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    Cetuximab-induced rash is associated with overall survival in patients with recurrent/metastatic squamous cell carcinoma of head and neck
    (Springer, 2021) Goksu, Sema Sezgin; Tatli, Ali Murat; Geredeli, Caglayan; Atci, Mustafa; Besen, Ali Ayberk; Mertsoylu, Huseyin; Uysal, Mukremin
    Purpose In this study, we looked for whether treatment-induced rash predicts treatment efficacy in patients with recurrent/metastatic HNSCC treated with Cetuximab and chemotherapy. Methods Patients who were treated with platinum-based chemotherapy and cetuximab for the first line treatment of recurrent/metastatic HNSCC were recruited. Presence of rash, hypomagnesemia, hypopotassemia, anemia, neutropenia, thrombocytopenia during treatment and treatment response, date of progression, date of last visit and death were recorded. Results A total of 138 patients' data were available for analysis. Any grade of rash was detected in 57 (44.5%) of the patients. The incidence of rash was significantly higher in patients with objective response than in patients with disease progression (%56.8 vs %14.3, p < 0.001). Progression free survival was 7.06 months (4.98-9.15) in patients treated with cetuximab and chemotherapy as first line treatment. In the multivariate analysis; rash was significantly correlated with longer PFS (HR 2.136; 95% CI 1.067-4.278; p = 0.032). Progression free survival was 9.65 months in patients who experienced rash, and 6.02 months in patients without rash, (p = 0.019, log-rank test). Overall survival was 11.24 months (9.65-12.82). In multivariate analysis, the survival of patients with rash was significantly longer than patients without rash (HR 1.954; 95% CI 1.162-3.285; p = 0.012). Overall survival was 15.08 months in patients who experienced rash, and 8.61 months in patients without rash (p = 0.05, log-rank test). Conclusion Cetuximab-induced rash is associated with better ORR and longer PFS and OS in patients with recurrent/metastatic HNSCC treated with Cetuximab and platinum-based chemotherapy.
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    The effect of BMI on the outcomes of CDK 4/6 inhibitor therapy in HR-positive metastatic breast cancer patients.
    (Lippincott Williams & Wilkins, 2022) Caglayan, Dilek; Kocak, Mehmet Zahid; Geredeli, Caglayan; Tatli, Ali Murat; Eryolmaz, Melek Karakurt; Goksu, Sema Sezgin; Araz, Murat
    [Abstract Not Availabe]
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    The effect of concomitant use of proton pump inhibitors with CDK 4/6 inhibitors on survival in metastatic breast cancer
    (Springer Heidelberg, 2023) Caglayan, Dilek; Kocak, Mehmet Zahid; Geredeli, Caglayan; Tatli, Ali Murat; Goksu, Sema Sezgin; Eryilmaz, Melek Karakurt; Araz, Murat
    Aim To evaluate the difference of progression free survival between the patients using concomitant proton pump inhibitors and non-users in the patients using CDK 4/6 inhibitors with HR + and HER2 negative mBC. Methods We included 86 patients with HR + and HER 2 negative mBC treated with CDK 4/6 inhibitors in this study. Patients were divided into two categories according to their status of PPI use. The primary end points was progression free survival (PFS). We compared PPI users and non-users. Results Forty-five (52.3%) patients used a PPI concomitantly with a CDK 4/6 inhibitor, and 41 (47.7%) did not. The median duration of follow-up was 10.68 (1.94-27.56) months. Of the patients, 50 (58.1%) palbociclib and 36 (41.9%) received ribociclib. The median progression free survival (mPFS) was 10.9 months (95% CI: 7.5-14.27) in the group with concomitant PPI use with a CDK 4/6 inhibitor, whereas the median progression free survival could not be reached in the group without concomitant PPI use (p = 0.04). In addition, concomitant PPI use with palbociclib was associated with a shorter PFS; there was no significant difference between the concomitant PPI users and non-users in terms of PFS in the patients using ribociclib. Conclusion Palbociclib and ribociclib are weak base drugs so their bioavailability is pH-dependent. PPIs can affect their solubility and their concentration in the plasma. Therefore, we must avoid concomitant use of PPIs and CDK 4/6 inhibitors. If we need to use concomitant PPI and CDK 4/6 inhibitors, we should prefer ribociclib than palbociclib.
