Efficacy of first-line CDK 4-6 inhibitors in premenopausal patients with metastatic breast cancer and the effect of dose reduction due to treatment-related neutropenia on efficacy: a Turkish Oncology Group (TOG) study.

The only phase 3 study on the effectiveness of CDK 4-6 inhibitors in first-line treatment in premenopausal patients with hormone receptor (HR) positive, HER2 negative metastatic breast cancer is the MONALEESA-7 study, and data on the effectiveness of palbociclib is limited. Data are also limited regarding the effectiveness of CDK 4-6 inhibitors in patients whose dose was reduced due to neutropenia, the most common side effect of CDK 4-6 inhibitors. In our study, we aimed to evaluate the effectiveness of palbociclib and ribociclib in first-line treatment in patients with premenopausal metastatic breast cancer and the effect of dose reduction due to neutropenia on progression-free survival. Our study is a multicenter, retrospective study, and factors affecting progression-free survival (PFS) were examined in patients diagnosed with metastatic premenopausal breast cancer from 29 different centers and receiving combination therapy containing palbociclib or ribociclib in the metastatic stage. 319 patients were included in the study. The mPFS for patients treated with palbociclib was 26.83 months, and for those receiving ribociclib, the mPFS was 29.86 months (p = 0.924). mPFS was 32.00 months in patients who received a reduced dose, and mPFS was 25.96 months in patients who could take the initial dose, and there was no statistical difference (p = 0.238). Liver metastasis, using a fulvestrant together with a CDK 4-6 inhibitor, ECOG PS 1 was found to be a negative prognostic factor. No new adverse events were observed. In our study, we found PFS over 27 months in patients diagnosed with premenopausal breast cancer with CDK 4-6 inhibitors used in first-line treatment, similar to post-menopausal patients. We did not detect any difference between the effectiveness of the two CDK 4-6 inhibitors, and we showed that there was no decrease in the effectiveness of the CDK 4-6 inhibitor in patients whose dose was reduced due to neutropenia.

The comparison of functional status and health-related parameters in ovarian cancer survivors with healthy controls.

PURPOSE: The primary purpose of this study was to evaluate functional status and health-related parameters in ovarian cancer (OC) survivors and to compare these parameters with healthy controls. The secondary purpose of this study was to compare these parameters in early and advanced OC survivors. METHODS: Thirty-two OC survivors (n = 15 early stage; n = 17 advanced stage) with no evidence/suspicion of cancer recurrence after completing adjuvant local and systemic treatments for at least 12 months and 32 healthy controls were recruited for functional- and health-related assessments. Participants were assessed using the following methods of measuring the following: 6-min walk test (6MWT) for functional exercise capacity, 30-s chair stand test (30 s-CST) for functional fitness and muscle endurance, a handheld dynamometer for peripheral muscle strength, and a handheld dynamometer for lower extremity strength, Medical Micro RPM for respiratory muscle strength, International Physical Activity Questionnaire-Short Form (IPAQ-SF) for physical activity level, and Eastern Cooperative Oncology Group Performance Scale (ECOG-PS) for performance status, Checklist Individual Strength (CIS) for fatigue, Treatment/Gynecological Oncology-Neurotoxicity (FACT/GOG-NTX) for neuropathy, the Hospital Anxiety and Depression Scale (HADS) for anxiety and depression level, and the World Health Organization-Five Well-Being Index (WHO-5) for generic quality of life. RESULTS: All OC survivors underwent surgery and chemotherapy, and only 9.4% received radiotherapy in addition to chemotherapy. The median recurrence-free period post-completion of adjuvant treatments was 24.00 (12.00-75.00) months. OC survivors had lower 6MWT (m) (p < 0.001, r = 1.50), peripheral muscle strength (p = 0.005, r = 0.72), knee extension (p < 0.001, r = 1.54), and respiratory muscle strength (maximal inspiratory pressure) (p < 0.001, r = 1.90) (maximal expiratory pressure) (p < 0.001, r = 1.68) compared to healthy controls. HADS-A (p = 0.005, r = 0.75) and CIS scores (p = 0.025, r = 0.59) were also higher in the OC survivors. Early-stage OC survivors had better 6MWT (m) than advanced-stage OC survivors (p = 0.005, r = 1.83). Peripheral muscle strength was lower in advanced-stage OC survivors (p = 0.013, r = 0.92). FACT/GOG-NTX scores were higher in early-stage OC survivors (p < 0.001, r = 1.42). No significant differences were observed between early- and advanced-stage OC survivors in other measures (p < 0.05). CONCLUSION: The findings suggest functional status, and health-related parameters are negatively affected in OC survivors. Additionally, higher levels of fatigue, neuropathy anxiety, and depression were reported in advanced OC survivors.

