Phase I Study of Lapatinib and Pemetrexed in the Second-Line Treatment of Advanced or Metastatic Non-Small-Cell Lung Cancer With Assessment of Circulating Cell Free Thymidylate Synthase RNA as a Potential Biomarker

Clinical Lung Cancer

Volumn 16, Issue 5, 2015, Pages 348-357

  Ramlau, Rodryg ^a   Thomas, Michael ^b   Novello, Silvia ^c   Plummer, Ruth ^d   Reck, Martin ^e   Kaneko, Tomomi ^f   Lau, Mike R ^f   Margetts, Jane ^d   Lunec, John ^d   Nutt, Joyce ^d   Scagliotti, Giorgio V ^c  

^a POZNAN UNIVERSITY OF MEDICAL SCIENCES   (Poland)

^b UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^c UNIVERSITY OF TURIN   (Italy)

^d NEWCASTLE UNIVERSITY   (United Kingdom)

^e KRANKENHAUS GROSSHANSDORF   (Germany)

^f GLAXOSMITHKLINE   (United Kingdom)

Author keywords

Epidermal growth factor receptor; Optimal treatment regimen; Tyrosine kinase inhibitor

Indexed keywords

ALKALINE PHOSPHATASE; BIOLOGICAL MARKER; C REACTIVE PROTEIN; CALCIUM; GLUCOSE; LAPATINIB; MESSENGER RNA; PEMETREXED; THYMIDYLATE SYNTHASE; ANTINEOPLASTIC AGENT; QUINAZOLINE DERIVATIVE; TUMOR MARKER;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ANEMIA; ARTICLE; ASTHENIA; BACKACHE; BONE PAIN; CALCIUM BLOOD LEVEL; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CLINICAL ARTICLE; CONJUNCTIVITIS; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DISEASE SEVERITY; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FEMALE; GLUCOSE BLOOD LEVEL; HEADACHE; HEART FAILURE; HUMAN; HYPERBILIRUBINEMIA; HYPERTRANSAMINASEMIA; LEUKOPENIA; LIMIT OF DETECTION; LYMPHOCYTOPENIA; MALE; MONOTHERAPY; MORNING DOSAGE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; NON SMALL CELL LUNG CANCER; OPTIMAL DRUG DOSE; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PHASE 1 CLINICAL TRIAL; PNEUMONIA; RASH; SIDE EFFECT; TREATMENT OUTCOME; TREATMENT RESPONSE; VOMITING; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; COMPARATIVE STUDY; DOSE RESPONSE; GENETICS; LUNG NEOPLASMS; METASTASIS; MIDDLE AGED; PATHOLOGY;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BIOMARKERS, TUMOR; CARCINOMA, NON-SMALL-CELL LUNG; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PEMETREXED; QUINAZOLINES; THYMIDYLATE SYNTHASE; TREATMENT OUTCOME;

EID: 84941421316     PISSN: 15257304     EISSN: 19380690     Source Type: Journal    
DOI: 10.1016/j.cllc.2015.01.004     Document Type: Article

References (37)

