Article ; Online: First-line cetuximab + platinum-based therapy for recurrent/metastatic head and neck squamous cell carcinoma: A real-world observational study-ENCORE.
Cancer reports (Hoboken, N.J.)
2023 Volume 6, Issue 5, Page(s) e1804
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 ... ...
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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MeSH term(s) | Humans ; Cetuximab/adverse effects ; Squamous Cell Carcinoma of Head and Neck/drug therapy ; Platinum/therapeutic use ; Carboplatin ; Prospective Studies ; Neoplasm Recurrence, Local/pathology ; Head and Neck Neoplasms/drug therapy ; Fluorouracil ; Cisplatin |
Chemical Substances | Cetuximab (PQX0D8J21J) ; Platinum (49DFR088MY) ; Carboplatin (BG3F62OND5) ; Fluorouracil (U3P01618RT) ; Cisplatin (Q20Q21Q62J) |
Language | English |
Publishing date | 2023-04-17 |
Publishing country | United States |
Document type | Observational Study ; Journal Article ; Research Support, Non-U.S. Gov't |
ISSN | 2573-8348 |
ISSN (online) | 2573-8348 |
DOI | 10.1002/cnr2.1804 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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