A Randomized,Multicenter, Phase II Study of Cetuximab With Docetaxel and Cisplatin as Induction Chemotherapy in Unresectable,Locally Advanced Head and Neck Cancer |
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| Authors: | Sung‐Bae Kim Sang‐Won Shin Jin‐Hyoung Kang Hong‐Gyun Wu Myung‐Whun Sung Bhumsuk Keam Dong‐Wan Kim Tae Min Kim Kwang Hyun Kim Tack‐Kyun Kwon J Hun Hah In‐Ah Kim Soon‐Hyun Ahn Dok Hyun Yoon Sang‐Wook Lee Sang Yoon Kim Soon Yuhl Nam Kwang‐Yoon Jung Seung‐Kuk Baek Sook Hee Hong Se‐Hoon Lee Dae Seog Heo |
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| Institution: | 1. Departments of Oncology;2. Departments of Internal Medicine and;3. Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea;4. Radiation Oncology, and;5. Otorhinolaryngology‐Head and Neck Surgery, Seoul National University Hospital, and;6. Departments of Internal Medicine;7. Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea;8. Otorhinolaryngology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea;9. Otolaryngology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea;10. Otorhinolaryngology‐Head and Neck Surgery, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea |
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| Abstract: | Lessons Learned- Addition 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. |
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