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1.
Article in English | MEDLINE | ID: mdl-38847197

ABSTRACT

BACKGROUND: The most important prognostic parameter is staging in colorectal cancers, and tumor budding (TB) is among the independent prognostic parameters that are increasing in significance. Cyclin D1 expression has been associated with poor prognosis as a marker of various tumors. AIMS AND OBJECTIVES: In this study, the aim was to determine the activity of cyclin D1 in colon adenocarcinomas, tumors, and tumor buds and to compare the results with prognostic parameters. MATERIALS AND METHODS: This study included 167 patients who were operated on for colorectal tumors. In subjects, tumor budding was evaluated on hematoxylin and eosin-stained slides, and cyclin D1 was applied immunohistochemically. The cyclin D1 intensity of staining was studied in both tumors and TB and its correlation with prognostic parameters in TB was examined. RESULTS: Lymph node (LN) metastasis was present in 93 (55.7%) of the cases, and distant metastasis in 35 (21%) cases. Tumor budding was present in 152 (91%) of the cases, and high-grade TB was detected in 55 (36.2%). The incidence of TB was higher in patients with LN metastasis (P = 0.02) and in patients with Stages 3 and 4 (P = 0.07). The intensity of cyclin D1 in intermediate and high-grade TB staining was higher. Cyclin D1 staining was more intense in patients with LN metastases and distant metastases as we determined, but it was not statistically significant. CONCLUSION: Thus, based on our study findings, the increased expression of cyclin D1, which is more concentrated in TB than tumors, may indicate a poor prognosis. In contrast, we found no statistically significant correlation between cyclin D activity and prognostic parameters in TB.

2.
Cancer ; 129(1): 118-129, 2023 01 01.
Article in English | MEDLINE | ID: mdl-36308296

ABSTRACT

BACKGROUND: In the EMPOWER-Lung 1 trial (ClinicalTrials.gov, NCT03088540), cemiplimab conferred longer survival than platinum-doublet chemotherapy for advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50%. Patient-reported outcomes were evaluated among trial participants. METHODS: Adults with NSCLC and Eastern Cooperative Oncology Group performance status 0 to 1 were randomly assigned cemiplimab 350 mg every 3 weeks or platinum-doublet chemotherapy. At baseline and day 1 of each treatment cycle, patients were administered the European Organization for Research and Treatment of Cancer Quality of Life-Core 30 (QLQ-C30) and Lung Cancer Module (QLQ-LC13) questionnaires. Mixed-model repeated measures analysis estimated overall change from baseline for PD-L1 ≥50% and intention-to-treat populations. Kaplan-Meier analysis estimated time to definitive deterioration. RESULTS: In PD-L1 ≥50% patients (cemiplimab, n = 283; chemotherapy, n = 280), baseline QLQ-C30 and QLQ-LC13 scores showed moderate-to-high functioning and low symptom burden. Change from baseline favored cemiplimab on global health status/quality of life (GHS/QOL), functioning, and most symptom scales. Risk of definitive deterioration across functioning scales was reduced versus chemotherapy; hazard ratios were 0.48 (95% CI, 0.32-0.71) to 0.63 (95% CI, 0.41-0.96). Cemiplimab showed lower risk of definitive deterioration for disease-related (dyspnea, cough, pain in chest, pain in other body parts, fatigue) and treatment-related symptoms (peripheral neuropathy, alopecia, nausea/vomiting, appetite loss, constipation, diarrhea) (nominal p < .05). Results were similar in the intention-to-treat population. CONCLUSIONS: Results support cemiplimab for first-line therapy of advanced NSCLC from the patient's perspective. Improved survival is accompanied by improvements versus platinum-doublet chemotherapy in GHS/QOL and functioning and reduction in symptom burden.


Subject(s)
Antibodies, Monoclonal, Humanized , Antineoplastic Agents, Immunological , Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Adult , Humans , B7-H1 Antigen , Carcinoma, Non-Small-Cell Lung/drug therapy , Lung , Lung Neoplasms/drug therapy , Pain/etiology , Patient Reported Outcome Measures , Platinum/therapeutic use , Quality of Life , Antibodies, Monoclonal, Humanized/therapeutic use , Antineoplastic Agents, Immunological/therapeutic use
3.
Future Oncol ; 18(10): 1235-1244, 2022 Mar.
Article in English | MEDLINE | ID: mdl-35081732

ABSTRACT

Aim: To compare the seropositivity rate of cancer patients with noncancer controls after inactive SARS-CoV-2 vaccination and evaluate the factors affecting seropositivity. Method: Spike IgG antibodies against SARS-CoV-2 were measured in blood samples of 776 cancer patients and 715 noncancer volunteers. An IgG level ≥50 AU/ml is accepted as seropositive. Results: The seropositivity rate was 85.2% in the patient group and 97.5% in the control group. The seropositivity rate and antibody levels were significantly lower in the patient group (p < 0.001). Age and chemotherapy were associated with lower seropositivity in cancer patients (p < 0.001). Conclusion: This study highlighted the efficacy and safety of the inactivated vaccine in cancer patients. Clinical Trials Registration: NCT04771559 (ClinicalTrials.gov).


