.

Conclusion: In patients with renal cell cancer, prognostic nutritional index is closely related to survival and has prognostic significance.
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http://dx.doi.org/10.1177/1078155219883004DOI Listing
July 2020

Development of de novo psoriasis during nivolumab therapy in a patient with small cell lung cancer.

J Oncol Pharm Pract 2020 Jan 29;26(1):256-258. Epub 2019 Sep 29.

Department of Preventive Oncology, Hacettepe University Cancer Institute, Ankara, Turkey.

Introduction: The immune checkpoint inhibitors recently entered to small cell lung cancer (SCLC) stage, firstly in the third and recently in the first lines of therapy. This efficacy comes at the expense of many toxicities including skin toxicity. This toxicity is usually in the form of rash and pruritis; however, rare reactions like psoriasis can also be seen.

Case Report: Herein, we report an SCLC case who developed de novo psoriasis while treated with nivolumab as the third-line treatment for SCLC.

Management And Outcome: The psoriatic plaques were regressed with the topical highly potent steroid therapy, and immunotherapy was continued without further complications.

Discussion: We think that rare adverse events like de novo psoriasis are important considering the expanding role of these agents; their timely recognition and treatment are important in the management of cancer patients.
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http://dx.doi.org/10.1177/1078155219877234DOI Listing
January 2020

Drug-related problems with targeted/immunotherapies at an oncology outpatient clinic.

J Oncol Pharm Pract 2020 Apr 25;26(3):595-602. Epub 2019 Jul 25.

Department of Medical Oncology, Hacettepe University, Hacettepe Cancer Institute, Ankara, Turkey.

Background: Some studies in the literature describe drug-related problems in patients with cancer, although few studies focused on patients receiving targeted chemotherapy and/or immunotherapy. To identify the incidence of drug-related problems in patients receiving targeted chemotherapy and/or immunotherapy, and demonstrate the impact of a clinical pharmacist in an outpatient oncology care setting.

Methods: Prospective study was conducted in a hospital outpatient oncology clinic between October 2015 and March 2016. Patients greater than 18 years old receiving cetuximab, nivolumab, ipilimumab, or pembrolizumab were included in the study and monitored over a three-month period by a clinical pharmacist. Drug-related problems were analyzed using the Pharmaceutical Care Network Europe classification system. The main outcome measures were the frequency and causes of drug-related problems and the degree of resolution achieved through the involvement of a clinical pharmacist.

Results: A total of 54 patients (mean age: 57 ± 12 years) were included. There were 105 drug-related problems and 159 associated causes. Among the planned interventions (n = 149), 92 interventions were at the patient-level with 88 (96%) being accepted by the doctors. This resulted in 68 (65%) drug-related problems being completely resolved and 9 (8.6%) being partially resolved. The most common drug-related problem identified was "adverse drug event" (n = 38, 36%). Of the 105 drug-related problems, 63 (60%) related to targeted chemotherapy and/or immunotherapy with 34 (54%) classified as an "adverse drug event."

Conclusion: Adverse drug events were the most common drug-related problems in patients with cancer. The involvement of a clinical pharmacist improved the identification of drug-related problems and helped optimize treatment outcomes in patients receiving targeted chemotherapy/immunotherapy.
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http://dx.doi.org/10.1177/1078155219861679DOI Listing
April 2020
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