Browsing by Author "Hacibekiroglu, I"

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    Comparison of immunogenicity for Sinovac-CoronaVac vaccine vs. natural infection during cancer treatment
    Çakir, E; Saydan, D; Gülbagci, B; Özen, M; Ugurlu, I; Demirci, A; Bilir, F; Hacibekiroglu, I; Yildiz, N; Akcali, S; Altindis, M; Varim, C; Yaylaci, S; Bilir, C
    - OBJECTIVE: Efficacy of the COVID-19 vaccines in cancer patients, especially during their active treatment, are lacking. Most of the studies in the literature compared the immuni-ty in cancer patients with a cross-sectional cohort or retrospectively. Our study investigated Sino-vac-CoronaVac COVID-19 vaccine immunogenici-ty and compared it with natural COVID-19 disease in cancer patients during their cancer therapy.PATIENTS AND METHODS: A total of 111 pa-tients with cancer and who are on active treat-ment were included in the study. This is a sin-gle-center study and was designed prospec-tively. Two group of patients were included in the study, natural disease and vaccinated group.RESULTS: A total of 111 patients were in-cluded in the study, 34 of whom had natural COVID-19 disease. Antibody levels following the first dose vaccine were 0.4 (0-1.9) U/ml while af-ter the second dose of vaccine were 2.6 (1.0-7.25) U/ml. Immunogenicity levels were 82.4% in the natural disease group and 75.8% in the vaccinated group after the second shot of the vaccine. Immunogenicity rate was significantly higher in non-chemotherapy (receiving immu-notehrapy/targeted therapy or biologic agent) group compared to chemotherapy drug (92.9% vs. 63.3%, p=0.004). There was a difference be-tween the antibody levels following the first and second vaccination [median (IQR): 0.3 (0-1.0) and 3.3 (2.0-6.7), p=0.001, respectively].CONCLUSIONS: The present study revealed that the Sinovac-CoronaVac vaccine showed an acceptable immunogenicity following two shots in cancer patients who were receiving ac-tive systemic therapy. On the other hand, nat-ural disease immunogenicity was higher than vaccinated group.
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    Efficacy of subsequent treatments in patients with hormone-positive advanced breast cancer who had disease progression under CDK 4/6 inhibitor therapy (vol 23, 136, 2023)
    Karacin, C; Oksuzoglu, B; Demirci, A; Keskinkiliç, M; Baytemür, NK; Yilmaz, F; Selvi, O; Erdem, D; Avsar, E; Paksoy, N; Demir, N; Göksu, SS; Türker, S; Bayram, E; Çelebi, A; Yilmaz, H; Kuzu, ÖF; Kahraman, S; Gökmen, I; Sakin, A; Alkan, A; Nayir, E; Ugrakli, M; Acar, Ö; Ertürk, I; Demir, H; Aslan, F; Sönmez, Ö; Korkmaz, T; Celayir, ÖM; Karadag, I; Kayikçioglu, E; Sakalar, T; Öktem, IN; Eren, T; Erul, E; Mocan, EE; Kalkan, Z; Yildirim, N; Ergün, Y; Akagündüz, B; Karakaya, S; Kut, E; Teker, F; Demirel, BÇ; Karaboyun, K; Almuradova, E; Ünal, OÜ; Oyman, A; Isik, D; Okutur, K; Öztosun, B; Gülbagci, BB; Kalender, ME; Sahin, E; Seyyar, M; Özdemir, Ö; Selçukbiricik, F; Kanitez, M; Dede, I; Gümüs, M; Gökmen, E; Yaren, A; Menekse, S; Ebinç, S; Aksoy, S; Imamoglu, GI; Altinbas, M; Çetin, B; Uluç, BO; Er, Ö; Karadurmus, N; Erdogan, AP; Artaç, M; Tanriverdi, Ö; Çiçin, I; Sendur, MAN; Oktay, E; Bayoglu, IV; Paydas, S; Aydiner, A; Salim, DK; Geredeli, Ç; Yavuzsen, T; Dogan, M; Hacibekiroglu, I