Cancer patients are at high risk for infection with SARS-CoV-2 and of developing the associated disease, COVID-19, which therefore puts them in the priority group for vaccination. This study evaluated the efficacy and safety of inactive SARSCoV-2 vaccination, an inactivated virus vaccine, in cancer patients. The immune response rate, defined as seropositivity, was 85.2% in the cancer patient group and 97.5% in the control group. The levels of antibodies, which are blood markers of immune response to the vaccine, were also significantly lower in the patient group, especially in those older than 60 years and receiving chemotherapy. These results highlight the importance of determining the effective vaccine type and dose in cancer patients to protect them from COVID-19 without disrupting their cancer treatment.


Subject(s)
Antibodies, Viral/blood , COVID-19 Vaccines/immunology , COVID-19/prevention & control , Neoplasms/immunology , SARS-CoV-2/immunology , Vaccination , Adult , Aged , Aged, 80 and over , COVID-19 Vaccines/adverse effects , Female , Humans , Male , Middle Aged , Prospective Studies , Vaccines, Inactivated/adverse effects , Vaccines, Inactivated/immunology , Young Adult
4.
Tumori ; 107(6): NP84-NP86, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34082639

ABSTRACT

BACKGROUND: Epidermal growth factor receptor tyrosine kinase inhibitors are effectively being used in the treatment of non-small cell lung cancer. Although most of their adverse effects are mild to moderate, they occasionally can cause life-threatening interstitial lung disease. We aimed to present a case of lung adenocarcinoma successfully re-treated with erlotinib after recovery with effective treatment of erlotinib-induced interstitial lung disease. CASE DESCRIPTION: A 54-year-old nonsmoking woman was diagnosed with metastatic adenocarcinoma of the lung. After progression with first-line chemotherapy, erlotinib 150 mg daily was initiated. On the 45th day of erlotinib treatment, interstitial lung disease occurred and erlotinib was discontinued. Clinical improvement was achieved with dexamethasone treatment and erlotinib was re-initiated. Ten weeks after re-initiation of erlotinib, 100 mg daily partial response was observed. CONCLUSIONS: Incidence of interstitial lung disease is higher in men, smokers, and patients with pulmonary fibrosis. Interstitial lung disease radiologically causes ground-glass opacity and consolidation. The physician should quickly evaluate new respiratory symptoms in patients treated with epidermal growth factor receptor tyrosine kinase inhibitors, discontinue the epidermal growth factor receptor tyrosine kinase inhibitor treatment, and initiate corticosteroids if clinical diagnosis is interstitial lung disease.


Subject(s)
Adenocarcinoma of Lung/drug therapy , Antineoplastic Agents/administration & dosage , Erlotinib Hydrochloride/administration & dosage , Lung Diseases, Interstitial/drug therapy , Lung Neoplasms/drug therapy , Retreatment/methods , Adenocarcinoma of Lung/pathology , Antineoplastic Agents/adverse effects , Female , Humans , Lung Diseases, Interstitial/chemically induced , Lung Diseases, Interstitial/pathology , Lung Neoplasms/pathology , Middle Aged , Remission Induction
5.
Lancet ; 397(10274): 592-604, 2021 02 13.
Article in English | MEDLINE | ID: mdl-33581821

