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Q. Shi
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P2.14 - Radiotherapy (ID 715)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Radiotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.14-011 - Recombinant Human Endostatin (Endostar) Combined with Concurrent Intensity Modulated Radiation Therapy for Elderly Local Advanced NSCLC (ID 9246)
09:30 - 09:30 | Author(s): Q. Shi
- Abstract
Background:
Recombinant human endostatin (Endostar) is an angiogentic medicine with mild toxicity and strong efficacy in systematic treatment of NSCLC. Recently, several studies proved that Endostar combined with radiotherapy could enhance NSCLC treatment efficiency according to mechanism of microenvironment normalization. However, this combination therapy has not tested in elderly population up to now. In this trial, we observed the efficacy and safety of Endostar combined with concurrent intensity modulated radiation therapy (IMRT) for inoperable elderly local advanced NSCLC.
Method:
This trial was perspective, open‐labeled study. A total of 40 inoperable elderly local advanced NSCLC were randomly assigned into two arms. Twenty patients received IMRT alone in control arm, the dosage of primary tumor and mediastinal lymph node metastasis was DT 60 66 G/30 33/6‐ 7w. Intravenous infusion of Endostar concurrently inducted with IMRT in experimental arm. Endostar is administrated in 15mg once daily for two weeks followed by one week interval, repeated twice. The efficacy was evaluated according to RECIST 1.1 criteria and recorded ORR, DCR, mDFS and mOS. Safety and efficacy evaluation were performed based on NCI CTC v4.0 criteria.
Result:
In the experimental arm, 15 cases were PR and 5 cases were SD. Although a superiority of patient number showed comparing to the control group, there is no statistical difference between two arms either ORR (75.0% vs. 80.0%, p=0.326) or DCR (100% vs. 90.0%, p = 0.031). The mDFS (9.4M vs. 6.8M, p=0.286) and mOS (17.5M vs. 14.1M, p=0.052) in the two groups were not significantly different. One year survival rate were 79.4% vs 61.1%, and 2 year survival rate was 9.0% vs 0% in experimental arm and control arm, respectively. In the experimental arm, risk of disease progression decreased by 35% by using Endostar plus IMRT, HR = 0.649 (95% CI, 0.288 to 1.464), meanwhile the risk of death decreased by 66%, HR = 0.435 (95% CI, 0.184 to 1.030) . Most toxicities occured in two arms were grade 1/2, there is no grade 3/4 adverse events occured. In contrast to the control arm, no difference in safety events was found in the Endostar plus IMRT group.
Conclusion:
Endostar combined with concurrent IMRT for inoperable elderly local advanced NSCLC had a good safety and activity profile. One and two year survival rates were all increased, with a tendency of prolonging median survival time. Therefore the conclusion is worth to further confirmed in similar clinical study but with larger sample size.