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    Efficacy of subsequent treatments in patients with hormone-positive advanced breast cancer who had disease progression under CDK 4/6 inhibitor therapy
    Karacin, C; Oksuzoglu, B; Demirci, A; Keskinkiliç, M; Baytemür, NK; Yilmaz, F; Selvi, O; Erdem, D; Avsar, E; Paksoy, N; Demir, N; Göksu, SS; Türker, S; Bayram, E; Çelebi, A; Yilmaz, H; Kuzu, ÖF; Kahraman, S; Gökmen, I; Sakin, A; Alkan, A; Nayir, E; Ugrakli, M; Acar, Ö; Ertürk, I; Demir, H; Aslan, F; Sönmez, Ö; Korkmaz, T; Celayir, ÖM; Karadag, I; Kayikçioglu, E; Sakalar, T; Öktem, IN; Eren, T; Urul, E; Mocan, EE; Kalkan, Z; Yildirim, N; Ergün, Y; Akagündüz, B; Karakaya, S; Kut, E; Teker, F; Demirel, BÇ; Karaboyun, K; Almuradova, E; Ünal, OÜ; Oyman, A; Isik, D; Okutur, K; Öztosun, B; Gülbagci, BB; Kalender, ME; Sahin, E; Seyyar, M; Özdemir, Ö; Selçukbiricik, F; Kanitez, M; Dede, I; Gümüs, M; Gökmen, E; Yaren, A; Menekse, S; Ebinç, S; Aksoy, S; Imamoglu, GI; Altinbas, M; Çetin, B; Uluç, BO; Er, Ö; Karadurmus, N; Erdogan, AP; Artaç, M; Tanriverdi, Ö; Çiçin, I; Sendur, MAN; Oktay, E; Bayoglu, IV; Paydas, S; Aydiner, A; Salim, DK; Geredeli, Ç; Yavuzsen, T; Dogan, M; Hacibekiroglu, I
    Background There is no standard treatment recommended at category 1 level in international guidelines for subsequent therapy after cyclin-dependent kinase 4/6 inhibitor (CDK4/6) based therapy. We aimed to evaluate which subsequent treatment oncologists prefer in patients with disease progression under CDKi. In addition, we aimed to show the effectiveness of systemic treatments after CDKi and whether there is a survival difference between hormonal treatments (monotherapy vs. mTOR-based). Methods A total of 609 patients from 53 centers were included in the study. Progression-free-survivals (PFS) of subsequent treatments (chemotherapy (CT, n:434) or endocrine therapy (ET, n:175)) after CDKi were calculated. Patients were evaluated in three groups as those who received CDKi in first-line (group A, n:202), second-line (group B, n: 153) and >= 3rd-line (group C, n: 254). PFS was compared according to the use of ET and CT. In addition, ET was compared as monotherapy versus everolimus-based combination therapy. Results The median duration of CDKi in the ET arms of Group A, B, and C was 17.0, 11.0, and 8.5 months in respectively; it was 9.0, 7.0, and 5.0 months in the CT arm. Median PFS after CDKi was 9.5 (5.0-14.0) months in the ET arm of group A, and 5.3 (3.9-6.8) months in the CT arm (p = 0.073). It was 6.7 (5.8-7.7) months in the ET arm of group B, and 5.7 (4.6-6.7) months in the CT arm (p = 0.311). It was 5.3 (2.5-8.0) months in the ET arm of group C and 4.0 (3.5-4.6) months in the CT arm (p = 0.434). Patients who received ET after CDKi were compared as those who received everolimus-based combination therapy versus those who received monotherapy ET: the median PFS in group A, B, and C was 11.0 vs. 5.9 (p = 0.047), 6.7 vs. 5.0 (p = 0.164), 6.7 vs. 3.9 (p = 0.763) months. Conclusion Physicians preferred CT rather than ET in patients with early progression under CDKi. It has been shown that subsequent ET after CDKi can be as effective as CT. It was also observed that better PFS could be achieved with the subsequent everolimus-based treatments after first-line CDKi compared to monotherapy ET.
