The Efficacy Observation Of Albumin-paclitaxel In Patients With Advanced Gastric Cancer And Comparison Of Its Efficacy With Docetaxel

Background and objective: Single-paclitaxel chemotherapy,as one of the second-line standard treatment strategies for advanced gastric cancer patients,has a better effect on stage IV gastric cancer patients with ascites or peritoneal mass.However,the high incidence of allergic reactions and the pretreatment before using limit the widespread use of paclitaxel.The combination of human serum albumin and paclitaxel forms albumin-paclitaxel through specific chemical structure,which greatly improves the solubility of paclitaxel in peripheral blood and significantly increases the bioavailability of paclitaxel.Compared with other different types of paclitaxel,the use of albumin-paclitaxel can also shorten infusion time.ABSOLUTE study confirmed the effect of albumin-paclitaxel and established the status of albumin-paclitaxel in the second-line scheme of gastric cancer.Another II stage clinical trial on gastric cancer conducted by Professor Xu Ruihua’s team,the combination of S1 and albumin-paclitaxel as a first-line regimen for advanced gastric cancer,further confirmed the efficacy of albumin-paclitaxel.The purpose of this study is to explore the efficacy of albumin-paclitaxel in the treatment of advanced gastric cancer and analyze the factors related to the prognosis of patients with advanced gastric cancer,and to study the advantages of albumin-paclitaxel versus docetaxel in the second-line treatment of advanced gastric cancer.Methods: In the first part,the real world study method was used to study the patients using albumin-paclitaxel monotherapy or combined chemotherapy.RECIST1.1 was used to evaluate the efficacy.The main efficacy indicators are PFS,the secondary indicators are OS,ORR,DCR and security.SPSS25.0 was used to make survivalcurves and establish Cox proportional regression model.All the factors that may affect the prognosis of advanced gastric cancer patients treated with albumin-paclitaxel were first analyzed by single-factor statistical analysis,and then risk factors with P<0.05 were included in the multi-factor analysis.Common Terminology Criteria for Adverse Events was used to grade the side effects of patients.In the second part,the tendency matching score was used to carry out 1:1 matching between the docetaxel patients and the albumin-paclitaxel patients.The matching baselines included gender,age,primary tumor site,tumor differentiation degree,presence or absence of ascites,presence or absence of peritoneal mass,Eastern Cooperative Oncology Group and BMI.The main observation index was PFS,and the secondary observation index was OS and drug-related adverse reactions.The survival curve was plotted by Kaplan-Meier,and the statistical differences between the two groups were compared and evaluated by the log-rank test.The CTCAE V4.0 standard was used to evaluate the degree of side effects and graded the degree of side effects in the two groups.Results: From March 1,2018 to September 30,2019,92 patients met the criteria and were included in our study.Other chemotherapeutic drugs were added after 1-2 cycles with the single albumin-paclitaxel for 57 patients,and 35 patients were always treated with albumin-paclitaxel combined with the basic chemotherapeutic drugs.40 patients were treated with albumin-paclitaxel as first-line regimen,and 52 patients were treated with albumin-paclitaxel as a second-line regimen.The median PFS of all enrolled patients was 4.67 months and the median OS was 7.45 months.The total ORR of patients with measurable lesions was 20.2%,DCR was 70.2%,ORR of first-line patients was 25.7%,DCR was 74.3%,ORR of second-line patients was16.3%,and DCR was 67.3%.ECOG,tumor differentiation,ascites and first line or second line were significantly correlated with the prognosis of the patients.The median PFS and OS of patients with ECOG=0-1 were both longer than ECOG=2patients(5.21 months vs 4.12 months,P<0.001.9.54 months vs 5.67 months,P<0.001).The median PFS and OS of patients with high or moderate differentiated gastric cancer were both longer than those with low differentiated gastric cancer(5.73 months vs 4.46 months,P<0.001.9.34 months vs 6.09 months,P<0.001).The median PFS and OS of patients with ascites were significantly shorter than those without ascites(4.06 months vs 5.37 months,P<0.001.5.12 months vs 10.8 months,P<0.001).PFS and OS of patients can be extended by using albumin-paclitaxel as first-line scheme compared with albumin-paclitaxel as second-line scheme(5.24 months vs4.32 months,P<0.001.12.0 months vs 5.77 months,P<0.001).Forty-six pairs of patients treated with albumin-paclitaxel or docetaxel as the second-line regimen were obtained by the propensity matching score.The PFS of patients in the albumin-paclitaxel group was statistically different from those in the docetaxel group(5.51 months vs 4.59 months,P=0.041)but there was no significant difference in OS between two groups.Conclusion: Patients with advanced gastric cancer treated with albumin-paclitaxel had a PFS of 4.67 months and an OS of 7.45 months.ORR was 20.2% and DCR was70.2%,The first-line use of albumin-paclitaxel had an ORR of 25.7% and DCR of74.3%,PFS was 5.24 months and OS was 12.0 months.The second-line use of ORR was 16.3% and DCR was 67.3%,PFS was 4.32 months and OS was 5.77 months.ECOG score,tumor differentiation,ascites,first-line or second-line are the main risk factors affecting the prognosis of patients with advanced gastric cancer.Albumin-paclitaxel as a second-line treatment plan can significantly prolong the PFS of patients compared with the efficacy of docetaxel.Patients with advanced gastric cancer can choose albumin-paclitaxel as second-line treatment scheme.