Abstract 3172
Background
Anti-VEGF target therapy is proven to be effective both in second and third line treatment in metastatic gastric cancer. As for Apatinib, which is the tyrosine kinase inhibitor showed highly affinity for VEGFR2, could not only reverse paclitaxel resistance but also improve the R0 resection rate in previous unresected gastric cancer in conversional settings. However, the safety and efficacy of Apatinib in combination with docetaxel plus S1 in the first line treatment of metastatic gastric cancer is unknown and worthy of investigation.
Methods
The study was expected to enroll 48 patients diagnosed with metastatic gastric cancer. Each participant was supposed to finish six cycles of chemotherapy plus apatinib (docetaxel 75mg/m2, d1, Q3W; S1 according to BSA: <1.25 40mg po bid; 1.25∼1.5 50mg po bid; >1.5 60mg po bid; d1-14, Q3W; apatinib 500mg po qd). The toxicity was determined according to CTCAE 4.0. Efficacy assessed every two cycles (6 weeks) during the study and every 2 months after finish the study. The primary endpoint was progression free survival (PFS). The secondary endpoint was OS, the objective response rate (ORR), the disease control rate (DCR). The tumor response was determined according to RECIST 1.1 criteria.
Results
From July 2017 to April 2019, 32 patients were enrolled. 11 female and 21 male, median age 54 years old, median matastasis organs are 3.5. 80% patients reported adverse events (AEs), most of them are 1-2 AEs. The incidence of grade 3-4 AEs was 35.7%, mainly oral mucositis (23.3%) and myelosuppression (21.5%). For ITT polulation, 24 patients were evaluable for response, 13 patients achieved PR, 4 patients achieved SD, 7 patients experienced PD. The ORR is 54.2%, the DCR is 70.8%. 8 out of 11 per protocol patients have reached primary endpoint, the median PFS is near 6.5 month.
Conclusions
Combination therapy with docetaxel and S1 plus apatinib as the first line treatment could be well tolerant, the spectrum of toxicity were not exceeding expectation. This modality also exhibits promising efficacy,which might provide a new therapeutic strategy for metastatic gastric cancer.
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
2674 - Multicenter Phase I Trial of Trastuzumab Emtansine (T-DM1) in Combination with Non-Pegylated Liposomal Doxorubicin (NPLD) in HER2[+] Metastatic Breast Cancer (MBC). THELMA Study
Presenter: Elena López-Miranda
Session: Poster Display session 2
Resources:
Abstract
1398 - Phase 1 study of liposomal formulation of eribulin (E7389-LF) in patients (pts) with advanced solid tumors: primary results of dose-escalation part
Presenter: Noboru Yamamoto
Session: Poster Display session 2
Resources:
Abstract
5818 - Polo-like Kinase 1 inhibitor onvansertib synergizes with paclitaxel in breast cancer carrying p53 mutation
Presenter: Antonio Giordano
Session: Poster Display session 2
Resources:
Abstract
5927 - Phase 1b study of heat shock protein 90 inhibitor, onalespib in combination with paclitaxel in patients with advanced, triple negative breast cancer (NCT02474173).
Presenter: Robert Wesolowski
Session: Poster Display session 2
Resources:
Abstract
1695 - Impact of pertuzumab and T-DM1 on prognosis of HER2-positive metastatic breast cancer (MBC) and factors affecting their efficacy: results from the AGMT_MBC-Registry
Presenter: Simon Peter Gampenrieder
Session: Poster Display session 2
Resources:
Abstract
1742 - Clinical profile and outcome of HER2 positive breast cancer patients with brain metastases treated with HER2 targeted therapy: Real world experience.
Presenter: Prabhat Bhargava
Session: Poster Display session 2
Resources:
Abstract
1846 - Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer: results of single arm phase IV COMACHI study
Presenter: Norikazu Masuda
Session: Poster Display session 2
Resources:
Abstract
5385 - Anti HER-2 Therapies and Left Ventricular Dysfunction The Renaissance Study
Presenter: ANDRES DANIELE
Session: Poster Display session 2
Resources:
Abstract
3320 - Safety and efficacy of T-DM1 in 128 patients with advanced HER2+ breast cancer: The Royal Marsden experience.
Presenter: Nicolò Battisti
Session: Poster Display session 2
Resources:
Abstract
4540 - Use of trastuzumab emtansine (T-DM1; K) after pertuzumab + trastuzumab (PH) in patients with HER2-positive metastatic breast cancer (mBC): challenges in assessing effectiveness of treatment sequencing in the real world (RW)
Presenter: Thibaut Sanglier
Session: Poster Display session 2
Resources:
Abstract