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    Clinical outcomes of cyclin-dependent kinase 4-6 (CDK 4-6) inhibitors in patients with male breast cancer: A multicenter study
    Yildirim, HC; Mutlu, E; Chalabiyev, E; Özen, M; Keskinkiliç, M; Ön, S; Çelebi, A; Dursun, B; Acar, O; Kahraman, S; Aykan, MB; Kaman, O; Dogan, A; Erdogan, AP; Celayir, OM; Günenç, D; Güven, DC; Bayoglu, IV; Yavuzsen, T; Hacibekiroglu, I; Inanç, M; Kiliçkap, S; Yalçin, S; Aksoy, S
    Background: Since breast cancer is less common in men than in women, data on the use of new therapeutic agents, including cyclin-dependent kinase 4-6 (CDK 4-6) inhibitors, are limited in patients with metastatic hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) male breast cancer. Therefore; we aimed to investigate the treatment responses of metastatic HR+, HER2-male breast cancer patients treated with CDK 4-6 inhibitors in a multicenter real-life cohort. Methods: Male patients with a diagnosis of HR+ and HER2-metastatic breast cancer, treated with any CDK 4-6 inhibitor, were included in the study. Demographic and clinical characteristics of the patients were recorded. We aimed to determine progression-free survival (PFS) time, response rates and drug related side effects. Results: A total 25 patients from 14 institutions were recruited. The mean age at diagnosis was 57 years. Median follow-up was 19.53 (95% CI: 14.04-25.02) months. The overall response rate was 60%. While the median PFS was 20.6 months in the whole cohort, it wasn't reached in those using CDK 4-6 inhibitors in first line and 10 months in the subsequent lines (p:0.009). No new adverse events were encountered. Conclusion: In our study, we found that CDK 4-6 inhibitors are effective and safe options in men with HR+ and HER2-metastatic breast cancer as in women. Our results support the use of CDK 4-6 inhibitor-based combinations in the first-line treatment of HR+ and HER2-metastatic male breast cancer.
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    EGFR Mutation in Patients with NSCLC and Its Relationship Between Survival and Clinicopathological Features: An Update Analysis
    Ozturk, A; Celik, S; Kodaz, H; Yildiz, I; Ocak, A; Hacibekiroglu, I; Bayoglu, IV; Ercelep, O; Ekinci, AS; Menekse, S; Gumusay, O; Oven, B; Aldemir, MN; Geredeli, C; Baykara, M; Uysal, M; Sevinc, A; Aksoy, A; Ulas, A; Inanc, M; Tanriverdi, O; Avci, N; Turan, N; Gumus, M
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    Frequency of EGFR Mutation in Nsclc and Its Relationship with Clinicopathological Features: A Multicenter Asmo Trial
    Yuksel, S; Kodaz, H; Yildiz, I; Odabasi, H; Ocak, A; Bayoglu, IV; Hacibekiroglu, I; Ercelep, O; Ekinci, AS; Erdogan, B; Mert, AG; Karaca, H; Salman, T; Menekse, S; Gumusay, O; Ustaalioglu, BO; Aldemir, MN; Geredeli, C; Baykara, M; Uysal, M; Sevinc, A; Aksoy, A; Ulas, A; Inanc, M; Tanriverdi, O; Avci, N; Turan, N; Aliustaoglu, M; Gumus, M
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    The effect of the gastrectomy on survival in patients with metastatic gastric cancer: a study of ASMO
    Yazici, O; Özdemir, N; Duran, AO; Menekse, S; Ali, M; Sendur, N; Karaca, H; Göksel, G; Arpaci, E; Hacibekiroglu, I; Bilgetekin, I; Kaçan, T; Özkan, M; Aksoy, S; Aksoy, A; Çokmert, S; Uysal, M; Elkiran, ET; Çiçin, I; Büyükberber, S; Zengin, N