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    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
    (Imprimatur Publications, 2020) Hacioglu, Muhammet Bekir; Kostek, Osman; Karabulut, Senem; Tastekin, Didem; Goksu, Sema Sezgin; Alandag, Celal; Akagunduz, Baran
    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 secondor third-line setting. Methods: In this retrospective and multicenter study, advanced HCC patients not eligible for local therapies, who received a secondor 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 (p(PFS)=0.22 and p(OS)=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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    Irinotecan and Ifosfamide Combination is an Effective and Safe Option in Patients with Refractory Small Cell Lung Cancer: A Retrospective Cross-Sectional Study
    (Kare Publ, 2020) Karaagac, Mustafa; Artac, Mehmet; Goksu, Sema Sezgin; Eryilmaz, Melek Karakurt; Coskun, Hasan Senol; Bozcuk, Hakan
    Objectives: Recurrent and progressive small cell lung cancer (SCLC) has a very poor prognosis, and treatment options are limited. Combination of irinotecan with ifosfamide ( I-I regimen) in SCLC has limited preliminary data. In this study, we aimed to evaluate the efficacy and toxicity of I-I regimen in patients with previously treated SCLC. Methods: A total of 25 patients were retrospectively reviewed. Ifosfamide dose was 1500 mg/m2/ per day, days 1-3, irinotecan 80 mg/m2 per day days 1.8 and 15 every four weeks. Results: Median age of patients was 55 years (range 42-80). Median chemotherapy cycles were 3 (range 1-7). The frequency of the second, third and fourth line treatments were 68%, 24%, and 8% respectively. Partial remission was obtained in 15 patients (60%) and complete remission in one patient (4%). Median progression free survival (PFS) and overall survival (OS) figures were 7.8 and 11.1 months, respectively. Granulocyte colony stimulating factor (G-CSF) was used in 40% of patients. Grade 3-4 anemia, leukopenia, and thrombocytopenia were seen in 20%, 36% and 12% of these cases, respectively. Conclusion: Ifosfamide and irinotecan combination is an effective and a tolerable treatment option for patients with platinum refractory SCLC.
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    Irinotecan and Ifosfamide Combination is an Effective and Safe Option in Patients with Refractory Small Cell Lung Cancer: A Retrospective Cross-Sectional Study
    (Kare Publ, 2020) Karaagac, Mustafa; Artac, Mehmet; Goksu, Sema Sezgin; Eryilmaz, Melek Karakurt; Coskun, Hasan Senol; Bozcuk, Hakan
    Objectives: Recurrent and progressive small cell lung cancer (SCLC) has a very poor prognosis, and treatment options are limited. Combination of irinotecan with ifosfamide ( I-I regimen) in SCLC has limited preliminary data. In this study, we aimed to evaluate the efficacy and toxicity of I-I regimen in patients with previously treated SCLC. Methods: A total of 25 patients were retrospectively reviewed. Ifosfamide dose was 1500 mg/m2/ per day, days 1-3, irinotecan 80 mg/m2 per day days 1.8 and 15 every four weeks. Results: Median age of patients was 55 years (range 42-80). Median chemotherapy cycles were 3 (range 1-7). The frequency of the second, third and fourth line treatments were 68%, 24%, and 8% respectively. Partial remission was obtained in 15 patients (60%) and complete remission in one patient (4%). Median progression free survival (PFS) and overall survival (OS) figures were 7.8 and 11.1 months, respectively. Granulocyte colony stimulating factor (G-CSF) was used in 40% of patients. Grade 3-4 anemia, leukopenia, and thrombocytopenia were seen in 20%, 36% and 12% of these cases, respectively. Conclusion: Ifosfamide and irinotecan combination is an effective and a tolerable treatment option for patients with platinum refractory SCLC.
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    Pazopanib in metastatic soft tissue sarcoma (STS): Results of a multi-institutional observational study.
    (Lippincott Williams & Wilkins, 2022) Bilici, Ahmet; Koca, Sinan; Karaagac, Mustafa; Eraslan, Emrah; Ocak, Birol; Aydin, Sabin Goktas; Goksu, Sema Sezgin
    [Abstract Not Availabe]
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    Prospective external validation of an updated algorithm to quantify risk of febrile neutropenia in cancer patients after a cycle of chemotherapy
    (Springer, 2022) Bozcuk, Hakan; Coskun, Hasan Senol; Ilhan, Yusuf; Goksu, Sema Sezgin; Yildiz, Mustafa; Bayram, Selami; Yerlikaya, Tahir
    Purpose Febrile neutropenia resulting from chemotherapy is a significant cause of morbidity and mortality in cancer patients. We had previously published the associates of the risk of febrile neutropenia, and this study now extends and modifies the previous model as well as tests its external validity. Methods We have recruited documented febrile neutropenia cases with solid tumors, in addition to a selected control group of cancer patients from one institution treated between 2015 and 2019. We then united our sample with our previously published original derivation group, to modify and update our previous model by logistic regression analysis. Additionally, consecutive cancer patients from 5 institutions were recruited in 2020 to test external validity of the resultant algorithm. Results A total of 4075 cycles of chemotherapy in 1282 cases were recruited in the updated, new model derivation group, and a total of 8 variables were selected for the updated algorithm. In the new external validation group, 653 cycles of chemotherapy in 624 patients were analyzed, to indicate that after cycles without prophylactic granulocyte colony-stimulating factor (GCSF) usage, the algorithm yielded a sensitivity value of 91%, specificity of 40%, and an area under curve (AUC) figure of 0.78, when a risk cutoff threshold value of >= 0.20 is chosen. This algorithm is now embedded in a web application for free clinical use. Conclusion Our algorithm identifies and quantifies the risk of febrile neutropenia in cancer patients. Further studies are required to improve this model with additional predictors.