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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 LU ; Brun, Eva LU ; Engström, Per LU ; Cange, Hedda Haugen ; Hammarstedt-Nordenvall, Lalle ; Reizenstein, Johan ; Nyman, Jan ; Abel, Edvard ; Friesland, Signe and Sjödin, Helena , et al. (2021) In Journal of Clinical Oncology 39(1). p.38-47
Abstract

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... (More)

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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publishing date
type
Contribution to journal
publication status
published
subject
in
Journal of Clinical Oncology
volume
39
issue
1
pages
10 pages
publisher
Lippincott Williams & Wilkins
external identifiers
  • pmid:33052757
  • scopus:85098325330
ISSN
0732-183X
DOI
10.1200/JCO.20.02072
language
English
LU publication?
yes
id
c6ed7cc0-1f33-4645-baeb-aedd286465fd
date added to LUP
2021-01-05 08:43:09
date last changed
2025-04-18 09:20:45
@article{c6ed7cc0-1f33-4645-baeb-aedd286465fd,
  abstract     = {{<p>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/m<sup>2</sup> 1 week before start of RT followed by 250 mg/m<sup>2</sup>/wk, or weekly intravenous cisplatin 40 mg/m<sup>2</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. 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.</p>}},
  author       = {{Gebre-Medhin, Maria and Brun, Eva and Engström, Per and Cange, Hedda Haugen and Hammarstedt-Nordenvall, Lalle and Reizenstein, Johan and Nyman, Jan and Abel, Edvard and Friesland, Signe and Sjödin, Helena and Carlsson, Henrik and Söderkvist, Karin and Thomasson, Marcus and Zackrisson, Björn and Nilsson, Per}},
  issn         = {{0732-183X}},
  language     = {{eng}},
  number       = {{1}},
  pages        = {{38--47}},
  publisher    = {{Lippincott Williams & Wilkins}},
  series       = {{Journal of Clinical Oncology}},
  title        = {{ARTSCAN III : A randomized phase III study comparing chemoradiotherapy with cisplatin versus cetuximab in patients with locoregionally advanced head and neck squamous cell cancer}},
  url          = {{http://dx.doi.org/10.1200/JCO.20.02072}},
  doi          = {{10.1200/JCO.20.02072}},
  volume       = {{39}},
  year         = {{2021}},
}