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  • Küçük Resim
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    Clinical outcomes of concomitant use of proton pump inhibitors and regorafenib in patients with metastatic colorectal cancer: a multicenter study
    (Springer Science and Business Media Deutschland GmbH, 2022) Yekedüz, Emre; Özbay, Mehmet Fatih; Çağlayan, Dilek; Yıldırım, Atila; Erol, Cihan; Yıldırım, Hasan Çağrı; Tunç, Sezai; Özyurt, Neslihan; Özdemir, Feyyaz; Şendur, Mehmet Ali Nahit; Işıkdoğan, Abdurrahman; Kılıçkap, Saadettin
    Aim: To compare survival outcomes, response rates, and adverse events (AEs) in proton pump inhibitor (PPI) user and non-user patients with metastatic colorectal cancer (mCRC) treated with regorafenib. Methods: We included 272 patients with mCRC treated with regorafenib in this study. Patients were divided into two categories according to their status of PPI use. The primary endpoint was overall survival (OS). The secondary endpoints were time to treatment failure (TTF), response rates, and safety. To exclude immortal time bias in survival analyses, we compared PPI non-user patients and all patients. Results: There were 141 and 131 patients in the PPI non-user and user groups. Baseline characteristics were similar in each group. Pantoprazole was the most used PPI. At the median 35.2 (95% confidence interval (CI): 32.6–37.9) months follow-up, the median OS was similar in PPI non-user and all patients (6.9 months (95% CI: 5.3–8.5) and 7.7 months (95% CI:6.6–8.8), p = 0.913). TTF was also similar in PPI non-user and all patients (3.3 months (95% CI: 2.7–3.9) and 3.5 months (95% CI: 3.0–4.0), p = 0.661). In multivariable analysis, no statistically significant difference was observed between PPI user and non-user groups in OS and TTF (hazard ratio (HR), 0.99; 95% CI, 0.77–1.28; p = 0.963 for OS; HR, 0.93; 0.77–1.20, p = 0.598 for TTF). The objective response rates (ORR) were similar in the PPI non-user and user groups (19.8% and 16.8%, p = 0.455). The rates of any grade AEs were also similar in each group. Conclusion: This study found no worse outcome in the combined use of PPI and regorafenib among patients with mCRC.
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    Öğe
    Clinical outcomes of concomitant use of proton pump inhibitors and regorafenib in patients with metastatic colorectal cancer: A multicenter study
    (Lippincott William & Wilkins, 2022) Yekedüz, Emre; Özbay, Mehmet Fatih; Çağlayan, Dilek; Yıldırım, Atila; Erol, Cihan; Yıldırım, Hasan Çağrı; Tunç, Sezai
    Background: Tyrosine kinase inhibitors (TKI) are the most common oral drugs in cancer patients. Similarly, proton pump inhibitors (PPI) are commonly used to relieve dyspeptic symptoms in patients with cancer. However, gastric pH levels may affect the absorption of TKI through the gastrointestinal system. However, all TKIs do not have the same chemical structure, and the absorption rate of each TKI depends on their solubility in different gastric pH levels. Limited data is available about the clinical outcomes of concomitant use of PPI and regorafenib in patients with metastatic colorectal cancer (mCRC). We present here the results of the multicenter study following the initial results of our single-center experience. Methods: Patients with mCRC treated with regorafenib were included in this multicenter and retrospective study. Patients prescribed PPI after initiation of regorafenib were assigned to the PPI user group, and the remaining patients were assigned to the PPI non-user group. To