Phase II study of pemetrexed and cisplatin plus cetuximab followed by pemetrexed and cetuximab maintenance therapy in patients with advanced nonsquamous non-small cell lung cancer

Lung Cancer

Volumn 81, Issue 3, 2013, Pages 428-434

  Schmid Bindert, Gerald ^a   Gebbia, Vittorio ^b   Mayer, Frank ^c   Arriola, Edurne ^d   Márquez Medina, Diego ^e   Syrigos, Kostas ^f   Biesma, Bonne ^g   Leschinger, Monika Iris ^h   Frimodt Moller, Bente ⁱ   Ripoche, Veronique ^j   Myrand, Scott P ⁱ   Nguyen, Tuan S ⁱ   Hozak, Rebecca R ⁱ   Zimmermann, Annamaria ⁱ   Visseren Grul, Carla ^j   Schuette, Wolfgang ^k  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b UNIVERSITY OF PALERMO   (Italy)

^c UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^d HOSPITAL DEL MAR   (Spain)

^e HOSPITAL UNIVERSITARI ARNAU DE VILANOVA   (Spain)

^f UNIVERSITY OF ATHENS MEDICAL SCHOOL   (Greece)

^g JEROEN BOSCH HOSPITAL   (Netherlands)

^h LILLY DEUTSCHLAND GMBH   (Germany)

ⁱ ELI LILLY AND COMPANY   (United States)

^j Eli Lilly France ^*  (Netherlands)

^k Krankenhaus Martha Maria Halle Doelau   (Germany)

more..

Author keywords

Cetuximab; Cisplatin; Epidermal growth factor receptor; Folate receptor alpha; NSCLC; Pemetrexed; Thymidylate synthase; Thyroid transcription factor

Indexed keywords

ANTIHISTAMINIC AGENT; CETUXIMAB; CISPLATIN; DEXAMETHASONE; EPIDERMAL GROWTH FACTOR RECEPTOR; FOLATE RECEPTOR 1; K RAS PROTEIN; PEMETREXED; THYMIDYLATE SYNTHASE; THYROID TRANSCRIPTION FACTOR 1;

ADULT; AGED; ANEMIA; ARTICLE; CONTROLLED STUDY; DEATH; DIARRHEA; DISEASE COURSE; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; FOLLOW UP; GENE MUTATION; HUMAN; KIDNEY FAILURE; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; NEUTROPENIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; RASH; SURVIVAL RATE; THROMBOCYTOPENIA; TRANSLATIONAL RESEARCH; TREATMENT RESPONSE; VITAMIN SUPPLEMENTATION; VOMITING;

CETUXIMAB; CISPLATIN; EPIDERMAL GROWTH FACTOR RECEPTOR; FOLATE RECEPTOR-ALPHA; NSCLC; PEMETREXED; THYMIDYLATE SYNTHASE; THYROID TRANSCRIPTION FACTOR;

ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; FEMALE; GLUTAMATES; GUANINE; HUMANS; INDUCTION CHEMOTHERAPY; LUNG NEOPLASMS; MAINTENANCE CHEMOTHERAPY; MALE; MIDDLE AGED; NEOPLASM STAGING; TRANSLATIONAL MEDICAL RESEARCH; TREATMENT OUTCOME;

EID: 84881659906     PISSN: 01695002     EISSN: 18728332     Source Type: Journal    
DOI: 10.1016/j.lungcan.2013.05.010     Document Type: Article

References (40)

