Clinical Trail Of Extracorporeal High-frequency Hyperthermia Combined With Pleural Cavity Infusion Of Arsenic Trioxide In Patients With Malignant Pleural Effusion

Objective:To observe the efficacy of extracorporeal high-frequency hyperthermia(referred to as hyperthermia)combined with pleural cavity infusion of Arsenic Trioxide in patients with malignant pleural effusion and improving the quality of life.Methods:Forty-five patients with malignant pleural effusion were enrolled. The patients were divided into three groups:A arm,B arm and C arm.To calculate the pleural effusion,all the patients were examined by X-ray or type B ultrasonic.All the patients were given thoracic close drainage with central intravenous catheter(produced by Blaun Company).The first drainage of the pleural effusion should be less than 600ml and it was drained persistently every day,but clamping without drainage.After the accumulation of pleural fluid had been adequately drained,A arm received alternate day hyperthermia for four times combined with intrapleural injections of arsenic trioxide 20mg; B arm were treated only with intrapleural injections of arsenic trioxide 20mg, without hyperthermia.While C arm were only given alternate day hyperthermia for four times without arsenic trioxide.All the patients were examined by type-B ultrasonic or X-ray after four weeks to record the rudimental pleural effusion.Type HG-2000 high-frequency hyperthermia in vitro were adopted which were produced by He Jia Corporation in Zhu Hai.Its frequency was 13.56MHz, and maximum output power was 1200 watt.The patients lay on the back after examined by type-B ultrasonic or X-ray.Two round plate electrodes placed to the chest and back of the patients respectively.The distance between the plate electrodes and the body surface were 3 to 7cm.And there was a aqueous capsule between them in order to enhance their coupling as well as cooling.According to the tolerance of patients,the temperature was set up between 42.5℃and 43℃,output power was between 40%to 60%and the time was 60 minutes per time.Then according to the criteria to the efficacy of pleural effusion, chemotherapeutic grading criteria of toxic reactions of malignancy and the Functional Living Index of Cancer,the response of the pleural effusion, quality of life,toxicity were evaluated between the three arms respectively.Results:From Jan.2007 to Mar.2008,forty-five patients with malignant pleural effusion were enrolled in this study.A patient was eliminated for uncontrolled brain metastasis.There were 15 cases were evaluated in A arm, 16 cases in B arm and 14 cases in C arm.In the term of efficacy of pleural effusion,9 patients achieved complete response,4 patients obtained partial response and 2 patients underwent no change in A group.While in B group,4 patients achieved complete response,6 patients obtained partial response and 6 patients underwent no change.In C arm,3 patients achieved complete response, 4 patients obtained partial response and 7 patients underwent no change.There was statistically significant difference between the three groups(P＜0.05) in the efficacy of pleural effusion.The efficacy of pleural effusion of A arm was better than B arm' s and C arm' s(P＜0.05).The overall response rate of the three group was 86.7%,62.5%,50%respectively.And the overall response rate of A arm was higher than B arm' s and C arm' s.As to the Karnosky Performance Status,the Karnofsky score were all increased in three groups after treatment.There was statistically significant difference between prior-treatment and post-treatment respectively in the term of KPS scores of the three arms(P＜0.01).The changes of KPS score of the three groups had significant difference(P＜0.01).The change of KPS score of A group was higher than B arm' s and C arm' s.The clinical symptoms and quality of life improved evidently in A arm,especially in the filed of PWA(Physical well-being and ability)and GQL.Compared with prior-treatment,statistically significant difference was present in A arm(P＜0.01).There was statistically significant difference in the term of HC(Hardship due to cancer)(P＜0.01).But in the filed of PCW(Psychological well-being),PCW(Psychological well-being), SW(Social well-being),NA(Nausea),there was no statistically significant difference(P＞0.05).Compared with prior-treatment respectively,there was no statistically significant difference in the terms of PWA,PCW,SW,NA,and GQL(P＞0.05)in B arms and C arms.After treatment,statistically significant difference was present in the filed of PWA and GQL(P＜0.01)between three groups.But there were no statistically significant difference in the other fileds.In toxicity,the three groups had no blood,heart,liver,kidney and other toxic reactions.One cases underwentⅠdegree pain response in A arm. There was no statistically significant difference between prior-treatment and post-treatment(P＞0.05).One cases underwentⅠdegree pain response in B arm. There was no statistically significant difference between prior-treatment and post-treatment(P＞0.05).There was no statistically significant difference in pain response between three groups after treatment(P＞0.05).The level of LDH in the pleural effusion of A arm had statistically significant difference between prior-treatment and post-treatment(P＜0.01).And the level of post-treatment was higher than that of prior-treatment.The level of LDH in the pleural effusion of B arm had statistically significant difference between prior-treatment and post-treatment(P＜0.01).And the level of post-treatment was higher than that of prior-treatment.The level of LDH in the pleural effusion of C arm had statistically significant difference between prior-treatment and post-treatment(P＜0.05).And the level of post-treatment was higher than that of prior-treatment.The changes in the level of LDH between three groups had significant difference(P＜0.01).The change in the level of LDH in A arm was higher than C arm' s.The change in the level of LDH in B arm was also higher than C arm' s.Compared with the ADA in the pleural effusion of three group before treatment respectively,no significant difference occurred in three groups(P＞0.05).The changes in the level of ADA between three groups had no significant difference(P＞0.05).The level of CEA in the pleural effusion of A arm had statistically significant difference between prior-treatment and post-treatment(P＜0.01).And the level of post-treatment was lower than that of prior-treatment.The level of CEA in the pleural effusion of B arm had statistically significant difference between prior-treatment and post-treatment(P＜0.01).And the level of post-treatment was lower than that of prior-treatment.The level of CEA in the pleural effusion of C arm had no statistically significant difference between prior-treatment and post-treatment(P＞0.05).The changes in the level of CEA between three groups had significant difference(P＜0.01).The change in the level of CEA in A arm was higher than B arm' s and C arm' s respectively.Conclusion: 1.The efficacy to malignant pleural effusion of extracorporeal high-frequency hyperthermia combined with pleural cavity infusion of Arsenic Trioxide is better than those of the method of pleural cavity infusion of Arsenic Trioxide and high-frequency hyperthermia.The first method has combined synergies.It is worth promoting in the clinical application.2.Compared with the other therapies,the combination of extracorporeal high-frequency hyperthermia and pleural cavity infusion of Arsenic Trioxide is better in relieving symptoms and improving survival quality of life.3.The treatment of extracorporeal high-frequency hyperthermia combined with pleural cavity infusion of Arsenic Trioxide is well tolerated with no adverse toxic reaction.