Kyung Hwan Kim1, Sang Joon Shin2, Min Soo Cho3, Joong Bae Ahn2, Minkyu Jung2, Tae Il Kim4, Young Suk Park5, Hoguen Kim6, Nam Kyu Kim7, Woong Sub Koom8. 1. Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. 2. Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. 3. Division of Colorectal Surgery, Department of Surgery, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. 4. Division of Gastroenterology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. 5. Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 6. Department of Pathology, Yonsei University College of Medicine, Seoul, Republic of Korea. 7. Division of Colorectal Surgery, Department of Surgery, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: NAMKYUK@yuhs.ac. 8. Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address: mdgold@yuhs.ac.
Abstract
BACKGROUND AND PURPOSE: To evaluate the efficacy and safety of upfront mFOLFOX6 followed by short-course radiotherapy (SCRT) and surgery in patients with locally advanced rectal cancer and liver-only metastases. MATERIALS AND METHODS: This single-arm phase II study involved 32 patients. mFOLFOX6 was administered for four cycles followed by SCRT and another four cycles of mFOLFOX6. Surgery was performed 4-6 weeks after the last chemotherapy cycle. The primary endpoint was complete (R0) resection rate. Secondary endpoints were response rate, progression-free survival (PFS), overall survival (OS), and complication rates. RESULTS: Surgical resection of the rectum and liver was performed in 25 patients (78%) and R0 resection was achieved in 20 patients (63%). Local tumor downstaging was observed in 54% of patients. Median OS and PFS were 38 and 9 months, respectively. One patient discontinued treatment due to toxicity and no treatment-related deaths occurred. Patients who progressed after 4 cycles of mFOLFOX6 were less likely to receive resection. CONCLUSIONS: This regimen was safe and effective in inducing local tumor response and achieving R0 resection in this patient population.
BACKGROUND AND PURPOSE: To evaluate the efficacy and safety of upfront mFOLFOX6 followed by short-course radiotherapy (SCRT) and surgery in patients with locally advanced rectal cancer and liver-only metastases. MATERIALS AND METHODS: This single-arm phase II study involved 32 patients. mFOLFOX6 was administered for four cycles followed by SCRT and another four cycles of mFOLFOX6. Surgery was performed 4-6 weeks after the last chemotherapy cycle. The primary endpoint was complete (R0) resection rate. Secondary endpoints were response rate, progression-free survival (PFS), overall survival (OS), and complication rates. RESULTS: Surgical resection of the rectum and liver was performed in 25 patients (78%) and R0 resection was achieved in 20 patients (63%). Local tumor downstaging was observed in 54% of patients. Median OS and PFS were 38 and 9 months, respectively. One patient discontinued treatment due to toxicity and no treatment-related deaths occurred. Patients who progressed after 4 cycles of mFOLFOX6 were less likely to receive resection. CONCLUSIONS: This regimen was safe and effective in inducing local tumor response and achieving R0 resection in this patient population.
Authors: Emma B Holliday; Andrew Hunt; Y Nancy You; George J Chang; John M Skibber; Miguel A Rodriguez-Bigas; Brian K Bednarski; Cathy Eng; Eugene J Koay; Bruce D Minsky; Cullen Taniguchi; Sunil Krishnan; Joseph M Herman; Prajnan Das Journal: J Gastrointest Oncol Date: 2017-12
Authors: Hong In Yoon; Woong Sub Koom; Tae Hyung Kim; Joong Bae Ahn; Minkyu Jung; Tae Il Kim; Hoguen Kim; Sang Joon Shin; Nam Kyu Kim Journal: PLoS One Date: 2016-08-18 Impact factor: 3.240