169P - Apatinib reverses resistance of paclitaxel-containing regimens in advanced gastric cancer: A phase II study

Abstract

Background: In the previous observational study, apatinib plus paclitaxel (PTX)-based regimens showed a progression-free survival (PFS) benefit of 4.1 months in 7 gastric cancer patients (pts) resistant to PTX-contained chemotherapy (ASCO-GI 2017, abstr. 89). Hence, we conducted a single-arm phase II clinical trial (Ahead-G323) to confirm apatinib in reversing resistance of PTX-containing regimens. The intermediate analysis has been reported in ASCO 2018 (abstr. e16055). Herein, we further released the updated data. Methods: Advanced or metastatic gastric cancer pts with measurable lesions resistant to PTX-containing regimens (disease progression during or within 3 months after chemotherapy) were recruited. According to ECOG performance status (PS) and drug resistance profile, pts received apatinib (850 mg or 750 mg, po, qd) combined with PTX alone (80 mg/m2, d1, d8, and d15; q4w), POF (PTX 135 mg/m2, oxaliplatin 85 mg/m2, and leucovorin 400 mg/m2, d1; 5-FU 2400 mg/m2 for 46 h; q2w) or other PTX-containing regimen. Results: As of 6/21/2018, all 20 preplanned pts were enrolled. The baseline characteristics are shown in the table. Seventeen pts were available for response evaluation: 5 got partial response, 9 had stable disease, and 3 had progressive disease, resulting in an overall response rate of 29.4% and a disease control rate of 82.4%%, at best response. The median PFS was 4.2 (95%CI, 2.0–6.8) months. The 6-month PFS was 34.6% (95%CI, 9.7%–59.5%). Pts were still in follow-up. Moreover, the most common adverse events (AEs) were neutropenia (80.0%), leukopenia (75.0%), and hypoproteinemia (65.0%). The most common grade 3/4 AEs include neutropenia (30.0%), leukopenia (30.0%), and hypertensionTable169P Baseline characteristicsCharacteristicsN (%)Total20Age, yearsMedian (range)54.50 (45.5, 61.0)GenderFemale8 (40.0%)ECOG PS05 (25.0%)115 (75.0%)Metastatic lesion≤212 (60.0%)>28 (40.0%)Prior chemotherapy, lines17 (35.0%)28 (40.0%)35 (25.0%) Open table in a new tab (30.0%). Conclusions: This study demonstrated that apatinib combined with PTX-containing regimen could bring benefit on responses and survival for advanced or metastatic gastric cancer pts resistant to PTX-containing regimen. Clinical trial identification: NCT02697838, March 3, 2016. Legal entity responsible for the study: Fujian Cancer Hospital. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.