Cost-utility analysis of tislelizumab monotherapy for second-line treatment of advanced or metastatic esophageal squamous cell carcinoma / 中国药房

OBJECTIVE To evaluate the cost-effectiveness of tislelizumab monotherapy in the second-line treatment of advanced or metastatic esophageal squamous cell carcinoma （ESCC），so as to provide reference for rational use of drug in clinic. METHODS A three-state partitioned survival model was constructed from the perspective of China’s health system， based on the data of RATIONALE-302 study，with simulation time limit of 10 years， cycle period of 1 month. The incremental cost-effectiveness ratio （ICER） was calculated with quality-adjusted life year （QALY） as utility index. The cost-effectiveness of tislelizumab monotherapy was compared with that of chemotherapy for second-line treatment of advanced or metastatic ESCC by cost-utility analysis. The stability of basic analysis results was validated through sensitivity analysis and scenario analysis. RESULTS The results of basic analysis showed that compared with chemotherapy group， incremental cost per capita of tislelizumab group was 35 025.32 yuan，and incremental utility per capita was 2.71 QALYs； ICER was 12 892.31 yuan/QALY， which was far lower than the willingness-to-pay （WTP） threshold of 3 times of China’s per capita gross domestic product （GDP） 242 928 yuan in 2021. The results of univariate sensitivity analysis showed that parameters such as the cost of apatinib， the utility value of disease progression status and the cost of adverse reactions in the chemotherapy group had a great impact on the ICER value， but these parameters could not cause the reversal of the basic analysis results. Probabilistic sensitivity analysis showed that WTP threshold was higher than 80 000 yuan/QALY，the probability of tislelizumab monotherapy possessed cost-effectiveness was 100%. Results of scenario analysis showed that in which model simulation time lasted for 5 or 20 years，ICER of tislelizumab was 8 331.00 yuan/QALY and 12 981.00 yuan/QALY， which were less than 3 times of China’s per capita GDP in 2021 as WTP threshold. CONCLUSIONS When three times of China’s GDP per capita in 2021 is taken as the WTP threshold， the second-line treatment of tirelizumab monotherapy for advanced or metastatic ESCC is more cost-effective than chemotherapy.

Effects of valproic acid on skeletal metabolism in children with epilepsy: a systematic evaluation and meta-analysis based on 14 studies.

BACKGROUND: Previous studies have reported that long-term use of valproic acid can cause changes in bone metabolism in children. We conducted this meta-analysis to determine the effects of valproic acid on bone metabolism and bone mineral density (BMD) in children with epilepsy. METHODS: Studies were searched from the databases of PubMed, Embase, Ovid, Cochrance Library, Springer Link and Web of Science. The effects of valproic acid on bone metabolism indicators and BMD were assessed through calculating the standardized mean difference (SMD) with 95% confidence interval (CI). RESULTS: Fourteen studies with 987 individuals were included in this analysis. The long-term use of valproic acid did not affect the levels of serum calcium (p = 0.99), phosphorus (p = 0.28), ALP (p = 0.76), PTH (p = 0.36) and osteocalcin (p = 0.72), but it led to a decrease in 25-OH-VitD (p = 0.01) and BMD (p = 0.002 for the vertebra; p = 0.004 for the femur) in treating children with epilepsy. CONCLUSION: Long-term use of valproic acid in treating children with epilepsy can lead to a reduction in 25-OH-VitD and BMD. Measurements of 25-OH-VitD and BMD should be performed regularly in children taking the drug to detect early osteopenia caused by the drug.

Elevated Hsp90-beta contributes to differential diagnosis of pleural effusion caused by lung cancer and correlates with malignant biological behavior of lung cancer.

BACKGROUND: Hsp90-beta has been investigated to be correlated with the occurrence and development of tumor. The intention of this research was to test the level of Hsp90-beta in malignant pleural effusion (MPE) of patients with lung cancer and disclose the clinical significance of Hsp90-beta as a potential tumor marker for differential diagnosis of pleural effusion caused by lung cancer. METHODS: The level of Hsp90-beta was determined using enzyme-linked immunosorbent assay. Calculations of the Hsp90-beta threshold, the sensitivity and specificity for distinguishing MPE from benign pleural effusion were performed using receiver operator characteristic curve. RESULTS: The level of Hsp90-beta in MPE of lung cancer patients was higher than that in control individuals (P < 0.05) and increased MPE Hsp90-beta was correlated with the pathological differentiation, tumor size and lymphatic metastasis (P < 0.05). The cutoff value of Hsp90-beta produced by receiver operator characteristic curve for distinguishing lung cancer from control individuals were 1.659 ng/mL and the sensitivity and specificity were 93.46 and 79%. CONCLUSIONS: Increased Hsp90-beta in MPE was correlated with malignant biological behavior of lung cancer patients, indicating that the level of Hsp90-beta could be a tool of referential value for differential diagnosis of pleural effusion caused by lung cancer.

