Mahmut Gümüş - Academia.edu (original) (raw)

Papers by Mahmut Gümüş

Cancer, Jan 6, 2018

Inotuzumab ozogamicin (InO), an anti-CD22 antibody-calicheamicin conjugate, demonstrated superior... more Inotuzumab ozogamicin (InO), an anti-CD22 antibody-calicheamicin conjugate, demonstrated superior clinical activity versus standard-of-care (SOC) chemotherapies for relapsed/refractory B-cell acute lymphoblastic leukemia in the phase 3 randomized controlled INO-VATE trial. The authors assessed patient-reported outcomes (PROs) from that study. Patients were randomized to receive either InO (1.8 mg/m per cycle for ≤6 cycles) or SOC (fludarabine/cytarabine [ara-C]/granulocyte colony-stimulating factor, or ara-C plus mitoxantrone, or high-dose ara-C for ≤4 cycles) and completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and the EuroQoL 5 Dimensions Questionnaires at baseline, on day 1 of each cycle, and at the end of treatment. Treatment differences in PROs were assessed using longitudinal mixed-effects models with random intercepts and slopes. Questionnaire completion rates in the InO (n = 164) and SOC (n = 162) arms were 85% and 65%, r...

Future Oncology, 2022

Aim: To compare the seropositivity rate of cancer patients with noncancer controls after inactive... more Aim: To compare the seropositivity rate of cancer patients with noncancer controls after inactive SARS-CoV-2 vaccination and evaluate the factors affecting seropositivity. Method: Spike IgG antibodies against SARS-CoV-2 were measured in blood samples of 776 cancer patients and 715 noncancer volunteers. An IgG level ≥50 AU/ml is accepted as seropositive. Results: The seropositivity rate was 85.2% in the patient group and 97.5% in the control group. The seropositivity rate and antibody levels were significantly lower in the patient group (p < 0.001). Age and chemotherapy were associated with lower seropositivity in cancer patients (p < 0.001). Conclusion: This study highlighted the efficacy and safety of the inactivated vaccine in cancer patients. Clinical Trials Registration: NCT04771559 (ClinicalTrials.gov)

European Journal of Breast Health, 2021

Objective: This study aimed to determine the differences in clinicopathological features of Turki... more Objective: This study aimed to determine the differences in clinicopathological features of Turkish patients with high-risk breast cancer based on the mutation status of two breast cancer susceptibility genes (BRCA1/2). Materials and Methods: This study enrolled patients with invasive breast cancer who have been evaluated for BRCA1/2 mutations due to the presence of high-risk factors admitted to two tertiary referral centers in Turkey. Clinical and histopathological features were analyzed in BRCA1 mutation carriers, BRCA2 mutation carriers, and non-carriers. Results: A total of 302 patients with a mean age of 44.2±9.9 (22-82) years were included. BRCA1/2 mutation was found in 75 (24%) patients, of whom 41 (13.6%) were BRCA1 mutation carriers and 37 (12.3%) were BRCA2 mutation carriers. Moreover, 104 (34.4%) and 4 (1.3%) patients had family history of breast and ovarian carcinoma, respectively. The rates of triple negativity (56.1%), histologic grade 3 (65.9%), and lymphovascular invasion (78%) were significantly higher in BRCA1 mutation carriers than in non-carriers and BRCA2 mutation carriers. Furthermore, 87% of triple-negative BRCA1 mutation carriers had histologic grade 3 tumors compared with 38.9% in non-triple-negative BRCA1 mutation carriers, and the difference was significant. Conclusion: Findings of this study showed that BRCA1-related breast cancers represent a distinct group with unique pathological features, which are usually associated with a poor prognosis.

Antihipertansif ilaçlardan alfa-I bloker olan Doksazosin, Angiotensin Konverting Enzim (ACE) İnhi... more Antihipertansif ilaçlardan alfa-I bloker olan Doksazosin, Angiotensin Konverting Enzim (ACE) İnhibitörü olan Ramipril ve Kalsiyum Kanal Blokeri olan Amlodipin'in tedavi dozlarında hipertansifhastalarda antihipertansif etkinlikleri , kan glukoz düzeyi ve lipid profili üzerine etkileri karşılaştırılmıştır. Çalışma, Ocak 1996-Haziran 1996 tarihleri arasında , hastanemizin Dahiliye Kliniği ve Polikliniğine başvuran toplam 72 hasta üzerinde yapılmıştır. Hastalara üç aylık tedavi verilmiş, tedavi öncesi ve üç ay sonunda telekardiografı, EKG, açlık kan şekeri(AKŞ), ALT, AST, total kolesterol , trigliserid, HDL-kolesterol , üre, kreatinin düzeylerine bakıimıştır. Çalışmada tüm sonuçlar ortalaına±SD olarak verilmiş olup anlamlılık analizinde Wilcoxon eşleştirilmiş iki örnek testİ kullanılmıştır. Doksazosin grubunun kan lipid protiline anlamlı olarak yararlı etkisinin olduğu, AKŞ düzeyindeki düşmenin ise anlamlı olmadığı saptanmıştır. Amlodipin ve Ramipril'in gerek lipid profili gerek...

