Necitumumab plus pemetrexed and cisplatin as first-line therapy in patients with stage IV non-squamous non-small-cell lung cancer (INSPIRE): An open-label, randomised, controlled phase 3 study

The Lancet Oncology

Volumn 16, Issue 3, 2015, Pages 328-337

[No Author Info available]

Author keywords

[No Author keywords available]

Indexed keywords

CISPLATIN; CORTICOSTEROID; CYANOCOBALAMIN; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB; FOLIC ACID; GEMCITABINE; NECITUMUMAB; PEMETREXED; ANTINEOPLASTIC AGENT; GLUTAMIC ACID DERIVATIVE; GUANINE; IMC-11F8 MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY;

ADULT; AGED; ANEMIA; ARTERIAL THROMBOEMBOLISM; ARTICLE; ASTHENIA; CANCER STAGING; CANCER SURVIVAL; CONTROLLED STUDY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; EYE DISEASE; FATIGUE; FEMALE; GASTROINTESTINAL DISEASE; HAZARD RATIO; HISTOPATHOLOGY; HUMAN; HYPOMAGNESEMIA; IMMUNOHISTOCHEMISTRY; INFUSION RELATED REACTION; INTENTION TO TREAT ANALYSIS; INTERACTIVE VOICE RESPONSE SYSTEM; INTERSTITIAL LUNG DISEASE; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NON SMALL CELL LUNG CANCER; NON SQUAMOUS NON SMALL CELL LUNG CANCER; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PREDICTIVE VALUE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; RANDOMIZED CONTROLLED TRIAL; RASH; SKIN DISEASE; SKIN MANIFESTATION; SMOKING; SYSTEMATIC REVIEW; TRANSLATIONAL RESEARCH; TREATMENT FAILURE; VENOUS THROMBOEMBOLISM; VISUAL ANALOG SCALE; VITAMIN SUPPLEMENTATION; ANALOGS AND DERIVATIVES; BRAZIL; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; COMPARATIVE STUDY; DISEASE COURSE; DISEASE FREE SURVIVAL; DRUG ADMINISTRATION; EUROPE; KAPLAN MEIER METHOD; LUNG NEOPLASMS; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PATHOLOGY; RISK FACTOR; TIME; TREATMENT OUTCOME; UNITED STATES;

AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BRAZIL; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; EUROPE; FEMALE; GLUTAMATES; GUANINE; HUMANS; KAPLAN-MEIER ESTIMATE; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; RISK FACTORS; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES;

EID: 84924971683     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(15)70046-X     Document Type: Article

References (38)

