title: Phase II study evaluating the addition of cetuximab to the concurrent delivery of weekly carboplatin, paclitaxel, and daily radiotherapy for patients with locally advanced squamous cell carcinomas of the head and neck.
abstract: OBJECTIVE
  To report the mature data of a prospective Phase II trial designed to evaluate the efficacy of an epidermal growth factor receptor inhibitor cetuximab (CTX) added to the concurrent therapy of weekly paclitaxel/carboplatin (PC) and daily radiation therapy (RT).
  
  
  METHODS
  From 2005 to 2009, a total of 43 patients were enrolled in the study. The median follow-up was 31 months (range, 9-59 months). All patients had Stage III/IV disease at presentation, and 67% had oropharyngeal primaries. The weekly IV dose schedules were CTX 250 mg/m(2) (400 mg/m(2) IV loading dose 1 week before RT), paclitaxel 40 mg/m(2), and carboplatin AUC 2. RT was given at 1.8 Gy per day to 70.2 Gy. Intensity-modulated RT was used in 70% of cases.
  
  
  RESULTS
  All patients completed the planned RT dose, 74% without any treatment breaks. The planned CTX and PC cycles were completed in 70% (91% with at least seven of planned nine cycles) and 56% (93% with at least seven of planned eight cycles) of patients, respectively. Toxicity included Grade 3 mucositis (79%), rash (9%), leucopenia (19%), neutropenia (19%), and RT dermatitis (16%). The complete response (CR) rate at the completion of therapy was 84%. The estimated 3-year local regional control rate was 72%. Six patients with an initial CR subsequently experienced a local recurrence, 10 patients experienced distant progression. The median overall survival and disease-free survivals have not been reached. The 3-year actuarial overall survival and disease-free survival were 59% and 58%, respectively.
  
  
  CONCLUSIONS
  The addition of CTX to weekly PC and daily RT was well tolerated and resulted in encouraging local control and survival rates.
authors: Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD, USA. msuntha@umm.edu
authors: Mohan
authors: M
authors: Suntharalingam
authors: Young
authors: Y
authors: Kwok
authors: Olga
authors: O
authors: Goloubeva
authors: Arti
authors: A
authors: Parekh
authors: Rodney
authors: R
authors: Taylor
authors: Jeffrey
authors: J
authors: Wolf
authors: Ann
authors: A
authors: Zimrin
authors: Scott
authors: S
authors: Strome
authors: Robert
authors: R
authors: Ord
authors: Kevin J
authors: KJ
authors: Cullen
references: Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):966-71
references: 14967457
references: J Clin Oncol. 2004 Jan 1;22(1):69-76
references: 14657228
references: J Natl Cancer Inst. 2008 Feb 20;100(4):261-9
references: 18270337
references: Int J Radiat Oncol Biol Phys. 2000 Aug 1;48(1):7-16
references: 10924966
references: J Natl Cancer Inst. 1999 Dec 15;91(24):2081-6
references: 10601378
references: N Engl J Med. 2007 May 10;356(19):1944-56
references: 17494927
references: Clin Cancer Res. 2000 Feb;6(2):701-8
references: 10690556
references: Eur J Cancer. 2001 Sep;37 Suppl 4:S16-22
references: 11597400
references: Lancet Oncol. 2010 Jan;11(1):21-8
references: 19897418
references: N Engl J Med. 2003 Nov 27;349(22):2091-8
references: 14645636
references: Int J Radiat Oncol Biol Phys. 2000 Apr 1;47(1):49-56
references: 10758304
references: J Clin Oncol. 2006 Mar 1;24(7):1072-8
references: 16505426
references: N Engl J Med. 2010 Jul 1;363(1):24-35
references: 20530316
references: Lancet. 2000 Mar 18;355(9208):949-55
references: 10768432
references: N Engl J Med. 2006 Feb 9;354(6):567-78
references: 16467544
references: Radiother Oncol. 2009 Jul;92(1):4-14
references: 19446902
references: Am J Clin Oncol. 2010 Apr;33(2):144-7
references: 19786848