Tissue or blood: which is more suitable for detection of EGFR mutations in non-small cell lung cancer?

BACKGROUND: Many studies have evaluated the accuracy of EGFR mutation status in blood against that in tumor tissues as the reference. We conducted this systematic review and meta-analysis to assess whether blood can be used as a substitute for tumor tissue in detecting EGFR mutations. METHODS: Investigations that provided data on EGFR mutation status in blood were searched in the databases of Medline, Embase, Ovid Technologies and Web of Science. The detect efficiency of EGFR mutations in paired blood and tissues was compared using a random-effects model of meta-analysis. Pooled sensitivity and specificity and diagnostic accuracy were calculated by receiver operating characteristic curve. RESULTS: A total of 19 studies with 2,922 individuals were involved in this meta-analysis. The pooled results showed the positive detection rate of EGFR mutations in lung cancer tissues was remarkably higher than that of paired blood samples (odds ratio [OR] = 1.47, p<0.001). The pooled sensitivity and specificity of blood were 0.65 and 0.91, respectively, and the area under the receiver operating characteristic curve was 0.89. CONCLUSIONS: Although blood had a better specificity for detecting EGFR mutations, the absence of blood positivity should not necessarily be construed as confirmed negativity. Patients with negative results for blood should decidedly undergo further biopsies to ascertain EGFR mutations.

Tissue or blood: which is more suitable for detection of EGFR mutations in non-small cell lung cancer?

BACKGROUND: Many studies have evaluated the accuracy of EGFR mutation status in blood against that in tumor tissues as the reference. We conducted this systematic review and meta-analysis to assess whether blood can be used as a substitute for tumor tissue in detecting EGFR mutations. METHODS: Investigations that provided data on EGFR mutation status in blood were searched in the databases of Medline, Embase, Ovid Technologies and Web of Science. The detect efficiency of EGFR mutations in paired blood and tissues was compared using a random-effects model of meta-analysis. Pooled sensitivity and specificity and diagnostic accuracy were calculated by receiver operating characteristic curve. RESULTS: A total of 19 studies with 2,922 individuals were involved in this meta-analysis. The pooled results showed the positive detection rate of EGFR mutations in lung cancer tissues was remarkably higher than that of paired blood samples (odds ratio [OR] = 1.47, p<0.001). The pooled sensitivity and specificity of blood were 0.65 and 0.91, respectively, and the area under the receiver operating characteristic curve was 0.89. CONCLUSIONS: Although blood had a better specificity for detecting EGFR mutations, the absence of blood positivity should not necessarily be construed as confirmed negativity. Patients with negative results for blood should decidedly undergo further biopsies to ascertain EGFR mutations.

Increased stathmin in serum as a potential tumor marker for lung adenocarcinoma.

BACKGROUND: Stathmin has been found to be involved in malignant tumors; the aim of this study was to investigate the relationship between serum stathmin and clinico-pathological features of lung cancer. METHODS: In three lung cancer cell lines, stathmin expression and its secretion level in the supernatant were examined by Western blot and enzyme-linked immunosorbent assay (ELISA). Expression of stathmin was examined by immunohistochemistry in 48 lung cancer tissues, and serum stathmin expression level was examined by ELISA in 96 patients with lung cancer and 82 normal individuals. Sensitivity and specificity of serum stathmin were determined by receiver operator characteristic curve (ROC). RESULTS: In the three cell lines and their supernatant, stathmin levels were higher than those in 16 HBE cell line. Lung cancer tissues expressed higher level stathmin more frequently than normal lung tissue (P < 0.05). Serum stathmin level was significantly higher in the patients with lung cancer than in normal individuals (P < 0.001). Increased stathmin level in cancer tissue and serum were significantly associated with adenocarcinoma histology, lymph node metastasis and advanced stage. The threshold level of serum stathmin for distinguishing lung cancer from normal individuals was 1.86 ng/ml. The sensitivity and specificity were 93.7% and 91.5%, respectively. CONCLUSIONS: Measurement of serum stathmin level could be a potential biomarker for lung cancer, especically those of adenocarcinoma, with lymph node metastasis and at advanced clinical stages.

