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    A multicenter, retrospective archive study of radiological and clinical features of ALK-positive non-small cell lung cancer patients and crizotinib efficacy
    (Lippincott williams & wilkins, 2024) Kılıçkap, Saadettin; Öztürk, Akın; Karadurmuş, Nuri; Korkmaz, Taner; Yumuk, Perran Fulden; Çiçin, İrfan
    To evaluate radiological and clinical features in metastatic anaplastic lymphoma kinase+ non-small cell lung cancer patients and crizotinib efficacy in different lines. This national, non-interventional, multicenter, retrospective archive screening study evaluated demographic, clinical, and radiological imaging features, and treatment approaches in patients treated between 2013-2017. Totally 367 patients (54.8% males, median age at diagnosis 54 years) were included. Of them, 45.4% were smokers, and 8.7% had a family history of lung cancer. On radiological findings, 55.9% of the tumors were located peripherally, 7.7% of the patients had cavitary lesions, and 42.9% presented with pleural effusion. Pleural effusion was higher in nonsmokers than in smokers (37.3% vs. 25.3%, P = .018). About 47.4% of cases developed distant metastases during treatment, most frequently to the brain (26.2%). Chemotherapy was the first line treatment in 55.0%. Objective response rate was 61.9% (complete response: 7.6%; partial response: 54.2%). The highest complete and partial response rates were observed in patients who received crizotinib as the 2nd line treatment. The median progression-free survival was 14 months (standard error: 1.4, 95% confidence interval: 11.2-16.8 months). Crizotinib treatment lines yielded similar progression-free survival (P = .078). The most frequent treatment-related adverse event was fatigue (14.7%). Adrenal gland metastasis was significantly higher in males and smokers, and pleural involvement and effusion were significantly higher in nonsmokers-a novel finding that has not been reported previously. The radiological and histological characteristics were consistent with the literature data, but several differences in clinical characteristics might be related to population characteristics.
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    Endocrine Adverse Events in Patients Treated with Immune Checkpoint Inhibitors: A Comprehensive Analysis
    (Multidisciplinary Digital Publishing Institute (MDPI), 2025) Dökmetaş, Meriç; Muğlu, Harun; Özcan, Erkan; Bayram Kuvvet, Buket; Helvacı, Kaan; Kalacı, Ender; Kahraman, Seda; Aykan, Musa Barış; Çiçin, İrfan; Selçukbiricik, Fatih; Ölmez, Ömer Fatih; Bilici, Ahmet
    Background and Objectives: Immune checkpoint inhibitors (ICIs) have revolutionized cancer therapy, but their use is associated with a spectrum of immune-related adverse events (irAEs), including endocrine disorders. This study aims to investigate the incidence, timing, treatment modalities, and impact of ICI-related endocrine side effects in cancer patients. Materials and Methods: This retrospective study analyzed 139 cancer patients treated with ICIs between 2016 and 2022. Data regarding endocrine irAEs, including hypothyroidism, hyperthyroidism, hypophysitis, and diabetes mellitus, were collected. The study examined the timing of irAE onset, management approaches, and the association between irAEs and treatment outcomes. Results: The most common endocrine irAE was hypothyroidism (65.5%), followed by hyperthyroidism (2.3%), hypophysitis (8.6%), and diabetes mellitus (0.7%). These disorders typically emerged within the first six months of ICI therapy. Most cases were managed conservatively or with hormone replacement therapy. Patients who developed endocrine irAEs exhibited a higher objective response rate (ORR) and clinical benefit rate (CBR) compared to those without irAEs. Conclusions: Endocrine dysfunction is a significant toxicity of ICI therapy. Early recognition, prompt diagnosis, and appropriate management are crucial to minimize their impact on patient health and quality of life. This study highlights the potential association between irAEs and improved clinical outcomes. Further research is needed to elucidate the underlying mechanisms and identify predictive biomarkers for irAE development. © 2025 by the authors.
