Cetuximab-based therapy in elderly comorbid patients with metastatic colorectal cancer

Abstract

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 ⩽65 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 ⩽65 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 ⩽65 and >65 years.

Applications of Nanoparticles for Anticancer Drug Delivery: A Review

“…The lower nephrotoxicity of lipoplatin, compared to cisplatin, was shown in rodent animals. 146 In a randomized clinical trial comparing lipoplatin combined with 5-fluorouracil versus cisplatin combined with 5-fluorouracil in patients with squamous cell carcinoma of the head and neck, Grade 3 renal toxicity was much lower after lipoplatin administration than after cisplatin treatment. Higher rates of myelotoxicity, mucositis and peripheral neuropathy were observed in the cisplatin arm than in the lipoplatin arm.…”

First-line single-agent panitumumab in frail elderly patients with wild-type KRAS metastatic colorectal cancer and poor prognostic factors: A phase II study of the Spanish Cooperative Group for the Treatment of Digestive Tumours

“…However, new targeted biological therapies and, specifically, epidermal growth factor receptor (EGFR)-inhibiting monoclonal antibodies, have fewer systemic toxic effects and potentially could be suitable in frail patients [9][10][11]26]. Panitumumab has demonstrated efficacy and a manageable safety profile as a monotherapy [27][28][29] and in combination with chemotherapy (as first [30]-or second-line [31] therapy), for the treatment of mCRC in patients with wild-type (WT) KRAS (exon 2) tumours.…”

“…The treatment of these patients has been controversial over the last years. Despite the traditional underrepresentation of patients aged >65 years in clinical trials [3,4], several studies have recently addressed the efficacy of chemotherapy and biological agents in the 'non-frail' elderly population with metastatic CRC (mCRC) [5][6][7][8][9][10][11][12][13][14][15][16][17][18]. A pivotal trial in elderly and/or frail mCRC patients demonstrated that single-agent fluoropyrimidines were not inferior in terms of treatment outcomes and resulted in better quality of life than a combination chemotherapy including oxaliplatin [19].…”

Patterns of Use and Tolerance of Anti–Epidermal Growth Factor Receptor Antibodies in Older Adults With Metastatic Colorectal Cancer

“…The largest cohort of older patients treated with anti-EGFR antibodies was reported in an observational study from Germany evaluating the efficacy and safety of these agents among 300 patients over the age of 65 compared to their younger counterparts. The study demonstrated similar toxicity and efficacy with the combination of cetuximab and irinotecan in older and younger patient cohorts 11 . The Spanish Group for Digestive Tumors Therapy (TTD) studied cetuximab as a single agent and in combination with irinotecan or capecitabine in the older population and demonstrated a similar toxicity profile to that seen among younger patients 12–14 .…”