Adaptive Neoadjuvant Chemotherapy Guided by 18F-FDG PET in Resectable Non-Small Cell Lung Cancers: The NEOSCAN Trial

被引:36
作者
Chaft, Jamie E. [1 ,2 ]
Dunphy, Mark [3 ]
Naidoo, Jarushka [1 ,2 ]
Travis, William D. [4 ]
Hellmann, Matthew [1 ,2 ]
Woo, Kaitlin [5 ]
Downey, Robert [6 ]
Rusch, Valerie [6 ]
Ginsberg, Michelle S. [3 ]
Azzoli, Christopher G. [7 ]
Kris, Mark G. [1 ,2 ]
机构
[1] Mem Sloan Kettering Canc Ctr, Dept Med, 1275 York Ave, New York, NY 10021 USA
[2] Weill Cornell Med Coll, Dept Med, New York, NY USA
[3] Mem Sloan Kettering Canc Ctr, Dept Radiol, 1275 York Ave, New York, NY 10021 USA
[4] Mem Sloan Kettering Canc Ctr, Dept Pathol, 1275 York Ave, New York, NY 10021 USA
[5] Mem Sloan Kettering Canc Ctr, Dept Epidemiol & Biostat, New York, NY 10021 USA
[6] Mem Sloan Kettering Canc Ctr, Dept Surg, 1275 York Ave, New York, NY 10021 USA
[7] Massachusetts Gen Hosp, Dept Med, Boston, MA 02114 USA
关键词
Neoadjuvant therapy; Non-small cell lung cancer; Adaptive clinical trial; F-18-FDG PET; PATHOLOGICAL COMPLETE RESPONSE; POSITRON-EMISSION-TOMOGRAPHY; INDUCTION CHEMOTHERAPY; PHASE-II; HISTOPATHOLOGIC RESPONSE; ADJUVANT CHEMOTHERAPY; SURVIVAL; VINORELBINE; PREDICTION; DOCETAXEL;
D O I
10.1016/j.jtho.2015.12.104
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Introduction: Although perioperative chemotherapy improves survival in patients with resectable lung cancers, systemic recurrence remains common. Neoadjuvant chemotherapy permits response assessment and an opportunity to switch treatment regimens. Response measured by fludeoxyglucose (F-18-FDG) positron emission tomography (PET) correlates with clinical outcomes better than computed tomography (CT) does. This trial assessed PET measured response rate to alternative chemotherapy in patients with a suboptimal PET response after two cycles of neoadjuvant chemotherapy. Methods: This phase II study enrolled patients with resectable stage IB-IIIA lung cancers (primary tumor >= 2 cm and peak standard uptake value [SUVpeak] >= 4.5). Patients had a pretreatment F-18-FDG PET/CT scan before two cycles of cisplatin (or carboplatin) plus gemcitabine (squamous cell carcinoma) or pemetrexed (adenocarcinoma) and then a repeat PET/CT scan. If SUVpeak in the primary tumor decreased by at least 35%, patients continued the initial chemotherapy. Individuals with less than a 35% PET response were switched to vinorelbine plus docetaxel. Postoperative radiotherapy was recommended to all patients with positive N2 nodes. A Simon's optimal two-stage design was used to evaluate the primary end point of a PET Response in Solid Tumors-defined response rate to vinorelbine plus docetaxel in previously nonresponding patients. Results: Forty patients were enrolled. Fifteen patients (38% [95% confidence interval: 38-53]) had less than a 35% decrease in SUVpeak, and 13 received vinorelbine plus docetaxel. The study met its primary end point with 10 of 15 PET metabolic responses to alternate therapy (67%). Chemotherapy toxicities never precluded surgical exploration. Conclusions: Utilizing F-18-FDG PET/CT to assess response and change preoperative chemotherapy in nonresponding patients can improve radiographic measures of response. This adaptive approach can also be used to test new drugs, attempting to optimize perioperative chemotherapy to achieve better long-term outcomes. (C) 2015 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
引用
收藏
页码:537 / 544
页数:8
相关论文
共 30 条
[1]  
[Anonymous], 2014, LANCET, V383, P383, DOI 10.1016/S0140-6736(14)60134-3
[2]  
[Anonymous], NCCN CLIN PRACT GUID
[3]   Prognostic factors affecting long-term outcomes in patients with resected stage IIIA pN2 non-small-cell lung cancer:: 5-year follow-up of a phase II study [J].
