Evaluation of Immune-Related Response Criteria and RECIST v1.1 in Patients With Advanced Melanoma Treated With Pembrolizumab

被引：596

作者：

Hodi, F. Stephen ^{[1
]}

Hwu, Wen-Jen ^{[2
]}

Kefford, Richard ^{[4
,5
]}

Weber, Jeffrey S. ^{[7
]}

Daud, Adil ^{[9
]}

Hamid, Omid ^{[10
]}

Patnaik, Amita ^{[3
]}

Ribas, Antoni ^{[11
]}

Robert, Caroline ^{[12
,13
]}

Gangadhar, Tara C. ^{[14
]}

Joshua, Anthony M. ^{[15
]}

Hersey, Peter ^{[6
]}

Dronca, Roxana ^{[16
]}

Joseph, Richard ^{[8
]}

Hille, Darcy ^{[17
]}

Xue, Dahai ^{[17
]}

Li, Xiaoyun Nicole ^{[17
]}

Kang, S. Peter ^{[17
]}

Ebbinghaus, Scot ^{[17
]}

Perrone, Andrea ^{[17
]}

Wolchok, Jedd D. ^{[18
]}

机构：

[1] Dana Farber Canc Inst, 450 Brookline Ave, Boston, MA 02215 USA

[2] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA

[3] South Texas Accelerated Res Therapeut, San Antonio, TX USA

[4] Westmead Hosp, Melanoma Inst Australia, Sydney, NSW, Australia

[5] Macquarie Univ, Sydney, NSW 2109, Australia

[6] Univ Sydney, Sydney, NSW 2006, Australia

[7] Univ S Florida, H Lee Moffitt Canc Ctr, Tampa, FL 33682 USA

[8] Mayo Clin, Jacksonville, FL 32224 USA

[9] Univ Calif San Francisco, San Francisco, CA 94143 USA

[10] Angeles Clin & Res Inst, Los Angeles, CA USA

[11] Univ Calif Los Angeles, Los Angeles, CA USA

[12] Gustave Roussy, Villejuif, France

[13] Univ Paris 11, Villejuif, France

[14] Abramson Canc Ctr, Philadelphia, PA USA

[15] Princess Margaret Hosp, Toronto, ON M4X 1K9, Canada

[16] Mayo Clin, Rochester, MN USA

[17] Merck, Kenilworth, NJ USA

[18] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2016年 / 34卷 / 13期

关键词：

SOLID TUMORS; PHASE-II; T-CELLS; IPILIMUMAB; GUIDELINES; SAFETY; PD-1;

D O I：

10.1200/JCO.2015.64.0391

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

Purpose We evaluated atypical response patterns and the relationship between overall survival and best overall response measured per immune-related response criteria (irRC) and Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) in patients with advanced melanoma treated with pembrolizumab in the phase lb KEYNOTE-001 study (clinical trial information: NCT01295827). Patients and Methods Patients received pembrolizumab 2 or 10 mg/kg every 2 weeks or every 3 weeks. Atypical responses were identified by using centrally assessed irRC data in patients with >= 28 weeks of imaging. Pseudoprogression was defined as >= 25% increase in tumor burden at week 12 (early) or any assessment after week 12 (delayed) that was not confirmed as progressive disease at next assessment. Response was assessed centrally per irRC and RECIST v1.1. Results Of the 655 patients with melanoma enrolled, 327 had> 28 weeks of imaging follow-up. Twenty-four (7%) of these 327 patients had atypical responses (15 [5%] with early pseudoprogression and nine [3%] with delayed pseudoprogression). Of the 592 patients who survived >= 12 weeks, 84 (14%) experienced progressive disease per RECIST v1.1 but nonprogressive disease per irRC. Two-year overall survival rates were 77.6% in patients with nonprogressive disease per both criteria (n = 331), 37.5% in patients with progressive disease per RECIST v1.1 but nonprogressive disease per irRC (n = 84), and 17.3% in patients with progressive disease per both criteria (n = 177). Conclusion Atypical responses were observed in patients with melanoma treated with pembrolizumab. Based on survival analysis, conventional RECIST might underestimate the benefit of pembrolizumab in approximately 15% of patients; modified criteria that permit treatment beyond initial progression per RECIST v1.1 might prevent premature cessation of treatment. (C) 2016 by American Society of Clinical Oncology

引用

页码：1510 / +

页数：11

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