Cetuximab plus cisplatin-5-fluorouracil versus cisplatin-5-fluorouracil alone in first-line metastatic squamous cell carcinoma of the esophagus: A randomized phase II study of the Arbeitsgemeinschaft Internistische Onkologie

Annals of Oncology

Volumn 20, Issue 10, 2009, Pages 1667-1673

  Lorenzen, S ^a   Schuster, T ^a   Porschen, R ^b   Al Batran, S E ^c   Hofheinz, R ^d   Thuss Patience, P ^e   Moehler, M ^f   Grabowski, P ^e   Arnold, D ^g   Greten, T ^h   Muller L ⁱ   Rothling N ^j   Peschel, C ^a   Langer, R ^a   Lordick, Florian ^k  

^a TECHNICAL UNIVERSITY OF MUNICH   (Germany)

^b Bremen Ost Hospital   (Germany)

^c KRANKENHAUS NORDWEST   (Germany)

^d UNIVERSITY OF HEIDELBERG   (Germany)

^e CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^f JOHANNES GUTENBERG UNIVERSITY   (Germany)

^g MARTIN LUTHER UNIVERSITY HALLE WITTENBERG   (Germany)

^h HANNOVER MEDICAL SCHOOL   (Germany)

ⁱ Oncological Main Focus Practice   (Germany)

^j Munich Centre for Clinical Studies   (Germany)

^k UNIVERSITY OF HEIDELBERG   (Germany)

more..

Author keywords

Cetuximab; Chemotherapy; Esophageal cancer; KRAS mutation; Squamous cell carcinoma

Indexed keywords

CETUXIMAB; CISPLATIN; FLUOROURACIL; IRINOTECAN; K RAS PROTEIN; PLATINUM COMPLEX; TAXANE DERIVATIVE;

ACNE; ADULT; ADVANCED CANCER; AGED; ANAPHYLACTIC SHOCK; ANAPHYLAXIS; ARTICLE; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CANCER CONTROL; CANCER SURVIVAL; CHILL; CLINICAL TRIAL; CODON; COLORECTAL CANCER; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; ESOPHAGEAL SQUAMOUS CELL CARCINOMA; FATIGUE; FEMALE; FEVER; GENE MUTATION; HAND FOOT SYNDROME; HUMAN; HUMAN CELL; HUMAN TISSUE; KIDNEY DYSFUNCTION; MAJOR CLINICAL STUDY; MALE; METASTASIS; MONOTHERAPY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUTATIONAL ANALYSIS; NAUSEA; NEPHROTOXICITY; NEUTROPENIA; NEUTROPHIL; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RASH; SENSORY NEUROPATHY; SEPTICEMIA; SIDE EFFECT; THROMBOCYTE; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, SQUAMOUS CELL; CISPLATIN; COMBINED MODALITY THERAPY; CROSS-OVER STUDIES; DIARRHEA; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; ESOPHAGEAL NEOPLASMS; FEMALE; FLUOROURACIL; FOLLOW-UP STUDIES; HUMANS; KAPLAN-MEIER ESTIMATE; MALE; MIDDLE AGED; NAUSEA; NEUTROPENIA; SURVIVAL ANALYSIS; TIME FACTORS; TREATMENT OUTCOME;

EID: 70349641356     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdp069     Document Type: Article

References (28)

