Metastatik safra yolu kanseri olan yaşlı hastalarda optimal tedavi yaklaşımları ve prognostik faktörler

Introduction: There is a lack of evidence of the outcomes in elderly patients advanced stage biliary tract cancer due to the patients aged over 65 years are less than 25% in many prospective trials. We designed a retrospective multicenter study to evaluate the factors affecting treatment and survival in elderly patients with advanced-stage biliary tract cancer. Materials and methods: A total of 116 patients with advanced stage biliary tract cancer aged ≥65 years were included, and the treatment responses, survival, and toxicity rates were evaluated with respect to age groups Results: There was no significant difference between age and response to treatment, survival, or toxicity. The median progression-free survival and overall survival were 5.3, and 11.8 months respectively. Multivariate analysis indicated that ECOG PS (p<0.001 CI95% 1.5-3.7) and PNI (p<0.001 CI 95% 0.14-0.41) were significant independent prognostic factors for PFS. The independent prognostic factors for OS were choice of frontline regimen, NLR and PNI (p=0.007 CI 95% 0.71 – 0.94, p=0.006 CI 95% 1.2 – 3.1, p=0.001 CI 95% 0.35 – 0.91, respectively). Discussion: This study confirms the general prognostic relevance of inflammatory parameters and the importance of frontline treatment in elderly patients with advanced-stage biliary tract tumors. Additionally, getting older does not indicate that treatment will be avoided or that they will have a worse prognosis and suffer from more toxicities.Giriş: 65 yaş üzeri hastaların klinik çalışmaların %25’inden daha azını oluşturması nedeniyle biliyer sistem kanseri olan ileri yaş hastaların yönetimi konusunda kanıt eksiği bulunmaktadır. Bu amaçla, metastatik safra yolu kanseri tanılı yaşlı hastalarda tedaviyi ve sağkalımı etkileyen faktörleri değerlendirmek için retrospektif çok merkezli bir çalışma tasarladık. Gereç ve yöntemler: Çalışmaya 65 yaş ve üzeri, ileri evre safra yolu kanseri tanısı almış, 116 hasta dahil edildi ve yaş gruplarına göre tedavi yanıtları, sağkalım ve toksisite oranları değerlendirildi. Bulgular: Median yaşa göre gruplandırılıdğında; yaş ile tedaviye yanıt, sağkalım, toksisite arasında anlamlı bir fark bulunmadı. Tüm populasyonda medyan progresyonsuz sağkalım (PSK) ve genel sağkalım (GSK) sırasıyla 5.3, 11.8 aydı. Multivariate analizde, PSK için bağımsız prognostik faktörler preformans durumu(ECOG PS) (p<0.001 CI95% 1.5-3.7) ve Prognostik nutrisyonel indek (PNI) (p<0.001 CI 95% 0.14-0.41) olarak bulundu. GSK için ise bağımsız prognostik faktörler, birinci sıra tedavi seçimi, Notrofil Lenfosit oranı (p=0,007 CI %95 0,71 – 0,94) ve PNI (p=0,001 CI %95 0,35 – 0,91) olarak bulundu. Tartışma: Metastatik safra yolu kanseri olan yaşlı hastalarda prognozu etkileyen temel faktöreler inflamatuar parametreler ve birinci basamakta seçilen kemoterapi rejimidir. İleri yaş ile sağkalım, toksiste profili ve tedavi toleransı farklılık göstermemektedir

Prognostic factors for regorafenib treatment in patients with refractory metastatic colorectal cancer: A real-life retrospective multi-center study

Regorafenib, an oral multikinase inhibitor, has improved survival in metastatic colorectal cancer (mCRC) patients who have progressed on standard therapies. Our study aimed to evaluate prognostic factors influencing regorafenib treatment and assess the optimal dosing regimen in a real-life setting. We retrospectively analyzed 263 patients with mCRC from multiple medical oncology clinics in Turkey. Treatment responses and prognostic factors for survival were evaluated using univariate and multivariate analysis. Of the patients, 120 were male and 143 were female; 28.9% of tumors were located in the rectum. RAS mutations were present in 3.0% of tumors, while BRAF, K-RAS, and N-RAS mutations were found in 3.0%, 29.7%, and 25.9% of tumor tissues, respectively. Dose escalation was preferred in 105 (39.9%) patients. The median treatment duration was 3.0 months, with an objective response rate (ORR) of 4.9%. Grade ≥ 3 treatment-related toxicity occurred in 133 patients, leading to discontinuation, interruption, and modification rates of 50.6%, 43.7%, and 79.0%, respectively. Median progression-free survival (PFS) and overall survival (OS) were 3.0 and 8.1 months, respectively. RAS/RAF mutation (hazard ratio [HR] 1.5, 95% confidence interval [CI] 1.1–2.3; P = 0.01), pre-treatment carcinoembryonic antigen (CEA) levels (HR 1.6, 95% CI 1.1–2.3; P = 0.008), and toxicity-related treatment interruption or dose adjustment (HR 1.6, 95% CI 1.1–2.4; P = 0.01) were identified as independent prognostic factors for PFS. Dose escalation had no significant effect on PFS but was associated with improved OS (P < 0.001). Independent prognostic factors for OS were the initial TNM stage (HR 1.3, 95% CI 1.0–1.9; P = 0.04) and dose interruption/adjustment (HR 0.4, 95% CI 0.2–0.9; P = 0.03). Our findings demonstrate the efficacy and safety of regorafenib. Treatment line influences the response, with dose escalation being more favorable than adjustment or interruption, thus impacting survival