Increased level of annexin A1 in bronchoalveolar lavage fluid as a potential diagnostic indicator for lung cancer.

BACKGROUND: Annexin A1 has been implicated in various tumor types, but few studies have investigated its involvement in lung cancer. The purpose of this investigation was to quantify the annexin A1 level in bronchoalveolar lavage fluid (BALF) and analyze its usefulness in lung cancer diagnosis. METHODS: Annexin A1 expression was measured by immunohistochemistry and enzyme immunoassay. The sensitivity and specificity of annexin A1 for distinguishing lung cancer were determined by receiver operator characteristic (ROC) curves. RESULTS: Tumor tissues, BALF and serum of patients with lung cancer contained higher levels of annexin A1 than those of the control group of patients with benign lung diseases. Moreover, an increased level of BALF annexin A1 was closely correlated with lymphatic invasion and malignant progression of lung cancer. The sensitivity and specificity of BALF annexin A1 for distinguishing lung cancer were 94.2% and 90.2%, respectively. CONCLUSIONS: Increased annexin A1 in BALF was correlated with lymphatic invasion and malignant progression of lung cancer, suggesting that it could be an indicator for discerning lung cancer and predicting outcome.

Stathmin overexpression is associated with growth, invasion and metastasis of lung adenocarcinoma.

Stathmin has been investigated as a tumor biomarker because it appear to be associated with tumorigenesis; however, the effect of stathmin in lung adenocarcinoma (LAC) remains poorly understood. The purpose of this study was to examine the expression of stathmin in lung adenocarcinoma, and to disclose the relationship between them. The expression of stathmin was examined by RT-PCR, IHC and Western blot. Furthermore, small interfering RNA (shRNA)-mediated silencing of stathmin was employed in LAC cells to investigate cell proliferation, invasion and apoptosis. In this study, we showed that overexpression of stathmin was significantly associated with poorly differentiated, lymph node metastasis and advance TNM stages of lung adenocarcinoma. And silencing of stathmin expression inhibited the proliferation, migration and invasion of lung adenocarcinoma PC-9 cells, and retarded the growth of PC-9 cells xenografts in nude mice. Additionally, the anticarcinogenic efficacy of stathmin silencing might be involved in P38 and MMP2 signaling pathways. In conclusion, these results showed that stathmin expression was significantly up-regulated in LAC, which may act as a biomarker for LAC. Furthermore, silence of stathmin inhibiting LAC cell growth indicated that stathmin may be a promising molecular target for LAC therapy.

Evaluation of efficacy and safety for recombinant human adenovirus-p53 in the control of the malignant pleural effusions via thoracic perfusion.

A certain number of studies have showed that p53 gene transfer has an anti-tumor activity in vitro and in vivo. This study was to evaluate the efficacy and safety of thoracic perfusion of recombinant human adenovirus p53 (rAd-p53, Gendicine) for controlling malignant pleural effusion (MPE). We searched for the relevant studies from the database of MEDLINE, Web of Science, EMBASE, Cochrance Library and CNKI to collect the trials concerning the efficacy and safety of rAd-p53 to treat MPE. Fourteen randomised controlled trials (RCTs) with 879 patients were involved in this analysis. The rAd-p53 combined with chemotherapeutic agents significantly improved the overall response rate (ORR) (P < 0.001; odds ratio = 3.73) and disease control rate (DCR) (P < 0.001; odds ratio = 2.32) of patients with MPE as well as the quality of life (QOL) of patients (P < 0.001; odds ratio = 4.27), compared with that of chemotherapeutic agents alone. In addition, the participation of rAd-p53 did not have an obvious impact on the most of incidence of adverse reactions (AEs) (P < 0.05) except the fever (P < 0.001). However, the fever was self-limited and could be tolerated well. The application of rAd-p53 through thoracic perfusion for treating MPE had a better efficacy and safety, which could be a potential choice for controlling MPE.

Thoracic perfusion of recombinant human endostatin (Endostar) combined with chemotherapeutic agents versus chemotherapeutic agents alone for treating malignant pleural effusions: a systematic evaluation and meta-analysis.

