Survival data were widely used in oncology clinical trials. The methods used, such as the log-rank test and Cox regression model, should meet the assumption of proportional hazards. However, the survival data with non-proportional hazard (NPH) are also quite usual, which will decrease the power of these methods and conceal the true treatment effect. Therefore, during the trial design, we need to test the proportional hazard assumption and plan different analysis methods for different testing results. This paper introduces some methods that are widely used for proportional hazard testing, and summarizes the application condition, advantages and disadvantages of analysis methods for non-proportional hazard survival data. When the non-proportional hazard occurs, we need to choose the suitable method case by case and to be cautious in the interpretation of the results.
ObjectiveTo investigate the expression and clinical significance of HOXB7 mRNA and protein in colorectal cancer (CRC) tissues.MethodsThe expressions of HOXB7 mRNA were evaluated in 6 cases of adjacent colorectal mucosal (ACRM) tissues and 6 cases of CRC tissues by using RT-PCR. The HOXB7 protein expressions were evaluated in 30 cases of ACRM tissues and 98 cases of CRC tissues by using immunohistochemistry. The correlations between the expression of HOXB7 protein, and the clinicopathologic factors or the patient’ survival were analyzed.ResultsRT-PCR results showed that expression level of HOXB7 mRNA in CRC tissues was significantly higher than that of ACRM tissues (P=0.003). Immunohistochemistry results showed that significantly higher positive-expression rate of HOXB7 protein in CRC tissues compared with ACRM tissues (P<0.05). Positive expression of HOXB7 protein was associated with depth of tumor invasion, lymph node metastasis, and the TNM stage (P<0.05). Kaplan-Meier survival curves showed that positive expression of HOXB7 protein was not inversely correlated with survival of CRC patients (P=0.865).ConclusionPositive expression of HOXB7 protein is a novel biomarker for estimating the progression of CRC, but remains of textual research may be to confirm the significance of HOXB7 protein for prognosis evaluation.
Objective
To make a survival analysis for the stage ⅠA non-small cell lung cancer patients who underwent lobectomy, segmentectomy or wedge resection and to discuss whether the segmentectomy and wedge resection can be used as a conventional operation.
Methods
The clinical data of 474 patients diagnosed with ⅠA non-small cell lung cancer from January 2012 to June 2015 in the First Affiliated Hospital of China Medical University were retrospectively anlyzed. There were 192 males and 282 females with a mean age of 60 years. Their sex, age, histological type, tumor size, surgical pattern, smoking, drinking, survival rate, disease-free survival rate, recurrence rate were compared.
Results
Disease-free survival rate of patients with wedge resection was significantly lower than that of the patients undergoing lobectomy and segmentectomy (P<0.05). When tumor diameter≤19 mm, the disease-free survival rate of patients with wedge resection was lower than that of patients with lobectomy (P=0.006) and segmentectomy (P=0.065). Disease-free survival rate of patients with tumor diameter of 20-<30 mm was significantly lower than that of patients with tumor diameter≤19 mm (P=0.026). Excluding patients with wedge resection, disease-free survival of the patients with lobectomy and segmentectomy and tumor diameter of 20-<30 mm was significantly lower than that of patients with tumor diameter≤19 mm (P=0.036). Patients with wedge resection had significant higher risk of local recurrence than that of patients undergoing lobectomy (P<0.001) and segmentectomy (P=0.002).
Conclusion
StageⅠA non-small cell lung cancer patients undergoing segmentectomy can obtain approximate survival and disease-free survival rate compared with those with lobectomy, especially in patients with tumor diameter≤19 mm. Pulmonary wedge resection as surgical treatment of lung cancer patients must be selected carefully according to the actual situation and surgical purposes.
