1404P - Update results of paclitaxel and cisplatin in combination with anlotinib as first-line treatment for patients with advanced ESCC: A multicenter, single-arm, open-label phase II clinical trial

Background

Paclitaxel combined with cisplatin regimen has been the standard of care as first-line therapy in advanced ESCC for almost two decades. PD-1 inhibitors combined with chemotherapy as first line setting exhibited superior efficacy for pts with ESCC recently. Anlotinib was a potential second-line monotherapy for pts with ESCC in China. Therefore, this study was designed to explore the efficacy and safety of paclitaxel and cisplatin combined with anlotinib as first-line therapy in advanced ESCC.

Methods

Pts with previously untreated metastatic or locally advanced ESCC were recruited and were given paclitaxel (135mg/m², iv, q3w) and cisplatin (60∼75mg/m², iv, d1∼3, q3w) plus anlotinib (10mg, po, d1∼14, q3w) for 4∼6 cycles as initial therapy. For those who did not have PD, maintenance treatment was adopted with anlotinib monotherapy (10mg, po, d1∼14, q3w) until PD or unacceptable toxicity. The tumor response was assessed according to RECIST 1.1 using CT scans every two cycles. The predefined sample size was 47. Primary endpoint was PFS and secondary endpoints included safety, ORR, DCR and DOR.

Results

From Oct 2019 to Mar 2021, a total of 47 pts were enrolled, 46 pts included in intention-to-treat analysis. The best overall response indicated that there were 1 CR (2.2%), 35 PR (76.1%) and 7 SD (15.2%). 3 pts were not available for efficacy assessment. Consequently, ORR was 78.3% (95%CI: 63.6-89.1) and DCR was 93.5% (95%CI: 82.1-98.6). At the data cut-off date, 20 pts discontinued treatment due to PD, the preliminary prognostic result indicated that the median PFS of the 46 pts was 8.38 months (95%CI: 5.86-10.90). Additionally, safety profile exhibited that the regimen was tolerable. Common grade ≥3 adverse reactions were myelosuppression (29.8%), gastrointestinal reaction (10.6%), hypertension (6.3%), fatigue (4.3%), hypokalemia (4.3%) and pain (2.1%).

Conclusions

Regimen of paclitaxel and cisplatin combined with anlotinib as first-line therapy for advanced ESCC exhibited encouraging efficacy and tolerable safety profile. And the conclusions needed to be confirmed in phase Ⅲ clinical trials.

Clinical trial identification

NCT04063683.

Editorial acknowledgement

Legal entity responsible for the study

Henan Cancer Hospital, Zhengzhou, China.

Funding

Jiangsu Chia Tai-Tianqing Pharmaceutical Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.