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The DOI matches its Crossref record; 26 of the 26 references it cites were found in a registry or an index.

Alectinib in Crizotinib-Refractory ALK-Rearranged Non–Small-Cell Lung Cancer: A Phase II Global Study

Ou, Sai-Hong Ignatius, Ahn, Jin Seok, De Petris, Luigi, Govindan, Ramaswamy, Yang, James Chih-Hsin, Hughes, Brett, Lena, Hervé, Moro-Sibilot, Denis, Bearz, Alessandra, Ramirez, Santiago Viteri, Mekhail, Tarek, Spira, Alexander, Bordogna, Walter, Balas, Bogdana, Morcos, Peter N., Monnet, Annabelle, Zeaiter, Ali, Kim, Dong-Wan·2016·Journal of Clinical Oncology

Abstract

Purpose: Crizotinib confers improved progression-free survival compared with chemotherapy in anaplastic lymphoma kinase (ALK)-rearranged non–small-cell lung cancer (NSCLC), but progression invariably occurs. We investigated the efficacy and safety of alectinib, a potent and selective ALK inhibitor with excellent CNS penetration, in patients with crizotinib-refractory ALK-positive NSCLC. Patients and Methods: Alectinib 600 mg was administered orally twice daily. The primary end point was objective response rate (ORR) by central independent review committee (IRC). Results: Of the 138 patients treated, 84 patients (61%) had CNS metastases at baseline, and 122 were response evaluable (RE) by IRC. ORR by IRC was 50% (95% CI, 41% to 59%), and the median duration of response (DOR) was 11.2 months (95% CI, 9.6 months to not reached). In 96 patients (79%) previously treated with chemotherapy, the ORR was 45% (95% CI, 35% to 55%). Median IRC-assessed progression-free survival for all 138 patients was 8.9 months (95% CI, 5.6 to 11.3 months). CNS disease control rate was 83% (95% CI, 74% to 91%), and the median CNS DOR was 10.3 months (95% CI, 7.6 to 11.2 months). CNS ORR in 35 patients with baseline measurable CNS lesions was 57% (95% CI, 39% to 74%). Of the 23 patients with baseline CNS metastases (measurable or nonmeasurable) and no prior radiation, 10 (43%) had a complete CNS response. At 12 months, the cumulative CNS progression rate (24.8%) was lower than the cumulative non-CNS progression rate (33.2%) for all patients. Common adverse events were constipation (33%), fatigue (26%), and peripheral edema (25%); most were grade 1 to 2. Conclusion: Alectinib is highly active and well tolerated in patients with advanced, crizotinib-refractory ALK-positive NSCLC, including those with CNS metastases.

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Metadata

Authors
Ou, S.-H. I., Ahn, J. S., De Petris, L., Govindan, R., Yang, J. C.-H., Hughes, B., Lena, H., Moro-Sibilot, D., Bearz, A., Ramirez, S. V., Mekhail, T., Spira, A., Bordogna, W., Balas, B., Morcos, P. N., Monnet, A., Zeaiter, A., & Kim, D.-W.
Venue
Journal of Clinical Oncology
Published
2016-03-01
Volume
34
Issue
7
Pages
661-668
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
OpenAlex
W2174368583
Cited by
580
References
26
FWCI
79.68
Type
journal article
Language
en
Open access
closed

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CoChat. (2026). Citation check: Alectinib in Crizotinib-Refractory ALK-Rearranged Non–Small-Cell Lung Cancer: A Phase II Global Study. https://app.cochat.ai/papers/10.1200/jco.2015.63.9443
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Ou, S.-H. I., Ahn, J. S., De Petris, L., Govindan, R., Yang, J. C.-H., Hughes, B., Lena, H., Moro-Sibilot, D., Bearz, A., Ramirez, S. V., Mekhail, T., Spira, A., Bordogna, W., Balas, B., Morcos, P. N., Monnet, A., Zeaiter, A., & Kim, D.-W. (2016). Alectinib in Crizotinib-Refractory ALK-Rearranged Non–Small-Cell Lung Cancer: A Phase II Global Study. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2015.63.9443

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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