    Aim: To investigate the role of surgical resection of primary tumor on overall survival (OS) in advanced gastric cancer patients at the time of diagnosis. Patients & methods: The survival rates of metastatic gastric cancer patients whose gastric primary tumor was resected at time of diagnosis were compared with metastatic gastric cancer patients whose primary tumor was nonresected. Results: The median progression-free survival and OS in operated and nonoperated group were 10 versus 6, 14 versus 9 months, respectively (p < 0.001). In multivariate analysis, gastric resection of primary tumor, Eastern Cooperative Oncology Group performance status, second-line chemotherapy had a significant effect on OS (hazard ratio [HR]: 0.52 [95% CI: 0.38-0.71], HR: 0.57 [95% CI: 0.42-0.78], HR: 1.48 [1.09-2.01]; p <= 0.001, p = 0.001 and p = 0.012, respectively). Conclusion: Subpopulations of patients with metastatic gastric cancer might benefit from surgical removal of primary tumor.
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    Evaluation of prognostic factors in localized high-grade undifferentiated pleomorphic sarcoma: report of a multi-institutional experience of Anatolian Society of Medical Oncology
    Ozcelik, M; Seker, M; Eraslan, E; Koca, S; Yazilitas, D; Ercelep, O; Ozaslan, E; Kaya, S; Hacibekiroglu, I; Menekse, S; Aksoy, A; Taskoylu, BY; Varol, U; Arpaci, E; Ciltas, A; Oksuzoglu, B; Zengin, N; Gumus, M; Aliustaoglu, M
    Most data on prognostic factors for patients with high-grade undifferentiated pleomorphic sarcoma (HGUPS) is obtained from analyses of soft tissue sarcomas. The purpose of this study was to evaluate the clinicopathologic features and their impact on outcomes specifically in patients diagnosed with HGUPS. In this multicenter trial, we retrospectively analyzed 112 patients who were diagnosed and treated at 12 different institutions in Turkey. We collected data concerning the patients, tumor characteristics, and treatment modalities. There were 69 males (61.6 %) and 43 females (38.4 %). Median age was 56 years (19-90). The most common anatomic site of tumor origin was the upper extremity. Pleomorphic variant was the predominant histological subtype. Median tumor size was 8.2 cm (0.6-30 cm). Tumors were mainly deeply seated (57.1 %). Fifty-seven patients (50.9 %) were stage II and the remainder were stage III at the time of diagnosis. Median follow-up was 30 months (2-160). The primary site of distant metastasis was the lung (73.5 %) and the second most common site was the liver (11.7 %). The 5-year overall survival, distant metastasis-free survival, and local recurrence-free survival rates were 56.3, 53.4, and 67.2 %, respectively. Multivariate analysis showed that Eastern Cooperative Oncology Group (ECOG) performance score of II (p = 0.033), deep tumor location (p = 0.000), and development of distant metastasis (p = 0.004) were negatively correlated with overall survival, and perioperative radiotherapy and negative microscopic margins were significant factors for local control rates (p = 0.000 for each). Deep tumor location (p = 0.003) was the only adverse factor related to distant metastasis-free survival. Deep tumor location, ECOG performance score of II, and development of distant metastasis carry a poor prognostic implication on overall survival. These will aid clinicians in predicting survival and treatment decision.
