Katayose Yu, Yamamoto Kuniharu, Nakagawal Kei, Takemura Shinichi, Takahashi Michinaga, Nakamura Ryuji, Shimamura Hiromune, Rikiyama Toshiki, Egawa Shinichi, Yoshda Hiroshi, Motoi Fuyuhiko, Naitoh Takeshi, Unno Michiaki
Hepatogastroenterology. 2015 Mar-Apr;62(138):303-8.
BACKGROUND/AIMS: This multicenter and single arm phase II clinical trial was performed to examine the safety and efficacy of modified FOLFOX6 (mFOLFOX6) as adjuvant treatment after resection of liver metastases from colorectal cancer.
Patients who had undergone R0-1 resection of liver metastases were assigned to 12 cycles of mFOLFOX6. The primary end point was disease-free survival (DFS).
We enrolled 49 cases and analyzed adverse events in 48 cases, since in one patient cancer recurred before starting treatment. As to the relative dose intensity, 5-FU was 78.8%, and oxaliplatin was 75.9%. Adverse events of Grade 3 and above includ- ed 18 cases of neutropenia (37.5%), 4 cases of sensory neuropathy (8.3%), 4 cases of thrombocytopenia (8.3%) and 4 cases of allergy (8.3%), and there were no cases of fatality caused by adverse events. The most difference of adverse event compared with MOSAIC trial (Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer) was thrombocytopenia. The 2-year DFS was 59.2% (95% CI: 36.7-78.4) in the 49 enrolled cases.
mFOLFOX6 after hepatectomy was tolerable. And mFOLFOX6 also seemed to improve DFS. mFOLFOX is one of the options for such patients and appears promising as an adjuvant treatment.
背景/目的：本多中心单臂II期临床试验旨在研究改良FOLFOX6（mFOLFOX6）作为结直肠癌肝转移切除术后辅助治疗的安全性和有效性。
对肝转移灶行R0-1切除的患者给予12个周期的mFOLFOX6治疗。主要终点为无病生存期（DFS）。
我们纳入了49例患者，其中48例分析了不良事件，因为有1例患者在开始治疗前癌症复发。关于相对剂量强度，5-氟尿嘧啶为78.8%，奥沙利铂为75.9%。3级及以上不良事件包括18例中性粒细胞减少（37.5%）、4例感觉神经病变（8.3%）、4例血小板减少（8.3%）和4例过敏（8.3%），且无不良事件导致死亡的病例。与MOSAIC试验（奥沙利铂/5-氟尿嘧啶-亚叶酸钙辅助治疗结肠癌的多中心国际研究）相比，不良事件最主要的差异是血小板减少。49例纳入患者的2年DFS为59.2%（95%CI：36.7-78.4）。
肝切除术后应用mFOLFOX6是可耐受的。mFOLFOX6似乎也能改善DFS。mFOLFOX是这类患者的选择之一，作为辅助治疗似乎很有前景。