Tip 2 diabet pategenezinin en önemli komponentleri; insülin salgısında ve insülin etkisinde defek... more Tip 2 diabet pategenezinin en önemli komponentleri; insülin salgısında ve insülin etkisinde defektlerdir. Bunlardan hangisi primer defekt olursa olsun, tip 2 diabette tedavi açısından şunlar dikkate alınmalıdır: 1. Hiperglisemik olan tip 2 diabetli tüm hastalar insülin salgısında biraz defekte sahiptir, 2. Açlık plazma glukozu ne kadar yüksekse insülin yeters iz liği o kadar şiddetlidir, 3. İnsülin direnci tip 2 diabetli hastaların çoğunda vardır, ancak bütün hastalarda yoktur, 4. İnsülin rezistansının derecesi tip 2 diabetli hastalar arasında değişkenlik gösterir ve obezite ile anlamlı şekilde ilgilidir ı. İnsülin direncinin primer defekt olduğu NIDDM başlangıcında , insülin direncini kompanse etmek için insülin salgısı artar ancak daha sonraki süreçte bu kompansasyon etkisiz hale gelir, insülin yetmezliği ortaya çıkar (Pankreasın Starling Eğrisi). NIDDM doğal seyrinin erken fazında, pankreasın beta hücre rezerv i iyi durumda iken, beta stimulan oral antidiabetik droglar tedavide y...

Swiss medical weekly, 2003

We report on a case of Wilson's disease in a young male presenting with status epilepticus du... more We report on a case of Wilson's disease in a young male presenting with status epilepticus during D-pencillamine treatment. The patient was admitted to our neurogical clinic for status epilepticus and was successfully treated with antiepileptic drugs. He had been on regular D-pencillamine treatment for three years. Magnetic resonance imaging showed lesions bilaterally in subcortical areas of frontal lobes, putamen, thalamus, globus pallidum and caudate nuclei. Wilson's disease had been diagnosed. Few patients with Wilson's disease presenting with epilepsy and status epilepticus have been reported. Although the patient had received D-pencillamine treatment, the diagnosis of Wilson's disease should he considered in patients who present with status epilepticus.

Five-year overall survival (OS) and disease-free survival rates for the entire group were 88.5% a... more Five-year overall survival (OS) and disease-free survival rates for the entire group were 88.5% and 52%, respectively. In univariate analysis, age (p<0.0001), stage (p<0.005), Eastern Cooperative Oncology Group (ECOG) performance status (p<0.0001), B symptoms (p=0.01), serum albumin levels (p=0.01), and serum lactate dehydrogenase (LDH) levels (p=0.04) significantly affected OS. Multivariate analysis showed that only ECOG performance status was an important prognostic factor for OS (p<0.001).

Five-year overall survival (OS) and disease-free survival rates for the entire group were 88.5% a... more Five-year overall survival (OS) and disease-free survival rates for the entire group were 88.5% and 52%, respectively. In univariate analysis, age (p<0.0001), stage (p<0.005), Eastern Cooperative Oncology Group (ECOG) performance status (p<0.0001), B symptoms (p=0.01), serum albumin levels (p=0.01), and serum lactate dehydrogenase (LDH) levels (p=0.04) significantly affected OS. Multivariate analysis showed that only ECOG performance status was an important prognostic factor for OS (p<0.001).

Over metastazi, en sik genital organlardan ardindan sirayla gastrointestinal sistem ve meme karsi... more Over metastazi, en sik genital organlardan ardindan sirayla gastrointestinal sistem ve meme karsinomundan gerceklesir. Bu yazida, meme kanseri nedeniyle adjuvan tedavilerini aldiktan sonra adjuvan anastrazol tedavisi altinda takip edilirken, yedi yil sonra izole over metastazi saptanan nuks meme kanseri olgusu sunuldu. Hasta sag alt karin agrisi ile basvurdu. Yapilan radyolojik incelemelerde uterus icerisinde miyoma uteri ile uyumlu kitle saptandi. Hastaya total abdominal histerektomi ve bilateral salpingooferektomi uygulandi. Histopatolojik incelemede sag overde karsinom infiltrasyonu saptandi. Alinan dokularin immunhistokimyasal (IHK) incelemesinde, tumor hucrelerinde sitokeratin (CK) 7 ile ve gross cyctic disease fluid protein (GCDFP-15) ile yaygin ve kuvvetli pozitiflik saptandi. Morfolojik, IHK ve klinik bulgular esliginde hastaya invaziv duktal karsinomun over metastazi tanisi konuldu. Postoperatif dort kur kemoterapi uygulanan hasta 21. ayinda halen hormonoterapi altinda hast...

