结直肠癌肝转移放射微粒栓塞结果(4)

化疗补救

结直肠癌肝转移患者放射微粒栓塞作为全身化疗抵抗的补救化疗的结果[1-5]

II临床试验：单独应用放射微粒栓塞作为结直肠癌肝转移化疗不敏感患者2线治疗方案[2]

M Cosimelli Br J Cancer 2010

Hendlisz 等人[5] 多中心、前瞻性随机比较比较单独静脉注射5FU和静脉注射5FU+放射微粒栓塞治疗结直肠癌肝转移III临床研究结果

RE + 5FU in lmCRC Salvage Therapy（补救治疗）
	单独静脉注射5FU（N=23)	静脉注射5FU+放射性微粒栓塞	HR P值（95% CI）
肝进展中位时间（TTLP）	2.1 months	5.5 months	0.38 (0.20–0.72) p=0.003
中位TTP	2.1 months	4.6 months	0.51 (0.28–0.94) p=0.03
中位生存时间	7.4 months	9.9 months*	0.92 (0.47–1.78) p=0.80

Belgian trial：SIRT + 5-FU vs 5-FU in mCRC Salvage Therapy-Primary endpoint : TTP in the liver[5]

Hendlisz A, et al. J Clin Oncol 2010

如果不作为补救治疗，而作为与全身化疗一线或二线治疗的结果如何呢？

放射性微粒栓塞联合全身化疗作为一线或二线治疗的结果
文献	治疗选择	方案	例数	ORR	TTP/PFS（月）	中位生存期
Lim[6]	二线	放射栓塞+5FU/LV	30	33%	5.3	NR
van Hazel[7]	二线	放射栓塞+伊立替康	25	48%	6 9.2（肝内）*	12.2
Gray[8]	一线（RCT）	放射栓塞+动脉灌注FUDR	36	44%*	15.9*	39%@2年
Gray[8]	一线（RCT）	动脉灌注 FUDR	34	18%	9.7	29%@2年
van Hazel[9]	一线（RCT）	放射栓塞+5FU/LV	11	91%*	18.6*	29.4*
van Hazel[9]	一线（RCT）	5FU/LV	10	0%	3.6	12.8
Sharma[10]	一线	放射栓塞+FOLFOX4	20	90%	9.2 14.2	NR

*统计学差异显著
** PFS
***肝内

究竟“放射微粒栓塞+标准的全身化疗”作为不可切除结直肠癌肝转移的一线治疗是否可以改善整体生存率？

有三项研究[8-10]结果显示放射微粒栓塞+化疗作为结直肠癌肝转移的一线治疗方法至少在整体反应率上好于传统的化疗+生物治疗。

以下为正在进行的关于放射微粒栓塞的III临床试验：不可切除结直肠癌肝转移作为一线治疗方案

试验样本	研究设计	研究终点	国家
SIRFLOX n=518 NCT00724503		PFS	澳大利亚 -欧洲
FOXFIRE n≤490 ISRCTN 83867919		OS	英国：2014年4月完成
FOXFIRE GLOBAL n=200-300 NCT01721954		OS	全球

Y-90 phase III trials：

SIR-Spheres + standard FOLFOX as first line in non-resectable CRC - LM

TheraSphere Following Failed First Line CTx in CRC LM

EPOCH 临床试验是由美国、加拿大和法国联合进行，计划募集360病人，2016年完成资料收集工作。

1. M. Seidensticker, R. Rühl, P. Kraus, T. Denecke, A. Pethe, M. Pech, H. Amthauer, J. Ricke Radioembolization with 90Y-resin microspheres as a salvage treatment for refractory liver-dominant colorectal metastases: a matched-pair analysis Eur J Cancer Supplements september Vol. 7, Issue 2, Page 343

