肝癌介入文献集.pdf
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1、目目 录录 Roles Played by chemolipiodolization and embolization in chemoembolization for Hepatocellular carcinoma: Single-Blind, randomized trial 1 经皮肝动脉栓塞化疗联合洛铂热灌注化疗治疗不能手术切除的肝细胞癌的近期 疗效观察 10 TACE 治疗大肝癌合并门脉癌栓:一项前瞻、非随机对照研究 13 洛铂与碘油栓塞化疗用于肝脏原位移植术后的复发性肝癌且不能通过手术切除 的患者 20 肝动脉栓塞化疗不同化疗方案治疗不可切除肝癌的肝动脉栓塞化疗不同化疗方 案治疗
2、不可切除肝癌的前瞻性随机对照研究 27 洛铂对肝癌的细胞周期抑制作用研究 31 肝癌介入文献集JNCI | Articles 59jnci.oxfordjournals.orgArticleroles Played by chemolipiodolization and embolization in chemoembolization for Hepatocellular carcinoma: Single-Blind, randomized trialMing Shi, Li-Gong Lu, Wan-Qiang Fang, Rong-Ping Guo, Min-Shan Chen, Yo
3、ng Li, Jun Luo, Li Xu, Ru-Hai Zou, Xiao-Jun Lin, Ya-Qi ZhangManuscript received June 25, 2012; revised September 17 , 2012; accepted September 17 , 2012.Correspondence to: Ming Shi, MD, Department of Hepatobiliary Oncology, Cancer Center, Sun Yat-sen University, Guangzhou, 510060, P .R. China (e-mai
4、l: ). Background The aim of our study was to compare the efficacy and safety of: 1)transarterial chemolipiodolization with gela-tin sponge embolization vs chemolipiodolization without embolization, and 2)chemolipiodolization with triple chemotherapeutic agents vs epirubicin alone. Methods A single-b
5、lind, three parallel arm, randomized trial was conducted at three clinical centers with patients with biopsy-confirmed unresectable hepatocellular carcinoma. Arm 1 received triple-drug chemolipiodolization and sponge embolization, whereas Arm 2 received triple-drug chemolipiodolization only. Patient
6、s in arm 3 were treated with single-drug chemolipiodolization and sponge embolization. We compared overall survival and time to progression. Eventtime distributions were estimated by the KaplanMeier method. All statistical tests were two-sided. Results From July 2007 to November 2009, 365 patients (
7、Arm 1: n=122; Arm 2: n=121; Arm 3: n=122) were recruited. The median tumor size was 10.9 cm (range=722 cm), and 34.5% had macrovascular invasion. The median sur-vivals and time to progression in Arm 1, Arm 2, and Arm 3 were 10.5 and 3.6months, 10.1 and 3.1months, and 5.9 and 3.1months, respectively.
8、 Survival was statistically significantly better in Arm 1 than in Arm 3 (P 60 109 platelets/L; hemoglobin: 8.5 g/L; and prothrom-bin time: 10 cm). For two centers, the random block size for each stratum was 9 and 18. For the third center, where the subject recruitment rate was expected to be lower,
9、the random block size for each stratum was 6 and 12. The three treatment groups were as follows:1. Arm 1 received triple-drug chemolipiodolization with embo-lization. Lobaplatin (50 mg), epirubicin (50 mg), and mitomy-cin C (6 mg) were mixed in 9 mL of water-soluble contrast medium and 1 mL of steri
10、le water for injection. The mixture was thoroughly mixed with 10 mL of lipiodol. After injec-tion of the emulsion, 20 mL of pure lipiodol were injected. The injection was stopped either at the point of near stasis within the main artery feeding the tumor or after the entire amount of the above agent
11、 was administered. The actual vol-ume administered was recorded. After that, embolization was performed with injection of gelatin-sponge particles 500 to 1000? m in diameter through the catheter to reach stasis in the tumor-feeding artery.2. Arm 2 received triple-drug chemolipiodolization without em
12、bolization. Chemolipiodolization was performed with the same combined regimen without gelatin-sponge embolization.3. Arm 3 received single-drug chemolipiodolization with embo-lization. Treatment was the same as for Arm 1, except that only a single-drug, epirubicin (50 mg), was used.Study EndpointThe