OBJECTIVES Ovarian cancer is associated with the highest mortality of gynecologic cancers. Epidem... more OBJECTIVES Ovarian cancer is associated with the highest mortality of gynecologic cancers. Epidemiological and genetic factors of ovarian cancer development are clearly defined but prognostic factors have not been adequately identified. Right and left ovarian cancers seem to act different behaviors at high-grade serous ovarian cancer (HGSOC) prognosis. The aim of this study is to explain this prognostic role of its sidedness. The aim of this study is to explain this prognostic role of its sidedness. MATERIAL AND METHODS We reviewed 160 consecutive patients with Figo stage 1-3 HGSOCs and undergone surgery at two high-volume hospitals. Prognostic effects of primary tumor location onset were evaluated in terms of 5-year disease free survival and overall survival rate. RESULTS One hundred-sixty patients with ovarian cancer records were analyzed using the Kaplan-Meier method, that demonstrated a significant difference in the 5-year disease-free survival rates between right and left-sided...

New England Journal of Medicine, 2021

BACKGROUND Pembrolizumab has efficacy in programmed death ligand 1 (PD-L1)-positive metastatic or... more BACKGROUND Pembrolizumab has efficacy in programmed death ligand 1 (PD-L1)-positive metastatic or unresectable cervical cancer that has progressed during chemotherapy. We assessed the relative benefit of adding pembrolizumab to chemotherapy with or without bevacizumab. METHODS In a double-blind, phase 3 trial, we randomly assigned patients with persistent, recurrent, or metastatic cervical cancer in a 1:1 ratio to receive pembrolizumab (200 mg) or placebo every 3 weeks for up to 35 cycles plus platinum-based chemotherapy and, per investigator discretion, bevacizumab. The dual primary end points were progression-free survival and overall survival, each tested sequentially in patients with a PD-L1 combined positive score of 1 or more, in the intentionto-treat population, and in patients with a PD-L1 combined positive score of 10 or more. The combined positive score is defined as the number of PD-L1-staining cells divided by the total number of viable tumor cells, multiplied by 100. All results are from the protocol-specified first interim analysis. RESULTS In 548 patients with a PD-L1 combined positive score of 1 or more, median progression-free survival was 10.4 months in the pembrolizumab group and 8.2 months in the placebo group (hazard ratio for disease progression or death, 0.62; 95% confidence interval [CI], 0.50 to 0.77; P<0.001). In 617 patients in the intention-to-treat population, progression-free survival was 10.4 months and 8.2 months, respectively (hazard ratio, 0.65; 95% CI, 0.53 to 0.79; P<0.001). In 317 patients with a PD-L1 combined positive score of 10 or more, progression-free survival was 10.4 months and 8.1 months, respectively (hazard ratio, 0.58; 95% CI, 0.44 to 0.77; P<0.001). Overall survival at 24 months was 53.0% in the pembrolizumab group and 41.7% in the placebo group (hazard ratio for death, 0.64; 95% CI, 0.50 to 0.81; P<0.001), 50.4% and 40.4% (hazard ratio, 0.67; 95% CI, 0.54 to 0.84; P<0.001), and 54.4% and 44.6% (hazard ratio, 0.61; 95% CI, 0.44 to 0.84; P = 0.001), respectively. The most common grade 3 to 5 adverse events were anemia (30.3% in the pembrolizumab group and 26.9% in the placebo group) and neutropenia (12.4% and 9.7%, respectively). CONCLUSIONS Progression-free and overall survival were significantly longer with pembrolizumab than with placebo among patients with persistent, recurrent, or metastatic cervical cancer who were also receiving chemotherapy with or without bevacizumab. (Funded by Merck Sharp and Dohme; KEYNOTE-826 ClinicalTrials.gov number, NCT03635567.

The Lancet, 2021

BACKGROUND We aimed to examine cemiplimab, a programmed cell death 1 inhibitor, in the first-line... more 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.

The Lancet, 2021

BACKGROUND We aimed to examine cemiplimab, a programmed cell death 1 inhibitor, in the first-line... more 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.

Turkish Journal of Oncology, 2021

Cancer Treatment and Research Communications, 2021

Background: We aimed to evaluate the association of serum carcinoembryonic antigen (CEA) and canc... more Background: We aimed to evaluate the association of serum carcinoembryonic antigen (CEA) and cancer antigen 15-3 (CA 15-3) levels with clinicopathological parameters in patients with breast cancer (BC) and their efficiency for the prediction of recurrence. Methods: The records of 482 female patients with breast cancer diagnosis followed in Medical Oncology and Radiation Oncology clinics of Kartal Dr. Lutfu Kirdar Education and Research Hospital were evaluated retrospectively. Results: The median age of the patients was 49. CEA levels were significantly higher in postmenopausal patients (p = 0.022). There was no association between CEA and CA 15-3 levels and nodal involvement (p = 0.689, 0.379; respectively). CEA levels were significantly higher in hormone receptor-positive patients (p = 0.007). HER2 negative patients had significantly higher levels of CEA and CA 15-3 (p = 0.017 and 0.011, respectively). The evaluation of metastatic patients showed that CEA and CA 15-3 levels before metastasis were significantly elevated (p = 0.016 ve 0.008, respectively). There was no relation between the metastasis site and CEA, CA 15-3 levels (p = 0.936, 0.201, respectively). Receiver operating characteristic (ROC) analysis was performed to determine the role of CEA and CA 15-3 levels in the prediction of metastasis, and cutoff values were 1.39 ng/ml and 14.54 U/ml, respectively. Sensitivities of CA 15-3 and CEA levels were 82.1% and 88.3%; specificities were 47.3% and 46.2%, respectively. Conclusions: CEA and CA 15-3 are useful as tumor markers for early diagnosis of metastases, and their elevations were associated with unfavorable clinicopathological parameters of breast cancer patients. Since these markers are considered a cheap and accessible way of predicting breast cancer prognosis, there is an increasing interest in the prognostic value of serum levels of tumor markers in recent years. More sensitive cutoff values for each marker are needed to be validated with further studies.

