Cetuximab-based therapy in elderly comorbid patients with metastatic colorectal cancer
Menée sur 657 patients atteints d'un cancer colorectal métastatique, cette étude évalue l'efficacité et la toxicité du cetuximab selon l'âge des patients (plus ou moins de 65 ans)
Background: Clinical trials under-represent patients (pts) >65 years. Non-interventional studies (NISs) help to evaluate therapies in daily practice. This NIS evaluates efficacy and safety of cetuximab in combination with chemotherapy in metastatic colorectal cancer (mCRC) pts aged >65 years vs less than or equal to65 years. Methods: A total of 657 pts were recruited into the NIS and analysed applying descriptive statistics and
χ2 or Fisher's exact test. Results:
A total of 309 and 305 pts aged less than or equal to65 and >65 years, respectively, were documented; 80% showing a reduced ECOG status of 1
–2 and 95% having received at least one palliative treatment. Cetuximab was combined with irinotecan according to approval status. Grade III/IV toxicities occurred in 20% of pts without any difference between age groups although the older pts had significantly more pre-existing comorbidities (P=0.001). A total of 64.2% of the pts developed skin rash, which was strongly related to response (P<0.0002) without any difference between age groups (P=0.34). The objective response rates were 37.9% for ages 18–65 years vs 35.4% for >65 years. Progression-free survival (PFS) did not differ between pts 18–65 years old (6.5 months) in comparison with pts >65 years (7.0 months). In a multivariate analysis only ECOG status had a negative impact on PFS (HR: 0,675; 95% Cl, 0.53–0.87; P=0.0019). Conclusion: This NIS reports one of the largest mCRC collectives >65 years and reduced performance status. Cetuximab has a similar efficacy and safety profile for pts aged less than or equal to65 and >65 years.