Testing for anaplastic lymphoma kinase rearrangement to target crizotinib therapy: Oncology, pathology and health economic perspectives

Expert Review of Anticancer Therapy

Volumn 13, Issue 5, 2013, Pages 625-636

  Lee, James A ^a   Bubendorf, Lukas ^b   Stahel, Rolf ^c   Peters, Solange ^d  

^a ALTARUM INSTITUTE   (United States)

^b UNIVERSITY HOSPITAL BASEL   (Switzerland)

^c UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^d LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

Author keywords

companion diagnostic; crizotinib; FISH; immunohistochemistry; non small cell lung cancer

Indexed keywords

ANAPLASTIC LYMPHOMA KINASE; CRIZOTINIB; ERLOTINIB; GEFITINIB; MONOCLONAL ANTIBODY;

ALK GENE; CANCER PALLIATIVE THERAPY; CANCER THERAPY; COMPANION DIAGNOSTICS; CORRELATION ANALYSIS; COST BENEFIT ANALYSIS; DIAGNOSTIC TEST; DRUG APPROVAL; DRUG COST; DRUG MARKETING; DRUG TARGETING; EUROPE; FLUORESCENCE IN SITU HYBRIDIZATION; FOOD AND DRUG ADMINISTRATION; GENE REARRANGEMENT; HEALTH CARE COST; HEALTH ECONOMICS; HUMAN; IMMUNOHISTOCHEMISTRY; INTRARATER RELIABILITY; LUNG ADENOCARCINOMA; LUNG NON SMALL CELL CANCER; ONCOLOGY; OUTCOME ASSESSMENT; PATHOLOGY; PREVALENCE; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RABBIT; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; REVIEW; SENSITIVITY AND SPECIFICITY; TREATMENT RESPONSE; UNITED STATES;

ANIMALS; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE-FREE SURVIVAL; DRUG COSTS; GENE REARRANGEMENT; HUMANS; IN SITU HYBRIDIZATION, FLUORESCENCE; LUNG NEOPLASMS; MOLECULAR TARGETED THERAPY; PROTEIN KINASE INHIBITORS; PYRAZOLES; PYRIDINES; RABBITS; RECEPTOR PROTEIN-TYROSINE KINASES;

EID: 84876881115     PISSN: 14737140     EISSN: 17448328     Source Type: Journal    
DOI: 10.1586/era.13.42     Document Type: Review

References (58)

