Panitumumab plus radiotherapy versus chemoradiotherapy in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-2): A randomised, controlled, open-label phase 2 trial

The Lancet Oncology

Volumn 16, Issue 2, 2015, Pages 221-232

  Giralt, Jordi ^a,b   Trigo, Jose ^c   Nuyts, Sandra ^d   Ozsahin, Mahmut ^e   Skladowski, Krzysztof ^f   Hatoum, Georges ^g   Daisne, Jean Francois ^h   Yunes Ancona, Alejandro César ⁱ   Cmelak, Anthony ^j   Mesía, Ricard ^k   Zhang, Alicia ^l   Oliner, Kelly S ^l   VanderWalde, Ari ^l  

^a HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^b UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^c HOSPITAL UNIVERSITARIO VIRGEN DE LA VICTORIA   (Spain)

^d UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^e LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^f INSTITUTE OF ONCOLOGY   (Poland)

^g UNIVERSITY OF MIAMI   (United States)

^h Clinique & Maternite Sainte Elisabeth Namer   (Belgium)

ⁱ Unidad de Oncologia y Servicios de Salud del Estado de Puebla   (Mexico)

^j VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^k CATALAN INSTITUTE OF ONCOLOGY   (Spain)

^l AMGEN INC   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CISPLATIN; PANITUMUMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ACNE; ADULT; AGED; AGEUSIA; ALCOHOL INTOXICATION; ANEMIA; APHAGIA; APHONIA; ARTICLE; ASTHENIA; BLEEDING; CANCER COMBINATION CHEMOTHERAPY; CANCER CONTROL; CANCER GRADING; CANCER PAIN; CANCER RADIOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CHEMORADIOTHERAPY; COMPARATIVE EFFECTIVENESS; CONFUSION; CONSTIPATION; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DEEP VEIN THROMBOSIS; DEHYDRATION; DELIRIUM; DERMATITIS; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG WITHDRAWAL; DYSGEUSIA; DYSPHAGIA; DYSPHONIA; DYSPNEA; EDEMA; ENDOCARDITIS; ERYTHEMA; ESOPHAGITIS; FACE EDEMA; FACE PAIN; FAINTNESS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; GLOSSODYNIA; HEAD AND NECK SQUAMOUS CELL CARCINOMA; HEADACHE; HEART INFARCTION; HEART LEFT VENTRICLE FAILURE; HERPES ZOSTER; HUMAN; HUMAN TISSUE; HYPERBILIRUBINEMIA; HYPERTENSION; HYPOALBUMINEMIA; HYPOGLYCEMIA; HYPOKALEMIA; HYPONATREMIA; INFECTION; INTERMETHOD COMPARISON; JAW PAIN; KIDNEY FAILURE; LEUKOCYTOCLASTIC VASCULITIS; LEUKOPENIA; LOWER RESPIRATORY TRACT INFECTION; MAJOR CLINICAL STUDY; MALE; MOLECULARLY TARGETED THERAPY; MOUTH PAIN; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NAUSEA; NECK PAIN; NEURALGIA; NEUTROPENIA; ODYNOPHAGIA; OROPHARYNGITIS; OROPHARYNX PAIN; OVERALL SURVIVAL; PHARYNGITIS; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PROGRESSION FREE SURVIVAL; PROSTATE HYPERTROPHY; PRURITUS; PULMONARY HYPERTENSION; RADIATION DOSE; RADIATION DOSE FRACTIONATION; RADIATION FIELD; RADIATION INJURY; RADIATION MUCOSITIS; RADIATION SKIN INJURY; RANDOMIZED CONTROLLED TRIAL; RASH; RESPIRATORY FAILURE; RESPIRATORY TRACT INFECTION; RESTLESSNESS; RISK BENEFIT ANALYSIS; ROSACEA; SEPTIC SHOCK; SKIN INFECTION; SKIN MANIFESTATION; STAPHYLOCOCCUS INFECTION; STOMACH PERFORATION; STOMATITIS; STRIDOR; THROMBOCYTOPENIA; THRUSH; TOOTH ABSCESS; UNSPECIFIED SIDE EFFECT; URTICARIA; VOMITING; XEROSTOMIA; ADOLESCENT; CLINICAL TRIAL; COMPARATIVE STUDY; FOLLOW UP; HEAD AND NECK NEOPLASMS; INTERNATIONAL COOPERATION; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; NEOPLASMS, SQUAMOUS CELL; PATHOLOGY; PROGNOSIS; SURVIVAL RATE; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHEMORADIOTHERAPY; CISPLATIN; DOSE FRACTIONATION; FEMALE; FOLLOW-UP STUDIES; HEAD AND NECK NEOPLASMS; HUMANS; INTERNATIONAL AGENCIES; MALE; MIDDLE AGED; NEOPLASM STAGING; NEOPLASMS, SQUAMOUS CELL; PROGNOSIS; SURVIVAL RATE; YOUNG ADULT;