1. Peters S., Adjei A.A., Gridelli C., Reck M., Kerr K., Felip E., et al. Metastatic non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2012, 23(Suppl. 7):vii56-vii64.
2. Azzoli C.G., Temin S., Aliff T., Baker S., Brahmer J., Johnson D.H., et al. 2011 Focused update of 2009 American Society of Clinical Oncology Clinical Practice Guideline Update on chemotherapy for stage IV non-small-cell lung cancer. J Clin Oncol 2011, 29:3825-3831.
3. Chattopadhyay S., Moran R.G., Goldman I.D. Pemetrexed: biochemical and cellular pharmacology, mechanisms, and clinical applications. Mol Cancer Ther 2007, 6:404-417.
4. Alimta; 2011. http://www.ema.europa.eu/ema/index.jsp?curl=pages/home/Home_Page.jsp&mid.
5. Alimta package insert, 5/2012 update. http://pi.lilly.com/us/alimta-pi.pdf.
6. Ohsaki Y., Tanno S., Fujita Y., Toyoshima E., Fujiuchi S., Nishigaki Y., et al. Epidermal growth factor receptor expression correlates with poor prognosis in non-small cell lung cancer patients with p53 overexpression. Oncol Rep 2000, 7:603-607.
7. Veale D., Ashcroft T., Marsh C., Gibson G.J., Harris A.L. Epidermal growth factor receptors in non-small cell lung cancer. Br J Cancer 1987, 55:513-516.
8. Butts C.A., Bodkin D., Middleman E.L., Englund C.W., Ellison D., Alam Y., et al. Randomized phase II study of gemcitabine plus cisplatin or carboplatin [corrected], with or without cetuximab, as first-line therapy for patients with advanced or metastatic non small-cell lung cancer. J Clin Oncol 2007, 25:5777-5784.
9. Lynch T.J., Patel T., Dreisbach L., McCleod M., Heim W.J., Hermann R.C., et al. Cetuximab and first-line taxane/carboplatin chemotherapy in advanced non-small-cell lung cancer: results of the randomized multicenter phase III trial BMS099. J Clin Oncol 2010, 28:911-917.
10. Pirker R., Pereira J.R., Szczesna A., von Pawel J., Krzakowski M., Ramlau R., et al. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet 2009, 373:1525-1531.
11. Rosell R., Robinet G., Szczesna A., Ramlau R., Constenla M., Mennecier B.C., et al. Randomized phase II study of cetuximab plus cisplatin/vinorelbine compared with cisplatin/vinorelbine alone as first-line therapy in EGFR-expressing advanced non-small-cell lung cancer. Ann Oncol 2008, 19:362-369.
12. Giovannetti E., Lemos C., Tekle C., Smid K., Nannizzi S., Rodriguez J.A., 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 2008, 73:1290-1300.
13. Baselga J. The EGFR as a target for anticancer therapy-focus on cetuximab. Eur J Cancer 2001, 37(Suppl. 4):S16-S22.
14. Bulgaru A.M., Mani S., Goel S., Perez-Soler R. Erlotinib (Tarceva): a promising drug targeting epidermal growth factor receptor tyrosine kinase. Expert Rev Anticancer Ther 2003, 3:269-279.
15. Scagliotti G.V., Parikh P., von Pawel J., Biesma B., Vansteenkiste J., Manegold C., et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 2008, 26:3543-3551.
16. National Cancer Institute Cancer Therapy Evaluation Program. National Cancer Institute Common Terminology Criteria (CTCAE), v3.0 2006, National Cancer Institute.
17. Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., Rubinstein L., et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000, 92:205-216.
18. Kerr K.M. Personalized medicine for lung cancer: new challenges for pathology. Histopathology 2012, 60:531-546.
19. Berghmans T., Paesmans M., Mascaux C., Martin B., Meert A.P., Haller A., et al. Thyroid transcription factor 1-a new prognostic factor in lung cancer: a meta-analysis. Ann Oncol 2006, 17:1673-1676.
20. Perner S., Wagner P.L., Soltermann A., LaFargue C., Tischler V., Weir B.A., et al. TTF1 expression in non-small cell lung carcinoma: association with TTF1 gene amplification and improved survival. J Pathol 2009, 217:65-72.
21. Sun J.M., Han J., Ahn J.S., Park K., Ahn M.J. Significance of thymidylate synthase and thyroid transcription factor 1 expression in patients with nonsquamous non-small cell lung cancer treated with pemetrexed-based chemotherapy. J Thorac Oncol 2011, 6:1392-1399.
