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Purpose@#We aimed to evaluate whether the addition of pemetrexed is effective in improving progression-free survival (PFS) in epidermal growth factor receptor (EGFR)–mutated patients with or without concomitant alterations. @*Materials and Methods@#This multicenter clinical trial was conducted in China from June 15, 2018, to May 31, 2019. A total of 92 non–small cell lung cancer (NSCLC) patients harboring EGFR-sensitive mutations were included and divided into concomitant and non-concomitant groups. Patients in each group were randomly treated with EGFR–tyrosine kinase inhibitor (TKI) monotherapy or EGFR-TKI combined with pemetrexed in a ratio of 1:1. PFS was recorded as the primary endpoint. @*Results@#The overall median PFS of this cohort was 10.1 months. There were no significant differences in PFS between patients with and without concomitant and between patients received TKI monotherapy and TKI combined with pemetrexed (p=0.210 and p=0.085, respectively). Stratification analysis indicated that patients received TKI monotherapy had a significantly longer PFS in non-concomitant group than that in concomitant group (p=0.002). In concomitant group, patients received TKI combined with pemetrexed had a significantly longer PFS than patients received TKI monotherapy (p=0.013). Molecular dynamic analysis showed rapidly emerging EGFR T790M in patients received TKI monotherapy. EGFR mutation abundance decreased in patients received TKI combined chemotherapy, which supports better efficacy for a TKI combined chemotherapy as compared to TKI monotherapy. A good correlation between therapeutic efficacy and a change in circulating tumor DNA (ctDNA) status was found in 66% of patients, supporting the guiding role of ctDNA minimal residual disease (MRD) in NSCLC treatment. @*Conclusion@#EGFR-TKI monotherapy is applicable to EGFR-sensitive patients without concomitant alterations, while a TKI combined chemotherapy is applicable to EGFR-sensitive patients with concomitant alterations. CtDNA MRD may be a potential biomarker for predicting therapeutic efficacy.
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Objective:To investigate the clinical value of neuron specific enolase (NSE) and bispectral index (BIS ) in predicting the neurological prognosis in patients with severe intracerebral hemorrhage.Methods:Patients with severe intracerebral hemorrhage admitted to the ICU of Xiaolan Hospital of Southern Medical University from January 2019 to December 2020 were selected, and serum NSE detection and BIS monitoring were performed at an early stage. According to the Glasgow outcome scale (GOS) at 90 days after intracerebral hemorrhage, the patients were divided into the good neurologic prognosis group (GOS 4-5) and poor neurologic prognosis group (GOS 1-3). The levels of NSE and BIS between the two groups were compared. Receiver operating characteristic (ROC) curve and area under the curve (AUC) were used to evaluate the predictive value of NSE, BIS and their combination in predicting neurological prognosis.Results:A total of 126 patients with severe intracerebral hemorrhage were enrolled in this study, and 32 patients (25.4%) had poor neurological prognosis. The level of NSC in the poor neurological prognosis group was significantly higher than that in the good neurologic prognosis group [28 (13.7, 50.4) ng/mL vs. 13.5 (9.6, 18.5) ng/mL, P < 0.05], while the BIS level was significantly lower than that in the good neurologic prognosis group [32 (25.2, 45) vs. 55 (48, 62.2), P <0.05]. For detection of poor neurologic outcome in patients with severe intracerebral hemorrhage, NSE and BIS yielded the AUC values of 0.768 (0.685, 0.839) and 0.866 (0.793, 0.920), respectively, with cut-off values of 21.7 ng/mL and 47, respectively. The combination of NSE and BIS yielded a remarkably higher AUC value of 0.927 (0.867, 0.966) for predicting poor neurologic outcome than each index alone ( P<0.05). Conclusions:Early monitoring of NSE and BIS can effectively predict the neurological prognosis of patients with severe intracerebral hemorrhage, and the combination of NSE and BIS can further improve the prediction efficiency.
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Objective To evaluate the clinical efficacy and safety of capecitabine continuous maintenance in treatment of re-currence of triple-negative breast cancer,which had responded to combined chemoradiotherapy.Methods The triple-negative breast cancer was defined as negative of ER,PR and HER2.A total of 46 patients of triple-negative breast cancer were divided into the treatment group (23 patients)and the control group (23 patients).The treatment group was given capecitabine continuous mainte-nance after 6 cycles of chemotherapy.The control group was given 6 cycles of combined chemotherapy only.The clinical efficacy and safety was evaluated between the two groups.Results The PR,PD,RR,and DCR in the treatment group were significantly higher than those in the control group(P 0.05).Conclusion Capecitabine continuous maintenance after combined chemoradiotherapy in treatment of recurrence of triple-neg-ative breast cancer is more effective,lower toxicity and tolerable.
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or =70years of age) with advanced non-small-cell lung cancer. Single agent vinorelbine should be selective chemotherapy in elderly patients with advanced non-small-cell lung cancer.