Kennedy Andrew, Cohn Michael, Coldwell Douglas M, Drooz Alain, Ehrenwald Eduardo, Kaiser Adeel, Nutting Charles W, Rose Steven C, Wang Eric A, Savin Michael A
Department of Radiation Oncology, Sarah Cannon Research Institute, Nashville, TN, USA.
Radiology Associates of Hollywood, Pembroke Pines, FL, USA.
J Gastrointest Oncol. 2017 Aug;8(4):614-624. doi: 10.21037/jgo.2017.03.10.
The Metastatic colorectal cancer liver metastases Outcomes after RadioEmbolization (MORE) study was a retrospective analysis of 606 patients with unresectable colorectal liver metastases treated with radioembolization (RE) using Y-labeled resin microspheres. The first analysis of this study was completed with a last patient follow-up of 77.7 months. We now provide an updated survival analysis through September 15, 2016, with a last patient follow-up of 125 months.
Y-RE was considered for patients with advanced liver-only or liver-dominant metastatic colorectal cancer which was deemed not suitable for surgery, ablation, or systemic therapy, and which had progressed or become refractory to at least one line of systemic therapy. All patients with a diagnosis of metastatic colorectal cancer who had received at least 1 RE treatment and 1 follow-up visit were included in the analysis. Patients were treated between July 2002 and December 2011 at one of 11 U.S. tertiary care centers. Data were collected at baseline, on the day of the first Y-RE treatment (day 0), and at all subsequent visits or until death. Patient medical charts and/or public records were accessed to obtain dates of death.
Dates of death were obtained for 574 out of a total of 606 patients, and overall survival (OS) data analyzed. Updated median OS was 10.0 months (95% CI: 9.2-11.8 months) at a median follow-up of 9.5 months versus the originally reported median OS of 9.6 months (95% CI: 9.0-11.1 months) at a follow-up of 8.6 months in the first MORE analysis. Patients received a median (range) of 2 (0 to 6) lines of chemotherapy. Baseline characteristics and factors significantly associated with patient survival (P<0.01) are consistent with those reported in the first safety analysis of the MORE study. These factors include poor ECOG performance status, markers of advanced disease such as increased extent of tumor-to-target liver involvement, poor baseline liver function, pre-treatment anemia, lung shunt fraction, and number of lines of prior chemotherapy. Patient age did not significantly affect survival outcomes.
Long-term follow-up confirms that Y-RE treatment offers favorable survival benefits for patients with unresectable metastatic colorectal cancer, even among patients who received 3 or more prior lines of chemotherapy. Our analysis also supports earlier reported prognostic factors for survival after Y-RE. Overall, our updated analysis confirms that Y-RE treatment provided a meaningful response and survival advantage for MORE patients across all ages and across diverse community and academic centers in the U.S.
转移性结直肠癌肝转移灶放射性栓塞治疗（MORE）研究是一项对606例不可切除的结直肠癌肝转移患者进行的回顾性分析，这些患者接受了使用钇标记树脂微球的放射性栓塞（RE）治疗。该研究的首次分析在最后一名患者随访77.7个月时完成。我们现在提供截至2016年9月15日的更新生存分析，最后一名患者随访时间为125个月。
对于仅肝转移或肝为主转移的晚期转移性结直肠癌患者，若被认为不适合手术、消融或全身治疗，且对至少一线全身治疗已进展或变得难治，则考虑进行钇-RE治疗。所有诊断为转移性结直肠癌且接受过至少1次RE治疗和1次随访的患者均纳入分析。患者于2002年7月至2011年12月在美国11家三级医疗中心之一接受治疗。在基线、首次钇-RE治疗当天（第0天）以及所有后续随访时或直至死亡时收集数据。查阅患者病历和/或公共记录以获取死亡日期。
在总共606例患者中，获得了574例患者的死亡日期，并对总生存（OS）数据进行了分析。更新后的中位OS为10.0个月（95%CI：9.2 - 11.8个月），中位随访时间为9.5个月，而在MORE研究的首次分析中，随访8.6个月时最初报告的中位OS为9.6个月（95%CI：9.0 - 11.1个月）。患者接受化疗的中位（范围）线数为2（0至6）线。与患者生存显著相关（P<0.01）的基线特征和因素与MORE研究首次安全性分析中报告的一致。这些因素包括东部肿瘤协作组（ECOG）体能状态差、疾病进展的标志物，如肿瘤累及靶肝范围增加、基线肝功能差、治疗前贫血、肺分流分数以及既往化疗线数。患者年龄对生存结果无显著影响。
长期随访证实，钇-RE治疗为不可切除的转移性结直肠癌患者提供了良好的生存获益，即使是在接受过3线或更多线既往化疗的患者中。我们的分析也支持了先前报道的钇-RE治疗后生存的预后因素。总体而言，我们的更新分析证实，钇-RE治疗为美国所有年龄段以及不同社区和学术中心的MORE患者提供了有意义的反应和生存优势。
