Dok Hyun Yoon1, Geundoo Jang2, Jong Hoon Kim3, Yong-Hee Kim4, Ji Youn Kim1, Hyeong Ryul Kim4, Hwoon-Yong Jung5, Gin-Hyug Lee5, Ho Young Song6, Kyung-Ja Cho7, Jin-Sook Ryu8, Sung-Bae Kim9. 1. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 2. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea; Department of Internal Medicine, Hallym Medical Center, Hallym University College of Medicine, Seoul, Korea. 3. Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 4. Department of Thoracic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 5. Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 6. Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 7. Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 8. Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 9. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Electronic address: sbkim3@amc.seoul.kr.
Abstract
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/m(2) on day 1 and S1 at 40 mg/m(2) twice daily on days 1-14, every 3 weeks) followed by concurrent chemoradiotherapy (CCRT) (46 Gy, 2 Gy/d with oxaliplatin 130 mg/m(2) on days 1 and 21 and S1 30 mg/m(2) 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.
RCT Entities:
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/m(2) on day 1 and S1 at 40 mg/m(2) twice daily on days 1-14, every 3 weeks) followed by concurrent chemoradiotherapy (CCRT) (46 Gy, 2 Gy/d with oxaliplatin 130 mg/m(2) on days 1 and 21 and S1 30 mg/m(2) 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.
Authors: Mian Xi; Zhongxing Liao; Wayne L Hofstetter; Ritsuko Komaki; Linus Ho; Steven H Lin Journal: J Nucl Med Date: 2017-05-18 Impact factor: 10.057
Authors: Peter S N van Rossum; David V Fried; Lifei Zhang; Wayne L Hofstetter; Linus Ho; Gert J Meijer; Brett W Carter; Laurence E Court; Steven H Lin Journal: Eur J Nucl Med Mol Imaging Date: 2016-08-11 Impact factor: 9.236