A phase II study of rh-endostatin combined with paclitaxel and nedaplatin in treating patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC).

Abstract

4522 Background: For patients (pts) with metastatic ESCC, the prognosis is poor. Rh-endostatin (endostar), a potent inhibitor of angiogenesis, has shown clinical activity when combined with chemoradiotherapy in treating locally advanced ESCC. This single-arm phase 2 study was designed to assess the efficacy and safety of endostar combined with paclitaxel and nedaplatin in treating pts with recurrent or metastatic ESCC. Methods: Eligible pts had recurrent or metastatic ESCC and Karnofsky score ≥70. Endostar (30 mg/day, continuous infusion, day 1-14) plus paclitaxel (150 mg/m2, day 4) and nedaplatin (80 mg/m2, day 4) were administered every 3 weeks for 6 cycles followed by maintenance therapy with endostar. Primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and adverse events (AEs). Results: From January 2015 to August 2019, 53 pts were enrolled. 44 (83%) pts were male. The median age was 59 years. 43 (81%) pts had pathology of poor or moderate differentiated ESCC. The middle and lower thirds of the esophagus (81%) were the most common primary tumor sites. 11 (21%) patients had undergone esophagectomy. At the time of treatment, 49 (93%) pts were diagnosed with clinical stage IVB. The most common metastatic sites were lymph node (91%), lung (32%) and liver (26%). 50 pts were assessable for response. No complete response was observed. 21 pts achieved a best response of partial response and 14 pts had stable disease. ORR was 42% and DCR was 70%. The median PFS and OS was 5.1 months (95% CI 3.7-6.6 months) and 13.2 months (95% CI 8.0-18.4 months) respectively. The most common AEs observed during this study were anemia (49.1%), neutropenia (34%), fatigue (28.3%) and anorexia (26.4%). The most common Grade 3/4 AE observed was neutropenia (17%). Conclusions: The combination of endostar plus paclitaxel and nedaplatin is a well tolerated treatment modality with promising activity in previously untreated recurrent or metastatic ESCC. Its efficacy and safety could be further studied in randomized trials. Clinical trial information: NCT02350517 .