A phase I trial of erlotinib and concurrent chemoradiotherapy for stage III and IV (M0) squamous cell carcinoma of the head and neck

Clinical Cancer Research

Volumn 18, Issue 6, 2012, Pages 1735-1742

  Gilbert, Jill ^a   Rudek, Michelle A ^c   Higgins, Michaela J ^e   Zhao, Ming ^c   Bienvenu, Sara ^b   Tsottles, Nancy ^c   Wahl, Richard ^d   Forastiere, Arlene ^c   Gillison, Maura ^f  

^a VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b HOSPITAL CORPORATION OF AMERICA   (United States)

^c JOHNS HOPKINS UNIVERSITY   (United States)

^d JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

^f THE OHIO STATE UNIVERSITY COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CISPLATIN; ERLOTINIB;

ADULT; AGED; ANOREXIA; ARTICLE; BIOLOGICAL ACTIVITY; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER SIZE; CANCER STAGING; CLINICAL ARTICLE; CONTROLLED STUDY; DIARRHEA; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG ERUPTION; DRUG MEGADOSE; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; EXTERNAL BEAM RADIOTHERAPY; FEMALE; FEVER; HEAD AND NECK CARCINOMA; HUMAN; LOW DRUG DOSE; LYMPHOCYTOPENIA; MALE; MAXIMUM TOLERATED DOSE; MONOTHERAPY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PATIENT COMPLIANCE; PHASE 1 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; RADIATION DERMATITIS; RADIATION DOSE FRACTIONATION; SQUAMOUS CELL CARCINOMA; TREATMENT DURATION; XEROSTOMIA;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, SQUAMOUS CELL; CHEMORADIOTHERAPY; CISPLATIN; DOSE FRACTIONATION; HEAD AND NECK NEOPLASMS; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; QUINAZOLINES;

EID: 84858206301     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-11-2544     Document Type: Article

References (26)

