Phase II study of pemetrexed in combination with cisplatin and cetuximab in recurrent or metastatic squamous cell carcinoma of the head and neck

European Journal of Cancer

Volumn 49, Issue 13, 2013, Pages 2877-2883

  Vermorken, J B ^a   Licitra, L ^b   Stohlmacher Williams J ^c   Dietz, A ^d   Lopez Picazo, J M ^e   Hamid, O ^f   Hossain, A M ^f   Chang, S C ^f   Gauler, T C ^g  

^a ANTWERP UNIVERSITY HOSPITAL   (Belgium)

^b NATIONAL CANCER INSTITUTE   (Italy)

^c UNIVERSITY HOSPITAL CARL GUSTAV CARUS   (Germany)

^d UNIVERSITY HOSPITAL LEIPZIG   (Germany)

^e UNIVERSITY CLINIC OF NAVARRA   (Spain)

^f ELI LILLY AND COMPANY   (United States)

^g UNIVERSITY HOSPITAL ESSEN   (Germany)

Author keywords

cell carcinoma; Cetuximab; Cisplatin; Head and neck squamous; Pemetrexed

Indexed keywords

BLEOMYCIN; CAPECITABINE; CARBOPLATIN; CETUXIMAB; CISPLATIN; CYANOCOBALAMIN; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOCETAXEL; DOXORUBICIN; FLUOROURACIL; FOLIC ACID; GEMCITABINE; METHOTREXATE; PACLITAXEL; PEMETREXED; TEGAFUR; TEMSIROLIMUS; URACIL;

ADULT; ANEMIA; ANOREXIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER SURVIVAL; DIARRHEA; DISTANT METASTASIS; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FATIGUE; FEMALE; HEAD AND NECK SQUAMOUS CELL CARCINOMA; HUMAN; HYPOKALEMIA; HYPOMAGNESEMIA; INFECTION; LARYNX; LEUKOPENIA; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OROPHARYNX; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; THROMBOCYTOPENIA; VOMITING;

CETUXIMAB; CISPLATIN; HEAD AND NECK SQUAMOUS CELL CARCINOMA; PEMETREXED;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, SQUAMOUS CELL; CISPLATIN; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; EUROPE; FEMALE; GLUTAMATES; GUANINE; HEAD AND NECK NEOPLASMS; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; TIME FACTORS; TREATMENT OUTCOME;

EID: 84881104049     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2013.05.002     Document Type: Article

References (22)

1. J. Ferlay, H.R. Shin, and F. Bray Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008 Int J Cancer 127 2010 2893 2917
2. J. Ferlay, D.M. Parkin, and E. Steliarova-Foucher Estimates of cancer incidence and mortality in Europe in 2008 Eur J Cancer 46 2010 765 781
3. A.A. Forastiere, B. Metch, and D.E. Schuller Randomized comparison of cisplatin plus fluorouracil and carboplatin plus fluorouracil versus methotrexate in advanced squamous-cell carcinoma of the head and neck: a Southwest Oncology Group study J Clin Oncol 10 1992 1245 1251
4. C. Jacobs, G. Lyman, and E. Velez-García A phase III randomized study comparing cisplatin and fluorouracil as single agents and in combination for advanced squamous cell carcinoma of the head and neck J Clin Oncol 10 1992 257 263
5. M. Clavel, J.B. Vermorken, and F. Cognetti Randomized comparison of cisplatin, methotrexate, bleomycin and vincristine (CABO) versus cisplatin and 5-fluorouracil (CF) versus cisplatin (C) in recurrent or metastatic squamous cell carcinoma of the head and neck. A phase III study of the EORTC Head and Neck Cancer Cooperative Group Ann Oncol 5 1994 521 526
6. M.K. Gibson, Y. Li, and B. Murphy Randomized phase III evaluation of cisplatin plus fluorouracil versus cisplatin plus paclitaxel in advanced head and neck cancer (E1395): an intergroup trial of the Eastern Cooperative Oncology Group J Clin Oncol 23 2005 3562 3567
7. S. Urba, C.M. van Herpen, and T.P. Sahoo Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer: final results of a randomized, double-blind, placebo-controlled, phase 3 study Cancer 118 2012 4694 4705
8. A. Argiris, Y. Li, and A. Forastiere Prognostic factors and long-term survivorship in patients with recurrent or metastatic carcinoma of the head and neck Cancer 101 2004 2222 2229
9. J.B. Vermorken, R. Mesia, and F. Rivera Platinum-based chemotherapy plus cetuximab in head and neck cancer N Engl J Med 359 2008 1116 1127
10. B. Burtness, M.A. Goldwasser, and W. Flood Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study J Clin Oncol 23 2005 8646 8654 [Erratum in J Clin Oncol 2006;24:724]
11. R. Mesía, F. Rivera, and A. Kawecki Quality of life of patients receiving platinum-based chemotherapy plus cetuximab first line for recurrent and/or metastatic squamous cell carcinoma of the head and neck Ann Oncol 21 2010 1967 1973
12. X. Pivot, E. Raymond, and B. Laguerre Pemetrexed disodium in recurrent locally advanced or metastatic squamous cell carcinoma of the head and neck Br J Cancer 85 2001 649 655
13. G.V. Scagliotti, P. Parikh, and J. von Pawel Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naïve patients with advanced-stage non-small-cell lung cancer J Clin Oncol 26 2008 3543 3551
14. N.J. Vogelzang, J.J. Rusthoven, and J. Symanowski Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma J Clin Oncol 21 2003 2636 2644
15. National Cancer Institute. Cancer therapy evaluation program common terminology criteria for adverse events, version 3.0. < http://ctep.cancer. gov/protocolDevelopment/electronic-applications/docs/ctcaev3.pdf#search= "ctcae" >; 2006.
16. T.J. Smith, J. Khatcheressian, and G.H. Lyman 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline J Clin Oncol 24 19 2006 3187 3205
17. P. Therasse, S.G. Arbuck, and E.A. Eisenhauer 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 92 2000 205 216
18. E.L. Kaplan, and P. Meier Nonparametric estimation of incomplete observations J Am Stat Assoc 53 1958 457 481
19. L.M. Leemis, and K.S. Trivedi A comparison of approximate interval estimators for the Bernoulli parameter Am Stat 50 1996 63 68
20. K.A. Price, and E.E. Cohen Current treatment options for metastatic head and neck cancer Curr Treat Options Oncol 13 2012 35 46
21. V. Grünwald, U. Keilholz, and A. Boehm Temsirolimus is active in refractory squamous cell carcinoma of the head and neck (SCCHN) failing platinum-based chemotherapy and cetuximab: efficacy and toxicity data from the phase II TEMHEAD study ESMO 2012 [abstract 1023]
22. M.W. Pedersen, H.J. Jacobsen, and K. Koefoed Sym004: a novel synergistic anti-epidermal growth factor receptor antibody mixture with superior anticancer efficacy Cancer Res 70 2010 588 597