Objective To systematically evaluate the benefits and safety of anti-PD-1/PD-L1 antibody in the treatment of advanced non-small cell lung cancer (NSCLC). Methods Randomized controlled trials (RCTs) about anti-PD-1/PD-L1 antibody versus conventional-dose chemotherapy in the treatment of advanced NSCLC were searched in PubMed, EMbase, The Cochrane Library (Issue 8, 2016), Web of Science, CBM, CNKI, and VIP databases from inception to September 2016. Two reviewers independently screened literature, extracted data and evaluated the risk of bias of eligible studies, then meta-analysis was conducted by using RevMan 5.3 software. Results A total of five RCTs involving 2 580 patients were included. The results of meta-analysis showed that: the objective response rate (ORR) and one year overall survival rate (OSR1y) in anti PD-1/PD-L1 monoclonal antibody group were higher than that of the conventional chemotherapy group (RR=1.86, 95%CI 1.37 to 2.52,P<0.001; RR=1.37, 95%CI 1.23 to 1.52,P<0.001, respectively). However, there were no significant differences between two groups in one-year progression-free survival rate (PFSR1y) (RR=1.85, 95%CI 0.61 to 5.59,P=0.28) and disease control rate (DCR) (RR=1.13, 95%CI 0.76 to 1.68,P=0.55). With regard to untoward effect, rate of adverse effects (AEs) and AEs of 3-5 grade in anti PD-1/PD-L1 monoclonal antibody group were higher than those of the conventional chemotherapy group (RR=0.85, 95%CI 0.76 to 0.95,P=0.004; RR=0.28, 95%CI 0.18 to 0.43,P<0.001), the difference was statistically significant. But there was no significant difference in AEs to discontinuation between the two groups (RR=0.60, 95%CI 0.26 to 1.39,P=0.23). Conclusion Compared with conventional-dose chemotherapy, anti-PD-1/PD-L1 antibody has considerable current effect and safety in the treatment of advanced NSCLC.
Objective To introduce a simple preoperative risk score for esophageal cancer (PRSEC) and its relationship with the prognosis of patients who underwent resection of esophageal carcinoma. Methods We retrospectively analyzed the clinical data of 498 patients receiving resection of esophageal carcinoma between 2005 and 2015 in our hospital. They were divided into three groups (PRSEC1, PRSEC2 and PRSEC3 groups) according to the results of PRSEC (revised cardiac risk index, model for end-stage liver disease score and pulmonary function test). Their overall survival (OS) and disease-free survival (DFS) were measured to find the relationship between the PRSEC and prognosis of patients. Results The mortality, morbidity, DFS and OS were correlative with the PRSEC. Therefore the PRSEC can be used to predict the short-term outcome. The patients with score 2 or 3 had higher risk of mortality and morbidity than those with score 1. In addition, the DFS and OS of patients with higher score were shorter (P<0.001). Conclusion The PRSEC is easy and efficient and can predict the morbidity, mortality, and long-term outcomes for the patients with resection of esophageal carcinoma.
Thymoma is aggressive and persistent, but does not belong to malignant tumors. In treatments, their optimal treatment protocols still need to be studied and how about the role and the place of use of postoperative radiotherapy is not clear. Some retrospective studies indicate a direction: for the first stage of thymoma, it is adequately treated with complete resection alone. For the second stage of the thymoma, postoperative radiotherapy needs further indications. For the third and fourth stages of thymoma, postoperative radiotherapy plays an important role. A research shows that the radiation dose at 50 Gy is suitable for microscopic tumors, and higher dose of radiation is suitable for macroscopic tumors. With the development of radiotherapy technology, its application scope becomes larger and larger. What kind of the role and the place for radiotherapy in the treatment of thymoma and what is the optimal management of thymoma need to be treated prudently.
