Gemcitabine Alone Versus Gemcitabine Plus Radiotherapy in Patients With Locally Advanced Pancreatic Cancer: An Eastern Cooperative Oncology Group Trial
Gemcitabine Alone Versus Gemcitabine Plus Radiotherapy in Patients With Locally Advanced Pancreatic Cancer: An Eastern Cooperative Oncology Group Trial
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DOI：
10.1200/jco.2011.34.8904
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发表时间：
2011-11-01
影响因子：
45.3
通讯作者：
Benson, Al B., III
中科院分区：
文献类型：
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作者：
Loehrer, Patrick J., Sr.;Feng, Yang;Benson, Al B., III
目的：本试验的目的是评价放射治疗同时使用吉西他滨（GEM）与单独使用GEM在局部不可切除胰腺癌患者中的作用。患者和方法局部不可切除的胰腺腺癌患者被随机分配单独接受GEM （1,000 mg/m2/周，第1至6周，随后休息1周，然后4周中的3周）或GEM （600 mg/m2/周，第1至5周，然后4周后1,000 mg/m2(2)， 4周中的3周）加放疗（从第1天开始，1.8 Gy/Fx，总计50.4 Gy）。使用癌症治疗功能评估-肝胆问卷对生活质量进行测量。在74名患者中，随机分配接受GEM单独（A组，n = 37）或GEM加放疗（B组，n = 34）， B组患者的4级和5级毒性发生率更高（41% vs 9%），但3级和4级毒性联合发生率相似（A组77% vs B组79%）。在6周、15周至16周和36周的生活质量测量中没有统计学差异。主要终点为生存期，A组和B组分别为9.2个月（95% CI, 7.9 ~ 11.4个月）和11.1个月（95% CI, 7.6 ~ 15.5个月）（分层log-rank检验单侧P = 0.017）。结论：该试验表明，局部不可切除的胰腺癌患者在GEM的基础上增加放射治疗可提高总生存率，毒性可接受。[J]中华临床杂志，29:4105-4112。(C) 2011年美国临床肿瘤学会
PurposeThe purpose of this trial was to evaluate the role of radiation therapy with concurrent gemcitabine (GEM) compared with GEM alone in patients with localized unresectable pancreatic cancer.Patients and MethodsPatients with localized unresectable adenocarcinoma of the pancreas were randomly assigned to receive GEM alone (at 1,000 mg/m(2)/wk for weeks 1 to 6, followed by 1 week rest, then for 3 of 4 weeks) or GEM (600 mg/m2/wk for weeks 1 to 5, then 4 weeks later 1,000 mg/m(2) for 3 of 4 weeks) plus radiotherapy (starting on day 1, 1.8 Gy/Fx for total of 50.4 Gy). Measurement of quality of life using the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire was also performed.ResultsOf 74 patients entered on trial and randomly assigned to receive GEM alone (arm A; n = 37) or GEM plus radiation (arm B; n = 34), patients in arm B had greater incidence of grades 4 and 5 toxicities (41% v 9%), but grades 3 and 4 toxicities combined were similar (77% in A v 79% in B). No statistical differences were seen in quality of life measurements at 6, 15 to 16, and 36 weeks. The primary end point was survival, which was 9.2 months (95% CI, 7.9 to 11.4 months) and 11.1 months (95% CI, 7.6 to 15.5 months) for arms A and B, respectively (one-sided P = .017 by stratified log-rank test).ConclusionThis trial demonstrates improved overall survival with the addition of radiation therapy to GEM in patients with localized unresectable pancreatic cancer, with acceptable toxicity. J Clin Oncol 29: 4105-4112. (C) 2011 by American Society of Clinical Oncology