BACKGROUND: Endostar is a new endogenous angiogenic inhibitor with implicated anti-tumor activity. This study was to investigate whether thoracic perfusion of Endostar could be used to control malignant pleural effusions (MPE). METHODS: We searched the databases of MEDLINE, Web of Science, EMBASE, Goggle, Cochrance Library and CNKI to select the studies regarding the efficacy of Endostar to treat MPE. A total of 13 randomised controlled trials (RCTs) with 1066 patients were included. RESULTS: The overall response rate (ORR) (P < 0.001; odds ratio = 3.58) and disease control rate (DCR) (P < 0.001; odds ratio = 2.97) of Endostar combined with chemotherapeutic agents were significantly higher than those of chemotherapeutic agents alone. In addition, Endostar combined treatment remarkably promoted quality of life (QOL) of patients (P < 0.001; odds ratio = 3.04) compared with that of chemotherapeutic agents alone. Moreover, Endostar combined treatment did not have an impact on the incidence of adverse reactions (AEs) (P < 0.05). CONCLUSIONS: The efficacy of Endostar combined chemotherapeutic agents was superior to chemotherapeutic agents alone through thoracic perfusion in treating MPE, which indicated that Endostar could be an effective agent for controlling MPE.

Efficacy and safety of icotinib in treating non-small cell lung cancer: a systematic evaluation and meta-analysis based on 15 studies.

Icotinib is a new epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that developed and used in China; this work was to evaluate its efficacy and safety in treating non-small cell lung cancer (NSCLC). Clinical studies evaluating the efficacy and safety of icotinib in treating NSCLC were identified from the databases of Medline, Web of Science, Embase and Cochrance Library. Pooled efficacy and safety of icotinib were calculated through a series of predefined search strategies. A total of 15 studies with 2,304 patients were involved in this study. The overall response rate (ORR) and disease control rate (DCR) of icotinib were 40.99% (95% CI: 33.77% to 48.22%) and 77.16% (95% CI: 51.43% to 82.31%). The pooled progression-free survival (PFS) and overall survival (OS) were 7.34 months (95% CI: 5.60 to 9.07) and 14.98 months (95% CI: 9.78 to 20.18). Patients with EGFR mutations exhibited better ORR (OR = 3.67, p < 0.001), DCR (OR = 1.39, p = 0.001) and PFS (11.0 ± 0.76 vs. 1.97 ± 0.82 months). Moreover, patients with rash had a higher ORR (OR = 2.14, p = 0.001) than those without rash. The common adverse effects (AEs) included skin rash (31.4%), diarrhea (14.2%), pruritus (6.7%) and hepatic toxicity (3.8%) and most of them were well tolerated. In conclusion, Icotinib is an effective and well tolerated regimen for Chinese patients with advanced NSCLC. Further randomized trials with large population are required to provide stronger evidence for icotinib in treating NSCLC.

Increased serum amyloid A as potential diagnostic marker for lung cancer: a meta-analysis based on nine studies.

BACKGROUND: Previous studies have disclosed that serum amyloid A (SAA) is likely involved in the lung cancer pathogenesis and progression. We performed a systematic evaluation and meta-analysis to disclose the correlation between the expression of SAA and lung cancer and to evaluate its value for lung cancer diagnosis. METHODS: We searched the relevant articles from the databases of Medline, Embase, Cochrance Library and Web of Science and calculated the standardized mean difference (SMD) with 95 % confidence interval (CI) to assess the expression difference of SAA between lung cancer and normal patients. Moreover, we counted the positive rate, sensitivity and specificity and drew a summary receiver operating characteristic curve (SROC) to evaluate the diagnostic value of SAA for lung cancer. RESULTS: A total of nine studies with 1392 individuals were included in this analysis. The results showed an increased SAA was correlated with the incidence of lung cancer (P < 0.001), especially with the lung squamous cell carcinoma (LSCC) (p = 0.012). The overall sensitivity and specificity of SAA for discerning lung cancer was 0.59 (95 % CI: 0.54-0.63) and 0.92 (95 % CI: 0.88-0.95), respectively. The area under the SROC curve was 0.9066 (SE = 0.0437). CONCLUSIONS: Increased SAA in lung cancer was intimately correlated with the development and progression of lung cancer. A higher specificity of SAA suggested that it should be a significant biomarker for discerning lung cancer from normal individuals, especially for LSCC (p = 0.012).

Overexpression of stathmin promotes metastasis and growth of malignant solid tumors: a systemic review and meta-analysis.