ObjectiveTo systematically review the postoperative recovery of lung function in patients with early stage non-small cell lung cancer (NSCLC) after different operation, such as lobectomy versus segmentectomy and video-assisted thoracoscopic surgery (VATS) versus traditional open chest surgery.MethodsClinical studies about effect of different surgical methods on lung function in patients with early NSCLC were searched from PubMed, EMbase, The Cochrane Library, CBM and CNKI databases from inception to October 1st, 2016. Two researchers independently screened literature, extracted data and evaluated the risk of bias of included studies, and then meta-analysis was conducted by RevMan 5.3 and MetaAnalyst software.ResultsA total of 25 studies involving 2 924 patients were included. The results of meta-analysis showed that: compared with lobectomy group, one-second rate difference (ΔFEV1%) (MD=–0.03, 95%CI –0.03 to –0.03, P<0.001) and predictive value of forced vital capacity difference (ΔFVC%) (MD=–0.09, 95%CI –0.11 to –0.06, P<0.001) of preoperative to postoperative in segmentectomy group were higher. However, there was no significant difference between two groups in first second forced expiratory volume difference (ΔFEV1) (MD=0.01, 95%CI –0.10 to 0.11, P=0.92). Compared with thoracotomy group, VATS group had lower ΔFEV1 (MD=–0.19, 95%CI –0.27 to –0.10, P<0.0001), ΔFVC (MD=–0.20, 95%CI –0.37 to –0.03, P=0.02), ΔFEV1% (MD=–0.03, 95%CI –0.06 to –0.01, P<0.001) of preoperative to postoperative (≤3 months), and maximum minute ventilation (ΔMVV) (MD=–5.59, 95%CI –10.38 to –1.52, P=0.008) of preoperative to postoperative (≥6 months). However, there were no statistically significant differences in difference of carbon monoxide diffusion rate (ΔDLCO%) (MD=–0.04, 95%CI –0.09 to 0.02, P=0.16), ΔFEV1% (MD=–0.02, 95%CI –0.06 to 0.02, P=0.32) and ΔFEV1 (MD=1.13, 95%CI –0.92 to 3.18, P=0.28).ConclusionThe protective effect of segmentectomy on postoperative pulmonary function is better than that of lobectomy. VATS has a protective effect on the ventilation function within 3 months and 6 months after surgery. Due to limited quantity and quality of included studies, the above conclusions are needed to be validated by more high quality studies.
Objectives To systematically review the efficacy and safety of non-systemic lymph dissection (NSMLD) vs. systemic lymph dissection (SMLD) for early stage non-small cell lung cancer (NSCLC). Methods PubMed, EMbase, Web of Science and The Cochrane Library databases were searched online to collect randomized controlled trials (RCTs) and non-randomized controlled studies (NRCTs) of NSMLD vs. SMLD for NSCLC patients from inception to October, 2016. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using RevMan 5.3 software. Results A total of 16 studies (4 RCTs and 12 NRCTs) involving 4 718 patients were included. The results of meta-analysis showed that: Compared with the SMLD group, the NSMLD group had higher mortality (HR=1.23, 95%CI 1.11 to 1.37, P<0.000 1). There were no significant differences in disease-free survival, local recurrence rate, distant metastasis rate, and safety between two groups. In addition, the NSMLD group had shorter operation time, and lower drainage and blood loss. Subgroup analysis was performed according to operation methods. The results showed that: NSMLD group by lymph node sampling (LN-S) had higher mortality than SMLD group (HR=1.43, 95%CI 1.17 to 1.75,P=0.004), NSMLD group by lobe-specific lymph node dissection (L-SLD) did not have higher mortality. Conclusions Current evidence shows that: compared with SMLD, NSMLD by L-SLD do not have higher mortality in early stage NSCLC patients, while NSMLD by LN-S have higher mortality. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusion.
Objective To compare lymph node sampling (LN-S) and lobe-specific lymph node dissection (L-SLD) in the clinical efficacy and safety for early-stage non-small cell lung cancer (NSCLC). Methods PubMed, Medline, EMbase, Web of Science and The Cochrane Library databases were searched up to March 2017 for English language studies. We collected randomized controlled trials (RCTs) and cohort studies (CS) which used the systematic mediastinal lymph node dissection (SMLD) and LN-S or L-SLD for the treatment of NSCLC. Direct meta-analysis was performed using RevMan 5.3 software and indirect meta-analysis with ITC software after two researchers screened the literature, extracted the data and evaluated the risk of bias independently. Results A total of 18 articles were included (4 RCTs and 14 CS, and 10 714 patients). Meta-analysis results showed that in the CS, compared with the the SMLD group, overall survival increased in the L-SLD group (HR=0.99, 95%CI 0.78 to 1.25, P=0.92), and overall survival decreased in the LN-S group with significant difference in CS (HR=1.43, 95%CI 1.17 to 1.75, P=0.000 4), but was not statistically significant in RCT (P=0.35). In terms of disease-free survival, there was no significant difference between the SMLD group and the LN-S group (HR=1.25, 95%CI 0.90, 1.62, P=0.10) as well as the L-SLD group (HR=1.15, 95%CI 0.92 to 1.43, P=0.23) in the CS. There was no significant difference in the local recurrence rate or distant metastasis rate between the non-systematic lymph node dissection (NSMLD) and SMLD in CS and RCTs (CS: P=0.43, P=0.39; RCT: P=0.43, P=0.10). There was no significant difference in the postoperative complications between NSMLD and SMLD in the CS (OR=0.79, 95%CI0.58 to 1.09, P=0.15) and RCTs (OR=0.36, 95%CI 0.09 to 1.45, P=0.15). Indirect meta-analysis showed that risk of death decreased by 31% and risk of recurrence by 35% in the L-SLD group compared with the LN-S group (HR=0.69, 95% CI 0.51 to 0.95, P=0.46; HR=0.65, 95% CI 0.65 to 1.30, P=0.72), but the difference was not statistically significant. Conclusion For early-stage NSCLC, L-SLD is not statistically different from SMLD in terms of survival; however, the overall survival of LN-S is lower than that of systematic lymphadenectomy. Indirect meta-analysis shows that L-SLD reduces the risk of death and recurrence risk compared with LN-S. There is no evidence to support both direct comparison of the prognosis of LN-S and L-SLD, therefore further prospective studies are still needed to verify.
