Continuation of Bevacizumab vs Cetuximab Plus Chemotherapy After First Progression in KRAS Wild-Type Metastatic Colorectal Cancer: The UNICANCER PRODIGE18 Randomized Clinical Trial.
Abstract | Importance: Objective: Design, Setting, and Participants: Interventions: Main Outcomes and Measures: The primary end point was the 4-month PFS rate. Secondary end points included safety, objective response rate, overall survival, and PFS. Results: A total of 132 patients (47 women and 85 men; median age, 63.0 years [range, 33.0-84.0 years]; 74 patients with an Eastern Cooperative Oncology Group performance status of 0, 54 patients with a performance status of 1, and 4 patients with unknown performance status) were included at 25 sites. The 4-month PFS rate was 80.3% (95% CI, 68.0%-88.3%) in arm A and 66.7% (95% CI, 53.6%-76.8%) in arm B. The median PFS was 7.1 months (95% CI, 5.7-8.2 months) in arm A and 5.6 months (95% CI, 4.2-6.5 months) in arm B (hazard ratio, 0.71; 95% CI, 0.50-1.02; P = .06), and the median overall survival was 15.8 months (95% CI, 9.5-22.3 months) in arm A and 10.4 months (95% CI, 7.0-16.2 months) in arm B (hazard ratio, 0.69; 95% CI, 0.46-1.04; P = .08). A central analysis of KRAS (exons 2, 3, and 4), NRAS (exons 2, 3, and 4), and BRAF (V600) was performed for 95 tumor samples. Eighty-one patients had wild-type KRAS and wild-type NRAS tumors. Conclusions and Relevance: Trial Registration: ClinicalTrials.gov identifier: NCT01442649 and clinicaltrialsregister.eu identifier: EUDRACT 2009-012942-22.
|
Authors | Jaafar Bennouna, Sandrine Hiret, Aurelie Bertaut, Olivier Bouché, Gael Deplanque, Christian Borel, Eric François, Thierry Conroy, François Ghiringhelli, Gaëtan des Guetz, Jean-François Seitz, Pascal Artru, Mohamed Hebbar, Trevor Stanbury, Marc G Denis, Antoine Adenis, Christophe Borg |
Journal | JAMA oncology
(JAMA Oncol)
Vol. 5
Issue 1
Pg. 83-90
(01 01 2019)
ISSN: 2374-2445 [Electronic] United States |
PMID | 30422156
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Biomarkers, Tumor
- KRAS protein, human
- Oxaliplatin
- Bevacizumab
- Irinotecan
- Proto-Oncogene Proteins p21(ras)
- Cetuximab
- Leucovorin
- Fluorouracil
|
Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Bevacizumab
(administration & dosage, adverse effects)
- Biomarkers, Tumor
(genetics)
- Cetuximab
(administration & dosage, adverse effects)
- Colorectal Neoplasms
(drug therapy, genetics, mortality, pathology)
- Disease Progression
- Female
- Fluorouracil
(administration & dosage)
- Humans
- Irinotecan
(administration & dosage)
- Leucovorin
(administration & dosage)
- Male
- Middle Aged
- Neoplasm Metastasis
- Oxaliplatin
(administration & dosage)
- Progression-Free Survival
- Prospective Studies
- Proto-Oncogene Proteins p21(ras)
(genetics)
- Time Factors
|
|
Join CureHunter, for free Research Interface BASIC access!
Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease.
Find out why thousands of doctors, pharma researchers and patient activists
around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!
|