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    Comparison of survival with somatostatin analog and chemotherapy and prognostic factors for treatment in 165 advanced neuroendocrine tumor patients with Ki-67 20% or less
    Özaslan, E; Karaca, H; Koca, S; Sevinç, A; Hacioglu, B; Özkan, M; Özçelik, M; Duran, AO; Hacibekiroglu, I; Yildiz, Y; Tanriverdi, Ö; Menekse, S; Aksoy, A; Bozkurt, O; Urvay, S; Uysal, M; Demir, H; Çiltas, A; Dane, F
    The objectives of this study were to compare progression-free survival (PFS) with somatostatin analog (SSA) versus chemotherapy (CTx) in first-line therapy and to determine the patient group in which these treatments were more effective in neuroendocrine tumors (NETs) with a Ki-67 index of 20% or less. Patients who received SSA or CTx and had unresectable locally advanced and metastatic NETs with a Ki-67 index of 20% or less were retrospectively selected from 13 centers in the Turkish database between 2000 and 2015. One hundred and sixty-five patients were enrolled. The median age was 56 years and the male-to-female ratio was 1.09. Seventy-four (45%) patients were of grade 1 NET and 91 (55%) were of grade 2. SSA was given to 104 patients, whereas 61 were treated with CTx. The objective response rate after SSA was 15.4%; another 73.1% had stable disease. The objective response rate after CTx was 36.1%, and 40.9% had stable disease (P = 0.008). The median PFS in SSA patients was 21 months (95% confidence interval: 12.4-29.6), and 8 months for CTx (95% confidence interval: 5.5-10.6) (P < 0.001). There was no significant difference between PFS of receiving SSA and CTx in pancreatic neuroendocrine tumor (PNET) patients; however, the PFS of receiving SSA was longer in non-PNET patients (P < 0.001). SSA was better treatment in advanced NET patients with a Ki-67 index of less than 5%, having a primary resected and a performance status of 0 (P < 0.05). SSA may be preferred over CTx in advanced NET patients with low-to-intermediate grade. Copyright (C) 2017 Wolters Kluwer Health, Inc. All rights reserved.
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    The role of the gastrectomy on survival in metastatic gastric cancer patients: A multicenter study of Anatolian Society of Medical Oncology (ASMO)
    Yazici, O; Ozdemir, N; Duran, AO; Menekse, S; Sendur, MAN; Karaca, H; Goksel, G; Arpaci, E; Eren, T; Hacibekiroglu, I; Bilgetekin, I; Kacan, T; Ozkan, M; Aksoy, S; Aksoy, A; Zengin, N
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    XELOX Plus Bevacizumab vs. FOLFIRI Plus Bevacizumab Treatment for First-line Chemotherapy in Metastatic Colon Cancer: a Retrospective Study of the Anatolian Society of Medical Oncology
    Duran, AO; Karaca, H; Besiroglu, M; Bayoglu, IV; Menekse, S; Yapici, HS; Yazilitas, D; Bahceci, A; Uysal, M; Sevinc, A; Hacibekiroglu, I; Aksoy, A; Tanriverdi, O; Arpaci, E; Inanc, M; Dane, F; Ozkan, M
    Background: XELOX plus bevacizumab (XELOX-Bev) and FOLFIRI plus Bevacizumab (FOLFIRI - Bev) treatments are an effective strategies patients with metastatic colorectal cancer (mCRC). The aim of this study was to compare efficacy of first-line XELOX-Bev treatment vs FOLFIRI-Bev treatment for mCRC. Materials and Methods: A total of 409 patients with mCRC who received chemotherapy were included and divided into 2 groups. Group 1 (n=298) received XELOX-Bev and Group 2 (n=111) FOLFIRI-Bev. Comparisons were made in terms of overall (OS) and progression-free (PFS) survival, response rate (RR), and grade 3-4 toxicity. Results: Median follow-up was 11 months in Group 1 and 15 months for Group 2. Complete remission was observed in 29 (9.7%) and 2 (1.8%) patients, partial remission in 139 (46.6%) and 27 (24.5%), stable disease in 88 (29.5%) and 49 (44.1%) and progressive disease in 42 (14.1%) and 33 (30.0%) patients in Group 1 and 2, respectively. Median OS was 25 months (range 2-57 months, 95% CI; 22.2-27.7) for Group 1 and 20 months (range 1-67 months, 95% CI; 16.8-23.1) for Group 2 (p=0.036). Median PFS was 9.6 months (range 2-36 months, 95% CI; 8.8-10.4) for Group 1 and 9 months (range 1-44 months, 95% CI; 7.4-10.5) for Group 2 (p=0.019). Objective RR was 56.4% in Group 1 and 26.1% in Group 2 (p<0.001). Conclusions: First-line XELOX-Bev is more effective with a better response rate, prolongation of median PFS/OS, and a superior safety profile compared with FOLFIRI-Bev.
