GEMOX联合或不联合特罗凯治疗晚期胆系肿瘤三期临床

Background: Currently, there is no standard regimen for palliative chemotherapy in metastatic, unresectable biliary tract cancer (BTC). A phase II trial of erlotinib monotherapy showed a promising anti-tumor activity in BTC with tolerable toxicity. Additionally, gemcitabine + erlotinib demonstrated superior efficacy when compared to gemcitabine alone in pancreatic cancer. Hence, we conducted a phase III trial to compare between GEMOX vs GEMOX+erlotinib (Tarceva [T]) (GEMOX/T) as first-line chemotherapy in unresectable, metastatic BTC.

Methods: Eligible patients were as follows: histologically confirmed adenocarcinoma of biliary tract (CCC), ampulla of vater (AOV) or gall bladder (GB); unresectable or metastatic; ECOG performance status of 0~2; adequate marrow, hepatic, renal and cardiac functions; no prior chemotherapy. The primary endpoint was progression free survival (PFS). The study regimen was gemcitabine 1,000mg/m2, oxaliplatin 100mg/m2, erlotinib 100mg qd daily q 2 weeks.

Results: From February 2009 to August 2010, 268 pts were randomized, 133 patients to GEMOX arm and 135 patients to GEMOX/T arm. Patient characteristics: median age 61 yrs (range 30-82); male (63.4%); CCC (n=180, 67.2%), GB (n=82, 30.6%), and AOV (n=6, 2.2%). With a median follow-up of 13.9 months (range, 6.7 – 25.0), median PFS was 5.8 months (95% CI, 4.6 - 7.0) in GEMOX/T arm and 4.2 months (95% CI, 2.7 - 5.7) in GEMOX arm (P=0.080). In subgroup analysis (CCC, n=180), however, median PFS was significantly longer in GEMOX/T arm (5.9 months) when compared with GEMOX arm (3.0 months, P=0.049). The overall response rate was significantly higher in the GEMOX/T arm when compared with GEMOX arm. There was no significant difference in overall survival between the two arms (GEMOX/T: 9.5 months, 95% CI, 7.6 – 11.4; GEMOX: 9.5 months, 95% CI, 7.5 – 11.5; P=0.611). The EGFR mutation testing results in correlation to responsiveness to erlotinib will be presented at the meeting.

Conclusions: This phase III represents the first multicenter, randomized trial to compare GEMOX vs GEMOX/T in unresectable, metastatic BTC. Although PFS was not prolonged in GEMOX/T, there was a significant benefit in terms of PFS in GEMOX/T arm for CCC patients.

http://www.asco.org/ASCOv2/Meeti ... mp;abstractID=79960

这项韩国的3期研究最终发表在杂志《Lancet oncology》上了www .sciencedirect.com/science/article/pii/S1470204511703011

深蓝，最好简明说一下研究结果吗，英文不行，呵呵

山水 发表于 2012-7-20 08:20

                               
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深蓝，最好简明说一下研究结果吗，英文不行，呵呵

GEMOX就是吉西他滨联合奥沙利铂的化疗方案。临床包含三种胆系癌：胆管癌，壶腹癌，胆囊癌。

结果：
1. 全组无进展期方面，联合特罗凯组与不联合特罗凯组接近（5.8个月对4.2个月）；
2. 胆管癌分组的无进展期方面，联合特罗凯组长于不联合特罗凯组（5.9个月对3.0个月）；
3. 联合特罗凯组的总有效率有明显提升。

bluest 发表于 2012-7-20 09:25

                               
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GEMOX就是吉西他滨联合奥沙利铂的化疗方案。临床包含三种胆系癌：胆管癌，壶腹癌，胆囊癌。

结果：

深蓝，真好!

我手里有特，医生建议同时口服化疗药，药名具体还不清楚，我估计也就是希罗达或替吉奥，按这组数据，医生的方案貌似也可行啊

走一步再走一步 发表于 2015-2-13 17:10
我手里有特，医生建议同时口服化疗药，药名具体还不清楚，我估计也就是希罗达或替吉奥，按这组数据，医生的 ...

希和替用过的患者很多，可以同时和特口服，但是帮助不大。当然副作用也不大，主要就是有可能对肝功有影响，代价可以接受。

bluest 发表于 2015-2-13 17:45
希和替用过的患者很多，可以同时和特口服，但是帮助不大。当然副作用也不大，主要就是有可能对肝功有影响 ...

医生推荐了阿帕和口服化疗药联用，我查了一下发现副作用非常可怕。而且看前辈们的反应效果也不咋地。因而没让哥哥同意这个方案。这段时间因为放支架一直在医院，所以和医生也有些交流。但是如憨豆先生和您所说，没事少跑医院，刚刚有点头绪的治疗思路都要被他们打乱了。{:soso_e101:} 不过黄疸的成功下降还是要感谢他们的。

走一步再走一步 发表于 2015-2-13 21:28
医生推荐了阿帕和口服化疗药联用，我查了一下发现副作用非常可怕。而且看前辈们的反应效果也不咋地。因而 ...

有些医生水平是可以的，只是他们没有像咱们这些人去研究这些未上市的药物和国外的临床，毕竟医生是医疗成果的应用者实践者，不是研究者或发明者，这些工作不是他们的业务范围，没必要受这个累。有些患者总是想不明白，非要向没有那些知识储备的医生求证怎么使用临床药，其实你已经进入了一个他们未曾进入的领域。

bluest 发表于 2015-2-13 22:22
有些医生水平是可以的，只是他们没有像咱们这些人去研究这些未上市的药物和国外的临床，毕竟医生是医疗成 ...

我是躲在论坛前辈的大树底下乘凉。不管治疗效果怎样，接下去可能会发生怎样的状况，怎样应对，总是有点心理准备了。医生是不能给予如此细致指导的，很感激你们的无私付出。