Clinicopathologic Analysis and Prognostic Factors for Survival in Patients with Operable Ampullary Carcinoma: A Multi-Institutional Retrospective Experience.

Background and Objectives: In ampullary cancer, 5-year survival rates are 30-50%, even with optimal resection and perioperative systemic therapies. We sought to determine the important clinicopathological features and adjuvant treatments in terms of the prognosis of patients with operable-stage ampullary carcinomas. Materials and Methods: We included 197 patients who underwent pancreaticoduodenectomy to treat ampullary carcinomas between December 2003 and May 2019. Demographics, clinical features, treatments, and outcomes/survival were analyzed. Results: The median disease-free survival (mDFS) and median overall survival (mOS) were 40.9 vs. 63.4 months, respectively. The mDFS was significantly lower in patients with lymphovascular invasion (p < 0.001) and lymph node involvement (p = 0.027). Potential predictors of decreased OS on univariate analysis included age ≥ 50 years (p = 0.045), poor performance status (p = 0.048), weight loss (p = 0.045), T3-T4 tumors (p = 0.018), surgical margin positivity (p = 0.01), lymph node involvement (p = 0.001), lymphovascular invasion (p < 0.001), perineural invasion (p = 0.007), and poor histological grade (p = 0.042). For the multivariate analysis, only nodal status (hazard ratio [HR]1.98; 95% confidence interval [CI], 1.08-3.65; p = 0.027) and surgical margin status (HR 2.61; 95% CI, 1.09-6.24; p = 0.03) were associated with OS. Conclusions: Nodal status and a positive surgical margin were independent predictors of a poor mOS for patients with ampullary carcinomas. Additional studies are required to explore the role of adjuvant therapy in patients with ampullary carcinomas.

Efficacy of adjuvant capecitabine in residual triple negative breast cancer: a multicenter observational Turkish Oncology Group (TOG) study.

BACKGROUND: Triple negative breast cancer (TNBC) is characterized by high rates of recurrence, especially in patients with residual disease after neoadjuvant chemotherapy (NAC). Capecitabine is being used as standard adjuvant treatment in residual TNBC. We aimed to investigate the real-life data regarding the efficacy of capecitabine in residual TNBC. DESIGN AND METHODS: In this retrospective multicenter study, TNBC patients with residual disease were evaluated. Patients, who received standard anthracycline and taxane-based NAC and adjuvant capecitabine were eligible. Overall survival (OS), disease free survival (DFS) and toxicity were analyzed. RESULTS: 170 TNBC patients with residual disease were included. Of these, 62.9% were premenopausal. At the time of analysis, the recurrence rate was 30% and death rate was 18%. The 3-year DFS and OS were 66% and 74%, respectively. In patients treated with adjuvant capecitabine, residual node positive disease stood out as an independent predictor of DFS (p = 0.024) and OS (p = 0.032). Undergoing mastectomy and the presence of T2 residual tumor was independent predictors of DFS (p = 0.016) and OS (p = 0.006), respectively. CONCLUSION: The efficacy of capecitabine was found lower compared to previous studies. Selected patients may have further benefit from addition of capecitabine. The toxicity associated with capecitabine was found lower than anticipated.

Potential Drug-Drug Interactions in Outpatient Lung Cancer Patients in a University Hospital.

INTRODUCTION: Concomitant use of drugs in the same or different indications can sometimes lead to undesirable interactions. The prevalence of drug interactions is high in cancer patients. In this study, we aimed to determine the frequency and clinical severity of drug interactions in outpatient lung cancer patients. METHODS: The drugs used, kidney and liver blood analysis results of 160 outpatient lung cancer patients over the age of 18 years who received chemotherapy between October 2020 and July 2021 were evaluated. The Lexi-Interact online database was used to identify the types of clinically significant drug interactions, frequently interacting drugs, and clinical outcomes predicted by the databases. RESULTS: The average number of drugs per patient was 4.2 ± 2.3. It was determined that there was a relationship between multidrug use and comorbidity, and the number of drugs used increased as the number of diagnoses increased. A relationship was also found between potential drug-drug interactions (pDDIs), which we observed in 52.5% of the patients, and the number of drugs used and age. The most common clinically significant C- (36.9%), D- (16.9%), and X- (10.6%) type pDDIs were detected between conventional paclitaxel-hydrochlorothiazide, conventional paclitaxel-carboplatin, and ipratropium-tiotropium, respectively. CONCLUSIONS: The use of frequently interacting drugs in outpatient lung cancer patients can lead to pDDIs. In these patients, the application of therapy by observing the drug-drug interaction may improve the quality of life.

Comparison of three equations for estimating glomerular filtration rate as predictors of cisplatin-related acute kidney injury in lung cancer patients with normal renal function.

