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    External Validation of a Novel Risk Model in Patients With Favorable Risk Renal Cell Carcinoma Defined by International Metastatic Renal Cell Carcinoma Database Consortium (IMDC): Results From the Turkish Oncology Group Kidney Cancer Consortium (TKCC) Database
    (Cig Media Group, Lp, 2023) Yekeduz, Emre; Karakaya, Serdar; Erturk, Ismail; Tural, Deniz; Ucar, Gokhan; Oztas, Nihan Senturk; Arikan, Rukiye
    In this report, we validated a novel prognostic model structured by the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) for patients with metastatic renal cell carcinoma. The former favor-able risk group was divided into 2 new categories: very favorable and favorable. Patients with very favorable risk had better survival than those with the novel favorable risk. Further studies are needed to evaluate whether less intensive therapies could be as effective as current combinations of therapies in the very favorable risk group. Background: A novel prognostic model was recommended for patients with metastatic RCC (mRCC) by the Interna-tional mRCC Database Consortium (IMDC). In this study, we aimed to externally validate a novel risk model for the IMDC-favorable risk group in patients with mRCC. Methods: The Turkish Oncology Group Kidney Cancer Consortium (TKCC) is a multicenter registry that includes 13 cancer centers in Turkey. As described by Schmidt et al., 3 parameters (ie, time from diagnosis to systemic therapy < 3 vs. >3 years, Kar nofsky Perfor mance Status [KPS] 80 vs. > 80, and the presence of brain, liver, or bone metastasis) were used to divide the IMDC favorable risk group into 2 new categories: very favorable and favorable risk groups. The primary endpoint was overall survival (OS). Time to treatment failure (TTF) and objective response rate (ORR) in the very favorable and favorable risk groups were the secondary endpoints. Results: A total of 545 patients with mRCC from all IMDC risk groups and 112 patients from the favorable risk group were included in this study. According to the novel classification model, 44 (39.3%) and 68 (60.7%) patients with former favorable risk were categorized into very favorable and favorable risk groups, respectively. The median OS (55.8 months vs. 34.2 months, P = .025) and TTF (25.5 months vs. 15.5 months, P = .010) were longer in the very favorable risk group than in the favorable risk group. The concordance index of the new IMDC model in all patients was 0.65 for OS. Despite the higher ORR in the very favorable risk group than in the favorable risk group, the difference between the groups was not statistically significant (52.4% vs. 44.7, P = .573). Conclusions: This was the first study to externally validate the novel IMDC risk model presented in the American Society of Clinical Oncology Genitourinary Cancers Symposium 2021.
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    Is the benefit of using adjuvant capecitabine in patients with residual triple-negative breast cancer related to pathological response to neoadjuvant chemotherapy?
    (Taylor & Francis Ltd, 2022) Dulgar, Ozgecan; Oven, Basak Bala; Atci, Muhammed Mustafa; Arikan, Rukiye; Ay, Seval; Ayhan, Murat; Selvi, Oguzhan
    Background Triple-negative-breast-cancer (TNBC) has a poor prognosis if pathologic complete response (pCR) cannot be achieved following neoadjuvant chemotherapy (NAC). The group of patients that benefit most from adjuvant capecitabine remains unclear. Materials and Methods We analyzed data of 160 consecutive patients with residual TNBC from eight cancer-center. Pathologic response was defined into two groups as having good-pathologic-response (MillerPayneGrading (MPG) IV-III) or poor-pathologic-response (MPG I-II). The characteristics of patients were compared regarding adjuvant capecitabine usage. Results Univariate-analysis revealed that age, histology, clinical-stage, tumor-size, lymph-nodes number, menopausal status, and pathological-stage were significantly different between two groups. In multivariate-analysis, menopausal status (p = 0.043) and residual tumor-size (p < 0.001) were found to be independent prognostic factors for pathological response. The hazard-ratio for disease recurrence and death in the poor-response group with adjuvant capecitabine was 2.94 (95% confidence-interval (CI), 1.21 to 7.10; p = 0.016) and 4.080 (95% CI, 1.22 to 13.64; p = 0.022), respectively. DFS (p = 0.58) and OS (p = 0.89) improvements with adjuvant capecitabine were not demonstrated in good-response groups. Conclusion This multicenter-study suggested that only the poor-response group to NAC achieved benefit from adjuvant capecitabine. Postmenopausal status and residual tumor-size were related to poor prognosis.
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    Nivolumab in metastatic renal cell carcinoma: results from the Turkish Oncology Group Kidney Cancer Consortium database
    (Future Medicine Ltd, 2021) Yekeduz, Emre; Erturk, Ismail; Tural, Deniz; Karadurmus, Nuri; Karakaya, Serdar; Hizal, Mutlu; Arikan, Rukiye
    Lay abstract Nivolumab is an immune checkpoint inhibitor (ICI) that blocks the communication between T cells and cancer cells and instead activates T cells to fight against cancer. Metastatic renal cell carcinoma (mRCC) is one of the most susceptible tumors to ICIs. The Checkmate 025 trial showed the efficacy of nivolumab in patients with previously treated mRCC. In this real-world study, 173 patients with mRCC were treated with nivolumab in the second line and beyond. Nivolumab was effective in the real-world setting without additional safety concerns. Aim: The authors present real-world data on the efficacy and safety of nivolumab in patients with metastatic renal cell carcinoma (mRCC). Methods: The Turkish Oncology Group Kidney Cancer Consortium (TKCC) database includes patients with mRCC from 13 cancer centers in Turkey. Patients with mRCC treated with nivolumab in the second line and beyond were extracted from the TKCC database. Results: A total of 173 patients were included. The rates of patients treated with nivolumab in the second, third, fourth and fifth lines were 47.4%, 32.4%, 14.5% and 5.7%, respectively. The median overall survival and progression-free survival were 24.2 months and 9.6 months, respectively. Nivolumab was discontinued owing to adverse events in 11 (6.4%) patients. Conclusion: Nivolumab was effective in patients with mRCC and no new safety signal was observed.