A phase II study of preoperative mFOLFOX6 with short-course radiotherapy in patients with locally advanced rectal cancer and liver-only metastasis

作者：Kim Kyung Hwan; Shin Sang Joon; Cho Min Soo; Ahn Joong Bae; Jung Minkyu; Kim Tae Ii; Park Young Suk; Kim Hoguen; Kim Nam Kyu^*; Koom Woong Sub^*

来源：Radiotherapy and Oncology, 2016, 118(2): 369-374.

DOI：10.1016/j.radonc.2015.11.029

• Short-course radiotherapy
• Rectal cancer
• Metastasis
• Chemotherapy

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 (RO) 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 RO 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 RO resection in this patient population.

• 出版日期2016-2