OBJECTIVE: Cisplatin-associated acute kidney injury is a common clinical event that causes increased morbidity and mortality in cancer patients even if they are categorized as having normal functioning kidneys. We aimed to determine predictive factors that can predict acute kidney injury associated with cisplatin therapy in patients with normal renal function by comparison of pre-chemotherapy estimated glomerular filtration rates calculated separately by Cockcroft and Gault (CG), the Modification of Diet in Renal Disease (MDRD), and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations and accompanying patient-associated factors. MATERIALS AND METHODS: A total of 200 patients diagnosed with lung cancer and determined to have normal functioning kidneys and considered cisplatin eligible by the attending physician before chemotherapy were included in this retrospective study. Acute kidney injury after cisplatin chemotherapy (c-AKI) was determined according to the National Cancer Institute's Common Terminology Criteria for Adverse Events v4.03. Pre-chemotherapy serum laboratory parameters and clinico-histopathological characteristics of patients were recorded from the hospital electronic system. The optimal cut-off for eGFR methods was determined by the area under the receiver operating characteristic curve (ROC-AUC) analysis. Predictive factor analysis for c-AKI was performed by regression analyses. RESULTS: C-AKI developed in 39 (19.5%) patients. In the univariate analysis, a significant correlation was observed between c-AKI and high body mass index (BMI) before treatment, older age (>62.5), female gender, eGFR by MDRD (≤94.5 mL/min) and eGFR by CKD-EPI (≤91.5 mL/min). There was no relation between eGFR by CG and c-AKI. Two different multivariate models were established. Model 1 showed that female gender (odds ratio [OR] =4.90, 95% confidence interval [CI]: 1.52-15.79, P = 0.008) and eGFR by MDRD less than or equal to 94.5 mL/min (OR = 3.52, 95% CI: 1.68-7.38, P = 0.001) were predictive markers for c-AKI. In Multivariate Model 2, female gender (OR = 5.51, 95% CI: 1.70-17.83, P = 0.004) and eGFR by CKD-EPI less than or equal to 91.5 mL/min (OR = 3.52, 95% CI: 1.67-7.42, P = 0.001) were found to be predictive markers for c-AKI. CONCLUSIONS: This study revealed that eGFR calculated based on MDRD (≤94.5 mL/min/m2) or CKD-EPI (≤91.5 mL/min/m2) before chemotherapy indicates a strong tendency for c-AKI. In addition, we detected a high risk of c-AKI for females compared to their counterparts. Although eGFR 60 mL/min is considered the threshold level to accept patients as cisplatin-eligible, we recommend close follow-up of high-risk patients for cisplatin nephrotoxicity we detected in our models.

Efficacy of Neoadjuvant Chemotherapy in Lobular and Rare Subtypes of Breast Cancer.

OBJECTIVE: To determine the predictive factors for the pathological complete response (pCR) in patients with non-ductal invasive breast cancer (ND-BC) receiving neoadjuvant chemotherapy. STUDY DESIGN: Observational study. Place and Duration of the Study: Departments of Medical Oncology, Tekirdag Namik Kemal University, Sirnak State Hospital, Aydin Adnan Menderes University, Marmara University, Bakirkoy Sadi Konuk Hospital, Basaksehir Cam and Sakura Hospital, Sakarya University, Balikesir Ataturk Hospital, Turkiye, from April 2016 to December 2022. METHODOLOGY: A total of 222 non-metastatic breast cancer patients who received neoadjuvant chemotherapy were included in this retrospective multicentric study. The clinicopathologic data were obtained from the hospitals' electronic-record-system. The logistic regression models were used to identify predictive factors for pCR. RESULTS: One hundred and twenty-six patients (56.8%) had invasive lobular carcinoma and 28 patients (12.6%) had signet ring cell/mucinous carcinoma. A total of 45 patients (20.3%) achieved pCR. The pCR rate was 14.3% for lobular carcinoma and 17.9% for signet ring cell/mucinous carcinoma. The univariate analysis showed that estrogen receptor-negative tumours (p = 0.017), high Ki-67 (p = 0.008), high histologic grade (p<0.001), HER2+ expression (p<0.001), and non-lobular histologic type (p = 0.012) were predictive factors for pCR. The multivariate model revealed that HER2 expression (p<0.001) and Ki-67 (p = 0.005) were independent predictors. CONCLUSION: Neoadjuvant chemotherapy demonstrated effectiveness in ND-BC patients, leading to favourable pCR rates and enabling breast-conserving surgery. Predictive markers for pCR varied depending on histologic types, with HER2 expression, ER status, Ki-67, and histologic grade showing significance in non-ductal subtypes, while HER2 status alone was predictive in lobular carcinoma. KEY WORDS: Neoadjuvant chemotherapy, Non-ductal breast cancer, Lobular carcinoma.

PROPSEA, safety evaluation of palbociclib and ribociclib in older patients with breast cancer: A prospective real-world TOG study.