The Relationship between Exercise Capacity and Muscle Strength, Physical Activity, Fatigue and Quality of Life in Patients with Cancer Cachexia.

BACKGROUND: Exercise capacity is a significant determinant of mortality for cancer patients, so knowing the possible determinants of exercise capacity will produce physical and psychological benefits for individuals with cancer cachexia. PURPOSE: To investigate the relationship between exercise capacity on peripheric and respiratory muscle strength, physical activity, fatigue and quality of life in subjects with cancer cachexia. METHODS: The study included 31 patients diagnosed with cancer cachexia. Functional capacity was assessed by 6-Minute Walk Test, hand grip strength and proximal muscle mass by hand dynamometer, respiratory muscle strength by the Maximum Expiratory Pressure and Maximum Inspiratory Pressure measurements, physical activity by International Physical Activity Questionnaire Short Form, fatigue by Brief Fatigue Inventory, and quality of life by EORT-QLQ-C30. The relationship between functional capacity and continuous independent variables was determined using Spearman's or Pearson's tests. RESULTS: A strong positive correlation was observed between exercise capacity and expiratory muscle strength (r = 0.75, p < 0.001), activity level (r = 0.68, p < 0.001), and quality of life global health status (r = 0.74, p < 0.001). Conversely, a strong negative correlation was found between exercise capacity and fatigue severity (r = -0.64, p < 0.001). CONCLUSION: Higher exercise capacity in cancer cachexia patients is linked to reduced fatigue, improved respiratory muscle strength, increased physical activity levels, and enhanced quality of life. When designing rehabilitation programs or exercise interventions for individuals with cancer cachexia, it is crucial to assess their exercise capacity and tailor the programs accordingly.

Investigation of the effectiveness of hyperthermic intraperitoneal chemotherapy in experimental colorectal peritoneal metastasis model.

Objectives: In our study, we aimed to (1) create a peritoneal metastasis (PM) model in nude mice, administer intraperitoneal chemotherapy using the peritoneal infusion pump we developed in this model, and (2) compare the efficacy of intraperitoneal chemotherapy using various drugs at different temperatures. Methods: The peritoneal metastasis model was established in nude mice using the CC531 colon carcinoma cell line. Models with peritoneal metastasis (PM) were randomized into four groups of seven animals each: Group 1, control group (n=7); Group 2, normothermic intraperitoneal chemotherapy (NIPEC) with mitomycin C(MMC) (n=7); Group 3, hyperthermic intraperitoneal chemotherapy (HIPEC) with mitomycin C (n=7), and Group 4, NIPEC with 5-fluorouracil (5-FU). Results: Tumor development was achieved in all animals. While the tumor burden decreased significantly in the treatment Group 3 (p=0.034), no significant difference was found in the other groups. In the PM mouse model, hyperthermic intraperitoneal administration of MMC had the highest tumoricidal effect. Conclusions: Our PM model provided a good opportunity to examine the efficacy of HIPEC and intraperitoneal infusion pump (IPIP). In future studies, we plan to evaluate efficacies of different drugs in the PM models we have created.

The effect of low HER2 expression on treatment outcomes in metastatic hormone receptor positive breast cancer patients treated with a combination of a CDK4/6 inhibitor and endocrine therapy: A multicentric retrospective study.