2. M. Cosimelli, Sr., R. Mancini, L. Carpanese, R. Sciuto, I. Sperduti, R. Golfieri, E. Giampalma, P. Cagol, S. Bacchetti, and F. Izzo. Clinical safety and efficacy of 90yttrium resin microspheres alone in unresectable, heavily pre-treated colorectal liver metastases: results of a phase II trial. J Clin Oncol 2008; 26 (May 20 Suppl) ASCO MEETING ABSTRACTS Aug 18, 2008:4078

3. Jakobs TF, Hoffmann RT, Dehm K, Trumm C, Stemmler HJ, Tatsch K, La Fougere C, Murthy R, Helmberger TK, Reiser MF.Hepatic yttrium-90 radioembolization of chemotherapy-refractory colorectal cancer liver metastases. J Vasc Interv Radiol. 2008 Aug;19(8):1187-95.

4. Kennedy AS, Coldwell D, Nutting C, Murthy R, Wertman DE Jr, Loehr SP, Overton C, Meranze S, Niedzwiecki J, Sailer S. Resin 90Y-microsphere brachytherapy for unresectable colorectal liver metastases: modern USA experience. Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):412-25.

5. Hendlisz A, Van den Eynde M, Peeters M, Maleux G, Lambert B, Vannoote J, De Keukeleire K, Verslype C, Defreyne L, Van Cutsem E, Delatte P, Delaunoit T, Personeni N, Paesmans M, Van Laethem JL, Flamen P. Phase III trial comparing protracted intravenous fluorouracil infusion alone or with yttrium-90 resin microspheres radioembolization for liver-limited metastatic colorectal cancer refractory to standard chemotherapy. J Clin Oncol. 2010 Aug 10;28(23):3687-94.

6. Lim L, Gibbs P, Yip D, Shapiro JD, Dowling R, Smith D, Little A, Bailey W, Liechtenstein M. A prospective evaluation of treatment with Selective Internal Radiation Therapy (SIR-spheres) in patients with unresectable liver metastases from colorectal cancer previously treated with 5-FU based chemotherapy. BMC Cancer. 2005 Oct 15;5:132.

7. van Hazel GA, Pavlakis N, Goldstein D, Olver IN, Tapner MJ, Price D, Bower GD, Briggs GM, Rossleigh MA, Taylor DJ, George J. Treatment of fluorouracil-refractory patients with liver metastases from colorectal cancer by using yttrium-90 resin microspheres plus concomitant systemic irinotecan chemotherapy. J Clin Oncol. 2009 Sep 1;27(25):4089-95.

8. Gray B, Van Hazel G, Hope M, Burton M, Moroz P, Anderson J, Gebski V. Randomised trial of SIR-Spheres plus chemotherapy vs. chemotherapy alone for treating patients with liver metastases from primary large bowel cancer. Ann Oncol. 2001 Dec;12(12):1711-20.

9. Van Hazel G, Blackwell A, Anderson J, Price D, Moroz P, Bower G, Cardaci G, Gray B. Randomised phase 2 trial of SIR-Spheres plus fluorouracil/leucovorin chemotherapy versus fluorouracil/leucovorin chemotherapy alone in advanced colorectal cancer. J Surg Oncol. 2004 Nov 1;88(2):78-85.

10. Sharma RA, Van Hazel GA, Morgan B, Berry DP, Blanshard K, Price D, Bower G, Shannon JA, Gibbs P, Steward WP. Radioembolization of liver metastases from colorectal cancer using yttrium-90 microspheres with concomitant systemic oxaliplatin, fluorouracil, and leucovorin chemotherapy. J Clin Oncol. 2007 Mar 20;25(9):1099-106.

11. Kennedy AS1, Coldwell D, Nutting C, Murthy R, Wertman DE Jr, Loehr SP, Overton C, Meranze S, Niedzwiecki J, Sailer S. Resin 90Y-microsphere brachytherapy for unresectable colorectal liver metastases: modern USA experience. Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):412-25.

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结直肠癌肝转移放射微粒栓塞结果(4)