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    Sacituzumab govitecan versus docetaxel for previously treated advanced or metastatic non-small cell lung cancer: the randomized, open-label phase III EVOKE-01 study
    (Lippincott williams and wilkins, 2024) Paz-Ares, Luis G.; Juan-Vidal, Oscar; Mountzios, Giannis S.; Felip, Enriqueta; Çiçin, İrfan
    PURPOSEThe open-label, phase III EVOKE-01 study evaluated sacituzumab govitecan (SG) versus standard-of-care docetaxel in metastatic non-small cell lung cancer (mNSCLC) with progression on/after platinum-based chemotherapy, anti-PD-(L)1, and targeted treatment for actionable genomic alterations (AGAs). Primary analysis is reported.METHODSPatients were randomly assigned 1:1 (stratified by histology, best response to last anti-PD-(L)1-containing regimen, and AGA treatment received or not) to SG (one 10 mg/kg intravenous infusion on days 1 and 8) or docetaxel (one 75 mg/m2 intravenous infusion on day 1) in 21-day cycles. Primary end point was overall survival (OS). Key secondary end points were investigator-assessed progression-free survival (PFS), objective response rate, patient-reported symptom assessment, and safety.RESULTSIn the intention-to-treat population (SG, n = 299; docetaxel, n = 304), 55.4% had one previous line of therapy. Median follow-up was 12.7 months (range, 6.0-24.0). The primary end point was not met. There was a numerical OS improvement for SG versus docetaxel (median, 11.1 v 9.8 months; hazard ratio [HR], 0.84 [95% CI, 0.68 to 1.04]; one-sided P = .0534), consistent across squamous and nonsquamous histologies. Median PFS was 4.1 versus 3.9 months (HR, 0.92 [95% CI, 0.77 to 1.11]). An OS benefit was observed for SG (n = 192) versus docetaxel (n = 191) in mNSCLC nonresponsive to last anti-PD-(L)1-containing regimen (3.5-month median OS increase; HR, 0.75 [95% CI, 0.58 to 0.97]); this was consistent across histologies. Among patients receiving SG and docetaxel, 6.8% and 14.2% discontinued because of treatment-related adverse events (TRAEs), respectively; 1.4% and 1.0%, respectively, had TRAEs leading to death.CONCLUSIONAlthough statistical significance was not met, OS numerically improved with SG versus docetaxel, which was consistent across histologies. Clinically meaningful improvement in OS was noted in mNSCLC nonresponsive to last anti-PD-(L)1-containing regimen. SG was better tolerated than docetaxel and consistent with its known safety profile, with no new safety signals.
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    Telisotuzumab vedotin monotherapy in patients with previously treated c-met protein-overexpressing advanced nonsquamous EGFR-wildtype non-small cell lung cancer in the phase II LUMINOSITY trial
    (Lippincott williams and wilkins, 2024) Camidge, D. Ross; Bar, Jair; Horinouchi, Hidehito; Goldman, Jonathan; Moiseenko, Fedor; Filippova, Elena; Çiçin, İrfan
    PURPOSE Telisotuzumab vedotin (Teliso-V) is a c-Met-directed antibody-drug conjugate with a monomethyl auristatin E cytotoxic payload. The phase II LUMINOSITY trial (ClinicalTrials.gov identifier: NCT03539536) aimed to identify the optimal c-Met protein-overexpressing non-small cell lung cancer (NSCLC) population for treatment with Teliso-V (stage I) and expand the selected group for efficacy evaluation (stage II). Stage II enrolled patients with nonsquamous epidermal growth factor receptor (EGFR)-wildtype NSCLC. METHODS Eligible patients had locally advanced/metastatic c-Met protein-overexpressing NSCLC and <= 2 previous lines of therapy (including <= 1 line of systemic chemotherapy). c-Met protein overexpression in nonsquamous EGFR-wildtype NSCLC was defined as >= 25% tumor cells with 3+ staining (high [>= 50% 3+]; intermediate [>= 25%-<50%]). Teliso-V was administered at 1.9 mg/kg once every 2 weeks. The primary end point was overall response rate (ORR) by independent central review. RESULTS In total, 172 patients with nonsquamous EGFR-wildtype NSCLC received Teliso-V in stages I and II. ORR was 28.6% (95% CI, 21.7 to 36.2; c-Met high, 34.6% [95% CI, 24.2 to 46.2]; c-Met intermediate, 22.9% [95% CI, 14.4 to 33.4]). The median duration of response was 8.3 months (95% CI, 5.6 to 11.3; c-Met high, 9.0 [95% CI, 4.2 to 13.0]; c-Met intermediate: 7.2 [95% CI, 5.3 to 11.5]). The median overall survival was 14.5 months (95% CI, 9.9 to 16.6; c-Met high, 14.6 [95% CI, 9.2 to 25.6]; c-Met intermediate, 14.2 [95% CI, 9.6 to 16.6]). The median progression-free survival was 5.7 months (95% CI, 4.6 to 6.9; c-Met high, 5.5 [95% CI, 4.1 to 8.3]; c-Met intermediate: 6.0 [95% CI, 4.5 to 8.1]). Most common any-grade treatment-related adverse events (AEs) were peripheral sensory neuropathy (30%), peripheral edema (16%), and fatigue (14%); the most common grade >= 3 AE was peripheral sensory neuropathy (7%). CONCLUSION Teliso-V was associated with durable responses in c-Met protein-overexpressing nonsquamous EGFR-wildtype NSCLC, especially in those with high c-Met. AEs were generally manageable.