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    Prognostic factors of patients who received chemotherapy after cranial irradiation for non-small cell lung cancer with brain metastases: A retrospective analysis of multicenter study (Anatolian Society of Medical Oncology)
    Inal, A; Kodaz, H; Odabas, H; Duran, AO; Seker, MM; Inanc, M; Elkiran, ET; Gunaydin, Y; Menekse, S; Topcu, TO; Urakci, Z; Tastekin, D; Bilici, M; Cihan, S; Geredeli, C; Sezer, E; Uncu, D; Arpaci, E; Ozturk, B; Bal, O; Uysal, M; Tanriverdi, O; Gumus, M; Ustaalioglu, BBO; Suner, A; Cokmert, S; Hacibekiroglu, I; Aydin, K; Isikdogan, A
    Purpose: Almost half of all patients diagnosed with non-small cell lung cancer (NSCLC) have distant metastases at presentation. One-third of patients with NSCLC will have brain metastases. Without effective treatment, the median survival is only 1 month. However, it is difficult to treat brain metastases with systemic chemotherapy since the agents have difficulty crossing the blood-brain barrier. Therefore, it is important to estimate the patient's survival prognosis. The aim of this study was to analyze prognostic factors for survival in Turkish patients who received chemotherapy after cranial irradiation for NSCLC with brain metastases. Methods: We retrospectively reviewed 698 patients with brain metastases resulting from NSCLC. Ten potential prognostic variables were chosen for analysis. Univariate and multivariate analyses were conducted to identify prognostic factors associated with overall survival (OS). Results: Among the 10 variables for univariate analysis, six were identified to have prognostic significance; these included sex, smoking history, histology, number of brain metastases, extracranial metastases, and neurosurgical resection. Multivariate analysis by the Cox proportional hazard model showed that a smoking history, extracranial metastases, and neurosurgical resection were independent negative prognostic factors for OS. Conclusion: Smoking history, extracranial metastases, and neurosurgical resection were considered independent negative prognostic factors for OS. These findings may facilitate pretreatment prediction of survival and can be used for selecting patients for more appropriate treatment options.
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    The prognostic impact of Her2 status in early triple negative breast cancer: a Turkish Oncology Group (TOG) study
    Özyurt, N; Alkan, A; Gülbagci, B; Seyyar, M; Aydin, E; Sahbazlar, M; Türker, M; Kinikoglu, O; Yerlikaya, T; Dinç, G; Aytaç, A; Kalkan, Z; Ebinç, S; Gültürk, I; Keskinkiliç, M; Isleyen, ZS; Çaglayan, D; Türkel, A; Aydin, E; Sakalar, T; Sekmek, S; Yildirim, N; Koçak, S; Okutur, K; Özveren, A; Dursun, B; Kitapli, S; Eren, OÖ; Beypinar, I; Hacibekiroglu, I; Çabuk, D; Karaman, E; Acar, Ö; Paydas, S; Eryilmaz, MK; Demir, B; Oruç, Z; Yilmaz, M; Biricik, FS; Salim, DK; Tanriverdi, Ö; Dogan, M