Journal of Turkish Society of Obstetric and Gynecology, 2020

Adding bevacizumab to chemotherapy in advanced stage cervical cancer is an effective and tolerabl... more Adding bevacizumab to chemotherapy in advanced stage cervical cancer is an effective and tolerable treatment for Turkish patients. Öz Amaç: Monoklonal, antivasküler endotelyal büyüme faktörü antikoru olan bevasizumabın sitotoksik kemoterepilerle birlikte kullanımının metastatik, tekrarlayan serviks kanserli Türk hasta popülasyonunda etkinliğini değerlendirmeyi amaçladık. Gereç ve Yöntemler: Metastatik, tekrarlayan serviks kanseri tanısıyla 2013 ve 2017 yılları arasında ilk seri tedavide sisplatin veya carboplatin ve paklitaksel kemoterapisi ile bevasizumab kullanan hastaların dosyalarını geriye dönük olarak inceledik. Bulgular: Altmış dört hastanın verisini değerlendirdik. Ortalama yaş 49 (aralık, 28-68), ortanca takip süresi 12 aydı (aralık, 2-53), ortanca progresyonsuz sağkalım süresi 8 ay ve ortanca genel sağkalım süresi 23 aydı. Ortanca bevasizumab ve kemoterapi kür sayısı altı idi. Bevasizumab ile birlikte kullanılan kemoterapi rejimleri 31 hastada (4%8) sisplatin ve paklitaksel, 33 hastada (%52) karboplatin, ve paklitakseldi. Daha önce radyoterapi duyarlılaştırıcı olarak sisplatin almayan hastalarda sağkalım süresi sisplatinli tedavi alan hastalarda karboplatinli tedaviden daha iyiydi (p=0,023). Bevasizumab dozu 30 hastada (%47) 7,5 mg/kg ve 34 hastada (%53) 15 mg/kg 21 günde bir idi. İki grup arasında genel sağkalım ve progresyonsuz sağkalım farkı yoktu. Tüm gradlarda en sık görülen yan etkiler bulantı, nötropeni, anemi ve periferal duysal nöropati, en sık görülen grad ≥3 yan etkiler ise nötropeni, anemi ve periferal duysal nöropatiydi.

Journal of Clinical Oncology, 2020

PURPOSE In the phase 3 KEYNOTE-407 study, the addition of pembrolizumab to carboplatin-paclitaxel... more PURPOSE In the phase 3 KEYNOTE-407 study, the addition of pembrolizumab to carboplatin-paclitaxel/nab-paclitaxel significantly improved overall survival, progression-free survival, and objective response rate in patients with previously untreated metastatic squamous non–small-cell lung cancer (NSCLC), with little impact on severe toxicity. We present patient-reported outcomes (PROs) from KEYNOTE-407. METHODS Patients were randomly assigned to receive 4 cycles of pembrolizumab 200 mg or placebo once every 3 weeks plus carboplatin plus paclitaxel or nab-paclitaxel, followed by pembrolizumab or placebo for an additional 31 cycles. Health-related quality of life (HRQoL) was evaluated using the European Organisation for Research and Treatment of Cancer Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and Quality of Life Questionnaire-Lung Cancer Module 13 (QLQ-LC13). Key PRO endpoints were change from baseline to weeks 9 and 18 (during and after platinum therapy) in th...

Oncology Research and Treatment, 2019

Background: Colorectal cancer (CRC) is a rare disease amongst children and adolescents. Previous ... more Background: Colorectal cancer (CRC) is a rare disease amongst children and adolescents. Previous studies have reported a number of differences between children/adolescents, young adults, and adult patients with CRC. However, none of these studies compared these age groups according to their clinicopathologic and prognostic characteristics. In the current study, we compare these three age groups. Methods:A total of 173 (1.1% of 15,654 patients) young CRC patients (≤25 years) were included in the study. As a control group, 237 adult CRC patients (>25 years) were also included. Patients were divided into three age groups: child/adolescent (10–19 years), young adult (20–25 years), and adult (>25 years). Results: Statistical differences amongst the three groups in terms of gender (p = 0.446), family history (p = 0.578), symptoms of presentation (p = 0.306), and interval between initiation of symptoms and diagnosis (p = 0.710) could not be demonstrated. Whilst abdominal pain (p <...

OncoTargets and therapy, 2018

We studied the comparative effectiveness of biosimilar filgrastim vs original filgrastim in patie... more We studied the comparative effectiveness of biosimilar filgrastim vs original filgrastim in patients with chemotherapy-induced neutropenia. 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. 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....

