Open AccessA Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer
Author(s) -
Lee KeunWook,
Koh Youngil,
Kim SungBae,
Shin SangWon,
Kang JinHyoung,
Wu HongGyun,
Sung MyungWhun,
Keam Bhumsuk,
Kim DongWan,
Kim Tae Min,
Kim Kwang Hyun,
Kwon TackKyun,
Hah J. Hun,
Kim InAh,
Ahn SoonHyun,
Yoon Dok Hyun,
Lee SangWook,
Kim Sang Yoon,
Nam Soon Yuhl,
Jung KwangYoon,
Baek SeungKuk,
Hong Sook Hee,
Lee SeHoon,
Heo Dae Seog
Publication year - 2015
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2015-0208
Subject(s) - cetuximab , medicine , docetaxel , induction chemotherapy , oncology , regimen , chemotherapy , head and neck cancer , cisplatin , clinical endpoint , chemotherapy regimen , head and neck squamous cell carcinoma , phases of clinical research , chemoradiotherapy , cancer , randomized controlled trial , colorectal cancer
Lessons LearnedAddition of cetuximab may affect tolerability and, in turn, affect eventual outcomes. The incidence of prior human papillomavirus infection has emerged as an important variable that can confound trials enrolling patients with oropharyngeal cancer.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. Conclusion. 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.