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Cancer Commun (Lond). 2019 Apr 2;39(1):16. doi: 10.1186/s40880-019-0359-7.

Irinotecan plus S-1 versus S-1 in patients with previously treated recurrent or metastatic esophageal cancer (ESWN 01): a prospective randomized, multicenter, open-labeled phase 3 trial.

Author information

1
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No 17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, P. R. China. huangjingwg@163.com.
2
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No 17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, P. R. China. xubinghe@csco.org.cn.
3
Department of Medical Oncology, Henan Cancer Hospital, Zhengzhou, 450008, Henan, P. R. China.
4
Department of Medical Oncology, Taizhou People's Hospital, Taizhou, 225300, Jiangsu, P. R. China.
5
Department of Medical Oncology, First Affiliated Hospital of Xinxiang Medical University, Xinxiang, 453100, Henan, P. R. China.
6
Department of Medical Oncology, Tianjin Cancer Hospital, Tianjin, 300060, P. R. China.
7
Department of Medical Oncology, Hunan Cancer Hospital, Changsha, 410006, Hunan, P. R. China.
8
Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, 150040, Heilongjiang, P. R. China.
9
Department of Medical Oncology, Shandong Cancer Hospital, Jinan, 250117, Shandong, P. R. China.
10
Department of Medical Oncology, Jiangsu Cancer Hospital, Nanjing, 210009, Jiangsu, P. R. China.
11
Department of Medical Oncology, Jilin Cancer Hospital, Changchun, 130012, Jilin, P. R. China.
12
Department of Radiotherapy, Shanxi Cancer Hospital, Taiyuan, 030013, Shanxi, P. R. China.
13
Department of Medical Oncology, Shanxi Cancer Hospital, Taiyuan, 030013, Shanxi, P. R. China.
14
Department of Medical Oncology, Tongji Hospital, Wuhan, 430030, Hubei, P. R. China.
15
Department of Medical Oncology, Chifeng Municipal Hospital, Chifeng, 024000, Inner Mongolia, P. R. China.
16
Department of Oncology, The Second Xiangya Hospital of Central South University, Changsha, 410011, Hunan, P. R. China.
17
Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, Henan, P. R. China.
18
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No 17 Panjiayuan Nanli, Chaoyang District, Beijing, 100021, P. R. China.

Abstract

BACKGROUND:

The benefit of systemic treatments in esophageal squamous cell carcinoma (ESCC) which has progressed after chemotherapy is still uncertain and optimal regimens based on randomized trials have not yet been established. We aimed to compare the efficacy of irinotecan plus S-1 with S-1 monotherapy in recurrent or metastatic ESCC patients who had resistance to platinum- or taxane-based chemotherapy.

METHODS:

We conducted a prospective randomized, multicenter, open-label, phase 3 trial in 15 centers across China. Eligible patients were adults with histologically confirmed recurrent or metastatic ESCC, and were randomly assigned (ratio, 1:1) to receive either irinotecan plus S-1 (intravenous infusion of irinotecan [160 mg/m2] on day 1 and oral S-1 [80-120 mg] on days 1-10, repeated every 14 days) or oral S-1 monotherapy (80-120 mg/day on days 1-14, repeated every 21 days) using a central computerized minimization procedure. The primary endpoint was progression-free survival (PFS).

RESULTS:

Between December 23, 2014 and July 25, 2016, we screened 148 patients and randomly assigned 123 patients to receive either irinotecan plus S-1 regimen (n = 61) or S-1 monotherapy (n = 62). After a median follow-up of 29.2 months (95% confidence interval [CI] 17.5-40.9 months), the median PFS was significantly longer in the irinotecan plus S-1 group than in the S-1 monotherapy group (3.8 months [95% CI 2.9-4.3 months] vs. 1.7 months [95% CI 1.4-2.7 months], hazard ratio = 0.58, 95% CI 0.38-0.86, P = 0.006). The objective response rates were 24.6% in the irinotecan plus S-1 group and 9.7% in the S-1 monotherapy group (P = 0.002). The patients in the irinotecan plus S-1 group presented with increased rates of grade 3-4 leukopenia (16.4% vs. 0%), neutropenia (14.8% vs. 1.6%), and nausea (4.9% vs. 0%). No significant difference in grade 3-4 diarrhea and no treatment-related deaths were observed in both groups.

CONCLUSIONS:

The combination of irinotecan with S-1 was similarly tolerable but significantly prolonged PFS compared to S-1 monotherapy as a second- or third-line treatment in patients with recurrent or metastatic ESCC. Clinical Trial Registration NCT02319187. Registered on December 9, 2014.

KEYWORDS:

Disease control rate; Esophageal squamous cell carcinoma; Irinotecan; Metastasis; Multicenter, open-label, randomized trial; Objective response rate; Overall survival; Progression-free survival; Recurrent; S-1

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