RESUMO
BACKGROUND: Osimertinib is a recommended treatment for advanced non-small-cell lung cancer (NSCLC) with an epidermal growth factor receptor (EGFR) mutation and as adjuvant treatment for resected EGFR-mutated NSCLC. EGFR-tyrosine kinase inhibitors have shown preliminary efficacy in unresectable stage III EGFR-mutated NSCLC. METHODS: In this phase 3, double-blind, placebo-controlled trial, we randomly assigned patients with unresectable EGFR-mutated stage III NSCLC without progression during or after chemoradiotherapy to receive osimertinib or placebo until disease progression occurred (as assessed by blinded independent central review) or the regimen was discontinued. The primary end point was progression-free survival as assessed by blinded independent central review. RESULTS: A total of 216 patients who had undergone chemoradiotherapy were randomly assigned to receive osimertinib (143 patients) or placebo (73 patients). Osimertinib resulted in a significant progression-free survival benefit as compared with placebo: the median progression-free survival was 39.1 months with osimertinib versus 5.6 months with placebo, with a hazard ratio for disease progression or death of 0.16 (95% confidence interval [CI], 0.10 to 0.24; P<0.001). The percentage of patients who were alive and progression free at 12 months was 74% (95% CI, 65 to 80) with osimertinib and 22% (95% CI, 13 to 32) with placebo. Interim overall survival data (maturity, 20%) showed 36-month overall survival among 84% of patients with osimertinib (95% CI, 75 to 89) and 74% with placebo (95% CI, 57 to 85), with a hazard ratio for death of 0.81 (95% CI, 0.42 to 1.56; P = 0.53). The incidence of adverse events of grade 3 or higher was 35% in the osimertinib group and 12% in the placebo group; radiation pneumonitis (majority grade, 1 to 2) was reported in 48% and 38%, respectively. No new safety concerns emerged. CONCLUSIONS: Treatment with osimertinib resulted in significantly longer progression-free survival than placebo in patients with unresectable stage III EGFR-mutated NSCLC. (Funded by AstraZeneca; LAURA ClinicalTrials.gov number, NCT03521154.).
RESUMO
Background: Breast cancer is the most common malignancy and remains the first cause of death related to cancer among Vietnamese women, with an incidence of 21,555 cases in 2020. Most breast cancer patients present with invasive disease and relatively large tumor sizes. While oncoplastic surgery (OPS) are commonly applied in Western countries, data on Asian population remains relatively limited. Objective: This study aims to assess the outcomes of level-2 oncoplastic techniques in breast-conserving surgeries at the Vietnam National Cancer Hospital. Methods: From January 2017 to June 2021, a cohort of 257 breast cancer patients who underwent breast-conserving surgery with OPS techniques were examined. Surgical complications, cosmetic outcome, recurrence and survival rates were assessed. Results: The mean age was 47.6±9.4 years, most patients had breast cup sizes B and C. The mean tumor size upon pathological examination was 2.00 ± 0.74 cm. Only 7 cases required reoperation, resulting in a mastectomy rate of 1.17%. The overall complication rate was low at 11.46%, with 9 cases (3.56%) experiencing delayed complications. Cosmetic results were rated as "excellent" in 20.6% and "good" in 60.5%, with a statistically significant difference. The rates of local recurrence, regional recurrence, and distant metastasis at five years were 2.78%, 1.19%, and 2.36%, respectively. Conclusion: The level 2 oncoplastic techniques had low complication rates, favorable oncological outcomes, and cosmetically satisfying results.