Abstract 4279
Background
Conventional chemotherapy agents such as doxorubicinare not curative and new therapies for metastatic sarcomas are urgently needed. Apatinib (YN968D1) as a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR-2) has been widely used as monotherapy or combined treatments. We performed a retrospective study with stage IV sarcoma cohort to investigate the efficacy of Apatinib with or without chemotherapy.
Methods
The information of 74 sarcoma patients in stage IV treated in Tianjin Medical University Cancer Hospital was collected and approved by the Institutional Review Board. Of these patients, 15 patients underwent Apatinib + traditional chemotherapy (combined group), and 59 received Apatinib as monotherapy (control group).
Results
We recruited 74 patients in this trial from Sep. 2015 to Apr. 2019. In the combined group, 6 of 15 patients (40.0%) recorded as partial response (PR), 7 of 15 patients (46.7%) recorded as stable disease (SD) and 2 patients (13.3%) was progressive disease (PD). The control group showed that 9 patients experienced PR (15.3%), 25 patients (42.4%) was SD and 25 patients (42.4%) was PD. The ORR (40.00% versus 15.25%, P = 0.034) and the DCR (86.67% versus 57.63%, P = 0.037) in the combined group showed significant higher than that of the control group. The median PFS of the combined group and control groups was 7.6 months and 7.9 months (P = 0.410). The median OS of the combined group and control group was 12.9 months and 17.3 months, respectively (P = 0.826). The mPFS and mOS shown no significant difference might due to the shorter follow-up time and small case number. Common AEs in combined group included hypertension (n = 7, 46.67%), hand-foot syndrome (n = 7, 46.67%), proteinuria (n = 8, 53.33%), anorexia (n = 4, 26.67%), fatigue (n = 4, 26.67%), transaminase increased (n = 4, 26.67%), diarrhea (n = 7, 46.67%), and anemia (n = 8, 53.33%), which all happened more frequently than in control group. No grade 4 AEs occurred, but 3 patients (20%) suffered from grade 3 AEs, which were mainly hypertension, hand-foot syndrome and proteinuria.
Conclusions
Chemotherapy combined with apatinib significantly increases the response rate and shows manageable adverse events.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
2935 - Correlation of progression free survival-2 and overall survival in solid tumors
Presenter: Paul Mainwaring
Session: Poster Display session 1
Resources:
Abstract
2273 - High performance of serial tumor biopsies in first in human (FIH) phase I trials.
Presenter: Jun Sato
Session: Poster Display session 1
Resources:
Abstract
5933 - Response rates and lesion-level progression patterns of solid tumor patients in an academic phase 1 program: implications for tumor heterogeneity
Presenter: Christopher Chen
Session: Poster Display session 1
Resources:
Abstract
3569 - Clinical Benefit and Response Rate in Early Phase Clinical Trials: First Report from a Single-Institution Study
Presenter: Antonio Marra
Session: Poster Display session 1
Resources:
Abstract
4139 - Patient (pt) selection for immunotherapeutic early-phase clinical trials (ieCTs): a single Phase I Unit experience
Presenter: Matteo Simonelli
Session: Poster Display session 1
Resources:
Abstract
4451 - Improving patient selection for immuno-oncology phase 1 trials: an external validation of five prognostic scores at Claudius Regaud Institute of Toulouse, Oncopôle (IUCT-O).
Presenter: Ghassan Al Darazi
Session: Poster Display session 1
Resources:
Abstract
1696 - Demonstrating the Changing Trends in Phase 1 Clinical Trials
Presenter: Christina Guo
Session: Poster Display session 1
Resources:
Abstract
3202 - Participation of Women in phase 1 oncology clinical trials
Presenter: Laura Vidal
Session: Poster Display session 1
Resources:
Abstract
4518 - Predictors for early trial discontinuation of patients with cancer participating in phase I clinical trials
Presenter: Joeri Douma
Session: Poster Display session 1
Resources:
Abstract
4368 - Safety of Tumor Treating Fields delivery to the torso: Meta analysis from TTFields clinical trials
Presenter: Federica Grosso
Session: Poster Display session 1
Resources:
Abstract