Department of Clinical Oncology, Leiden University Medical Center, Leiden.
Department of Medical Oncology, Radboud University Nijmegen Medical Center, Nijmegen.
Ann Oncol. 2010 Aug;21(8):1662-1667. doi: 10.1093/annonc/mdp589. Epub 2010 Jan 28.
To compare the median overall survival of patients with isolated nonresectable liver metastases in comparable groups of patients treated with either isolated hepatic perfusion (IHP) with melphalan or systemic chemotherapy.
Colorectal cancer patients with isolated liver metastases, who underwent IHP, were included in this study. The control group consisted of a subgroup of colorectal cancer patients with liver metastases only, who were enrolled in the randomized CApecitabine, IRinotecan, Oxaliplatin (CAIRO) phase III study.
Ninety-nine patients were treated with IHP, and 111 patients were included in the control group. All patient characteristics were comparable except for age. Median follow-up was 78.1 months for IHP versus 54.7 months in the control group. Median overall survival was 25.0 [95% confidence interval (CI) 19.4-30.6] months for IHP and 21.7 (95% CI 19.6-23.8) months for systemic treatment and did not differ significantly (P = 0.29). Treatment-related mortality was 2% for the systemic treatment and 6% for IHP (P = 0.11).
Compared with a patient group with comparable characteristics treated with systemic chemotherapy, IHP does not provide a benefit in overall survival in patients with isolated nonresectable colorectal liver metastases. Currently, the use of IHP cannot be advocated outside the scope of clinical studies.
比较孤立性不可切除肝转移患者在接受孤立性肝脏灌注(IHP)联合美法仑或全身化疗的可比患者组中的中位总生存期。
本研究纳入了接受 IHP 的孤立性肝转移结直肠癌患者。对照组由仅患有肝转移的结直肠癌患者亚组组成,他们参加了随机 CApecitabine、IRinotecan、Oxaliplatin(CAIRO)III 期研究。
99 例患者接受 IHP 治疗,111 例患者纳入对照组。除年龄外,所有患者特征均相似。IHP 的中位随访时间为 78.1 个月,对照组为 54.7 个月。IHP 的中位总生存期为 25.0[95%置信区间(CI)19.4-30.6]个月,全身治疗为 21.7(95%CI 19.6-23.8)个月,差异无统计学意义(P=0.29)。全身治疗的治疗相关死亡率为 2%,IHP 为 6%(P=0.11)。
与接受全身化疗的具有相似特征的患者组相比,IHP 不能提高孤立性不可切除结直肠癌肝转移患者的总生存期。目前,IHP 的使用不能在临床研究范围之外得到提倡。