已入深夜,您辛苦了!由于当前在线用户较少,发布求助请尽量完整的填写文献信息,科研通机器人24小时在线,伴您度过漫漫科研夜!祝你早点完成任务,早点休息,好梦!

Abstract PS10-23: Five year median follow-up data from a prospective, randomized, placebo-controlled, single-blinded, multicenter, phase IIb study evaluating the reduction of recurrences using HER2/neu peptide GP2 + GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in HER2 positive women with operable breast cancer

医学 HER2/东北 安慰剂 内科学 中期分析 乳腺癌 临床试验 外科 多中心试验 随机对照试验 胃肠病学 癌症 多中心研究 病理 替代医学
作者
Snehal S. Patel,David B. McWilliams,Marisa Patel,Christine T. Fischette,Jaye Thompson,F. Joseph Daugherty
出处
期刊:Cancer Research [American Association for Cancer Research]
卷期号:81 (4_Supplement): PS10-23 被引量:7
标识
DOI:10.1158/1538-7445.sabcs20-ps10-23
摘要

Abstract Background: The final analysis of the GP2 prospective, randomized, placebo-controlled, single-blinded, multicenter Phase IIb trial investigating GP2+GM-CSF administered in the adjuvant setting to node-positive and high-risk node-negative breast cancer patients with tumors expressing any degree of HER2 (immuno-histochemistry [IHC] 1-3+) (NCT00524277) is now complete with 5 year follow-up. The trial enrolled HLA-A02 patients randomized to receive GP2+GM-CSF versus GM-CSF alone. The trial's primary objective was to determine if treatment with GP2, a HER2-derived peptide, reduces recurrence rates. Three and 4 year interim analyses for this trial and 3 Phase I studies showing GP2 to be safe and immunogenic have been previously reported by Mittendorf et al. Methods: Each enrolled and consented GP2-treated patient was scheduled to receive a total of 6 GP2+GM-CSF (500 mcg GP2: 125 mcg GM-CSF) intradermal injections every 3-4 weeks as part of the Primary Immunization Series (PIS) for the first 6 months and 4 GP2+GM-CSF booster intradermal injections every 6 months thereafter. Boosters were introduced during the trial, thus some patients did not receive all 4 boosters. Each enrolled and consented placebo patient was scheduled to receive a total of 6 GM-CSF only intradermal injections every 3-4 weeks for the first 6 months and 4 GM-CSF only booster intradermal injections every 6 months thereafter. Results: This 168 patient (ITT: n=180) basket trial across 16 clinical sites explored 96 HER2 3+ patients, who received a standard course of trastuzumab after surgery and subsequently completed the full PIS or placebo, starting the PIS at median 17.1 months after surgery, and 72 HER2 1-2+ patients, who did not receive trastuzumab after surgery and subsequently completed the full PIS or placebo, starting the PIS at median 10.8 months after surgery. Since GP2 is synergistic with trastuzumab, and the HER2 1-2+ patients did not receive trastuzumab, it was prespecified to compare recurrence rates ITT versus per protocol in these 2 distinct, independently reported populations, excluding those patients who did not complete the PIS. GP2 was shown to be well tolerated with no SAEs and elicited a potent immune response measured by local skin tests and immunological assays, which suggest peak immunity is reached at 6 months upon completion of the PIS. After 5 years of follow-up, the Kaplan-Meier estimated 5-year DFS rate in the 46 HER2 3+ patients treated with GP2+GM-CSF, if the patient completed the PIS, was 100% versus 89.4% (95% CI:76.2, 95.5%) in the 50 placebo patients treated with GM-CSF (p = 0.0338). The treated versus placebo HER2 3+ patients were well-matched, where 53% were stage T1, 41% were stages T2-T4, 55% were node positive, 58% were HR positive and received endocrine therapy, 77% received adjuvant radiation, 77% received adjuvant chemotherapy, and 89% received trastuzumab. After 5 years of follow-up, the Kaplan-Meier estimated 5-year DFS rate in the 35 HER2 1-2+ patients treated with GP2+GM-CSF, if the patient completed the PIS, was 77.1% (95% CI:59.5, 87.9%) versus 77.6% (95% CI:60.1, 88.2%) in the 37 placebo patients treated with GM-CSF (p = 0.9142). Conclusions: This study demonstrated that completion of the GP2+GM-CSF PIS safely elicited a potent immune response and reduced recurrence rates to 0% in HER2 3+ patients, who received a standard course of trastuzumab after surgery. A pivotal Phase III trial is being initiated to treat HER2 3+ patients in the neoadjuvant setting. GP2 also may be effective when used in parallel to trastuzumab based therapeutics or in combination with trastuzumab based therapeutics in HER2 1-2+ or other HER2 expressing cancers. Citation Format: Snehal S Patel, David B McWilliams, Marisa S Patel, Christine T Fischette, Jaye Thompson, F Joseph Daugherty. Five year median follow-up data from a prospective, randomized, placebo-controlled, single-blinded, multicenter, phase IIb study evaluating the reduction of recurrences using HER2/neu peptide GP2 + GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in HER2 positive women with operable breast cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS10-23.

