Randomized phase 2 trial of s1 and oxaliplatin-based chemoradiotherapy with or without induction chemotherapy for esophageal cancer

Dok Hyun Yoon, Geundoo Jang, Jong Hoon Kim, Yong Hee Kim, Ji Youn Kim, Hyeong Ryul Kim, Hwoon Yong Jung, Gin Hyug Lee, Ho Young Song, Kyung Ja Cho, Jin Sook Ryu, Sung Bae Kim

Research output: Contribution to journalArticlepeer-review

38 Scopus citations


Purpose To assess, in a randomized, phase 2 trial, the efficacy and safety of chemoradiotherapy with or without induction chemotherapy (ICT) of S1 and oxaliplatin for esophageal cancer. Patients and Methods Patients with stage II, III, or IVA esophageal cancer were randomly allocated to either 2 cycles of ICT (oxaliplatin 130 mg/m2 on day 1 and S1 at 40 mg/m2 twice daily on days 1-14, every 3 weeks) followed by concurrent chemoradiotherapy (CCRT) (46 Gy, 2 Gy/d with oxaliplatin 130 mg/m2 on days 1 and 21 and S1 30 mg/m2 twice daily, 5 days per week during radiation therapy) and esophagectomy (arm A), or the same CCRT followed by esophagectomy without ICT (arm B). The primary endpoint was the pathologic complete response (pCR) rate. Results A total of 97 patients were randomized (arm A/B, 47/50), 70 of whom underwent esophagectomy (arm A/B, 34/36). The intention-to-treat pCR rate was 23.4% (95% confidence interval [CI] 11.2-35.6%) in arm A and 38% (95% CI 24.5% to 51.5%) in arm B. With a median follow-up duration of 30.3 months, the 2-year progression-free survival rate was 58.4% in arm A and 58.6% in arm B, whereas the 2-year overall survival rate was 60.7% and 63.7%, respectively. Grade 3 or 4 thrombocytopenia during CCRT was more common in arm A than in arm B (35.4% vs 4.1%). The relative dose intensity of S1 (89.5% ± 20.6% vs 98.3% ± 5.2%, P=.005) and oxaliplatin (91.4% ± 16.8% vs 99.0% ± 4.2%, P=.007) during CCRT was lower in arm A compared with arm B. Three patients in arm A, compared with none in arm B, died within 90 days after surgery. Conclusions Combination chemotherapy of S1 and oxaliplatin is an effective chemoradiotherapy regimen to treat esophageal cancer. However, we failed to show that the addition of ICT to the regimen can improve the pCR rate.

Original languageEnglish (US)
Pages (from-to)489-496
Number of pages8
JournalInternational Journal of Radiation Oncology Biology Physics
Issue number3
StatePublished - Mar 1 2015

Bibliographical note

Publisher Copyright:
© 2015 Elsevier Inc. All rights reserved.


Dive into the research topics of 'Randomized phase 2 trial of s1 and oxaliplatin-based chemoradiotherapy with or without induction chemotherapy for esophageal cancer'. Together they form a unique fingerprint.

Cite this