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Impact of second-line cetuximab-containing therapy in patients with KRAS wild-type metastatic colorectal cancer: Results from the ITACa randomized clinical trial
- Source :
- Scientific Reports, Scientific Reports, Vol 7, Iss 1, Pp 1-8 (2017)
- Publication Year :
- 2017
-
Abstract
- The ITACa trial was designed to define the role of cetuximab (Cet) and bevacizumab (Bev) in combination with standard chemotherapy (CT, FOLFIRI or FOLFOX4) as first- and second-line treatment in metastatic colorectal cancer. All patients with WT KRAS tumors who had been enrolled in the first-line trial were randomized onto two independent second-line trials: CT or CT + Cet (study 2A) and CT + Bev or CT + Bev + Cet (study 2B). Patients with mutated KRAS were not eligible for randomization and were treated with CT alone (study 2A) or CT + Bev (study 2B). The primary endpoint was progression-free survival (PFS). 48 and 56 KRAS WT patients were randomized while 31 and 40 KRAS mutated patients were treated without randomization. Study 2A: median PFS was 3.4 (95%CI 2.3–4.6) and 6.2 (95%CI 4.3–7.8) months for the CT and CT + Cet arms, respectively, with a hazard ratio (HR) = 0.64 (95%CI 0.35–1.16, p = 0.144). Study 2B: median PFS was 7.7 (95%CI 4.1–10.1) and 4.9 (95%CI 3.2–7.0) months for CT + Bev and CT + Cet + Bev arms, respectively, with a HR = 1.31 (95%CI 0.76–2.26, p = 0.330). Notwithstanding limitations due to the small sample size, among patients with WT KRAS the addition of Cet to second-line CT increased PFS, whereas the addition of Cet to CT + Bev was associated with worse PFS.
- Subjects :
- Oncology
Male
medicine.medical_specialty
Bevacizumab
Colorectal cancer
lcsh:Medicine
Cetuximab
Kaplan-Meier Estimate
medicine.disease_cause
Article
law.invention
Proto-Oncogene Proteins p21(ras)
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Clinical endpoint
Humans
030212 general & internal medicine
Neoplasm Metastasis
lcsh:Science
Aged
Neoplasm Staging
Aged, 80 and over
Multidisciplinary
business.industry
lcsh:R
Hazard ratio
Middle Aged
medicine.disease
Surgery
Treatment Outcome
030220 oncology & carcinogenesis
Retreatment
FOLFIRI
lcsh:Q
Female
KRAS
business
Colorectal Neoplasms
medicine.drug
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Scientific Reports, Scientific Reports, Vol 7, Iss 1, Pp 1-8 (2017)
- Accession number :
- edsair.doi.dedup.....73ce8d5d4abf2d695ee0ca92d42c4fd5