A double-blind placebo-controlled, randomised study comparing gemcitabine and marimastat with gemcitabine and placebo as first line therapy in patients with advanced pancreatic cancer.
A double-blind placebo-controlled, randomised study comparing gemcitabine and marimastat with gemcitabine and placebo as first line therapy in patients with advanced pancreatic cancer.
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DOI：
10.1038/sj.bjc.6600446
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发表时间：
2002-07-15
影响因子：
8.8
通讯作者：
Buckels, JAC
中科院分区：
文献类型：
--
作者：
Bramhall, SR;Schulz, J;Nemunaitis, J;Brown, PD;Baillet, M;Buckels, JAC
在西方世界，胰腺癌是癌症死亡的第五大常见原因，且不可切除疾病的预后仍然很差。常规化疗的最新进展以及具有不同毒性特征的新型“分子”治疗策略的发展，作为联合治疗策略值得研究。这项针对胰腺癌的随机研究比较了马立马司他（口服基质金属蛋白酶抑制剂）联合吉西他滨与单独使用吉西他滨的效果。239名不可切除胰腺癌患者被随机分配接受吉西他滨（1000mg/m²）联合马立马司他或安慰剂治疗。主要终点是生存期。还评估了客观肿瘤反应和反应持续时间、治疗失败时间和疾病进展、生活质量以及安全性。吉西他滨联合马立马司他与吉西他滨联合安慰剂在生存期方面没有显著差异（P = 0.95对数秩检验）。中位生存期分别为165.5天和164天，1年生存率分别为18%和17%。治疗组之间在总体反应率（分别为11%和16%）、无进展生存期（P = 0.68对数秩检验）或治疗失败时间（P = 0.70对数秩检验）方面没有显著差异。吉西他滨和马立马司他的联合用药耐受性良好，只有2.5%的患者因推测为马立马司他的毒性而停药。在接受马立马司他治疗的患者中，只有4%报告出现3级或4级肌肉骨骼毒性，尽管59%接受马立马司他治疗的患者报告了一些肌肉骨骼事件。这项研究的结果没有证据支持在晚期胰腺癌患者中马立马司他与吉西他滨联合使用。马立马司他与吉西他滨的联合用药耐受性良好。在吉西他滨治疗后出现反应或病情稳定的情况下，将马立马司他作为维持治疗进行进一步研究可能是合理的。
《英国癌症杂志》（2002年）87卷，161 - 167页。doi:10.1038/sj.bjc.6600446 www.bjcancer.com
© 2002英国癌症研究中心
Pancreatic cancer is the fifth most common cause of cancer death in the western world and the prognosis for unresectable disease remains poor. Recent advances in conventional chemotherapy and the development of novel ‘molecular’ treatment strategies with different toxicity profiles warrant investigation as combination treatment strategies. This randomised study in pancreatic cancer compares marimastat (orally administered matrix metalloproteinase inhibitor) in combination with gemcitabine to gemcitabine alone. Two hundred and thirty-nine patients with unresectable pancreatic cancer were randomised to receive gemcitabine (1000 mg m−2) in combination with either marimastat or placebo. The primary end-point was survival. Objective tumour response and duration of response, time to treatment failure and disease progression, quality of life and safety were also assessed. There was no significant difference in survival between gemcitabine and marimastat and gemcitabine and placebo (P=0.95 log-rank test). Median survival times were 165.5 and 164 days and 1-year survival was 18% and 17% respectively. There were no significant differences in overall response rates (11 and 16% respectively), progression-free survival (P=0.68 log-rank test) or time to treatment failure (P=0.70 log-rank test) between the treatment arms. The gemcitabine and marimastat combination was well tolerated with only 2.5% of patients withdrawn due to presumed marimastat toxicity. Grade 3 or 4 musculoskeletal toxicities were reported in only 4% of the marimastat treated patients, although 59% of marimastat treated patients reported some musculoskeletal events. The results of this study provide no evidence to support a combination of marimastat with gemcitabine in patients with advanced pancreatic cancer. The combination of marimastat with gemcitabine was well tolerated. Further studies of marimastat as a maintenance treatment following a response or stable disease on gemcitabine may be justified. British Journal of Cancer (2002) 87, 161–167. doi:10.1038/sj.bjc.6600446 www.bjcancer.com © 2002 Cancer Research UK
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吉西他滨和5-氟尿嘧啶在晚期胰腺癌中的结合，这是意大利群体研究消化道癌研究（GISCAD）的一份报告。
影响因子：
8.8
作者：
Cascinu, S;Silva, RR;Barni, S;Labianca, R;Frontini, L;Piazza, E;Pancera, G;Giordani, P;Giuliodori, L;Pessi, MA;Fusco, V;Luporini, G;Cellerino, R;Catalano, G
通讯作者：
Catalano, G
影响因子：
9.6
作者：
PALMER, KR;KERR, M;LEONARD, RCF
通讯作者：
LEONARD, RCF
影响因子：
64.8
作者：
SATO, H;TAKINO, T;SEIKI, M
通讯作者：
SEIKI, M
影响因子：
6.4
作者：
GRESS, TM;MULLERPILLASCH, F;ADLER, G
通讯作者：
ADLER, G
影响因子：
45.3
作者：
Bramhall, SR;Rosemurgy, A;Buckels, JAC
通讯作者：
Buckels, JAC