Suenaga Mitsukuni, Matsusaka Satoshi, Watanabe Toshiyasu, Kuboki Yasutoshi, Shinozaki Eiji, Chin Keisho, Mizunuma Nobuyuki, Ueno Masashi, Yamaguchi Toshiharu, Hatake Kiyohiko
Department of Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Asia Pac J Clin Oncol. 2011 Jun;7(2):129-35. doi: 10.1111/j.1743-7563.2011.01385.x.
In Japan the combination of fluorouracil (5-FU), leucovorin and oxaliplatin (FOLFOX) was approved as adjuvant therapy for stage III or high-risk stage II colon cancer only in September 2009. In this study we evaluated the safety and efficacy of FOLFOX as adjuvant chemotherapy for stage IIIb or IV colorectal cancer (CRC) patients in a Japanese group at a single institute.
A total of 45 consecutive patients received 12 cycles of adjuvant FOLFOX for stage IIIb (n = 31) or IV (n = 14) CRC. Toxicity and disease-free survival (DFS) were analyzed retrospectively.
The median dose intensities of oxaliplatin and 5-FU were 0.7 and 0.74, respectively. Oxaliplatin was discontinued in 10 (22%) patients due to an allergic reaction in five, neurotoxicity in four and gastrointestinal toxicity in one. No severe neurotoxicity occurred. The median duration from completion of treatment until complete recovery from peripheral neuropathy was 582 days (95% CI, 486-678). Two-year DFS for stages IIIb and IV was 56.9% and 56.3%, respectively (log-rank, P = 0.533). Univariate analysis revealed that severe vessel invasion, liver metastasis and higher baseline levels of CA19-9 were associated with shorter DFS in stage IV patients. Multivariate analysis including the selected biomarkers revealed none as a significant prognostic factor.
Adjuvant FOLFOX was well tolerated in a Japanese cohort of both stage IIIb and IV CRC patients.
在日本，氟尿嘧啶（5-FU）、亚叶酸钙和奥沙利铂联合方案（FOLFOX）直到2009年9月才被批准用于III期或高危II期结肠癌的辅助治疗。在本研究中，我们评估了FOLFOX作为单中心日本人群中IIIb期或IV期结直肠癌（CRC）患者辅助化疗的安全性和疗效。
共有45例连续患者接受了12周期的FOLFOX辅助化疗，其中IIIb期（n = 31）或IV期（n = 14）CRC患者。对毒性和无病生存期（DFS）进行回顾性分析。
奥沙利铂和5-FU的中位剂量强度分别为0.7和0.74。10例（22%）患者因过敏反应停药5例，神经毒性4例，胃肠道毒性1例。未发生严重神经毒性。从治疗结束到周围神经病变完全恢复的中位持续时间为582天（95%CI，486-678）。IIIb期和IV期的两年DFS分别为56.9%和56.3%（对数秩检验，P = 0.533）。单因素分析显示，严重血管侵犯、肝转移和较高的CA19-9基线水平与IV期患者较短的DFS相关。包括所选生物标志物的多因素分析未发现有显著的预后因素。
在日本的IIIb期和IV期CRC患者队列中，辅助性FOLFOX耐受性良好。