1. Fakhry LC, Westra WH, Li S, Cmelak A, Ridge JA, Pinto H, et al. Improved survival of patients with human papillomavirus-positive head and neck squamous cell carcinoma in a prospective clinical trial. J Natl Cancer Inst 2008;100:261-9. (Pubitemid 351480538)
2. Forastiere AA, Goepfert H, Maor M, Pajak TF, Weber R, Morriosn W, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med 2003;349:2091-8. (Pubitemid 37464533)
3. Tobias JS, Monson K, Gupta N, Macdougall H, Glaholm J, Hutchison I, et al. Chemoradiotherapy for locally advanced head and neck cancer: 10-year follow-up of the UK Head and Neck (UKHANA1) trial. Lancet Oncol 2009;11:66-74.
4. Cmelak AJ, Li S, Goldwasser MA, Murphy B, Cannon M, Pinto H, et al. Phase II trial of chemoradiation for organ preservation in resectable stage III or IV squamous cell carcinomas of the larynx or oropharynx: results of Eastern Cooperative Group Study E2399. J Clin Oncol 2007;25:3971-7. (Pubitemid 47477276)
5. Denis F, Garaud P, Bardet E, Alfonsi M, Sire C, Germain T, et al. Final results of the 94-01 french head and neck oncology and radiotherapy group randomized trial comparing radiotherapy alone with concomitant radiochemotherapy in advanced stage oropharynx carcinoma. J Clin Oncol 2004;22:69-76. (Pubitemid 41095116)
6. Jeremic B, Milicic B, Dagovic A, Vaskovic Z, Tadic L. Radiation therapy with or without concurrent low dose daily chemotherapy in locally advanced, nonmetastatic squamous cell carcinoma of the head and neck. J Clin Oncol 2004;22:3540-8. (Pubitemid 41103660)
7. Jeremic B, Shibamoto Y, Milicic B, Nikolic N, Dagovic A, Aleksandrovic J, et al. Hyperfractionated radiation therapy with or without concurrent low dose daily cisplatin in locally advanced squamous cell carcinoma of the head and neck: a prospective randomized trial. J Clin Oncol 2000;18:1458-64. (Pubitemid 30205391)
8. Woodburn J. The epidermal growth factor receptor and its inhibition in cancer therapy. Pharmacol Ther 1999;82:241-50. (Pubitemid 29255919)
9. Chung CH, Ely K, McGavran L, Varella-Garcia M, Parker J, Parker N, et al. Increased epidermal growth factor receptor gene copy number is associated with poor prognosis in head and neck squamous cell carcinomas. J Clin Oncol 2006;24:4170-6. (Pubitemid 46622295)
10. Kong CS, Narasimhan B, Cao H, Kwok S, Erickson JP, Koong A, et al. The relationship between human papillomavirus status and other molecular prognostic markers in head and neck squamous cell carcinomas. Int J Radiat Oncol Biol Phys 2009;74:553-61.
11. Huang S, Bock J, Harari P. Epidermal growth factor receptor blockade with C225 modulates proliferation, apoptosis, and radiosensitivity in squamous cell carcinomas of the head and neck. Cancer Res 1999;59:1935-40. (Pubitemid 29186168)
12. CernigliaGJ, Pore N, TsaiJH, Schultz S, Mick R,Choe R, et al.Epidermal growth factor receptor inhibition modulates the microenvironment byvascular normalization to improve chemotherapy and radiotherapy efficacy. PLoS One 4 2009:e6539.
13. Meira DD, de Almeida VH, Mororo JS, Nobrega I, Bardella L, Silva RL, et al. Combination of cetuximab with chemoradiation, trastuzumab or MAPK inhibitors: mechanisms of sensitisation of cervical cancer cells. Br J Cancer 2009;101:782-91.
14. Ahsan A, Hiniker SM, Davis MA, Lawrence TS, Nyati MK. Role of cell cycle in epidermal growth factor receptor inhibitor-mediated radiosensitization. Cancer Res 2009;69:5108-14.
15. Raben D, Helfrich B, Chan DC, Ciardiello F, Zhao L, Franklin W, et al. The effects of cetuximab alone and in combination with radiation and/ or chemotherapy in lung cancer. Clin Cancer Res 2005;11:795-805. (Pubitemid 40116908)
16. Thomas F, Rochaix P, Benlyazid A, Sarini J, Rives M, Lefebvre JL, et al. Pilot study of neoadjuvant treatment with erlotinib in nonmetastatic head and neck squamous cell carcinoma. Clin Cancer Res 2007;13: 7086-92. (Pubitemid 350276892)
17. Soulieres D, Senzer NN, Vokes EE, Hidalg M, Agarwala SS, Siu LL. Multicenter phase II study of erlotinib and oral epidermal growth factor receptor tyrosine kinase inhibitor, in patientswith recurrent ormetastatic squamous cell cancer of the headand neck. J ClinOncol 2004;22:77-85. (Pubitemid 41095117)
18. Siu LL, Soulieres D, Chen EX, Pond GR, Chin SF, Francis P, et al. Phase I/II trial of erlotinib and cisplatin in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: a Princess Margaret Hospital Phase II Consortium and National Cancer Institute of Canada Clinical Trials Group Study. J Clin Oncol 2007;25:2178-83. (Pubitemid 46954640)
19. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-16. (Pubitemid 30099779)
20. Wahl RL, Jacene H,Kasamon Y, Lodge MA. From RECIST to PERCIST: evolving considerations for PET response criteria in solid tumors. J Nucl Med 2009;50:122s-50s.
21. Zhao M, He P, Rudek MA, Hidalgo M, Baker SD. Specificmethod for determination of OSI-774 and its metabolite OSI-420 in human plasma by using liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2003;793: 413-20. (Pubitemid 37271981)
22. Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, et al. Radiotherapy plus cetuximab for squamous cell carcinoma of the head and neck. N Engl J Med 2006;354:567-78. (Pubitemid 43209104)
23. Pfister DG, Su YB, Kraus DH, Wolden SL, Lis E, Aliff TB, et al. Concurrent cetuximab, cisplatin and concomitant boost radiotherapy for locoregionally advanced, squamous cell head and neck cancer: a pilot phase II study of a new combined modality paradigm. J Clin Oncol 2006;24:1072-8. (Pubitemid 46638804)
24. Chen C, Kane M, Song J, Campana J, Raben A, Hu K, et al. Phase I trial of gefitinib in combination with radiation or chemoradiation for patients with locally advanced squamous cell head and neck cancer. J Clin Oncol 2007;25:4880-6. (Pubitemid 350220417)
25. Van Waes C, Allen CT, Citrin D, Gius D, Colevas AD, Harold NA, et al. Molecular and clinical responses in a pilot study of gefitinib with paclitaxel and radiation in locally advanced head and neck cancer. Int J Radiat Oncol Biol Phys 2010;77:447-54.
26. Worden FP, Kumar B, Lee JS, Wolf GT, Cordell KG, Taylor JM, et al. Chemoselection as a strategy for organ preservation in advanced oropharynx cancer: response and survival positively associated with HPV16 copy number. J Clin Oncol 2008;26:3138-46.