22. Goldman I.D., Zhao R. Molecular, biochemical, and cellular pharmacology of pemetrexed. Semin Oncol 2002, 29(6 Suppl. 18):3-17.
23. Theti D.S., Jackman A.L. The role of alpha-folate receptor-mediated transport in the antitumor activity of antifolate drugs. Clin Cancer Res 2004, 10:1080-1089.
24. Christoph D.C., Asuncion B.R., Hassan B., Tran C., Maltzman J.D., O'Shannessy D.J., et al. Significance of folate receptor alpha and thymidylate synthase protein expression in patients with non-small-cell lung cancer treated with pemetrexed. J Thorac Oncol 2013, 8:19-30.
25. Takezawa K., Okamoto I., Okamoto W., Takeda M., Sakai K., Tsukioka S., et al. Thymidylate synthase as a determinant of pemetrexed sensitivity in non-small cell lung cancer. Br J Cancer 2011, 104:1594-1601.
26. Lee H.J., Xu X., Choe G., Chung D.H., Seo J.W., Lee J.H., et al. Protein overexpression and gene amplification of epidermal growth factor receptor in nonsmall cell lung carcinomas: comparison of four commercially available antibodies by immunohistochemistry and fluorescence in situ hybridization study. Lung Cancer 2010, 68:375-382.
27. Pirker R., Pereira J.R., von Pawel J., Krzakowski M., Ramlau R., Park K., et al. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol 2012, 13:33-42.
28. Nunez M.I., Behrens C., Woods D.M., Lin H., Suraokar M., Kadara H., et al. High expression of folate receptor alpha in lung cancer correlates with adenocarcinoma histology and mutation. J Thorac Oncol 2012, 7:833-840.
29. Miller R., Siegmund D. Maximally selected chi square statistics. Biometrics 2012, 38(4):1011-1016.
30. Ibrahim E.M., Abouelkhair K.M., Al-Masri O.A., Chaudry N.C., Kazkaz G.A. Cetuximab-based therapy is effective in chemotherapy-naive patients with advanced and metastatic non-small-cell lung cancer: a meta-analysis of randomized controlled trials. Lung 2011, 189:193-198.
31. Fischer J.R., Griesinger F., Fink T., Salm T., Marseille A., Wolf M. Docetaxel-carboplatin chemotherapy combined with cetuximab in patients with locally advanced or metastatic non small-cell lung cancer (NSCLC)-results of the nonrandomised phase II study TaxErb. Lung Cancer 2012, 75:348-352.
32. Blom J.W., Doggen C.J., Osanto S., Rosendaal F.R. Malignancies, prothrombotic mutations, and the risk of venous thrombosis. JAMA 2005, 293:715-722.
33. Corrales-Rodriguez L., Blais N. Lung cancer associated venous thromboembolic disease: a comprehensive review. Lung Cancer 2012, 75:1-8.
34. Alimta summary of product characteristics; 2011. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Product_Information/human/000564/WC500025611.pdf.
35. Erbitux summary of product characteristics; 2012. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Product_Information/human/000558/WC500029119.pdf.
36. European Medicines Agency Assessment Report for Erbitux. Procedure No. EMEA/H/C/558/II/0029 2010, http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Assessment_Report_Variation/human/000558/WC500075683.pdf.
37. O'Byrne K.J., Gatzemeier U., Bondarenko I., Barrios C., Eschbach C., Martens U.M., et al. Molecular biomarkers in non-small-cell lung cancer: a retrospective analysis of data from the phase 3 FLEX study. Lancet Oncol 2011, 12:795-805.
38. Gatzemeier U., Paz-Ares L., Rodrigues Pereira J., von Pawel J., Ramlau R., Roh J.K., et al. Molecular and clinical biomarkers of cetuximab efficacy: data from the phase III FLEX study in non-small cell lung cancer (NSCLC). J Thorac Oncol 2009, 4(Suppl. 1):S324.
39. Khambata-Ford S., Harbison C.T., Hart L.L., Awad M., Xu L.A., Horak C.E., et al. Analysis of potential predictive markers of cetuximab benefit in BMS099, a phase III study of cetuximab and first-line taxane/carboplatin in advanced non-small-cell lung cancer. J Clin Oncol 2010, 28:918-927.
40. Mack P.C., Holland W.S., Redman M., Lara P.N., Snyder L.J., Hirsch F.R., et al. KRAS mutation analysis in cetuximab-treated advanced stage non-small cell lung cancer (NSCLC): SWOG experience with S0342 and S0536. J Clin Oncol 2009, 27:15s. [suppl; abstr 8022].