A Randomized, Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Cancer

作者：Lee Keun Wook; Koh Youngil; Kim Sung Bae; Shin Sang Won; Kang Jin Hyoung; Wu Hong Gyun; Sung Myung Whun; Keam Bhumsuk; Kim Dong Wan; Kim Tae Min; Km Kwang Hyun; Kwon Tack Kyun; Hah J Hun; Kim In Ah; Ahn Soon Hyun; Yoon Dok Hyun; Lee Sang Wook; Kim Sang Yoon; Nam Soon Yuhl; Jung Kwang Yoon; Baek Seung Kuk; Hong Sock Hee; Lee Se Hoon^*; Heo Dae Seog

来源：Oncologist, 2015, 20(10): 1119-1120.

DOI：10.1634/theoncologist.2015-0208

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.

• 出版日期2015-10