exclude immortal time bias, the log-rank test was performed between PPI non-user and all patients. The primary outcome was overall survival (OS), and secondary outcomes were time to treatment failure (TTF) and adverse events (AEs) profile. Results: Two hundred and seventy-two patients from eight cancer centers were included in this study. Most patients were male (59.9%), had liver metastasis (62.1%), and received regorafenib in the third line (52.2%). The median age at the initiation of regorafenib was 60 years (interquartile range (IQR): 51-66)). Eastern Cooperative Oncology Group performance score was 0 or 1 in approximately three out of four patients. The rate of patients with K-RAS mutation was 46.7%. There were 131 (48.2%) and 141 (51.8%) in the PPI user and non-user groups, respectively. The most prescribed PPI was pantoprazole (40.4%). At a median 34.2 months follow-up, the median OS was 6.9 months (95% Confidence Interval (CI): 5.3-8.5) and 7.7 months (95% CI:6.6-8.8) in the PPI non-user and all patients, respectively. No statistical significance was observed between the groups (p = 0.913). The median TTF was 3.3 months (95% CI: 2.6-3.9) and 3.4 months (95% CI:2.9-4.0) in the PPI non-user and all patients, respectively. No statistical significance was observed between the groups (p = 0.651). In the time-dependent covariate Cox regression model, there was no difference between PPI user and non-user groups in OS and TTF (adjusted Hazard Ratio (aHR):0.96, 95% CI:0.74-1.24, p = 0.735 for OS; aHR:0.88, 0.68-1.14, p = 0.354 for TTF). The rates of all AEs were also similar in the PPI user and non-user groups (p = 0.628). Conclusions: To our knowledge, this was the first study evaluating the effect of concomitant use of PPI and regorafenib in patients with mCRC, and no adverse survival and safety outcome was observed with the concomitant use of PPI and regorafenib in those patients.
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    Evaluation of Immunotherapy and Targeted Therapies in the Treatment of Metastatic Malignant Melanoma
    (2022) Kaplan, Muhammet Ali; Kalkan, Ziya; Tunç, Sezai; İleri, Serdar; Oruç, Zeynep; Ebınc, Senar; Urakçı, Zuhat
    Objectives: The prognosis of metastatic malignant melanoma is poor. In this study, we aim to evaluate the response rates, PFS and OS times obtained with Nivolumab, Ipilimumab and Dabrafenib plus Trametinib in the treatment of advanced malignant melanoma, as well as the side effect profiles of these three agents. Methods: This study included 58 patients diagnosed with advanced malignant melanoma who received Nivolumab, Ipilimumab or Dabrafenib plus Trametinib therapy between January 2010 - March 2021 and had follow-up at our clinic. Response rates, survival times and side effects associated with each of the three treatment arms were evaluated. Nivolumab, Ipilimumab and Dabrafenib plus Trametinib were compared with regard to effectiveness and tolerability. Results: The Nivolumab, Ipilimumab and Dabrafenib plus Trametinib treatment arms, included 34 (58.6%), 13 (22.4%) and 11 (19%) patients, respectively. The comparison of Nivolumab, Ipilimumab and Dabrafenib plus Trametinib yielded, respectively; ORR (53%, 38.5%, 72.8%), mPFS (7 months, 3 months, 9 months) (p=0.57), mOS (12 months, 16 months, 15 months) (p=0.85). Conclusion: In this study that we conducted with real life data, we confirmed that Nivolumab, Ipilimumab and Dab rafenib plus Trametinib have different effectiveness adn manageable side effect profiles in the treatment of advanced malignant melanoma.