BACKGROUND: CDK4/6 inhibitors combined with endocrine therapy have significantly improved treatment outcomes for metastatic hormone receptor-positive (HR+) breast cancer patients. However, the impact of low HER2 expression on treatment response and progression-free survival (PFS) remains unclear. METHODS: This multicenter retrospective study included 204 HR+ breast cancer patients treated with a combination of CDK4/6 inhibitor and endocrine therapy. HER2-zero disease was detected in 138 (68%) and HER2-low disease in 66 (32%) patients. Treatment-related characteristics and clinical outcomes were analyzed, with a median follow-up of 22 months. RESULTS: The objective response rate (ORR) was 72.7% in the HER2 low group and 66.6% in the HER2 zero group (p = 0.54). Median PFS was not significantly different between the HER2-low and HER2 zero groups (19 months vs.18 months, p = 0.89), although there was a trend toward longer PFS in the HER2-low group for first-line treatment (24 months progression-free survival rate 63% vs 49%). In recurrent disease, the median PFS was 25 months in the HER2-low group and 12 months in the HER2-zero group (p = 0.08), while in de novo metastatic disease, the median PFS was 18 months in the HER2-low group and 27 months in the HER2-zero group (p = 0.16). The order of CDK4/6 inhibitor use and the presence of visceral metastasis were identified as independent variables affecting PFS. CONCLUSION: Low HER2 expression did not significantly impact treatment response or PFS in HR+ breast cancer patients treated with a CDK4/6 inhibitor and endocrine therapy. Because of the conflicting results in the literature, further prospective studies are needed to evaluate the clinical significance of HER2 expression in HR+ breast cancer.

Anna Karenina principle in personalized treatment of bladder cancer according to oncogram: which drug for which patient?

Aim: To evaluate the ex vivo efficacy of chemotherapy, immunotherapy and targeted agents with the oncogram method in patients with bladder cancer and determine the most appropriate personalized treatment agent using immune markers. Materials & methods: Bladder cancer tissues were obtained from each patient. After cultivation, cell cultures were divided into 12 groups for each patient and 11 drugs were administered. Cell viability and immunohistochemistry expression were examined. Results: A good response rate was determined to be a 23% viability drop. The nivolumab good response rate was slightly better in PD-L1-positive patients and the ipilimumab good response rate was slightly better in tumoral CTLA-4-positive cases. Interestingly, the cetuximab response was worse in EGFR-positive cases. Conclusion: Although good responses of drug groups after their ex vivo application by using oncogram were found to be higher than control group, this outcome differed on a per patient basis.

Bladder cancer primary cell cultures were shown to be effective for drug sensitivity and also able to be used ex vivo in the process of determining personalized treatment. The ex vivo efficacy of 11 different agents was evaluated with oncogram in bladder cancer cell cultures obtained from patients. Together with clinicopathological features, evaluation of drug responses detected by oncogram can provide important information for pretreatment drug selection when deciding on individualized treatment.

The prognostic indicator in breast cancer treated with CDK4/6 inhibitors: the prognostic nutritional index.

Aims: The aim of this study was to evaluate the effect of prognostic nutritional index (PNI) on prognosis in patients with hormone receptor-positive, HER2-negative metastatic breast cancer who received CDK4/6 inhibitor + endocrine therapy. Methods: Patients receiving a CDK4/6 inhibitor were evaluated retrospectively. The PNI was calculated as: (10 × serum albumin [g/dl]) + (total lymphocyte count [×109/l] × 5). Results: In a study of 106 patients, a statistically significant survival advantage was observed in the high-PNI group over the low-PNI group (mean overall survival: 28.03 ± 0.487 months vs 22.46 ± 1.14 months; p = 0.013). Conclusion: For the first time in the literature, this study demonstrated the prognostic role of PNI in patients with hormone receptor-positive, HER2-negative metastatic breast cancer treated with CDK4/6 inhibitors.

Major and minor salivary gland cancers: A multicenter retrospective study.

BACKGROUND: Most of the studies on salivary gland cancers are limited for various reasons such as being single-center, small number of patients, including only major or minor SGCs, or only including epidemiological data. METHODS: A total of 37 medical oncology clinics from different regions of Turkey participated in this retrospective-multicenter study. The analyzed data included clinical and demographical features, primary treatment, metastasis localizations, and treatments and includes certain pathologic features. RESULTS: The study included data from a total of 443 SGCs. 56.7% was in major salivary glands and 43.3% was in minor salivary glands. Distant metastasis in the major SGCs was statistically significantly more common than in the minor SGCs, locoregional recurrence was statistically significantly more common in the minor SGCs than in the major SGCs (p = 0.003). CONCLUSIONS: Epidemiological information, metastasis and recurrence patterns, treatment modalities, and survival analysis of the patients over 20 years of follow-up are presented.

Predictors of the 6-min walk test in patients with ovarian cancer.

