Cisplatin plus Gemcitabine versus Gemcitabine for Biliary Tract Cancer.

被引：3475

作者：

Valle, Juan ^{[2
]}

Wasan, Harpreet ^{[3
]}

Palmer, Daniel H. ^{[8
]}

Cunningham, David ^{[4
]}

Anthoney, Alan ^{[9
]}

Maraveyas, Anthony ^{[10
]}

Madhusudan, Srinivasan ^{[11
]}

Iveson, Tim ^{[12
]}

Hughes, Sharon ^{[5
,6
]}

Pereira, Stephen P. ^{[7
]}

Roughton, Michael ^{[5
,6
]}

Bridgewater, John ^{[1
]}

机构：

[1] UCL, Inst Canc, London WC1E 6AA, England

[2] Christie Hosp, Manchester, Lancs, England

[3] Hammersmith Hosp, Imperial Coll Hlth Care Trust, London, England

[4] Royal Marsden Hosp, London SW3 6JJ, England

[5] Canc Res United Kingdom, London, England

[6] UCL, Canc Trials Ctr, London, England

[7] UCL, Inst Hepatol, London, England

[8] Univ Hosp Birmingham, Birmingham, W Midlands, England

[9] St James Hosp, Leeds, W Yorkshire, England

[10] Castle Hill Hosp, Kingston Upon Hull, N Humberside, England

[11] Univ Nottingham Hosp, Nottingham NG7 2UH, England

[12] Southampton Univ Hosp, Southampton, Hants, England

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2010年 / 362卷 / 14期

关键词：

RANDOMIZED PHASE-II; CHOLANGIOCARCINOMA; COMBINATION; TRIAL; CARCINOMA; SURVIVAL; TUMORS; ACID; GENE;

D O I：

10.1056/NEJMoa0908721

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background: There is no established standard chemotherapy for patients with locally advanced or metastatic biliary tract cancer. We initially conducted a randomized, phase 2 study involving 86 patients to compare cisplatin plus gemcitabine with gemcitabine alone. After we found an improvement in progression-free survival, the trial was extended to the phase 3 trial reported here. Methods: We randomly assigned 410 patients with locally advanced or metastatic cholangiocarcinoma, gallbladder cancer, or ampullary cancer to receive either cisplatin (25 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter on days 1 and 8, every 3 weeks for eight cycles) or gemcitabine alone (1000 mg per square meter on days 1, 8, and 15, every 4 weeks for six cycles) for up to 24 weeks. The primary end point was overall survival. Results: After a median follow-up of 8.2 months and 327 deaths, the median overall survival was 11.7 months among the 204 patients in the cisplatin-gemcitabine group and 8.1 months among the 206 patients in the gemcitabine group (hazard ratio, 0.64; 95% confidence interval, 0.52 to 0.80; P<0.001). The median progression-free survival was 8.0 months in the cisplatin-gemcitabine group and 5.0 months in the gemcitabine-only group (P<0.001). In addition, the rate of tumor control among patients in the cisplatin-gemcitabine group was significantly increased (81.4% vs. 71.8%, P=0.049). Adverse events were similar in the two groups, with the exception of more neutropenia in the cisplatin-gemcitabine group; the number of neutropenia-associated infections was similar in the two groups. Conclusions: As compared with gemcitabine alone, cisplatin plus gemcitabine was associated with a significant survival advantage without the addition of substantial toxicity. Cisplatin plus gemcitabine is an appropriate option for the treatment of patients with advanced biliary cancer. (ClinicalTrials.gov number, NCT00262769.) N Engl J Med 2010;362:1273-81.

引用

页码：1273 / 1281

页数：9

共 21 条

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