Cancer, Jan 6, 2018

Inotuzumab ozogamicin (InO), an anti-CD22 antibody-calicheamicin conjugate, demonstrated superior... more Inotuzumab ozogamicin (InO), an anti-CD22 antibody-calicheamicin conjugate, demonstrated superior clinical activity versus standard-of-care (SOC) chemotherapies for relapsed/refractory B-cell acute lymphoblastic leukemia in the phase 3 randomized controlled INO-VATE trial. The authors assessed patient-reported outcomes (PROs) from that study. Patients were randomized to receive either InO (1.8 mg/m per cycle for ≤6 cycles) or SOC (fludarabine/cytarabine [ara-C]/granulocyte colony-stimulating factor, or ara-C plus mitoxantrone, or high-dose ara-C for ≤4 cycles) and completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and the EuroQoL 5 Dimensions Questionnaires at baseline, on day 1 of each cycle, and at the end of treatment. Treatment differences in PROs were assessed using longitudinal mixed-effects models with random intercepts and slopes. Questionnaire completion rates in the InO (n = 164) and SOC (n = 162) arms were 85% and 65%, r...

Future Oncology, 2022

Aim: To compare the seropositivity rate of cancer patients with noncancer controls after inactive... more Aim: To compare the seropositivity rate of cancer patients with noncancer controls after inactive SARS-CoV-2 vaccination and evaluate the factors affecting seropositivity. Method: Spike IgG antibodies against SARS-CoV-2 were measured in blood samples of 776 cancer patients and 715 noncancer volunteers. An IgG level ≥50 AU/ml is accepted as seropositive. Results: The seropositivity rate was 85.2% in the patient group and 97.5% in the control group. The seropositivity rate and antibody levels were significantly lower in the patient group (p < 0.001). Age and chemotherapy were associated with lower seropositivity in cancer patients (p < 0.001). Conclusion: This study highlighted the efficacy and safety of the inactivated vaccine in cancer patients. Clinical Trials Registration: NCT04771559 (ClinicalTrials.gov)

European Journal of Breast Health, 2021

Objective: This study aimed to determine the differences in clinicopathological features of Turki... more Objective: This study aimed to determine the differences in clinicopathological features of Turkish patients with high-risk breast cancer based on the mutation status of two breast cancer susceptibility genes (BRCA1/2). Materials and Methods: This study enrolled patients with invasive breast cancer who have been evaluated for BRCA1/2 mutations due to the presence of high-risk factors admitted to two tertiary referral centers in Turkey. Clinical and histopathological features were analyzed in BRCA1 mutation carriers, BRCA2 mutation carriers, and non-carriers. Results: A total of 302 patients with a mean age of 44.2±9.9 (22-82) years were included. BRCA1/2 mutation was found in 75 (24%) patients, of whom 41 (13.6%) were BRCA1 mutation carriers and 37 (12.3%) were BRCA2 mutation carriers. Moreover, 104 (34.4%) and 4 (1.3%) patients had family history of breast and ovarian carcinoma, respectively. The rates of triple negativity (56.1%), histologic grade 3 (65.9%), and lymphovascular invasion (78%) were significantly higher in BRCA1 mutation carriers than in non-carriers and BRCA2 mutation carriers. Furthermore, 87% of triple-negative BRCA1 mutation carriers had histologic grade 3 tumors compared with 38.9% in non-triple-negative BRCA1 mutation carriers, and the difference was significant. Conclusion: Findings of this study showed that BRCA1-related breast cancers represent a distinct group with unique pathological features, which are usually associated with a poor prognosis.

Antihipertansif ilaçlardan alfa-I bloker olan Doksazosin, Angiotensin Konverting Enzim (ACE) İnhi... more Antihipertansif ilaçlardan alfa-I bloker olan Doksazosin, Angiotensin Konverting Enzim (ACE) İnhibitörü olan Ramipril ve Kalsiyum Kanal Blokeri olan Amlodipin'in tedavi dozlarında hipertansifhastalarda antihipertansif etkinlikleri , kan glukoz düzeyi ve lipid profili üzerine etkileri karşılaştırılmıştır. Çalışma, Ocak 1996-Haziran 1996 tarihleri arasında , hastanemizin Dahiliye Kliniği ve Polikliniğine başvuran toplam 72 hasta üzerinde yapılmıştır. Hastalara üç aylık tedavi verilmiş, tedavi öncesi ve üç ay sonunda telekardiografı, EKG, açlık kan şekeri(AKŞ), ALT, AST, total kolesterol , trigliserid, HDL-kolesterol , üre, kreatinin düzeylerine bakıimıştır. Çalışmada tüm sonuçlar ortalaına±SD olarak verilmiş olup anlamlılık analizinde Wilcoxon eşleştirilmiş iki örnek testİ kullanılmıştır. Doksazosin grubunun kan lipid protiline anlamlı olarak yararlı etkisinin olduğu, AKŞ düzeyindeki düşmenin ise anlamlı olmadığı saptanmıştır. Amlodipin ve Ramipril'in gerek lipid profili gerek...

