ARTSCAN III: A Randomized Phase III Study Comparing Chemoradiotherapy With Cisplatin Versus Cetuximab in Patients With Locoregionally Advanced Head and Neck Squamous Cell Cancer
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- Maria Gebre-Medhin
- Department of Hematology, Oncology, and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden
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- Eva Brun
- Department of Hematology, Oncology, and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden
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- Per Engström
- Department of Hematology, Oncology, and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden
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- Hedda Haugen Cange
- Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden
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- Lalle Hammarstedt-Nordenvall
- Division of Ear, Nose, and Throat Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden
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- Johan Reizenstein
- Department of Oncology, Örebro University Hospital, Örebro, Sweden
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- Jan Nyman
- Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden
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- Edvard Abel
- Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden
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- Signe Friesland
- Theme Cancer, Karolinska University Hospital, Stockholm, Sweden
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- Helena Sjödin
- Theme Cancer, Karolinska University Hospital, Stockholm, Sweden
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- Henrik Carlsson
- Department of Hematology, Oncology, and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden
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- Karin Söderkvist
- Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden
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- Marcus Thomasson
- Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden
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- Björn Zackrisson
- Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden
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- Per Nilsson
- Department of Hematology, Oncology, and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden
Description
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> We performed an open-label randomized controlled phase III study comparing treatment outcome and toxicity between radiotherapy (RT) with concomitant cisplatin versus concomitant cetuximab in patients with locoregionally advanced head and neck squamous cell carcinoma (HNSCC; stage III-IV according to the Union for International Cancer Control TNM classification, 7th edition). </jats:p></jats:sec><jats:sec><jats:title>MATERIALS AND METHODS</jats:title><jats:p> Eligible patients were randomly assigned 1:1 to receive either intravenous cetuximab 400 mg/m<jats:sup>2</jats:sup> 1 week before start of RT followed by 250 mg/m<jats:sup>2</jats:sup>/wk, or weekly intravenous cisplatin 40 mg/m<jats:sup>2</jats:sup>, during RT. RT was conventionally fractionated. Patients with T3-T4 tumors underwent a second random assignment 1:1 between standard RT dose 68.0 Gy to the primary tumor or dose escalation to 73.1 Gy. Primary end point was overall survival (OS) evaluated using adjusted Cox regression analysis. Secondary end points were locoregional control, local control with dose-escalated RT, pattern of failure, and adverse effects. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> Study inclusion was prematurely closed after an unplanned interim analysis when 298 patients had been randomly assigned. At 3 years, OS was 88% (95% CI, 83% to 94%) and 78% (95% CI, 71% to 85%) in the cisplatin and cetuximab groups, respectively (adjusted hazard ratio, 1.63; 95% CI, 0.93 to 2.86; P = .086). The cumulative incidence of locoregional failures at 3 years was 23% (95% CI, 16% to 31%) compared with 9% (95% CI, 4% to 14%) in the cetuximab versus the cisplatin group (Gray’s test P = .0036). The cumulative incidence of distant failures did not differ between the treatment groups. Dose escalation in T3-T4 tumors did not increase local control. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> Cetuximab is inferior to cisplatin regarding locoregional control for concomitant treatment with RT in patients with locoregionally advanced HNSCC. Additional studies are needed to identify possible subgroups that still may benefit from concomitant cetuximab treatment. </jats:p></jats:sec>
Journal
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 39 (1), 38-47, 2021-01-01
American Society of Clinical Oncology (ASCO)
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Details 詳細情報について
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- CRID
- 1360861709543574912
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- ISSN
- 15277755
- 0732183X
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- Data Source
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- Crossref