1. Bradbury PA, Tu D, Seymour L et al.; NCIC Clinical Trials Group Working Group on Economic Analysis. Economic analysis: randomized placebo-controlled clinical trial of erlotinib in advanced non-small cell lung cancer. J. Natl Cancer Inst. 102(5), 298-306 (2010).
2. Responding to the Challenge of Cancer in Europe. Coleman MP, Alexe D-M, Albreht T, McKee M (Eds). Institute of Public Health of the Republic of Slovenia, Slovenia (2008).
3. Shaw AT, Solomon B, Kenudson MM. Crizotinib and testing for ALK. J. Natl Compr. Canc. Netw. 9(12), 1335-1341 (2011).
4. Shaw AT, Yeap BY, Solomon BJ et al. Effect of crizotinib on overall survival in patients with advanced non-small-cell lung cancer harbouring ALK gene rearrangement: a retrospective analysis. Lancet Oncol. 12(11), 1004-1012 (2011).
5. Blackhall FH, Peters S, Kerr KM et al. Prevalence and clinical outcomes for patients with ALK-positive denocarcinoma in Europe. Presented at: The European Thoracic Oncology Platform Lungscape Project. Vienna, Austria, 28 September-2 October 2012.
6. de Lima Lopes G Jr, Segel JE, Tan DS, Do YK, Mok T, Finkelstein EA. Cost-effectiveness of epidermal growth factor receptor mutation testing and first-line treatment with gefitinib for patients with advanced adenocarcinoma of the lung. Cancer 118(4), 1032-1039 (2012).
7. Zimmermann S, Peters S. Going beyond EGFR. Ann. Oncol. 23(Suppl. 10), 197-203 (2012).
8. Takano T, Fukui T, Ohe Y, et al. EGFR mutations predict survival benefit from gefitinib in patients with advanced lung adenocarcinoma ahistorical comparison of patients treated before and after gefitinib approval in Japan. J. Clin. Oncol. 26(34), 5589-5595 (2008).
9. Shaw AT, Yeap BY, Mino-Kenudson M et al. Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK. J. Clin. Oncol. 27(26), 4247-4253 (2009).
10. Soda M, Choi YL, Enomoto M et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature 448(7153), 561-566 (2007).
11. Dai Z, Kelly JC, Meloni-Ehrig A et al. Incidence and patterns of ALK FISH abnormalities seen in a large unselected series of lung carcinomas. Mol. Cytogenet. 5(1), 44 (2012).
12. Camidge DR, Doebele RC. Treating ALK-positive lung cancer -early successes and future challenges. Nat. Rev. Clin. Oncol. 9(5), 268-277 (2012).
13. Kwak EL, Bang YJ, Camidge DR et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N. Engl. J. Med. 363(18), 1693-1703 (2010).
14. Sasaki T, Rodig SJ, Chirieac LR, Jänne PA. The biology and treatment of EML4-ALK non-small cell lung cancer. Eur. J. Cancer 46(10), 1773-1780 (2010).
15. Camidge DR, Bang YJ, Kwak EL et al. Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a Phase 1 study. Lancet Oncol. 13(10), 1011-1019 (2012).
16. Kim D. Results of a global Phase II study with crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC). Presented at: ASCO Annual 12th Meeting. Chicago, IL, USA, 1-5 June 2012.
17. Shaw AT. Phase III trial shows crizotinib superior to single-agent chemotherapy for ALK-positive advanced NSCLC. Presented at: ESMO Congress. Vienna, Austria, 28 September-2 October 2012.
18. 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. 18(5), 1472-1482 (2012).
19. Katayama R, Shaw AT, Khan TM et al. Mechanisms of acquired crizotinib resistance in ALK-rearranged lung cancers. Sci. Transl. Med. 4(120), 120ra17 (2012).
20. Thunnissen E, Bubendorf L, Dietel M et al. EML4-ALK testing in non-small cell carcinomas of the lung: a review with recommendations. Virchows Arch. 461(3), 245-257 (2012).
21. Sun JM, Choi YL, Won JK et al. A dramatic response to crizotinib in a non-small-cell lung cancer patient with IHC-positive and FISH-negative ALK. J. Thorac. Oncol. 7(12), e36-e38 (2012).
22. Thunnissen E, Kerr KM, Herth FJ et al. The challenge of NSCLC diagnosis and predictive analysis on small samples. Practical approach of a working group. Lung Cancer 76(1), 1-18 (2012).
23. Savic S, Bubendorf L. Role of fluorescence in situ hybridization in lung cancer cytology. Acta Cytol. 56(6), 611-621 (2012).
24. Moreira AL, Hasanovic A. Molecular characterization by immunocytochemistry of lung adenocarcinoma on cytology specimens. Acta Cytol. 56(6), 603-610 (2012).
25. Using the Einheitlicher Bemessungsmassstab (EBM) or Uniform Valuation Scale for 2012 and the following codes 11310 -Analysing the sample, e.g., chromosome analysis of cells from the hematopoietic system €138; 11312 -Special visualization of chromosome structures, e.g., by use of FISH (per probe) €44 × 2 = €88; and, 40100 Posting and transport €2.60. Total reimbursement for 2-Probe FISH test is of € 228.60.
26. Code no. 37.0530 -Histopathology/ cytopathology, non-medical services to the attention of a specialist in pathology: in situ hybridization, each probe from the Tarmed Suisse list 2012. Each probe is valued at 571.46 points per probe for a total of 1142.92 points. The value of a point varies from canton to canton with a range of 0.80 to 0.98 Swiss Francs per point. Using an average value of 0.86 Swiss Francs per point, 1142.92 points X 0.86 SFr/point x 0.83 Euro/SFr = €815.81.
27. McLeer-Florin A, Moro-Sibilot D, Melis A et al. Dual IHC and FISH testing for ALK gene rearrangement in lung adenocarcinomas in a routine practice: a French study. J. Thorac. Oncol. 7(2), 348-354 (2012).
28. Ellison G, Zhu G, Moulis A, Dearden S, Speake G, McCormack R. EGFR mutation testing in lung cancer: a review of available methods and their use for analysis of tumour tissue and cytology samples. J. Clin. Pathol. 66(2), 79-89 (2013).