INTRODUCTION: In this study, the toxicities and management of palbociclib and ribociclib in older patients (≥65 years) with metastatic breast cancer patients were investigated. MATERIALS AND METHODS: Among older patients receiving palbociclib and ribociclib, Geriatric 8 (G8) and Groningen Frailty Index were used to evaluate frailty status. Dose modifications, drug withdrawal and other serious adverse events (SAEs) were recorded and analyzed according to baseline patient characteristics. RESULTS: A total of 160 patients from 28 centers in Turkey were included (palbociclib = 76, ribociclib = 84). Forty-three patients were ≥ 75 years of age. The most common cause of first dose modification was neutropenia for both drugs (97% palbociclib, 69% ribociclib). Liver function tests elevation (10%) and renal function impairment (6%) were also causes for ribociclib dose modification. Drug withdrawal rate was 3.9% for palbociclib and 6% for ribociclib. SAEs were seen in 11.8% of those taking palbociclib and 15.5% of those on riboclib. An ECOG performance status of ≥2 and being older than 75 years were associated with dose reductions. Severe neutropenia was more common in patients with non-bone-only metastatic disease, those receiving treatment third-line therapy or higher, coexistance of non-neutropenic hematological side effects (for ribociclib). Neutropenia was less common among patients with obesity. DISCUSSION: Our results show that it can be reasonable to start palbociclib and ribociclib at reduced dose in patients aged ≥75 years and/or with an ECOG performance status ≥2.

Decrease in estimated glomerular filtration rates in non-small cell lung cancer patients treated with crizotinib.

Introduction: Crizotinib is a tyrosine kinase inhibitor used in patients with non-small cell lung cancer, and there are uncertainties about its effect on kidney function. In this study, it was aimed to document the possible adverse effect of the drug on kidney functions. Materials and Methods: The estimated glomerular filtration rates (eGFRs) of the patients were calculated by creatinine-based Chronic Kidney Disease Epidemiology Collaboration and compared by months using the paired samples t-test. Kaplan-Meier survival method was used for progression-free survival and overall survival (OS) analysis. Results: Twenty-six patients who received crizotinib were included in the study, and the median progression-free survival time with crizotinib was 14.2 months and the median OS time was 27.4 months. There was a significant reduction of eGFR after the 1st month of crizotinib treatment when compared to the rate before treatment initiation (P < 0.001). The eGFR values at the end of the 1st month and the 2nd month of treatment and the 2nd and 3rd months of treatment were statistically similar (P = 0.086, P = 0.663; respectively). This decrease in eGFR values was reversible, and there was no difference detected between pretreatment and posttreatment discontinuation (P = 0.100). Conclusion: A reversible decrease in renal functions was detected in patients using crizotinib. When the literature data are examined, it is thought that the reason for this decrease may be related to the increase in renal inflammation or a pseudo decrease due to the decrease in creatinine excretion. When evaluating renal functions in these patients, using noncreatine-based (iothalamate, etc.) calculations can give more accurate results.

Is the serum level of survivin, an antiapoptotic protein, a potential predictive and prognostic biomarker in metastatic pancreatic cancer?

In the present study, we aimed to assess the association between the serum survivin level and overall survival and treatment response rates in metastatic pancreatic cancer (MPC). Serum samples were prospectively collected from 41 patients with newly diagnosed MPC patients and 41 healthy individuals (control group) to assess the survivin levels. The median survivin level was 136.2 ng/mL in patients with MPC and 52 ng/mL in healthy individuals (P = .028). Patients were divided into low- and high-survivin groups according to the baseline median survivin level. Patients with a high serum survivin level compared with a low serum survivin level had shorter median progression-free survival (2.39 vs 7.06 months; P = .008, respectively) and overall survival (3.74 vs 9.52 months; P = .026, respectively). Patients with higher serum survivin levels had significantly worse response rates (P = .007). The baseline high level of serum survivin in patients with MPC may be associated with treatment resistance and poor prognosis. A confirmation will be needed for these results in future large multicenter prospective studies.

Tamoxifen or aromatase inhibitors: which one is the culprit of urinary incontinence in premenopausal breast cancer patients receiving adjuvant hormone therapy?

