新功能、新界面、新体验,扫描即可下载生物谷APP!
首页 » BIOON报道 » J Clin Oncol:延长晚期黑色素瘤患者生存期的潜在药物

J Clin Oncol:延长晚期黑色素瘤患者生存期的潜在药物

来源:生物谷 2014-03-04 20:39

2014年3月4日讯 /生物谷BIOON/--近日,约翰霍普金斯大学科学研究证实一种实验性药物(Nivolumab),运用人体的免疫系统对抗癌症,可以帮助治疗一些晚期黑色素瘤患者。研究人员认为这种药物可以帮助重置免疫系统,当肿瘤增加新的细胞成员,免疫系统能够清除它们。

约翰霍普金斯大学研究作者Suzanne Topalian博士说:我们假设,我们已经重置免疫系统和肿瘤之间的平衡,免疫系统能够更好清除它们。Anthony Olszanski博士表示:这确实为患者提供巨大希望,可能延长患者的生存。

这一发现是最新一轮Nivolumab早期试验结果的一部分,早期试验对107例患者进行测试,这些患者在2008至2012年之间被招募研究。在研究中,患者有危险的皮肤癌称为晚期黑素瘤,80%的患者黑色素瘤已经扩散到其他器官。超过一半的患者曾试图选择至少两个以上的治疗手段,但都没有成功。

在研究中,患者接受静脉注射药物每两个星期,最长为两年。如果他们的肿瘤消失、副作用太毒、他们的肿瘤继续生长或他们撤回同意参与这项研究,病人停止治疗。大约有一半的服用该药的患者出现副作用。最常见的是疲劳,皮疹和腹泻。严重不良反应主要出现在五例病人中。大多数副作用发生在治疗的前六个月内。

33例患者服用该药后他们的肿瘤缩小了至少50%。在少数情况下,肿瘤完全消失。另七名患者病情稳定,这意味着他们的癌症并没有变得更糟或更好,至少在六个月内。总体而言,一年后,参加试验的患者62%还活着,43%的患者两年后仍然活着。

截至2013年3月,最后更新的研究中,研究人员报道称19例患者仍然活着,有几位患者在最后一次服药后,维持他们的治疗结果超过了一年。这项研究结果发表在3月3日的Journal of Clinical Oncology杂志上。(生物谷Bioon.com)

Survival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab

Suzanne L. Topalian, et al.

Purpose Programmed cell death 1 (PD-1) is an inhibitory receptor expressed by activated T cells that downmodulates effector functions and limits the generation of immune memory. PD-1 blockade can mediate tumor regression in a substantial proportion of patients with melanoma, but it is not known whether this is associated with extended survival or maintenance of response after treatment is discontinued.

Patients and Methods Patients with advanced melanoma (N = 107) enrolled between 2008 and 2012 received intravenous nivolumab in an outpatient setting every 2 weeks for up to 96 weeks and were observed for overall survival, long-term safety, and response duration after treatment discontinuation.

Results Median overall survival in nivolumab-treated patients (62% with two to five prior systemic therapies) was 16.8 months, and 1- and 2-year survival rates were 62% and 43%, respectively. Among 33 patients with objective tumor regressions (31%), the Kaplan-Meier estimated median response duration was 2 years. Seventeen patients discontinued therapy for reasons other than disease progression, and 12 (71%) of 17 maintained responses off-therapy for at least 16 weeks (range, 16 to 56+ weeks). Objective response and toxicity rates were similar to those reported previously; in an extended analysis of all 306 patients treated on this trial (including those with other cancer types), exposure-adjusted toxicity rates were not cumulative.

Conclusion Overall survival following nivolumab treatment in patients with advanced treatment–refractory melanoma compares favorably with that in literature studies of similar patient populations. Responses were durable and persisted after drug discontinuation. Long-term safety was acceptable. Ongoing randomized clinical trials will further assess the impact of nivolumab therapy on overall survival in patients with metastatic melanoma.

温馨提示:87%用户都在生物谷APP上阅读,扫描立刻下载! 天天精彩!


相关标签

最新会议 培训班 期刊库