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Encorafenib in Combination With Cetuximab After Systemic Therapy in Patients With BRAFV600E Mutant Metastatic Colorectal Cancer: German Health Technology Assessment-Driven Analyses From the BEACON CRC Study.
Stintzing, Sebastian; Seufferlein, Thomas; Rosé, Christian; Reichenbach, Frank; Lüftner, Diana.
Afiliación
  • Stintzing S; Charité - Universitaetsmedizin Berlin, Dept. of Hematology, Oncology and Cancer Immunology (CCM), Berlin, Germany. Electronic address: sebastian.stintzing@charite.de.
  • Seufferlein T; Ulm University Medical Center, Internal Medicine I, Ulm, Germany.
  • Rosé C; Pierre Fabre Pharma GmbH, Freiburg, Germany.
  • Reichenbach F; Pierre Fabre Pharma GmbH, Freiburg, Germany.
  • Lüftner D; Charité - Universitaetsmedizin Berlin, Dept. of Hematology, Oncology and Cancer Immunology (CBF), Berlin, Germany.
Clin Colorectal Cancer ; 21(3): 244-251, 2022 09.
Article en En | MEDLINE | ID: mdl-35654691
BACKGROUND: Purpose of this analysis was to report data of the BEACON CRC trial used in the German Health Technology Assessment (HTA) and previously unpublished data focusing on the dual blockade (encorafenib + cetuximab) and appropriate comparative therapy (ACT/control: cetuximab + irinotecan-based chemotherapy) of patients with BRAFV600E-mutant mCRC. MATERIALS AND METHODS: Analyses included overall survival (OS) and time-to-event analyses of morbidity and safety. RESULTS: A total of 220 patients received encorafenib + cetuximab and 221 patients ACT/control. Median OS was 9.3 (encorafenib + cetuximab) versus 5.9 months (ACT/control) (stratified hazard ratio (HRstrat): 0.61 [95% confidence interval: 0.48-0.77]). Time-to-response (TTR) showed a statistically significant advantage for encorafenib + cetuximab compared to ACT/control (HRstrat [95% CI]: 10.46 [3.75; 29.15]; P < .0001). Median progression-free survival 2, ie, PFS after initiation of subsequent treatment after completion of study treatment, was 8.3 (dual blockade) versus 5.3 months (ACT/control), representing a statistically significant benefit for the dual blockade (HRstrat [95% CI]: 0.62 [0.48; 0.78]; P < .0001). The statistically significant advantage for diarrhea (EORTC QLQ-C30) reached clinical relevance (LS-mean [95% CI]; P-value / Hedges'g [95% CI]: -12.61 [-17.75; -7.47]; P < .0001 / -0.53 [-0.74; -0.31]). The time-to-event analyses showed a statistically significant benefit for the dual blockade for serious adverse events (AE), severe AEs and AEs leading to discontinuation. CONCLUSION: In the HTA, the German G-BA granted a "hint for a considerable additional benefit" of encorafenib + cetuximab compared to the ACT in BRAFV600E-mutant mCRC patients. This treatment is considered the new standard of care for these patients.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias del Recto / Neoplasias Colorrectales / Neoplasias del Colon Tipo de estudio: Health_technology_assessment Límite: Humans Idioma: En Revista: Clin Colorectal Cancer Asunto de la revista: GASTROENTEROLOGIA / NEOPLASIAS Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias del Recto / Neoplasias Colorrectales / Neoplasias del Colon Tipo de estudio: Health_technology_assessment Límite: Humans Idioma: En Revista: Clin Colorectal Cancer Asunto de la revista: GASTROENTEROLOGIA / NEOPLASIAS Año: 2022 Tipo del documento: Article Pais de publicación: Estados Unidos