ObjectiveTo investigate the prognostic relevance of serum triglyceride (TG) levels in patients with anti-melanoma differentiation-associated gene 5 (MDA5) antibody-positive dermatomyositis-associated interstitial lung disease (ILD). Methods A retrospective data collection was conducted on patients diagnosed with anti-MDA5 antibody-positive dermatomyositis-associated ILD at West China Hospital of Sichuan University between February 2017 and July 2021. The clinical data, laboratory tests, and imaging examinations were collected, and the patients were followed up. According to the survival and death status of patients, they were divided into survival group and death group. According to TG levels, the patients were divided into a TG high level group and a TG low level group. We employed Cox proportional hazard models to investigate the variables linked to the mortality of individuals afflicted with anti-MDA5 antibody-positive dermatomyositis-associated ILD. Results A total of 204 patients with anti-MDA5 antibody-positive dermatomyositis-associated ILD were included. Among them, whose age ranged from 30 to 81 years old, with an average of (49.5±11.8) years old, there were 69 males and 135 females, 53 deaths and 151 survivors, 57 cases of rapidly progressive pulmonary interstitial fibrosis (RPILD) and 47 cases of non-RPILD. The results of multivariate Cox regression analysis showed that TG≥1.65 mmol/L, combined with RPILD, combined with dyspnea, age, lactate dehydrogenase≥321 U/L, and albumin<30 g/L were independent factors affecting the long-term prognosis of patients (P<0.05). The Kaplan-Meier method analysis results showed that the survival rate of the TG high level group was lower than that of the TG low level group (P=0.032). Conclusions Elevated TG levels can serve as a clinical indicator of adverse prognosis in patients with dermatomyositis-associated ILD who exhibit positive anti-MDA5 antibody status. Additionally, age, comorbidity with RPILD, combined with dyspnea, lactate dehydrogenase≥321 U/L, and albumin<30 g/L are independent factors contributing to the increased mortality risk among individuals with dermatomyositis-associated ILD who test positive for anti-MDA5 antibody.
Objective To analyze the efficacy of breast-conserving surgery with adjuvant radiation therapy (BCS+RT) vs. mastectomy (MAST) for early breast cancer among young Chinese patients. Methods Young female breast cancer patients (≤40 years old) treated at West China Hospital of Sichuan University between January 1st, 2008, and December 31st, 2019 were analyzed for clinical staging, molecular subtypes, surgical techniques, and prognostic assessments using follow-up data. Results Of 974 eligible patients in this study, 211 underwent BCS+RT and 763 underwent MAST. The Kaplan-Meier analyses indicated that there was no significant difference in the 5-year locoregional recurrence-free survival rate (99.1% vs. 99.4%, P=0.299), distant metastasis-free survival rate (97.9% vs. 96.4%, P=0.309), breast cancer-specific survival rate (100.0% vs. 97.0%, P=0.209), or overall survival rate (99.4% vs. 96.8%, P=0.342) between patients who underwent BCS+RT and those who underwent MAST. The multiple Cox proportional hazards regression analyses revealed that the treatment approach (BCS+RT or MAST) did not significantly predict locoregional recurrence-free survival (P=0.427), distant metastasis-free survival (P=0.154), breast cancer-specific survival (P=0.155), or overall survival (P=0.263). Subgroup analyses showed that there was no statistically significant difference in survival outcomes between BCS+RT and MAST in different clinical stages or molecular subtypes. Clinical stage and molecular subtype should also not be regarded as independent factors in deciding the treatment approach. Conclusions Receiving BCS+RT or MAST treatment does not affect the survival outcomes of young early-stage breast cancer patients, showing similar efficacy across various clinical stages and molecular subtypes. Choosing BCS+RT is considered safe for early-stage young female breast cancer patients eligible for breast conservation.