AIM: The primary aim of this study was to compare tamoxifen versus aromatase inhibitors (AI) in terms of urinary incontinence (UI) in premenopausal female patients receiving adjuvant hormone therapy for breast cancer. A secondary aim was to investigate the prevalence and the affecting factors of UI. METHODS: This study was designed as a multicenter, cross-sectional that included consecutive premenopausal breast cancer patients ≤50 years of age receiving tamoxifen (with/without LHRHa) or AI (with LHRHa) for at least 6 months, between June 2021 and September 2022. Patients with urinary incontinence before hormone treatments and metastatic patients were excluded from the study. Turkish validation of The International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ UI-SF) was used to determine the UI. Using logistic regression methods, we analyzed potential predictive factors for UI. RESULTS: A total of 206 breast cancer patients were included in this study. A total of 120 (58.2%) patients were receiving tamoxifen plus LHRHa, 40 (19.4%) patients were receiving aromatase inhibitor plus LHRHa, and 46 (22.3%) patients were receiving tamoxifen only. In this study, the prevalence of urinary incontinence was found to be 35.9% (n:74). 41% of the patients receiving tamoxifen and 15.0% of those receiving aromatase inhibitors had complaints of urinary incontinence. There was a statistically significant difference between patients receiving tamoxifen or aromatase inhibitor in terms of urinary incontinence (p=0.001). In the univariate analysis established to predict UI, parity (≥2 vs <2) (OR = 3.23, 95% CI: 1.62-6.46, p= 0.001), tamoxifen (vs AI) (OR = 3.97, 95% CI: 1.58-9.98, p= 0.003), age ( ≥40 vs. <40) (OR = 2.80, 95% CI: 1.37-5.71, p= 0.005), vaginal deliveries (≥2 vs. <2) (OR = 3.28, 95% CI: 1.44-7.46, p= 0.005), hypertension (OR = 3.59, 95% CI: 1.43-9.02, p= 0.007), diuretic use (OR = 2.55, 95% CI: 1.09-5.95, p= 0.031) ), and body mass index (≥25 vs <25) (OR = 1.94, 95% CI: 1.05-3.63), p= 0.034) was found to be predictive. Tamoxifen (OR = 4.71, 95% CI: 1.77-12.56, p= 0.002), hypertension (OR = 3.48, 95% CI: 1.27-9.52, p= 0.015), and age (OR = 2.35, 95% CI: 1.10-5.02, p= 0.027) remained independent predictors for incontinence in multivariate analyses. CONCLUSION: We found that tamoxifen had increased the risk of urinary incontinence compared to aromatase inhibitors in patients receiving hormone therapy for breast cancer. In addition, we showed that age and hypertension were also independent predictors for UI. In the context of quality of life, we recommend close follow-up of these patients, as drug adherence may be affected in the event of urinary incontinence.

A New Mortality Prediction Model in Advanced Stage Cancer Patients Requiring Hospitalisation while Receiving Active Systemic Therapy.

OBJECTIVE: To predict short and long-term mortality in patients who were admitted to the emergency department and then hospitalised unplanned in medical oncology-ward. STUDY DESIGN:  An observational study. Place and Duration of the Study: Department of Medical Oncology, Tekirdag Namik Kemal University Hospital, Tekirdag, Turkiye, from May 2021 to May 2022. METHODOLOGY: Consecutive patients admitted to the emergency department with unplanned hospitalisation in the oncology ward, were included. Patients receiving treatment with the curative intent, patients hospitalised for febrile neutropenia, and terminally ill patients requiring intensive care unit follow-up at admission  were  excluded  from  the study.  Univariate  and  multivariate  logistic  regression  analyses were used to identify predictive factors for short and long-term mortality-dependent variables. RESULTS: This study included 253 advanced cancer patients. The number of patients who died in the ward within 10 days (short-term mortality) was 28 (11.1%). Ninety patients (35.6%) died afterwards anytime in the ward during the study (long-term mortality). In the multivariate analysis established for short-term mortality, higher ALT (OR = 6.75, 95% CI: 2.09 - 21.85, p=0.001), rapid deterioration in performance status (OR = 5.49, 95% CI: 1.81-16.67, p=0.003), higher CRP (OR = 5.86, 95% CI: 1.20-28.53, p=0.029), higher procalcitonin (OR = 7.94, 95% CI: 0.99 - 63.82, p=0.051), and higher lactate (OR = 2.47, 95% CI: 0.94-6.51, p=0.067) showed significant predictive features. CONCLUSION: The decision of whether to continue treatment or not is challenging in cancer patients who require unplanned hospitalisation while receiving palliative systemic therapy. New mortality estimation models can be used in making the transition from life-long to palliative treatments. KEY WORD: Mortality prediction, Hospitalisation, Estimation of survival, Chemotherapy.

A logarithmic model for hormone receptor-positive and breast cancer patients treated with neoadjuvant chemotherapy.

OBJECTIVE: The aim of this study was to investigate the predictive importance of the previously validated log(ER)*log(PgR)/Ki-67 predictive model in a larger patient population. METHODS: Patients with hormone receptor positive/HER-2 negative and clinical node positive before chemotherapy were included. Log(ER)*log(PgR)/Ki-67 values of the patients were determined, and the ideal cutoff value was calculated using a receiver operating characteristic curve analysis. It was analyzed with a logistic regression model along with other clinical and pathological characteristics. RESULTS: A total of 181 patients were included in the study. The ideal cutoff value for pathological response was 0.12 (area under the curve=0.585, p=0.032). In the univariate analysis, no statistical correlation was observed between luminal subtype (p=0.294), histological type (p=0.238), clinical t-stage (p=0.927), progesterone receptor level (p=0.261), Ki-67 cutoff value (p=0.425), and pathological complete response. There was a positive relationship between numerical increase in age and residual disease. As the grade of the patients increased, the probability of residual disease decreased. Patients with log(ER)*log(PgR)/Ki-67 above 0.12 had an approximately threefold increased risk of residual disease when compared to patients with 0.12 and below (odds ratio: 3.17, 95% confidence interval: 1.48-6.75, p=0.003). When age, grade, and logarithmic formula were assessed together, the logarithmic formula maintained its statistical significance (odds ratio: 2.47, 95% confidence interval: 1.07-5.69, p=0.034). CONCLUSION: In hormone receptor-positive breast cancer patients receiving neoadjuvant chemotherapy, the logarithmic model has been shown in a larger patient population to be an inexpensive, easy, and rapidly applicable predictive marker that can be used to predict response.