PURPOSE: To identify the predictors of the 6-min walk test (6MWT) and investigate the relationship between 6MWT, performance status, functional mobility, fatigue, quality of life, neuropathy, physical activity level, and peripheral muscle strength in patients with ovarian cancer (OC). METHODS: Twenty-four patients diagnosed with stage II-III ovarian cancer were included in the study. Patients were assessed using the following measurement methods: 6MWT for walking capacity, Eastern Cooperative Oncology Group Performance Scale (ECOG-PS) for performance status, an armband physical activity monitor for physical activity level, Checklist Individual Strength (CIS) for fatigue, Functional Cancer Treatment Evaluation with Quality of Life-Extreme (FACT-O) for quality of life, Functional Evaluation of Cancer Treatment/Gynecological Oncology-Neurotoxicity (FACT/GOG-NTX) for neuropathy, a hand-held dynamometer for peripheral muscle strength, and 30-s chair-stand test for functional mobility. RESULTS: The mean 6MWT distance was 578.48 ± 115.33 meters. 6MWT distance correlated with ECOG-PS score (r = -0.438, p = 0.032), handgrip strength (r = 0.452, p= 0030), METs (r = 0.414, p = 0.044) 30s-CST (r= 0.417, p= 0.043), and neuropathy score (r = 0.417, p = 0.043) significantly. There was no relationship between 6MWT distance and other parameters (p> 0.05). Multiple linear regression analysis demonstrated that performance status was the sole predictor of 6MWT. CONCLUSION: The walking capacity seems to be associated with performance status, peripheral muscle strength, level of physical activity, functional mobility, and severity of neuropathy in patients with ovarian cancer. Evaluating these may help clinicians to understand factors behind the decreased walking capacity.

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.

GNRI And Conut Scores: Simple Predictors of Sarcopenia in Metastatic Colorectal Cancer Patients.

OBJECTIVE: To evaluate the correlation between sarcopenia and inflammation- and nutrition-based markers in metastatic colorectal cancer (mCRC) patients. MATERIALS AND METHODS: Age, body mass index (BMI), neutrophil/lymphocyte ratio (NLR), modified Glasgow prognostic score (mGPS), prognostic nutrition index (PNI), cachexia index (CIn), skeletal muscle index (SMI), controlling nutritional status (CONUT) score, and geriatric nutritional risk index (GNRI) were evaluated in 185 patients. Ideal cut-off values for the GNRI score were determined with the ROC curve analysis, and the patients were divided into two groups as low and high GNRI. Sarcopenia was diagnosed using CT scanning, the gold standard method. Univariate and multivariate Cox proportional hazard analyses were done based on the above-listed parameters to assess the correlation between sarcopenia and changes in immuno-nutrition and inflammatory response. Kaplan-Meier analysis was also done to evaluate survival. RESULTS: Univariate analysis of the 185 patients based on the EGWSOP 2018 threshold values showed correlation between the presence of sarcopenia and male gender, diagnosed colon cancer, history of metastasectomy, BMI < 24, high mGPS score, PNI score ≥ 45, high CONUT score, and low GNRI score (p < 0.05). In multivariate analysis, low GNRI (HR: 2.40; 95% CI: 1.03-5.544; p = 0.040), and high-CONUT scores (HR: 2.01; 95% CI: 1.06-3.73; p = 0.029) were identified as independent prognostic factors for the presence of sarcopenia. CONCLUSION: GNRI and CONUT scores are elementary and practical predictors for sarcopenia, a condition which is associated with poor outcomes in mCRC patients.

Evaluation of hereditary/familial breast cancer patients with multigene targeted next generation sequencing panel and MLPA analysis in Turkey.

Breast cancer, a worldwide leading cause of cancer in women, may occur in familial cases. Germline mutations in BRCA1/2 genes are responsible for 15% of the familial cases. With the power of next generation sequencing (NGS) analysis, it is possible to analyze genes related to hereditary susceptibility to breast cancer and investigate the genetic etiology more thoroughly. In this study, we investigated 30 genes identified frequent pathogenic alleles in Turkish population. The study includes 495 unrelated individuals diagnosed with breast cancer who are selected for genetic testing according to NCCN criteria for hereditary breast cancer. All patients were analyzed by NGS for BRCA1/2 genes. Deletion/duplication investigation by Multiplex ligation-dependent probe amplification (MLPA) and massive sequencing of 30 breast cancer-related genes (Oncorisk Gene Panel) were performed in a stepwise manner. BRCA1/2 variants are the most frequent pathogenic variants which are found in 45 of 495 (9.1%) patients. Four previously unreported, novel, pathogenic variants of BRCA2 gene are identified. In four cases, exonic deletions of BRCA1/2 genes are determined and there is no duplication of these genes. NGS panel investigation involving other moderate-high risk genes contributed genetic diagnosis in an extra 39 out of 419 (9.3%) cases. Our study presents the cost effectiveness of the gene panel approach. We suggest that gene panels should be the first-tier genetic testing for hereditary breast cancer and MLPA analysis of BRCA1/2 genes should be investigated as a complementary method of NGS analysis.

