| Introduction:Malignant pleural effusion(MPE)is most commonly seen with lung cancer invading the pleura,as a common symptom and concomitant manifestation of lung cancer metastasis.Non-small cell lung cancer(NSCLC)is the most common type of lung cancer,accounting for about 80% of cases.Chest medicine injection is a new treatment of malignant pleural effusion.The domestic drug Recombinant Human Endostatin,also known as Endostar,has the effect of inhibiting tumor angiogenesis.Endostar,as a commonly used drug for chest medicine injection in China,inhibits the formation of malignant pleural effusion by inhibiting tumor hyperosmotic angiogenesis through a variety of mechanisms,and has achieved good efficacy in clinical practice.The commonly used dose of Endostar is 45mg/ time,and it has been reported that the higher dose of 60 mg Endostar has better effect and good safety,but the clinical efficacy and safety of the higher dose of Endostar are unknown.Object:By comparing different administration regimens,the shortterm efficacy and safety of high-dose Endostar(90mg/ time,first and fourth day,weekly course)in NSCLC patients with MPE were investigated,so as to explore a new direction for the treatment of malignant pleural effusion.Methods:A total of 115 NSCLC patients with MPE were randomly divided into group A,B,C and D.After chest ultrasound and positioning were completed,thoracic puncture was performed and A single-cavity drainage tube was placed for drainage.All the 4 groups were given medicine on the 1st and 4th day after full drainage,and the course of treatment was one week.Group A received intrapleural injection of highdose Endostar,90mg/ time;Group B was infused with Endostar 45mg/ time.Group C received intrapleural injection of cisplatin 40mg/ time.Group D was given Endostar 45mg/ time and Cisplatin 40mg/ time simultaneously.Objective response rate(ORR),changes in Karnofsky functional status score(KPS),adverse reactions,changes in arterial blood oxygen partial pressure and PFS were compared in each group.Results:The clinical baseline characteristics of the 4 groups were balanced.The ORR of the four groups were 83.33%,46.43%,42.86% and72.41%(P=0.002).The ORR of group A was higher than that of group B and C(P=0.003,P=0.001).ORR of group A and group D were roughly the same(P=0.312).The ORR of group B and group C were the same(P=0.788).The ORR of group D was higher than that of group B and C(P=0.046,P=0.024).The proportion of people in the four groups who obtained improvement in quality of life was 80.00%,50.00%,46.43% and75.86%,respectively.The proportion of quality of life improvement in group A was higher than that in group B and C(P =0.016,P =0.008).There was no significant difference in the proportion of improvement in quality of life between group A and group D(P =0.701).The proportion of quality of life improvement in group B and group C was the same(P =0.789).The proportion of quality of life improvement was different between group B and group D(P =0.043),and group D was higher than group B.The proportion of improvement in quality of life in group D was higher than that in group C(P =0.022).Four groups of adverse events for 14 cases(46.67%),12 cases(42.86%),21 cases(75.00%),22 cases(75.86%),are Ⅰ～ Ⅱ degrees.The adverse reactions returned to normal or significantly relieved after symptomatic treatment or the end of chest medicine injection.Pairwise comparison showed that the incidence of adverse events in group A and B was the same(P =0.771).The incidence of adverse events in group A was lower than that in group C and D(P =0.028,P =0.022).The incidence of adverse events in group B was lower than that in group C and D(P=0.014,P=0.011).The incidence of adverse events was the same in group C and D(P =0.940).After treatment,the increase of Pa O2 in group A was the most obvious,followed by that in group D,followed by that in group B and C,and the difference was statistically significant(P<0.05).The median PFS in the four groups was 87,61,49 and 71 days,respectively.The median PFS of group A was longer than that of group B,C and D(P=0.040,P<0.001,P=0.022);The median PFS of group B was longer than that of group C(P=0.021),and there was no statistical significance between group B and group D(P=0.081).The median PFS in group C was shorter than that in group D(P=0.032).Conclusions:1.There was no significant difference in efficacy and quality of life improvement between 90 mg Endostar monotherapy and45 mg Endostar combined with 40 mg Cisplatin in the treatment of NSCLC with MPE,but it was better than 45 mg Endostar and 40 mg Cisplatin monotherapy.2.90 mg Endostar monotherapy has the same safety as 45 mg Endostar monotherapy,which is superior to other dosage regimens,and has the best performance in improving respiratory function and prolonging patients’ PFS. |
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