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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ARTSCAN III : A randomized phase III study comparing chemoradiotherapy with cisplatin versus cetuximab in patients with locoregionally advanced head and neck squamous cell cancer

Gebre-Medhin, Maria (author): Lund University,Lunds universitet,Huvud- och halscancergruppen,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Head and Neck Cancer Research Group,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Skåne University Hospital

Brun, Eva (author): Lund University,Lunds universitet,Huvud- och halscancergruppen,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Head and Neck Cancer Research Group,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Skåne University Hospital

Engström, Per (author): Lund University,Lunds universitet,Radiotherapy Physics,Forskargrupper vid Lunds universitet,Lund University Research Groups,Skåne University Hospital

Haugen, Hedda, 1970 (author): Gothenburg University,Göteborgs universitet,University of Gothenburg,Sahlgrenska University Hospital,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology

Hammarstedt-Nordenvall, Lalle (author): Karolinska Institutet,Karolinska Institute,Karolinska University Hospital

Reizenstein, Johan (author): Örebro University Hospital

Nyman, Jan, 1956 (author): Gothenburg University,Göteborgs universitet,University of Gothenburg,Sahlgrenska University Hospital,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology

Abel, Edvard, 1970 (author): Gothenburg University,Göteborgs universitet,University of Gothenburg,Sahlgrenska University Hospital,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology

Friesland, Signe (author): Karolinska Institutet,Karolinska Institute,Karolinska University Hospital

Sjödin, Helena (author): Karolinska University Hospital

Carlsson, Henrik (author): Lund University,Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Strålterapi,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Radiation therapy,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital

Söderkvist, Karin (author): Umeå universitet,Umeå University,Onkologi

Thomasson, Marcus (author): Umeå universitet,Umeå University,Onkologi

Zackrisson, Björn (author): Umeå universitet,Umeå University,Onkologi

Nilsson, Per (author): Lund University,Lunds universitet,Radiotherapy Physics,Forskargrupper vid Lunds universitet,Lund University Research Groups,Skåne University Hospital

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American Society of Clinical Oncology, 2021
2021
English 10 s.
In: Journal of Clinical Oncology. - : American Society of Clinical Oncology. - 0732-183X .- 1527-7755. ; 39:1, s. 38-47

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Journal article (peer-reviewed)

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PURPOSE 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). MATERIALS AND METHODS Eligible patients were randomly assigned 1:1 to receive either intravenous cetuximab 400 mg/m2 1 week before start of RT followed by 250 mg/m2/wk, or weekly intravenous cisplatin 40 mg/m2, 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. RESULTS 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 5 .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 5 .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. CONCLUSION 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.

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By the author/editor: Gebre-Medhin, Ma ...; Brun, Eva; Engström, Per; Haugen, Hedda, 1 ...; Hammarstedt-Nord ...; Reizenstein, Joh ...; show more...; Nyman, Jan, 1956; Abel, Edvard, 19 ...; Friesland, Signe; Sjödin, Helena; Carlsson, Henrik; Söderkvist, Kari ...; Thomasson, Marcu ...; Zackrisson, Björ ...; Nilsson, Per; show less...

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Cancer and Oncol ...

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Radiology Nuclea ...

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By the university: Lund University; Umeå University; Karolinska Institutet; University of Gothenburg

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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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