First‐line cetuximab + platinum‐based therapy for recurrent/metastatic head and neck squamous cell carcinoma: A real‐world observational study—ENCORE
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 mu...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2023-05-01
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| Series: | Cancer Reports |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/cnr2.1804 |
| _version_ | 1797829535550406656 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Christophe Le Tourneau |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T13:22:33Z |
| format | Article |
| id | doaj.art-2aac3541984b4cb79407e47c1b6ba1ae |
| institution | Directory Open Access Journal |
| issn | 2573-8348 |
| language | English |
| last_indexed | 2024-04-09T13:22:33Z |
| publishDate | 2023-05-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Reports |
| spelling | doaj.art-2aac3541984b4cb79407e47c1b6ba1ae2023-05-11T02:44:36ZengWileyCancer Reports2573-83482023-05-0165n/an/a10.1002/cnr2.1804First‐line cetuximab + platinum‐based therapy for recurrent/metastatic head and neck squamous cell carcinoma: A real‐world observational study—ENCOREChristophe Le Tourneau0Massimo Ghiani1Maria Chiara Cau2Roberta Depenni3Graziana Ronzino4Pierluigi Bonomo5Vincenzo Montesarchio6Luigi Leo7Jeltje Schulten8Satu Salmio9Diethelm Messinger10Andrea Sbrana11Edith Borcoman12Maria Grazia Ghi13Department of Drug Development and Innovation (D3i) Institut Curie Paris FranceDepartment of Oncology Azienda Ospedaliera Brotzu Cagliari ItalyDepartment of Oncology Azienda Ospedaliera Brotzu Cagliari ItalyDepartment of Oncology and Hematology Università degli Studi di Modena e Reggio Emilia Modena ItalyOncology Unit Ospedale, Vito Fazzi Lecce ItalyRadiation Oncology Azienda Ospedaliero‐Universitaria Careggi Florence ItalyAORN dei Colli Monaldi Hospital Naples ItalyAORN dei Colli Monaldi Hospital Naples ItalyGlobal Medical Unit Oncology Merck Healthcare KGaA Darmstadt GermanyGlobal Medical Unit Oncology Merck Healthcare KGaA Darmstadt GermanyStatistics Prometris GmbH Mannheim GermanyService of Pneumo‐Oncology Azienda Ospedaliero‐Universitaria Pisana Pisa ItalyDepartment of Drug Development and Innovation (D3i) Institut Curie Paris FranceOncology Unit 2 Istituto Oncologico Veneto–IRCCS Padova ItalyAbstract 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.https://doi.org/10.1002/cnr2.1804cetuximabcombination chemotherapyfirst‐lineobservational studysquamous cell carcinoma of head and neck |
| spellingShingle | 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 First‐line cetuximab + platinum‐based therapy for recurrent/metastatic head and neck squamous cell carcinoma: A real‐world observational study—ENCORE Cancer Reports cetuximab combination chemotherapy first‐line observational study squamous cell carcinoma of head and neck |
| title | First‐line cetuximab + platinum‐based therapy for recurrent/metastatic head and neck squamous cell carcinoma: A real‐world observational study—ENCORE |
| title_full | First‐line cetuximab + platinum‐based therapy for recurrent/metastatic head and neck squamous cell carcinoma: A real‐world observational study—ENCORE |
| title_fullStr | First‐line cetuximab + platinum‐based therapy for recurrent/metastatic head and neck squamous cell carcinoma: A real‐world observational study—ENCORE |
| title_full_unstemmed | First‐line cetuximab + platinum‐based therapy for recurrent/metastatic head and neck squamous cell carcinoma: A real‐world observational study—ENCORE |
| title_short | First‐line cetuximab + platinum‐based therapy for recurrent/metastatic head and neck squamous cell carcinoma: A real‐world observational study—ENCORE |
| title_sort | first line cetuximab platinum based therapy for recurrent metastatic head and neck squamous cell carcinoma a real world observational study encore |
| topic | cetuximab combination chemotherapy first‐line observational study squamous cell carcinoma of head and neck |
| url | https://doi.org/10.1002/cnr2.1804 |
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