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    Quality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine+nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study
    (BioMed Central Ltd., 2020) Yalçın, Şuayib; Dane, Faysal; Öksüzoǧlu, Berna Çakmak; Özdemir, Nuriye Yıldırım; Işıkdoğan, Abdurrahman; Özkan, Metin; Demiragğ, Güzin Gönüllü; Çoşkun, Hasan Şenol; Karabulut, Bülent; Evrensel, Türkkan; Ustaoglu, Mehmet Ali; Özdemir, Feyyaz
    Background: Combination of gemcitabine and nab-paclitaxel has superior clinical efficacy than gemcitabine alone. Nevertheless, health-related quality of life. (QoL) associated with this combination therapy when administered at first-line in advanced pancreatic adenocarcinoma is unknown. Methods: A total of 125 patients were randomized to combination therapy (1000 mg/m2 gemcitabine + 125 mg/m2 nab-paclitaxel) and single-agent gemcitabine (1000 mg/m2) arms to take treatment weekly for 7 of 8 weeks, and following 3 of 4 weeks, until progression or severe toxicity. Primary endpoints were three-months of definitive deterioration free percent of patients, and QoL. Results: Overall QoL analyses showed that 34 and 58.3% of cases in gemcitabine and gemcitabine+nab-P arms had no deterioration in 3rd month QoL scores (p = 0.018). These proportions were 27.3 and 36.6% in 6th month assessments, respectively (p = 0.357). Median overall survivals in combination and single-agent arms were 9.92 months and 5.95 months, respectively (HR: 0.64, 95% CI: 0.42-0.86, p = 0.038). Median progression free survivals in these treatment arms were 6.28 and 3.22 months, respectively (HR: 0.58, 95% CI: 0.39-0.87, p = 0.008). Median time-to-deterioration were 5.36 vs 3.68 months, and objective response rates were 37.1% vs 23.7% (p = 0.009), respectively in combination and single-agent arms. Conclusions: Combination therapy with gemcitabine + nab-paclitaxel had better overall and progression-free survival than gemcitabine alone. Also, combination therapy showed increased response rate without toxicity or deteriorated QoL. Combination treatment with gemcitabine and nab-paclitaxel may provide significant benefit for advanced pancreatic cancer. Trial registration: This study has been registered in ClinicalTrials.gov as NCT03807999 on January 8, 2019 (retrospectively registered)
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    Superiority of Pathologic Lymph Node Ratio over Positive Lymph Node Count in Operated Early-Stage Breast Cancer
    (Edizioni Luigi Pozzi, 2024) Urakçı, Zuhat; Ali Kaplan, Muhammet; Oruç, Zeynep; Gümüş, Mahmut; Uncu, Doğan; Ebinç, Senar; Özkan, Metin
    AIM: In early-stage breast cancer, the axillary lymph nodes play a crucial role in determining the prognosis of the disease. The rate of lymph node involvement might be a more valuable prognostic factor than the number of positive lymph nodes. Therefore, we aimed to evaluate whether the lymph node ratio (LNR) is a superior prognostic indicator compared to the pathologic lymph node count in early-stage disease. METHODS: We included 3053 non-metastatic, lymph node-positive breast cancer patients who were treated and followed at 6 medical oncology centers in Türkiye between 2004–2018. Based on LNR, patients were classified into three risk groups: high (>0.65), intermediate (0.21–0.65), and low (≤0.20). RESULTS: Classification of patients according to the TNM8 system based on the number of positive lymph nodes revealed that pathologic lymph node count (pN)1 accounted for 49.0% (n = 1495), pN2 for 30.0% (n = 917), and pN3 for 21.0% (n = 641). Based on the LNR risk group, the low-risk group accounted for 45.4% (n = 1385), intermediate for 36.2% (n = 1105), and high for 18.4% (n = 563) of the total patients. For the entire patient cohort, the 5-and 10-year disease-free survival (DFS) were 93% and 67%, respectively, while overall survival (OS) rates were 95% and 75%, respectively. The median DFS for patients with N1, N2, and N3 disease was 149 months (94.2–203.7), 120.1 months (108.2–132.0), and 81.8 months (68.4–131.1), respectively (p < 0.001). The median DFS for the three LNR risk groups (low, intermediate, and high risk) was 148.9 months (95.3–202.6), 118.7 months (99.9–137.7), and 81.8 months (68.2– 95.3) respectively. Increasing LNR rate was an independent prognostic factor for DFS, according to multivariate analysis (p < 0.001). Furthermore, the median DFS was 133 months for pathologic N1 patients in the LNR intermediate-high risk group, while the median DFS was not reached in patients with LNR and the pN2 low risk group (p = 0.034). CONCLUSIONS: This study confirms the significance of LNR as a prognostic factor for DFS. The results show that in certain specific subgroups, LNR provides more information than pathologic lymph node counts. © 2024 The Author(s).