A logarithmic model for hormone receptor-positive and breast cancer patients treated with neoadjuvant chemotherapy

SUMMARY OBJECTIVE: The aim of this study was to investigate the predictive importance of the previously validated log(ER)*log(PgR)/Ki-67 predictive model in a larger patient population. METHODS: Patients with hormone receptor positive/HER-2 negative and clinical node positive before chemotherapy were included. Log(ER)*log(PgR)/Ki-67 values of the patients were determined, and the ideal cutoff value was calculated using a receiver operating characteristic curve analysis. It was analyzed with a logistic regression model along with other clinical and pathological characteristics. RESULTS: A total of 181 patients were included in the study. The ideal cutoff value for pathological response was 0.12 (area under the curve=0.585, p=0.032). In the univariate analysis, no statistical correlation was observed between luminal subtype (p=0.294), histological type (p=0.238), clinical t-stage (p=0.927), progesterone receptor level (p=0.261), Ki-67 cutoff value (p=0.425), and pathological complete response. There was a positive relationship between numerical increase in age and residual disease. As the grade of the patients increased, the probability of residual disease decreased. Patients with log(ER)*log(PgR)/Ki-67 above 0.12 had an approximately threefold increased risk of residual disease when compared to patients with 0.12 and below (odds ratio: 3.17, 95% confidence interval: 1.48-6.75, p=0.003). When age, grade, and logarithmic formula were assessed together, the logarithmic formula maintained its statistical significance (odds ratio: 2.47, 95% confidence interval: 1.07-5.69, p=0.034). CONCLUSION: In hormone receptor-positive breast cancer patients receiving neoadjuvant chemotherapy, the logarithmic model has been shown in a larger patient population to be an inexpensive, easy, and rapidly applicable predictive marker that can be used to predict response.

Real-life comparison of afatinib and erlotinib in non-small cell lung cancer with rare EGFR exon 18 and exon 20 mutations: a Turkish Oncology Group (TOG) study.

OBJECTIVES: To compare the survival of first- and second-generation tyrosine kinase inhibitors (TKIs) in patients with rare EGFR exon 18 and exon 20 mutation-positive non-small cell lung cancer (NSCLC). MATERIALS AND METHODS: We retrospectively evaluated survival characteristics of 125 patients with EGFR exon 18 and exon 20 mutated NSCLC who received erlotinib or afatinib as first line treatment between 2012 and 2021 from 34 oncology centres. Since exon 20 insertion is associated with TKI resistance, these 18 patients were excluded from the study. RESULTS: EGFR exon 18 mutations were seen in 60%, exon 20 mutations in 16%, and complex mutations in 24% of the patients with NSCLC who were evaluated for the study. There were 75 patients in erlotinib treated arm and 50 patients in afatinib arm. Patients treated with erlotinib had progression-free survival time (PFS) of 8.0 months and PFS was 7.0 months in the afatinib arm (p = 0.869), while overall survival time (OS) was 20.0 vs 24.8 months, respectively (p = 0.190). PFS of exon 18 mutated arm was 7.0 months, exon 20 mutated arm was 4.3 months, and complex mutation positive group was 17.3 months, and this was statistically significant (p = 0.036). The longest OS was 32.5 months, seen in the complex mutations group, which was not statistically different than exon 18 and in exon 20 mutated groups (21.0 and 21.2 months, respectively) (p = 0.323). CONCLUSION: In this patient group, especially patients with complex mutations are as sensitive to EGFR TKI treatment similar to classical mutations, and in patients with rare exon 18 and exon 20 EGFR mutation both first- and second-generation EGFR-TKIs should be considered, especially as first- and second-line options.

Prognostic factors of perioperative FLOT regimen in operable gastric and gastroesophageal junction tumors: real-life data (Turkish Oncology Group).

BACKGROUND: Perioperative FLOT regimen is a standard of care in locally advanced operable gastric and GEJ adenocarcinoma. We aimed to determine the efficacy, prognostic factors of perioperative FLOT chemotherapy in real-life gastric and GEJ tumors. METHODS: The data of patients who were treated with perioperative FLOT chemotherapy were retrospectively analyzed from 34 different oncology centers in Turkey. Baseline clinical and demographic characteristics, pretreatment laboratory values, histological and molecular characteristics were recorded. RESULTS: A total of 441 patients were included in the study. The median of age our study population was 60 years. The majority of patients with radiological staging were cT3-4N(+) (89.9%, n = 338). After median 13.5 months (IQR: 8.5-20.5) follow-up, the median overall survival was NR (95% CI, NR to NR), and median disease free survival was 22.9 (95% CI, 18.6 to 27.3) months. The estimated overall survival at 24 months was 62%. Complete pathological response (pCR) and near pCR was achieved in 23.8% of all patients. Patients with lower NLR or PLR have significantly longer median OS (p = 0.007 and p = 0.033, respectively), and patients with lower NLR have significantly longer median DFS (p = 0.039), but PLR level did not affect DFS (p = 0.062). The OS and DFS of patients with better ECOG performance scores and those who could receive FLOT as adjuvant chemotherapy instead of other regimens were found to be better. NLR was found to be independent prognostic factor for OS in the multivariant analysis. At least one adverse event reported in 57.6% of the patients and grade 3-4 toxicity was seen in 23.6% patients. DISCUSSION: Real-life perioperative FLOT regimen in operable gastric and GEJ tumors showed similar oncologic outcomes compared to clinical trials. Better performance status, receiving adjuvant chemotherapy as same regimen, low grade and low NLR and PLR improved outcomes in real-life. However, in multivariate analysis, only NLR affected OS.