Association of illness perception with chemotherapy-induced nausea and vomiting: a Turkish Oncology Group (TOG) study.

Chemotherapy-induced nausea and vomiting (CINV) may be linked to the psychological status of cancer patients. Therefore, the authors aimed to better understand the underlying risk factors for CINV using the Brief Illness Perception Questionnaire. A total of 238 patients were recruited during three cycles of chemotherapy. Patient, disease and treatment characteristics were noted at the onset of chemotherapy. The Brief Illness Perception Questionnaire was administered face-to-face prior to chemotherapy. The relationship between illness perceptions and CINV was analyzed using Spearman's rank correlation. Positive illness perception parameters, including personal and treatment control, were negatively correlated, whereas negative illness perception parameters, including consequences, timeline, identity, concern and emotions, were positively correlated with CINV after adjusting for age, sex and emetogenic potential of chemotherapy (p < 0.001). Illness perception may be an underlying risk factor for CINV.

Factors influencing physical activity in patients with colorectal cancer.

BACKGROUND: Physical activity (PA) is a modifiable health behaviour in patients with colorectal cancer (CRC). Knowing the possible predictors of PA will contribute to producing physical and psychological benefits for CRC patients. OBJECTIVE: To investigate the factors that influence PA in patients with CRC. METHODS: This cross-sectional study was conducted with 47 participants with CRC. Demographic and clinical characteristics, neuropathic pain (Douleur Neuropathique 4 (DN4)), peripheral muscle strength (knee extensor and flexor, hip extensor and flexor, and ankle dorsiflexor muscle strength), balance (Balance Master System (BMS) and Berg Balance Scale (BBS)), fatigue (Brief Fatigue Inventory (BFI)), PA (International PA Questionnaire Short Form (IPAQ-SF)), and quality of life (36-item Short Form Health Survey (SF-36)) were evaluated. Multiple linear regression analysis was used to determine the variables that have the greatest influence on PA. RESULTS: IPAQ-SF score had moderate correlations with knee extensor muscle strength (r = 0.310, p = 0.034), BBS (r = 0.361, p = 0.013), and limit of stability test (movement velocity) score (r = 0.385, p = 0.008), BFI- severity of fatigue (r = - 0.488, p = 0.001), impact of fatigue on daily functioning (r = - 0.421, p = 0.003), and the SF-36 sub-parameters (role limitations due to physical health problems, physical functioning, general health perceptions and vitality) (p < 0.05). Role limitations due to physical problems, knee extensor muscle strength, and severity of fatigue had the greatest influence on PA in patients with CRC with explaining 43% of the variance in PA. CONCLUSIONS: This study suggests that quality of life, knee extensor muscle strength, and fatigue have the greatest influence on PA in patients with CRC.

Worse patient-physician relationship is associated with more fear of cancer recurrence (Deimos Study): A study of the Palliative Care Working Committee of the Turkish Oncology Group (TOG).

OBJECTIVE: Fear of cancer recurrence (FCR) is an important psychological trauma associated with reduction in the quality of life, disruptions in the level of adjustment, emotional distress and anxiety. The purpose of the study was to evaluate the impact of patient-physician relationship on FCR. METHODS: The study was designed as a multicentre survey study. The cancer survivors, who were under remission, were evaluated with structured questionnaires. Patient-physician relationship (PPR) scale in which higher scores indicate better relationship and FCR inventory was used. RESULTS: Between January and April 2019, 1,580 patients were evaluated. The median age was 57.0 (19-88), and 66% were female. There was high level of FCR scores in 51% of participants. There was a negative correlation between PPR and FCR scores (r = -.134, p < .001). In multivariate analysis, young age, female gender, history of metastasectomy and worse PPR were associated with high levels of FCR. CONCLUSION: It is the first data showing the adverse impact of worse PPR on FCR. The strategies to improve the PPR should be practised. In addition, the cancer survivors, who are under the risk of FCR, should be evaluated and managed.

The Reliability and Validity of Quality of Life Questionnaire Upper Limb Lymphedema (ULL-27) Turkish Patient With Breast Cancer Related Lymphedema.

