Linsitinib (OSI-906) versus placebo for patients with locally advanced or metastatic adrenocortical carcinoma: A double-blind, randomised, phase 3 study

The Lancet Oncology

Volumn 16, Issue 4, 2015, Pages 426-435

  Fassnacht, Martin ^a,b   Berruti, Alfredo ^c   Baudin, Eric ^d   Demeure, Michael J ^e   Gilbert, Jill ^f   Haak, Harm ^g,h,i   Kroiss, Matthias ^a   Quinn, David I ^j   Hesseltine, Elizabeth ^k   Ronchi, Cristina L ^b   Terzolo, Massimo ^l   Choueiri, Toni K ^m   Poondru, Srinivasu ⁿ   Fleege, Tanya ⁿ   Rorig, Ramona ⁿ   Chen, Jihong ⁿ   Stephens, Andrew W ^o   Worden, Francis ^k   Hammer, Gary D ^k  

^a UNIVERSITY OF WÜRZBURG   (Germany)

^b UNIVERSITY HOSPITAL WÜRZBURG   (Germany)

^c UNIVERSITY OF BRESCIA   (Italy)

^d INSTITUT GUSTAVE ROUSSY   (France)

^e TRANSLATIONAL GENOMICS RESEARCH INSTITUTE   (United States)

^f VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g MÁXIMA MEDICAL CENTER   (Netherlands)

^h MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

ⁱ MAASTRICHT UNIVERSITY   (Netherlands)

^j UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^k UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^l UNIVERSITY OF TURIN   (Italy)

^m DANA FARBER CANCER INSTITUTE   (United States)

ⁿ ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

^o Piramal Enterprises Limited   (India)

more..

Author keywords

[No Author keywords available]

Indexed keywords

3-(8-AMINO-1-(2-PHENYLQUINOLIN-7-YL)IMIDAZO(1,5-A)PYRAZIN-3-YL)-1-METHYLCYCLOBUTANOL; IMIDAZOLE DERIVATIVE; PLACEBO; PROTEIN KINASE INHIBITOR; PYRAZINE DERIVATIVE;

ADRENOCORTICAL CARCINOMA; ADULT; ADVERSE DRUG REACTION; AGED; CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; KAPLAN MEIER METHOD; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PATHOLOGY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; VERY ELDERLY;

ADRENOCORTICAL CARCINOMA; ADULT; AGED; AGED, 80 AND OVER; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; HUMANS; IMIDAZOLES; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PLACEBOS; PROTEIN KINASE INHIBITORS; PYRAZINES;

EID: 84933522088     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(15)70081-1     Document Type: Article

References (30)