ObjectivesTo systematically review the efficacy and safety of anti-PD-1/PD-L1 antibody in the treatment of advanced non-small cell lung cancer (NSCLC).MethodsNon-comparative binary data on anti-PD-1/PD-L1 monoclonal antibodies in the treatment of advanced NSCLC from PubMed, EMbase and The Cochrane Library databases were collected from inception to August 1st 2017. Two reviewers screened literature, extracted data and independently evaluated the risk of bias of included studies, then meta-analysis was conducted by RevMan 5.3 software.ResultsForty-four trials were included. The results of meta-analysis showed that the pooled objective response rate (ORR), overall 1-year survival rate (OSR1 year) and progression-free survival rate at 1 year (PFSR1 year ) of anti-PD-1/PD-1 antibodies were 22% (RD=0.22, 95%CI 0.20 to 0.25, P<0.001), 54% (RD=0.54, 95%CI 0.46 to 0.63,P<0.001) and 27% (RD=0.27, 95%CI 0.20 to 0.33,P<0.001), respectively. The rate of adverse effects (AEs) was 61% (RD=0.61, 95%CI 0.54 to 0.68,P<0.001), and the rate of grade 3 to 5 AEs was 13% (RD=0.13, 95%CI 0.10 to 0.15,P<0.001).ConclusionsAnti- PD-1/PD-1 antibodies show good efficacy and safety in the treatment of advanced NSCLC. Due to limited quality and quantity of included studies, more high-quality studies are needed to verify the above conclusions.
Objective To assess the quality of reporting of randomized controlled trials(RCTs) on traditional Chinese medicine(TCM) in China from 1999 to 2004 by CONSORT statement and Jadad scale. Methods We randomly selected 13 journals of TCM including Chinese Journal of Integrated Chinese and Western Medicine,ect using stratified sampling from about 100 journals of TCM in mainland China, and all issues of selected journals published from 1999 to 2004 were hand-searched according to the hand-search guideline developed by Cochrane Collaboration. All reviewers were trained in the method of evaluating RCTs . A comprehensive quality assessment of each RCT was completed using methods including the revised consolidated standards of reporting trials (CONSORT) checklist and Jadad scale. Disagreements were resolved by consensus. Results A total of 7422 RCTs were identified, and the percentage of RCTs was significantly increased by 18.6%, 23.9%, 27.5%, 28.8%, 33.0% and 35.6% from 1999 to 2004. The mean Jadad score was 1.03 ± 0.61 in all trials with 1 RCT with 5 points, 14 with 4 points, and 102 with 3 points, from 1999 to 2004, the mean Jadad score was 0.85±0.53 (n=746), 0.82±0.63 (n=941), 0.90±0.61 (n=1 243), 1.03±0.60 (n=1 325), 1.12±0.58 (n=1 533) and 1.20±0.62 (n=1 634) respectively, which was improved continuously but slowly. 39.4% of the items in CONSORT, which was equivalent to 11.82 (standard deviation=5.78) of a total of 30 items, were reported across those trials. Some important methodological components of RCTs such as sample size calculation (1.1%), randomization sequence (7.9%), allocation concealment (0.3%), implementation of the random allocation sequence (0.0%) , analysis of intention to treat (0.0%), were incompletely reported. Conclusion Our study suggests that the quality of reporting has been improved but still in poor status, which would urgently promote the establishment of the CONSORT for TCM.