Cancer Reports (May 2023)

First‐line cetuximab + platinum‐based therapy for recurrent/metastatic head and neck squamous cell carcinoma: A real‐world observational study—ENCORE

  • Christophe Le Tourneau,
  • Massimo Ghiani,
  • Maria Chiara Cau,
  • Roberta Depenni,
  • Graziana Ronzino,
  • Pierluigi Bonomo,
  • Vincenzo Montesarchio,
  • Luigi Leo,
  • Jeltje Schulten,
  • Satu Salmio,
  • Diethelm Messinger,
  • Andrea Sbrana,
  • Edith Borcoman,
  • Maria Grazia Ghi

DOI
https://doi.org/10.1002/cnr2.1804
Journal volume & issue
Vol. 6, no. 5
pp. n/a – n/a

Abstract

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Abstract Background ENCORE, an observational, prospective, open‐label study, investigated real‐world treatment practices and outcomes with cetuximab plus platinum‐based therapy (PBT) in first‐line (1L) recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). Aims This multinational study aimed to investigate the long‐term use of cetuximab plus PBT for 1L R/M SCCHN in a clinical setting. In particular, this study aimed to explore clinical considerations such as the decision to prescribe cetuximab plus PBT in R/M SCCHN, the mode and duration of treatment, and patient outcomes. Methods and Results Previously untreated patients with R/M SCCHN whose planned treatment was cetuximab plus PBT were enrolled from 6 countries. Among 221 evaluable patients, planned treatments included cetuximab plus carboplatin (31.2%), cisplatin plus 5‐fluorouracil (31.7%), or carboplatin plus 5‐fluorouracil (23.1%); 3.2% included a taxane, and 45.2% did not include 5‐fluorouracil. Cetuximab treatment was planned for a fixed duration (≤24 weeks) in 15 patients (6.8%) and until disease progression in 206 (93.2%). Median progression‐free survival and overall survival were 6.5 and 10.8 months, respectively. Grade ≥3 adverse events occurred in 39.8% of patients. Serious adverse events occurred in 25.8% of patients; 5.4% were cetuximab‐related. Conclusion In patients with R/M SCCHN, first‐line cetuximab plus PBT was feasible and modifiable in a real‐world setting with similar toxicity and efficacy as in the pivotal phase III EXTREME trial. Clinical trial registration number: EMR 062202‐566.

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