title: A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer.
abstract: BACKGROUND
  We investigated the efficacy of cetuximab when added to induction chemotherapy followed by concurrent chemoradiotherapy (CCRT) in patients with locally advanced head and neck squamous cell carcinoma.
  
  
  METHODS
  Patients were randomized to receive three cycles of docetaxel and cisplatin (TP regimen) with or without cetuximab (TP plus cetuximab [CTP] vs. TP) as induction chemotherapy. Patients in the CTP arm received CCRT with cetuximab and cisplatin, whereas patients in the TP arm received cisplatin alone. The primary endpoint was the objective response rate (ORR) after induction chemotherapy.
  
  
  RESULTS
  Overall, 92 patients were enrolled. The ORRs for induction chemotherapy in the CTP and TP arms were not different (81% vs. 82%). Adding cetuximab lowered the completion rate of induction chemotherapy and CCRT and resulted in more frequent dose reductions of the induction chemotherapy, although this did not reach statistical significance. In the CTP and TP arms, respectively, the 3-year progression-free survival (PFS) rates were 70% and 56% (p = .359), and the overall survival (OS) rates were 88% and 74% (p = .313). When limited to patients who completed induction chemotherapy, 3-year PFS rates of 78% and 59% (p = .085) and OS rates of 94% and 73% (p = .045) were observed in the CTP and TP arms, respectively.
  
  
  CONCLUSIONS
  Adding cetuximab to sequential treatment did not increase the treatment efficacy and resulted in greater toxicity. In the intent-to-treat population, neither PFS nor OS was improved by the addition of cetuximab to sequential treatment; however, a suggestion of improved survival outcomes was observed in patients completing cetuximab-containing induction chemotherapy.
authors: Departments of Internal Medicine, sehoon.lee119@gmail.com.
authors: Keun-Wook
authors: KW
authors: Lee
authors: Departments of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea;
authors: Youngil
authors: Y
authors: Koh
authors: Departments of Oncology.
authors: Sung-Bae
authors: SB
authors: Kim
authors: Departments of Internal Medicine and.
authors: Sang-Won
authors: SW
authors: Shin
authors: Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
authors: Jin-Hyoung
authors: JH
authors: Kang
authors: Radiation Oncology, and.
authors: Hong-Gyun
authors: HG
authors: Wu
authors: Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, and.
authors: Myung-Whun
authors: MW
authors: Sung
authors: Departments of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea;
authors: Bhumsuk
authors: B
authors: Keam
authors: Departments of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea;
authors: Dong-Wan
authors: DW
authors: Kim
authors: Departments of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea;
authors: Tae Min
authors: TM
authors: Kim
authors: Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, and.
authors: Kwang Hyun
authors: KH
authors: Kim
authors: Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, and.
authors: Tack-Kyun
authors: TK
authors: Kwon
authors: Otorhinolaryngology-Head and Neck Surgery, Seoul National University Hospital, and.
authors: J Hun
authors: JH
authors: Hah
authors: Radiation Oncology, and.
authors: In-Ah
authors: IA
authors: Kim
authors: Otorhinolaryngology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea;
authors: Soon-Hyun
authors: SH
authors: Ahn
authors: Departments of Oncology.
authors: Dok Hyun
authors: DH
authors: Yoon
authors: Radiation Oncology, and.
authors: Sang-Wook
authors: SW
authors: Lee
authors: Otolaryngology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea;
authors: Sang Yoon
authors: SY
authors: Kim
authors: Otolaryngology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea;
authors: Soon Yuhl
authors: SY
authors: Nam
authors: Otorhinolaryngology-Head and Neck Surgery, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea;
authors: Kwang-Yoon
authors: KY
authors: Jung
authors: Otorhinolaryngology-Head and Neck Surgery, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea;
authors: Seung-Kuk
authors: SK
authors: Baek
authors: Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
authors: Sook Hee
authors: SH
authors: Hong
authors: Departments of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea; sehoon.lee119@gmail.com.
authors: Se-Hoon
authors: SH
authors: Lee
authors: Departments of Internal Medicine, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea;
authors: Dae Seog
authors: DS
authors: Heo
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068818:Cetuximab / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D006801:Humans; D060828:Induction Chemotherapy / Q000009:adverse effects / Q000379:methods*; D008297:Male; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000068818:Cetuximab