Multicenter, phase II study of cetuximab in combination with carboplatin in patients with recurrent or metastatic nasopharyngeal carcinoma

Journal of Clinical Oncology

Volumn 23, Issue 15, 2005, Pages 3568-3576

  Chan, Anthony T C ^a   Hsu, Mow Ming ^b   Goh, Boon C ^b   Hui, Edwin P ^b   Liu, Tsang Wu ^b   Millward, Michael J ^b   Hong, Ruey Long ^b   Whang Peng, Jacqueline ^b   Ma, Brigette B Y ^b   To, Ka F ^b   Mueser, Matthias ^b   Amellal, Nadia ^b   Lin, Xiao ^b   Chang, Alex Y ^b  

^a CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANTIHISTAMINIC AGENT; CARBOPLATIN; CETUXIMAB; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR; GEMCITABINE; NAVELBINE; PACLITAXEL; PLATINUM DERIVATIVE; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ACNE; ADULT; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BLOOD TOXICITY; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONSTIPATION; COUGHING; DIARRHEA; DISEASE COURSE; DISEASE SEVERITY; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG RESPONSE; DRUG SAFETY; DRY SKIN; DYSPHAGIA; DYSPNEA; EPISTAXIS; FEMALE; FEVER; HEADACHE; HUMAN; HYPOKALEMIA; INFECTION; INSOMNIA; LEUKOPENIA; MALE; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYASTHENIA; NAIL DISEASE; NASOPHARYNX CARCINOMA; NAUSEA; NEURALGIA; NEUROPATHY; NEUTROPHIL; PAIN; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PNEUMONIA; PRIORITY JOURNAL; PROTEIN EXPRESSION; PRURITUS; RASH; RECURRENT CANCER; RHINITIS; SIDE EFFECT; SKIN TOXICITY; SPUTUM; STOMATITIS; SURVIVAL TIME; THROMBOCYTOPENIA; VOMITING; CANCER INVASION; COMPARATIVE STUDY; DOSE RESPONSE; DRUG ADMINISTRATION; FOLLOW UP; INTRAVENOUS DRUG ADMINISTRATION; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MORTALITY; NASOPHARYNX TUMOR; PATHOLOGY; RISK ASSESSMENT; SINGLE BLIND PROCEDURE; SURVIVAL; TREATMENT OUTCOME; TUMOR RECURRENCE;

ADULT; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NASOPHARYNGEAL NEOPLASMS; NEOPLASM INVASIVENESS; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; RISK ASSESSMENT; SINGLE-BLIND METHOD; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 20644435370     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2005.02.147     Document Type: Article

References (37)

