Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: A single-group, multicentre, phase 2 trial

The Lancet Oncology

Volumn 17, Issue 2, 2016, Pages 234-242

  Shaw, Alice T ^a   Gandhi, Leena ^b   Gadgeel, Shirish ^c   Riely, Gregory J ^d   Cetnar, Jeremy ^e   West, Howard ^f   Camidge, D R ^g   Socinski, Mark A ^h   Chiappori, Alberto ⁱ   Mekhail, Tarek ^j   Chao, Bo H ^k   Borghaei, Hossein ^l   Gold, Kathryn A ^m   Zeaiter, Ali ⁿ   Bordogna, Walter ⁿ   Balas, Bogdana ⁿ   Puig, Oscar ⁿ   Henschel, Volkmar ⁿ   Ou, Sai Hong Ignatius ^o  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b DANA FARBER CANCER INSTITUTE   (United States)

^c WAYNE STATE UNIVERSITY   (United States)

^d MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^e OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^f Thoracic and Esophageal Surgery   (United States)

^g UNIVERSITY OF COLORADO   (United States)

^h UNIVERSITY OF PITTSBURGH MEDICAL CENTER   (United States)

ⁱ H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^j FLORIDA HOSPITAL CANCER INSTITUTE   (United States)

^k OHIO STATE UNIVERSITY   (United States)

^l FOX CHASE CANCER CENTER   (United States)

^m UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

ⁿ F HOFFMANN LA ROCHE LTD   (Switzerland)

^o UNIVERSITY OF CALIFORNIA   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALECTINIB; ANAPLASTIC LYMPHOMA KINASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CREATINE KINASE; CRIZOTINIB; ANTINEOPLASTIC AGENT; CARBAZOLE DERIVATIVE; PIPERIDINE DERIVATIVE; PROTEIN TYROSINE KINASE; PYRAZOLE DERIVATIVE; PYRIDINE DERIVATIVE;

ABNORMAL LABORATORY RESULT; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BACKACHE; BILIRUBIN BLOOD LEVEL; BLEEDING; BRAIN EDEMA; BRAIN VENTRICLE DILATATION; CANADA; CANCER GROWTH; CANCER MORTALITY; CANCER STAGING; CENTRAL NERVOUS SYSTEM METASTASIS; CEREBROVASCULAR ACCIDENT; CONFUSION; CONSTIPATION; COUGHING; CREATINE KINASE BLOOD LEVEL; DIARRHEA; DIZZINESS; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; EDEMA; EMBOLIC STROKE; FATIGUE; FEMALE; FOLLOW UP; HEADACHE; HEMIPARESIS; HUMAN; HYPERAMMONEMIA; HYPERTRIGLYCERIDEMIA; HYPOALBUMINEMIA; HYPOCALCEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; IMPAIRED GLUCOSE TOLERANCE; INFLUENZA; INSOMNIA; INTENTION TO TREAT ANALYSIS; INTERSTITIAL LUNG DISEASE; INTESTINE OBSTRUCTION; LIVER FAILURE; LUNG INFECTION; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MALNUTRITION; MULTICENTER STUDY; MYALGIA; NAUSEA; NEUTROPENIA; NON SMALL CELL LUNG CANCER; OBSTRUCTIVE AIRWAY DISEASE; OPEN STUDY; OUTCOME ASSESSMENT; PARTIAL THROMBOPLASTIN TIME; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PHOTOSENSITIVITY; PRIORITY JOURNAL; PROTEIN EXPRESSION; QT PROLONGATION; SEIZURE; SIDE EFFECT; STAPHYLOCOCCAL BACTEREMIA; TOXIC HEPATITIS; TREATMENT DURATION; TREATMENT RESPONSE; UNITED STATES; UPPER RESPIRATORY TRACT INFECTION; VOMITING; WEIGHT GAIN; AGED; ANTAGONISTS AND INHIBITORS; BLOOD; CARCINOMA, NON-SMALL-CELL LUNG; CHEMICALLY INDUCED; CLINICAL TRIAL; DRUG RESISTANCE; ENZYMOLOGY; LUNG NEOPLASMS; MIDDLE AGED; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; RETREATMENT;

ADULT; AGED; ALANINE TRANSAMINASE; ANTINEOPLASTIC AGENTS; ASPARTATE AMINOTRANSFERASES; CARBAZOLES; CARCINOMA, NON-SMALL-CELL LUNG; CONSTIPATION; CREATINE KINASE; DRUG RESISTANCE, NEOPLASM; EDEMA; FATIGUE; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; MYALGIA; PIPERIDINES; PYRAZOLES; PYRIDINES; RECEPTOR PROTEIN-TYROSINE KINASES; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; RETREATMENT;

EID: 84959324643     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(15)00488-X     Document Type: Article

References (28)