Predictors of lymphovascular invasion in estrogen receptor positive/Her-2 negative breast cancer patients treated with neoadjuvant chemotherapy.

BACKGROUND: Lymphovascular invasion (LVI) is considered a high-risk factor for recurrence in early-stage breast cancer, hence examination of LVI in pathological samples is an absolute recommendation. We aim to investigate predictive factors of LVI in preneoadjuvant chemotherapy (NAC) patients with estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) molecular subtypes of breast cancer. METHODS: One hundred and thirty-four patients treated with NAC were included in this study who were ER+/HER2-. The clinical characteristics of the patients, the data obtained from the core needle biopsy before NAC and the LVI status in the pathology that examined after breast surgery were collected. Univariate and multivariate analysis were performed using the logistic regression model. RESULTS: An examination of the association between LVI and clinical-pathological patient characteristics showed that advanced age (>40 years old) (p = 0.021), ductal histology (p = 0.039), and presence of axillary lymph node metastasis (p = 0.005) were predictors of LVI. Independent predictors of LVI in a multivariate logistic model included advanced age (p = 0.037), and the presence of axillary lymph node metastasis prior to NAC (p = 0.006). The median RFS (Recurrence-free survival) time was 22.8 months for all patients. RFS was shorter in patients with LVI (log-rank p = 0.037). DISCUSSION: Independent predictors of LVI are advanced age and lymph node positivity at the time of diagnosis. Our study is the first study that evaluates pre-NAC predictive factors of LVI in ER+/HER2- breast cancer patients treated with NAC.

Comprehensive Analysis of Prognostic Factors in Advanced Gastric Cancer Patients Treated with Chemotherapy.

OBJECTIVE: To evaluate the strongest prognostic factors in advanced gastric cancer. STUDY DESIGN: Observational study. PLACE AND DURATION OF STUDY: Department of Medical Oncology, Tekirdag Namik Kemal University, Tekirdag, Turkey, between March 2012 and April 2022. METHODOLOGY: Adult patients with metastatic cancer who had completed at least two months of chemotherapy, without any other comorbidity were included. Using Kaplan-Meier methodology and Cox regression methods, potential prognostic factors were analysed for overall survival. Two different models were created for multivariate analysis by using statistically significant factors in univariate analysis. RESULTS: The median overall survival in 216 patients was 7.8 months. The univariate analysis showed that body-mass index, performance status, liver metastasis, albumin, gamma-glutamyl transferase, carcinoembryonic antigen, carbohydrate antigen (CA 19-9), neutrophil-lymphocyte ratio (NLR), systemic immune-inflammation index, albumin-to-alkaline phosphatase ratio, sodium-globulin ratio (SGR) prognostic nutritional index (PNI), albumin-bilirubin ratio, and albumin-globulin ratio were associated with survival. In Model 1, which included only laboratory indices, multivariate analyses revealed that NLR (p=0.001), SGR (p=0.025), and PNI (p=0.032) were prognostic for overall survival. In Model 2, established with all parameters, NLR (p=0.003), albumin (p=0.003), performance status (p<0.001), and CA 19-9 (p<0.001) were found to be independent prognostic factors. CONCLUSION: Pretreatment NLR, SGR, PNI, albumin, performance status, and CA 19-9 are strong prognostic factors in patients with advanced gastric cancer. These prognostic factors, which are easily accessible in clinical practice, may be utilised as useful tools for clinicians. KEY WORDS: Gastric cancer, Prognosis, Overall survival, Chemotherapy, Metastasis, Prognostic biomarkers.