Tip 2 diabet pategenezinin en önemli komponentleri; insülin salgısında ve insülin etkisinde defek... more Tip 2 diabet pategenezinin en önemli komponentleri; insülin salgısında ve insülin etkisinde defektlerdir. Bunlardan hangisi primer defekt olursa olsun, tip 2 diabette tedavi açısından şunlar dikkate alınmalıdır: 1. Hiperglisemik olan tip 2 diabetli tüm hastalar insülin salgısında biraz defekte sahiptir, 2. Açlık plazma glukozu ne kadar yüksekse insülin yeters iz liği o kadar şiddetlidir, 3. İnsülin direnci tip 2 diabetli hastaların çoğunda vardır, ancak bütün hastalarda yoktur, 4. İnsülin rezistansının derecesi tip 2 diabetli hastalar arasında değişkenlik gösterir ve obezite ile anlamlı şekilde ilgilidir ı. İnsülin direncinin primer defekt olduğu NIDDM başlangıcında , insülin direncini kompanse etmek için insülin salgısı artar ancak daha sonraki süreçte bu kompansasyon etkisiz hale gelir, insülin yetmezliği ortaya çıkar (Pankreasın Starling Eğrisi). NIDDM doğal seyrinin erken fazında, pankreasın beta hücre rezerv i iyi durumda iken, beta stimulan oral antidiabetik droglar tedavide y...

Swiss medical weekly, 2003

We report on a case of Wilson's disease in a young male presenting with status epilepticus du... more We report on a case of Wilson's disease in a young male presenting with status epilepticus during D-pencillamine treatment. The patient was admitted to our neurogical clinic for status epilepticus and was successfully treated with antiepileptic drugs. He had been on regular D-pencillamine treatment for three years. Magnetic resonance imaging showed lesions bilaterally in subcortical areas of frontal lobes, putamen, thalamus, globus pallidum and caudate nuclei. Wilson's disease had been diagnosed. Few patients with Wilson's disease presenting with epilepsy and status epilepticus have been reported. Although the patient had received D-pencillamine treatment, the diagnosis of Wilson's disease should he considered in patients who present with status epilepticus.

Five-year overall survival (OS) and disease-free survival rates for the entire group were 88.5% a... more Five-year overall survival (OS) and disease-free survival rates for the entire group were 88.5% and 52%, respectively. In univariate analysis, age (p<0.0001), stage (p<0.005), Eastern Cooperative Oncology Group (ECOG) performance status (p<0.0001), B symptoms (p=0.01), serum albumin levels (p=0.01), and serum lactate dehydrogenase (LDH) levels (p=0.04) significantly affected OS. Multivariate analysis showed that only ECOG performance status was an important prognostic factor for OS (p<0.001).

Five-year overall survival (OS) and disease-free survival rates for the entire group were 88.5% a... more Five-year overall survival (OS) and disease-free survival rates for the entire group were 88.5% and 52%, respectively. In univariate analysis, age (p<0.0001), stage (p<0.005), Eastern Cooperative Oncology Group (ECOG) performance status (p<0.0001), B symptoms (p=0.01), serum albumin levels (p=0.01), and serum lactate dehydrogenase (LDH) levels (p=0.04) significantly affected OS. Multivariate analysis showed that only ECOG performance status was an important prognostic factor for OS (p<0.001).

Over metastazi, en sik genital organlardan ardindan sirayla gastrointestinal sistem ve meme karsi... more Over metastazi, en sik genital organlardan ardindan sirayla gastrointestinal sistem ve meme karsinomundan gerceklesir. Bu yazida, meme kanseri nedeniyle adjuvan tedavilerini aldiktan sonra adjuvan anastrazol tedavisi altinda takip edilirken, yedi yil sonra izole over metastazi saptanan nuks meme kanseri olgusu sunuldu. Hasta sag alt karin agrisi ile basvurdu. Yapilan radyolojik incelemelerde uterus icerisinde miyoma uteri ile uyumlu kitle saptandi. Hastaya total abdominal histerektomi ve bilateral salpingooferektomi uygulandi. Histopatolojik incelemede sag overde karsinom infiltrasyonu saptandi. Alinan dokularin immunhistokimyasal (IHK) incelemesinde, tumor hucrelerinde sitokeratin (CK) 7 ile ve gross cyctic disease fluid protein (GCDFP-15) ile yaygin ve kuvvetli pozitiflik saptandi. Morfolojik, IHK ve klinik bulgular esliginde hastaya invaziv duktal karsinomun over metastazi tanisi konuldu. Postoperatif dort kur kemoterapi uygulanan hasta 21. ayinda halen hormonoterapi altinda hast...