Stathmin has been investigated to be involved in development and progress of malignant tumors. This study was to clarify the relationship between expression of stathmin and tumors and assess its clinical significance. We identified 25 studies with a total of 3,571 individuals from the electronic bibliographic databases and strictly evaluated the quality and heterogeneity of included studies. We analysed the relationship between expression of stathmin and clinical characteristics by the fixed-effects and random-effects of meta-analysis and constructed a summary receiver-operator characteristic curve to estimate the test characteristics. The results showed that patients with cancer displayed a higher stathmin expression than those of non-cancer individuals (OR, 0.31), and overexpression of stathmin correlated with tumor cell differentiation (OR, 0.73), lymph node invasion (OR, 0.80) and high TNM stage (OR, 0.67). The pooled sensitivity of stathmin for distinguishing malignant tumors was 0.73 and the specificity was 0.77. The maximum balance joint for sensitivity and specificity (the Q-value) was 0.7566 and the area under the curve (AUC) was 0.8234. In conclusion, these results showed that overexpression of stathmin intimately correlated with malignant behavior of tumors, suggesting it could be a risk factor of malignant tumors. Stathmin had great sensitivity and specificity indicated it should be a significant molecular biomarker for malignant tumors.

Stathmin-dependent molecular targeting therapy for malignant tumor: the latest 5 years' discoveries and developments.

Knowledge of the molecular mechanisms on malignant tumors is very critical for the development of new treatment strategies like molecularly targeted therapies. In last 5 years, many investigations suggest that stathmin is over-expressed in a variety of human malignant tumors, and potentially promotes the occurrence and development of tumors. Rather, down-regulation of stathmin can reduce cell proliferation, motility and metastasis and induce apoptosis of malignant tumors. Thus, a stathmin antagonist, such as a specific inhibitor (antibody, small molecule compound, peptide, or siRNA), may be a novel strategy of molecular targeted therapy. This review summarizes the research progress of recent 5 years on the role of stathmin in tumorigenesis, the molecular mechanisms and development of anti-stathmin treatment, which suggest that continued investigations into the function of stathmin in the tumorigenesis could lead to more rationally designed therapeutics targeting stathmin for treating human malignant tumors.

Thoracic perfusion of matrine as an adjuvant treatment improves the control of the malignant pleural effusions.

BACKGROUND: Many studies have investigated the efficacy and safety of matrine in treating malignant pleural effusion by thoracic perfusion. This study is an analytic value of available evidence. METHODS: Twelve studies were analyzed in this study. Pooled odds ratios and hazard ratio with 95 % confidence intervals were calculated using the fixed effects model. RESULTS: Overall response rate of matrine combined with other medications in treating malignant pleural effusion (MPE) was significantly higher than those of other medications alone (p < 0.05). Time to pleural effusion relief and quality of life were improved after the treatment of matrine combined with other medications (p < 0.05). Moreover, matrine combined with other medications had a lower incidence of adverse reactions (p < 0.05). CONCLUSIONS: Matrine combined with other medications improves the control of the malignant pleural effusions and decreases the incidence of adverse reactions.

Co-overexpression of Hsp90-ß and annexin A1 with a significantly positive correlation contributes to the diagnosis of lung cancer.

AIM: Hsp90-ß and annexin A1 have been demonstrated to be associated with tumorigenesis. However, the effect of Hsp90-ß and annexin A1 in lung cancer remains poorly understood. In this research, the correlation of Hsp90-ß and annexin A1 in lung cancer patients were analyzed. METHODS: The expression levels of Hsp90-ß and annexin A1 were examined by immunohistochemistry and ELISA. RESULTS: Lung cancer tissues and serum exhibited higher co-expression of Hsp90-ß and annexin A1 than control groups (p < 0.05). Hsp90-ß and annexin A1 could discriminate lung cancer from the control groups (sensitivity of Hsp90-ß was 80.2% in tissues and 96% in serum; specificity of Hsp90-ß was 80% in tissues and 83.33% in serum; sensitivity of annexin A1 was 68.76% in tissues and 95.23% in serum; specificity of annexin A1 was 75% in tissues and 85.7% in serum) and multi-index combined detection had a better diagnostic value. CONCLUSION: The expression levels of Hsp90-ß and annexin A1 positively correlated and such co-overexpression of Hsp90-ß and annexin A1 contributed to lung cancer diagnosis.

Annexin A1 in malignant tumors: current opinions and controversies.

