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Gastrointestinal tumours, non-colorectal

2637 - Randomized, open-label, phase III study comparing irinotecan plus S-1 with S-1 alone in patients with advanced esophageal squamous cell carcinoma after failure of prior platinum- or taxane-based chemotherapy: Results of an interim analysis

Date

08 Oct 2016

Session

Gastrointestinal tumours, non-colorectal

Presenters

Jing Huang

Citation

Annals of Oncology (2016) 27 (6): 1-36. 10.1093/annonc/mdw435

Authors

J. Huang1, Y. Liu2, S. Dai3, P. Lu4, Y. Ba5, L. Wu6, Y. Bai7, S. Zhang8, J. Feng9, Y. Cheng10, J. Li11, L. Wen12, X. Yuan13, C. Ma14, Q. Fan15, X. Wang1, B. Xu1

Author affiliations

  • 1 Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CAMS), 100021 - Beijing/CN
  • 2 Medical Oncology, Henan Cancer Hospital, Zhangzhou/CN
  • 3 Medical Oncology, Taizhou Municipal Hospital, Taizhou/CN
  • 4 Medical Oncology, First Affiliated Hospital of Xinxiang Medical University, Xinxiang/CN
  • 5 Medical Oncology, Tianjin Cancer Hospital, Tianjin/CN
  • 6 Medical Oncology, Hunan Cancer Hospital, Changsha/CN
  • 7 Medical Oncology, Herbin Medical University Cancer Hospital, Herbin/CN
  • 8 Dept. Of Medical Oncology, Shandong Cancer Hospital, 250117 - Jinan/CN
  • 9 Medical Oncology, Jiangsu Cancer Hospital, Nanjing/CN
  • 10 Medical Oncology, Jilin Cancer Hospital, Changchun/CN
  • 11 Radiotherapy, Shanxi Cancer Hospital, Taiyuan/CN
  • 12 Medical Oncology, Shanxi Cancer Hospital, Taiyuan/CN
  • 13 Medical Oncology, Tongji hospital, Wuhan/CN
  • 14 Medical Oncology, Chifeng Municipal Hospital, Chifeng/CN
  • 15 Oncology, 1st Affiliated Hospital of Zhengzhou University, 450000 - Zhengzhou/CN
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Resources

Abstract 2637

Background

There was no established standard second-line chemotherapy for patients with advanced esophageal squamous cell carcinoma. This phase III study compared irinotecan plus S-1with S-1 alone in patients with advanced esophageal squmous cell carcinoma refractory to platinum-based or taxane-based first-line chemotherapy. Here we present the results of an interim analysis of efficacy and safety outcomes.

Methods

Patients were randomly assigned to receive either irinotecan (160 mg/m2 intravenously on day 1 every 2 weeks) and S-1 (initial oral dose 40 ∼ 60mg twice a day on days 1-10 every 2 weeks), or S-1 (initial oral dose 40 ∼ 60mg twice a day on days 1-14 every 3 weeks) alone. The primary end point was progression-free survival (PFS), and secondary end points were response rate, disease control rate and overall survival (OS).

Results

PFS, the primary endpoint of the study, was significant for patients who received the irinotecan and S-1 compared with S1 only (3.9 months vs. 1.8 months, respectively; p = 0. 0019). Similarly, response rate was significantly higher with the irinotecan and S-1 treatment at 28.3% compared with 12.2% in the S1 arm (p = 0.045). In addition, median OS was slightly prolonged with the irinotecan and S-1 treatment at 7.0 months compared with 6.3 months in the S-1 arm (p = 0.2622). The most frequent adverse events in the irinotecan and S-1 arm were nausea, vomiting, and neutropenia.

Conclusions

As compared with S-1 alone, irinotecan plus S-1 regimen was associated with a significant PFS advantage. Irnotecan plus S-1regimen is an appropriate treatment option in patients with advanced esophageal squamous cell carcinoma after failure of prior platinum- or taxane-based chemotherapy.

irinotecan and S-1 (n = 53) S-1 (n = 49) P value
Age 0.90800a
≤65 45 (84.9%) 42 (85.7%)
>65 8 (15.1%) 7 (14.3%)
Sex 1.00000b
Women 5 (9.4%) 5 (10.2%)
Men 48 (90.6%) 44 (89.8%)
ECOG 0.79700b
0 21 (39.6%) 17 (34.7%)
1 29 (54.7%) 30 (61.2%)
2 3 (5.7%) 2 (4.1%)
Tumor grade 0.73700b
Poorly differentiated 23 (43.4%) 23 (46.9%)
Moderately differentiated 27 (50.9%) 25 (51.0%)
Well differentiated 3 (5.7%) 1 (2.0%)
Number of metastatic sites 0.19000a
0-2 48 (90.6%) 40 (81.6%)
>2 5 (9.4%) 9 (18.4%)
Previous chemotherapy 0.62100a
1 regimen 44 (83.0%) 38 (79.2%)
2 regimens 9 (17.0%) 10 (20.8%)
Previous surgery 0.12000a
No 30 (56.6%) 35 (71.4%)
Yes 23 (43.4%) 14 (28.6%)
Previous radiotherapy 0.92500a
No 26 (49.1%) 24 (50.0%)
Yes 27 (50.9%) 24 (50.0%)

Clinical trial identification

NCT02319187

Legal entity responsible for the study

N/A

Funding

Cancer Institute & Hospital, Chinese Academy of Medical Sciences

Disclosure

All authors have declared no conflicts of interest.

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