OBJECTIVES Ovarian cancer is associated with the highest mortality of gynecologic cancers. Epidem... more OBJECTIVES Ovarian cancer is associated with the highest mortality of gynecologic cancers. Epidemiological and genetic factors of ovarian cancer development are clearly defined but prognostic factors have not been adequately identified. Right and left ovarian cancers seem to act different behaviors at high-grade serous ovarian cancer (HGSOC) prognosis. The aim of this study is to explain this prognostic role of its sidedness. The aim of this study is to explain this prognostic role of its sidedness. MATERIAL AND METHODS We reviewed 160 consecutive patients with Figo stage 1-3 HGSOCs and undergone surgery at two high-volume hospitals. Prognostic effects of primary tumor location onset were evaluated in terms of 5-year disease free survival and overall survival rate. RESULTS One hundred-sixty patients with ovarian cancer records were analyzed using the Kaplan-Meier method, that demonstrated a significant difference in the 5-year disease-free survival rates between right and left-sided...

New England Journal of Medicine, 2021

BACKGROUND Pembrolizumab has efficacy in programmed death ligand 1 (PD-L1)-positive metastatic or... more BACKGROUND Pembrolizumab has efficacy in programmed death ligand 1 (PD-L1)-positive metastatic or unresectable cervical cancer that has progressed during chemotherapy. We assessed the relative benefit of adding pembrolizumab to chemotherapy with or without bevacizumab. METHODS In a double-blind, phase 3 trial, we randomly assigned patients with persistent, recurrent, or metastatic cervical cancer in a 1:1 ratio to receive pembrolizumab (200 mg) or placebo every 3 weeks for up to 35 cycles plus platinum-based chemotherapy and, per investigator discretion, bevacizumab. The dual primary end points were progression-free survival and overall survival, each tested sequentially in patients with a PD-L1 combined positive score of 1 or more, in the intentionto-treat population, and in patients with a PD-L1 combined positive score of 10 or more. The combined positive score is defined as the number of PD-L1-staining cells divided by the total number of viable tumor cells, multiplied by 100. All results are from the protocol-specified first interim analysis. RESULTS In 548 patients with a PD-L1 combined positive score of 1 or more, median progression-free survival was 10.4 months in the pembrolizumab group and 8.2 months in the placebo group (hazard ratio for disease progression or death, 0.62; 95% confidence interval [CI], 0.50 to 0.77; P<0.001). In 617 patients in the intention-to-treat population, progression-free survival was 10.4 months and 8.2 months, respectively (hazard ratio, 0.65; 95% CI, 0.53 to 0.79; P<0.001). In 317 patients with a PD-L1 combined positive score of 10 or more, progression-free survival was 10.4 months and 8.1 months, respectively (hazard ratio, 0.58; 95% CI, 0.44 to 0.77; P<0.001). Overall survival at 24 months was 53.0% in the pembrolizumab group and 41.7% in the placebo group (hazard ratio for death, 0.64; 95% CI, 0.50 to 0.81; P<0.001), 50.4% and 40.4% (hazard ratio, 0.67; 95% CI, 0.54 to 0.84; P<0.001), and 54.4% and 44.6% (hazard ratio, 0.61; 95% CI, 0.44 to 0.84; P = 0.001), respectively. The most common grade 3 to 5 adverse events were anemia (30.3% in the pembrolizumab group and 26.9% in the placebo group) and neutropenia (12.4% and 9.7%, respectively). CONCLUSIONS Progression-free and overall survival were significantly longer with pembrolizumab than with placebo among patients with persistent, recurrent, or metastatic cervical cancer who were also receiving chemotherapy with or without bevacizumab. (Funded by Merck Sharp and Dohme; KEYNOTE-826 ClinicalTrials.gov number, NCT03635567.

The Lancet, 2021

BACKGROUND We aimed to examine cemiplimab, a programmed cell death 1 inhibitor, in the first-line... more 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.

The Lancet, 2021

BACKGROUND We aimed to examine cemiplimab, a programmed cell death 1 inhibitor, in the first-line... more 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.

Turkish Journal of Oncology, 2021

Cancer Treatment and Research Communications, 2021

Background: We aimed to evaluate the association of serum carcinoembryonic antigen (CEA) and canc... more Background: We aimed to evaluate the association of serum carcinoembryonic antigen (CEA) and cancer antigen 15-3 (CA 15-3) levels with clinicopathological parameters in patients with breast cancer (BC) and their efficiency for the prediction of recurrence. Methods: The records of 482 female patients with breast cancer diagnosis followed in Medical Oncology and Radiation Oncology clinics of Kartal Dr. Lutfu Kirdar Education and Research Hospital were evaluated retrospectively. Results: The median age of the patients was 49. CEA levels were significantly higher in postmenopausal patients (p = 0.022). There was no association between CEA and CA 15-3 levels and nodal involvement (p = 0.689, 0.379; respectively). CEA levels were significantly higher in hormone receptor-positive patients (p = 0.007). HER2 negative patients had significantly higher levels of CEA and CA 15-3 (p = 0.017 and 0.011, respectively). The evaluation of metastatic patients showed that CEA and CA 15-3 levels before metastasis were significantly elevated (p = 0.016 ve 0.008, respectively). There was no relation between the metastasis site and CEA, CA 15-3 levels (p = 0.936, 0.201, respectively). Receiver operating characteristic (ROC) analysis was performed to determine the role of CEA and CA 15-3 levels in the prediction of metastasis, and cutoff values were 1.39 ng/ml and 14.54 U/ml, respectively. Sensitivities of CA 15-3 and CEA levels were 82.1% and 88.3%; specificities were 47.3% and 46.2%, respectively. Conclusions: CEA and CA 15-3 are useful as tumor markers for early diagnosis of metastases, and their elevations were associated with unfavorable clinicopathological parameters of breast cancer patients. Since these markers are considered a cheap and accessible way of predicting breast cancer prognosis, there is an increasing interest in the prognostic value of serum levels of tumor markers in recent years. More sensitive cutoff values for each marker are needed to be validated with further studies.