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    Third-line Therapy for Metastatic Renal Cell Carcinoma and Its Effect on Quality of Life and Overall Survival: A National, Multicenter, Observational Study
    (2020) Öztop, İlhan; Özkan, Metin; Alacacıoğlu, Ahmet; Dane, Faysal; Uncu, Doğan; Elkıran, Emin; Öksüzoğlu, Ömür
    Objective: The study aimed to evaluate the efficacy of targeted therapies used as the third-line treatment after first-line cytokineand second-line tyrosine kinase inhibitor (TKI) therapies in metastatic renal cell carcinoma (mRCC) patients and assess the quality of life (QoL)of patients. Material and Methods: This national, multicenter, non-interventional study included patients aged ?18 years with histologicallyconfirmed mRCC, receiving targeted therapies as the third-line treatment for the last one month. Overall survival (OS), progression-free survival (PFS), adverse events (AEs), and QoL were evaluated. Results: The study included 102 mRCC patients (74 males) (median age of 61years). The median disease duration since diagnosis was 27.5 months (ranging 4-201 months). Of all the patients, 75.5% and 24.5% were receiving Axitinib and Everolimus, respectively, as third-line therapy. In all patients, the one-year PFS and OS rates were 62.9% and 79.9%,respectively. Seventy-one AEs (mostly mild) developed in 29 (28.4%) patients, fatigue being the most common (9.8%) AE. As compared tothe baseline, no significant change was observed in the QoL scores of patients in the 12th month. The Axitinib and Everolimus groups did notdiffer significantly as regards to PFS and OS. Of the 11 patients with grade III-IV AEs, four were from the Everolimus group, and seven belonged to the Axitinib group. The QoL scores did not show a significant difference between the two groups except for that in the 12th month.Conclusion: Third-line therapy in mRCC patients was found to be effective and tolerable. Prolonged survival in mRCC patients receiving anincreasing number of therapy lines requires further evaluation of QoL, considering it to be a part of treatment assessment.
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    Türkiye’de meme kanserli hastaların tanı ve tedavi yöntemlerine ulaşım hızı; çok merkezli gözlemsel çalışma
    (2011) Uygun, Kazım; Özdemir, Feyyaz; Demirkan, Binnaz; Demirağ, Güzin Gönüllü; Özkan, Metin; Aydoğan, Fatma; Kaplan, Mehmet Ali
    Amaç: Bu çalışmada Türkiye’deki meme kanserli hastaların hastalıklarını ilk fark ettikleri tarihten tanı ve tedavi yöntemlerine ulaşana kadar geçen zamanı ve ilişkili faktörleri belirlemek amaçlanmıştır. Yöntem ve Gereçler: Çalışmamızda veriler 1–28 Şubat 2010 tarihleri arasında Türkiye’deki 14 farklı tibbi onkoloji kliniğine başvuran 535 hasta ile yapılan anket ile elde edildi. Büyükşehirlerde -İstanbul, Ankara, İzmir- bulunan merkezler Grup 1 (n=161), İç Anadolu ve Marmara bölgesinde yer alan Kocaeli, Bursa, Edirne ve Kayseri’deki merkezler Grup 2 (n=189), Karadeniz ve Doğu-Güneydoğu Anadolu’da bulunan Zonguldak, Samsun, Trabzon, Elazığ ve Diyarbakır’daki merkezler (n=185) Grup 3 merkezler olarak gruplandı. Merkezlerin gruplanmasında bulundukları illerin sosyo-ekonomik gelişmişlik sıralaması dikkate alındı. Bulgular: Ortanca yaş 48 ± 11.2 (24–89), yaşı ?50 olan hasta sayısı 282 (%56.1) idi. Hastaların %85’i eline kitle gelmesi sonrası doktora başvurmuş ve elli yaş üzeri hastaların %27’si tanı anına kadar meme USG ve/veya mamografi çektirmemişti. Hastalığın fark edilmesi-sağlık kuruluşuna başvuru arası süre ortanca 10 gün, başvurubiyopsi arası 19 gün, biyopsi-ameliyat arası 10 gün, ameliyat-sistemik tedavi arası 31 gün idi. Grup 1, Grup 2 ve Grup 3 merkezlerde hastalığın fark edilmesi-başvuru arası süre sırasıyla 15, 10 ve 14 gün, biyopsi-ameliyat arası sırasıyla 14, 1.5 ve 12 gün idi. Grup 2 merkezlerde ilk fark etme-başvuru ve biyopsi-ameliyat arası süre grup 1 ve 3 merkezlerden daha kısa idi (p<0.05). Sonuç: Hastalığın fark edilmesi ile sağlık kuruluşuna başvuru arasında geçen sürenin 10 gün olması ülkemizde meme kanseri farkındalığının yüksek olduğunu düşündürmektedir. Başvurudan biyopsi, ameliyat ve sistemik tedaviye kadar geçen zaman gelişmiş ülkeler ile karşılaştırıldığında daha uzundur ve bölgeler arasında belirgin farklılıklar görülmektedir.