ObjectiveTo explore the risk factors affecting the prognosis of patients with metastatic breast cancer (MBC) and construct a nomogram survival prediction model.MethodsThe patients with MBC from 2010 to 2013 were collected from surveillance, epidemiology, and end results (SEER) database, then were randomly divided into training group and validation group by R software. SPSS software was used to compare the survival and prognosis of MBC patients with different metastatic sites in the training group by log-rank method and construct the Kaplan-Meier survival curve. The Cox proportional hazards model was used to analyze the factors of 3-year overall survival, then construct a nomogram survival prediction model by the independent prognostic factors. The C-index was used to evaluate its predictive value and the calibration curve was used to verify the nomogram survival prediction model by internal and external calibration graph.ResultsA total of 3 288 patients with MBC were collected, including 2 304 cases in the training group and 984 cases in the validation group. The data of the two groups were comparable. The median follow-up time of training group and validation group was 34 months and 34 months, respectively. In the training group, the results of Cox proportional hazards model showed that the older, black race, higher histological grading, without operation, ER (–), PR (–), HER-2 (–), and metastases of bone, brain, liver and lung were the risk factors of survival prognosis (P<0.05) and constructed the nomogram survival prediction model with these independent prognostic factors. The nomogram survival prediction showed a good accuracy with C-index of 0.704 [95%CI (0.691, 0.717)] in internal validation (training group) and C-index of 0.691 [95%CI (0.671, 0.711)] in external validation (validation group) in predicting 3-year overall survival. All calibration curves showed excellent consistency.ConclusionNomogram for predicting 3-year overall survival of patients with MBC in this study has a good predictive capability, and it is conducive to development of individualized clinical treatment.
Objective To analyze the clinical efficacy and survival outcome of totally thoracoscopic redo mitral valve replacement and evaluate its efficiency and safety. Methods The clinical data of patients with totally thoracoscopic redo mitral valve replacement in Guangdong Provincial People’s Hospital between 2013 and 2019 were retrospectively analyzed. Survival analysis was performed using the Kaplan-Meier method. Univariate and multivariate Cox regression analyses were used to determine the risk factors for postoperative death. Results There were 48 patients including 29 females and 19 males with a median age of 53 (44, 66) years. All the procedures were performed successfully with no conversion to median sternotomy. A total of 15, 10 and 23 patients received surgeries under non-beating heart, beating heart and ventricular fibrillation, respectively. The in-hospital mortality rate was 6.25% (3/48), and the incidence of early postoperative complications was 18.75% (9/48). Thirty-five (72.92%) patients had their tracheal intubation removed within 24 hours after the operation. The 1- and 6-year survival rates were 89.50% (95%CI 81.30%-98.70%) and 82.90% (95%CI 71.50%-96.20%), respectively. Age>65 years was an independent risk factor for postoperative death (P=0.04). Conclusion Totally thoracoscopic redo mitral valve replacement is safe and reliable, with advantages of rapid recovery, reducing blood transfusion rate, reducing postoperative complications and acceptable long-term survival rate. It is worthy of being widely popularized in the clinic.
ObjectiveTo investigate the expression and clinical significance of cytochromes b561 (CYB561) in hepatocellular carcinoma (HCC). MethodsThe expression of CYB561 mRNA in HCC tissues and its relationship with prognosis were analyzed by database data. Immunohistochemistry (IHC) was used to detect the expression of CYB561 protein in 61 matched HCC tissues and their adjacent tissues, and the relationship between CYB561 protein expression and clinicopathological features and prognosis of HCC was analyzed. Kaplan-Meier method was used to draw the survival curve and Cox proportional hazard regression model was used to analyze the correlation between the expression of CYB561 protein and the prognosis of HCC. ResultsThe analysis of database data showed that the relative expression of CYB561 mRNA in HCC tissues was higher than that in adjacent tissues (P<0.001). Compared with HCC patients with negative expression of CYB561 mRNA, HCC patients with positive expression of CYB561 mRNA had worse overall survival (OS), relapse-free survival, progression-free survival and disease-free survival (all P<0.05). The results of IHC showed that the positive rates of CYB561 protein in HCC tissues and adjacent tissues were 57.38% (35/61) and 21.31%(13/61), respectively. The former was higher than the latter, with statistical significance (χ2=16.624, P<0.001). Survival analysis showed that the OS of patients with positive expression of CYB561 protein was worse than that of patients with negative expression (P<0.05). Multivariate Cox proportional hazard regression analysis showed that the positive expression of CYB561 protein was a risk factor for postoperative OS in HCC patients [HR=3.308, 95%CI (1.344, 8.144), P=0.009]. ConclusionCYB561 is positively expressed in HCC and suggests a worse survival, and may serve as a potential prognostic biomarker for HCC.