Purpose: Breast cancer is the most common cancer amongst women both in Turkey and in the world. Lymphedema, which negatively affects the quality of life, is one of the most prevalent problems reported by breast cancer survivors. Upper Limb Lymphedama 27 (ULL-27) questionnaire is a valid and reliable tool that assesses the quality of life in patients with breast cancer-related lymphedema. Until now, a Turkish-language version was lacking. The aim of this study was to perform a cross-cultural validation and reliability of the Turkish version of the ULL-27 questionnaire. Methods: This cross-sectional study involved forward- backward translation, and cross-cultural adaptation. 81 women (mean age and body mass index 54.96 ± 11.35 years and 29.50 ± 5.74 kg/m2) who had breast cancer related-upper extremity lymphedema were evaluated using the ULL-27 Quality of life questionnaire-Turkish version. Assessment of limb size was quantified by using circumferential limb measurements. European Organization for Research and Treatment of Cancer (EORTC) 30-item Quality of Life Questionnaire and Quality of Life Questionnaire breast cancer-23 (QLQ-BR23) were analyzed by Pearson's correlation analysis with the ULL-27 Turkish Version to indicate the convergent validity. Cronbach's alpha (internal consistency) and exploratory factor analysis were used to assess the questionnaire's reliability. Results: The mean of lymphedema duration and severity were 23.12 ± 30.88 months. Mild lymphedema was reported in 42% (34 people) of the cases included in the study. It was observed that 33.3% (27 people) had moderate lymphedema and 24.7% (20 people) had severe lymphedema. The alpha coefficient (internal consistency) for the Turkish ULL-27 total score was high (alpha = 0.93). Content validity was good because all questions were understandable for all participants (The alpha coefficient for the subgroups of the scale of physical, psychological, social scores, were 0.90, 0.87, and 0.75, respectively). External construct validity was highly confirmed by expected correlations with comparator scales, EORTC-30, and QLQ-BR23 (p < 0.01). Conclusions: The Turkish version of the ULL-27 Questionnaire is a valid and reliable tool for evaluating QoL in women with upper limb lymphedema related to breast cancer.

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.

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).

Perspective of Turkish Medicine Students on Cancer, Cancer Treatments, Palliative Care, and Oncologists (ARES Study): a Study of the Palliative Care Working Committee of the Turkish Oncology Group (TOG).

Cancer is one of the most common causes of death all over the World (Rahib et al. in Cancer Res 74(11):2913-2921, 2014; Silbermann et al. in Ann Oncol 23(Suppl 3):iii15-iii28, 2012). It is crucial to diagnose this disease early by effective screening methods and also it is very important to acknowledge the community on various aspects of this disease such as the treatment methods and palliative care. Not only the oncologists but every medical doctor should be educated well in dealing with cancer patients. Previous studies suggested various opinions on the level of oncology education in medical schools (Pavlidis et al. in Ann Oncol 16(5):840-841, 2005). In this study, the perspectives of medical students on cancer, its treatment, palliative care, and the oncologists were analyzed in relation to their educational status. A multicenter survey analysis was performed on a total of 4224 medical school students that accepted to enter this study in Turkey. After the questions about the demographical characteristics of the students, their perspectives on the definition, diagnosis, screening, and treatment methods of cancer and their way of understanding metastatic disease as well as palliative care were analyzed. The questionnaire includes questions with answers and a scoring system of Likert type 5 (absolutely disagree = 1, completely agree = 5). In the last part of the questionnaire, there were some words to detect what the words "cancer" and "oncologist" meant for the students. The participant students were analyzed in two study groups; "group 1" (n = 1.255) were phases I and II students that had never attended an oncology lesson, and "group 2" (n = 2.969) were phases III to VI students that had attended oncology lessons in the medical school. SPSS v17 was used for the database and statistical analyses. A value of p < 0.05 was noted as statistically significant. Group 1 defined cancer as a contagious disease (p = 0.00025), they believed that early diagnosis was never possible (p = 0.042), all people with a diagnosis of cancer would certainly die (p = 0.044), and chemotherapy was not successful in a metastatic disease (p = 0.003) as compared to group 2. The rate of the students that believed gastric cancer screening was a part of the national screening policy was significantly more in group 1 than in group 2 (p = 0.00014). Group 2 had a higher anxiety level for themselves or their family members to become a cancer patient. Most of the students in both groups defined medical oncologists as warriors (57% in group 1 and 40% in group 2; p = 0.097), and cancer was reminding them of "death" (54% in group 1 and 48% in group 2; p = 0.102). This study suggested that oncology education was useful for the students' understanding of cancer and related issues; however, the level of oncology education should be improved in medical schools in Turkey. This would be helpful for medical doctors to cope with many aspects of cancer as a major health care problem in this country.