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    Factors predicting pathological complete response to neoadjuvant chemotherapy in patients diagnosed with non- metastatic muscle invasive urothelial bladder cancer
    (2023) Urakçı, Zuhat; Ebinç, Senar; Tunç, Sezai; Oruç, Zeynep; Küçüköner, Mehmet; Kaplan, Muhammet Ali; Işıkdoğan, Abdurrahman
    Aim: In this study, we aimed to investigate the factors that may have the potential to predict pathological complete response (pCR) with platinum-based neoadjuvant chemotherapy (NAC) in non-metastatic muscle-invasive bladder cancer (MIBC). Methods: Our study included 46 patients diagnosed with non-metastatic MIBC, who applied to Dicle University Medical Oncology Clinic between 2016-2019 years and received NAC. Age, gender, ECOG performance score, tumor grade, pathological tumor (pT) stage, clinical lymph node (cN) status, localization of the primary tumor in the bladder, presence of comorbid diseases, renal failure status, hydronephrosis, and NAC regimens were analyzed. Results: Of the total 46 patients included in the study, 42 (81.3%) were male and 4 (8.7%) were female. The median age at diagnosis was 61.5 (34-77) years. In the group of patients aged <65 years, pCR was achieved in 9 patients (33.3%) and pCR was not achieved in 18 patients. The rate of pCR after NAC in the patient group aged <65 years was higher than in the age ≥65 group, which was statistically significant (p: 0.03). While the median disease-free survival (DFS) was not reached in the pCR arm, the median DFS was calculated as 26 months (95% CI: 4.6-47.3) in the non-pCR arm (Log Rank p=0.23). The mean overall survival (OS) value in the pCR arm was 126 months (95% CI: 106.5- 145.4) and the mean OS value in the non-pCR arm was 53.5 months (95% CI: 44.2-62.9) (Log Rank p=0.05). Conclusion: In our study, age <65 years was found to be an independent prognostic factor for pCR in the neoadjuvant treatment of non-metastatic MIBC. Mean OS was better in patients who achieved pCR.
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    Kronik hepatit B enfeksiyonunda tenofovir ve entekavir tedavi sonuçlarının karşılaştırılması
    (2017) Tunç, Sezai; Kaya, Muhsin
    Hepatit B virüsü (HBV) akut hepatit, kronik hepatit, siroz ve hepatosellüler karsinomun en önemli etkenlerinden birisidir. Hepatit B virüsü (HBV) büyük bir global sağlık sorunu olup yaklaşık olarak 240 milyon insanın kronik enfekte olduğu tahmin edilmektedir (1, 2). Çalışmamızda KHB enfeksiyonunda kullanılan oral antiviral ajanlardan tenofovir ve entekavirin uzun dönem etkinlikleri değerlendirilmiştir. Çalışmaya toplamda 400 hasta dahil edilmiş, tenofovir grubunda 234 ve entekavir grubunda 166 hasta değerlendirmeye alınmıştır. 0-3-6-9-12. ayda ve sonrasında 6 ayda bir HBV DNA, ALT, AST değerleri; 0-6-12. ay ve sonrasında 12 ayda bir HBsAg, HBeAg, anti-HBe ve 0-6-12. ayda ALP, GGT, total bilurubin değerleri değerlendirmeye alınmıştır. Her iki grup arasında yaş, cinsiyet, başlangıç ALT, AST, HBV DNA, HBeAg pozitifliği, HAI ve fibroz değerlerine bakıldığında istatistiksel açıdan anlamlı fark saptanmamıştır. Her iki grubun sonuçlarına bakıldığında, HBV DNA negatifleşmesi açısından entekavir tenofovire göre genel olarak daha etkili görünmesine rağmen, istatistiki açıdan anlamlı fark saptanmadı. İki grup arasında ALT normalleşmesi açısından bakıldığında, entekavirin tenofovire göre daha etkili olduğu görünmesine rağmen, istatiksel olarak sadece 6. ve 60. ayda entekavirin daha etkili olduğu saptandı. HBeAg serokonversiyonu ve HBsAg kayıp oranlarına bakıldığında iki grup arasında fark bulunmadı. Anahtar Kelimeler: Kronik Hepatit B, Tenofovir, Entekavir
  • Küçük Resim
    Öğe
    Neoadjuvan kemoterapi alan luminal tip meme kanserli hastalarda patolojik tam yanıtı predikte eden faktörler
    (Dicle Üniversitesi Tıp Fakültesi, 2023) Urakçı, Zuhat; Akdeniz, Nadiye; Tunç, Sezai; Oruç, Zeynep; Küçüköner, Mehmet; Kaplan, Muhammet Ali; Büyükbayram, Hüseyin; Işıkdoğan, Abdurrahman
