Apatinib combined with paclitaxel-based chemotherapy in patients with taxane-resistant advanced gastric cancer: a single-arm exploratory study

Abstract

Background: Apatinib combined with chemotherapy might be effective and safe for the management of advanced gastric cancer, but the available data are limited. To investigate the efficacy and safety of apatinib in combination with paclitaxel (PTX) alone or POF (PTX, oxaliplatin, and 5-fluorouracil) in patients with taxane-resistant advanced gastric cancer.

Methods: Patients with taxane-resistant advanced gastric cancer were enrolled in the single-center, open-labeled, single-arm, exploratory study (ClinicalTrials.gov #NCT02697838). Apatinib was administered at 850 mg po in combination with weekly PTX or the POF regimen. The primary endpoint was the objective response rate (ORR). The secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), the time to tumor progression (TTP), and safety.

Results: Twenty participants were recruited from 08/2016 to 01/2018. The duration of the study treatment was 2.07 (0.03-16.2) months. The median follow-up was 24.8 (0.3-26.0) months. The reasons for termination of treatment were disease progression (n=6), adverse events (AEs) (n=5), and patients' will (n=9). The ORR was 11.1% (95% CI: 1.4-34.7%) and the DCR was 77.8% (95% CI: 52.4-93.6%). The median PFS was 3.5 (95% CI: 1.9-5.1) months, the median OS was 4.7 (95% CI: 2.0-7.3) months, and the median TTP was 4.2 (95% CI: 0.562-7.838) months. All 20 (100%) patients had AEs, 17 (85%) had apatinib treatment-emergent AEs (TEAEs), and 18 (90%) had chemotherapy TEAEs. The main grade 3-4 TEAEs were neutropenia, leukopenia, hypertension, and anemia.

Conclusions: This preliminary study suggests that apatinib combined with PTX or POF might be effective and tolerable in patients with chemotherapy-refractory gastric cancer. Studies are necessary to confirm the results.

Trial registration: ClinicalTrials.gov #NCT02697838.

Keywords: Apatinib; advanced stage; drug resistance; gastric cancer; paclitaxel (PTX).

Conflict of interest statement

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/atm-20-5841). Dr. Lin reports grants from the Fujian Provincial Health Technology Project, grants from Natural Science Foundation of Fujian Province, grants from Beijing Xisike Clinical Oncology Research Foundation, during the conduct of the study; Dr. Zhao reports grants from Natural Science Foundation of Fujian Province, during the conduct of the study. The other authors have no conflicts of interest to declare.

2020 Annals of Translational Medicine. All rights reserved.

Figures

Figure 1

Waterfall plot of best change in tumor dimension.

Figure 2

Kaplan-Meier plot of progression-free survival (A) and overall survival (B). The median progression-free survival was 3.5 (95% CI: 1.9–5.1) months. The median overall survival was 4.7 (95% CI: 2.0–7.3) months.