Abstract 4890
Background
A prospective, multicenter, non-intervention registered study of apatinib is being conducted in advanced gastric cancer patients (pts). The result of interim analysis on efficacy and safety was released in ESMO 2017 Congress (695P). Herein, we mainly aimed to identify pts who benefit from apatinib treatment.
Methods
Pts with advanced or metastatic adenocarcinoma of stomach or gastro-esophageal junction who received apatinib administration were included in this real world study. The subgroup analyses were stratified by numbers of metastatic sites, ECOG PS, dosage of apatinib, and occurrence of adverse events (AEs).
Results
As of January 2018, data on 321 pts were available for final analysis. The median progression free survival (mPFS) and median overall survival (mOS) were 4.0 mos and 8.2 mos, respectively. 239 pts (74.5%) reported AEs. Main AEs were proteinuria (17.1%), hypertension (15.9%), and hand-foot syndrome (8.7%). As in table, the mPFS and mOS of pts with ≤2 metastatic sites were longer than those of pts with >2 metastatic sites (mPFS: p = 0.0087, mOS: p = 0.0006). For pts with ECOG PS 0, 1, and ≥2, the differences among groups were significant (mPFS, p < 0.001; mOS, p = 0.0316). Among different dose groups, dose ≥500 mg got longer mPFS (p < 0.001) and mOS (p = 0.0059). What’s more, pts who reported proteinuria, hypertension, hand-foot syndrome, or leukopenia had longer mPFS (ps < 0.05) and mOS (ps < 0.05) compared with those who didn't.Table: 682P
Prognostic factors associated with apatinib treatment
| n | mPFS, mos | p | mOS, mos | p | ||
|---|---|---|---|---|---|---|
| Metastatic site | ≤2 | 199 | 5.0 | 0.0087 | 9.1 | 0.0006 |
| >2 | 67 | 4.0 | 6.6 | |||
| ECOG PS | 0 | 80 | 5.7 | <0.001 | 8.7 | 0.0316 |
| 1 | 168 | 4.3 | 8.2 | |||
| ≥2 | 73 | 3.0 | 6.6 | |||
| Dosage, mg | 250 | 111 | 3.4 | <0.001 | 7.7 | 0.0059 |
| 500 | 187 | 4.5 | 9.5 | |||
| >500 | 23 | 5.0 | 11.8 | |||
| Proteinuria | No | 266 | 3.6 | 0.0003 | 8.0 | 0.0035 |
| Yes | 55 | 5.6 | 9.2 | |||
| Hypertension | No | 270 | 3.6 | <0.001 | 8.0 | 0.0212 |
| Yes | 51 | 6.0 | 8.8 | |||
| Hand-foot syndrome | No | 293 | 3.8 | 0.0015 | 8.0 | <0.001 |
| Yes | 28 | 6.2 | 11.3 | |||
| Leukopenia | No | 261 | 3.5 | <0.001 | 7.7 | <0.001 |
| Yes | 60 | 7.3 | 9.6 |
Conclusions
The real world study confirms that apatinib is safe and effective for advanced gastric cancer pts. Factors associated with better prognosis were ≤2 metastatic sites, ECOG PS 0/1, dose ≥500 mg, and occurrence of proteinuria, hypertension, hand-foot syndrome, or leukopenia.
Clinical trial identification
ChiCTR-OPN-15006601, release date June 11, 2015.
Legal entity responsible for the study
Jiangsu Cancer Hospital.
Funding
Has not received any funding.
Editorial Acknowledgement
There is no editorial assistance.
Disclosure
All authors have declared no conflicts of interest.
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