Colon Adenocarcinoma
Conditions
Keywords
metastatic colorectal adenocarcinom, low doses, chemotherapy, monoclonal antibodies
Brief summary
In this retrospective observational study, the case series of patients undergoing first-line treatment for metastatic colorectal adenocarcinoma with doublet fixed-dose and reduced-dose chemotherapy in combination with full-dose monoclonal antibody in patients aged 70 years or older is collected.
Detailed description
Treatment in the elderly first-line patient of metastatic colorectal cancer is often conditioned by the age and general condition of the patient. Such treatment involves the combination of chemotherapy and biological therapy targeted on the basis of the site and genetic mutations of the colorectal tumour, in particular RAS and BRAF. With regard to targeted biologic therapy, the choice of monoclonal antibody is determined by tumour site and mutations. In particular, for right-sided and/or RAS/BRAF mutated tumours anti-VEGF therapy with Bevacizumab is the best option, whereas for left-sided and RAS/BRAF WT tumours monoclonal antibodies Panitumunab or Cetuximab are the choice. In the elderly patient, the intensity of chemotherapy to be combined with targeted biologic therapy varies according to the patient's age, general condition and treatment goals. In particular for patients aged 70 years or older, a valid option is the combination of monochemotherapy with fluorodrugs in combination with bevacizumab. In addition, an Italian randomised trial tested monochemotherapy with 5-Fluorouracil in combination with Panitumumab in RAS WT/BRAF WT tumours and obtained the same efficacy as a doublet of chemotherapy with FOLFOX also in combination with Panitumumab. Full-dose doublet chemotherapy is hardly feasible in the elderly patient because of the frailty of these patients and the high risk of toxicity. In this retrospective observational study, we report on the case series of patients undergoing first-line treatment for metastatic colorectal adenocarcinoma with doublet of fixed-dose and reduced-dose chemotherapy in combination with full-dose monoclonal antibody in patients 70 years of age and older.
Interventions
None listed
Sponsors
Matteo Clavarezza
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with metastatic colorectal adenocarcinoma not treated with any therapy in the metastatic phase. Previous (neo)-adjuvant treatment with fluoroderivatives with or without Oxaliplatin is permitted. 2. Age ≥ 70 years 3. G8 score ≥ 12 4. Patients with colorectal adenocarcinoma MSS 5. Patients with BRAF WT colorectal adenocarcinoma 6. Ability to understand and sign the informed consent form.
Exclusion criteria
1. Patients with MSI tumours 2. Patients with BRAF V600E mutated tumours 3. Patients not eligible for doublet chemotherapy by clinical decision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neutropenia incidence | 24 months | overall incidence of grade 4 neutropenia or febrile neutropenia of less than 8% |
| Diarrehea incidence | 24 months | incidence of grade 3-4 diarrhea of less than 8%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 24 months | Progression Free Survival (PFS), i.e. the time from day 1 of cycle 1 of treatment to the date of progression or death, whichever occurs first |
| OS | 24 months | Overall Survival (OS), which is the time between the date of cycle day 1 of treatment and death |
| differences in toxicity of anti-VEGF monoclonal antibodies | 24 months | Assess toxicity between in ANTI-VEGF monoclonal antibodies |
| differences in toxicity of anti-EGFR monoclonal antibodies | 24 months | Assess toxicity between in ANTI-EGFR monoclonal antibodies |
Countries
Italy
Contacts
CONTACTMatteo Clavarezza
CONTACTDavide S Corradengo
PRINCIPAL_INVESTIGATORMatteo Clavarezza
E.O. Ospedali Galliera
Outcome results
None listed