    Amaç: Luminal tip meme kanserinde birçok çalışma yapılmış olmasına rağmen günümüzde bu tip meme kanserinde patolojik tam yanıtı (pCR) predikte eden faktörler halen net olarak bilinmemektedir. Bu çalışmamızda neoadjuvan kemoterapi alan luminal tip meme kanserli hastalarda patolojik tam yanıtı predikte eden faktörleri incelemeyi amaçladık. Yöntemler: Çalışmaya Ocak 2010 ile Aralık 2018 arasında onkoloji merkezimizde neoadjuvan kemoterapi alan, luminal tip lokal ve lokal ileri evre meme kanserli, 18 yaşından büyük, 122 kadın hasta dahil edildi. Çalışmamızda neoadjuvan kemoterapi alan luminal tip meme kanseri tanılı hastalarda patolojik tam yanıtı predikte etme potansiyeli olan faktörleri retrospektif olarak inceledik. Bulgular: Hastaların menopozal durumu (p=0.638), tümör lokalizasyonu (sağ-sol) (p=0.791) ve tümör boyutu (p=0.861) ile pCR arasında istatistiksel olarak anlamlı ilişki izlenmedi. Patolojik tam yanıt ile invaziv duktal karsinom histolojisine sahip olma (p=0.001), östrojen reseptör (ER) negatifliği (p=0.034), insan epidermal büyüme faktörü reseptör-2 pozitifliği (HER2) (p=0.030) ve nod negatifliği (p=0.023) arasında istatistiksel olarak anlamlı ilişki saptandı. Patolojik tam yanıt ile hastalığın evresi (II-III) (p=0.051) ve Ki-67 düzeyi (<%20/ ≥%20) (p=0.060) arasında sınırda istatistiksel anlamlılık mevcuttu. Regresyon analizinde, diğer potansiyel prognostik faktörler ile birlikte değerlendirildiğinde, nod negatifliği ve ER negatifliği pCR’ı predikte eden bağımsız faktörler olarak saptandı (p=0.008, p=0.040, sırası ile). Patolojik tam yanıt elde edilen hasta grubuyla pCR sağlanamayan grup arasında hem hastalıksız sağkalım (DFS) hem de genel sağkalım (OS) açısından farklılık izlenmedi (p=0.315, p=0.576 sırası ile). Sonuç: Çalışmamızda ER negatifliği ve nod negatifliği pCR’ı predikte eden bağımsız faktörler olarak saptandı. Ki-67’nin %20 üzerinde olması pCR açısından sınırda anlamlılık göstermekteydi. Luminal tip meme kanserli hasta grubunda patolojik tam yanıt prognostik bir faktör olarak saptanmadı.
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    Prognostıc Factors In Testıcular Cancer
    (2024) Sezgin, Yasin; Karhan, Oğur; Biçer, Abdurrahman; İleri, Serdy; Yerlikaya, Halis; Tunç, Sezai; Aydın, İbrahim
    Aim: Testicular cancer is the most common cancer in men aged 15-35 years and accounts for 1% of all lifetime male cancers. There are two histologic subtypes: seminoma and nonseminoma. In our study, we aimed to investigate the factors predicting recurrence in early-stage testicular cancer. Materials and Methods: Our study is a retrospective study of early stage testicular cancer admitted to the medical oncololi clinic of our hospital between 2006-2018. During the study, 344 patient files were reviewed and 130 patients who met the study criteria were included in the study. Our primary aim in this study was to investigate the factors predictive of recurrence in early stage testicular cancer. Results: When evaluating PFS in patients with nonseminoma with and without lymphovascular invasion, no median PFS value was reached in either group. However, PFS was worse in patients with LVI (p=0.037). When comparing stage 1 with stage 2 seminoma patients, no median PFS values could be reached, but there was a statistical difference between the two groups in terms of recurrence (p=0.019). Conclusions: In our study, we found no association between tumor size, embryonal carcinoma predominance, tunica albuginea invasion, spermatic cord involvement and tumor marker values and recurrence in nonseminoma germ cell testicular tumors. PFS was shorter in patients with LVI compared to those without LVI. Lymphovascular invasion, spermatic cord involvement, tunica albuginea involvement, and rete testis involvement were not associated with disease recurrence in seminoma patients, whereas higher disease stage predicted the risk of recurrence.