Recombinant human endostatin plus paclitaxel/nedaplatin for recurrent or metastatic advanced esophageal squamous cell ca
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PHASE II STUDIES
Recombinant human endostatin plus paclitaxel/nedaplatin for recurrent or metastatic advanced esophageal squamous cell carcinoma: a prospective, single-arm, open-label, phase II study Zhi-Qiang Wang 1 & De-Shen Wang 1 & Feng-Hua Wang 1 & Chao Ren 1 & Qiong Tan 1 & Yu-Hong Li 1 Received: 23 September 2020 / Accepted: 12 October 2020 # Springer Science+Business Media, LLC, part of Springer Nature 2020
Summary Background The prognosis of esophageal squamous cell carcinoma (ESCC) are still poor. Nedaplatin/paclitaxel regimen has shown activity with lower toxicity in metastatic ESCC. Recombinant human endostatin (Rh-endostatin), an inhibitor of angiogenesis, has shown inhibitory effects on ESCC xenograft. We assessed the activity and safety of Rh-endostatin plus paclitaxel/ nedaplatin in patients with recurrent or metastatic advanced ESCC. Methods In this single-center, open-label, single-arm, phase II study, patients with recurrent/metastatic or unresectable advanced ESCC were recruited. Eligible patients received the multidrug combination therapy with Rh-endostatin (30 mg/day on days 1–14), paclitaxel (150 mg/m2 on day 4) and nedaplatin (80 mg/m2 on day 4) every 3 weeks. The primary endpoint was progression-free survival. Secondary endpoints included objective response rate, disease control rate, overall survival. Results Between Jan 29, 2015 and Dec 31, 2019, 53 patients were enrolled and received at least one dose of Rh-endostatin. Median progression-free survival was 5.1 months (95% CI: 3.7–6.6), with a 6 month progression-free survival of 41% (95% CI: 25–56). Median overall survival was 13.2 months (95% CI: 8.0-18.4), with a 1year overall survival of 51% (95% CI: 36–67). 21 (42%, 95% CI: 28–56) of 50 patients had an objective response and 35 (70.00%, 95% CI: 57–83) had a disease control. Treatment-related adverse events of grade 3 or worse were reported in 13 (24.5%) patients. The most common grade 3 or 4 treatment-related adverse events were neutropenia (9 patients [17%]) and anaemia (2 [3.8%]). No treatment-related death occurred. Conclusions Rh-endostatin plus paclitaxel/nedaplatin has anti-tumour activity with acceptable tolerability in patients with recurrent or metastatic advanced ESCC. Randomized controlled trial is needed to confirm the efficacy of this regimen. Keywords Recombinant human endostatin . Paclitaxel . Nedaplatin . Esophageal squamous cell carcinoma
Introduction Esophageal cancer is currently the sixth leading cause of cancer related mortality worldwide [1]. Thereinto, esophageal squamous cell carcinoma (ESCC) is the dominant histological
type of esophageal cancer accounting for approximately 90%, although the incidence of esophageal adenocarcinoma is rising in North America and Europe [2, 3]. Epidemiology investigations have revealed that ESCC is particularly common in certain regions of Asia [4, 5]. Particularly, about half of all
* Yu-Hong Li [email protected]
Chao Ren [email protected]
Zhi-Qiang Wang [email protected] De-Shen Wang [email protected] Feng-H
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