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    Treatment patterns and attrition in metastatic renal cell carcinoma: real-life experience from the Turkish oncology group kidney cancer consortium (TKCC) database
    (Elsevier inc., 2025) Bölek, Hatice; Sertesen, Elif; Kuzu, Ömer Faruk; Tural, Deniz; Sim, Saadet; Nahit Şendur, Mehmet Ali; Uçar, Gökhan; Işık, Selver; Hacıoğlu, Bekir; Çiçin, İrfan; Arslan, Çağatay; Göksu, Sema Sezgin; Sever, Özlem Nuray; Karaçin, Cengiz; Karadurmuş, Nuri; Özgüroğlu, Mustafa; Yekedüz, Emre; Ürün, Yüksel
    Introduction: Despite the rapid evolution in management of metastatic renal cell carcinoma (mRCC) over the past decade, challenges remain in accessing new therapies in some parts of the world. Despite therapeutic advancements, attrition rates remain persistently high. This study aims to assess the treatment patterns and attrition rates of patients with mRCC in oncology clinics across Turkey. Patients and Methods: Patients diagnosed with mRCC between January 1, 2008, and December 31, 2022, with first-line systemic treatment data, were retrospectively evaluated using the Turkish Oncology Group Kidney Cancer Consortium (TKCC) Database. Results: The final analysis included a total of 1126 patients. The percentages of patients treated in the 2nd, 3rd, 4th, and 5th lines of therapy were 62.8%, 27.4%, 8.9%, and 2.1%, respectively. The drugs that were most commonly used in the groups were tyrosine kinase inhibitors (TKIs) (52.2%) and interferon (IFN)-alpha (43.3%) for the first line, TKIs (66.3%) and immunotherapy (IO) monotherapy (25.9%) for the second line, TKI (41.4%) and mTOR inhibitors (28.8%) for the third line, TKI (44.4%) and mTOR inhibitors (29%) for the fourth line, and IO monotherapy (37.5%) and TKI (25%) for the fifth line. For the first-line treatment, the primary cause of attrition was disease progression (66.4%), followed by toxicity (16.5%), death (11.2%), and patient preference (5.9%). The primary reason for attrition across all treatment lines was disease progression. Over time, the use of TKIs in first-line treatment increased, while IFN-alpha usage declined. IOs began to be utilized in earlier lines, predominantly in second-line treatment, though use of IO-based combination therapies remains limited. Conclusion: This study underscores that despite significant progress in therapeutic options, the adoption of novel agents remains slow, and attrition rates are still high. These findings indicate a disparity in systemic therapy compared to developed countries.
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    Treatment patterns and attrition in metastatic renal cell carcinoma: real-life experience from the Turkish oncology group kidney cancer consortium (TKCC) database
    (CIG media group, 2024) Bölek, Hatice; Sertesen, Elif; Kuzu, Ömer Faruk; Tural, Deniz; Sim, Saadet; Şendur, Mehmet Ali Nahit; Uçar, Gökhan; Işık, Selver; Hacıoğlu, Bekir; Çiçin, İrfan; Arslan, Çağatay; Göksu, Sema Sezgin; Sever, Özlem Nuray; Karaçin, Cengiz; Karadurmuş, Nuri; Özgüroğlu, Mustafa; Yekedüz, Emre; Ürün, Yüksel
    The inclusion of patients with more favorable prognoses in clinical trials imits generalizability to broader and more diverse patient group. This study examines treatment patterns and attrition rates in Turkish oncology clinics for metastatic renal cell carcinoma. The percentages of patients receiving treatment in the second, third, and fourth lines of therapy were 62.8%, 27.4%, and 8.9%, respectively. Disease progression was the primary cause of attrition, followed by toxicity. Introduction: Despite the rapid evolution in management of metastatic renal cell carcinoma (mRCC) over the past decade, challenges remain in accessing new therapies in some parts of the world. Despite therapeutic advancements, attrition rates remain persistently high. This study aims to assess the treatment patterns and attrition rates of patients with mRCC in oncology clinics across Turkey. Patients and Methods: Patients diagnosed with mRCC between January 1, 2008, and December 31, 2022, with first-line systemic treatment data, were retrospectively evaluated using the Turkish Oncology Group Kidney Cancer Consortium (TKCC) Database. Results: The final analysis included a total of 1126 patients. The percentages of patients treated in the 2nd, 3rd, 4th, and 5th lines of therapy were 62.8%, 27.4%, 8.9%, and 2.1%, respectively. The drugs that were most commonly used in the groups were tyrosine kinase inhibitors (TKIs) (52.2%) and interferon (IFN)-alpha (43.3%) for the first line, TKIs (66.3%) and immunotherapy (IO) monotherapy (25.9%) for the second line, TKI (41.4%) and mTOR inhibitors (28.8%) for the third line, TKI (44.4%) and mTOR inhibitors (29%) for the fourth line, and IO monotherapy (37.5%) and TKI (25%) for the fifth line. For the first-line treatment, the primary cause of attrition was disease progression (66.4%), followed by toxicity (16.5%), death (11.2%), and patient preference (5.9%). The primary reason for attrition across all treatment lines was disease progression. Over time, the use of TKIs in first-line treatment increased, while IFN-alpha usage declined. IOs began to be utilized in earlier lines, predominantly in second-line treatment, though use of IO-based combination therapies remains limited. Conclusion: This study underscores that despite significant progress in therapeutic options, the adoption of novel agents remains slow, and attrition rates are still high. These findings indicate a disparity in systemic therapy compared to developed countries.