1. C. Eheman, S.J. Henley, R. Ballard-Barbash, and et al. Annual report to the nation on the status of cancer, 1975-2008, featuring cancers associated with excess weight and lack of sufficient physical activity Cancer 118 2012 2338 2366
2. International Agency for Research on Cancer. World Health Organization. GLOBOCAN 2012. Estimated cancer incidence, mortality, and prevalence worldwide in 2012. Available at: http://globocan.iarc.fr/Pages/fact-sheets-cancer.aspx. Accessed 18 August 2014.
3. J. Montesinos, M. Bare, E. Dalmau, and et al. The changing pattern of non-small cell lung cancer between the 90th and 2000th decades Open Respir Med J 5 2011 24 30
4. C.G. Azzoli, S. Baker Jr., S. Temin, and et al. American Society of Clinical Oncology Clinical Practice Guideline update on chemotherapy for stage IV non-small-cell lung cancer J Clin Oncol 27 2009 6251 6266
5. G.V. Scagliotti, F. De Marinis, M. Rinaldi, and et al. The role of histology with common first-line regimens for advanced non-small-cell lung cancer: a brief report of the retrospective analysis of a three-arm randomized trial J Thorac Oncol 4 2009 1568 1571
6. D.G. Pfister, D.H. Johnson, C.G. Azzoli, and et al. American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003 J Clin Oncol 22 2004 330 353
7. F.R. Hirsch, M. Varella-Garcia, W.A. Franklin, and et al. Evaluation of HER-2/neu gene amplification and protein expression in non-small-cell lung carcinomas Br J Cancer 86 2002 1449 1456
8. F. Cappuzzo, M. Varella-Garcia, H. Shigematsu, and et al. Increased HER2 gene copy number is associated with response to gefitinib therapy in epidermal growth factor receptor-positive non-small-cell lung cancer patients J Clin Oncol 23 2005 5007 5018
9. H. Nakamura, N. Kawasaki, M. Taguchi, and K. Kabasawa Survival impact of epidermal growth factor receptor overexpression in patients with non-small-cell lung cancer: a meta-analysis Thorax 61 2006 140 145
10. T.J. Pugh, G. Bebb, L. Barclay, and et al. Correlations of EGFR mutations and increases in EGFR and HER2 copy number to gefitinib response in a retrospective analysis of lung cancer patients BMC Cancer 7 2007 128
11. P. Carter, L. Presta, C. Gorman, and et al. Humanization of an anti-p185HER2 antibody for human cancer therapy Proc Natl Acad Sci U S A 89 1992 4285 4289
12. U. Gatzemeier, G. Groth, C. Butts, and et al. Randomized phase II trial of gemcitabine-cisplatin with or without trastuzumab in HER2-positive non-small-cell lung cancer Ann Oncol 15 2004 19 27
13. R.G. Zinner, B.S. Glisson, F.V. Fossella, and et al. Trastuzumab in combination with cisplatin and gemcitabine in patients with HER2-overexpressing, untreated, advanced non-small-cell lung cancer: report of a phase II trial and findings regarding optimal identification of patients with HER2-overexpressing disease Lung Cancer 44 2004 99 110
14. M. Narayan, J.A. Wilken, L.N. Harris, A.T. Baron, K.D. Kimbler, and N.J. Maihle Trastuzumab-induced HER reprogramming in "resistant" breast carcinoma cells Cancer Res 69 2009 2191 2194
15. H.A. Burris 3rd, H.I. Hurwitz, E.C. Dees, and et al. Phase I safety, pharmacokinetics, and clinical activity study of lapatinib (GW572016), a reversible dual inhibitor of epidermal growth factor receptor tyrosine kinases, in heavily pretreated patients with metastatic carcinomas J Clin Oncol 23 2005 5305 5313
16. Tykerb (lapatinib) tablets [presribing information] 2012 GlaxoSmithKline Research Triangle Park, NC
17. R. Diaz, P.A. Nguewa, R. Parrondo, and et al. Antitumor and antiangiogenic effect of the dual EGFR and HER-2 tyrosine kinase inhibitor lapatinib in a lung cancer model BMC Cancer 10 2010 188
18. H.J. Ross, G.R. Blumenschein Jr., J. Aisner, and et al. Randomized phase II multicenter trial of two schedules of lapatinib as first- or second-line monotherapy in patients with advanced or metastatic non-small-cell lung cancer Clin Cancer Res 16 2010 1938 1949