13、 primary endpoint was the comparison of overall survival among the different treatment arms. After inclusion of the last patient in the study, a follow-up period of 12months was scheduled. Follow-up ended on December 1, 2010. The secondary outcome was the time to radiological progression (TTP), whic
14、h was defined as the time from random assignment to disease progression.Statistical AnalysisFor comparisons of baseline variables, the Students t test for continuous variables and the ?2 test for categorical variables were used. Treatment response and survival time were determined on an intent-to-tr
15、eat basis. The survival curves and univariable analysis were calculated by the KaplanMeier method and compared using a log-rank test. Any factors that were statistically significant at P less than .10 in the univariate analysis were candidates for entry into a multivariable Cox proportional hazards
16、model, the results of which are presented for the last step of the reverse selection of random variables. The proportional hazard assumption was checked by graphical inspection of the linearity of the hazards over time and loglog plots and by plotting Schoenfeld residuals over time. P values less th
17、an .05 were considered statistically significant. All statistical tests were two-sided. We analyzed the data for differences by sex but did not analyze ethnicity data. All statistical processing was performed by the Statistical Package for Social Science version 13.0 (SPSS Inc., Chicago, IL).肝癌介入文献集
18、第 2 页,共 39 页1. 组1接受三联化疗药物碘化油乳剂联合动脉栓塞。洛铂(50 m g )、表柔比星(50 m g )、丝裂霉素(6 m g )混入9m l 水溶性造影剂和1m l 无菌注射用水中,将混合物与10 m l 的碘化油充分混匀。注射乳剂后,再注射2 0 m l 纯碘化油。组2 接受三联化疗药物碘化油乳剂,不联合动脉栓塞组3接受单药化疗药物碘化油乳剂联合动脉栓塞。治疗方法同组1相同, 但只使用一种化疗药物,表柔比星(50 m g )。JNCI | Articles 61jnci.oxfordjournals.orgresultsPatient CharacteristicsFr
19、om July 2007 to November 2009, 381 patients were registered for the study; 16 (4.2%) patients were excluded because the TACE procedure could not be accomplished (Figure1). In total, 122, 121, and 122 patients were allocated to Arm 1, Arm 2, and Arm 3, respec-tively. The data from these patients were
20、 included in all subsequent analyses. The median tumor size was 10.9 cm (range=722 cm). Figure1. CONSORT flow diagram. TACE=transarterial chemoembolization.肝癌介入文献集第 3 页,共 39 页Vol. 105, Issue 1 | January 2, 201262 Articles | JNCITable1. Baseline characteristics and univariable analysis for all recrui
21、ted patients*Baseline characteristics analysisUnivariable analysisCharacteristicArm 1, n=122Arm 2, n=121Arm 3, n=122PNo.Median survival time, monthsPSex.31.07 Men1151131093378.3 Women78132812.4Age, y.54.001 507768722177 .2 5045535014811.9Neutrophil:lymphocyte ratio.94.001 372727021410.9 35049521515.
22、9Platelet count, 109/L.08.83 1008716319.1 1001141141063348.3Prothrombin time, s.50.04 141091061003158.9 14121521487 .2Hepatitis B surface antigen.02.06 Positive1141021143308.1 Negative81983512.2HBV DNA, copy.90.15 10004546431349.3 10007775792318.1Alanine aminotransferase, U/L.39.54 404049411308.4 40
23、8272812358.3Aspartate aminotransferase, U/L.16.007 452434238112.4 459887992847 .6Alkaline phosphatase, U/L.17.05 11049574314910.4 1107364792167 .6Glutamyl transpeptidase, U/L.331008791972757 .3Serum albumin, g/L.19.001 37272335857 .0 379598872809.5Total bilirubin, mol/L.81.001 209793932839.7 2025282
24、9825.6Alpha-fetoprotein, ng/mL.842007976812366.8Indocyanine green retention rate in 15 min, %.57.73 101081041003128.4 10141722537 .2Liver cirrhosis.90.58 No cirrhosis5258531638.4 Child A7063692028.3Tumor size, cm.27.007 1046585315710.9 107663692087 .4Tumor number.27.78 Single4951531538.7 Multiple737
25、0692128.3Portal vein tumor thrombus.7626150501618.2BCLC stage.79.001 Stage B (intermediate)82807723911.9 Stage C (advanced)4041451265.4* Arm 1?=?three-drug chemolipiodolization with embolization; Arm 2?=?three-drug chemolipiodolization without embolization; Arm 3?=?single-drug chemolipiodolization w
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