‍‍‍‍‍‍‍‍医脉通编译，转载请务必注明出处

‍‍‍2015年ASCO年会将于5月29日—6月2日在美国芝加哥召开。5月30日下午消化系统（结直肠）肿瘤口头报告专场上，将会发表射频消融（RFA）联合化疗治疗不能切除的结直肠癌肝转移（CRC LM）的长期生存结果，即随机II期EORTC-NCRI CCSG-ALM 国际40004研究（ELOCC）的长期生存结果。医脉通整理如下：

该项研究评估了系统性化疗（CT）联合射频消融局部破坏肿瘤病灶治疗在不能切除的CRC LM（肝脏病灶多达9处，但无肝外病变）中的疗效。本研究的30个月时的总生存期（OS），无进展生存期（PFS）结果已进行报告（参考文献：Ann Oncol. 23(10): 2619-26, 2012）。经历长达中位9.7年的随访，现在报告OS的结果。

研究方法：

2002年至2007年，随机入组119例患者接受单纯CT（59例）或RFA+CT（60例）治疗。两组中，CT组为6个月FOLFOX（奥沙利铂85mg/m2和LV5FU2），2005年10月以后联合了贝伐珠单抗。在CT组中，当不能切除病灶转化为可切除病灶时，给予了手术切除。主要目标是联合治疗组30个月的OS＞38%。次要终点是OS和PFS。

研究结果：

在RFA+CT组，56例患者（93.3%）接受RFA治疗，其中有27例患者（45%）联合手术切除，1例患者切除所有转移病灶（不合格），2例未接受治疗，1例局部治疗数据缺失。RFA+CT组中有51例（85%）接受CT，而CT组全组59例均接受CT。CT组中最终有6例接受了肝切除术。本研究在30月时已达到了主要终点，联合治疗组30个月的OS为61.7%（95%CI：48.2-73.9）。然而，CT组30个月的OS仅为57.6%（95%CI：44.1-70.4），高于预期。经过中位9.7年的随访，死亡病例92例，其中CT组53例，RFA+CT组39例。

CT组的死亡原因主要为疾病进展（49例），死因未知4例；而RFA+CT组的死亡原因为疾病进展（35例），其他原因（2例）和未知（2例）。RFA+CT组在OS上具有明显的优势且差异显著（HR=0.58，95%CI：0.38-0.88，P=0.01）。研究观察到RFA+CT组的中位OS为45.6个月（95%CI：30.3-67.8）vs.CT组40.5个月（95%CI：27.5-47.7）。

结论：

本项研究第一次前瞻性探讨了RFA+CT在不能手术切除的CRC LM中的疗效。在本次II期试验中，与单独CT相比，RFA+CT能够延长患者的长期OS。临床试验信息：NCT00043004。

会议专题》》》2015年ASCO年会专题报道

阅读原文摘要

Radiofrequency ablation (RFA) combined with chemotherapy for unresectable colorectal liver metastases (CRC LM): Long-term survival results of a randomized phase II study of the EORTC-NCRI CCSG-ALM Intergroup 40004 (CLOCC).（Abstract 3501）

Authors：Theo Ruers, Cornelis J. A. Punt，et al.

Session Type：Oral Abstract Session

Background：This study evaluates the benefit of combining systemic chemotherapy (CT) with local tumor destruction by RFA in patients with unresectable CRC LM up to 9 lesions and without extrahepatic disease. Overall survival (OS) at 30 months and progression free survival (PFS) results were reported (Ann Oncol. 23(10): 2619-26, 2012). We now report on OS results, after a long term median follow-up of 9.7 years. 

Methods：Between 2002 and 2007, 119 pts were randomized between CT alone (59) or RFA+CT (60). In both arms, CT consisted of 6 months FOLFOX (oxaliplatin 85mg/m2 and LV5FU2) plus, since October 2005, bevacizumab. In the CT arm resection was allowed when unresectable disease was converted by CT to resectable disease. Primary objective was a 30-months OS rate > 38% for the combined treatment group. OS and PFS were secondary endpoints. 

Results：In the RFA+CT arm, 56 pts (93.3%) received RFA which was combined with resection in 27 pts (45%), 1 pt had all metastases resected (ineligible), 2 pts were not treated at all, in 1 pt no local treatment data were available. 51 patients (85%) in the RFA+CT arm received CT compared to all 59 in the CT arm. 6 pts in the CT arm eventually underwent hepatic resection. The primary endpoint was met, 30-months OS rate was 61.7% (95% CI: 48.2-73.9) for combined treatment. However, 30-month OS for systemic treatment only was 57.6% (95% CI: 44.1-70.4), higher than anticipated. At a median follow-up of 9.7 years, 92 deaths were reported, 53 in the CT arm and 39 in the RFA+CT arm. Causes of death in the CT arm were progressive disease (49 pts), and unknown for 4 pts, and in the RFA+CT arm, progressive disease (35 pts), other causes (2 pts) and unknown (2 pts). There was a significant difference in OS in favor of the RFA+CT arm (HR = 0.58, 95% CI: 0.38-0.88, p = 0.01). Observed median OS was 45.6 months (95% CI: 30.3 – 67.8) in the RFA+CT arm vs. 40.5 months (95% CI: 27.5 - 47.7) in the CT arm. 

Conclusions：This is the first study that prospectively investigated the efficacy of RFA +CT in pts with unresectable CRC LM. In this phase II trial, RFA+CT was associated with improved long-term OS compared to CT alone. Clinical trial information: NCT00043004