19. F. Russo, A. Bearz, and G. Pampaloni Investigators of Italian Pemetrexed Monotherapy of NSCLC Group. Pemetrexed single agent chemotherapy in previously treated patients with locally advanced or metastatic non-small-cell lung cancer BMC Cancer 8 2008 216
20. G. Bepler, K.E. Sommers, A. Cantor, and et al. Clinical efficacy and predictive molecular markers of neoadjuvant gemcitabine and pemetrexed in resectable non-small-cell lung cancer J Thorac Oncol 3 2008 1112 1118
21. K. Takezawa, I. Okamoto, W. Okamoto, and et al. Thymidylate synthase as a determinant of pemetrexed sensitivity in non-small-cell lung cancer Br J Cancer 104 2011 1594 1601
22. D.R. Budman, R. Soong, A. Calabro, J. Tai, and R. Diasio Identification of potentially useful combinations of epidermal growth factor receptor tyrosine kinase antagonists with conventional cytotoxic agents using median effect analysis Anticancer Drugs 17 2006 921 928
23. E. Giovannetti, C. Lemos, C. Tekle, and et al. Molecular mechanisms underlying the synergistic interaction of erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor, with the multitargeted antifolate pemetrexed in non-small-cell lung cancer cells Mol Pharmacol 73 2008 1290 1300
24. M. Chefrour, G. Milano, P. Formento, and et al. Positive interaction between lapatinib and capecitabine in human breast cancer models: study of molecular determinants Fundam Clin Pharmacol 26 2012 530 537
25. A.F. Gazdar Activating and resistance mutations of EGFR in non-small-cell lung cancer: role in clinical response to EGFR tyrosine kinase inhibitors Oncogene 28 suppl 1 2009 S24 S31
26. M.J. Piccart-Gebhart, M. Procter, B. Leyland-Jones, and et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer N Engl J Med 353 2005 1659 1672
27. E. Sueoka, N. Sueoka, K. Iwanaga, and et al. Detection of plasma hnRNP B1 mRNA, a new cancer biomarker, in lung cancer patients by quantitative real-time polymerase chain reaction Lung Cancer 48 2005 77 83
28. S.M. Lledo, E. Garcia-Granero, F. Dasi, and et al. Real time quantification in plasma of human telomerase reverse transcriptase (hTERT) mRNA in patients with colorectal cancer Colorectal Dis 6 2004 236 242
29. S. Novakovic, M. Hocevar, J. Zgajnar, N. Besic, and V. Stegel Detection of telomerase RNA in the plasma of patients with breast cancer, malignant melanoma or thyroid cancer Oncol Rep 11 2004 245 252
30. U. Deligezer, F. Yaman, E. Darendeliler, and et al. Post-treatment circulating plasma BMP6 mRNA and H3K27 methylation levels discriminate metastatic prostate cancer from localized disease Clin Chim Acta 411 2010 1452 1456
31. V. Garcia, J.M. Garcia, C. Pena, and et al. Thymidylate synthase messenger RNA expression in plasma from patients with colon cancer: prognostic potential Clin Cancer Res 12 2006 2095 2100
32. N.B. Tsui, E.K. Ng, and Y.M. Lo Stability of endogenous and added RNA in blood specimens, serum, and plasma Clin Chem 48 2002 1647 1653
33. S.A. Bustin, and T. Nolan Pitfalls of quantitative real-time reverse-transcription polymerase chain reaction J Biomol Tech 15 2004 155 166
34. J.P. Zhou, X. Chen, S. Feng, and et al. Systems biology modeling reveals a possible mechanism of the tumor cell death upon oncogene inactivation in EGFR addicted cancers PLoS One 6 2011 e28930
35. N. Fujimoto, M. Wislez, J. Zhang, and et al. High expression of ErbB family members and their ligands in lung adenocarcinomas that are sensitive to inhibition of epidermal growth factor receptor Cancer Res 65 2005 11478 11485
36. W. Pao, V.A. Miller, K.A. Politi, and et al. Acquired resistance of lung adenocarcinomas to gefitinib or erlotinib is associated with a second mutation in the EGFR kinase domain PLoS Med 2 2005 e73
37. H.A. Yu, M.E. Arcila, and N. Rekhtman Analysis of tumor specimens at the time of acquired resistance to EGFR TKI therapy in 155 patients with EGFR mutant lung cancers Clin Cancer Res 19 2013 2240 2247