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    Understanding of clinical trials among patients with cancer and their relatives
    (Amer medical assoc, 2025) Tolunay, Pinar Kubilay; Erol, Cihan; Kahraman, Seda; Tacar, Seher Yıldız; Özcan, Erkan; Basal, Fatma Buğdaycı; Köse, Fatih; Sendur, Mehmet Ali Nahit; Tural, Deniz; Çiçin, İrfan; Öksüzoğlu, Berna; Kılıçkap, Saadettin
    ImportanceClinical trials are vital for advancing cancer treatments and improving patient outcomes. Understanding the factors that influence participants' decision-making is critical for enhancing trial recruitment. ObjectiveTo evaluate the attitudes of patients with cancer and their relatives toward clinical trial participation, identifying key barriers and motivators that affect their willingness to engage in such trials. Design, Setting, and ParticipantsThis cross-sectional survey study was conducted between April 2020 and April 2021. Face-to-face questionnaires were administered by physicians across 6 tertiary hospital medical oncology departments in Turkey. Adults with cancer and their relatives were recruited. Data were analyzed from April to December 2021. ExposureParticipants' knowledge, perceptions, and motivations regarding clinical trial participation were assessed through a structured questionnaire. Main Outcomes and MeasuresParticipants' demographic information, their willingness to participate in clinical trials, their perceptions about the clinical trial participation, and the facilitators and barriers to participation. ResultsA total of 978 participants were surveyed, with a median (range) age of 52 (18-82) years; 485 (49.6%) were male and 479 (49.0%) female. Of these, 578 (59.1%) were patients with cancer and 382 (39.1%) family members. Prior clinical trial experience was reported by 174 participants (17.8%), and 428 (43.8%) expressed a willingness to participate in clinical trials. Participants well-informed about clinical trials showed higher willingness (50 of 87 [57.5%] very willing) compared with those with no knowledge (27 of 303 [8.9%] very willing) (chi(2 )= 275.095; P < .001). Greater willingness was observed in participants from less developed cities compared with the most developed cities (88 of 321 [27.4%] vs 94 of 615 [15.3%]; chi(2 )= 21.093; P < .001), in individuals with a high school degree or greater compared with those with less than a high school degree (105 of 489 [21.5%] vs 76 of 452 [16.8%]; chi(2) = 33.311; P < .001), in those with monthly incomes above compared with below the poverty line (81 of 409 [19.8%] vs 100 of 512 [19.5%]; chi(2 ) = 16.145; P = .003), in those without prior cancer treatment compared with those with prior cancer treatment (125 of 591 [21.2%] vs 40 of 289 [13.8%]; chi(2 ) = 13.801; P = .008), and in participants with prior trial experience compared with those without (74 of 166 [44.6%] vs 111 of 786 [14.1%]; chi(2 )= 87.771; P < .001). Participants were motivated by potential personal health benefits (604 [61.8%]) and access to new treatments (522 [53.4%]). The primary concerns included potential adverse effects (555 [56.7%]), feeling like a "test subject" (284 [29.0%]), and the risk of receiving a placebo (197 [20.1%]). Conclusions and RelevanceIn this survey study of patients with cancer and their relatives, significant gaps in knowledge and persistent concerns about clinical trial safety were highlighted, impacting participation. Addressing these concerns through targeted education and transparent communication is essential for improving participation rates and ensuring more inclusive cancer research.