Hirano Gen, Makiyama Akitaka, Makiyama Chinatsu, Esaki Taito, Oda Hisanobu, Uchino Keita, Komoda Masato, Tanaka Risa, Matsushita Yuzo, Mitsugi Kenji, Shibata Yoshihiro, Kumagai Hozumi, Arita Shuji, Ariyama Hiroshi, Kusaba Hitoshi, Akashi Koichi, Baba Eishi
Department of Hematology and Oncology, Japan Community Health Care Organization Kyushu Hospital, Kitakyushu, Japan.
Department of Gastrointestinal and Medical Oncology, National Kyushu Cancer Center, Fukuoka, Japan.
Anticancer Res. 2015 Jan;35(1):371-7.
Salvage-line regorafenib monotherapy exhibited a marked survival benefit for metastatic colorectal cancer (mCRC). However, the toxicity of this regimen has resulted in the clinical use of a reduced dose of regorafenib.
Thirty-two Japanese mCRC patients (median age=61 years) who had been treated with regorafenib were retrospectively examined.
Best objective response rate was 0% and stable disease (SD) was 31%. Median progression-free survival was 81 days and median overall survival was 233 days. Adverse events of any grade were observed in all patients: 17 (53%) patients suffered grade 3 or 4 adverse events including fatigue (13%), anorexia (13%), hand-foot skin reaction (22%) and elevations of alanine aminotransferase/aspartate aminotransferase (19%/16%). One patient with grade 5 liver dysfunction was identified (3%). Twenty-nine (91%) patients required treatment dose reduction or a delay in treatment. The relative dose intensity was 59%. Regorafenib treatments were terminated because of disease progression (59%) or adverse events (34%).
Despite a decrease in the intensity of regorafenib treatment, because of severe adverse events, a fairly favorable efficacy was achieved in Japanese patients.
挽救性瑞戈非尼单药治疗对转移性结直肠癌（mCRC）显示出显著的生存获益。然而，该方案的毒性导致临床使用降低剂量的瑞戈非尼。
对32例接受过瑞戈非尼治疗的日本mCRC患者（中位年龄 = 61岁）进行回顾性研究。
最佳客观缓解率为0%，疾病稳定（SD）率为31%。中位无进展生存期为81天，中位总生存期为233天。所有患者均观察到任何级别的不良事件：17例（53%）患者发生3级或4级不良事件，包括疲劳（13%）、厌食（13%）、手足皮肤反应（22%）以及丙氨酸氨基转移酶/天冬氨酸氨基转移酶升高（19%/16%）。确定1例5级肝功能障碍患者（3%）。29例（91%）患者需要降低治疗剂量或延迟治疗。相对剂量强度为59%。瑞戈非尼治疗因疾病进展（59%）或不良事件（34%）而终止。
尽管瑞戈非尼治疗强度降低，但由于严重不良事件，日本患者仍取得了相当不错的疗效。