    The studies evaluating the impact of Her2 levels in neoadjuvant setting have conflicting data. The aim of the study was to evaluate the prognostic impact of Her2 status in early triple negative breast cancer(TNBC). In the study TNBC patients who were treated with neoadjuvant chemotherapy (NAC) and surgery were analyzed retrospectively. The primary aim of the study was to analyze the impact of Her2 status(Her2-0 and Her2-low) on pathological complete response (pCR). The secondary objectives were disease free survival (DFS) and overall survival (OS). 620 female triple negative breast cancer patients were evaluated. 427 patients (68.9%) had Her2-0 and 193(31.1%) had her2-low pathology. The pCR rates were similar between Her2-0 and Her2-low patients (33.0% vs. 27.5%, p = 0.098). Although Her2-0 group has better DFS (106 vs. 50 months, p = 0.002), in multivariate analysis it had a HR of 0.74 (p = 0.06). In addition, OS was similar (131 vs. 105 months, p = 0.13) with a HR of 0.88 (p = 0.61). In multivariate analysis; presence of LVI (HR:2.2 (95% CI 1.1-3.5) p = 0.001), Clinical stage T1/T2 (HR:0.39 (95% CI 0.2-0.6) p < 0.001) and lymph node negativity (HR:0.35 (95% CI 0.1-0.9) p = 0.03) were independent factors for OS. Although there were pathological and clinical differences, the pCR, DFS and OS were similar between Her2-0 and Her2-low TNBC patients. The importance of Her2 status of TNBC in neoadjuvant setting should be further studied.
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    Efficacy and safety of folfiri plus aflibercept in second-line treatment of metastatic colorectal cancer: Real-life data from Turkish oncology group
    Erol, C; Sendur, MAN; Bilgetekin, I; Garbioglu, DB; Hamdard, J; Akbas, S; Hizal, M; Arslan, C; Sevinc, A; Kucukarda, A; Erdem, D; Kahraman, S; Cakir, E; Demirkiran, A; On, S; Dogan, I; Erdogan, AP; Koca, S; Kubilay, P; Eren, OO; Cilbir, E; Celik, E; Araz, M; Ozyukseler, DT; Yildirim, ME; Bahceci, A; Taskaynatan, H; Oyman, A; Deniz, GI; Menekse, S; Kut, E; Gulmez, A; Sakin, A; Nayir, E; Acar, R; Sen, E; Inal, A; Turhal, S; Kaya, AO; Paydas, S; Tastekin, D; Hacibekiroglu, I; Cincin, I; Bilici, A; Mandel, NM; Dede, DS; Akinci, MB; Oksuzoglu, B; Uncu, D; Yalcin, B; Artac, M
    Aims: The addition of aflibercept to the fluorouracil and irinotecan (FOLFIRI) regimen significantly improved clinical outcomes in patients with metastatic colorectal cancer (CRC) previously treated with oxaliplatin. We aimed to investigate the efficacy and safety of second-line FOLFIRI and aflibercept combination in patients with metastatic CRC in real-life experience. Materials and Methods: Four hundred and thirty-three patients who treated with FOLFIRI and aflibercept in the second-line were included in the study. The clinical and pathological features of the patients were recorded retrospectively. Survival (overall and progression-free survival [PFS]), response rates, and safety data were analyzed. Results: The median age was 61. Majority of patients (87.5%) received first-line bevacizumab and 10.1% of patients received anti-epidermal growth factor receptor agents. About 80% of patients had KRAS, 18.6% of patients had NRAS, and 6.4% of patients had BRAF mutations. The median OS was 11.6 months (95% confidence interval [CI], 10.6-12.6) and the median PFS was 6 months (95% CI, 5.5-6.5). About 4.6% of patients had complete response and 30.6% of patients had partial response as best tumor response. Grade 1-2 toxicities were seen in 33.4% of patients, while grade 3-4 toxicities were recorded in 27% of patients. Eight patients (2%) died due to treatment toxicity. Conclusions: Overall and PFS were similar in routine clinical practice compared to phase III pivotal VELOUR trial. However, response rates were found to be higher. It was observed that there were fewer adverse events compared to the VELOUR trial.