Antitumour activity of pembrolizumab in advanced mucosal melanoma: a post-hoc analysis of KEYNOTE-001, 002, 006.
Antitumour activity of pembrolizumab in advanced mucosal melanoma: a post-hoc analysis of KEYNOTE-001, 002, 006.
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DOI：
10.1038/s41416-018-0207-6
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发表时间：
2018-09
影响因子：
8.8
通讯作者：
Butler M
中科院分区：
文献类型：
--
作者：
Hamid O;Robert C;Ribas A;Hodi FS;Walpole E;Daud A;Arance AS;Brown E;Hoeller C;Mortier L;Schachter J;Long J;Ebbinghaus S;Ibrahim N;Butler M
黏膜黑色素瘤是一种侵袭性黑色素瘤，预后差。我们在Keynote-001(NCT01295827)、−002(NCT01704287)和−006(NCT01866319)中评估了培溴利珠单抗对晚期粘膜黑色素瘤患者的疗效。培溴利珠单抗2 mg/kg，每3周1次(Q3w)或10 mg/kg q2w或q3w。根据RECIST v1.1，通过独立的中央审查对反应进行评估。共治疗1567例，其中84例(5%)发生粘膜黑色素瘤。84人中有51人是ipilimumab幼稚的。黏膜黑色素瘤患者的客观有效率为19%(95%可信区间11~29%)，中位有效时间为27.6个月(1.1 + ~27.6个月)。中位无进展生存期(PFS)为2.8个月(95%CI 2.7~2.8)，中位总生存期(OS)为11.3个月(7.7~16.6)。Ipilimumab-naive和ipilimumab治疗的ORR分别为22%(95%CI 11-35%)和15%(95%CI 5-32%)。Pembrolizumab在晚期粘膜黑色素瘤患者中提供持久的抗肿瘤活性，而不考虑先前的ipilimumab。
Mucosal melanoma is an aggressive melanoma with poor prognosis. We assessed efficacy of pembrolizumab in patients with advanced mucosal melanoma in KEYNOTE-001 (NCT01295827), −002 (NCT01704287), and −006 (NCT01866319). Patients received pembrolizumab 2 mg/kg every 3 weeks (Q3W) or 10 mg/kg Q2W or Q3W. Response was assessed by independent central review per RECIST v1.1. 1567 patients were treated and 84 (5%) had mucosal melanoma. Fifty-one of 84 were ipilimumab-naive. In patients with mucosal melanoma, the objective response rate (ORR) was 19% (95% CI 11–29%), with median duration of response (DOR) of 27.6 months (range 1.1 + to 27.6). Median progression-free survival (PFS) was 2.8 months (95% CI 2.7–2.8), with median overall survival (OS) of 11.3 months (7.7–16.6). ORR was 22% (95% CI 11–35%) and 15% (95% CI 5–32%) in ipilimumab-naive and ipilimumab-treated patients. Pembrolizumab provides durable antitumour activity in patients with advanced mucosal melanoma regardless of prior ipilimumab.
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影响因子：
51.1
作者：
Ribas, Antoni;Puzanov, Igor;Dummer, Reinhard;Schadendorf, Dirk;Hamid, Omid;Robert, Caroline;Hodi, F. Stephen;Schachter, Jacob;Pavlick, Anna C.;Lewis, Karl D.;Cranmer, Lee D.;Blank, Christian U.;O'Day, Steven J.;Ascierto, Paolo A.;Salama, April K. S.;Margolin, Kim A.;Loquai, Carmen;Eigentler, Thomas K.;Gangadhar, Tara C.;Carlino, Matteo S.;Agarwala, Sanjiv S.;Moschos, Stergios J.;Sosman, Jeffrey A.;Goldinger, Simone M.;Shapira-Frommer, Ronnie;Gonzalez, Rene;Kirkwood, John M.;Wolchok, Jedd D.;Eggermont, Alexander;Li, Xiaoyun Nicole;Zhou, Wei;Zernhelt, Adriane M.;Lis, Joy;Ebbinghaus, Scot;Kang, S. Peter;Daud, Adil
通讯作者：
Daud, Adil
影响因子：
158.5
作者：
Robert, Caroline;Schachter, Jacob;Ribas, Antoni
通讯作者：
Ribas, Antoni
影响因子：
3
作者：
Yamazaki N;Takenouchi T;Fujimoto M;Ihn H;Uchi H;Inozume T;Kiyohara Y;Uhara H;Nakagawa K;Furukawa H;Wada H;Noguchi K;Shimamoto T;Yokota K
通讯作者：
Yokota K
影响因子：
2.5
作者：
Keller, Deborah S.;Thomay, Alan A.;Farma, Jeffrey M.
通讯作者：
Farma, Jeffrey M.
影响因子：
120.7
作者：
Ribas, Antoni;Hamid, Omid;Robert, Caroline
通讯作者：
Robert, Caroline