ObjectiveTo evaluate the diagnostic value of various severity assessment scoring systems for sepsis after cardiac surgery and the predictive value for long-term prognosis.MethodsThe clinical data of patients who underwent cardiac sugeries including coronary artery bypass grafting (CABG) and (or) valve reconstruction/valve replacement were extracted from Medical Information Mark for Intensive Care-Ⅲ (MIMIC-Ⅲ). A total of 6 638 patients were enrolled in this study, including 4 558 males and 2 080 females, with an average age of 67.0±12.2 years. Discriminatory power was determined by comparing the area under the receiver operating characteristic (ROC) curve (AUC) for each scoring system individually using the method of DeLong. An X-tile analysis was used to determine the optimal cut-off point for each scoring system, and the patients were grouped by the cut-off point, and Kaplan-Meier curves and log-rank test were applied to analyze their long-term survival.ResultsCompared with the sequential organ failure assessment (SOFA) score, acute physiology score-Ⅲ (APS-Ⅲ, P<0.001), the simplified acute physiology score-Ⅱ (SAPS-Ⅱ, P<0.001) and logistic organ dysfunction score (LODS, P<0.001) were more accurate in distinguishing sepsis. Compared with the non-septic group, the 10-year overall survival rate of the septic group was lower (P<0.001). Except for the systemic inflammation response score (SIRS) system, the 10-year overall survival rates of patients in the high risk layers of SOFA (HR=2.50, 95%CI 2.23-2.80, P<0.001), SAPS (HR=2.93, 95%CI 2.64-3.26, P<0.001), SAPS-Ⅱ (HR=2.77, 95%CI 2.51-3.04, P<0.001), APS-Ⅲ (HR=2.90, 95%CI 2.63-3.20, P<0.001), LODS (HR=2.17, 95%CI 1.97-2.38, P<0.001), modified logistic organ dysfunction score (MLODS, HR=2.04, 95%CI 1.86-2.25, P<0.001) and the Oxford acute severity of illness score (OASIS, HR=2.37, 95%CI 2.16-2.60, P<0.001) systems were lower than those in the low risk layers.ConclusionCompared with SOFA score, APS-Ⅲ score may have higher value in the diagnosis of sepsis in patients who undergo isolated CABG, a valve procedure or a combination of both. Except for SIRS scoring system, SOFA, APS-Ⅲ, SAPS, SAPS-Ⅱ, LODS, MLODS and OASIS scoring systems can be applied to predict the long-term outcome of patients after cardiac surgery.
Objective
Establishing Nomogram to predict the overall survival (OS) rate of patients with gastric adenocarcinoma by utilizing the database of the Surveillance, Epidemiology, and End Results (SEER) Program.
Methods
Obtained the data of 3 272 gastric adenocarcinoma patients who were diagnosed between 2004 and 2014 from the SEER database. These patients were randomly divided into training (n=2 182) and validation (n=1 090) cohorts. The Cox proportional hazards regression model was performed to evaluate the prognostic effects of multiple clinicopathologic factors on OS. Significant prognostic factors were combined to build Nomogram. The predictive performance of Nomogram was evaluated via internal (training cohort data) and external validation (validation cohort data) by calculating index of concordance (C-index) and plotting calibration curves.
Results
In the training cohort, the results of Cox proportional hazards regression model showed that, age at diagnosis, race, grade, 6th American Joint Committee on Cancer (AJCC) stage, histologic type, and surgery were significantly associated with the survival prognosis (P<0.05). These factors were used to establish Nomogram. The Nomograms showed good accuracy in predicting OS rate, with C-index of 0.751 ［95%CI was (0.738, 0.764)］ in internal validation and C-index of 0.753 ［95% CI was (0.734, 0.772)］ in external validation. All calibration curves showed excellent consistency between prediction by Nomogram and actual observation.
Conclusion
Novel Nomogram for patients with gastric adenocarcinoma was established to predict OS in our study has good prognostic significance, it can provide clinicians with more accurate and practical predictive tools which can quickly and accurately assess the patients’ survival prognosis individually, and can better guiding clinicians in the follow-up treatment of patients.