1. Travis WD, Brambilla E, Riely GJ New pathologic classification of lung cancer: relevance for clinical practice and clinical trials. J Clin Oncol 2013, 31:992-1001.
2. Thomas A, Rajan A, Lopez-Chavez A, Wang Y, Giaccone G From targets to targeted therapies and molecular profiling in non-small cell lung carcinoma. Ann Oncol 2013, 24:577-585.
3. Reck M, Popat S, Reinmuth N, et al. Metastatic non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2014, 25(suppl 3):iii27-iii39.
4. Cooper WA, Lam DC, O'Toole SA, Minna JD Molecular biology of lung cancer. J Thorac Dis 2013, 5(suppl 5):S479-S490.
5. Gerber DE, Gandhi L, Costa DB Management and future directions in non-small cell lung cancer with known activating mutations. Am Soc Clin Oncol Educ Book 2014, e353-e365.
6. Kerr KM, Bubendorf L, Edelman MJ, et al. Second ESMO consensus conference on lung cancer: pathology and molecular biomarkers for non-small-cell lung cancer. Ann Oncol 2014, 25:1682-1690.
7. Douillard JY, Pirker R, O'Byrne KJ, et al. Relationship between EGFR expression, EGFR mutation status, and the efficacy of chemotherapy plus cetuximab in FLEX study patients with advanced non-small-cell lung cancer. J Thorac Oncol 2014, 9:717-724.
8. Pirker R, Pereira JR, Szczesna A, 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.
9. Dienstmann R, Felip E Necitumumab in the treatment of advanced non-small cell lung cancer: translation from preclinical to clinical development. Expert Opin Biol Ther 2011, 11:1223-1231.
10. Cohen MH, Justice R, Pazdur R Approval summary: pemetrexed in the initial treatment of advanced/metastatic non-small cell lung cancer. Oncologist 2009, 14:930-935.
11. Scagliotti GV, Parikh P, von Pawel J, 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.
12. Thatcher N, Hirsch FR, Szczesna A, et al. A randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin (GC) chemotherapy plus necitumumab (IMC-11F8/LY3012211) versus GC alone in the first-line treatment of patients (pts) with stage IV squamous non-small cell lung cancer (sq-NSCLC). J Clin Oncol 2014, 32:8008.
13. Edge S, Byrd DR, Compton CC, Fritz AG, Greene FL, Trotti A AJCC Cancer Staging Manual 2010, Springer, New York. 7th edn.
14. Therasse P, Arbuck SG, Eisenhauer EA, 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.
15. Nomenclature and criteria for diagnosis of diseases of the heart and great vessels 1994, The Criteria Committee of the New York Heart Association, Little, Brown and Company, Boston, MA. 9th edn.
16. A registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) 2009, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) MedDRA the Medical Dictionary for Regulatory Activities, Northrop Grumman MSSO, Chantilly, VA.
17. Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 National Cancer Institute, National Institutes of HealthNational Institutes of Health, US Department of Health and Human ServicesUS Department of Health and Human Services, (accessed Feb 8, 2015). http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf.
18. Hollen PJ, Gralla RJ, Kris MG, et al. Measurement of quality of life in patients with lung cancer in multicenter trials of new therapies. Psychometric assessment of the Lung Cancer Symptom Scale. Cancer 1994, 73:2087-2098.
19. Nord E EuroQol: health-related quality of life measurement. Valuations of health states by the general public in Norway. Health Policy 1991, 18:25-36.
20. Pirker R, Pereira JR, von Pawel J, 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.
21. Hirsch FR, Varella-Garcia M, Bunn PA, et al. Epidermal growth factor receptor in non-small-cell lung carcinomas: correlation between gene copy number and protein expression and impact on prognosis. J Clin Oncol 2003, 21:3798-3807.
22. Witteveen PO, Ruijter R, et al. A phase I pharmacologic study of necitumumab (IMC-11F8), a fully human IgG1 monoclonal antibody directed against EGFR in patients with advanced solid malignancies. Clin Cancer Res 2010, 16:1915-1923. Kuenen B1.
23. Kim ES, Neubauer M, Cohn A, et al. Docetaxel or pemetrexed with or without cetuximab in recurrent or progressive non-small-cell lung cancer after platinum-based therapy: a phase 3, open-label, randomised trial. Lancet Oncol 2013, 14:1326-1336.
24. Pujol JL, Pirker R, Lynch TJ, et al. Meta-analysis of individual patient data from randomized trials of chemotherapy plus cetuximab as first-line treatment for advanced non-small cell lung cancer. Lung Cancer 2014, 83:211-218.
25. Petrelli F, Borgonovo K, Cabiddu M, Ghilardi M, Barni S Risk of anti-EGFR monoclonal antibody-related hypomagnesemia: systematic review and pooled analysis of randomized studies. Expert Opin Drug Saf 2012, 11(suppl 1):S9-19.
26. Segaert S, Van Cutsem E Clinical signs, pathophysiology and management of skin toxicity during therapy with epidermal growth factor receptor inhibitors. Ann Oncol 2005, 16:1425-1433.
27. Seng S, Liu Z, Chiu SK, et al. Risk of venous thromboembolism in patients with cancer treated with cisplatin: a systematic review and meta-analysis. J Clin Oncol 2012, 30:4416-4426.
28. Petrelli F, Cabiddu M, Borgonovo K, Barni S Risk of venous and arterial thromboembolic events associated with anti-EGFR agents: a meta-analysis of randomized clinical trials. Ann Oncol 2012, 23:1672-1679.
29. Butts CA, Bodkin D, Middleman EL, et al. Randomized phase II study of gemcitabine plus cisplatin or carboplatin, 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.
30. Lynch TJ, Patel T, Dreisbach L, 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.
31. Rosell R, Robinet G, Szczesna A, 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.
32. Hartmann JT, Kollmannsberger C, Cascorbi I, et al. A phase I pharmacokinetic study of matuzumab in combination with paclitaxel in patients with EGFR-expressing advanced non-small cell lung cancer. Invest New Drugs 2013, 31:661-668.
33. Schiller JH, von Pawel J, Schutt P, et al. Pemetrexed with or without matuzumab as second-line treatment for patients with stage IIIB/IV non-small cell lung cancer. J Thorac Oncol 2010, 5:1977-1985.
34. Blumenschein GR, Reckamp K, Stephenson GJ, et al. Phase 1b study of motesanib, an oral angiogenesis inhibitor, in combination with carboplatin/paclitaxel and/or panitumumab for the treatment of advanced non-small cell lung cancer. Clin Cancer Res 2010, 16:279-290.
35. Crawford J, Swanson P, Schwarzenberger P, et al. A phase 2 randomized trial of paclitaxel and carboplatin with or without panitumumab for first-line treatment of advanced non-small-cell lung cancer. J Thorac Oncol 2013, 8:1510-1518.
36. Meert AP, Martin B, Delmotte P, et al. The role of EGF-R expression on patient survival in lung cancer: a systematic review with meta-analysis. Eur Respir J 2002, 20:975-981.
37. Nakamura H, Kawasaki N, Taguchi M, Kabasawa K Survival impact of epidermal growth factor receptor overexpression in patients with non-small cell lung cancer: a meta-analysis. Thorax 2006, 61:140-145.
38. Nicholson RI, Gee JM, Harper ME EGFR and cancer prognosis. Eur J Cancer 2001, 37(suppl 4):S9-15.