Efficacy and safety of trastuzumab emtansine treatment in patients with metastatic HER-2 positive breast cancer: a single center study / Eficacia y seguridad del tratamiento con trastuzumab emtansina en pacientes con cáncer de mama metastásico HER-2 positivo: estudio de un solo centro

Introduction: Trastuzumab emtansine (T-DM1) is one of the effective treatment options in human epidermal growth factor receptor 2 (HER2) positive breast cancer patients. In this study, we aimed to find the effect of T-DM1 on survival, its tolerability and prognostic factors of T-DM1 treatment. Material and methods: The study was designed as a single-center, retrospective study that included patients treated in the oncology department of a university hospital in Turkey. HER2-positive patients with metastatic breast cancer who had a progression response to trastuzumab and taxane treatment and received T-DM1 treatment for at least 2 months between 2016-2022 were included in the study. Adverse events were defined according to the Common Terminology Criteria for Adverse Events v5.0 (CTCAE). Kaplan-Meier methodology and Cox proportional hazard modelling were used for survival analyses. Results: The median progression-free survival (mPFS) for T-DM1 was 10.4 months and the median overall survival (mOS) was 22 months. In the created univariate cox regression model, liver metastasis, ECOG performance status, and pre-treatment serum CA 15-3 were found to be factors associated with PFS. Liver metastasis (HR=2.54, p=0.019), ECOG performance status (HR=4.66, p=0.002), and serum CA 15-3 (HR= 2.55, p=0.041) maintained their statistical significance for PFS in the established multivariate analysis. In the regression analysis for OS, only ECOG performance status (HR= 2.61, p=0.023) was found to be prognostic. While toxicity occurred in 46 (82.1%) of the patients, grade 3-4 toxicity developed in 10 (17.9%) patients. The most common side effects were anemia, thrombocytopenia, fatigue and nausea. Conclusions: T-DM1 is a safe and tolerable agent that prolongs survival. Liver metastasis, ECOG performance status, and pre-treatment serum CA 15-3 levels are independent prognostic factors for patients using T-DM1. (AU)

Introducción: Trastuzumab emtansina (T-DM1) es una de las opciones de tratamiento eficaces en pacientes con cáncer de mama positivo para el receptor 2 del factor de crecimiento epidérmico humano (HER2). En este estudio, nuestro objetivo fue encontrar el efecto de T-DM1 en la supervivencia, su tolerabilidad y los factores pronósticos del tratamiento con T-DM1. Material y métodos: El estudio se diseñó como un estudio retrospectivo unicéntrico que incluyó pacientes tratados en el departamento de oncología de un hospital universitario en Turquía. Se incluyeron en el estudio pacientes HER2 positivas con cáncer de mama metastásico que tuvieron una respuesta progresiva al tratamiento con trastuzumab y taxanos y recibieron tratamiento con T-DM1 durante al menos 2 meses entre 2016 y 2022. Los eventos adversos se definieron de acuerdo con los Criterios de Terminología Común para Eventos Adversos v5.0 (CTCAE). Se utilizaron la metodología de Kaplan-Meier y el modelo de riesgos proporcionales de Cox para los análisis de supervivencia. Resultados: La mediana de supervivencia libre de progresión (mPFS) para T-DM1 fue de 10,4 meses y la mediana de supervivencia general (mOS) fue de 22 meses. En el modelo de regresión de cox univariable creado, se encontró que la metástasis hepática, el estado funcional ECOG y el CA 15-3 sérico previo al tratamiento son factores asociados con la SLP. La metástasis hepática (HR = 2,54, p = 0,019), el estado funcional ECOG (HR = 4,66, p = 0,002) y el suero CA 15-3 (HR = 2,55, p = 0,041) mantuvieron su significación estadística para la SLP en el estudio multivariable establecido. análisis. En el análisis de regresión para OS, solo se encontró que el estado funcional ECOG (HR= 2.61, p=0.023) era pronóstico. Si bien se produjo toxicidad en 46 (82,1 %) de los pacientes, se desarrolló toxicidad de grado 3-4 en 10 (17,9 %) pacientes. Los efectos secundarios más comunes fueron anemia, trombocitopenia, fatiga y náuseas. Conclusiones: . ... . (AU)

Soluble B7H3 level in breast cancer and its relationship with clinicopathological variables and T cell infiltration.

Aim of the study: Although early diagnosis of breast cancer (BC) is often associated with a good prognosis, there is currently no biomarker with high sensitivity serving this purpose. B7H3, a recently identified member of the B7 family, appears to inhibit antitumor immunity. We investigated the soluble B7H3 (sB7H3) level in BC and its relationship with clinicopathological variables and stromal tumor-infiltrating lymphocytes (sTILs). Material and methods: The study, which was designed as a cross-sectional trial between January 2020 and September 2021, included 93 BC patients, 20 patients with benign breast disease (BBD) and 14 healthy volunteers as the control group. Serum sB7H3 levels were measured using the ELISA (enzyme-linked immunosorbent assay) method and sTILs were measured by immunohistochemistry using Tru-cut biopsy materials. Results: sB7H3 levels in BC patients were significantly higher than those in patients with BBD and healthy volunteers. Receiver operating characteristic curve analysis results showed that sB7H3 level may be a potential biomarker for distinguishing patients with BC from those with BBD (AUC: 0.807; sensitivity: 0.786; specificity: 0.706) and from healthy volunteers (AUC: 0.731; sensitivity: 0.700; specificity: 0.692). Conclusions: To the best of our knowledge, the present study is the first to investigate the relationship between sB7H3 and disease parameters in BC. We found that sB7H3 may be a clinically practical and meaningful biomarker in differentiating BC from BBD. In order to evaluate the relationship of B7H3 with clinical variables in BC, and especially with sTILs, tissue-based studies with higher numbers of patients are needed.