1. Soda M, Choi YL, Enomoto M, et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature 2007, 448:561-566.
2. Kwak EL, Bang YJ, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 2010, 363:1693-1703.
3. Shaw AT, Kim DW, Nakagawa K, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med 2013, 368:2385-2394.
4. Solomon BJ, Mok T, Kim DW, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med 2014, 371:2167-2177.
5. Costa DB, Shaw AT, Ou SH, et al. Clinical experience with crizotinib in patients with advanced ALK-rearranged non-small-cell lung cancer and brain metastases. J Clin Oncol 2015, 33:1881-1888.
6. Costa DB, Kobayashi S, Pandya SS, et al. CSF concentration of the anaplastic lymphoma kinase inhibitor crizotinib. J Clin Oncol 2011, 29:e443-e445.
7. Katayama R, Lovly CM, Shaw AT Therapeutic targeting of anaplastic lymphoma kinase in lung cancer: a paradigm for precision cancer medicine. Clin Cancer Res 2015, 21:2227-2235.
8. Choi YL, Soda M, Yamashita Y, et al. EML4-ALK mutations in lung cancer that confer resistance to ALK inhibitors. N Engl J Med 2010, 363:1734-1739.
9. Katayama R, Shaw AT, Khan TM, et al. Mechanisms of acquired crizotinib resistance in ALK-rearranged lung cancers. Sci Transl Med 2012, 4:120ra17.
10. Doebele RC, Pilling AB, Aisner DL, et al. Mechanisms of resistance to crizotinib in patients with ALK gene rearranged non-small cell lung cancer. Clin Cancer Res 2012, 18:1472-1482.
11. Crystal AS, Shaw AT, Sequist LV, et al. Patient-derived models of acquired resistance can identify effective drug combinations for cancer. Science 2014, 346:1480-1486.
12. Lovly CM, McDonald NT, Chen H, et al. Rationale for co-targeting IGF-1R and ALK in ALK fusion-positive lung cancer. Nat Med 2014, 20:1027-1034.
13. Shaw AT, Kim DW, Mehra R, et al. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med 2014, 370:1189-1197.
14. Gadgeel SM, Gandhi L, Riely GJ, et al. Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a phase 1/2 study. Lancet Oncol 2014, 15:1119-1128.
15. Seto T, Kiura K, Nishio M, et al. CH5424802 (RO5424802) for patients with ALK-rearranged advanced non-small-cell lung cancer (AF-001JP study): a single-arm, open-label, phase 1-2 study. Lancet Oncol 2013, 14:590-598.
16. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982, 5:649-655.
17. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000, 92:205-216.
18. Wen PY, Macdonald DR, Reardon DA, et al. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol 2010, 28:1963-1972.
19. Ou S-HI, Ahn JS, De Petris L, et al. Alectinib in crizotinib-refractory ALK-rearranged non-small-cell lung cancer: a phase II global study. J Clin Oncol 2015, published online Nov 23. 10.1200/JCO.2015.63.9443.
20. Solomon BJ, Felip E, Blackhall FH, et al. Overall and intracranial efficacy results and time to symptom deterioration in PROFILE 1014: 1st-line crizotinib vs pemetrexed-platinum chemotherapy (PPC) in patients (pts) with advanced ALK-positive non-squamous non-small cell lung cancer (NSCLC). Ann Oncol 2014, 25(suppl 4):iv427. abstr 1225O.
21. Camidge DR, Bazhenova L, Salgia R, et al. Safety and efficacy of brigatinib (AP26113) in advanced malignancies, including ALK+ non-small cell lung cancer (NSCLC). Proc Am Soc Clin Oncol 2015, 33(suppl):8062.
22. Kodama T, Hasegawa M, Takanashi K, et al. Antitumor activity of the selective ALK inhibitor alectinib in models of intracranial metastases. Cancer Chemother Pharmacol 2014, 74:1023-1028.
23. Highlights of prescribing information for Zykadia US Food and Drug Administration, (accessed Dec 11, 2015). http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205755lbl.pdf.
24. Shaw AT, Mehra R, Tan DS, et al. Evaluation of ceritinib-treated patients with anaplastic lymphoma kinase rearranged (ALK+) non-small cell lung cancer (NSCLC) and brain metastases in the ASCEND-1 study. Ann Oncol 2014, 25(suppl 4):iv426-iv470.
25. Gainor JF, Sherman CA, Willoughby K, et al. Alectinib salvages CNS relapses in ALK-positive lung cancer patients previously treated with crizotinib and ceritinib. J Thorac Oncol 2015, 10:232-236.
26. Sakamoto H, Tsukaguchi T, Hiroshima S, et al. CH5424802, a selective ALK inhibitor capable of blocking the resistant gatekeeper mutant. Cancer Cell 2011, 19:679-690.
27. Zou HY, Friboulet L, Kodack DP, et al. PF-06463922, an ALK/ROS1 inhibitor, overcomes resistance to first and second generation ALK inhibitors in preclinical models. Cancer Cell 2015, 28:70-81.
28. Tamura T, Seto T, Nakagawa K, et al. Updated data of a phase I/II study (AF-001JP) of alectinib, a CNS-penetrant, highly selective ALK inhibitor in ALK-rearranged advanced NSCLC. Int J Radiat Oncol Biol Phys 2014, 90(suppl):S6. abstr 10.