Pathological response after neoadjuvant chemotherapy in resectable non-small-cell lung cancers: proposal for the use of major pathological response as a surrogate endpoint

被引：579

作者：

Hellmann, Matthew D. ^{[1
]}

Chaft, Jamie E. ^{[1
]}

William, William N., Jr.

Rusch, Valerie ^{[3
]}

Pisters, Katherine M. W.

Kalhor, Neda ^{[5
,6
]}

Pataer, Apar ^{[4
]}

Travis, William D. ^{[2
]}

Swisher, Stephen G. ^{[4
]}

Kris, Mark G. ^{[1
]}

机构：

[1] Mem Sloan Kettering Canc Ctr, Dept Med, Thorac Oncol Serv, Div Solid Tumor Oncol, New York, NY 10065 USA

[2] Mem Sloan Kettering Canc Ctr, Dept Pathol, New York, NY 10065 USA

[3] Mem Sloan Kettering Canc Ctr, Thorac Serv, Dept Surg, New York, NY 10065 USA

[4] Univ Texas MD Anderson Canc Ctr, Dept Thorac & Cardiovasc Surg, Div Surg, Houston, TX 77030 USA

[5] Univ Texas MD Anderson Canc Ctr, Dept Thorac Head & Neck Med Oncol, Div Canc Med, Houston, TX 77030 USA

[6] Univ Texas MD Anderson Canc Ctr, Dept Pathol, Houston, TX 77030 USA

来源：

LANCET ONCOLOGY | 2014年 / 15卷 / 01期

关键词：

SURGICAL ADJUVANT BREAST; VINORELBINE PLUS CISPLATIN; PHASE-II TRIAL; PREOPERATIVE CHEMOTHERAPY; RANDOMIZED-TRIAL; INDUCTION CHEMOTHERAPY; HISTOPATHOLOGIC RESPONSE; DOCETAXEL-CISPLATIN; TUMOR-REGRESSION; CLINICAL-TRIALS;

D O I：

10.1016/S1470-2045(13)70334-6

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

Improvements in outcomes for patients with resectable lung cancers have plateaued. Clinical trials of resectable non-small-cell lung cancers with overall survival as the primary endpoint require a decade or longer to complete, are expensive, and limit innovation. A surrogate for survival, such as pathological response to neoadjuvant chemotherapy, has the potential to improve the efficiency of trials and expedite advances. 10% or less residual viable tumour after neoadjuvant chemotherapy, termed here major pathological response, meets criteria for a surrogate; major pathological response strongly associates with improved survival, is reflective of treatment effect, and captures the magnitude of the treatment benefit on survival. We support the incorporation of major pathological response as a surrogate endpoint for survival in future neoadjuvant trials of resectable lung cancers. Additional prospective studies are needed to confirm the validity and reproducibility of major pathological response within individual histological and molecular subgroups and with new drugs.

引用

页码：E42 / E50

页数：9

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