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

Cited 15 time in Web of Science Cited 13 time in Scopus
Authors
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; Kim, 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, Sook Hee; Lee, Se-Hoon; Heo, Dae Seog
Issue Date
2015-10
Citation
Oncologist, Vol.20 No.10, pp.1119-1120
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. 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.
ISSN
1083-7159
URI
http://hdl.handle.net/10371/165348
DOI
https://doi.org/10.1634/theoncologist.2015-0208
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College of Medicine/School of Medicine (의과대학/대학원)Cancer Research Institute (암연구소)Journal Papers (저널논문_암연구소)
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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