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
大幅提高文件上传限制,最高150M (2024-4-1)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
1秒前
今后应助Wang采纳,获得10
3秒前
Singularity发布了新的文献求助10
3秒前
乐悠发布了新的文献求助10
4秒前
4秒前
丢丢发布了新的文献求助10
4秒前
HCLonely应助Kristine采纳,获得10
5秒前
孤独的大灰狼完成签到 ,获得积分10
6秒前
6秒前
tim完成签到,获得积分10
6秒前
8秒前
Huobol完成签到,获得积分10
10秒前
wave发布了新的文献求助10
12秒前
斯文败类应助十里采纳,获得10
13秒前
15秒前
嘿哈完成签到,获得积分10
17秒前
20秒前
20秒前
千纸鹤发布了新的文献求助10
22秒前
如意果汁发布了新的文献求助10
25秒前
FashionBoy应助谦让寄容采纳,获得10
25秒前
完美世界应助plumephoenix采纳,获得10
28秒前
morena应助迅速的八宝粥采纳,获得80
28秒前
852应助乐悠采纳,获得10
29秒前
32秒前
斯文败类应助科研通管家采纳,获得10
33秒前
CodeCraft应助科研通管家采纳,获得10
33秒前
33秒前
杳鸢应助科研通管家采纳,获得10
33秒前
酷波er应助科研通管家采纳,获得10
33秒前
34秒前
35秒前
35秒前
陌路人发布了新的文献求助30
36秒前
如意果汁完成签到,获得积分20
37秒前
谦让寄容发布了新的文献求助10
38秒前
plumephoenix完成签到,获得积分10
38秒前
44秒前
ranqi完成签到,获得积分10
49秒前
49秒前
高分求助中
歯科矯正学 第7版(或第5版) 1004
Semiconductor Process Reliability in Practice 1000
Smart but Scattered: The Revolutionary Executive Skills Approach to Helping Kids Reach Their Potential (第二版) 1000
Nickel superalloy market size, share, growth, trends, and forecast 2023-2030 600
GROUP-THEORY AND POLARIZATION ALGEBRA 500
Mesopotamian divination texts : conversing with the gods : sources from the first millennium BCE 500
Days of Transition. The Parsi Death Rituals(2011) 500
热门求助领域 (近24小时)
化学 医学 生物 材料科学 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 基因 遗传学 催化作用 物理化学 免疫学 量子力学 细胞生物学
热门帖子
关注 科研通微信公众号,转发送积分 3234378
求助须知:如何正确求助?哪些是违规求助? 2880736
关于积分的说明 8216789
捐赠科研通 2548319
什么是DOI,文献DOI怎么找? 1377665
科研通“疑难数据库(出版商)”最低求助积分说明 647925
邀请新用户注册赠送积分活动 623304