Immunogenicity and safety of the CoronaVac vaccine in patients undergoing treatment for breast and lung cancer.

OBJECTIVE: To compare seroconversion for SARS-CoV-2 receptor-binding domain (RBD) specific IgG positivity against two doses of the CoronaVac vaccine in breast and lung cancer patients receiving systemic therapy, to determine the factors affecting seropositivity, and to observe long-term results up to a secondary booster vaccine. RESULTS: The analysis included 201 cancer patients (99 breasts, 102 lungs; median age: 59 years (range: 28-92), 42.3 % men) and 97 controls (median age: 62 years (range: 24-87), 38.1 % men). The seropositivity rate for RBD IgG after 2 doses of vaccine in the cancer group was 81.6 % (n=164) and 93.8 % (n=91) in the control group (p=0.005). The median IgG titer of cancer patients was significantly lower than in the control group (338 (IQR, 95-933) AU/mL vs 676 (IQR, 389-1270) AU/mL; p<0.001). Multivariate analysis of all the patients determined that having cancer (OR: 0.303, 95%CI: 0.123-0.750, p=0.010) and being over 60 years of age (OR: 0.447, 95%CI: 0.218-0.917, p=0.028) was associated with a reduced vaccine response. A subgroup analysis of cancer patients revealed that seroconversion was lower in men than in women (75.3 % vs 86.2 %, p=0.049) and lower in ≥60 patients than in <60 patients (75.9 % vs 89.4 %, p=0.014). DISCUSSION AND CONCLUSION: Cancer patients receiving an active systemic therapy with two doses of the CoronaVac vaccine had a lower antibody response than the non-cancer population, and deaths due to COVID-19 may occur in these patients despite the vaccine. Therefore, extensive protective measures should be taken to protect against COVID-19 in cancer patients aged 60 years and older, who have received two doses of the CoronaVac vaccine (Tab. 4, Fig. 4, Ref. 27).

Prospective comparison of the value of CARG, G8, and VES-13 toxicity tools in predicting chemotherapy-related toxicity in older Turkish patients with cancer.

BACKGROUND: In older patients with cancer, it is very important to choose the appropriate treatment because they are at high risk for chemotherapy toxicity. Our study investigated characteristics of Cancer and Aging Research Group (CARG), Geriatric 8 (G8), and Vulnerable Elders Survey (VES-13) screening tools for predicting chemotherapy-related toxicity (CRT) prospectively. MATERIALS AND METHODS: 208 patients aged ≥65 years old for whom chemotherapy was planned to treat non-haematological cancer between February 2021-September 2021 were included in the study. The CARG, G8, and VES-13 toxicity tools were completed by the oncologist through face-to-face interviews before starting the first chemotherapy treatment. CRTs during chemotherapy were evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events v4.03. Logistic regression models, the area under the receiver operating characteristic curve (ROC-AUC), and correlation analyses were used for comparing questionnaires. RESULTS: Median age was 70.4 (range 65-86) years. Of the participants, 103 (49.5%) participants experienced grade 3-5 CRT (32.2% haematological, 28.4% non-haematological) during chemotherapy. ROC-AUC value of CARG was determined as 0.827 (95% CI [confidence interval]: 0.77-0.88, p < 0.001), it was determined as 0.744 (95% CI: 0.68-0.81, p < 0.001) for G8 and 0.726 (95% CI: 0.66-0.80, p < 0.001) for VES-13. In the univariate regression analysis, CARG (OR [odds ratio] = 13.57, 95% CI: 6.0-30.72, p < 0.001), G8 (OR = 3.19, 95% CI: 1.62-6.29, p = 0.001), and VES-13 (OR = 9.5, 95% CI: 5.01-17.89, p < 0.001) were found to be predictive for CRT. The multivariate analysis (included stage, Eastern Cooperative Oncology Group [ECOG] performance status, presence of comorbid disease, platinum-based treatment regimen, taxane-based treatment regimen, CARG, VES-13, G8) showed that CARG (OR = 12.08, 95% CI: 5.11-28.56, p < 0.001), VES-13 (OR = 10.06, 95% CI: 4.92-22.98, p < 0.001), and G8 (OR = 2.20, 95% CI: 1.04-4.69, p = 0.040) screening tools were strong predictors for CRT. The CARG and VES-13 questionnaires were predictive for reducing the initial treatment dose (p = 0.004, p = 0.004, respectively), interruption of treatment (p < 0.001, p < 0.001, respectively), discontinuing treatment (p = 0.002, p = 0.002, respectively), and unexpected hospitalisation (p = 0.012, p = 0.003, respectively). CONCLUSIONS: We showed that all three CARG, G8, and VES-13 questionnaires are helpful tools in the decision-making process for ideal chemotherapy to predict severe CRT; however, CARG and VES-13 questionnaires appear more useful in daily oncology practice than the G8 questionnaire.