ABSTRACT
OBJECTIVES: Head and neck cancers (HNCs) represent a significant global health concern due to high morbidity and mortality rates. Despite therapeutic advances, the prognosis for advanced or recurrent cases remains challenging. Nivolumab obtained approval for recurrent or metastatic HNC based on the Phase III CheckMate 141 trial. This study aimed to evaluate the real-world outcomes of nivolumab in patients with non-nasopharyngeal HNC. DESIGN: In this multicenter retrospective study, we analyzed 124 patients with recurrent or metastatic non-nasopharyngeal HNC who received nivolumab in the second-line setting and beyond. Data were collected from 20 different cancer centers across Turkey. The effectiveness and safety of the treatment and survival outcomes were evaluated. RESULTS: Nivolumab exhibited favorable clinical responses, yielding an objective response rate of 29.9% and a disease control rate of 55.7%. Safety assessments revealed a generally well-tolerated profile, with no instances of treatment discontinuation or mortality due to side effects. Survival analysis disclosed a median overall survival (OS) of 11.8 (95% CI 8.4-15.2) months. Multivariate analysis revealed that ECOG-PS ≥ 1 (HR: 1.64, p = 0.045), laryngeal location (HR: 0.531, p = 0.024), and neutrophil-to-lymphocyte ratio > 3.5 (HR: 1.97, p = 0.007) were independent predictors of OS. CONCLUSIONS: Nivolumab is an effective and safe treatment option for patients with recurrent or metastatic non-nasopharyngeal HNC in real-world settings. Further studies are needed on factors affecting response to treatment and survival outcomes.
ABSTRACT
OBJECTIVE: The prognosis of breast cancer (BC) is determined directly based on the stage of disease at the time of diagnosis. Proliferative breast lesions (PBLs) are an important risk factor for BC development. The risk of developing BC varies according to the presence of extent of proliferation in the breast lesions. We aimed to investigate the effect of BC risk factors on the PBLs in this study. MATERIALS AND METHODS: Patients who visited the surgical clinic of the university during the past 6 years who presented with PBLs with or without atypia by fine/core needle aspiration biopsy were included in this study. The relationship between PBLs and BC risk factors such as the age, mass size, Body Mass index (BMI), smoking, sports activity, BC family history, the use of hormone replacement therapy, number of pregnancies, and the duration of breastfeeding were compared. RESULTS: A total of 74 (96.1%) of all patients were women and three were men. The median age of the patients was 38 (range: 19-74) years; the cut-off value of age was 35.5 years. The mean age of patients with PBL-with atypia (PBL-WA) was higher (p=0.005) in the malignant group based on the final pathology and radiological imaging features (for both, p<0.001). The mean size of the mass was large at 2.53±1.33 (1-6) cm; and the cut-off value of the tumor size was 2.5 cm. The mean size was greater in the PBL-WA patients (p=0.171) in the malignant group based on the final pathology and radiological characteristic (respectively, p=0.004 and p=0.016). The mean BMI was 26.8±4.4 kg/m2 (18.8-35.1) and the cut-off value was 25.4 kg/m2. BMI was greater in the PBL-WA group and in the malignant group based on the final pathology (respectively, p=0.002 and p=0.001). Smoking was positive in 66.2% (n=51) of the patients, and it was high in the PBL-WA patients (p=0.001). The percentage of patients with no sports activity was 63.6% (n=49), while it was 20.8% (n=16) for those with once a week sports activity and 15.6% (n=12) for those with twice a week activity. There was family history of BC in 16.9% (n=13) of all patients. The number of positive cases of family history of BC was greater in the malignant group (p=0.001). Hormone replacement therapy was recorded in 11.7% (n=9) of the patients. The mean numbers of pregnancies (2.1±2.4) and breastfeeding duration (32.5±37.4 months) were low in the benign groups due to the relatively lower average age of the patients. CONCLUSION: Based on our analysis, age is an extremely important aspect for assessing PBLs. The age of the patient was statistically significantly greater in the patients with malignant lesions in all groups. The factors lesion size, BMI, smoking habit, and BC family history were also more frequent in the malignant groups. The rate of sports activity was lower in the malignant groups. Thus, it is necessary to evaluate patients individually when evaluating PBLs. It is recommended to evaluate PBLs together with BC risk factors for the better understanding.