EID: 84921885267     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(14)71200-8     Document Type: Article

References (17)

1. Vermorken JB, Mesia R, Rivera F, et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med 2008, 359:1116-1127.
2. 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.
3. Bonner JA, Harari PM, Giralt J, et al. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol 2010, 11:21-28.
4. Pignon JP, Bourhis J, Domenge C, Designe L Chemotherapy added to locoregional treatment for head and neck squamous-cell carcinoma: three meta-analyses of updated individual data. Lancet 2000, 355:949-955. for the MACH-NC Collaborative Group.
5. Ang KK, Zhang QE, Rosenthal DI, et al. A randomized phase III trial (RTOG 0522) of concurrent accelerated radiation plus cisplatin with or without cetuximab for stage III-IV head and neck squamous cell carcinomas (HNC). Proc Am Soc Clin Oncol 2011, 29(suppl):5500. (abstr).
6. Mesía R, Henke M, Fortin A, et al. Chemoradiotherapy with or without panitumumab in patients with unresected, locally advanced squamous-cell carcinoma of the head and neck (CONCERT-1): a randomised, controlled, open-label, phase 2 trial. Lancet Oncol 2015, http://dx.doi.org/10.1016/S1470-2045(14)71198-2.
7. Vermorken JB, Stöhlmacher-Williams J, Davidenko I, et al. Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial. Lancet Oncol 2013, 14:697-710. for the SPECTRUM investigators.
8. Kruser TJ, Armstrong EA, Ghia AJ, et al. Augmentation of radiation response by panitumumab in models of upper aerodigestive tract cancer. Int J Radiat Oncol Biol Phys 2008, 72:534-542.
9. Brittain E, Schlesselman JJ Optimal allocation for the comparison of proportions. Biometrics 1982, 38:1003-1009.
10. Ang KK, Harris J, Wheeler R, et al. Human papillomavirus and survival of patients with oropharyngeal cancer. N Engl J Med 2010, 363:24-35.
11. Pignon JP, le Maitre A, Maillard E, Bourhis J Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol 2009, 92:4-14.
12. Gregoire V, Lefebvre JL, Licitra L, Felip E Squamous cell carcinoma of the head and neck: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2010, 21(suppl 5):v184-v186.
13. Adelstein DJ, Li Y, Adams GL, et al. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol 2003, 21:92-98.
14. Rischin D, Peters LJ, O'Sullivan B, et al. Tirapazamine, cisplatin, and radiation versus cisplatin and radiation for advanced squamous cell carcinoma of the head and neck (TROG 02.02, HeadSTART): a phase III trial of the Trans-Tasman Radiation Oncology Group. J Clin Oncol 2010, 28:2989-2995.
15. Bourhis J, Sire C, Graff P, et al. Concomitant chemoradiotherapy versus acceleration of radiotherapy with or without concomitant chemotherapy in locally advanced head and neck carcinoma (GORTEC 99-02): an open-label phase 3 randomised trial. Lancet Oncol 2012, 13:145-153.
16. Yang BB, Lum P, Chen A, et al. Pharmacokinetic and pharmacodynamic perspectives on the clinical drug development of panitumumab. Clin Pharmacokinet 2010, 49:729-740.
17. Lefebvre JL, Pointreau Y, Rolland F, et al. Induction chemotherapy followed by either chemoradiotherapy or bioradiotherapy for larynx preservation: the TREMPLIN randomized phase II study. J Clin Oncol 2013, 31:853-859.