Betticher, DC ;
Schmitz, SFH ;
Tötsch, M ;
Hansen, E ;
Joss, C ;
von Briel, C ;
Schmid, R ;
Pless, M ;
Habicht, J ;
Roth, AD ;
Spiliopoulos, A ;
Stahel, R ;
Weder, W ;
Stupp, R ;
Egli, F ;
Furrer, M ;
Honegger, H ;
Wernli, M ;
Cerny, T ;
Ris, HB .
BRITISH JOURNAL OF CANCER, 2006, 94 (08) :1099-1106
[4]   Phase II study of docetaxel and vinorelbine as adjuvant chemotherapy for resected non-small cell lung cancers [J].
Chaft, Jamie E. ;
Rekhtman, Natasha ;
Sima, Camelia S. ;
Rusch, Valerie ;
Kris, Mark G. ;
Zakowski, Maureen ;
Azzoli, Christopher G. .
CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2013, 72 (04) :931-934
[5]   Prognostic stratification of stage IIIA-N2 non-small-cell lung cancer after induction chemotherapy: A model based on the combination of morphometric-pathologic response in mediastinal nodes and primary tumor response on serial 18-fluoro-2-deoxy-glucose positron emission tomography [J].
Dooms, Christophe ;
Verbeken, Eric ;
Stroobants, Sigrid ;
Nackaerts, Kris ;
De Leyn, Paul ;
Vansteenkiste, Johan .
JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (07) :1128-1134
[6]   New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) [J].
Eisenhauer, E. A. ;
Therasse, P. ;
Bogaerts, J. ;
Schwartz, L. H. ;
Sargent, D. ;
Ford, R. ;
Dancey, J. ;
Arbuck, S. ;
Gwyther, S. ;
Mooney, M. ;
Rubinstein, L. ;
Shankar, L. ;
Dodd, L. ;
Kaplan, R. ;
Lacombe, D. ;
Verweij, J. .
EUROPEAN JOURNAL OF CANCER, 2009, 45 (02) :228-247
[7]   Pathologic Complete Response Predicts Recurrence-Free Survival More Effectively by Cancer Subset: Results From the I-SPY 1 TRIAL-CALGB 150007/150012, ACRIN 6657 [J].
Esserman, Laura J. ;
Berry, Donald A. ;
DeMichele, Angela ;
Carey, Lisa ;
Davis, Sarah E. ;
Buxton, Meredith ;
Hudis, Cliff ;
Gray, Joe W. ;
Perou, Charles ;
Yau, Christina ;
Livasy, Chad ;
Krontiras, Helen ;
Montgomery, Leslie ;
Tripathy, Debasish ;
Lehman, Constance ;
Liu, Minetta C. ;
Olopade, Olufunmilayo I. ;
Rugo, Hope S. ;
Carpenter, John T. ;
Dressler, Lynn ;
Chhieng, David ;
Singh, Baljit ;
Mies, Carolyn ;
Rabban, Joseph ;
Chen, Yunn-Yi ;
Giri, Dilip ;
van 't Veer, Laura ;
Hylton, Nola .
JOURNAL OF CLINICAL ONCOLOGY, 2012, 30 (26) :3242-3249
[8]   Pathological response after neoadjuvant chemotherapy in resectable non-small-cell lung cancers: proposal for the use of major pathological response as a surrogate endpoint [J].
Hellmann, Matthew D. ;
Chaft, Jamie E. ;
William, William N., Jr. ;
Rusch, Valerie ;
Pisters, Katherine M. W. ;
Kalhor, Neda ;
Pataer, Apar ;
Travis, William D. ;
Swisher, Stephen G. ;
Kris, Mark G. .
LANCET ONCOLOGY, 2014, 15 (01) :E42-E50
[9]   Prognostic relevance of response evaluation using [18F]-2-fluoro-2-deoxy-D-glucose positron emission tomography in patients with locally advanced non-small-cell lung cancer [J].
Hoekstra, CJ ;
Stroobants, SG ;
Smit, EF ;
Vansteenkiste, J ;
van Tinteren, H ;
Postmus, PE ;
Golding, RP ;
Biesma, B ;
Schramel, FJHM ;
van Zandwijk, N ;
Lammertsma, AA ;
Hoekstra, OS .
JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (33) :8362-8370
[10]   Meta-analysis of the association of breast cancer subtype and pathologic complete response to neoadjuvant chemotherapy [J].
Houssami, Nehmat ;
Macaskill, Petra ;
von Minckwitz, Gunter ;
Marinovich, Michael L. ;
Mamounas, Eleftherios .
EUROPEAN JOURNAL OF CANCER, 2012, 48 (18) :3342-3354