1. Bilimoria KY, Shen WT, Elaraj D, et al. Adrenocortical carcinoma in the United States: treatment utilization and prognostic factors. Cancer 2008, 113:3130-3136.
2. Berruti A, Baudin E, Gelderblom H, et al. Adrenal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2012, 23:131-138.
3. Else T, Kim AC, Sabolch A, et al. Adrenocortical carcinoma. Endocr Rev 2014, 35:282-326.
4. Fassnacht M, Kroiss M, Allolio B Update in adrenocortical carcinoma. J Clin Endocrinol Metab 2013, 98:4551-4564.
5. Terzolo M, Angeli A, Fassnacht M, et al. Adjuvant mitotane treatment for adrenocortical carcinoma. N Engl J Med 2007, 356:2372-2380.
6. Hermsen IG, Fassnacht M, Terzolo M, et al. Plasma concentrations of o,p'DDD, o,p'DDA, and o,p'DDE as predictors of tumor response to mitotane in adrenocortical carcinoma: results of a retrospective ENS@T multicenter study. J Clin Endocrinol Metab 2011, 96:1844-1851.
7. Malandrino P, Ghuzlan AA, Castaing M, et al. Prognostic markers of survival after combined mitotane- and platinum-based chemotherapy in metastatic adrenocortical carcinoma. Endocr Relat Cancer 2010, 17:797-807.
8. Wangberg B, Khorram-Manesh A, Jansson S, et al. The long-term survival in adrenocortical carcinoma with active surgical management and use of monitored mitotane. Endocr Relat Cancer 2010, 17:265-272.
9. Else T, Williams AR, Sabolch A, Jolly S, Miller BS, Hammer GD Adjuvant therapies and patient and tumor characteristics associated with survival of adult patients with adrenocortical carcinoma. J Clin Endocrinol Metab 2014, 99:455-461.
10. Fassnacht M, Terzolo M, Allolio B, et al. Combination chemotherapy in advanced adrenocortical carcinoma. N Engl J Med 2012, 366:2189-2197.
11. de Fraipont F, El Atifi M, Cherradi N, et al. Gene expression profiling of human adrenocortical tumors using complementary deoxyribonucleic Acid microarrays identifies several candidate genes as markers of malignancy. J Clin Endocrinol Metab 2005, 90:1819-1829.
12. Gicquel C, Bertagna X, Gaston V, et al. Molecular markers and long-term recurrences in a large cohort of patients with sporadic adrenocortical tumors. Cancer Res 2001, 61:6762-6767.
13. Giordano TJ, Thomas DG, Kuick R, et al. Distinct transcriptional profiles of adrenocortical tumors uncovered by DNA microarray analysis. Am J Pathol 2003, 162:521-531.
14. Rosenzweig SA, Atreya HS Defining the pathway to insulin-like growth factor system targeting in cancer. Biochem Pharmacol 2010, 80:1115-1124.
15. Barlaskar FM, Spalding AC, Heaton JH, et al. Preclinical targeting of the type I insulin-like growth factor receptor in adrenocortical carcinoma. J Clin Endocrinol Metab 2009, 94:204-212.
16. Haluska P, Worden F, Olmos D, et al. Safety, tolerability, and pharmacokinetics of the anti-IGF-1R monoclonal antibody figitumumab in patients with refractory adrenocortical carcinoma. Cancer Chemother Pharmacol 2010, 65:765-773.
17. Lerario AM, Worden FP, Ramm CA, et al. The combination of insulin-like growth factor receptor 1 (IGF1R) antibody cixutumumab and mitotane as a first-line therapy for patients with recurrent/metastatic adrenocortical carcinoma: a multi-institutional NCI-sponsored trial. Horm Canc 2014, 5:232-239.
18. Ji QS, Mulvihill MJ, Rosenfeld-Franklin M, et al. A novel, potent, and selective insulin-like growth factor-I receptor kinase inhibitor blocks insulin-like growth factor-I receptor signaling in vitro and inhibits insulin-like growth factor-I receptor dependent tumor growth in vivo. Mol Cancer Ther 2007, 6:2158-2167.
19. Jones R, Kim E, Nava-Parada P, et al. Phase I study of intermittent oral dosing of the insulin-like growth factor-1 and insulin receptors inhibitor OSI-906 in patients with advanced solid tumors. Clin Cancer Res 2015, 21:693-700.
20. Puzanov I, Lindsay CR, Goff L, et al. Phase I, dose-escalation study of continuous oral dosing of OSI-906, a dual inhibitor of insulin-like growth factor receptor 1 and insulin receptor tyrosine kinases, in patients with advanced solid tumors. Clin Cancer Res 2015, 21:701-711.
21. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009, 45:228-247.
22. Pavlicek A, Lira ME, Lee NV, et al. Molecular predictors of sensitivity to the insulin-like growth factor 1 receptor inhibitor figitumumab (CP-751,871). Mol Cancer Ther 2013, 12:2929-2939.
23. Ronchi CL, Sbiera S, Kraus L, et al. Expression of excision repair cross complementing group 1 and prognosis in adrenocortical carcinoma patients treated with platinum-based chemotherapy. Endocr Relat Cancer 2009, 16:907-918.
24. Volante M, Terzolo M, Fassnacht M, et al. Ribonucleic reductase large subunit (RRM1) gene expression may predict efficacy of adjuvant mitotane in adrenocortical cancer. Clin Cancer Res 2012, 18:3452-3461.
25. Kroiss M, Quinkler M, Johanssen S, et al. Sunitinib in refractory adrenocortical carcinoma: a phase II single-arm, open-label trial. J Clin Endocrinol Metab 2012, 97:3495-3503.
26. Sierra JR, Cepero V, Giordano S Molecular mechanisms of acquired resistance to tyrosine kinase targeted therapy. Mol Cancer 2010, 9:75.
27. Pollak M The insulin and insulin-like growth factor receptor family in neoplasia: an update. Nat Rev Cancer 2012, 12:159-169.
28. Jin Q, Esteva FJ Cross-talk between the ErbB/HER family and the type I insulin-like growth factor receptor signaling pathway in breast cancer. J Mammary Gland Biol Neoplasia 2008, 13:485-498.
29. Naing A, Lorusso P, Fu S, et al. Insulin growth factor receptor (IGF-1R) antibody cixutumumab combined with the mTOR inhibitor temsirolimus in patients with metastatic adrenocortical carcinoma. Br J Cancer 2013, 108:826-830.
30. Heaton JH, Wood MA, Kim AC, et al. Progression to adrenocortical tumorigenesis in mice and humans through insulin-like growth factor 2 and β-catenin. Am J Pathol 2012, 181:1017-1033.