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.
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).
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.
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|
|≤65||45 (84.9%)||42 (85.7%)|
|>65||8 (15.1%)||7 (14.3%)|
|Women||5 (9.4%)||5 (10.2%)|
|Men||48 (90.6%)||44 (89.8%)|
|0||21 (39.6%)||17 (34.7%)|
|1||29 (54.7%)||30 (61.2%)|
|2||3 (5.7%)||2 (4.1%)|
|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%)|
|1 regimen||44 (83.0%)||38 (79.2%)|
|2 regimens||9 (17.0%)||10 (20.8%)|
|No||30 (56.6%)||35 (71.4%)|
|Yes||23 (43.4%)||14 (28.6%)|
|No||26 (49.1%)||24 (50.0%)|
|Yes||27 (50.9%)||24 (50.0%)|
Clinical trial identification
Legal entity responsible for the study
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
All authors have declared no conflicts of interest.
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