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J. Bi
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P2.04 - Poster Session with Presenters Present (ID 466)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.04-025 - Recombinant Human Endostatin and/or Cisplatin in Treatment of Malignant Hydrothorax and Ascites: A Multicenter Randomized Study (ID 5615)
14:30 - 14:30 | Author(s): J. Bi
- Abstract
Background:
To evaluate the clinical efficacy and safety of intra-pleural injection of recombinant human endostatin (Endostar) and/or Cisplatin in treatment of malignant hydrothorax and ascites.
Methods:
A total of 317 patients with more than moderate amount of pericardial effusion malignant hydrothorax and ascites were randomly divided into group A (Endostar group, n=105), group B (Cisplatin group, n=104) and group C (Endostar combined Cisplatin, n=108). After puncture and drainage, Endostar, 45 mg per time by intrathoracic injection or 60 mg per time by intraperitoneal injection was performed in Group A. Cisplatin, 40 mg per time by intra-pleural injection on day 1, 4 and 7, was administrated in group B. Group C was administrated with combined therapy of Endostar and Cisplatin.
Results:
A total of 317 patients were included in full analysis set (FAS), and 275 patients were included in per-protocol set (PPS) . There were 298 cases and 273 cases qualified for evaluation on drug efficacy in FAS and PPS respectively. There was a significant difference in ORR among three groups (P＜0.05), and ORR was higher in Group C than that in Groups A and B (P＜0.05 or P＜0.01). Patients without intracavitary treatment history, with hydrothorax, female, without systemic chemotherapy, with initial treatment on effusion, with sufficient drainage, with hemorrhagic effusion and without diagnosis of gastric carcinoma had better outcome in ORR after treatment (P＜0.05 or P＜0.01). In those with hemorrhagic effusion, the ORRs in Groups A and C were significantly higher than that of Group C (P＜0.01). The median TTP was 68.869 d, 44.951 d, 69.030 d in Groups A, B and C, respectively, with a significant difference (P＜0.01), and was shorter in Group B than that in Groups A and C (P＜0.05 or P＜0.01). The proportion of patients with improved QOL and KPS in Group A was higher than that in Groups B and C after third and sixth administration, respectively (P＜0.05 or P＜0.01). The incidence of adverse reactions was lower in Group A than that in Group B (P＜0.01), but no significant difference was shown between Groups B and C (P＞0.05).
Conclusion:
Intra-pleural injection of Endostar is potentially effective in treatment of patients with malignant hydrothorax and ascites, especially those with hemorrhagic effusion. It shows a synergistic effect with Cisplatin in improving the clinical efficacy, TTP and QOL, but without increasing the risk of adverse reactions.
