HU Xing-sheng, WANG Hong-yu, ZHANG Chang-gong, LIU Peng, WANG Yan, LI Jun-ling, SHI Yuan-kai
Objective : To observe the clinical efficacy and safety of intra-thoracic chemotherapy with recombinant human endostatin (endostar) combined with cisplatin in the treatment of malignant pleural effusion. Methods : A total of 84 patients with malignant pleural effusion were randomly divided into intra-thoracic chemotherapy with endostatin combined with cisplatin group (combination group) and single cisplatin group (single group). Before treatment, pleural effusion was completely resolved. Combination group was treated with intra-thoracic injection of cisplatin 40~50 mg and endostatin 60 mg, twice/week and 4 times as a cycle at most, while single group with single cisplatin 40~50 mg,twice/week, and 4 times as a cycle.WHO hydrothorax evaluation criteria and NCI-CTC AE 3.0 version classification criteria were selected to evaluate the clinical efficacy and adverse and toxic responses, respectively. Results : The effective rates of combination group and single group with initial treatment were 63.6% and 40.6%, respectively, and there was significant difference (X 2=2.737, P =0.022). The effective rates of above groups in the whole groups were 58.1% and 36.6%, respectively, and the difference was significant (X 2=4.877, P =0.019). The progression-free survival of combination group was 95 d, evidently higher than which was 53 d in single group (X 2=3.872, P =0.039). No degree IV adverse and toxic response was observed in the whole groups.However, the rates of adverse responses (including neutropenia, anemia, fatigue and increase of blood pressure,etc.) in combination group were higher than in control group, but there was no significant difference (P > 0.05). Conclusion : Intra-thoracic injection of single cisplatin was effective in treating patients with malignant pleural effusion, and is more superior when combined with endostatin.Additionally, the combination of the above two drugs had synergistic action and better safety, deserved to be further promoted in clinic.