29. Lee J, Tollefson E, Daly M, Kielb E. Generalized health economic and outcomes research model for evaluation of companion diagnostics and targeted therapies. Expert Rev. Pharmacoecon. Outcomes Res. 13(3), (2013) (In Press).
30. Meunnig P. Cost-Effectiveness Analysis in Health: A Practical Approach (2nd Edition). Jossey-Bass Publishers, San Francisco, CA, USA (2008).
31. Donaldson C, Baker R, Mason H et al. The social value of a QALY: raising the bar or barring the raise? BMC Health Serv. Res. 11, 8 (2011).
32. Whitehead SJ, Ali S. Health outcomes in economic evaluation: the QALY and utilities. Br. Med. Bull. 96, 5-21 (2010).
33. Atherly AJ, Camidge DR. The cost-effectiveness of screening lung cancer patients for targeted drug sensitivity markers. Br. J. Cancer 106(6), 1100-1106 (2012).
34. Katayama R, Khan TM, Benes C et al. Therapeutic strategies to overcome crizotinib resistance in non-small cell lung cancers harboring the fusion oncogene EML4-ALK. Proc. Natl Acad. Sci. USA 108(18), 7535-7540 (2011).
35. Ceccon M, Mologni L, Bisson W, Scapozza L, Gambacorti-Passerini C. Crizotinibresistant NPM-ALK mutants confer differential sensitivity to unrelated Alk inhibitors. Mol. Cancer Res. 11(2), 122-132 (2013).
36. Peters S, Taron M, Bubendorf L, Blackhall F. Treatment and detection of ALK-rearranged NSCLC. Lung Cancer (2013) (In Press).
37. Normant E, Paez G, West KA et al. The Hsp90 inhibitor IPI-504 rapidly lowers EML4-ALK levels and induces tumor regression in ALK-driven NSCLC models. Oncogene 30(22), 2581-2586 (2011).
38. Sequist LV, von Pawel J, Garmey EG et al. Randomized Phase II study of erlotinib plus tivantinib versus erlotinib plus placebo in previously treated non-small-cell lung cancer. J. Clin. Oncol. 29(24), 3307-3315 (2011).
39. Lee JO, Kim TM, Lee SH et al. Anaplastic lymphoma kinase translocation: a predictive biomarker of pemetrexed in patients with non-small cell lung cancer. J. Thorac. Oncol. 6(9), 1474-1480 (2011).
40. Lee HY, Ahn HK, Jeong JY et al. Favorable clinical outcomes of pemetrexed treatment in anaplastic lymphoma kinase positive non-small-cell lung cancer. Lung Cancer 79(1), 40-45 (2013).
41. Shaw AT, Varghese AM, Solomon BJ et al. Pemetrexed-based chemotherapy in patients with advanced, ALK-positive non-small cell lung cancer. Ann. Oncol. 24(1), 59-66 (2013).
42. Ross JS, Cronin M. Whole cancer genome sequencing by next-generation methods. Am. J. Clin. Pathol. 136(4), 527-539 (2011).
43. Paik JH, Choe G, Kim H et al. Screening of anaplastic lymphoma kinase rearrangement by immunohistochemistry in non-small cell lung cancer: correlation with fluorescence in situ hybridization. J. Thorac. Oncol. 6(3), 466-472 (2011).
44. Banoo S, Bell D, Bossuyt P et al. Evaluation of diagnostic tests for infectious diseases: general principles. Nat. Rev. Microbiol. 12, S17-S29 (2010).
45. Yi ES, Boland JM, Maleszewski JJ et al. Correlation of IHC and FISH for ALK gene rearrangement in non-small cell lung carcinoma: IHC score algorithm for FISH. J. Thorac. Oncol. 69, 459-465 (2011).
46. Yang P, Kulig K, Boland JM et al. Worse disease-free survival in never-smokers with ALK+ lung adenocarcinoma. J. Thorac. Oncol. 7, 90-97 (2012).
47. Mino-Kenudson M, Chirieac LR, Law K et al. A novel, highly sensitive antibody allows for the routine detection of ALK-rearranged lung adenocarcinomas by standard immunohistochemistry. Clin. Cancer. Res. 16, 1561-1571 (2010).
48. Mitsudomi T, Tomizawa K, Horio Y et al. Comparison of high sensitive IHC, FISH, and RT-PCR direct sequencing for detection of ALK translocation in lung cancer. J. Clin. Oncol. 29, Abstract 7534 (2011).
49. GLOBOCAN 2008, International Agency for Research on Cancer, Section of Cancer Information (excludes non-melanoma skin cancers). http://globocan.iarc. fr/factsheet.asp
50. Centers for Medicare and Medicaid Services, 2012B Physician Fee Schedule, CPT 88360 for IHC and 2 probe manual CPT 88368 for ALK FISH considering both the technical and professional (global) fee for both tests. www.cms.gov/apps/ physician-fee-schedule
51. Average of tariff for Code GEQE006 Bronchoscopy with transbronchial lung biopsy unguided and GEQH002 Bronchoscopy with transbronchial lung biopsy with radiological guidance. www.aideaucodage.fr/ccam
52. Tariff for Code ZZQP108 Exam of a paraffin-embedded sample and IHC testing €84.00. www.aideaucodage.fr/ccam-zzqp108
53. European Society of Pathology Lung European Quality Assurance Program. http://lung.eqascheme.org
54. German Society of Pathology Quality Assurance Initiative (QuIP). www.dgp-berlin.de/index.php/menuringversuche/ ringversuche-2012
55. pan-Canadian Oncology Drug Review Initial Economic Guidance Report, Crizotinib (Xalkori) for Advanced Non-Small Cell Lung Cancer, 2 August 12. www.pcodr.ca/wcpc/portal/Home/ FindaReview/Xalkori?- afrLoop= 165617941893000&-afrWindowMode= 0&-adf.ctrlstate= m923qh4vx-75
56. Tariff for Code ZZQP186 Histological examination by in situ hybridization. www.aideaucodage.fr/ccam-zzqp186
57. Ventana anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody Package Insert Reference 790 4794 1011623EN Rev C 4 Sep 2012. http://productlibrary.ventana. com/ ventana-portal/OpenOverlayServlet?launc hIndex=1&objectId=790- 47941011623EN
58. www.pcodr.ca/wcpc/portal/Home/ FindaReview/XalkoriAdvNSCLCResub?- afrLoop=1943729659328000&-afrWindowMode= 0&-adf.ctrlstate= i4i8gx7o8-47