Real-life analysis of treatment approaches and the role of inflammatory markers on survival in patients with advanced biliary tract cancer

Objectives: Advanced-stage biliary tract cancers (BTC) are rare malignancies with poor prognosis. There are few prospective trials, but several retrospective studies regarding treatment options. In this study, we aimed to investigate the role of systemic inflammatory parameters (SIP) and other possible independent factors that may affect survival and treatment approaches and to determine the benefit of later-line treatments in these patients. Methods: A total of 284 patients, initially diagnosed with advanced stage or progressed after curative treatment of BTC, from different oncology centers in Turkey were included in this retrospective study. The prognostic significance of clinicopathological factors, SIPs and treatment options was analyzed. Results: At a median follow-up of 13 months, the median progression-free survival (PFS) was 6.1 months (95% CI:5.51–6.82), and the median overall survival (OS) time was 16.8 months (95% CI: 13.9–19.6). Treatment choice (p <.001 HR:0.70 CI95% 0.55–0.9), performance status (p <.001 HR:2.74 CI 95% 2.12–3.54) and neutrophil-to-lymphocyte ratio (NLR) (p =.02 HR:1.38 CI 95% 1.03–1.84) were independent prognostic factors for PFS. For OS, the independent prognostic indicators were determined as The Eastern Cooperative Oncology Group Performance Status (ECOG PS) (p <.001 HR:1.78 CI 95% 1.5–2.3), Systemic Immune-inflammation Index (SII) (p <.001 HR:0.51 CI95% 0.36–0.73) and stage at diagnosis (p =.002 HR:1.79 CI 95% 1.24–2.59). Furthermore, second and third line treatments significantly prolonged OS in advanced BTC (p <.001 HR:0.55 CI 95% 0.38–0.79; p =.007 HR:0.51 CI95% 0.31–0.83, respectively). Conclusion: SII and NLR are useful prognostic factors and may be helpful in making treatment decisions. Additionally, second and later-line treatments in advanced BTC have a significant impact on survival under real-life conditions

Clinical outcomes of cyclin-dependent kinase 4-6 (CDK 4-6) inhibitors in patients with male breast cancer: A multicenter study.

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

Immunogenicity and safety of the CoronaVac vaccine in patients with cancer receiving active systemic therapy

Aim: To evaluate the immunogenicity and safety of the CoronaVac vaccine in patients with cancer receiving active systemic therapy. Methods: This multicenter, prospective, observational study was conducted with 47 patients receiving active systemic therapy for cancer. CoronaVac was administered as two doses (3 mu g/day) on days 0 and 28. Antibody level higher than 1 IU/ml was defined as 'immunogenicity.' Results: The immunogenicity rate was 63.8% (30/47) in the entire patient group, 59.5% (25/42) in those receiving at least one cytotoxic drug and 100% (five of five) in those receiving monoclonal antibody or immunotherapy alone. Age was an independent predictive factor for immunogenicity (odds ratio: 0.830; p = 0.043). Conclusion: More than half of cancer patients receiving active systemic therapy developed immunogenicity. Tweetable abstract Immunogenicity developed with CoronaVac in 25 (59.5%) of 42 patients who received at least one cytotoxic drug and in all patients (n = 5) who received monoclonal antibody or immunotherapy alone

The efficacy of palbociclib and ribociclib in the first-line treatment of metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer in male patients: a Turkish oncology group (TOG) study.

IntroductionMale breast cancer, comprising approximately 1% of all breast cancer cases, often leads to the exclusion of male patients as a criterion in clinical trials. While the efficacy of Cyclin-dependent kinases 4 and 6 (CDK 4/6) inhibitors has been established in metastatic hormone receptor-positive (HR +) and human epidermal growth factor receptor 2-negative (HER2 -) breast cancer in women, limited data exist on their effectiveness in male patients.We aimed to evaluate the efficacy and safety of palbociclib or ribociclib in male patients with breast cancer.IntroductionMale breast cancer, comprising approximately 1% of all breast cancer cases, often leads to the exclusion of male patients as a criterion in clinical trials. While the efficacy of Cyclin-dependent kinases 4 and 6 (CDK 4/6) inhibitors has been established in metastatic hormone receptor-positive (HR +) and human epidermal growth factor receptor 2-negative (HER2 -) breast cancer in women, limited data exist on their effectiveness in male patients.We aimed to evaluate the efficacy and safety of palbociclib or ribociclib in male patients with breast cancer.MethodsThis study is a multicenter, retrospective study. We included male patients with HR + and HER2-metastatic breast cancer who received palbociclib or ribociclib as first-line treatment. Our primary endpoints were progression-free survival (PFS), overall response rates (ORR), and drug-related adverse effects.ResultsA total of 46 male patients from 27 institutions were enrolled. The median age at initiation of CDK 4/6 inhibitors was 63.64 +/- 13.69 years, with a median follow-up of 21.33 (95% CI 14.92-27.74) months. The ORR were 84% for palbociclib and 76.2% for ribociclib. The mPFS for the entire cohort was 28.06 months (95% CI 18.70-37.42). No significant difference in PFS was observed between palbociclib and ribociclib (mPFS: 24.46 months (95% CI 11.51-37.42) vs 28.33 months (95% CI 14.77-41.88), respectively, p = 0.211). No new adverse events were reported.DiscussionThis study demonstrates that palbociclib and ribociclib are effective and safe options for first-line treatment in male patients with HR + /HER2 - metastatic breast cancer. However, further prospective studies are warranted to establish their efficacy in this population