1. Chan AT, Teo PM, Johnson PJ: Nasopharyngeal cancer. Cancer Treat Res 114:275-293, 2003
2. Teo P, Yu P, Lee WY, et al: Significant prognosticators after primary radiotherapy in 903 nondisseminated nasopharyngeal carcinoma evaluated by computer tomography. Int J Radiat Oncol Biol Phys 36:291-304, 1996
3. Teo PM, Kwan WH, Lee WY, et al: Prognosticators determining survival subsequent to distant metastasis from nasopharyngeal carcinoma. Cancer 77:2423-2431, 1996
4. Vikram B, Mishra UB, Strong EW, et al: Patterns of failure in carcinoma of the nasopharynx: Failure at distant sites. Head Neck Surg 8:276-279, 1986
5. Leung SF, Teo PM, Shiu WW, et al: Clinical features and management of distant metastases of nasopharyngeal carcinoma. J Otolaryngol 20:27-29, 1991
6. Geara FB, Sanguineti G, Tucker SL, et al: Carcinoma of the nasopharynx treated by radiotherapy alone: Determinants of distant metastasis and survival. Radiother Oncol 43:53-61, 1997
7. Hui EP, Leung SF, Au JS, et al: Lung metastasis alone in nasopharyngeal carcinoma: A relatively favorable prognostic group-A study by the Hong Kong Nasopharyngeal Carcinoma Study Group. Cancer 101:300-306, 2004
8. Ciardiello F, Tortora G: A novel approach in the treatment of cancer: Targeting the epidermal growth factor receptor. Clin Cancer Res 7:2958-2970, 2001
9. Mendelsohn J: Targeting the epidermal growth factor receptor for cancer therapy. J Clin Oncol 20:1S-13S, 2002 (suppl)
10. Zheng X, Hu L, Chen F, et al: Expression of Ki67 antigen, epidermal growth factor receptor and Epstein-Barr virus-encoded latent membrane protein (LMP1) in nasopharyngeal carcinoma. Eur J Cancer B Oral Oncol 306:290-295, 1994
11. Roychowdhury DF, Tseng A Jr, Fu KK, et al: New prognostic factors in nasopharyngeal carcinoma: Tumor angiogenesis and C-erbB2 expression. Cancer 77:1419-1426, 1996
12. Sheen TS, Huang YT, Chang YL, et al: Epstein-Barr virus-encoded latent membrane protein 1 co-expresses with epidermal growth factor receptor in nasopharyngeal carcinoma. Jpn J Cancer Res 90:1285-1292, 1999
13. Fujii M, Yamashita T, Ishiguro R, et al: Significance of epidermal growth factor receptor and tumor associated tissue eosinophilia in the prognosis of patients with nasopharyngeal carcinoma. Auris Nasus Larynx 29:175-181, 2002
14. Leong JL, Loh KS, Putti TC, et al: Epidermal growth factor receptor in undifferentiated carcinoma of the nasopharynx. Laryngoscope 114:153-157, 2004
15. Putti TC, To KF, Hsu HC, et al: Expression of epidermal growth factor receptor in head and neck cancers correlates with clinical progression: A multicentre immunohistochemical study in the Asia-Pacific region. Histopathology 41:144-151, 2002
16. Ma BB, Poon TC, To KF, et al: Prognostic significance of tumor angiogenesis, Ki 67, p53 oncoprotein, epidermal growth factor receptor and HER2 receptor protein expression in undifferentiated nasopharyngeal carcinoma: A prospective study. Head Neck 25:864-872, 2003
17. Chua DT, Nicholls JM, Sham JS, et al: Prognostic value of epidermal growth factor receptor expression in patients with advanced stage nasopharyngeal carcinoma treated with induction chemotherapy and radiotherapy. Int J Radiat Oncol Biol Phys 59:11-20, 2004
18. Mendelsohn J, Baselga J: Status of epidermal growth factor receptor antagonists in the biology and treatment of cancer. J Clin Oncol 21:2787-2799, 2003
19. Fan Z, Baselga J, Masui H, et al: Antitumor effect of anti-epidermal growth factor receptor monoclonal antibodies plus cis-diamminedichloroplatinum on well established A431 cell xenografts. Cancer Res 53:46374642, 1993
20. Huang SM, Bock JM, Harari PM: Epidermal growth factor receptor blockade with C225 modulates proliferation, apoptosis, and radiosensitivity in squamous cell carcinomas of the head and neck. Cancer Res 59:1935-1940, 1999
21. Ciardiello F, Bianco R, Damiano V, et al: Antitumor activity of sequential treatment with topotecan and anti-epidermal growth factor receptor monoclonal antibody C225. Clin Cancer Res 5:909-916, 1999
22. Inoue K, Slaton JW, Perrotte P, et al: Paclitaxel enhances the effects of the antiepidermal growth factor receptor monoclonal antibody ImClone C225 in mice with metastatic human bladder transitional cell carcinoma. Clin Cancer Res 6:4874-4884, 2000
23. Prewett MC, Hooper AT, Bassi R, et al: Enhanced antitumor activity of anti-epidermal growth factor receptor monoclonal antibody IMC-C225 in combination with irinotecan (CPT-11) against human colorectal tumor xenografts. Clin Cancer Res 8:994-1003, 2002
24. Shin DM, Donato NJ, Perez-Soler R, et al: Epidermal growth factor receptor-targeted therapy with C225 and cisplatin in patients with head and neck cancer. Clin Cancer Res 7:1204-1213, 2001
25. Humblet Y: Cetuximab: An IgG(1) monoclonal antibody for the treatment of epidermal growth factor receptor-expressing tumours. Expert Opin Pharmacother 5:1621-1633, 2004
26. Cunningham D, Humblet Y, Siena S, et al: Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 351:337-345, 2004
27. Baselga J, Trigo J, Bourhis J, et al: Cetuximab (C225) plus cisplatin/carboplatin is active in patients (pts) with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) progressing on a same dose and schedule platinum-based regimen. Proc Am Soc Clin Oncol 21:226, 2002 (abstr 900)
28. Trigo J, Hitt R, Koralewski P, et al: Cetuximab monotherapy is active in patients (pts) with platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN): Results of a phase II study. Proc Am Soc Clin Oncol 23:488, 2004 (abstr 5502)
29. Sun Y, Fry DW, Vincent P, et al: Growth inhibition of nasopharyngeal carcinoma cells by EGF receptor tyrosine kinase inhibitors. Anticancer Res 19:919-924, 1999
30. 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 92:205-216, 2000
31. Chan AT, Teo PM, Leung TW, et al: The role of chemotherapy in the management of nasopharyngeal carcinoma. Cancer 82:1003-1012, 1998
32. Airoldi M, Pedani F, Marchionatti S, et al: Carboplatin plus Taxol is an effective third-line regimen in recurrent undifferentiated nasopharyngeal carcinoma. Tumori 88:273-276, 2002
33. Chua DT, Sham JS, Au GK: A phase II study of capecitabine in patients with recurrent and metastatic nasopharyngeal carcinoma pretreated with platinum-based chemotherapy. Oral Oncol 39:361-366, 2003
34. Kies MS, Arquette MA, Nabell L, et al: Final report of the efficacy and safety of the anti-epidermal growth factor antibody Erbitux (IMC-C225), in combination with cisplatin in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN) refractory to cisplatin containing chemotherapy. Proc Am Soc Clin Oncol 21:232, 2002 (abstr 925)
35. Humblet Y, Vega-Villegas E, Mesia R, et al: Phase I study of cetuximab in combination with cisplatin or carboplatin and 5-fluorouracil (5-FU) in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Proc Am Soc Clin Oncol 23:491, 2004 (abstr 5513)
36. Burtness BA, Li Y, Flood W, et al: Phase III trial comparing cisplatin (C) + placebo (P) to C + anti-epidermal growth factor antibody (EGF-R) C225 in patients (pts) with metastatic/recurrent head and neck cancer (HNC). Proc Am Soc Clin Oncol 21:226, 2002 (abstr 901)
37. Bonner JA, Giralt J, Harari PM, et al: Cetuximab prolongs survival in patients with locoregionally advanced squamous cell carcinoma of head and neck: A phase III study of high dose radiation therapy with or without cetuximab. Proc Am Soc Clin Oncol 23:489, 2004 (abstr 5507)