Efficacy of alectinib in central nervous system metastases in crizotinib-resistant ALK-positive non–small-cell lung cancer: comparison of RECIST 1.1 and RANO-HGG criteria

Gandhi, Leena, Ou, Sai-Hong Ignatius, Shaw, Alice T., Barlesi, Fabrice, Dingemans, Anne-Marie C., Kim, Dong-Wan, Camidge, D. Ross, Hughes, Brett G. M., Yang, James C. -H., de Castro, Javier, Crino, Lucio, Lena, Herve, Do, Pascal, Golding, Sophie, Bordogna, Walter, Zeaiter, Ali, Kotb, Ahmed and Gadgeel, Shirish (2017) Efficacy of alectinib in central nervous system metastases in crizotinib-resistant ALK-positive non–small-cell lung cancer: comparison of RECIST 1.1 and RANO-HGG criteria. European Journal of Cancer, 82 27-33. doi:10.1016/j.ejca.2017.05.019


Author Gandhi, Leena
Ou, Sai-Hong Ignatius
Shaw, Alice T.
Barlesi, Fabrice
Dingemans, Anne-Marie C.
Kim, Dong-Wan
Camidge, D. Ross
Hughes, Brett G. M.
Yang, James C. -H.
de Castro, Javier
Crino, Lucio
Lena, Herve
Do, Pascal
Golding, Sophie
Bordogna, Walter
Zeaiter, Ali
Kotb, Ahmed
Gadgeel, Shirish
Title Efficacy of alectinib in central nervous system metastases in crizotinib-resistant ALK-positive non–small-cell lung cancer: comparison of RECIST 1.1 and RANO-HGG criteria
Journal name European Journal of Cancer   Check publisher's open access policy
ISSN 1879-0852
0959-8049
Publication date 2017-09-01
Sub-type Article (original research)
DOI 10.1016/j.ejca.2017.05.019
Open Access Status Not yet assessed
Volume 82
Start page 27
End page 33
Total pages 7
Place of publication Kidlington, Oxford, United Kingdom
Publisher Pergamon Press
Language eng
Subject 2730 Oncology
1306 Cancer Research
Abstract Background Central nervous system (CNS) progression is common in patients with anaplastic lymphoma kinase–positive (ALK+) non–small-cell lung cancer (NSCLC) receiving crizotinib. Next-generation ALK inhibitors have shown activity against CNS metastases, but accurate assessment of response and progression is vital. Data from two phase II studies in crizotinib-refractory ALK+ NSCLC were pooled to examine the CNS efficacy of alectinib, a CNS-active ALK inhibitor, using Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) and Response Assessment in Neuro-Oncology high-grade glioma (RANO-HGG) criteria. Methods Both studies enrolled patients aged ≥18 years who had previously received crizotinib. NP28761 was conducted in North America and NP28673 was a global study. All patients received 600 mg oral alectinib twice daily and had baseline CNS imaging. CNS response for those with baseline CNS metastases was determined by an independent review committee. Results Baseline measurable CNS disease was identified in 50 patients by RECIST and 43 by RANO-HGG. CNS objective response rate was 64.0% by RECIST (95% confidence interval [CI]: 49.2–77.1; 11 CNS complete responses [CCRs]) and 53.5% by RANO-HGG (95% CI: 37.7–68.8; eight CCRs). CNS responses were durable, with consistent estimates of median duration of 10.8 months with RECIST and 11.1 months with RANO-HGG. Of the 39 patients with measurable CNS disease by both RECIST and RANO-HGG, only three (8%) had CNS progression according to one criteria but not the other (92% concordance rate). Conclusion Alectinib demonstrated promising efficacy in the CNS for ALK+ NSCLC patients pretreated with crizotinib, regardless of the assessment criteria used.
Keyword Alectinib
CNS metastases
NSCLC
RANO-HGG
RECIST
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
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