ABSTRACT

BACKGROUND: We aimed to examine cemiplimab, a programmed cell death 1 inhibitor, in the first-line treatment of advanced non-small-cell lung cancer with programmed cell death ligand 1 (PD-L1) of at least 50%. METHODS: In EMPOWER-Lung 1, a multicentre, open-label, global, phase 3 study, eligible patients recruited in 138 clinics from 24 countries (aged ≥18 years with histologically or cytologically confirmed advanced non-small-cell lung cancer, an Eastern Cooperative Oncology Group performance status of 0-1; never-smokers were ineligible) were randomly assigned (1:1) to cemiplimab 350 mg every 3 weeks or platinum-doublet chemotherapy. Crossover from chemotherapy to cemiplimab was allowed following disease progression. Primary endpoints were overall survival and progression-free survival per masked independent review committee. Primary endpoints were assessed in the intention-to-treat population and in a prespecified PD-L1 of at least 50% population (per US Food and Drug Administration request to the sponsor), which consisted of patients with PD-L1 of at least 50% per 22C3 assay done according to instructions for use. Adverse events were assessed in all patients who received at least one dose of the assigned treatment. This study is registered with ClinicalTrials.gov, NCT03088540 and is ongoing. FINDINGS: Between June 27, 2017 and Feb 27, 2020, 710 patients were randomly assigned (intention-to-treat population). In the PD-L1 of at least 50% population, which consisted of 563 patients, median overall survival was not reached (95% CI 17·9-not evaluable) with cemiplimab (n=283) versus 14·2 months (11·2-17·5) with chemotherapy (n=280; hazard ratio [HR] 0·57 [0·42-0·77]; p=0·0002). Median progression-free survival was 8·2 months (6·1-8·8) with cemiplimab versus 5·7 months (4·5-6·2) with chemotherapy (HR 0·54 [0·43-0·68]; p<0·0001). Significant improvements in overall survival and progression-free survival were also observed with cemiplimab in the intention-to-treat population despite a high crossover rate (74%). Grade 3-4 treatment-emergent adverse events occurred in 98 (28%) of 355 patients treated with cemiplimab and 135 (39%) of 342 patients treated with chemotherapy. INTERPRETATION: Cemiplimab monotherapy significantly improved overall survival and progression-free survival compared with chemotherapy in patients with advanced non-small-cell lung cancer with PD-L1 of at least 50%, providing a potential new treatment option for this patient population. FUNDING: Regeneron Pharmaceuticals and Sanofi.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , B7-H1 Antigen/metabolism , Carcinoma, Non-Small-Cell Lung/drug therapy , Immune Checkpoint Inhibitors/therapeutic use , Lung Neoplasms/drug therapy , Aged , Antineoplastic Agents, Immunological/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , B7-H1 Antigen/antagonists & inhibitors , Carboplatin/administration & dosage , Carcinoma, Non-Small-Cell Lung/metabolism , Carcinoma, Non-Small-Cell Lung/pathology , Cisplatin/administration & dosage , Deoxycytidine/administration & dosage , Deoxycytidine/analogs & derivatives , Female , Humans , Lung Neoplasms/metabolism , Male , Middle Aged , Paclitaxel/administration & dosage , Pemetrexed/administration & dosage , Progression-Free Survival , Survival Rate , Gemcitabine
6.
Oncol Res Treat ; 41(9): 545-549, 2018.
Article in English | MEDLINE | ID: mdl-30121640

ABSTRACT

BACKGROUND: The aim of this study was to identify the possible relationship of 5-fluorouracil (5-FU)-related arterial vasoconstriction with urotensin-2 (UT-2), which has a high potential as an endogenic vasoconstrictor. METHODS: We assigned the patients to 1 of 3 groups. Patients in group 1 received a bolus of 5-FU, those in group 2 a continuous infusion (CI) of 5-FU, and those in group 3 no 5-FU, which was also a control group. Pre- and post-treatment UT-2 levels and brachial arterial diameters were measured and recorded in all patients. RESULTS: 132 patients were included in the study. Pre- and post-treatment brachial artery diameters were similar in all groups: in group 1 (3.28 ± 0.52 vs. 3.25 ± 0.44 mm, p = 0.740), in group 2 (3.57 ± 0.47 vs. 3.46 ± 0.45 mm, p = 0.441) and in the control group (3.51 ± 0.52 vs. 3.25 ± 0.44 mm, p = 0.818). Pre- and post-treatment UT-2 levels were significantly different in each group: in group 1 (39.5 ± 30.9 vs. 56.7 ± 27.1 ng/ml, p = 0.0001), in group 2 (37.7 ± 33.7 vs. 62.5 ± 37.7 ng/ml, p = 0.0001) and in the control group (52.9 ± 40.2 vs. 60.8 ± 40.7 ng/ml, p = 0.006). CONCLUSION: Our findings suggest that UT-2 has a high potential as a vasoconstrictor agent in our bodies and its level increases through a bolus or CI 5-FU. Increased UT-2 levels are likely to play a role in 5-FU-related cardiac toxicity pathogenesis.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/adverse effects , Cardiotoxicity/pathology , Fluorouracil/adverse effects , Neoplasms/drug therapy , Urotensins/metabolism , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Brachial Artery/diagnostic imaging , Brachial Artery/drug effects , Brachial Artery/pathology , Cardiotoxicity/diagnosis , Cardiotoxicity/etiology , Electrocardiography , Female , Fluorouracil/administration & dosage , Humans , Infusions, Intravenous , Male , Middle Aged , Ultrasonography , Urotensins/analysis , Vasoconstriction/drug effects , Young Adult
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