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 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.

INTRODUCTION: Male 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. METHODS: This 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. RESULTS: A 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. DISCUSSION: This 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.

Is virtual nutritional counseling efficacious for cancer patients during the COVID-19 pandemic?

This study investigates the outcomes of virtual nutritional counseling (VNC) for oncology patients during the Covid-19 pandemic. Our study evaluated the nutritional status data of cancer patients at the baseline and after VNC. An oncology dietitian evaluated the patients by video calling each patient via WhatsApp and sent an individual nutrition diet plan and recommendations via e-mail. Patient-Generated Subjective Global Assessment (PG-SGA) was used as a screening and evaluation tool to assess nutritional status. A total of 157 patients with a mean age of 55.8 ± 14.7 (r = 19-89) were included in the study. Researchers detected at least one nutrition-related sign in 77.7% of patients. After the VNC and based on the final PG-SGA assessments, 62.2% of the patients whose baseline PG-SGA Score-B improved to Score-A, 12.5% with a baseline PG-SGA Score-C improved to Score-A and 54.2% with a baseline Score-C improved to a Score-B (χ2 = 55,000, P < 0.001). Based on the number of VNCs, the improvement in malnutrition status following two sessions and three or more sessions was found to be 17.6% and 35.7%, respectively (P < 0.001). Our results confirm that VNC can improve the nutritional status of cancer patients. Hence, nutritional counseling should be an integral part of oncological treatment.

Efficacy of subsequent treatments in patients with hormone-positive advanced breast cancer who had disease progression under CDK 4/6 inhibitor therapy.

BACKGROUND: There is no standard treatment recommended at category 1 level in international guidelines for subsequent therapy after cyclin-dependent kinase 4/6 inhibitor (CDK4/6) based therapy. We aimed to evaluate which subsequent treatment oncologists prefer in patients with disease progression under CDKi. In addition, we aimed to show the effectiveness of systemic treatments after CDKi and whether there is a survival difference between hormonal treatments (monotherapy vs. mTOR-based). METHODS: A total of 609 patients from 53 centers were included in the study. Progression-free-survivals (PFS) of subsequent treatments (chemotherapy (CT, n:434) or endocrine therapy (ET, n:175)) after CDKi were calculated. Patients were evaluated in three groups as those who received CDKi in first-line (group A, n:202), second-line (group B, n: 153) and ≥ 3rd-line (group C, n: 254). PFS was compared according to the use of ET and CT. In addition, ET was compared as monotherapy versus everolimus-based combination therapy. RESULTS: The median duration of CDKi in the ET arms of Group A, B, and C was 17.0, 11.0, and 8.5 months in respectively; it was 9.0, 7.0, and 5.0 months in the CT arm. Median PFS after CDKi was 9.5 (5.0-14.0) months in the ET arm of group A, and 5.3 (3.9-6.8) months in the CT arm (p = 0.073). It was 6.7 (5.8-7.7) months in the ET arm of group B, and 5.7 (4.6-6.7) months in the CT arm (p = 0.311). It was 5.3 (2.5-8.0) months in the ET arm of group C and 4.0 (3.5-4.6) months in the CT arm (p = 0.434). Patients who received ET after CDKi were compared as those who received everolimus-based combination therapy versus those who received monotherapy ET: the median PFS in group A, B, and C was 11.0 vs. 5.9 (p = 0.047), 6.7 vs. 5.0 (p = 0.164), 6.7 vs. 3.9 (p = 0.763) months. CONCLUSION: Physicians preferred CT rather than ET in patients with early progression under CDKi. It has been shown that subsequent ET after CDKi can be as effective as CT. It was also observed that better PFS could be achieved with the subsequent everolimus-based treatments after first-line CDKi compared to monotherapy ET.

Evaluation of Human Epidermal Growth Factor Receptor 2 Overexpression, Clinicopathological Characteristics, and Factors Affecting Survival in Gastric Cancer.

OBJECTIVES: The objective of the study was to evaluate the human epidermal growth factor receptor 2 (HER2) overexpression, clinicopathological features, and factors affecting survival in patients with gastric cancer. METHODS: The study is a retrospective study conducted with 128 cases of gastric cancer who were admitted to Sisli Hamidiye Etfal Training and Research Hospital between 2005 and 2012. Patients' demographic characteristics, performance score, tumor localization, information about surgery, HER2 measurements, histopathological characteristics, stage, treatment features, metastasis sites, and overall survival time were obtained from medical records. Immunohistochemical analysis was performed for HER2 scoring. RESULTS: There were 89 (69.5%) men and 39 (30.5%) women in the study group, and the median age of the patients was 64 years. The median survival time of the patients was 24.43 months. The survival rate of the patients was calculated as 35.4±5.9%. Overall survival time was found to be shorter in the group with higher HER2 levels and also those with advanced-stage cancer. The survival rate was found to be significantly lower in patients with perineural invasion and advanced stage. However, the survival rate was not associated with lymphovascular invasion, surgical margin involvement, and HER2 levels. In the multivariate Cox Regression analysis performed to assess the effects of gender, histological subtype, stage, and surgical margin on overall survival, disease stage was found to be the only factor effective on survival. Gender, histological subtype, and the surgical margin did not affect prognosis. CONCLUSION: The survival rate in gastric cancers was found to be lower in those with advanced-stage disease. Higher HER2 level and the disease stage were associated with shorter overall survival time.