Abstract 1448P
Background
The efficacy and prognosis of paclitaxel and cisplatin as first-line regimen for patients (pts) with advanced ESCC remains poor. As a novel multitarget tyrosine kinase inhibitor mainly targeting VEGFR1-3, anlotinib was demonstrated to be an effective second-line monotherapy in advanced or recurrent ESCC in Chinese patients. The aim of this study is to investigate the efficacy and safety of paclitaxel and cisplatin combined with anlotinib as first line regimen for advanced ESCC.
Methods
Pts who had not been treated or relapsed >6 months after the completion of (neo) adjuvant therapy/radical surgery were recruited to this study. Eligible pts received paclitaxel (135mg/m2, iv, q3w) and cisplatin (60∼75mg/m2, iv, d1∼3, q3w) combined with anlotinib (10mg, po, d1∼14, q3w) for 6 cycles during initial therapy. For those without progressive disease, maintenance treatment was administrated with anlotinib (10mg, po, d1∼14, q3w) until disease progression or intolerable adverse reactions. The tumour response was assessed by investigators according to RECIST version 1.1 with CT scans every two cycles. The primary endpoint was progression-free survival (PFS), secondary endpoints were safety, objective response rate (ORR), disease control rate (DCR) and duration of response (DOR).
Results
From Oct 2019 to Apr 2020, 18 pts were enrolled, with 10 pts available for efficacy evaluation. Assessment of overall response showed 30% CR (3/10), 60% PR (6/10) and 10% SD (1/10). The preliminary ORR was 90% and DCR was 100%. The median PFS of the 10 pts was not yet available. The safety profile indicated that the most common drug-related adverse events were nausea, hypertension, insomnia, myelosuppression, hepatotoxicity and tachycardia. No grade ≥3 adverse events were noted. Table: 1448P
| Overall response | Paclitaxel and cisplatin + anlotinib (n=10) |
| CR | 3 |
| PR | 6 |
| SD | 1 |
| PD | 0 |
| ORR, n (%, 95%CI) | 9 (90, 57.4∼100.0) |
| DCR, n (%, 95%CI) | 10 (100, 67.9∼100.0) |
Conclusions
The preliminary results suggested that paclitaxel and cisplatin combined with anlotinib as first line regimen for advanced ESCC showed encouraging efficacy and moderate adverse events. This should be validated in more pts.
Clinical trial identification
NCT04063683.
Editorial acknowledgement
Dao-Yu Zhang, Ji-Ye Huang and Yi-Hua Ma from Chia Tai Tian Qing pharmaceutical group co. LTD (CTTQ).
Legal entity responsible for the study
The authors.
Funding
Chia Tai Tian Qing Pharmaceutical group co. LTD (CTTQ).
Disclosure
All authors have declared no conflicts of interest.