Annexin A1 is a 37 kDa calcium and phospholipid-binding protein that participates in several biological processes, such as inflammatory reactions, modulation of cell proliferation, regulation of cell death signaling, apoptosis, and, most importantly, tumor formation and development. Although annexin A1 has been implicated in the biology of various tumors, the findings are highly controversial and information regarding the underlying mechanism remains limited. Moreover, the mechanism by which annexin A1 participates in carcinogenesis and tumor progression is rather unclear. In the current study, we review the important biological functions of annexin A1 in different tumors. This work indicates that annexin A1 is a possible target for novel therapeutic intervention and that it is a potential biomarker for tumor diagnosis and screening.

Differential diagnostic CYFRA 21-1 level for benign and malignant pleural effusions: a meta-analysis in the Chinese population.

INTRODUCTION: Many studies have investigated the usefulness of cytokeratin 19 fragments (CYFRA 21-1) in pleural fluid for the differential diagnosis of benign (BPE) and malignant pleural (MPE) effusions. In the present meta-analysis, the reported studies on the diagnosis between CYFRA 21-1 and pleural effusion were assessed to summarize the diagnostic characteristics of CYFRA 21-1 in Chinese patients. MATERIAL AND METHODS: The data sources from the creation of each database up to January 2011 included Medline, Chinese National Knowledge Infrastructure, EMBASE, Cochrane Library, and bibliographies of review and original articles. Through a systematic literature search for publications, the data from 22 studies were summarized based on their discussions on the result of the CYFRA 21-1 assay in pleural effusion and differential diagnosis evaluation in the Chinese population. RESULTS: A total of 22 studies were available for analysis, and the high CYFRA 21-1 level in MPE was significantly associated with risk for lung cancer (standardized mean difference [SMD] = 1.65, 95% confidence interval [CI] = 1.48-1.82, Z = 18.97, p < 0.00001) compared with BPE. The CYFRA 21-1 level in pleural effusion (13 studies) was significantly higher than that in serum (SMD = 1.10, 95% CI = 0.71-1.48, Z = 5.59, p < 0.00001). The risk for squamous cell carcinoma (SCC) for CYFRA 21-1 was 1.03 (95% CI = 0.64-1.42, Z = 5.15, p < 0.00001) compared with that of adenocarcinoma (8 studies). The sensitivity of CYFRA 21-1 reported in the articles ranged from 46% to 94%, and the specificity ranged from 57% to 100%. The summary measure of the test characteristics derived from the summary receiver operating characteristic curve was 81% for both sensitivity and specificity (17 studies). CONCLUSIONS: The measurement of pleural CYFRA 21-1 is likely to be a useful diagnostic tool for the confirmation of MPE.

Maintenance therapy of gefitinib for non-small-cell lung cancer after first-line chemotherapy regardless of epidermal growth factor receptor mutation: a review in Chinese patients.

PURPOSE: Gefitinib is a well known therapy for non-small-cell lung cancer (NSCLC). The purpose of this study was to review clinical reports of gefitinib as maintenance therapy after first-line chemotherapy regardless of epidermal growth factor receptor (EGFR) mutation, and assess its efficacy and safety in Chinese patients. MATERIALS AND METHODS: Systematic computerized searches of the following databases were conducted from the start of each database up to July 2012; these include Medline, EMBASE, CNKI and www.clinicaltrials.gov. Terms searched include 'non-small-cell lung cancer', 'NSCLC', 'lung cancer', 'lung tumor', 'gefitinib', 'Iressa', 'EGFR' and 'epidermal growth factor receptor tyrosine kinase inhibitors'. A total of 22 studies were reviewed. RESULTS: In general, the overall response rate (ORR), disease control rate (DCR) and one year survival (OYS) of gefitinib maintenance therapy were 30.89%, 67.5% and 50.6% respectively, in addition, the median overall survival (OS) and median progression free survival (PFS) were 13.09 and 7.88 months respectively. Moreover, ORR, DCR, median survival time (MST) and PFS of female, nonsmoking, lung adenocarcinoma (LAC) patients and patients with rash had higher performance than male, smoking, non-LAC patients and patients without rash (p < 0.05). The adverse events (AEs) were mainly skin rashes and diarrhea, most of which were grades 1 or 2 and were well tolerated. CONCLUSION: Gefitinib produced encouraging efficacy, safety and survival when delivered as maintenance therapy for NSCLC in Chinese patients after first-line chemotherapy regardless of EGFR mutation, especially for the patients who were female, non-smokers, LAC and with rash. Key limitations of this review include limited subgroup data, small sample sizes, and the lack of EGFR/KRAS data.