1. Bleiberg H, Conroy T, Paillot B et al. Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell oesophageal cancer. Eur J Cancer 1997; 33: 1216-1220.
2. Ilson DH, Kelsen DP. Management of esophageal cancer. Oncology (Williston Park) 1996; 10: 1385-1396, 1401-1402; discussion 1402-1408.
3. Polee MB, Kok TC, Siersema PD et al. Phase II study of the combination cisplatin, etoposide, 5-fluorouracil and folinic acid in patients with advanced squamous cell carcinoma of the esophagus. Anticancer Drugs 2001; 12: 513-517.
4. Hanawa M, Suzuki S, Dobashi Y et al. EGFR protein overexpression and gene amplification in squamous cell carcinomas of the esophagus. Int J Cancer 2006; 118: 1173-1180.
5. Gibault L, Metges JP, Conan-Charlet V et al. Diffuse EGFR staining is associated with reduced overall survival in locally advanced oesophageal squamous cell cancer. Br J Cancer 2005; 93: 107-115.
6. Wang KL, Wu TT, Choi IS et al. Expression of epidermal growth factor receptor in esophageal and esophagogastric junction adenocarcinomas: association with poor outcome. Cancer 2007; 109: 658-667.
7. Ozawa S, Ueda M, Ando N et al. Prognostic significance of epidermal growth factor receptor in esophageal squamous cell carcinomas. Cancer 1989; 63: 2169-2173.
8. Lemmon MA, Bu Z, Ladbury JE et al. Two EGF molecules contribute additively to stabilization of the EGFR dimer. EMBO J 1997; 16: 281-294.
9. Gibson AD, Lamerdin JA, Zhuang P et al. Orientation of heparin-binding sites in native vitronectin. Analyses of ligand binding to the primary glycosaminoglycan-binding site indicate that putative secondary sites are not functional. J Biol Chem 1999; 274: 6432-6442.
10. Fan Z, Baselga J, Masui H, Mendelsohn J. Antitumor effect of anti-epidermal growth factor receptor monoclonal antibodies plus cis-diamminedichloroplatinum on well established A431 cell xenografts. Cancer Res 1993; 53: 4637-4642.
11. Baselga J, Norton L, Masui H et al. Antitumor effects of doxorubicin in combination with anti-epidermal growth factor receptor monoclonal antibodies. J Natl Cancer Inst 1993; 85: 1327-1333.
12. Cunningham D, Humblet Y, Siena S et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 2004; 351: 337-345.
13. Butts CA, Bodkin D, Middleman EL et al. Randomized phase II study of gemcitabine plus cisplatin, 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.
14. Burtness B, Goldwasser MA, Flood W et al. 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 2005; 23: 8646-8654.
15. Baselga J, Trigo JM, Bourhis J et al. Phase II multicenter study of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with platinum-refractory metastatic and/or recurrent squamous cell carcinoma of the head and neck. J Clin Oncol 2005; 23: 5568-5577.
16. Herbst RS, Arquette M, Shin DM et al. Phase II multicenter study of the epidermal growth factor receptor antibody cetuximab and cisplatin for recurrent and refractory squamous cell carcinoma of the head and neck. J Clin Oncol 2005; 23: 5578-5587.
17. Vermorken JB, Trigo J, Hitt R et al. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol 2007; 25: 2171-2177.
18. Bonner JA, Harari PM, Giralt J et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med 2006; 354: 567-578.
19. Brink M, de Goeij AF, Weijenberg MP et al. K-ras oncogene mutations in sporadic colorectal cancer in The Netherlands Cohort Study. Carcinogenesis 2003; 24: 703-710.
20. Xiong HQ, Rosenberg A, LoBuglio A et al. Cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor, in combination with gemcitabine for advanced pancreatic cancer: A multicenter phase II trial. J Clin Oncol 2004; 22: 2610-2616.
21. Ilson DH, Saltz L, Enzinger P et al. Phase II trial of weekly irinotecan plus cisplatin in advanced esophageal cancer. J Clin Oncol 1999; 17: 3270-3275.
22. Ilson DH, Ajani J, Bhalla K et al. Phase II trial of paclitaxel, fluorouracil, and cisplatin in patients with advanced carcinoma of the esophagus. J Clin Oncol 1998; 16: 1826-1834.
23. Zhang X, Shen L, Li J et al. A phase II trial of paclitaxel and cisplatin in patients with advanced squamous-cell carcinoma of the esophagus. Am J Clin Oncol 2008; 31: 29-33.
24. Lee J, Im YH, Cho EY et al. A phase II study of capecitabine and cisplatin (XP) as first-line chemotherapy in patients with advanced esophageal squamous cell carcinoma. Cancer Chemother Pharmacol 2008; 62: 77-84.
25. Taylor JM, Braun TM, Li Z. Comparing an experimental agent to a standard agent: Relative merits of a one-arm or randomized two-arm phase II design. Clin Trials 2006; 3: 335-348.
26. Massarelli E, Varella-Garcia M, Tang X et al. KRAS mutation is an important predictor of resistance to therapy with epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer. Clin Cancer Res 2007; 13: 2890-2896.
27. Janmaat ML, Gallegos-Ruiz MI, Rodriguez JA et al. Predictive factors for outcome in a phase II study of gefitinib in second-line treatment of advanced esophageal cancer patients. J Clin Oncol 2006; 24: 1612-1619.
28. Lievre A, Bachet JB, Boige V et al. KRAS mutations as an independent prognostic factor in patients with advanced colorectal cancer treated with cetuximab. J Clin Oncol 2008; 26: 374-379.