Journal of Turkish Society of Obstetric and Gynecology, 2020

Adding bevacizumab to chemotherapy in advanced stage cervical cancer is an effective and tolerabl... more Adding bevacizumab to chemotherapy in advanced stage cervical cancer is an effective and tolerable treatment for Turkish patients. Öz Amaç: Monoklonal, antivasküler endotelyal büyüme faktörü antikoru olan bevasizumabın sitotoksik kemoterepilerle birlikte kullanımının metastatik, tekrarlayan serviks kanserli Türk hasta popülasyonunda etkinliğini değerlendirmeyi amaçladık. Gereç ve Yöntemler: Metastatik, tekrarlayan serviks kanseri tanısıyla 2013 ve 2017 yılları arasında ilk seri tedavide sisplatin veya carboplatin ve paklitaksel kemoterapisi ile bevasizumab kullanan hastaların dosyalarını geriye dönük olarak inceledik. Bulgular: Altmış dört hastanın verisini değerlendirdik. Ortalama yaş 49 (aralık, 28-68), ortanca takip süresi 12 aydı (aralık, 2-53), ortanca progresyonsuz sağkalım süresi 8 ay ve ortanca genel sağkalım süresi 23 aydı. Ortanca bevasizumab ve kemoterapi kür sayısı altı idi. Bevasizumab ile birlikte kullanılan kemoterapi rejimleri 31 hastada (4%8) sisplatin ve paklitaksel, 33 hastada (%52) karboplatin, ve paklitakseldi. Daha önce radyoterapi duyarlılaştırıcı olarak sisplatin almayan hastalarda sağkalım süresi sisplatinli tedavi alan hastalarda karboplatinli tedaviden daha iyiydi (p=0,023). Bevasizumab dozu 30 hastada (%47) 7,5 mg/kg ve 34 hastada (%53) 15 mg/kg 21 günde bir idi. İki grup arasında genel sağkalım ve progresyonsuz sağkalım farkı yoktu. Tüm gradlarda en sık görülen yan etkiler bulantı, nötropeni, anemi ve periferal duysal nöropati, en sık görülen grad ≥3 yan etkiler ise nötropeni, anemi ve periferal duysal nöropatiydi.

Journal of Clinical Oncology, 2020

PURPOSE In the phase 3 KEYNOTE-407 study, the addition of pembrolizumab to carboplatin-paclitaxel... more PURPOSE In the phase 3 KEYNOTE-407 study, the addition of pembrolizumab to carboplatin-paclitaxel/nab-paclitaxel significantly improved overall survival, progression-free survival, and objective response rate in patients with previously untreated metastatic squamous non–small-cell lung cancer (NSCLC), with little impact on severe toxicity. We present patient-reported outcomes (PROs) from KEYNOTE-407. METHODS Patients were randomly assigned to receive 4 cycles of pembrolizumab 200 mg or placebo once every 3 weeks plus carboplatin plus paclitaxel or nab-paclitaxel, followed by pembrolizumab or placebo for an additional 31 cycles. Health-related quality of life (HRQoL) was evaluated using the European Organisation for Research and Treatment of Cancer Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and Quality of Life Questionnaire-Lung Cancer Module 13 (QLQ-LC13). Key PRO endpoints were change from baseline to weeks 9 and 18 (during and after platinum therapy) in th...

Oncology Research and Treatment, 2019

Background: Colorectal cancer (CRC) is a rare disease amongst children and adolescents. Previous ... more Background: Colorectal cancer (CRC) is a rare disease amongst children and adolescents. Previous studies have reported a number of differences between children/adolescents, young adults, and adult patients with CRC. However, none of these studies compared these age groups according to their clinicopathologic and prognostic characteristics. In the current study, we compare these three age groups. Methods:A total of 173 (1.1% of 15,654 patients) young CRC patients (≤25 years) were included in the study. As a control group, 237 adult CRC patients (>25 years) were also included. Patients were divided into three age groups: child/adolescent (10–19 years), young adult (20–25 years), and adult (>25 years). Results: Statistical differences amongst the three groups in terms of gender (p = 0.446), family history (p = 0.578), symptoms of presentation (p = 0.306), and interval between initiation of symptoms and diagnosis (p = 0.710) could not be demonstrated. Whilst abdominal pain (p <...

OncoTargets and therapy, 2018

We studied the comparative effectiveness of biosimilar filgrastim vs original filgrastim in patie... more We studied the comparative effectiveness of biosimilar filgrastim vs original filgrastim in patients with chemotherapy-induced neutropenia. 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. 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....