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Y. Shi
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MINI 25 - Trials, Radiation and Other (ID 142)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
- Presentations: 1
- Moderators:J.M. Clavero, R. Hassan
- Coordinates: 9/08/2015, 16:45 - 18:15, 702+704+706
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MINI25.02 - A Clinical Study on Intra-Thoracic Chemotherapy of Recombinant Human Endostatin Combined with Cisplatin for Malignant Pleural Effusion (ID 1304)
16:50 - 16:55 | Author(s): Y. Shi
- Abstract
- Presentation
Background:
To observe the efficacy and safety of intra-thoracic chemotherapy of 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 of Endostar 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 40～50 mg cisplatin and 60 mg Endostar twice a week, and 4 times were as a cycle at most. Single group was only treated with cisplatin, and other operations were the same as the combination group. RECIST1.0 hydrothorax evaluation criteria and NCI-CTC AE 3.0 version classification criteria were applied to evaluate the efficacy and adverse reactions, respectively.
Results:
The response rates of initially-treated patients in combination group and single group were 63.6% and 40.6%, respectively, and significant difference was presented (X[2]＝2.737, P＝0.022). The response rates of all patients in combination group and single group were 58.1% and 36.6%, respectively, and the difference was significant (X[2]＝4.877, P＝0.019). The progression-free survival (PFS) in combination group was dramatically longer than in single group (95 d vs. 53 d; X[2]＝3.872, P＝0.039). No adverse reactions at degree Ⅳ were observed in all groups. Incidences of adverse reactions including neutropenia, anemia, fatigue and increase of blood pressure in combination group were all higher than in control group, but there was no statistical significance (P＞0.05).
Conclusion:
Intra-thoracic injection of cisplatin alone is effective for treating patients with malignant pleural effusion, and its efficacy is better in combination with Endostar. Cisplatin combined with Endostar has a synergistic effect and better safety, being worthy of further popularization in clinic.
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ORAL 03 - New Kinase Targets (ID 89)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:F. Blackhall, R. Juergens
- Coordinates: 9/07/2015, 10:45 - 12:15, Mile High Ballroom 4a-4f
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ORAL03.01 - Anlotinib as 3rd-Line Treatment for Refractory Advanced NSCLC: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial (ID 2570)
10:45 - 10:56 | Author(s): Y. Shi
- Abstract
- Presentation
Background:
Anlotinib is a multi-target RTK inhibitor, especially on VEGFR2/3, EGFR, c-Kit, PDGF, FDFR, c-MET, with highly selective inhibition effect. This phase II study was to investigate efficacy and safety of anlotinib in refractory NSCLC patients
Methods:
Patients ≥18 years with metastatic or recurrent advanced NSCLC and ECOG status of 0–1 were randomized 1:1 to receive Anlotinib or placebo (Anlotinib 12mg/day, po, day 1-14 each 3-week) until progression, unacceptable toxicity, withdrawal or death. Patients had received first and second line treatment for advanced NSCLC. Patients were stratified by gender, smoking status and age. We used RECIST (version 1.1) criteria to assess response and progression. Primary endpoint was PFS in ITT population; secondary endpoints included ORR, OS, biomarkers and safety.
Results:
From Aug. 2013 to May 2014, we enrolled 117 patients from 13 centers, including 60 patients to anlotinib arm and 57 patients to placebo. Baseline characteristics were similar in both treatment groups. PFS was prolonged with anlotinib 4.83 month vs placebo 1.23 months (HR 0.32, 95% CI 0.20–0.51, p<0.0001). ORR was improved with addition of anlotinib: 10% vs 0% with placebo (p<0.027).DCR was 83.3% with anlotinib vs 31.5% with placebo (p<0.0001). mOS was prolonged with Anlotinib 10.33 months vs placebo 6.3 months. (HR, 0.656; 95% CI, 0.411 to 1.048; P = 0.0776; Cutoff date: April 12, 2015. This mOS is an estimated data, OS events for both arms still not reach 75%). OS rate of >12 months is 22.8% in placebo arm and 38.3% in anlotinib arm. AEs occurred more frequently with anlotinib than placebo; the most common AEs of any grade were hypertension (53.33%), increased TSH (36.67%), hand foot syndrome (28.33%), increased TG (26.67%), increased TC (25%), cough (21.67%), diarrhea (21.67%), increased LDL (16.67%), hemoptysis (16.67%) oral mucositis (13.33%), and sore throat (13.33%). Grade III/IV treatment-related AEs increased 16.4% in anlotinib group (anlotinib: 21.6% , placebo: 5.3%, p=0.0140).
Conclusion:
This study confirms that anlotinib to third-line platinum-based chemotherapy appears to provide significant PFS benefits in Chinese patients with refractory advanced NSCLC compared with placebo. No serious safety concerns were reported in the study.
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