Effectiveness of Kinesio Taping on Anastomotic Regions in Patients with Breast Cancer-Related Lymphedema: A Randomized Controlled Pilot Study.

Background: The purpose of the study was to investigate the effect of using Kinesio Taping® (KT) on anastomotic regions along with complex decongestive physiotherapy (CDP) in patients with breast cancer-related lymphedema (BCRL). Methods and Results: Patients with unilateral BCRL were divided into two groups in this randomized controlled study: Group 1 (CDP, n = 14) and Group 2 (CDP+ KT, n = 18). Assessment of limb size was quantified by using circumferential limb measurements and then calculated for each segment by using the frustum formula. CDP included manual lymphatic drainage, compression bandages, exercises, and skin care. KT was applied to lymphatic anastomosis. All patients received treatment for 1 hour per day, 5 days per week for 4 weeks. The outcome measure was difference in the reduction of limb volumes between the groups. There was a significant difference in both groups before and after treatment (p < 0.05), but there was no significant difference between the two groups regarding changes in limb volume (p > 0.05). Conclusion: The results suggest that applying KT to lymphatic anastomotic regions is not effective in reducing limb volume in the management of BCRL.

Can Inflammatory and Nutritional Serum Markers Predict Chemotherapy Outcomes and Survival in Advanced Stage Nonsmall Cell Lung Cancer Patients?

Purpose. To determine the values of prognostic nutritional and inflammatory markers in chemotherapy outcomes and survival in the patients with advanced nonsmall cell lung cancer (NSCLC) and also in the secondary malnutrition and cachexia. Methods. Twenty-five patients with diagnosis of aNSCLC were registered for the prospective study. Malnutrition was determined by the Subjective Global Assessment (SGA) and performance status by criteria of the Eastern Cooperative Oncology Group (ECOG). Before treatment, serum levels of albumin, prealbumin, vitamin D, zinc (Zn), C-reactive protein (CRP), IL-6, IL-1 ß, TNF-α, lipoprotein lipase (LPL), and the Glasgow Prognostic Score (GPS) were recorded. Patients were followed prospectively for treatment outcomes and survival. Results. Due to the deaths of 18 patients during the 4-month follow-up period, no adequate measurements of inflammatory and nutritional markers could be performed. However, seven patients completed the treatment period and evaluations of these markers could be performed during the three periods. Eighty-four percent of patients were male with a mean age of 63.3 ± 8.7 years. Evaluation of the malnutrition by SGA showed that 5 (20%) patients were well nourished (A), 12(48%) were moderately malnourished (B), and 8(32%) were severely malnourished (C). Low levels of serum albumin (<3.5g/dl), prealbumin (<20 mg/ml), 25-hydroxycholecalciferol (<30 ng/ml), and Zn (<70mg/ml) were detected in 15(60%), 17(68%), 24 (96%), and 22 (88%) patients, respectively. Elevated levels of CRP (≥10 mg/L), IL6 (≥18pg/ml), TNF-α (≥24pg/ml), IL-1ß (≥10pg/ml), and LPL (<12pg/ml) were found in 24 (96%), 11(44%), 9(36), 13(52%), and 11(44%) patients, respectively. Moderate and severe malnutrition, acute phase response, and reduced survival were determined in patients with NCSLC. In 7 patients that completed the treatment period, there was an association between elevated serum levels of IL-6, IL-1ß, TNF-α, CRP, and LPL and also the reduced serum levels of albumin, prealbumin, Zn, vitamin D, and GPS, respectively. Similarly, Friedman analysis indicated that prealbumin significantly increased (p=0.007) in the follow-up period. But the serum levels of CRP (mean 37.3±22.3; Wilcoxon test P=0.368) in the seven patients were lower than those of the 18 patients that expired (mean 75.82±56.2). Conclusion. Malnutrition and cachexia negatively influence oncological outcomes in patients with NSCLC. These nutritional/inflammatory markers may be useful for selection of high risk and reduced survival in patients with aNSCLC undergoing adjuvant chemotherapy.